chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Inappropriate schedule of product administration
Clinical narrative: Second dose administered 2 weeks after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Second dose administered 2 weeks after first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Context: This consumer is the patient who reported after having been administered both doses of the Pfizer-BioNTech COVID-19 Vaccine he had a blood test performed that showed he has no COVID-19 antibodies. His second dose was administered 2 weeks after first dose of Pfizer-BioNTech COVID-19 Vaccine. First dose administered on 19Jan2021. Second dose administered on 02Feb2021. He asked for information on having no COVID-19 antibodies after having been administered both doses of Pfizer-BioNTech COVID-19 Vaccine; if there is any recommendations on what he should do regarding this test result.  Additional Lot/NDC/Expiry: Not provided, caller unwilling to complete report. PC filed. Caller was unwilling to complete report, further details for report and vaccine supplemental form not provided. Is there a Product Complaint: Yes  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little soreness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Mar2021 10:10 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Verbatim: ADHD, related to amphetamines that patient takes for ADHD; "Hypertension" (unspecified if ongoing), notes: related to amphetamines that patient takes for ADHD, they really raise his blood pressure; "Asthma" (unspecified if ongoing), notes: diagnosed patient's whole life; patient had reactive airway as an infant; "Obesity" (unspecified if ongoing), notes: had for the last few years; "Smoker" (unspecified if ongoing), notes: Verbatim: Smoker. The patient's concomitant medications were not reported. Past drug history included: Tetanus for immunization, reaction(s): "whole thigh was erythematous"; Diphtheria for immunization, reaction(s): "whole thigh was erythematous". The following information was reported: PAIN (non-serious), outcome "unknown", described as "a little soreness".  Additional Information: Consumer also mentioned that when her son received his first dose of the vaccine, he reported a little soreness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Jaw disorder
Clinical narrative: Jaw problem; Jaw infection/ Infection has worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (Lot number: ER2613) at the age of 64 years as dose 1, single and administration date 12Apr2021 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Jaw problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: JAW DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Jaw problem"; INFECTION (non-serious) with onset 2021, outcome "unknown", described as "Jaw infection/ Infection has worsened". Therapeutic measures were taken as a result of jaw disorder, infection.  Additional information: Consumer asked if there was any interaction or negative impact on the efficacy of the vaccine if he takes Amoxicillin close to when he got the second vaccine dose. Caller reported that he received his first vaccine dose on 22Mar2021 (Lot- ER2613) and afterward began having a "jaw problem" for which he has been prescribed Amoxicillin. He reports that he knew he was about to get his second vaccine dose on 12Apr2021 (lot er8731) and so he held off on taking the Amoxicillin for fear there may be an interaction between the antibiotic and the vaccine. He reports that he has had this "jaw problem" before but after his first dose it came back, and so he was prescribe Amoxicillin which he reported that they knew that takes care of it. Caller reported that he spoke with his doctor who advised him to take the antibiotic and there shouldn't be a problem or interaction. Caller called for additional guidance and clarification on if there was an interaction or if the antibiotic could have a negative impact on the efficacy of the vaccine. Caller completed the Pfizer vaccination series and asked if he can take antibiotics (Amoxicillin) for his jaw infection. Patient said that his infection has worsened. Patient had his second dose last 12th of April. Patient also asked if it will affect the efficacy of the vaccine upon taking the antibiotics (Amoxicillin).  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Grade 1 severity soreness in arm where vaccination was administered.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Apr2021 15:30 (Lot number: EP6955) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Apr2021 07:00, outcome "not recovered", described as "Grade 1 severity soreness in arm where vaccination was administered.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Adverse event reported grade 1 severity soreness in arm where vaccination was administered. Onset 1 day after administration. Date of first awareness is 13Apr2021. No prior to vaccination, was the patient diagnosed with COVID-19. Patient tested and result is negative other medical history reported as none. No known allergies. Vaccine Facility information, Ethnicity, Race information available.