chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Immunisation, Urine flow decreased
Clinical narrative: Urine flow/slowed to a painful drip. Urination became incredibly difficult; Urine flow/slowed to a painful drip. Urination became incredibly difficult; Dose number=3; This is a spontaneous report received from a contactable Other HCP. The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Dec2021 15:00 (Lot number: 33025BD) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Possible prostate hypertrophy" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; CEFUROXIME. Vaccination history included: Bnt162b2 (dose number=2, product=COVID 19, brand=Pfizer, lot number=EW0151, administration date=14Apr2021, administration time=05:15 PM, vaccine location=Right arm), administration date: 14Apr2021, when the patient was 59 years old, for Covid-19 Immunization; Bnt162b2 (product=COVID 19, brand=Pfizer , lot number=EN6207, administration date=22Mar2021, administration time=06:00 PM, dose number=1, vaccine location=Right arm), administration date: 22Mar2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 15:00, outcome "unknown", described as "Dose number=3"; URINE FLOW DECREASED (non-serious), DYSURIA (non-serious) all with onset 20Dec2021 19:00, outcome "recovered" (Dec2021) and all described as "Urine flow/slowed to a painful drip. Urination became incredibly difficult". The event "urine flow/slowed to a painful drip. urination became incredibly difficult" and "urine flow/slowed to a painful drip. urination became incredibly difficult" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of urine flow decreased, dysuria.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with COVID-19. Within 4-6 hours post vaccine, urine flow, which had been improving slowed to a painful drip. Urination became incredibly difficult over the next 36hrs and then it began to improve.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Chills, Feeling hot, Immunisation, Nausea
Clinical narrative: Temp was 99.4. At 6 pm temp was 100.6; shivering uncontrollably; nauseaus; began to ache all over; Hands very cold rest of body hot; body hot; Arm was sore within a couple of hours; Patient received booster dose; This is a spontaneous report received from 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 29Dec2021 09:45 (Lot number: Tf2590) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE), administered in arm right, administration date 29Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "mild depression" (unspecified if ongoing); "post concussion syndrome" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CELEXA [CELECOXIB]. Past drug history included: Known allergies=codeine, reaction(s): "Known allergies=Codeine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ez3249, Location of injection: Arm Left), administration date: 26Feb2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ez3249, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 05Feb2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 09:45, outcome "unknown", described as "Patient received booster dose"; PERIPHERAL COLDNESS (non-serious) with onset 30Dec2021, outcome "unknown", described as "Hands very cold rest of body hot"; FEELING HOT (non-serious) with onset 30Dec2021, outcome "unknown", described as "body hot"; PAIN (non-serious) with onset 30Dec2021 14:00, outcome "unknown", described as "began to ache all over"; PAIN IN EXTREMITY (non-serious) with onset 29Dec2021 16:00, outcome "unknown", described as "Arm was sore within a couple of hours"; CHILLS (non-serious) with onset 30Dec2021 16:00, outcome "unknown", described as "shivering uncontrollably"; NAUSEA (non-serious) with onset 30Dec2021 16:00, outcome "unknown", described as "nauseaus"; PYREXIA (non-serious) with onset 30Dec2021 18:00, outcome "unknown", described as "Temp was 99.4. At 6 pm temp was 100.6". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient's Arm was sore within a couple of hours of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain, Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: Temp was 99.4. At 6 pm temp was 100.6; shivering uncontrollably; nauseaus; began to ache all over; Hands very cold rest of body hot; body hot; Arm was sore within a couple of hours; Patient received booster dose; This is a spontaneous report received from 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 29Dec2021 09:45 (Lot number: Tf2590) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE), administered in arm right, administration date 29Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "mild depression" (unspecified if ongoing); "post concussion syndrome" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CELEXA [CELECOXIB]. Past drug history included: Known allergies=codeine, reaction(s): "Known allergies=Codeine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ez3249, Location of injection: Arm Left), administration date: 26Feb2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ez3249, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 05Feb2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 09:45, outcome "unknown", described as "Patient received booster dose"; PERIPHERAL COLDNESS (non-serious) with onset 30Dec2021, outcome "unknown", described as "Hands very cold rest of body hot"; FEELING HOT (non-serious) with onset 30Dec2021, outcome "unknown", described as "body hot"; PAIN (non-serious) with onset 30Dec2021 14:00, outcome "unknown", described as "began to ache all over"; PAIN IN EXTREMITY (non-serious) with onset 29Dec2021 16:00, outcome "unknown", described as "Arm was sore within a couple of hours"; CHILLS (non-serious) with onset 30Dec2021 16:00, outcome "unknown", described as "shivering uncontrollably"; NAUSEA (non-serious) with onset 30Dec2021 16:00, outcome "unknown", described as "nauseaus"; PYREXIA (non-serious) with onset 30Dec2021 18:00, outcome "unknown", described as "Temp was 99.4. At 6 pm temp was 100.6". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient's Arm was sore within a couple of hours of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: Two cyst extractions that came about after the first dose; 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 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CYST (medically significant), outcome "unknown", described as "Two cyst extractions that came about after the first dose". Therapeutic measures were taken as a result of cyst. The patient is due to get second vaccine next week and wants to know does taking an antibiotic have any effect on the vaccine. The patient has not started it yet. He had two cyst extractions that came about after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: slight headache; little fatigue; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "in a lot of pain due to his torn left knee that needs the surgery" (unspecified if ongoing), notes: notified in November 2020 that he will need a left knee replacement; "has titanium in his back" (unspecified if ongoing), notes: before having the vaccines; "right knee replacement surgery (artificial right knee)" (unspecified if ongoing), notes: before having the vaccines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), administration date: 27Feb2021, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 22Mar2021, outcome "unknown", described as "slight headache"; FATIGUE (non-serious) with onset 22Mar2021, outcome "unknown", described as "little fatigue".  Additional Information: The patient was asking when was the best time for him to get blood work done in preparation for a left knee replacement surgery. He was asking if he needed to wait for another 14 days. The patient was notified in November 2020 that he will need a knee replacement. Consequently, the patient was in a lot of pain that he was complaining about due to his torn left knee that needs the surgery. The patient mentioned that it was causing him trouble in his daily activities and that he needs an urgent answer to his questions so that he could schedule his left knee replacement surgery.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "myasthenia gravis" (unspecified if ongoing); "cancer" (unspecified if ongoing), notes: twice; "anaphylactic reaction / anaphylaxis" (unspecified if ongoing), notes: to Sulfa / sulfonamides; "sulfa" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation, reaction(s): "didn't have any reaction at all". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Additional information:  Eleven hours after getting the second shot, the patient had a little bit of a sore arm that lasted for a few hours. The patient reported that she was currently taking 26 other drugs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021318289 Same reporter, drug and event; different patient.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: constant headache on the left posterior side that is a zapping pain; 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 44 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 16:00 (Lot number: EL9264) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: diagnosed as a child; "Thyroidectomy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 2007 (ongoing). The following information was reported: HEADACHE (non-serious) with onset 11Mar2021, outcome "recovering", described as "constant headache on the left posterior side that is a zapping pain". Therapeutic measures were taken as a result of headache.  Additional information: The patient had not received any other vaccines within 4 weeks prior vaccination. The patient had no additional vaccines administered on same date of BNT162B2. The events did not require a visit to physician office or emergency room. Advil Liqui-gels and Tylenol were taken as treatment of the events. The patient had minimal relief with any pain reliever.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Feeling abnormal
Clinical narrative: felt weird sensations hours later but have since subsided; disoriented for a couple of days after the vaccine; 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 69 year-old male patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 10Mar2021, outcome "recovering", described as "felt weird sensations hours later but have since subsided"; DISORIENTATION (non-serious) with onset Mar2021, outcome "recovered", described as "disoriented for a couple of days after the vaccine".  Additional Information: The reporter's deepest concern was he and his wife was scheduled for the second shot in less than 10 days and the point was that most people have no reaction to the first shot and a heavy reaction with the second shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2021 14:00 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pacemaker" (unspecified if ongoing); "mild syncope episodes" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE; CALCIUM; METOPROLOL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Arm soreness".  Additional information: The patient has no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medication included multivitamins (as reported). It was reported that the event was experienced for 24 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia
