chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Irregular painful periods very heavy with severe bleeding; Irregular painful periods very heavy with severe bleeding; Irregular painful periods very heavy with severe bleeding; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), administered in arm left, administration date 10Jun2021 13:15 (Lot number: EWO1217) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shellfish allergy" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Dairy allergy" (unspecified if ongoing). Concomitant medications included: hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); cetirzine. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0185, Location: Arm Left, Administration Time: 13:00), administration date: 13May2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION IRREGULAR (non-serious), DYSMENORRHOEA (non-serious) all with onset 01Jul2021, outcome "not recovered" and all described as "Irregular painful periods very heavy with severe bleeding". Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation irregular, dysmenorrhoea.  Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccine in four weeks of vaccination. Events resulted in none of the above.  Follow-Up (30Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Skin discolouration
Clinical narrative: After my booster shot in Oct, I developed two patches on my face; After my booster shot in Oct, I developed two patches on my face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), administration date: 27Feb2021, for COVID-19 Immunization, reaction(s): "Psoriasis", "I had flaking and build up of skin around my ears"; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), administration date: 20Mar2021, for COVID-19 Immunization, reaction(s): "Psoriasis", "I had flaking and build up of skin around my ears".  The following information was reported: IMMUNISATION (non-serious) with onset 21Oct2021, outcome "unknown", SKIN DISCOLOURATION (non-serious) with onset Oct2021, outcome "unknown" and all described as "After my booster shot in Oct, I developed two patches on my face".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Diarrhoea, Gastrointestinal disorder
Clinical narrative: diarrhea; bowel issues; fever runs low; headache; chills; muscles are sore; cough; congestion; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 75-year-old female patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 75 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. Vaccination history included: Covid-19 vaccine (dose 1 , Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (dose 2 , Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "fever runs low"; HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "muscles are sore"; COUGH (non-serious) with onset 18Nov2021, outcome "unknown", described as "cough"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 18Nov2021, outcome "unknown", described as "congestion"; DIARRHOEA (non-serious) with onset 21Nov2021, outcome "unknown", described as "diarrhea"; GASTROINTESTINAL DISORDER (non-serious) with onset 21Nov2021, outcome "unknown", described as "bowel issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache.  Additional information: The patient took Tylenol (paracetamol) for her headache and fever which helps it subside for a while but then it comes back. The patient reported that she took her Enbrel weekly on Wednesdays. The patient had bowel issues but this came out of the blue. The fever runs low grade in the 90s but also get up into the 100s. Patient reported that having the diarrhea today made her pretty nervous and concerned. She may try to get into a walk in clinic to see a doctor. Her Rheumatologist told her that she had a lesser chance of getting COVID since she was on Enbrel. The causal relationship between the events gastrointestinal disorder, chills, respiratory tract congestion, cough, diarrhoea, headache, pyrexia, myalgia and Enbrel, Single Dose Prefilled Syringe was not provided by the consumer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: diarrhea; bowel issues; fever runs low; headache; chills; muscles are sore; cough; congestion; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 75-year-old female patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 75 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. Vaccination history included: Covid-19 vaccine (dose 1 , Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (dose 2 , Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "fever runs low"; HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "muscles are sore"; COUGH (non-serious) with onset 18Nov2021, outcome "unknown", described as "cough"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 18Nov2021, outcome "unknown", described as "congestion"; DIARRHOEA (non-serious) with onset 21Nov2021, outcome "unknown", described as "diarrhea"; GASTROINTESTINAL DISORDER (non-serious) with onset 21Nov2021, outcome "unknown", described as "bowel issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache.  Additional information: The patient took Tylenol (paracetamol) for her headache and fever which helps it subside for a while but then it comes back. The patient reported that she took her Enbrel weekly on Wednesdays. The patient had bowel issues but this came out of the blue. The fever runs low grade in the 90s but also get up into the 100s. Patient reported that having the diarrhea today made her pretty nervous and concerned. She may try to get into a walk in clinic to see a doctor. Her Rheumatologist told her that she had a lesser chance of getting COVID since she was on Enbrel. The causal relationship between the events gastrointestinal disorder, chills, respiratory tract congestion, cough, diarrhoea, headache, pyrexia, myalgia and Enbrel, Single Dose Prefilled Syringe was not provided by the consumer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asphyxia, Cough, Diarrhoea, Dyspnoea
