chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Headache, Immunisation, Lethargy, Pyrexia
Clinical narrative: lethargy; headache; low grade fever; tiredness; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 26 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Dec2021 17:30 (Batch/Lot number: unknown) at the age of 26 years as dose 3, (booster) single for covid-19 immunisation; influenza vaccine (FLU), administration date 17Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM, Route of Administration: Intramuscular), administration date: 16Jun2021, when the patient was 26 years old, for COVID-19 Immunization; Comirnaty (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM, Route of Administration: Intramuscular), administration date: 26May2021, when the patient was 26 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "booster"; LETHARGY (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "lethargy"; HEADACHE (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "headache"; PYREXIA (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "low grade fever"; FATIGUE (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "tiredness". Therapeutic measures were not taken as a result of immunisation, lethargy, headache, pyrexia, fatigue. Additional info- It was reported that Since the vaccination,  the patient had not  been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Immunisation
Clinical narrative: headache; Fever; chills; sore throat; tiredness; Dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 08:30 (Batch/Lot number: unknown) at the age of 42 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 Number: 2, Brand: Pfizer, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Brand: Pfizer, Batch/Lot No: Unknown. Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 08:30, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "headache"; PYREXIA (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "Fever"; CHILLS (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "chills"; OROPHARYNGEAL PAIN (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "sore throat"; FATIGUE (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia, chills, oropharyngeal pain, fatigue.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Yes covid was tested post vaccination.  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: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: headache; Fever; chills; sore throat; tiredness; Dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 08:30 (Batch/Lot number: unknown) at the age of 42 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 Number: 2, Brand: Pfizer, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Brand: Pfizer, Batch/Lot No: Unknown. Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 08:30, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "headache"; PYREXIA (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "Fever"; CHILLS (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "chills"; OROPHARYNGEAL PAIN (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "sore throat"; FATIGUE (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia, chills, oropharyngeal pain, fatigue.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Yes covid was tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Nausea, Sitting disability
Clinical narrative: Booster; can't sit straight; extreme nausea; he is very dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Covid-19 vaccine (Unknown dose), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 21Dec2021, outcome "unknown", described as "extreme nausea"; DIZZINESS (non-serious) with onset 21Dec2021, outcome "unknown", described as "he is very dizzy"; SITTING DISABILITY (non-serious) with onset 21Dec2021, outcome "unknown", described as "can't sit straight".  Additional information: Reporter was calling on behalf of her husband who received the Pfizer covid-19 vaccine booster shot this morning, about 6 hours ago and now he was experiencing side effects. Reporter mentioned, "extreme nausea, failing up (sounds like) he is very dizzy and can't sit straight." Reporter added, "looks like he had IBUPROFEN he had been taking prescriptions of IBUPROFEN." Reporter wanted to know if IBUPROFEN had an interaction with the vaccine. Upon checking the official PI I did not find any potential interaction or interaction study for the administration of IBUPROFEN to patients who experienced side effects after getting the vaccine, this may not have been studied.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Appendicitis, Immunisation, Pain, SARS-CoV-2 test
Clinical narrative: just received her 'third dose' of the pfizer covid vaccine today; developed a pain like an 'appendicitis'; developed a pain like an 'appendicitis'; her stomach turned and then she vomited; her stomach turned and then she vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 2021, stop date: 2021, notes: Covid 19 infection lasted about 4-5 days, she isolated for 10 days. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "Covid-19", "Vaccination failure"; Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "Covid-19", "Vaccination failure". The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021, outcome "unknown", described as "just received her 'third dose' of the pfizer covid vaccine today"; APPENDICITIS (medically significant), PAIN (non-serious) all with onset 21Dec2021, outcome "unknown" and all described as "developed a pain like an 'appendicitis'"; ABDOMINAL DISCOMFORT (non-serious), VOMITING (non-serious) all with onset 21Dec2021, outcome "unknown" and all described as "her stomach turned and then she vomited". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: tested negative twice afterwards; negative, notes: tested negative twice afterwards.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: just received her 'third dose' of the pfizer covid vaccine today; developed a pain like an 'appendicitis'; developed a pain like an 'appendicitis'; her stomach turned and then she vomited; her stomach turned and then she vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 2021, stop date: 2021, notes: Covid 19 infection lasted about 4-5 days, she isolated for 10 days. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "Covid-19", "Vaccination failure"; Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "Covid-19", "Vaccination failure". The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021, outcome "unknown", described as "just received her 'third dose' of the pfizer covid vaccine today"; APPENDICITIS (medically significant), PAIN (non-serious) all with onset 21Dec2021, outcome "unknown" and all described as "developed a pain like an 'appendicitis'"; ABDOMINAL DISCOMFORT (non-serious), VOMITING (non-serious) all with onset 21Dec2021, outcome "unknown" and all described as "her stomach turned and then she vomited". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: tested negative twice afterwards; negative, notes: tested negative twice afterwards.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pallor, SARS-CoV-2 test, Somnolence