Clinical narrative: Muscle tightness and soreness; Muscle tightness and soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 09:00 (Lot number: EL3247) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; GIANVI; BIOTIN; VITAMIN D NOS. Vaccination history included: Bnt162b2 (dose 1, lot number: EL3247, administration time: 09:00 AM, vaccine location: Right arm), administration date: 01Mar2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: MUSCLE TIGHTNESS (non-serious), MYALGIA (non-serious) all with onset 22Mar2021 20:00, outcome "recovered" (24Mar2021) and all described as "Muscle tightness and soreness". Therapeutic measures were not taken as a result of muscle tightness, myalgia. Additional information: That patient had no other vaccine in four weeks. The patient had no covid prior vaccination and was not tested for covid post vaccination. It was reported that the events lasted only for another 24 hours as the patient woke up on Wednesday, 24Mar2021, like normal.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: threw up about 4 time; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: VOMITING (non-serious), outcome "recovering", described as "threw up about 4 time". Additional Information: The patient asked if vomiting was 1 of the side effects of having the COVID vaccine. She received her first shot yesterday and reported "I felt fine but when I woke up this morning to get ready for work I threw up about 4 times". She felt better now, she asked if this was from the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Injection site soreness; Tired; Slight chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 11:30 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Mar2021 19:00, outcome "recovering", described as "Injection site soreness"; FATIGUE (non-serious) with onset 22Mar2021 19:00, outcome "recovering", described as "Tired"; CHILLS (non-serious) with onset 22Mar2021 19:00, outcome "recovering", described as "Slight chills". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19. The patient has no allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: heard a hissing sound on her left ear which then became a ringing sound; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 01Mar2021, outcome "unknown", described as "heard a hissing sound on her left ear which then became a ringing sound". The event "heard a hissing sound on her left ear which then became a ringing sound" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Caller mentioned that she received her first dose of the vaccine on 27Feb2021 and about 2 days later heard a hissing sound on her left ear which then became a ringing sound. She has had tinnitus in her left ear since she got the first dose, and it has been ringing for 24 hours a day. She consulted with her primary which stated that there was nothing wrong and that her ears were clear. She then consulted with an ENT who again said that there was nothing wrong with her after examination. She was prescribed Prednisone for 5 days, but she held off on it because she received her 2nd dose last Saturday on 20Mar2021. The doctor told her to take it 24 hours later. She was asking if there have reports of tinnitus after getting vaccinated because her doctors cannot confirm that but she has read on articles that it may be plausible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Hypoacusis, Tinnitus
Clinical narrative: heard a hissing sound on her left ear which then became a ringing sound; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 01Mar2021, outcome "unknown", described as "heard a hissing sound on her left ear which then became a ringing sound". The event "heard a hissing sound on her left ear which then became a ringing sound" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Caller mentioned that she received her first dose of the vaccine on 27Feb2021 and about 2 days later heard a hissing sound on her left ear which then became a ringing sound. She has had tinnitus in her left ear since she got the first dose, and it has been ringing for 24 hours a day. She consulted with her primary which stated that there was nothing wrong and that her ears were clear. She then consulted with an ENT who again said that there was nothing wrong with her after examination. She was prescribed Prednisone for 5 days, but she held off on it because she received her 2nd dose last Saturday on 20Mar2021. The doctor told her to take it 24 hours later. She was asking if there have reports of tinnitus after getting vaccinated because her doctors cannot confirm that but she has read on articles that it may be plausible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Slight loss of hearing; Tinnitus / ringing in her left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 09:30 (Lot number: EN6202) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Tinnitus / ringing in her left ear"; HYPOACUSIS (non-serious) with onset 11Mar2021, outcome "unknown", described as "Slight loss of hearing". The events "tinnitus / ringing in her left ear" and "slight loss of hearing" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Hypoacusis, Tinnitus
Clinical narrative: Slight loss of hearing; Tinnitus / ringing in her left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 09:30 (Lot number: EN6202) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Tinnitus / ringing in her left ear"; HYPOACUSIS (non-serious) with onset 11Mar2021, outcome "unknown", described as "Slight loss of hearing". The events "tinnitus / ringing in her left ear" and "slight loss of hearing" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tooth extraction