Clinical narrative: Diarrhea; Coughing; Extreme Fatigue; Headache; could not breathe; Stomach was upset; she felt like she was suffocating before; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 15Nov2021 15:46 (Lot number: FF2588) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot EN6200 , left arm in the muscle), administration date: 10Mar2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (2nd dose, Lot EN6204, right arm in the muscle), administration date: 31Mar2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: ASPHYXIA (medically significant) with onset Nov2021, outcome "unknown", described as "she felt like she was suffocating before"; COUGH (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Coughing"; FATIGUE (non-serious) with onset 15Nov2021, outcome "recovering", described as "Extreme Fatigue"; HEADACHE (non-serious) with onset 15Nov2021, outcome "recovering", described as "Headache"; DIARRHOEA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Diarrhea"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "could not breathe"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "Stomach was upset".  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Diarrhea; Coughing; Extreme Fatigue; Headache; could not breathe; Stomach was upset; she felt like she was suffocating before; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 15Nov2021 15:46 (Lot number: FF2588) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot EN6200 , left arm in the muscle), administration date: 10Mar2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (2nd dose, Lot EN6204, right arm in the muscle), administration date: 31Mar2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: ASPHYXIA (medically significant) with onset Nov2021, outcome "unknown", described as "she felt like she was suffocating before"; COUGH (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Coughing"; FATIGUE (non-serious) with onset 15Nov2021, outcome "recovering", described as "Extreme Fatigue"; HEADACHE (non-serious) with onset 15Nov2021, outcome "recovering", described as "Headache"; DIARRHOEA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Diarrhea"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "could not breathe"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "Stomach was upset".  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death, Drug ineffective
Clinical narrative: My son has died from a Pfizer vaccine; I have a dead child in my arms; I have a dead 6 years old in my arms; Vaccine doesn't work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2) (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: DEATH (death, medically significant), outcome "fatal", described as "My son has died from a Pfizer vaccine; I have a dead child in my arms; I have a dead 6 years old in my arms"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Vaccine doesn't work". The patient date of death was unknown. The reported cause of death was "My son has died from a Pfizer vaccine; I have a dead child in my arms; I have a dead 6 years old in my arms". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: My son has died from a Pfizer vaccine; I have a dead child in my arms; I have a dead 6 years old in my arms
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Haemorrhage, Immunisation
Clinical narrative: Along with alot of extra bleeding; my menstrual periods have become more painful and my period was excruciating for a few days; my menstrual periods have become more painful/ booster did the same thing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 12:30 (Lot number: FJ1620) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Torn ACL", start date: 2017 (unspecified if ongoing); "Penicillin" (unspecified if ongoing). If other vaccine in four weeks was no and other medications in two weeks was none. If covid prior vaccination was no and if covid tested post vaccination was no.The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0185, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 18May2021, for COVID-19 immunization, reaction(s): "Ever since I received the second shot, my menstrual periods have become more painful."; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0171, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 27Apr2021, for Covid-19 immunization. The following information was reported: HAEMORRHAGE (medically significant) with onset 19Nov2021 12:00, outcome "recovering", described as "Along with alot of extra bleeding"; IMMUNISATION (medically significant) with onset 18Nov2021 12:30, outcome "recovering", described as "my menstrual periods have become more painful/ booster did the same thing"; DYSMENORRHOEA (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "my menstrual periods have become more painful and my period was excruciating for a few days". Therapeutic measures were not taken as a result of haemorrhage, immunisation, dysmenorrhoea.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Lethargy
Clinical narrative: became very lethargic; developed an intense headache; kept taking deep breaths while holding her chest, saying it felt tight.; having a hard time getting a good breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Nov2021 09:30 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Connective tissue disease" (unspecified if ongoing); "repaired heart VSD/ASD" (unspecified if ongoing); "repaired heart VSD/ASD" (unspecified if ongoing); "Unruptured brain aneurysm" (unspecified if ongoing); "angioid streaks in right eye" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FLUARIX QUADRIVALENT, administration date 10Nov2021. The following information was reported: DYSPNOEA (medically significant) with onset 23Nov2021, outcome "recovered" (Nov2021), described as "having a hard time getting a good breath"; LETHARGY (medically significant) with onset 23Nov2021 10:00, outcome "recovered" (Nov2021), described as "became very lethargic"; HEADACHE (medically significant) with onset 23Nov2021 10:00, outcome "recovered" (Nov2021), described as "developed an intense headache"; CHEST DISCOMFORT (medically significant) with onset 23Nov2021 10:00, outcome "recovered" (Nov2021), described as "kept taking deep breaths while holding her chest, saying it felt tight.". The events "having a hard time getting a good breath", "became very lethargic", "developed an intense headache" and "kept taking deep breaths while holding her chest, saying it felt tight" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dyspnoea, lethargy, headache, chest discomfort and included diphenhydramine hcl (BENADRYL). The clinical course was described as follows: The patient waited the 15 minutes required at the hospital after receiving the COVID vaccine. Then left to go shopping at a store within a close distance and within 10 minutes she was having a hard time getting a good breath. She became very lethargic and developed an intense headache. She kept taking deep breaths while holding her chest, saying it felt tight.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Illness, Pain, Pyrexia
