chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my first two shots with no problems other than a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Feb2021 (Lot number: EN6202) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine based medication makes me nauseous", notes: Known allergies: Codeine based medication makes me, nauseous; Codeine, reaction(s): "Known allergies: Codeine based medication makes me nauseous", notes: Known allergies: Codeine based medication makes me, nauseous. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Jan2022, outcome "not recovered", described as "my first two shots with no problems other than a sore arm". The event "my first two shots with no problems other than a sore arm" was evaluated at the physician office visit and emergency room visit. No follow-up attempts are possible. No further information is expected. Additional Information: The patient reported that she got her first two shots with no problems other than a sore arm. When she got her booster, she got a fever; chills; body aches; nausea; sore, swollen glands; and a sore arm. She was not alarmed but figured it was an immune response. However, within the month she got shingles. She believed that had she not gotten this booster, she would not have gotten shingles. She believed people should be instructed to be vaccinated against the shingles prior to receiving this Covid vaccine. She wonder how many others this has happened to that have not reported it or thought there was a connection. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medication within 2 weeks. The patient did not have covid prior vaccination. The patient was not tested with covid post vaccination.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Penis disorder
Clinical narrative: Penis doesn't go up anymore; gets big but does not get hard; he has not been able to stand or use his legs.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administration date 26May2021 (Lot number: EW0179) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1 , Lot Number: EW0179, NDC and Expiry Date: Unknown by the caller), administration date: 05May2021, when the patient was 44 years old, for Covid-19 Immunization. The following information was reported: PENIS DISORDER (non-serious), outcome "unknown", described as "Penis doesn't go up anymore; gets big but does not get hard"; DYSSTASIA (non-serious), outcome "unknown", described as "he has not been able to stand or use his legs.".  Additional information: Is report related to a study or programme- No. The patient wants to know what he can do about this.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Menstruation irregular, Oligomenorrhoea
Clinical narrative: had gotten it back by the end of OCT and right now patient still has it.; lost her menstrual cycle; 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 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 (Lot number: EW0173) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, lot number of EW0151, Date: 20Apr2021), administration date: 20Apr2021, when the patient was 16 years old, for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Jul2021, outcome "unknown", described as "lost her menstrual cycle"; OLIGOMENORRHOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "had gotten it back by the end of OCT and right now patient still has it.". The events "lost her menstrual cycle" and "had gotten it back by the end of oct and right now patient still has it." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had no issues besides being tired. Caller declines to make a report. It is unknown if the patient had medical history including any illness at the time of vaccination. Patients regular doctor suggested the labs and they didn't find any problems and the next step is birth control to get patient back regulated.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Hot flush, Hyperhidrosis, Hysteroscopy, Investigation
Clinical narrative: Constant hot flashes; sweating; missed period for 3 months; Endometrial polyp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:00 (Lot number: FJ8762) at the age of 45 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: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Prev dose brand unknown=False, Prev dose lot unknown=False), administration date: 19Apr2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Prev dose brand unknown=False, Prev dose lot unknown=False), administration date: 27Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: HOT FLUSH (non-serious) with onset 06Dec2021, outcome "unknown", described as "Constant hot flashes"; HYPERHIDROSIS (non-serious) with onset 06Dec2021, outcome "unknown", described as "sweating"; AMENORRHOEA (non-serious) with onset 06Dec2021, outcome "unknown", described as "missed period for 3 months"; UTERINE POLYP (non-serious) with onset 06Dec2021, outcome "unknown", described as "Endometrial polyp". The events "constant hot flashes", "sweating", "missed period for 3 months" and "endometrial polyp" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hot flush, hyperhidrosis, amenorrhoea, uterine polyp.  Additional information:The events were treated with blood tests, ultrasound and hysteroscopy. The patient did not have COVID prior vaccination but on 22Jan2022 the patient was tested positive for Covid test (Nasal Swab) post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Ultrasound scan, Uterine polyp