Clinical narrative: Tooth extraction; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received BNT162B2 (BNT162B2), administration date 2021 (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: TOOTH EXTRACTION (non-serious) with onset Mar2021, outcome "unknown", described as "Tooth extraction". Therapeutic measures were taken as a result of tooth extraction.  Additional Information: The reporter mentioned that he was a senior citizen who had already received the first dose of the vaccine 3 weeks ago (2021) and had experienced no side effects. He was scheduled to take his second dose today (date unspecified) but was calling to ask information because he had a tooth extraction 4 days ago (Mar2021) and was prescribed amoxicillin 500mg three times a day and acetaminophen (TYLENOL) 650mg extended three times a day. He was asking if there was any effect on the vaccine and any of his medications, including heart medications. He mentioned that he spoke to someone from the number and they mentioned that he should not take any ibuprofen for the vaccine but was unsure of the acetaminophen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: had an infection; This is a spontaneous report received from a contactable consumer from medical information team.  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "heart transplant", start date: 2001 (unspecified if ongoing), notes: 20 years prior; "skin cancer" (unspecified if ongoing), notes: which had an infection. The patient's concomitant medications were not reported. The following information was reported: INFECTION (non-serious), outcome "unknown", described as "had an infection". Therapeutic measures were taken as a result of infection.  Additional information: The reporter mentioned that his husband had a heart transplant 20 years ago, and also developed skin cancer which had an infection. He was prescribed cephalexin 500mg capsule for this infection. The patient was scheduled to get the second dose of the vaccine on 26Mar2021. The reporter was seeking information if the vaccine would have an effect with infection, and vice versa.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting continuously for 3 hours; 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 66 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 12:00 (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: VOMITING (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021 03:00), described as "vomiting continuously for 3 hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: swollen lymphomas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included: TRAMADOL; MELOXICAM; HUMIRA. Past drug history included: Doxycyclin, reaction(s): "Drug allergy". The following information was reported: LYMPHOMA (medically significant), outcome "recovered with sequelae", described as "swollen lymphomas". Therapeutic measures were not taken as a result of lymphoma. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Otorrhoea
Clinical narrative: My ears are draining water/my ear got started draining with fluid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 03Mar2021 11:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: ESTRADIOL. The following information was reported: OTORRHOEA (non-serious) with onset 08Mar2021, outcome "not recovered", described as "My ears are draining water/my ear got started draining with fluid". The event "my ears are draining water/my ear got started draining with fluid" was evaluated at the physician office visit.  No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: threw up; bad headache; became very tired after the shot; This is a spontaneous report received from a contactable consumer. The reporter is the parent.  A 23-year-old female patient (unknown if pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Mar2021 11:00 (Batch/Lot number: unknown) at the age of 23 years 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: FATIGUE (non-serious) with onset 22Mar2021, outcome "unknown", described as "became very tired after the shot"; HEADACHE (non-serious) with onset 22Mar2021 17:00, outcome "unknown", described as "bad headache"; VOMITING (non-serious) with onset 23Mar2021 13:30, outcome "unknown", described as "threw up". Therapeutic measures were not taken as a result of fatigue, headache, vomiting.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient called her parent at 14:48 and said she was tired and was going to go to sleep. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness/ lightheadedness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm, administration date 10Mar2021 08:45 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2003 (ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 20Mar2021, outcome "not recovered", described as "dizziness/ lightheadedness". The event "dizziness/ lightheadedness" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of dizziness. Additional information: The patient received unspecified vertigo pills as treatment for the event. The patient has no relevant family history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  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: Pain in extremity
Clinical narrative: The caller's arm was sore after the first dose; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Feb2021 11:00 (Lot number: EN6202) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cancer survivor" (unspecified if ongoing), notes: Verbatim: cancer survivor; "slipped discs" (unspecified if ongoing), notes: The caller has 3 slipped discs in her back.; "radical hysterectomy" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN taken for pain. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The caller's arm was sore after the first dose". Additional Information: The patient's lymph nodes were not taken out, radical hysterectomy, year 6 on that. The patient's arm was sore after the first dose. The patient has no history of all previous immunization and has no additional vaccines administered on same date of the COVID-19 vaccine. The adverse events did not require a visit to emergency room nor physician office visit. The patient has no family medical history relevant to the adverse events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021319777 same patient, same drug, different event, different dose of vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: felt terribly sick/ really sick; ached all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt terribly sick/ really sick"; PAIN (non-serious), outcome "unknown", described as "ached all over". Additional information: The patient's age was "85" (unit not reported). The patient has been in bed the whole time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left (Lot number: EN6203) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney" (unspecified if ongoing); "Hemoglobin" (unspecified if ongoing); "known allergy: dust pollen any trees" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: GLIMEPIRIDE taken for diabetes mellitus; AMLODIPINE taken for blood pressure measurement; OLMESARTAN taken for blood pressure measurement; PREDNISONE [PREDNISONE ACETATE]; SYNTHROID.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient stated she got the first dose and had no problem just a sore arm.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Vomiting
