chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable other health care professional (patient). A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot number: EN6198) administered on left arm on 23Feb2021 13:30 via unspecified route of administration as a 1st dose, single dose for Covid-19 immunisation at a pharmacy or drug store. Medical history included Pre diabetic. Concomitant medication included Lisinopril (MANUFACTURER UNKNOWN), Fluoxetine (MANUFACTURER UNKNOWN), Levothyroxine (MANUFACTURER UNKNOWN), Lovastatin (MANUFACTURER UNKNOWN). Patient had no allergies of food, medicines and other medicinal products. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. On 23Feb2021 18:30, the patient experienced left upper arm soreness. About 5 hours after injection, her upper arm got very sore. She could not put pressure on it trying to lay down on left side as very sore. Felt as though someone slugged her as hard as they could. Was pretty much gone by am. No treatment was received for the adverse event. The clinical outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Palpitations
Clinical narrative: heart palpitations; flu like effects; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received first dose of BNT162B2 (BNT162B2) (Lot/batch no: unknown Not available/provided to reporter at the time of report completion) via an unspecified route of administration in the left arm on 13Mar2021 at 08:30 as 1st dose single for COVID-19 vaccination. Medical history included probable a fib but no episode since last summer. The patient reported there were allergies to medications, food, or other products; however not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (thyroxine, MANUFACTURER UNKNOWN) used within last two weeks of vaccination for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 10:00 a.m., the patient experienced heart palpitations lasted for three days and flu like side effects. The patient did not receive any treatment for the events. The clinical outcome of heart palpitations was recovered on 16Mar2021 and flu like side effects was recovered in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Skin discolouration, Vaccination site discolouration
Clinical narrative: Toes turned purple; Large purple circle on my arm below the injection site; numbness in my lower left lip which spread to my chin and lower cheek the following day.; numbness in my lower left lip which spread to my chin and lower cheek; This is a spontaneous report from a contactable patient. A 58-year-old non-pregnant female patient received second single dose (Pfizer -BioNTech Covid-19 mRNA Vaccine,) via an unspecified route of administration on the right arm on 24Feb2021 for COVID-19 immunisation. Her medical history included hypothyroidism. She has no allergies to medications, food, or other products. Prior to vaccination, she was not diagnosed with COVID- 19 and has not tested for COVID-19, since the vaccination. Furthermore, she has not received other vaccines within 4 weeks prior to the COVID vaccine. She received concomitant medications within 2 weeks of vaccination were multivitamin, atorvastatin (LIPITOR 20mg) and levothyroxine (SYNTHROID 112 mg). Her past vaccination history included (Pfizer -BioNTech Covid-19 mRNA Vaccine) first single dose via unspecified route administered on right arm on 04Feb2021 for COVID-19 immunisation. On 24Feb2021 (the same day of vaccination), she had large purple circle on her arm below the injection site. On 25Feb2021, the patient toes turned purple but cleared quickly. On an unreported date (9 days post vaccination on an unknown date in 2021), she experienced some numbness in her lower left lip which spread to chin and lower cheek the following day. She felt better after a couple of days but still felt a slight numbness in her lower lip. It was reported that she did not receive any treatment for the events. At the time of the report, she has recovered from toes turned purple and was recovering from numbness in face and lips however the clinical outcome of large purple circle on my arm below the injection site was unknown. No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: Swollen lips; Swollen tongue; Swollen face; Itchy throat; Lightheaded; weak; feeling Sore on right arm; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EN 6204) via an unspecified route of administration in right arm on 12Mar2021 at 08:45 AM (at the age of 27-years) as a single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 12Mar2021, post the vaccination, the patient felt soreness on the right arm. On 13Mar2021 at 12.00 PM, he started to become very weak, and light headed. On 14Mar2021, he woke up and his entire face was swollen including his tongue and his throat was itchy and on 17Mar2021, his lips and tongue were still swollen. Therapeutic measures included treatment with methylprednisolone acetate (DEPO-MEDROL) 40 mg/ml injection. The clinical outcome of the events vaccination site pain, weakness, light headedness, swollen face, swollen tongue, swollen lips, and itchy throat was reported as not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination site pain
