chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Muscle twitching
Clinical narrative: Intermittent twitching of right eye lasting periods of a few minutes each following booster (3rd) dose.; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 07Dec2021 at 14:00 (Lot number: EW0191) at the age of 25 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Polycystic kidney" (unspecified if ongoing), notes: Polycystic kidney disease; "Eczema" (unspecified if ongoing) and "polycystic ovarian syndrome" (unspecified if ongoing), notes: PCOS. Concomitant medications included: SPIRONOLACTONE and TRETINOINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6202; Administration time:15:00; Anatomical Location: Left Arm), administration date: 28Feb2021, when the patient was 24 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: FR8727; Administration time:15:00; Anatomical Location: Left Arm), administration date: 21Mar2021, when the patient was 24 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 14:00, outcome "unknown", described as "Dose received: 3"; MUSCLE TWITCHING (non-serious) with onset 08Dec2021 at 08:00, outcome "unknown", described as "Intermittent twitching of right eye lasting periods of a few minutes each following booster (3rd) dose".  Additional information: The patient had no known allergies. 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 COVID-19 vaccine. Concomitant medication TRETINOINE was taken topically. Since the vaccination, the patient had not been tested for COVID-19. The event was described as first noticed at 8am morning after 3rd dose (17 hours) and again at 30 hours. Total duration of each event was about an hour. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Pain
Clinical narrative: Sore arm; Fatigue; Chills; Headache; Achy; Dose received: 3; This is a spontaneous report from a non-contactable reporter (consumer or other hcp). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 at 11:45 (Lot number: unknown) at the age of 63 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, SINGLE; Lot number: unknown; Anatomical site: unspecified; Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical site: unspecified; Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 at 11:45, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Sore arm"; FATIGUE (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Achy". Therapeutic measures were not taken as a result of pain in extremity, fatigue, chills, headache and pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; Fatigue; Chills; Headache; Achy; Dose received: 3; This is a spontaneous report from a non-contactable reporter (consumer or other hcp). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 at 11:45 (Lot number: unknown) at the age of 63 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, SINGLE; Lot number: unknown; Anatomical site: unspecified; Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical site: unspecified; Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 at 11:45, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Sore arm"; FATIGUE (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Achy". Therapeutic measures were not taken as a result of pain in extremity, fatigue, chills, headache and pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Immunisation, Pain
Clinical narrative: My left shoulder is a little sore where I received the vaccine; I also feel cold as if a fever is coming on.; Body hurts; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in left arm , administration date 09Dec2021 at 16:00 (Lot number: unknown) at the age of 50 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, SINGLE, Lot Number: EP6955,vaccine location: Left arm, Administration time: 10:30), administration date: 04Mar2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EL3247,vaccine location: Right arm, Administration time: 10:30), administration date: 25Mar2021, when the patient was 49 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 16:00, outcome "unknown", described as "Dose number 3"; ARTHRALGIA (non-serious) with onset 10Dec2021 at 05:00, outcome "not recovered", described as "My left shoulder is a little sore where I received the vaccine"; FEELING COLD (non-serious) with onset 10Dec2021 at 05:00, outcome "not recovered", described as "I also feel cold as if a fever is coming on"; PAIN (non-serious) with onset 10Dec2021 at 05:00, outcome "not recovered", described as "Body hurts". Therapeutic measures were not taken as a result of arthralgia, feeling cold and pain.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not 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.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Muscle twitching, SARS-CoV-2 test