Clinical narrative: passed out; became very pale grayish-blue; Was hard to wake and stay awake; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 10:30 (Lot number: fk5618) at the age of 7 years as dose 2, single for covid-19 immunisation.  The patient's relevant medical history was not reported. No covid experienced prior vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1. Batch/Lot No: fk5127. Location of injection: Arm Left), administration date: 04Nov2021, when the patient was 7 years old, for COVID-19 immunization. No other vaccine received in four weeks. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 26Nov2021 11:45, outcome "not recovered", described as "passed out"; PALLOR (non-serious) with onset 26Nov2021 11:45, outcome "not recovered", described as "became very pale grayish-blue"; SOMNOLENCE (non-serious) with onset 26Nov2021 11:45, outcome "not recovered", described as "Was hard to wake and stay awake". The clinical course of events was as follows: Patient became very pale grayish-blue and passed out. He was hard to wake and stay awake. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) unknown results, notes: Covid test result: Pending. Therapeutic measures were not taken as a result of loss of consciousness, pallor, somnolence. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Immunisation, Menstrual disorder, Oligomenorrhoea
Clinical narrative: Got period 10 days after the start of previous cycle and much heavier flow and clotting than usual; Menstrual cycle changes one week after receiving Covid vaccine booster; Got period 10 days after the start of previous cycle; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Got period 10 days after the start of previous cycle and much heavier flow and clotting than usual"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Menstrual cycle changes one week after receiving Covid vaccine booster"; OLIGOMENORRHOEA (non-serious), outcome "unknown", described as "Got period 10 days after the start of previous cycle"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster".  Additional information: No known underlying conditions or concomitant medication. Experienced menstrual cycle changes one week after receiving Covid vaccine booster. Got period 10 days after the start of previous cycle and much heavier flow and clotting than usual. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Burning sensation in her armpit like a sunburn or swim burn (left); Tiredness; Cramps in her legs, in her calf area; Booster; She feels like if she was beat up with rocks, that it is hurting bad; Pain in her left 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 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 14:00 (Lot number: SE3594) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Lot number of ER8732), administration date: 01Apr2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Stated that she did not experience side effects with first two"; Covid-19 vaccine (Dose: 2, Lot number of EW0164), administration date: 30Apr2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Stated that she did not experience side effects with first two"; None (Patient History: No). The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:00, outcome "unknown", described as "Booster"; BURNING SENSATION (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Burning sensation in her armpit like a sunburn or swim burn (left)"; PAIN (non-serious) with onset 20Dec2021, outcome "not recovered", described as "She feels like if she was beat up with rocks, that it is hurting bad"; FATIGUE (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Tiredness"; MUSCLE SPASMS (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Cramps in her legs, in her calf area"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Pain in her left arm". Therapeutic measures were taken as a result of burning sensation, pain, fatigue, muscle spasms.  Additional information: The patient did not experience side effects with first two. She got the shot in her left arm and under her arm pit is like a burning sensation like a sunburn or swim burn. The patient wanted to make sure if this is normal. She did great with the first two. She experienced body feels like it has been beat up with rocks after she laid down a few hours later after coming from the site. It got more intense when she woke up around 5am this morning and her armpit a sensation of burning. She got the shot yesterday at 2pm. She was tired after she woke up this tired. The leg cramps comes and goes and started this morning. Stated that the leg cramps were in her calf area. She took Tylenol for body feels like it has been beat up with rocks. Stated that she put a cold rag underneath her armpit. Stated that she has been lying down drinking fluids for tired. Stated that she rubbed her legs with alcohol.  No follow-up attempts are required. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; tested positive for COVID-19 despite having had the 3rd booster shot; tested positive for COVID-19 despite having had the 3rd booster shot; This is a spontaneous report received from contactable reporters (Consumer).  A 44-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It's unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported IMMUNISATION (medically significant), outcome unknown; DRUG INEFFECTIVE (medically significant) with onset 20Dec2021, outcome unknown, COVID-19 (medically significant) with onset 20Dec2021, outcome recovering and all described as tested positive for COVID-19 despite having had the 3rd booster shot. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures sars-cov-2 test (20Dec2021) positive. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: pericarditis; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis". A patient was suffering from pericarditis three days after receiving the second dose of the vaccine. Consumer inquired if they can receive the booster dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Disturbance in attention, Energy increased, Immunisation, Psychomotor hyperactivity, Tinnitus