Clinical narrative: High fever; Extreme body ache; I still have chills and feel sick; I still have chills and feel sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: PYREXIA (non-serious), outcome "unknown", described as "High fever"; PAIN (non-serious), outcome "unknown", described as "Extreme body ache"; CHILLS (non-serious), ILLNESS (non-serious), outcome "not recovered" and all described as "I still have chills and feel sick".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Pruritus, Rash, Urticaria
Clinical narrative: Hives/rash; Hives/rash; extreme itching, appearing on different locations of the body.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 14:15 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3, single. Relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, unknown lot number, 04:30 PM, administered on the left arm), administration date: 18Apr2021, when the patient was 61 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, unknown lot number, 04:30 PM, administered on the left arm), administration date: 09May2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 14:15, outcome "unknown", described as "booster"; URTICARIA (non-serious), RASH (non-serious) all with onset 27Nov2021, outcome "unknown" and all described as "Hives/rash"; PRURITUS (non-serious) with onset 27Nov2021, outcome "unknown", described as "extreme itching, appearing on different locations of the body.". Therapeutic measures were taken as a result of urticaria, rash, pruritus. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature abnormal, Cough, Headache, Immunisation
Clinical narrative: off label use; Dose Number 3; painful injection site; severe headache; cough; complete body pain- especially spine; complete body pain- especially spine; upset stomach; COVID like symptoms: temp, severe headache, cough, complete body pain- especially spine, upset stomach, and painful injection site.; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer (patient ) reported for herself that:  A 67 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 27Nov2021 11:15 (Lot number: FG3527) at the age of 67 years as dose 3, (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: En6206, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 22Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 01Mar2021, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "off label use"; IMMUNISATION (non-serious) with onset 27Nov2021 21:00, outcome "recovered", described as "Dose Number 3"; VACCINATION SITE PAIN (non-serious) with onset 27Nov2021 21:00, outcome "recovered" (2021), described as "painful injection site"; HEADACHE (non-serious) with onset 27Nov2021 21:00, outcome "recovered" (2021), described as "severe headache"; COUGH (non-serious) with onset 27Nov2021 21:00, outcome "recovered" (2021), described as "cough"; PAIN (non-serious), SPINAL PAIN (non-serious) all with onset 27Nov2021 21:00, outcome "recovered" (2021) and all described as "complete body pain- especially spine"; ABDOMINAL DISCOMFORT (non-serious) with onset 27Nov2021 21:00, outcome "recovered" (2021), described as "upset stomach"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 27Nov2021 21:00, outcome "recovered" (2021), described as "COVID like symptoms: temp, severe headache, cough, complete body pain- especially spine, upset stomach, and painful injection site.". Therapeutic measures were taken as a result of immunisation, vaccination site pain, headache, cough, pain, spinal pain, abdominal discomfort, body temperature abnormal.  Follow-up (02Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Spinal pain, Vaccination site pain
Clinical narrative: off label use; Dose Number 3; painful injection site; severe headache; cough; complete body pain- especially spine; complete body pain- especially spine; upset stomach; COVID like symptoms: temp, severe headache, cough, complete body pain- especially spine, upset stomach, and painful injection site.; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer (patient ) reported for herself that:  A 67 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 27Nov2021 11:15 (Lot number: FG3527) at the age of 67 years as dose 3, (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: En6206, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 22Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 01Mar2021, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "off label use"; IMMUNISATION (non-serious) with onset 27Nov2021 21:00, outcome "recovered", described as "Dose Number 3"; VACCINATION SITE PAIN (non-serious) with onset 27Nov2021 21:00, outcome "recovered" (2021), described as "painful injection site"; HEADACHE (non-serious) with onset 27Nov2021 21:00, outcome "recovered" (2021), described as "severe headache"; COUGH (non-serious) with onset 27Nov2021 21:00, outcome "recovered" (2021), described as "cough"; PAIN (non-serious), SPINAL PAIN (non-serious) all with onset 27Nov2021 21:00, outcome "recovered" (2021) and all described as "complete body pain- especially spine"; ABDOMINAL DISCOMFORT (non-serious) with onset 27Nov2021 21:00, outcome "recovered" (2021), described as "upset stomach"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 27Nov2021 21:00, outcome "recovered" (2021), described as "COVID like symptoms: temp, severe headache, cough, complete body pain- especially spine, upset stomach, and painful injection site.". Therapeutic measures were taken as a result of immunisation, vaccination site pain, headache, cough, pain, spinal pain, abdominal discomfort, body temperature abnormal.  Follow-up (02Dec2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Death