Clinical narrative: Swollen lips; Swollen tongue; Swollen face; Itchy throat; Lightheaded; weak; feeling Sore on right arm; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EN 6204) via an unspecified route of administration in right arm on 12Mar2021 at 08:45 AM (at the age of 27-years) as a single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 12Mar2021, post the vaccination, the patient felt soreness on the right arm. On 13Mar2021 at 12.00 PM, he started to become very weak, and light headed. On 14Mar2021, he woke up and his entire face was swollen including his tongue and his throat was itchy and on 17Mar2021, his lips and tongue were still swollen. Therapeutic measures included treatment with methylprednisolone acetate (DEPO-MEDROL) 40 mg/ml injection. The clinical outcome of the events vaccination site pain, weakness, light headedness, swollen face, swollen tongue, swollen lips, and itchy throat was reported as not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site is sore to touch; a red bullseye is on the arm after more than 4 days following second shot; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via unspecified route on the left arm on 12Mar2021 at 11:00 AM as 2nd dose single for COVID-19 immunisation. The patient's medical history included possible atrial fibrillation from an unknown date. There were allergies to medications, food, or other products; however, details were not reported. Concomitant medications included other drugs used within two weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via unspecified route on the left arm on 19Feb2021 as a single dose for Covid-19 Immunisation (at the age of 75 years).The patient received did not receive any other vaccine within 4 weeks prior to the vaccination. The patient had no symptoms associated with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Mar2021 at 21:00, the patient experienced injection site soreness and a red bullseye on the arm in Mar2021 after more than 4 days following second shot. The patient did not receive any treatment for the reported events. The clinical outcome of vaccination site pain and vaccination site erythema were reported as not recovered. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure systolic
Clinical narrative: Blood pressure rose to 250 systolic/Blood pressure has dropped to 85 and has gone a high as 270; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via unspecified route of administration in right arm on 11Jan2021 12:00PM (at the age of 68-year-old) as 1st dose single for COVID-19 immunisation. Medical history included diabetes and Hypertension and were ongoing at the time of report. Patient reported he was not allergic to any medications, food, or other products. Concomitant medications included metformin taken for Diabetes and high blood pressure medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Within 2 days (13Jan2021), patient blood pressure rose to 250 systolic. He went to emergency room. He had been to the emergency room twice since. Blood pressure had dropped to 85 and had gone a high as 270. He was totally controlled before receiving the vaccine. Event lead to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included medications to control blood pressure. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in left arm on 11Feb2021 as a single dose for COVID-19 immunisation. The clinical outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: This case upgrade to serious due to medically significant; patient age calculated as 68 years based on date of birth and event onset date; lab data added separately; Event occurred after first dose of BNT162B2 not second dose; Events considered lead to Emergency Room Visit and physician office visit; event considered as blood pressure fluctuation rather than simply blood pressure increased; patient receive unspecified treatment for event; patient received unspecified concomitant medication for high blood pressure.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Rash macular
Clinical narrative: Tingling and numbness in lips; blotchy rash on neck and chest; Tingling and numbness in lips; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received her first dose of BNT162b2 (Pfizer -BioNTech Covid-19 mRNA VACCINE; lot number: EP7534) via an unspecified route of administration in the left arm on 15Mar2021 at 10:30 (at the age of 68-years-old) for COVID-19 immunization. Medical history included diabetic. The patient had allergy to sulfa based drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 10:45, the patient experienced tingling and numbness in lips, blotchy rash on neck and chest. Therapeutic measures were taken as a result of tingling and numbness in lips, blotchy rash on neck and chest and included treatment with diphenhydramine (BENADRYL) from an unknown date. The clinical outcome of tingling and numbness in lips, blotchy rash on neck and chest were recovered at an unknown date. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number EH9899 and expiration date 01Mar2021), via unspecified route on 08Jan2021 at single dose for covid-19 immunization. Medical history was not reported. The patient was not pregnant. The patient's concomitant medications were not reported. On 18Dec2020 20:00, the patient experienced injection site pain-minor, tiredness-moderate/fatigue, headache-mild to moderate, muscle pain-minor/muscle aches, fever-low grade, nausea-comes and goes, muscle weakness, and weak. The patient recovered from vaccination site pain on 20Dec2020, from headache after two weeks and on unknown date for the other events. On 18Dec2020 the patient experience also chills and injection site redness light pink with outcome of recovering. On 19Dec2020 the patient experienced feeling unwell-mild to moderate with outcome of recovering. The events injection site pain-minor, tiredness-moderate/fatigue, headache-mild to moderate, muscle pain-minor/muscle aches, fever-low grade, nausea-comes and goes, muscle weakness, feeling unwell-mild to moderate and weak were serious due to hospitalization. The patient took ibuprofen for fever and headache. No treatment was received for the other events. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested post vaccination. On unknown date in Jan2021, after receiving the second dose, the patient experienced a mild headache and no other side effects for 1-2 days and then she felt fine. The patient did not received treatment for the adverse event. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Feeling cold, Headache, Malaise, Pain
Clinical narrative: Upon awakening (17 hours after injection), had a headache; As the day progressed, my whole body started to ache as well; intermittant shooting pains in my ears; Arm started to be sore at bed time (about 8-10 hours after injection); Woke up in middle of night (atypical for me) with general feeling of being unwell; do not have a fever but have been feeling colder than normal; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 16Mar2021 at 14:00 (at the age of 39-years-old) as single dose for COVID-19 immunisation. Medical history included kiwi allergy psoriasis, exercise induced asthma and HLAB27 associated anterior uveitis, all from an unknown date and unknown if ongoing. The patient previously took first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in left arm on 23Feb2021 at 14:15 for COVID-19 immunisation and had sore arm. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccine within four weeks of vaccination. Concomitant medication(s) included norethindrone, Vitamin D3, fish oil and multi-vitamin. On 16Mar2021 at 22:00 (8-10 hours after vaccination), patient arm started to be sore at bedtime and woke up in middle of night (which was atypical for patient) with general feeling of being unwell. On 17Mar2021 (17-hours after vaccination), upon awakening patient had a headache and as the day progressed, whole body started to ache as well and experienced intermittent shooting pains in her ears. On an unspecified date, patient not had fever but had been feeling colder than normal. Patient received no treatment for the events. Since the vaccination, patient had not been tested for COVID-19. The outcome of all the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Upon awakening (17 hours after injection), had a headache; As the day progressed, my whole body started to ache as well; intermittant shooting pains in my ears; Arm started to be sore at bed time (about 8-10 hours after injection); Woke up in middle of night (atypical for me) with general feeling of being unwell; do not have a fever but have been feeling colder than normal; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 16Mar2021 at 14:00 (at the age of 39-years-old) as single dose for COVID-19 immunisation. Medical history included kiwi allergy psoriasis, exercise induced asthma and HLAB27 associated anterior uveitis, all from an unknown date and unknown if ongoing. The patient previously took first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in left arm on 23Feb2021 at 14:15 for COVID-19 immunisation and had sore arm. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccine within four weeks of vaccination. Concomitant medication(s) included norethindrone, Vitamin D3, fish oil and multi-vitamin. On 16Mar2021 at 22:00 (8-10 hours after vaccination), patient arm started to be sore at bedtime and woke up in middle of night (which was atypical for patient) with general feeling of being unwell. On 17Mar2021 (17-hours after vaccination), upon awakening patient had a headache and as the day progressed, whole body started to ache as well and experienced intermittent shooting pains in her ears. On an unspecified date, patient not had fever but had been feeling colder than normal. Patient received no treatment for the events. Since the vaccination, patient had not been tested for COVID-19. The outcome of all the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Vaccination site pain