Clinical narrative: Headache; Throw up; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm (left shoulder), administration date 22Mar2021 07:00 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 23Mar2021 14:00, outcome "recovering", described as "Headache"; VOMITING (non-serious) with onset 23Mar2021 14:00, outcome "recovering", described as "Throw up". The events "headache" and "throw up" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, vomiting.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and other medications within two weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. He has no allergies to medications, food, or other products. Tylenol and other medicine were subscribed as treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Dysgeusia, Fatigue
Clinical narrative: Metallic taste; low body temperature 97.1; fatigue; 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 (not pregnant) received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 08Mar2021, outcome "not recovered", described as "Metallic taste"; BODY TEMPERATURE DECREASED (non-serious) with onset 08Mar2021, outcome "not recovered", described as "low body temperature 97.1"; FATIGUE (non-serious) with onset 08Mar2021, outcome "not recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia, body temperature decreased, fatigue. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling hot, Palpitations
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Feb2021 (Lot number: EL9261) at the age of 33 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "light headedness"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "generalized chills"; FEELING HOT (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "warmth to body"; PALPITATIONS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "palpitations". Therapeutic measures were not taken as a result of dizziness, chills, feeling hot, palpitations. Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness on my left arm 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. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness on my left arm at the injection site".  Additional information: Patient stated, "had the vaccine first dose Monday afternoon, had been told before I went to ask about the length of the needle. I did ask, they didn't seem to know there was a difference or anything to be concerned about. I had been told if you have a bigger arm, there are weight guidelines and to take a look at the arm." They told her at the vaccination site, that doesn't matter. "I checked guidelines. 1' to 1.5" needles. I only knew to ask because of my friend that I may need the 1.5" needle.  "I am not sure I got the correct size needle, it may be very wide spread, because there is not consistent knowledge. There seems to be a lack of knowledge regarding needle size".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Fall, Loss of personal independence in daily activities, Nausea
Clinical narrative: Vomiting; Weakness; Loss of balance; Nausea at very little; Fell on bathroom floor; Could not get up; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Feb2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing); "ulcerative colitis" (ongoing); "Crohns" (ongoing); "Pulmonary Embolism" (ongoing). Concomitant medications included: MERCAPTOPURINE taken for crohn's disease, colitis ulcerative, start date: Feb1993 (ongoing); ELIQUIS taken for pulmonary embolism, start date: Jan2016 (ongoing); PAROXETINE HCL taken for depression (ongoing); BUPROPION HCL taken for depression (ongoing). Vaccination history included: BNT162B2 (Dose 1, single (Lot Number: Not provided)), administration date: 25Jan2021, when the patient was 81 years old, for COVID-19 immunisation, reactions: "Sick with diarrhea", "Dry heaves", "She went to living room and fell", "Couldn't get up", "Tiredness", "She has a sore throat", "Fever blister on her mouth", "Severe headache", "Muscle pain in back of her neck and back", "Violent chills", "Almost 10 pounds in the two and half weeks with all this stuff", "Nausea", "weakness", "loss of balance". The following information was reported: NAUSEA (non-serious) with onset 18Feb2021, outcome "recovered" (21Feb2021), described as "Nausea at very little"; VOMITING (non-serious) with onset 22Feb2021 12:00, outcome "unknown", described as "Vomiting"; ASTHENIA (non-serious) with onset 22Feb2021 12:00, outcome "unknown", described as "Weakness"; BALANCE DISORDER (non-serious) with onset 22Feb2021 12:00, outcome "unknown", described as "Loss of balance"; FALL (non-serious) with onset 2021, outcome "unknown", described as "Fell on bathroom floor"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Could not get up".  Additional Information: On 18Feb2021 to 21Feb2021, the patient experienced nausea at very little and on 22Feb2021 at 12:00PM, she experienced vomiting, weakness, and loss of balance. The patient fell on bathroom floor, could not get up, and slept on the floor for about 3 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148886 Same patient and drug; Different dose and events