Clinical narrative: ringing in ears; Hyperactivity; extreme energy; inability to concentrate; dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 14:30 (Lot number: FJ8757) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), administered in arm left, administration date 20Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Goat/sheep milk" (unspecified if ongoing), notes: known allergies: Goat/sheep milk; "Hypertension" (unspecified if ongoing); "Herpes" (unspecified if ongoing); "PVC's" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; TOPIRAMATE; PHENTERMINE; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left), administration date: 07May2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "ringing in ears", "Hyperactivity", "extreme energy", "inability to concentrate"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:30, outcome "unknown", described as "dose received 3"; TINNITUS (non-serious) with onset 20Dec2021 16:00, outcome "recovering", described as "ringing in ears"; PSYCHOMOTOR HYPERACTIVITY (non-serious) with onset 20Dec2021 16:00, outcome "recovering", described as "Hyperactivity"; ENERGY INCREASED (non-serious) with onset 20Dec2021 16:00, outcome "recovering", described as "extreme energy"; DISTURBANCE IN ATTENTION (non-serious) with onset 20Dec2021 16:00, outcome "recovering", described as "inability to concentrate". Therapeutic measures were not taken as a result of tinnitus, psychomotor hyperactivity, energy increased, disturbance in attention.  Additional Information: No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus/ ringing in my ear; 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 76 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6202) 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, Lot: EL296Z), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Feb2021, outcome "not recovered", described as "tinnitus/ ringing in my ear". No follow-up attempts are possible. No further information is expected.  Additional information: Patient reported that after getting the second dose she developed a tinnitus and she was about to get the booster shot. She was refusing to get the Booster shot because she was afraid or scared about her tinnitus might be worsened after getting the booster shot. So, she was basically asking for an advice if she can skip getting the booster shot. Patient stated "I got the first and second Pfizer vaccine and then after the second one I noticed I was getting very strong tinnitus, ringing in my ear and it has not gone away, that was back in Feb and it is strong. Now while they are talking about getting a booster shot and how the variant is all over the world and my Doctor does not recommend I get the booster and I am not getting the booster because I don't want to this tinnitus to get any worst. But I don't know Pfizer must have other people who have got tinnitus and I was wondering do you know if after a longer time, well I was one of the first ones if they have found that it has gone better or what do you suggest for people who cannot get the booster? Now, I know Pfizer is going to come out with pills that are antiviral pills. They have not approved yet. But the FDA has approved something by Astra Zeneca, it is an injection an antibody treatment which I am thinking well may be that is an equivalent sort of a booster."  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: tinnitus/has it in the left ear; Sounds are distorted; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: TINNITUS (medically significant), outcome "unknown", described as "tinnitus/has it in the left ear"; HYPOACUSIS (medically significant), outcome "unknown", described as "Sounds are distorted". Therapeutic measures were taken as a result of tinnitus, hypoacusis including steroid shots (unspecified). Additional information: The patient wanted to know if tinnitus was a symptom after the second vaccination. The patient has it in the left ear. The sounds are distorted and steroid shorts from the ENT did not help.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her daughters covid 19 infection lasted about 4-5 days; her daughters covid 19 infection lasted about 4-5 days; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent. A 20-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "recovered" (2021) and all described as "her daughters covid 19 infection lasted about 4-5 days". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative; (2021) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The parent called on behalf of her 20-year-old daughter just received her 'third dose' of the Pfizer covid vaccine today (21Dec2021). She stated that her daughter recovered from covid 19 about 2-3 weeks ago (around thanksgiving [Nov2021]). States her daughters covid 19 infection lasted about 4-5 days (Nov2021), she isolated for 10 days (2021), tested negative twice afterwards (2021). She confirmed that her daughter received primary series of the Pfizer covid vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid 19; Tested positive for covid 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 27 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test (2021) positive. Patient received COVID 19 vaccination on an unspecified date in May/Jun2021. She had headache, sore throat, chills, cough, muscle aches2, and was tested positive for COVID 19. It was reported that, event took place after use of product.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive to Covid 19; Tested positive to Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date Jun2021 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single and intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications within 2 weeks 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. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021, outcome recovering. The event tested positive to covid 19 and tested positive to covid 19 was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (20Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. It was reported that the patient tested positive to Covid-19 with headache, sore throat, chills, muscle aches, and cough. Since the vaccination, has the patient 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Body temperature decreased, Breast discomfort, Breast pain