Clinical narrative: Pain on site of upper left arm; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN6208), via an unspecified route of administration in the left arm on 16Mar2021 at 14:00 (at the age of 56-years-old) as a single dose for COVID-19 Immunisation. The patient had a history of allergy to bee sting and methylchloroisothiazolinone and methylisothiazolinone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) and vitamin c (MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any vaccine within 4 weeks prior to the COVID-19 vaccine. On 16Mar2021 at 19:00, the patient had pain on site of upper arm which started a few hours later and still continued the following morning (on 17Mar2021). It was 4/10 in the scale of 0/10. The patient did not receive any treatment for the adverse event. The clinical outcome of pain on site of upper arm was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Very bad muscle aches; Fatigue; headache; Fever of 102; Sweats; Uncontrollable chills; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown, Dose number: 2) via an unspecified route of administration in the left arm on 10Mar2021 at 10:30 AM (age unknown at the time of vaccination) as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient medical history and concomitant medications were not reported. The patient past drug history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown, Dose number: 1) via an unspecified route of administration in the left arm on 17Feb2021 10:30 AM as a single dose for COVID-19 immunization. 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 vaccination. Approximately 10 hours after the second dose on 10Mar2021 patient started having uncontrollable chills and fever of 102. A couple of hours after the chills had subsided, but she started having headache and very bad muscle aches. It continued all night into the morning. Therapeutic measures included Advil for headache and muscle aches. The muscle aches, fatigue and low-grade fever continued for 4 days after the second dose. Patient still continued to struggle with fatigue and started having sweats. The clinical outcome of the events sweating and fatigue was not resolved and for the events muscle ache, headache, fever and chills were resolved on 14Mar2021 (reported as 4 days after second dose). Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Very bad muscle aches; Fatigue; headache; Fever of 102; Sweats; Uncontrollable chills; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown, Dose number: 2) via an unspecified route of administration in the left arm on 10Mar2021 at 10:30 AM (age unknown at the time of vaccination) as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient medical history and concomitant medications were not reported. The patient past drug history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown, Dose number: 1) via an unspecified route of administration in the left arm on 17Feb2021 10:30 AM as a single dose for COVID-19 immunization. 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 vaccination. Approximately 10 hours after the second dose on 10Mar2021 patient started having uncontrollable chills and fever of 102. A couple of hours after the chills had subsided, but she started having headache and very bad muscle aches. It continued all night into the morning. Therapeutic measures included Advil for headache and muscle aches. The muscle aches, fatigue and low-grade fever continued for 4 days after the second dose. Patient still continued to struggle with fatigue and started having sweats. The clinical outcome of the events sweating and fatigue was not resolved and for the events muscle ache, headache, fever and chills were resolved on 14Mar2021 (reported as 4 days after second dose). Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pressure increased, Blood pressure measurement
Clinical narrative: spike in blood pressure; spike in blood sugar; This is a spontaneous report from a contactable/non-contactable Consumer or other non HCP[C.2.r.4 (Reporter Type)].  A [D.2.2a; age]-None[ D.2.2b; age unit]-old Female[D.5; gender] patient received BNT162B2[G.k.2.2; suspect product(s) generic name(s) BNT162B2[G.k.2.3.r.1] 1[dose number .G.k.4.r.13] dose:,None[ G.k.4.r.1a; G.k.4.r.1b], None[route(s) of administration or unspecified route G.k.4.r.10.1], administered in Arm Right[add the anatomical location G.k.4.r.11.x1] on 202103041200[G.k.4.r.4; start dates or unspecified date; and time if provided], EN6203[G.k.4.r.7 batch/lot number [Lot #], Expiration date [EXPIRATIONDATE Expiration Date or indicate if they were not reported], [for vaccine indicate the following information] at the age of vaccination [.D.2.1a]; as dose(s) with unit] single[DRUGDOSEFREQUENCY], for COVID-19 immunisation[G.k.7.r.1;  indication(s). Medical history included [any information regarding past medical history, concurrent conditions, social history, and family history].   