Clinical narrative: Constant hot flashes; sweating; missed period for 3 months; Endometrial polyp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:00 (Lot number: FJ8762) at the age of 45 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: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Prev dose brand unknown=False, Prev dose lot unknown=False), administration date: 19Apr2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Prev dose brand unknown=False, Prev dose lot unknown=False), administration date: 27Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: HOT FLUSH (non-serious) with onset 06Dec2021, outcome "unknown", described as "Constant hot flashes"; HYPERHIDROSIS (non-serious) with onset 06Dec2021, outcome "unknown", described as "sweating"; AMENORRHOEA (non-serious) with onset 06Dec2021, outcome "unknown", described as "missed period for 3 months"; UTERINE POLYP (non-serious) with onset 06Dec2021, outcome "unknown", described as "Endometrial polyp". The events "constant hot flashes", "sweating", "missed period for 3 months" and "endometrial polyp" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hot flush, hyperhidrosis, amenorrhoea, uterine polyp.  Additional information:The events were treated with blood tests, ultrasound and hysteroscopy. The patient did not have COVID prior vaccination but on 22Jan2022 the patient was tested positive for Covid test (Nasal Swab) post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Just a little pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 14 year-old male patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (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: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Just a little pain". Additional information: Reporter had two male patients yesterday (21Feb2021) that asked for a booster [Pfizer BioNTech Covid-19 Vaccine]. 14 years old and 15 years old. Their last doses were given in the summer. Their mother was telling that they were given in Aug2021. She gave them the booster, 0.3mL, to both. The LOT number was FK9896. She made a mistake and did not ask for their vaccination cards until after and saw that their first dose was 11Aug2021 and their second dose was 12Oct2021. She was counting the interval between their last dose and the booster, and it was 19 days short of five months. They did very good with the first two doses. Just a little pain. So, she was hoping they do okay with the booster even though they got it early. Reporter have one or two patients to whom the first dose was given and didn't come to get their second dose for a month or two after the first dose, but reporter went ahead and gave the second dose. Some had diarrhea and vomiting after eating something, but it was not related to the vaccine. Two patient's reporter before had a big interval before the second dose. Reporter also asking, the booster dose was 0.3 (mL) Or was it 0.5, and thought it was 0.5mL for adults.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200317235 same reporter/different patient/same AE.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: taking naps after the Covid vaccine; felt a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "taking naps after the Covid vaccine"; FATIGUE (non-serious), outcome "unknown", described as "felt a little tired".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: several brain fog; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jul2021 11:00 (Lot number: fa9100) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: exo575, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 20Jun2021, when the patient was 23 years old, for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 13Jul2021, outcome "recovered with sequelae", described as "several brain fog"; FATIGUE (non-serious) with onset 13Jul2021, outcome "recovered with sequelae", described as "fatigue". The events "several brain fog" and "fatigue" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of feeling abnormal, fatigue.  Additional information: Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received multivitamins within 2 weeks of vaccination. Since the vaccination, patient had not been tested for COVID-19. There were no known allergies. There were no other medical history. Patient received 3rd dose on 08Feb2022 at 4:30 PM on right arm (lot no fk9729).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Just a little pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (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: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Just a little pain".  Additional information: Reporter had two male patients yesterday (21Feb2021) that asked for a booster [Pfizer BioNTech Covid-19 Vaccine]. 14 years old and 15 years old. Their last doses were given in the summer. Their mother was telling that they were given in Aug2021. She gave them the booster, 0.3mL, to both. The LOT number was FK9896. She made a mistake and did not ask for their vaccination cards until after and saw that their first dose was 11Aug2021 and their second dose was 12Oct2021. She was counting the interval between their last dose and the booster, and it was 19 days short of five months. They did very good with the first two doses. Just a little pain. So, she was hoping they do okay with the booster even though they got it early. Reporter have one or two patients to whom the first dose was given and didn't come to get their second dose for a month or two after the first dose, but reporter went ahead and gave the second dose. Some had diarrhea and vomiting after eating something, but it was not related to the vaccine. Two patients reporter before had a big interval before the second dose. Reporter also asking, the booster dose was 0.3 (mL) Or was it 0.5, and thought it was 0.5mL for adults.  The lot number for bnt162b2 was not provided and will be requested during follow up.Sender's Comments: Linked Report(s) : US-PFIZER INC-202200315805 same reporter/different patient/same AE