Clinical narrative: Feeling dizzy upon getting up from bed; Daily frontal headaches; Eye twitching; This is a spontaneous report from a contactable reporter (Physician).  A 11-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Dec2021 at 10:15 (Lot number: FK5127) at the age of 11 years as dose 1 (tris), single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication included: FLUZONE taken for Immunization, start date: 23Nov2021, stop date: 23Nov2021. The following information was reported: DIZZINESS (non-serious) with onset 04Dec2021 at 08:00, outcome "not recovered", described as "Feeling dizzy upon getting up from bed"; HEADACHE (non-serious) with onset 04Dec2021 at 08:00, outcome "not recovered", described as "Daily frontal headaches"; MUSCLE TWITCHING (non-serious) with onset 04Dec2021 at 08:00, outcome "not recovered", described as "Eye twitching". The events "Feeling dizzy upon getting up from bed", "Daily frontal headaches" and "Eye twitching" were evaluated at the emergency room visit and physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The known allergies was not applicable. Prior to vaccination, the patient was not diagnosed with COVID-19. After 24 hours of vaccination, patient started feeling dizzy upon getting up from bed and has daily frontal headaches with eye twitching. Since the vaccination, the patient had been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: My diagnosed essential tremor greatly increased when I received the vaccination and has not diminished or returned to the same state before vaccination.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm , administration date 06Mar2021 at 12:45 (Lot number: EN6202) at the age of 52 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes and "Essential tremor" (unspecified if ongoing), notes: My diagnosed essential tremor greatly increased when I received the vaccination. Concomitant medications were not reported. Past drug history included: Scopolamine, reactions: "Drug allergy", notes: known allergies: Scopolamine.  The following information was reported: TREMOR (non-serious) with onset 06Mar2021, outcome "recovered with sequelae" (an unknown date in 2021), described as "My diagnosed essential tremor greatly increased when I received the vaccination and has not diminished or returned to the same state before vaccination". The event "My diagnosed essential tremor greatly increased when I received the vaccination and has not diminished or returned to the same state before vaccination." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tremor.  Additional Information: Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Treatment as a result of reported event included medications (unspecified) to decrease tremor. Since the vaccination, the patient had been tested for COVID-19.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Vaccination site pain
Clinical narrative: Headache; Injection site pain; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP).   A 50-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 09Dec2021 at 12:30 (Lot number: 1620) at the age of 50 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 (DOSE 2, SINGLE, Lot Number: 6955, Anatomical location: Left arm, Administration time: 11:00), administration date: 08Apr2021, when the patient was 49 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot Number: 6955, Anatomical location: Left arm, Administration time:13:30), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 12:30, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious) with onset 10Dec2021 at 09:00, outcome "not recovered", described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021 at 09:00, outcome "not recovered", described as "Injection site pain". Therapeutic measures were not taken as a result of headache and vaccination site pain.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Very sore site of injection; Large red area at injection site.; Very warm to touch at injection site.; By 6:00 pm on day of injection was having pretty heavy diarrhea, this lasted about 3 days; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 08Dec2021 at 10:00 (Lot number: FW8027) at the age of 69 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high", notes: High blood pressure; "Irritable bowel syndrome", notes: IBS and "GERD"; (unspecified if ongoing). Concomitant medications included: AMLODIPINE; ESOMEPRAZOLE and VIT D. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6206, vaccine location: Left arm, administration time: 13:00), administration date: 19Mar2021, when the patient was 68 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0162, vaccine location: Left arm, administration time: 10:00), administration date: 10Apr2021, when the patient was 68 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 at 10:00, outcome "unknown", described as "Dose received: 3"; DIARRHOEA (non-serious) with onset 08Dec2021 at 18:00, outcome "recovered" (11Dec2021), described as "By 6:00 pm on day of injection was having pretty heavy diarrhea, this lasted about 3 days"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021 at 11:00, outcome "recovering", described as "Very sore site of injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 10Dec2021 at 11:00, outcome "not recovered", described as "Large red area at injection site"; VACCINATION SITE WARMTH (non-serious) with onset 10Dec2021 at 11:00, outcome "not recovered", described as "Very warm to touch at injection site". Therapeutic measures were not taken as a result of diarrhoea, vaccination site pain, vaccination site erythema and vaccination site warmth.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Immunisation, Musculoskeletal chest pain, Painful respiration