Clinical narrative: Sick in the Stomach; He passed away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Kidney problems" (unspecified if ongoing); "colon cancer" (unspecified if ongoing); "Heart Problem" (unspecified if ongoing); "Cancer surgery" in Feb2021. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer), administration date: Jan2021, for COVID-19 Immunization. On an unspecified date in 2021, the patient went to the emergency room (ER) because he had cancer surgery and after he was being sick to his stomach. The patient was hospitalized from 02Apr2021. The outcome of "being sick to his stomach" was unknown. He passed away on 11Apr2021. The cause of death was unknown. No autopsy was performed.  Additional information provided: She thinks it was colon cancer that he had. Reporter commented: The reason he went to the ER was because he had cancer surgery and after he was being sick to his stomach, there was some issue, but when they went to the ER they overlooked it.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: He passed away
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (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: COVID-19 (medically significant) with onset 26Nov2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive. Clinical course: Patient tested positive for COVID on 26Nov2021 following exposure from his young daughter. Experiencing mild symptoms (runny nose and slight cough). The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid Infection; Covid Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Nov2021, outcome "unknown" and all described as "Covid Infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) covid infection. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Any other vaccine in four weeks: Unknown, if covid prior vaccination: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: ADAMTS13 activity assay, Autoantibody test, Thrombotic thrombocytopenic purpura
Clinical narrative: Acquired Thrombotic Thrombocytopenic Purpura; This is a literature report.  A 80 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unk, single (second dose) for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing); "type II diabetes mellitus" (ongoing); "hyperlipidemia" (ongoing); "gout" (ongoing); "iron deficiency anemia" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Bnt162b2 for COVID-19 Vaccination, reaction(s): "No adverse event". The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (medically significant), outcome "recovered", described as "Acquired Thrombotic Thrombocytopenic Purpura". Symptoms included generalized weakness, malaise. The patient underwent the following laboratory tests and procedures: adamts13 activity assay: less than 2; autoantibody test: 182 %. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura including Plasma exchange, corticosteroids, rituximab.; Sender's Comments: Based on plausible temporal relationship the causal role of the BNT162B2 Vaccination cannot be excluded for reported event.  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
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Sciatic nerve injury
Clinical narrative: my left arm went bad-could not raise arm; my left arm went bad-could not raise arm/could not hold glass; left leg was numb, and hurting; left leg was numb, and hurting; the sciatic nerve had been inflamed irritated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (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) with onset 2021, outcome "unknown", described as "my left arm went bad-could not raise arm"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "my left arm went bad-could not raise arm/could not hold glass"; HYPOAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "unknown" and all described as "left leg was numb, and hurting"; SCIATIC NERVE INJURY (non-serious) with onset 2021, outcome "unknown", described as "the sciatic nerve had been inflamed irritated". The events "my left arm went bad-could not raise arm", "my left arm went bad-could not raise arm/could not hold glass", "left leg was numb, and hurting", "left leg was numb, and hurting" and "the sciatic nerve had been inflamed irritated" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, hypoaesthesia, hypoaesthesia, pain in extremity, sciatic nerve injury. Additional information: After the second shot patient's left arm went dead- could not raise arm, could not hold glass, also patient's left arm was numb, and hurting. In about 10 days with exercise patient's arm was better-the pain in leg diminished but did not disappear. The patient had consulted a chiropractor, the sciatic venue had been irritated, treatment had been some help but did not eradicate all pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The pain in her arm was way less than the first time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Apr2021 (Lot number: ER8734) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Additional Information for Other Conditions: she got arthritis early. In her mid thirties; "she had knee issues" (unspecified if ongoing), notes: she had knee issues; "degeneration in her joints" (unspecified if ongoing), notes: degeneration in her joints.; "Torn rotator cuff" (unspecified if ongoing), notes: Verbatim: she has a torn rotator cuff. Concomitant medication(s) included: DULOXETINE (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "The pain in her arm was way less than the first time".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm is still very sore; It is painful; Unable to reach above his head; I am losing range in it; I can''t reach certain ranges with it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is still very sore; It is painful"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "Unable to reach above his head; I am losing range in it; I can''t reach certain ranges with it".  Additional information: The patient had received his second dose of the Covid-19 Vaccine about five months ago and his arm was still very sore and he was unable to reach above his head. So, he wanted to know, how long was the sore arm come to normal and whether, he needed to be transferred to medical information as well. Consumer stated, his arm wa sore and he was losing range in it and it was painful and he could not reach certain ranges with it. Consumer stated, he did not have vaccination card with him to give the Lot number.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: Discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (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: DISCOMFORT (non-serious), outcome "unknown", described as "Discomfort".   Additional information: She remembers having some discomfort with the second dose, more so than the first. Caller clarified that she received the Pfizer Covid-19 Vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Vaccination site pain