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 13:15 (Lot number: ER8733) at the age of 31 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Moderate Obesity" (unspecified if ongoing), notes: verbatim: Moderate Obesity; "Metabolic Syndrome" (unspecified if ongoing), notes: verbatim: Metabolic Syndrome. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 29Mar2021 13:15, outcome "recovered" and all described as "Moderately sore arm. Was difficult to lift hand above eye level for about first 2 to 18 hours after inoculation. Driving with both hands on the steering wheel the morning after was challenging". Therapeutic measures were not taken as a result of pain in extremity, loss of personal independence in daily activities. Additional information: It was reported that, Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He had not received other medications within 2 weeks of vaccination. Since the vaccination, he was not tested for COVID-19. Prior to vaccination, he was not diagnosed with COVID-19. Allergies to medications, food, or other products reported as none. No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: chills; headache; exhausted; sore at injection site and left underarm; sore at injection site and left underarm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 17:45 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "penicillin" (unspecified if ongoing), notes: known allergies: allergic to penicillin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (administration date=24Mar2021,, administration_time=05:45 PM,, vaccine_location=Left arm,, dose 1), administration date: 24Mar2021, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 13Apr2021 09:00, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 13Apr2021 09:00, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 13Apr2021 09:00, outcome "recovering", described as "exhausted"; VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 13Apr2021 09:00, outcome "recovering" and all described as "sore at injection site and left underarm". Therapeutic measures were not taken as a result of chills, headache, fatigue, vaccination site pain, axillary pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Treatment was not received for the adverse event. Patient did not receive any other vaccine within four weeks. Patient did not receive any other medications in two weeks. Patient was not tested for covid post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: stayed in bed the whole weekend; diarrhea; stated not feeling well; headaches; extreme fatigue; can not get enough sleep; she experiences chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 29Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "stayed in bed the whole weekend"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "stated not feeling well"; HEADACHE (non-serious), outcome "not recovered", described as "headaches"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; INSOMNIA (non-serious), outcome "unknown", described as "can not get enough sleep"; CHILLS (non-serious), outcome "unknown", described as "she experiences chills".  Additional information: Patient stated that she had the first dose of the pfizer covid 19 vaccine on 29Jan2021 and the second dose on 5Mar2021. Patient stated that she was still having the same problems since the first dose of the vaccine. Patient stated that she got the vaccine on a Friday and stayed in bed the whole weekend , had diarrhea and stated not feeling well. Patient stated she told them when she was sitting there that she was having headaches and extreme fatigue. Patient stated she told them it might be the lighting in there. Patient stated she was still suffering headaches and was so fatigued. Patient stated that she was at her breaking point and can not get enough sleep. Patient stated that she got twinges of headaches and sometimes they last and sometimes they go away. Patient stated that the twinges are constant all day and never stop. Patient stated she can not get rid of the headache or fatigue. Patient stated that she experienced chills here and there. Patient stated that it all together felt like she was coming down with something. Caller stated she does not know what to do.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise
Clinical narrative: stayed in bed the whole weekend; diarrhea; stated not feeling well; headaches; extreme fatigue; can not get enough sleep; she experiences chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 29Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "stayed in bed the whole weekend"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "stated not feeling well"; HEADACHE (non-serious), outcome "not recovered", described as "headaches"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; INSOMNIA (non-serious), outcome "unknown", described as "can not get enough sleep"; CHILLS (non-serious), outcome "unknown", described as "she experiences chills".  