Clinical narrative: Dose number=3; Ribs hurt after getting booster shot and describe it getting hit by a car feels like; Upper back hurts too; Whenever as little as breathe ribs hurt; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 19-year-old female patient received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 19 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 2, SINGLE; Lot number: UNKNOWN; Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose number=3"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "recovering", described as "Ribs hurt after getting booster shot and describe it getting hit by a car feels like"; BACK PAIN (non-serious), outcome "recovering", described as "Upper back hurts too"; PAINFUL RESPIRATION (non-serious), outcome "recovering", described as "Whenever as little as breathe ribs hurt". Therapeutic measures were not taken as a result of musculoskeletal chest pain, back pain and painful respiration.  Additional Information: The events happened the day after getting the booster. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Immunisation, Skin exfoliation
Clinical narrative: Peeling hands and feet; Numbness and slight burning feeling in hands and feet. These sensations come and go, but seem to be worse lately in that the numbness/burning sensation is in my lower legs, not just my feet; Numbness and slight burning feeling in hands and feet. These sensations come and go, but seem to be worse lately in that the numbness/burning sensation is in my lower legs, not just my feet; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other hcp). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 at 15:30 (Lot number: FF2593) at the age of 72 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "CREST syndrome" (unspecified if ongoing), notes: Forme fruste CREST syndrome and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications included: PLAQUENIL; TEMAZEPAM and ATIVAN. Past drug history included: Mint oil, reaction: "Drug allergy", notes: known allergies: mint oil. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN5318; Anatomical site: left arm; Route of administration: unspecified; Administration time: 11:30), administration date: 05Feb2021, when the patient was 71 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EN6198; Anatomical site: right arm; Route of administration: unspecified; Administration time: 11:30), administration date: 26Feb2021, when the patient was 71 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Nov2021 at 15:30, outcome "unknown", described as "Dose received: 3"; SKIN EXFOLIATION (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Peeling hands and feet"; HYPOAESTHESIA (non-serious), BURNING SENSATION (non-serious) all with onset 17Nov2021, outcome "not recovered", and all described as "Numbness and slight burning feeling in hands and feet. These sensations come and go, but seem to be worse lately in that the numbness/burning sensation is in my lower legs, not just my feet". The events "Peeling hands and feet" and "Numbness and slight burning feeling in hands and feet. These sensations come and go, but seem to be worse lately in that the numbness/burning sensation is in my lower legs, not just my feet" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of skin exfoliation, hypoaesthesia and burning sensation.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pregnancy test
Clinical narrative: Have felt nauseous; Had horrible headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 12:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gluten-celiac disease allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 04Nov2021, outcome "not recovered", described as "Have felt nauseous"; HEADACHE (non-serious) with onset 04Nov2021, outcome "not recovered", described as "Had horrible headaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, headache.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient had not been diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm has extreme pain and can not be extend in different directions (over head, behind back, etc.); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Left Shoulder), administration date 23Mar2021 (Lot number: EL3248) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication included: ZYRTEC. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Right), administration date: 02Mar2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "not recovered", described as "Left arm has extreme pain and can not be extend in different directions (over head, behind back, etc.)". The event "left arm has extreme pain and can not be extend in different directions (over head, behind back, etc.)" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Left area shot was in much greater pain and the time of inoculation compared to the right. Treatment included exercises.No covid prior vaccination and no covid tested post vaccination. Known allergies were none.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: did contract covid on 09Jun2021; did contract covid on 09Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 13:30 (Lot number: EP7534) at the age of 24 years as dose 2, single and administered in arm left, administration date 17Mar2021 13:30 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: JUNEL taken for contraception, start date: Jan2021, stop date: Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jun2021, outcome "unknown" and all described as "did contract covid on 09Jun2021". The patient did contract covid on 09Jun2021 (at least that was the day the patient started showing symptoms).   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation
Clinical narrative: slight burning sensation/irritation in the eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (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: EYE IRRITATION (non-serious) with onset 04Mar2021, outcome "unknown", described as "slight burning sensation/irritation in the eyes". Therapeutic measures were not taken as a result of eye irritation.  Additional information: It was reported covid prior vaccination and covid tested post vaccination was none and allergies were reported as unknown. Other vaccine in four weeks and other medications in two weeks were reported as Unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Blood test, Headache, Myalgia
Clinical narrative: soreness; headache; bilateral hamstring muscle pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic Lymphocytic Leukemia" (unspecified if ongoing); "anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose no. 1), administration date: 05Jan2021, for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "soreness"; HEADACHE (non-serious), outcome "unknown", described as "headache"; MYALGIA (non-serious), outcome "unknown", described as "bilateral hamstring muscle pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She receives IVIG treatment every 30-32 days. She did a blood test to detect antibodies against COVID infection on 26Feb2021 and the results was negative. Antibodies in some persons can be detected within the first week of illness onset. In SARS-CoV-2 infections, IgM and IgG antibodies can arise nearly simultaneously in serum within 2 to 3 weeks after illness onset. Thus, detection of IgM without IgG is uncommon. How long IgM and IgG antibodies remain detectable following infection is not known. It is also important to note that some persons do not develop detectable IgG or IgM antibodies following infection. Thus, the absence of detectable IgM or IgG antibodies does not necessarily rule out that they could have previously been infected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness; headache; bilateral hamstring muscle pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic Lymphocytic Leukemia" (unspecified if ongoing); "anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose no. 1), administration date: 05Jan2021, for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "soreness"; HEADACHE (non-serious), outcome "unknown", described as "headache"; MYALGIA (non-serious), outcome "unknown", described as "bilateral hamstring muscle pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She receives IVIG treatment every 30-32 days. She did a blood test to detect antibodies against COVID infection on 26Feb2021 and the results was negative. Antibodies in some persons can be detected within the first week of illness onset. In SARS-CoV-2 infections, IgM and IgG antibodies can arise nearly simultaneously in serum within 2 to 3 weeks after illness onset. Thus, detection of IgM without IgG is uncommon. How long IgM and IgG antibodies remain detectable following infection is not known. It is also important to note that some persons do not develop detectable IgG or IgM antibodies following infection. Thus, the absence of detectable IgM or IgG antibodies does not necessarily rule out that they could have previously been infected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: cyst in my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 31Jan2021 (Batch/Lot number: unknown) as dose1, single and administration date 21Feb2021 (Batch/Lot number: unknown) as dose2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CYST (non-serious) with onset 2021, outcome "unknown", described as "cyst in my neck". Therapeutic measures were taken as a result of cyst.  Additional information: Patient stated that  "Yesterday his  HCP prescribed antibiotics: sulfamethoxazole-tmp dx (generic for Bactrim) to treat a cyst in his neck would antibiotics detract in anyway the vaccine"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Lightheadedness; dizziness; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient's husband) from medical information team. A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 13:15 (Lot number: EN6202) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single,, LOT:EM9809 , Anatomical location: Left Arm.), administration date: 04Feb2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 25Feb2021, outcome "unknown", described as "dizziness"; VERTIGO (non-serious) with onset 25Feb2021, outcome "unknown", described as "vertigo"; DIZZINESS (non-serious) with onset 25Feb2021 13:15, outcome "not recovered", described as "Lightheadedness".  Additional information: The reporter stated that he was transferred. He reported that his wife received her second dose of the Pfizer Covid vaccine on 25Feb2021. She had experienced dizziness/vertigo since receiving the vaccine. He wants to know if anyone else has reported this and how long it could last. Patient, had been experiencing lightheadedness on and off for a week. Reporter states he was trying to find online and couldn't find anything about it. Reporter states patient felt the lightheadedness right after she got the second dose that day. Reporter states patient attributed it to being nerved up that day about the shot, but now it has been going on, on and off, for a week. Reporter states that they wanted to call and see if it is a reported side effect. No other Product were received and no other history and no investigation Assessment. No additional Vaccines Administered on Same Date of the Pfizer Suspect and AE(s) did not require to visit to Emergency Room or Physician Office. No prior Vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. No family Medical History Relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Lethargy, Somnolence