Clinical narrative: moderate fatigue; mild injection site pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 00:45 (Lot number: fh8027) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: en6203, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 43 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en6203, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 02Mar2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021 00:45, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "moderate fatigue"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "mild injection site pain". Therapeutic measures were not taken as a result of fatigue, vaccination site pain.  Additional Information: The patient had moderate fatigue lasting 48 hours post vaccine mild injection site pain lasting 24hours post vaccine. The patient did not have covid prior to vaccination. The patient did not have known allergies. The patient did not tested covid post vaccination.   No follow up attempts are needed. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Product administered at inappropriate site, Pyrexia
Clinical narrative: Fever (100.1 F); Nausea; Vaccine location: left leg; This is a spontaneous report received from a contactable reporter (consumer or other non HCP).  A 7-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in leg left, administration date 02Dec2021 at 15:00 (Lot number: 5618) at the age of 7 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Drug allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE , Lot number: FK5127, Route of administration: intramuscular), administration date: 09Nov2021, when the patient was 7 years old, for COVID-19 immunisation.  The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 02Dec2021 at 15:00, outcome "unknown", described as "Vaccine location: left leg"; PYREXIA (non-serious) with onset 03Dec2021, outcome "not recovered", described as "Fever (100.1 F)"; NAUSEA (non-serious) with onset 03Dec2021, outcome "not recovered", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia and nausea.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Immunisation, Lymphadenopathy
Clinical narrative: booster; Had to remain bedridden for the day due to extreme fatigue; ran a fever of 100.9 which lasted about 36 hrs; had an excruciating headache accompanied by body aches and pains; had an excruciating headache accompanied by body aches and pains; Lymph nodes in neck and underarm pits were swollen the next morning and remain swollen 72 hrs after; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Bnt162b2 (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; FATIGUE (non-serious), outcome "unknown", described as "Had to remain bedridden for the day due to extreme fatigue"; PYREXIA (non-serious), outcome "unknown", described as "ran a fever of 100.9 which lasted about 36 hrs"; HEADACHE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "had an excruciating headache accompanied by body aches and pains"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph nodes in neck and underarm pits were swollen the next morning and remain swollen 72 hrs after". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (09Dec2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: booster; Had to remain bedridden for the day due to extreme fatigue; ran a fever of 100.9 which lasted about 36 hrs; had an excruciating headache accompanied by body aches and pains; had an excruciating headache accompanied by body aches and pains; Lymph nodes in neck and underarm pits were swollen the next morning and remain swollen 72 hrs after; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Bnt162b2 (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; FATIGUE (non-serious), outcome "unknown", described as "Had to remain bedridden for the day due to extreme fatigue"; PYREXIA (non-serious), outcome "unknown", described as "ran a fever of 100.9 which lasted about 36 hrs"; HEADACHE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "had an excruciating headache accompanied by body aches and pains"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph nodes in neck and underarm pits were swollen the next morning and remain swollen 72 hrs after". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (09Dec2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Ventricular extrasystoles
Clinical narrative: Asthma diagnosed 02Dec2021; Ventricular premature depolarization diagnosed 10Nov2021; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8734) at the age of 63 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing) and "Enlarged prostate" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6207; Anatomical site: left arm; Route of administration: unspecified), administration date: 12Mar2021, when the patient was 63 years old, for COVID-19 immunisation.  The following information was reported: ASTHMA (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Asthma diagnosed 02Dec2021"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Ventricular premature depolarization diagnosed 10Nov2021". The events "Asthma diagnosed 02Dec2021" and "Ventricular premature depolarization diagnosed 10Nov2021" were evaluated at the physician office visit. Therapeutic measures were taken as a result of asthma and ventricular extrasystoles.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment included Albuterol inhaler.