Sex: M
Vaccine: COVID19
Symptoms: Heat stroke, Hyperhidrosis, Muscular weakness
Clinical narrative: Muscle weakness; sweating; overheating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Muscle weakness"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; HEAT STROKE (non-serious), outcome "unknown", described as "overheating".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Muscular weakness, Vaccination site haemorrhage
Clinical narrative: general feeling of weakness; it's hard to a hard to do things her to walk; yes i''m i got the booster shot on january twentieth and i''ve had a lot of weakness in both legs; the spot or i got the injection this is generate twentieth it still hasn't healed up i'm still getting blood out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 20Jan2022 (Batch/Lot number: unknown) at the age of 79 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: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 20Jan2022, outcome "not recovered", described as "yes i''m i got the booster shot on january twentieth and i''ve had a lot of weakness in both legs"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 20Jan2022, outcome "not recovered", described as "the spot or i got the injection this is generate twentieth it still hasn't healed up i'm still getting blood out"; ASTHENIA (non-serious), outcome "unknown", described as "general feeling of weakness"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "it's hard to a hard to do things her to walk".  Additional information: Patient had a lot of weakness in both legs and a the spot or she got the injection this was like 26Jan2022 it still hasn't healed up she was still getting blood out of it but the week or something problems with weakness in her legs she was waiting for the vaccines went off and so this would go away so it's really annoying it's hard to a hard to do things hard to walk just a general feeling of weakness from this so and she heard other people have had this problem too so she did nt plan on getting any more booster this is so her friends had booster they didnt had problems she was the only one that had so that she knew of.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Dyspnoea, Fatigue, Heavy menstrual bleeding, Lethargy
Clinical narrative: Menstrual cycle lasts for over 2 weeks and is very heavy and painful; Menstrual cycle lasts for over 2 weeks and is very heavy and painful; Menstrual cycle lasts for over 2 weeks and is very heavy and painful; Very tired; lethargic; Unable to catch breath when running; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) received via regulatory authority. The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 15:00 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin Allergy" (unspecified if ongoing); "COVID-19", start date: 05Apr2021 (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot No: Unknown, Unable to locate or read the details, Anatomical Location: Arm Left, Vaccination time: 03:00 PM), administration date: 09Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: OLIGOMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 30Apr2021, outcome "not recovered" and all described as "Menstrual cycle lasts for over 2 weeks and is very heavy and painful"; FATIGUE (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Very tired"; LETHARGY (non-serious) with onset 30Apr2021, outcome "not recovered", described as "lethargic"; DYSPNOEA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Unable to catch breath when running". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oligomenorrhoea, heavy menstrual bleeding, dysmenorrhoea, fatigue, lethargy, dyspnoea.  Additional information: Patient did not receive other vaccine in four weeks. Patient's other medications in two weeks included birth control contraception. Patient had no COVID prior vaccination. Patient was tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea, SARS-CoV-2 test
Clinical narrative: Menstrual cycle lasts for over 2 weeks and is very heavy and painful; Menstrual cycle lasts for over 2 weeks and is very heavy and painful; Menstrual cycle lasts for over 2 weeks and is very heavy and painful; Very tired; lethargic; Unable to catch breath when running; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) received via regulatory authority. The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 15:00 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin Allergy" (unspecified if ongoing); "COVID-19", start date: 05Apr2021 (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot No: Unknown, Unable to locate or read the details, Anatomical Location: Arm Left, Vaccination time: 03:00 PM), administration date: 09Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: OLIGOMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 30Apr2021, outcome "not recovered" and all described as "Menstrual cycle lasts for over 2 weeks and is very heavy and painful"; FATIGUE (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Very tired"; LETHARGY (non-serious) with onset 30Apr2021, outcome "not recovered", described as "lethargic"; DYSPNOEA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Unable to catch breath when running". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oligomenorrhoea, heavy menstrual bleeding, dysmenorrhoea, fatigue, lethargy, dyspnoea.  