Clinical narrative: her mother has been very lethargic; difficult to wake after receiving the vaccine; fatigue; her mom can barely walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 93-years-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number: Unknown) administration date 25Feb2021 (age at the time of vaccination was 93-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. The following information was reported: LETHARGY (non-serious), outcome "unknown", described as "her mother has been very lethargic"; SOMNOLENCE (non-serious), outcome "unknown", described as "difficult to wake after receiving the vaccine"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "her mom can barely walk".  Additional Information: Caller was reporting adverse events that her 93-years-old mother experienced after receiving the first dose of PFIZER-BIONTECH COVID-19 vaccine last Thursday, 25Feb2021. Caller stated that her mother had been very lethargic and difficult to wake after receiving the vaccine, that it really knocked her for a loop and she was very healthy before. Caller stated, she had to slap her mother on the face to wake her up to get her to drink but she was able to give her some GATORADE and ice chips this afternoon and afterwards she seemed to perk up a little bit. She also stated that because of the fatigue, her mother could barely walk and someone must be in front of and behind her while walking. She also mentioned her mother was healthier than all of them and the only medications she takes were SYNTHROID and an antacid. Caller asked if could this be a result of the vaccine. What do we do to treat it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: she experienced soreness at the injection site.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (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: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "she experienced soreness at the injection site.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Osteoporosis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (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: OSTEOPOROSIS (non-serious), outcome "unknown", described as "osteoporosis".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasopharyngitis, Nausea, Throat irritation
Clinical narrative: felt queasy to her stomach; feeling like she was catching a head cold.; Headache; scratchy throat; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (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: NAUSEA (non-serious), outcome "unknown", described as "felt queasy to her stomach"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "feeling like she was catching a head cold."; HEADACHE (non-serious), outcome "unknown", described as "Headache"; THROAT IRRITATION (non-serious), outcome "unknown", described as "scratchy throat"; FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional information: Caller states she received the first dose of the vaccine on Tuesday and within an hour she felt queasy to her stomach. Caller states yesterday she ran around all day and was tired at the end of the day but attributed it to the running around all day. Caller states today she started feeling like she was catching a head cold. Caller states she had a headache, scratchy throat, and she was feeling tired. Caller would like to know if her symptoms were normal and what to do about them?  Caller also given website to report adverse event at pfizersafetyreporting.com. Caller is 51-year-old female.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Caller states he feels "a little sore" at the injection site, but not very much.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 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: MYALGIA (non-serious), outcome "unknown", described as "Caller states he feels "a little sore" at the injection site, but not very much.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under left arm. Same as injection site. It was the size of a softball. It felt like a third breast.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling, redness & itchy around the injection site; swelling, redness & itchy around the injection site; swelling, redness & itchy around the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Lot number: EN6198) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "post-oblative hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM. Past drug history included: Amoxicillin, reaction(s): "known allergy: amoxicillin". The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 02Mar2021, outcome "unknown" and all described as "swelling, redness & itchy around the injection site". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pruritus.  Additional information: The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination included levothyroxine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt. received Anthrax Vaccine 5 days prior than the due date. NO side effects or adverse reactions.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fluid retention, Headache, Myositis, Skin induration