Additional information: Patient stated that she had the first dose of the pfizer covid 19 vaccine on 29Jan2021 and the second dose on 5Mar2021. Patient stated that she was still having the same problems since the first dose of the vaccine. Patient stated that she got the vaccine on a Friday and stayed in bed the whole weekend , had diarrhea and stated not feeling well. Patient stated she told them when she was sitting there that she was having headaches and extreme fatigue. Patient stated she told them it might be the lighting in there. Patient stated she was still suffering headaches and was so fatigued. Patient stated that she was at her breaking point and can not get enough sleep. Patient stated that she got twinges of headaches and sometimes they last and sometimes they go away. Patient stated that the twinges are constant all day and never stop. Patient stated she can not get rid of the headache or fatigue. Patient stated that she experienced chills here and there. Patient stated that it all together felt like she was coming down with something. Caller stated she does not know what to do.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node on right side by collarbone became hard, painful, and swollen on March 22nd, ten days after my initial vaccination.; Lymph node on right side by collarbone became hard, painful, and swollen on March 22nd, ten days after my initial vaccination.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 (Lot number: ER8737) as dose 2, single and administered in arm right, administration date 14Mar2021 10:45 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD, combined type" (unspecified if ongoing), notes: ADHD, combined type; "Ehlers-Danlos syndrome" (unspecified if ongoing), notes: hypermobile Ehler's Danlos; "Asthma" (unspecified if ongoing), notes: Moderate to severe asthma. Concomitant medication(s) included: MONTELUKAST; ADDERALL; DULERA. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 22Mar2021, outcome "not recovered" and all described as "Lymph node on right side by collarbone became hard, painful, and swollen on March 22nd, ten days after my initial vaccination.". The event "lymph node on right side by collarbone became hard, painful, and swollen on march 22nd, ten days after my initial vaccination." and "lymph node on right side by collarbone became hard, painful, and swollen on march 22nd, ten days after my initial vaccination." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient had no known allergies. 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 did not receive any other vaccines within four weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Vital signs measurement
Clinical narrative: Fell; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 87 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Apr2021 11:50 (Lot number: EP7533) at the age of 87 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (ongoing); "COPD" (ongoing); "Diabetes" (unspecified if ongoing); "Heart attack", start date: Feb2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single (NDC number of Covid-19 vaccine: 59267-1000-01, lot number: EL3302, Expiry Date: Jul2021, right arm), administration date: 27Jan2021, when the patient was 87 years old, for COVID-19 Immunisation, reaction(s): "Sore arm", "Heart attack". The following information was reported: FALL (non-serious) with onset 13Apr2021, outcome "unknown", described as "Fell". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccination facility type was pharmacy and not military facility. The patient was not overweight and probably 5'8 inch or 5'9 inch. The reporter guessed the patient was around 160 pounds. No family medical History Relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular extrasystoles
Clinical narrative: Chronic Sinus Rhythm with Supraventricular Ectopy continues to persist to date; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8734) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Neuropathy" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "DCIS stage 0" (unspecified if ongoing). Concomitant medication(s) included: TETANUS DIPHTHERIA, start date: 20Mar2021; CYMBALTA; BACLOFEN. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EN6207,, lot unknown=False,, administration date=12Mar2021,, administration time=01:00 PM,, vaccine location=Left arm,, dose number=1), administration date: 12Mar2021, when the patient was 52 years old, for COVID-19 immunisation, reaction(s): "Onset of chronic Sinus Rhythm with Supraventricular Ectopy with chest tightness and respiratory difficulty immediatey 5 minutes after the first Covid vaccine dose", "Onset of chronic Sinus Rhythm with Supraventricular Ectopy with chest tightness and respiratory difficulty immediatey 5 minutes after the first Covid vaccine dose", "Onset of chronic Sinus Rhythm with Supraventricular Ectopy with chest tightness and respiratory difficulty immediatey 5 minutes after the first Covid vaccine dose". The following information was reported: SUPRAVENTRICULAR EXTRASYSTOLES (non-serious) with onset Apr2021, outcome "not recovered", described as "Chronic Sinus Rhythm with Supraventricular Ectopy continues to persist to date". The event "chronic sinus rhythm with supraventricular ectopy continues to persist to date" was evaluated at the physician office visit. Therapeutic measures were taken as a result of supraventricular extrasystoles.  No follow-up attempts are possible. No further information is expected.  Additional information: Patient took other vaccine in four weeks. Patient took other medications in two weeks Cymbalta and Baclofen. Ae resulted in [Doctor or other healthcare professional office/clinic visit]. Ae treatment was heart monitor and diagnosis. Treatment was DBT. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination . Patient had no known allergies.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Myalgia