Clinical narrative: Left armpit grew to the size of a baseball and was very hard and extremely painful to a point it was hard to move my arm; Left armpit grew to the size of a baseball; Breast tissue on left side was hardened and very painful as well.; Breast tissue on left side was hardened and very painful as well.; Temperature reading at 95.6 F; Aches and pains.; Left armpit grew to the size of a baseball and was very hard and extremely painful to a point it was hard to move my arm; Dose number = 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 11:45 (Lot number: FJ8762) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: APRI taken for contraception. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 19May2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151), administration date: 28Apr2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 11:45, outcome "unknown", described as "Dose number = 3"; AXILLARY PAIN (non-serious), MOBILITY DECREASED (non-serious) all with onset 21Dec2021 14:00, outcome "not recovered" and all described as "Left armpit grew to the size of a baseball and was very hard and extremely painful to a point it was hard to move my arm"; LYMPHADENOPATHY (non-serious) with onset 21Dec2021 14:00, outcome "not recovered", described as "Left armpit grew to the size of a baseball"; BREAST DISCOMFORT (non-serious), BREAST PAIN (non-serious) all with onset 21Dec2021 14:00, outcome "not recovered" and all described as "Breast tissue on left side was hardened and very painful as well."; BODY TEMPERATURE DECREASED (non-serious) with onset 21Dec2021 14:00, outcome "not recovered", described as "Temperature reading at 95.6 F"; PAIN (non-serious) with onset 21Dec2021 14:00, outcome "not recovered", described as "Aches and pains.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of axillary pain, lymphadenopathy, breast discomfort, breast pain, body temperature decreased, pain, mobility decreased.  Additional information: Ae treatment was told to take an anti-inflammatory drug and ice the area to bring down swelling. Patient did not have covid prior vaccination and covid was not tested post vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Mobility decreased, Pain
Clinical narrative: Left armpit grew to the size of a baseball and was very hard and extremely painful to a point it was hard to move my arm; Left armpit grew to the size of a baseball; Breast tissue on left side was hardened and very painful as well.; Breast tissue on left side was hardened and very painful as well.; Temperature reading at 95.6 F; Aches and pains.; Left armpit grew to the size of a baseball and was very hard and extremely painful to a point it was hard to move my arm; Dose number = 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 11:45 (Lot number: FJ8762) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: APRI taken for contraception. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 19May2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151), administration date: 28Apr2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 11:45, outcome "unknown", described as "Dose number = 3"; AXILLARY PAIN (non-serious), MOBILITY DECREASED (non-serious) all with onset 21Dec2021 14:00, outcome "not recovered" and all described as "Left armpit grew to the size of a baseball and was very hard and extremely painful to a point it was hard to move my arm"; LYMPHADENOPATHY (non-serious) with onset 21Dec2021 14:00, outcome "not recovered", described as "Left armpit grew to the size of a baseball"; BREAST DISCOMFORT (non-serious), BREAST PAIN (non-serious) all with onset 21Dec2021 14:00, outcome "not recovered" and all described as "Breast tissue on left side was hardened and very painful as well."; BODY TEMPERATURE DECREASED (non-serious) with onset 21Dec2021 14:00, outcome "not recovered", described as "Temperature reading at 95.6 F"; PAIN (non-serious) with onset 21Dec2021 14:00, outcome "not recovered", described as "Aches and pains.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of axillary pain, lymphadenopathy, breast discomfort, breast pain, body temperature decreased, pain, mobility decreased.  Additional information: Ae treatment was told to take an anti-inflammatory drug and ice the area to bring down swelling. Patient did not have covid prior vaccination and covid was not tested post vaccination.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Nausea, Pain, Vomiting
Clinical narrative: he is having a similar reaction to that he had to his second dose where he is just nauseous; throwing up; Chills; sore and achy; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Lot number: FJ8762) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose of covid vaccine, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (2nd dose of covid vaccine, manufacturer unknown), for COVID-19 Immunization, reaction(s): "nauseous". The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 21Dec2021 06:00, outcome "unknown", described as "he is having a similar reaction to that he had to his second dose where he is just nauseous"; VOMITING (non-serious) with onset 21Dec2021 06:00, outcome "unknown", described as "throwing up"; CHILLS (non-serious) with onset 21Dec2021 06:00, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 21Dec2021 06:00, outcome "unknown", described as "sore and achy". Therapeutic measures were taken as a result of nausea, vomiting, chills, pain.  