Clinical narrative: 1.) Occasional sharp pain in the left rear area of my brain 2.) Tissue just below left arm pit, was sore soon after injection. Two days later the area adjacent to my left pectoral muscle looked a felt bigger compared to my right pectoral muscle. The tissue felt as if there was a water balloon underneath the skin. It is now four days since the injection and the muscle tissue underneath my skin appears to be getting bigger and now firm.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Feeling cold, Headache
Clinical narrative: In the middle of the night I woke up really sick and my brother was also really sick too after our 2nd COVID shot. We had the same symptoms. The symptoms started around 12 but weren't really recognizable until 3am. I had severe chills all over my body at 3am and by this time I realized I had symptoms and I didn't know where they came from. I had extreme dizziness, a really bad sickness feeling in my whole body. I stood up and was about to head to the emergency room the next day with my brother and I felt like my heart stopped after becoming dizzy and I felt like I was going to die from how bad my symptoms were. I felt the virus disrupting the blood in my whole body and like a tidal wave of blood came up to try to wash away the function of my heart around 8am. The symptoms got really bad by the next day. The symptoms got better after leaving the emergency room (without an examination the wait was too long) but it didn't go away until 2 days later.   This is not as sick as I was I can't remember my other symptoms right now but I had sweating or feeling cold I can't remember and I think I had nausea no vomiting but I felt like I was going to. I think I had a headache, and maybe sore throat I'm not sure.   I've had sickness problems since getting this vaccine with nausea, vomiting and dirrahea off and on since the vaccine which is still going on and headache sometimes.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Nausea, Sleep disorder, Vomiting
Clinical narrative: In the middle of the night I woke up really sick and my brother was also really sick too after our 2nd COVID shot. We had the same symptoms. The symptoms started around 12 but weren't really recognizable until 3am. I had severe chills all over my body at 3am and by this time I realized I had symptoms and I didn't know where they came from. I had extreme dizziness, a really bad sickness feeling in my whole body. I stood up and was about to head to the emergency room the next day with my brother and I felt like my heart stopped after becoming dizzy and I felt like I was going to die from how bad my symptoms were. I felt the virus disrupting the blood in my whole body and like a tidal wave of blood came up to try to wash away the function of my heart around 8am. The symptoms got really bad by the next day. The symptoms got better after leaving the emergency room (without an examination the wait was too long) but it didn't go away until 2 days later.   This is not as sick as I was I can't remember my other symptoms right now but I had sweating or feeling cold I can't remember and I think I had nausea no vomiting but I felt like I was going to. I think I had a headache, and maybe sore throat I'm not sure.   I've had sickness problems since getting this vaccine with nausea, vomiting and dirrahea off and on since the vaccine which is still going on and headache sometimes.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Generalized random location urticaria that does not control with antihistamines. Ne fever or malaise with no previous history of these lesions. They appear and disappear after 30-60 min.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, Immunodeficiency, SARS-CoV-2 test positive
Clinical narrative: Pt admitted to hospital 9/10/21 with COVID+ pna. Pt had received 2 doses of Pfizer (1/29/21 & 2/19/21). Pt is immunocompromised on chronic prednisone.   Hospitalized 9/10-9/14, then re-admitted 9/20 & passed 9/21
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient did not report any adverse outcomes at the time of this report. It was identified a few hours after the patient was given her vaccination that she was incorrectly administered a booster dose of the Pfizer vaccine for 12 years and older. She is outside of the eligible age range for booster doses.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2021 12:30 (Lot number: EL9265) as dose 1, single for covid-19 immunisation. Relevant medical history included: "well controlled seizure disorder" (unspecified if ongoing); "well controlled HTN" (unspecified if ongoing); "IBS" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "local skin reaction of redness", start date: 29Sep2020 (unspecified if ongoing); "swelling", start date: 29Sep2020 (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: UNITHROID, stop date: 25Feb2021 14:00; PHENYTOIN; TOPROL; METAMUCIL [PLANTAGO OVATA]; LORAZEPAM. Past drug history included: Erythromycin, reaction(s): "known allergies"; Epinephrine, reaction(s): "Known allergies". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "sore injection site". The event "sore injection site" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain.  Additional information: Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.