Clinical narrative: muscle aches; bad migraine; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 14:00 (Lot number: ER 2613) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Shrimp" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS; CRANBERRY; DOTERRA BALANCE. Past drug history included: Sesame, reaction(s): "Known allergies: sesame"; Avoid z-pak, reaction(s): "Known allergies: Avoid Z-pak". The following information was reported: MYALGIA (non-serious) with onset 17Mar2021 14:30, outcome "recovering", described as "muscle aches"; MIGRAINE (non-serious) with onset 17Mar2021 14:30, outcome "recovering", described as "bad migraine"; DIZZINESS (non-serious) with onset 17Mar2021 14:30, outcome "recovering", described as "dizziness". Therapeutic measures were not taken as a result of myalgia, migraine, dizziness.  Additional information: Reporter stated that, patient didn't take other vaccine in four weeks. Patient didn't have COVID prior vaccination. Patient didn't test COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, X-ray
Clinical narrative: arm stiffness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 11:30 (Lot number: EP7534, Expiration Date: 21Mar2021) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "COVID-19 during Mar2020", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Apr2021, outcome "not recovered", described as "arm stiffness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of musculoskeletal stiffness.  Additional information: The facility type vaccine was Pharmacy or Drug Store. No other vaccine was given in four weeks. No other medications were given in two weeks. It was unknown whether the patient had COVID prior vaccination. COVID not tested post vaccination. The patient was tested for common allergies and had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Myalgia, Pain
Clinical narrative: experiencing muscle soreness at the injection arm; pain; take Ibuprofen or Tylenol; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 13Apr2021 13:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "experiencing muscle soreness at the injection arm"; PAIN (non-serious), outcome "unknown", described as "pain"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "take Ibuprofen or Tylenol".  Additional information: Reporter mentioned that he was experiencing muscle soreness at the injection arm and was asking if he can take Tylenol or ibuprofen for it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Apr2021, outcome "unknown", described as "have pain on the injection site"; FATIGUE (non-serious) with onset 14Apr2021, outcome "unknown", described as "feeling really tired"; PAIN (non-serious) with onset 14Apr2021, outcome "unknown", described as "body hurts"; CHILLS (non-serious) with onset 14Apr2021, outcome "unknown", described as "chills". Additional information: The patient received the Pfizer Covid 19 vaccine and today (14Apr2021) he woke up feeling really tired, he had pain on the injection site, his body hurts and had chills. He was asking whether these side effects was of vaccine or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 188/119 and 170/120.  Clinical Course: A female animal technician said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine 2 weeks ago, and scheduled to receive the 2nd dose on Thursday. She said she never had a high blood pressure, but ever since she took the 1st dose of the vaccine, her blood pressure rose up to 188/119 and 170/120. She wanted to know what would happen if she does not receive the 2nd dose and if it would be dangerous.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeding disorder, Feeling abnormal, Nausea, Pain