Additional information: Patient did not receive other vaccine in four weeks. Patient's other medications in two weeks included birth control contraception. Patient had no COVID prior vaccination. Patient was tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: arm was a little tender from shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 27Oct2021 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high Blood pressure" (unspecified if ongoing), notes: I do have high Blood pressure and take Meds for it; "breast cancer" (unspecified if ongoing), notes: she has had breast cancer, 20 years ago. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Date: 27Feb2021, Anatomical site of injection: Arm, Route of administration: Intramuscular), administration date: 27Feb2021, when the patient was 70 years old, for Covid-19 immunization; Bnt162b2 (2nd Dose, Date: 20Mar2021, Anatomical site of injection: Arm , Route of administration: Intramuscular), administration date: 20Mar2021, when the patient was 71 years old, for Covid-19 Immunization. The following information was reported: TENDERNESS (non-serious), outcome "unknown", described as "arm was a little tender from shot". Therapeutic measures were taken as a result of tenderness. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Insomnia, Off label use, Product use issue, Restlessness
Clinical narrative: Sleeplessness lasting 3 weeks, could not sleep more than 2-3 hours at a time/ sleeplessness; General feeling of agitation after dose 1, only way to describe it is what I would imagine an athlete on steroids feels. Peaked at about week 2/ agitation; Restlessness; Nursing mother; BNT162b2 was administered to breast feeding mother/ Nursing mother; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Sep2021 14:30 (Lot number: EW0180) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious) with onset 01Sep2021 14:30, outcome "unknown", described as "Nursing mother", PRODUCT USE ISSUE (non-serious) with onset 01Sep2021 14:30, outcome "unknown", described as "BNT162b2 was administered to breast feeding mother/ Nursing mother", INSOMNIA (non-serious) with onset 03Sep2021 10:00, outcome "recovered" (Sep2021), described as "Sleeplessness lasting 3 weeks, could not sleep more than 2-3 hours at a time/ sleeplessness", AGITATION (non-serious) with onset 03Sep2021 10:00, outcome "recovered", described as "General feeling of agitation after dose 1, only way to describe it is what I would imagine an athlete on steroids feels. Peaked at about week 2/ agitation", RESTLESSNESS (non-serious) with onset 03Sep2021 10:00, outcome "recovered", described as "Restlessness". Therapeutic measures were not taken as a result of insomnia, agitation, restlessness.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported of a general feeling of agitation after dose 1, only way to describe it was what she would imagine an athlete on steroids feels. It peaked at about week 2. The patient waited as long as she could before receiving dose 2 but required to receive it before the end of September due to mandate. Nursing mother. 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. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: Patient's white blood cells dropped dramatically and it started after getting the 1st dose; 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.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "Patient's white blood cells dropped dramatically and it started after getting the 1st dose". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Heavy bleeding; Irregular menstrual cycles; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 13:00 (Lot number: 023M20A) at the age of 46 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: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 03Dec2021, outcome "unknown", described as "Heavy bleeding"; MENSTRUATION IRREGULAR (non-serious) with onset 03Dec2021, outcome "unknown", described as "Irregular menstrual cycles". The events "heavy bleeding" and "irregular menstrual cycles" were evaluated at the physician office visit. Therapeutic measures were taken as a result of heavy menstrual bleeding, menstruation irregular.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: None. Patient had irregular menstrual cycles after the vaccine. It was heavy bleeding, and this never happened to her before this vaccine. Adverse event result in any other healthcare professional office/clinic visit. OB visit and medications to control bleeding was given as a treatment. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Loss of personal independence in daily activities, Malaise
Clinical narrative: Not feeling to well; He had cold chills; Muscle aches; Joint pain; Fatigue; He is not able to work; Aches; He had cold chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2), administration date Feb2022 (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 (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset Feb2022, outcome "unknown", described as "Not feeling to well"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset Feb2022, outcome "unknown" and all described as "He had cold chills"; MYALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Muscle aches"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Joint pain"; FATIGUE (non-serious) with onset Feb2022, outcome "unknown", described as "Fatigue"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Feb2022, outcome "unknown", described as "He is not able to work"; PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Aches".  Additional Information: Other products and investigation assessment was not provided. Reporter stated that she was calling for her husband. Stated he took his booster shot yesterday and last night as he was getting ready for work, he was complaining he was not feeling to well, he had cold chills. Stated he went to work and today came back and all day he had cold chills and muscle aches and not feeling too well, he also had joint pain.  Reporter clarified that patient was not in need of emergent care, he felt more like fatigue, joint pain, aches and all that. Reporter was asking how long the report takes as she needs to get going. Stated he got the batch number was either FK or FC 9896 on his card. It was Stated he got it because his job needed him to get the booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Pain