Concomitant medication(s) included Suspect[G.k.1 with value of 2: all concomitant medication names] taken for [indication(s) (if provided)] from [start dates] to [stop dates]. The patient previously took [D.8.r.1; past product] for [indication] and experienced [past event]. The patient experienced spike in blood pressure,spike in blood sugar[E.i.1.2; AE(s)] and [indicate the appropriate seriousness criterion at the appropriate point in the description] on 20210306[E.i.4; AE(s) onset date(s)]. The patient underwent lab tests and procedures, which included 20210306[F.r.1 ;any information regarding laboratory tests and procedures]. [He/She] was diagnosed as having [provisional/differential/definitive diagnoses]. The [non-vaccine suspect product(s) only do not add this statement for vaccines products] was/were [action taken] on[date of temporary interruption/withdrawn to be included if applicable]. Therapeutic measures were taken as a result of [AE] and included treatment with [treatment product(s)] from [start date(s) of treatment product(s)] to [stop date(s) of treatment product(s)]. The patient not recovered/not resolved/ongoing[E.i.7: outcome(s) of the event(s)]/died] on [E.i.5; AE(s) stop date(s)].
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: having hives in some part of her body like in the  wrist and knees; This is a spontaneous case received from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer COVID 19 Vaccine, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on 08Mar2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Mar2021, the patient having hives in some part of her body like in the wrist and knees. The patient reported that the hives was occasionally. She mentioned that regarding the condition is it possible to take the second dose and having the same reaction. The outcome of the event was unknown.    Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Underdose
Clinical narrative: tested positive for covid 19 but had no symptoms; they gave him half a dose of his first Pfizer-BioNTech COVID-19 vaccine; This is a spontaneous report from a contactable consumer reported for father. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Caller stated her 64-year-old father was told by the vaccination provider that they gave him half a dose of his first Pfizer-BioNTech COVID-19 vaccine, because he was on blood thinners. She added the next day, which was a Friday, they had to go test for COVID-19 because of her mother who tested positive and he father also tested positive but has no symptoms. She asked do people on blood thinner get half a dose of the vaccine. Caller asked if getting the first dose of the Pfizer-BioNTech COVID-19 vaccine while being infected with COVID-19 would cause an impact on the vaccine. She specified she thought her father might have had COVID-19 the day he got the vaccine. The outcome of the event was unknown. Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the 1st dose of COVID vaccine on 06Mar2021 and started feeling bad that day. On the 10th she lost taste and smell. On 13th she tested positive for COVID-19. Patient believes she might have been infected prior to receiving the vaccine. The event was reported as non-serious. Her 2nd dose was scheduled for 27th and she was wondering if she can take it. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive herself on 27Mar2021; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer-sponsored program.   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 17Mar2021 (Batch/Lot Number: EP7534) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Mar2021, the patient experienced covid 19. She was exposed to a Covid patient on 23Mar2021, became symptomatic on 26Mar2021 which was the day she found out about her friend testing positive and tested positive herself on 27Mar2021. She was scheduled to receive her second dose of the vaccine on 09Apr2021. The patient wanted to know what the recommendations were for receiving the second vaccine if she has tested positive for Covid after receiving the first vaccine. She wanted to know the suggestions about waiting after being positive. She was feeling better today and that she read that on day 12 you may have built up immunity by 52 percent and that was good. She had no issues with the first vaccine. The outcome of the events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Mar2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: i had a mild headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via intramuscular route of administration on 15Mar2021 at 13:00 (at the age of 65-year-old) as 2nd dose, single in upper left arm for COVID-19 immunisation at public health department. The patient's medical history and concomitant medications were not reported. The patient did not receive any other medications prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201) via intramuscular route of administration on 24Feb2021 at 01:00 PM, as single dose in upper left arm for COVID-19 immunisation. On 25mar2021, at 06:00 AM, the patient experienced mild headache. There was no treatment received for the adverse events. Patient did not experienced nausea and fainting. The clinical outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Pruritus, Rash, SARS-CoV-2 test negative, Urticaria