Clinical narrative: not eat anything; extremely nauseas/Nausea was reported as worsened; feeling really bad/ feels like she got hit by a car/head feel like going to explode was reported as worsened; feeling really bad/ feels like she got hit by a car/head feel like going to explode was reported as worsened; body aches/progressively aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: Reporter stated her mother has had this for 30 plus years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Reporter stated her mother had received the first dose with no issues.), for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: NAUSEA (non-serious) with onset 13Apr2021, outcome "unknown", described as "extremely nauseas/Nausea was reported as worsened"; FEELING ABNORMAL (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 13Apr2021, outcome "unknown" and all described as "feeling really bad/ feels like she got hit by a car/head feel like going to explode was reported as worsened"; PAIN (non-serious) with onset 13Apr2021, outcome "unknown", described as "body aches/progressively aches"; FEEDING DISORDER (non-serious), outcome "unknown", described as "not eat anything". Therapeutic measures were not taken as a result of nausea, feeling abnormal, condition aggravated, pain, feeding disorder.  Additional Context: . Reporter stated her mother got the second shot yesterday and has increasingly had feelings of nausea, head feel like it is going to explode, and feels like she got hit by a car because her body aches. Reporter stated the symptoms started yesterday within a few hours of receiving the vaccine. Nausea: Reporter stated she spoke with her mother a little while ago and she can not eat anything because she is so nauseous.  feels like she got hit by a car because her body aches: Reporter stated her mother has a lot of aches that are progressively aches. Reporter stated her dad had to help her mother get out of bed. Treatment: Reporter stated no because she is not sure if she is able to take anything. Time the Vaccination Was Given: Reporter stated her mother received the second dose around 12:00 and the first dose was received sometime in the morning. The patient did not had prior Vaccinations within 4 weeks. The patient had no AE(s) following prior vaccinations. No family medical history relevant to AE.Reporter stated her dad is high risk.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Fatigue; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 29Mar2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 29Mar2021, outcome "unknown", described as "Fatigue"; CHILLS (non-serious) with onset 29Mar2021, outcome "unknown", described as "Chills". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: she had the first dose of the Pfizer covid 19 vaccine on 28Mar2021 and her second dose is due 18Apr2021. Caller stated she will be out of town on 18Apr2021 and the 23rd through the 26th. Caller asked how long she can go before she can get her second dose and it will still be effective. Caller asked if she goes over the 6 weeks she does not need to go back to dose one. Caller reported that she will try to get the second dose 27Apr2021 -2May2021. Caller stated she had side effects the day after the first dose and reported to facility. It was reported that 28Mar2021 was her first dose of the covid vaccine. 29Mar2021 she had headache, fatigue, chills. 18Apr2021 is the second dose. She will be out of town, wondering how long she can go before receiving the second dose without losing efficacy of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy", notes: like I did with my codeine allergy. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller states she had a reaction "like I did with my codeine allergy" to the 1st Pfizer vaccine dose". Additional information: Caller stated she was just speaking to "PRIVATE" regarding side effects. Caller states her 1st dose was 3 weeks ago this coming Saturday, 17Apr2021, and is scheduled to receive the 2nd dose on Saturday, 17Apr2021. Caller states she had a reaction "like I did with my codeine allergy" to the 1st Pfizer vaccine dose. Should I get my 2nd dose? How much protection do I have from taking one dose? No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 08:30 (Lot number: ER8733) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Mar2021, outcome "recovered" (2021), described as "arm pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: No any other vaccine in four weeks. Shot 1 - arm pain - radiation up the back to neck. Last 6 hours. Shot 2 - 12- 48 hours - arm pain, foggy brain, tiredness. 3-7 days - lymph node swelling under left arm. There was no covid prior vaccination. Did not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Received her 1st dose on 27Mar2021 and experienced pain on the arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 17Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Received her 1st dose on 27Mar2021 and experienced pain on the arm.".  Additional information: Reporter was asking when she was allowed to take medicine for headaches such as Ibuprofen, Tylenol or Advil after she receives her 2nd dose on Saturday,17Apr2021. She was inquiring just in case, because she read that vaccine recipients are not allowed to take any Ibuprofen, Tylenol or Advil after dosing. She also mentioned that she received her 1st dose on 27Mar2021 and experienced pain on the arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Nasopharyngitis