Additional information: Patient was stated adverse event after booster dose and similar reaction as second dose, Nauseous. Patient stated throwing up, chills, sore and achy. The patient received treatment with Zoloft for  nausea, vomiting, chills, pain  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough Case of Covid-19.She received Positive Rapid test result on Dec 20 but is awaiting PCR confirmation.; Breakthrough Case of Covid-19.She received Positive Rapid test result on Dec 20 but is awaiting PCR confirmation.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in arm right, administration date 13Apr2021 10:00 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single, and intramuscular, administered in arm right, administration date 23Mar2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included High Blood Pressure (unspecified if ongoing); Chronic Eyeritis (ongoing). No covid prior vaccination. Concomitant medication(s) included AMLODIPINE; VITAMIN D; IRON. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Dec2021, outcome recovering. She received Positive Rapid test result on Dec 20 but is awaiting PCR confirmation. The patient underwent the following laboratory tests and procedures SARS-CoV-2 test (20Dec2021) positive, Rapid test; (20Dec2021) unknown, PCR. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Culture urine, Immunisation, Pyrexia
Clinical narrative: Booster; she had fever after the booster for two days and then it went away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 08Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "she had fever after the booster for two days and then it went away". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On 08/DEC/2021, last week Wednesday, the patient took the booster for COVID-19 (corona virus disease 2019) so her doctor had her skip her Enbrel last Saturday 11/DEC/2021. On an unknown date in DEC/2021, she had fever after the booster for two days and then it went away. The patient now had new symptoms of fever and she did not know what from. On 15/DEC/2021, a day prior to this report, the patient had a urine sample checked and was waiting for the results. The fever was currently gone when on Tylenol and she did not have any urinary symptoms. The patient would wait for the results and call her health care professional (HCP) if still having fever or on antibiotics when due for her Enbrel on Saturday. On 15/DEC/2021, urine sample was performed. Treatment for the event fever included Tylenol (paracetamol). The causal relationship between the event pyrexia and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. No further information has been requested. Etanercept (ENBREL) is under agreement with Amgen. Causality Assessment: Fever Per Company (Amgen) = No.   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: Granulomatous liver disease, Pulmonary granuloma, SARS-CoV-2 test, Splenic granuloma
Clinical narrative: Multiple calcified granulomas in lung liver and spleen; Multiple calcified granulomas in lung liver and spleen; Multiple calcified granulomas in lung liver and spleen; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Jul2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Kidney cancer", start date: 2018 (unspecified if ongoing); "Chronic kidney disease" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: PTSD; "ECT" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to vaccination. The patient received other medications within 2 weeks of vaccination. The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Not available/provided to reporter at the time of report completion), administration date: 09Jun2021, when the patient was 39 years old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: PULMONARY GRANULOMA (disability), GRANULOMATOUS LIVER DISEASE (disability), SPLENIC GRANULOMA (disability) all with onset 13Jul2021, outcome "not recovered" and all described as "Multiple calcified granulomas in lung liver and spleen". The event "multiple calcified granulomas in lung liver and spleen" was evaluated at the physician office visit. The patient underwent COVID-19 test/ sars-cov-2 test: (13Jul2021) negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of pulmonary granuloma, granulomatous liver disease, splenic granuloma. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information given in narrative, the causal relationship between the events PULMONARY GRANULOMA, GRANULOMATOUS LIVER DISEASE, SPLENIC GRANULOMA and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Diarrhoea, Illness, Immunisation
Clinical narrative: Caller states she became sick and started getting sick; Booster; congestion; cough; sore throat; fever; diarrhea; she thinks no appetite.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 19Oct2021 (Lot number: FF2588) at the age of 49 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: 01, lot number:  PF EN6207), administration date: 17Mar2021, when the patient was 49 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 02, lot number: EW0162, Anatomical Location of Administration of Pfizer vaccine considered as suspect: left upper arm), administration date: 05Apr2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "the 2nd dose she got was diluted too much and was recommended to get revaccinated for the 2nd shot", "the 2nd dose she got was diluted too much and was recommended to get revaccinated for the 2nd shot". The following information was reported: IMMUNISATION (non-serious) with onset 19Oct2021, outcome "unknown", described as "Booster"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "diarrhea"; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "she thinks no appetite."; ILLNESS (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Caller states she became sick and started getting sick". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (21Dec2021): This is a spontaneous follow-up report from same contactable Consumer. This 49-year-old female patient reported for herself that:  Updated information: Reporter information, Patient information, Relevant Medical History, Historical Vaccine, Lab data, Suspect product information and Event information were added  No follow-up attempts are possible. No further information is expected.