Clinical narrative: 2 days after shot, itchy rash is starting to appear all over body.; Itchy hives all over body; Lip swelling; Itchy hives all over body; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8732, expiration date not reported), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 (age at vaccination 41-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation at workplace clinic. Medical history included Allergies to medications, food: penicillin and shrimp. Patient took concomitant medications within 2 weeks of vaccination included trazodone (TRAZODONE), loratadine (LORATADINE), vitamin d (VITAMIN D NOS) and naproxen sodium (ALEVE) all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number EN6199 and expiration date not reported) via unspecified route of administration on left on 05Mar2021 09:15 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with covid-19. On 04Apr2021 at 06:00 (2 days after shot), the patient experienced itchy rash is starting to appear all over body, Itchy hives all over body and lip swelling. Patient received treatment oral steroids, Benadryl and zyrtec. The events were assessed as non-serious by reporter with no seriousness criteria (Results in death/ life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). The patient underwent lab tests and procedures which included nasal swab negative on 16Apr2021. It was unknown if the patient received treatment for events. Outcome of the events was unknown for rash and not recovered for all other events.  Follow-up attempts are completed. No further information is expected
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Eye swelling, Lip swelling, Pain, Pain in extremity
Clinical narrative: 2 days after shot, itchy rash is starting to appear all over body.; Itchy hives all over body; Lip swelling; Itchy hives all over body; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8732, expiration date not reported), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 (age at vaccination 41-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation at workplace clinic. Medical history included Allergies to medications, food: penicillin and shrimp. Patient took concomitant medications within 2 weeks of vaccination included trazodone (TRAZODONE), loratadine (LORATADINE), vitamin d (VITAMIN D NOS) and naproxen sodium (ALEVE) all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number EN6199 and expiration date not reported) via unspecified route of administration on left on 05Mar2021 09:15 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with covid-19. On 04Apr2021 at 06:00 (2 days after shot), the patient experienced itchy rash is starting to appear all over body, Itchy hives all over body and lip swelling. Patient received treatment oral steroids, Benadryl and zyrtec. The events were assessed as non-serious by reporter with no seriousness criteria (Results in death/ life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). The patient underwent lab tests and procedures which included nasal swab negative on 16Apr2021. It was unknown if the patient received treatment for events. Outcome of the events was unknown for rash and not recovered for all other events.  Follow-up attempts are completed. No further information is expected
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: 2 days after shot, itchy rash is starting to appear all over body.; Itchy hives all over body; Lip swelling; Itchy hives all over body; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8732, expiration date not reported), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 (age at vaccination 41-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation at workplace clinic. Medical history included Allergies to medications, food: penicillin and shrimp. Patient took concomitant medications within 2 weeks of vaccination included trazodone (TRAZODONE), loratadine (LORATADINE), vitamin d (VITAMIN D NOS) and naproxen sodium (ALEVE) all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number EN6199 and expiration date not reported) via unspecified route of administration on left on 05Mar2021 09:15 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with covid-19. On 04Apr2021 at 06:00 (2 days after shot), the patient experienced itchy rash is starting to appear all over body, Itchy hives all over body and lip swelling. Patient received treatment oral steroids, Benadryl and zyrtec. The events were assessed as non-serious by reporter with no seriousness criteria (Results in death/ life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). The patient underwent lab tests and procedures which included nasal swab negative on 16Apr2021. It was unknown if the patient received treatment for events. Outcome of the events was unknown for rash and not recovered for all other events.  Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: she has bronchitis; tested positive of Covid; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Apr2021 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her 1st dose on 04Apr2021. The patient stated that she had bronchitis; and tested positive of Covid last Wednesday, 14Apr2021. The patient wanted to cancel her second dose appointment on 02May2021, and she asked if bronchitis was a reaction to the 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: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: diagnosed with having the Covid; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the first dose of the COVID vaccine on Sunday (date unspecified). On Wednesday (date unspecified), patient started to feel badly. Yesterday, patient was diagnosed with having the COVID.  The reporter wanted to know if this person is safe at all. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: Vision loss in Left eye in addition to the normal side effects listed; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 20Apr2021 09:45 (Lot Number: EW0170) at the age of 30-year-old at a single dose for covid-19 immunisation in hospital. The patient's medical history was not reported. 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 vaccine. The patient previously took amoxicillin and codeine. The patient experienced vision loss in left eye in addition to the normal side effects listed on 20Apr2021 13:00 which result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Lip injury, Rash
Clinical narrative: small painful skin eruptions on my lower right back, back of left leg and left rib cage.; increased dehydration; lips splitting; debilitating fatigue for over 6 days and counting; This is a spontaneous report from a contactable consumer (patient) from RA. This 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0151) via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunisation. Medical history included chronic fatigue syndrome (CFS) from 2011 and unknown if ongoing, myalgic encephalomyelitis (ME) from 2011 and unknown if ongoing, and shingles from an unknown date and unknown if ongoing. The patient reported her CFS/ME was in remission since 2013 but seemed to have reactivated; she also suffered shingles many times. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included citalopram from an unknown date for an unknown indication. The patient previously received penicillin from an unknown date for an unknown indication; and the first dose of BNT162B2 (lot number EN6208) on 17Mar2021 at 11:30 for COVID-19 immunisation. The patient reported after her second shot, she got small painful skin eruptions on her lower right back, back of her left leg and left rib cage. She also reported increased dehydration and lip splitting. She stated that two weeks after the second shot, she experienced debilitating fatigue for over six days and counting. She stated she suffered CFS/ME for a year and a half in 2011; further reporting this felt like a reactivation of that virus in the herpes family. The clinical outcomes of small painful skin eruptions on her lower right back, back of left leg and left rib cage, increased dehydration, and lip splitting were unknown and the outcome of debilitating fatigue for over 6 days and counting was not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Vaccination site erythema
Clinical narrative: chest tightness; redness on my left arm BCG childhood vaccination spot about 5 days after the vaccination; This is a spontaneous report from a contactable consumer (patient). This 37-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0164) via an unspecified route of administration on 13Apr2021 at 12:30 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included dietary supplements, vitamin B, and gummy bear vitamins from unknown dates for unknown indications. The patient previously received Bacillus Calmette-Guerin (BCG)  vaccine on an unknown date. On 18Apr2021 at 08:00, about 5 days after receiving BNT162B2 the patient experienced redness on her left arm  BCG childhood vaccination spot. The patient also experienced chest tightness for about 5 minutes "at breading" and that occurred about 10 days after the first shot (23Apr2021). The patient did not receive any treatment for the events. The outcomes of redness and chest tightness were recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is spontaneous report from a contactable consumer (patient). This 25-year-old non-pregnant female patient received the first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE;) via an unspecified route of administration in the left arm on 23Apr2021 at 13:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, anorexia, anxiety, osteopenia, and sulfa allergy, all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included oxcarbazepine from an unknown date for an unknown indication. The patient reported she experienced a sore throat that started the night she got the vaccine and had persisted for almost a week on 23Apr2021 at 22:30; further reporting she experienced no other symptoms. No treatment was received for the event. The clinical outcome of sore throat was not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.