Clinical narrative: chills; Cold; she feels sick; Extremely tired; headache; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 11:30 (Lot number: EW0153) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 09Apr2021, outcome "recovering", described as "body aches"; CHILLS (non-serious), outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 09Apr2021, outcome "recovering", described as "Extremely tired"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; ILLNESS (non-serious), outcome "unknown", described as "she feels sick". Therapeutic measures were taken as a result of headache.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: chills; Cold; she feels sick; Extremely tired; headache; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 11:30 (Lot number: EW0153) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 09Apr2021, outcome "recovering", described as "body aches"; CHILLS (non-serious), outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 09Apr2021, outcome "recovering", described as "Extremely tired"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; ILLNESS (non-serious), outcome "unknown", described as "she feels sick". Therapeutic measures were taken as a result of headache.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal disorder, Epinephrine increased
Clinical narrative: I am having adrenal surges or adrenaline surges when I'm not doing anything I had one last night 13Apr2021 in the evening while I was sitting watching TV.  I'm having one now; I am having adrenal surges or adrenaline surges when I'm not doing anything I had one last night 13Apr2021 in the evening while I was sitting watching TV.  I'm having one now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 08:15 (Lot number: Ew0164) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: EPINEPHRINE INCREASED (non-serious), ADRENAL DISORDER (non-serious) all with onset 13Apr2021, outcome "unknown" and all described as "I am having adrenal surges or adrenaline surges when I'm not doing anything I had one last night 13Apr2021 in the evening while I was sitting watching TV.  I'm having one now". Therapeutic measures were not taken as a result of epinephrine increased, adrenal disorder.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not receive any medication in two weeks. The patient had not covid prior vaccination and she had not been covid tested post vaccination. She had no known allergies. Patient reported that she was having adrenal surges or adrenaline surges when she was not doing anything, she had one last night on 13Apr2021 in the evening while she was sitting watching TV. She was having one now and the patient was in esthetician working in a spa environment which was very relaxing.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Muscle spasms, Muscle twitching, Nausea, Pain
Clinical narrative: Twitches; not been sleeping or eating right; not been sleeping or eating right; nauseous from pain; his left calf has like a knot in it and it hurts/nauseous from pain / he is hurting; cramp on my left calf; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021424408 (pfizer).  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 (Lot number: ER8729) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "cramp on my left calf"; MUSCLE TWITCHING (non-serious) with onset 13Apr2021, outcome "not recovered", described as "Twitches"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (non-serious), DECREASED APPETI TE (non-serious) all with onset 08Apr2021, outcome "not recovered" and all described as "not been sleeping or eating right"; NAUSEA (non-serious) with onset 08Apr2021, outcome "not recovered", described as "nauseous from pain"; PAIN (non-serious) with onset 08Apr2021, outcome "not recovered", described as "his left calf has like a knot in it and it hurts/nauseous from pain / he is hurting". Therapeutic measures were taken as a result of muscle spasms, pain.  Additional information: patient states that he got the shot on the 05Apr 2021 and by Wednesday  he has had a cramp in the calf of his left leg and it has hurt ever since then. Patient said that he went to bed fine and woke up with it. It has gone on for 7 days now. He states that he doesn't normally get cramps like that. He drinks plenty of water, takes magnesium and has been stretching. He has done everything possible and the cramp is still there. Patient states that nothing seems to work. He wants to know  if it would that be from the shot? He said that nothing seems to work. He states that his left calf has like a knot in it and it hurts. He states that it comes and goes when you rub it and massage it with Bengay or whatever  he has handy. He states that it goes away a little bit while using Bengay but it comes right back. He states that the only thing that kind of helps is a little bit of walking. He also states that he has not been sleeping or eating right since Thursday. He has been nauseous from the pain. He states that these side  effects are still on going and persisting. Patient also added that last night when he was sleeping he was woke up by two big twitches. No Emergency Room/Physician Office visit, no Prior Vaccinations (within 4 weeks). Bengay, patient states he was using Bengay on his cramp and it goes away for a little bit but then it comes right back. Lot number not queried.   No follow-up attempts are possible. No further information is expected.