Clinical narrative: Not feeling to well; He had cold chills; Muscle aches; Joint pain; Fatigue; He is not able to work; Aches; He had cold chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2), administration date Feb2022 (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 (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset Feb2022, outcome "unknown", described as "Not feeling to well"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset Feb2022, outcome "unknown" and all described as "He had cold chills"; MYALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Muscle aches"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Joint pain"; FATIGUE (non-serious) with onset Feb2022, outcome "unknown", described as "Fatigue"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Feb2022, outcome "unknown", described as "He is not able to work"; PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Aches".  Additional Information: Other products and investigation assessment was not provided. Reporter stated that she was calling for her husband. Stated he took his booster shot yesterday and last night as he was getting ready for work, he was complaining he was not feeling to well, he had cold chills. Stated he went to work and today came back and all day he had cold chills and muscle aches and not feeling too well, he also had joint pain.  Reporter clarified that patient was not in need of emergent care, he felt more like fatigue, joint pain, aches and all that. Reporter was asking how long the report takes as she needs to get going. Stated he got the batch number was either FK or FC 9896 on his card. It was Stated he got it because his job needed him to get the booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 11:30 (Lot number: EL1283) at the age of 60 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: LETHARGY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Lethargic".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Pruritus, Rash
Clinical narrative: Rash; Bumps; Itching; Red skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774).  A female patient received bnt162b2 (BNT162B2) (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 number unk, Unknown manufacturer.), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Bumps"; PRURITUS (non-serious), outcome "unknown", described as "Itching"; ERYTHEMA (non-serious), outcome "unknown", described as "Red skin".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: their first dose was 11Aug2021 and their second dose was 12Oct2021; Just a little pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 14 year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (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), administration date: 11Aug2021, for COVID-19 Immunization, reaction(s): "Just a little pain". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "their first dose was 11Aug2021 and their second dose was 12Oct2021"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Just a little pain".  Additional Information: Caller had two male patients in his office on 21Feb2021 that asked for a booster [Pfizer BioNTech Covid-19 Vaccine]. 14 years old and 15 years old. They told him their last doses were given in the summer. Their mother was telling him they were given in Aug2021. He gave them the booster, 0.3mL, to both. The LOT number was FK9896. He made a mistake and did not ask for their vaccination cards until after, and he saw that their first dose was 11Aug2021 and their second dose was 12Oct2021. He was counting the interval between their last dose and the booster, and it was 19 days short of five months. They did very good with the first two doses. Just a little pain. So, he was hoping they do okay with the booster even though they got it early. Caller asking for any supporting documentation Pfizer may have to shed further light on her situation regarding efficacy and safety of a booster dose given earlier than 5 months after completing the primary series. Caller went on to say, he have one or two patients to whom he gave the first dose that didn't come to get their second dose for a month or two after the first dose, but he went ahead and gave the second dose. Some had diarrhoea and vomiting after eating something but it was not related to the vaccine. Two patients he had from before had a big interval before the second dose. Caller also asking, the booster dose is 0.3 (mL) Or is it 0.5 he thought it was 0.5mL for adults.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200317235 same reporter/different patient/same AE;US-PFIZER INC-202200323191 same reporter/different patient/same AE
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: their first dose was 11Aug2021 and their second dose was 12Oct2021; Just a little pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (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 (First Dose, They did very good with the first two doses. Just a little pain.), administration date: 11Aug2021, for COVID-19 Immunization, reaction(s): "They did very good with the first two doses. Just a little pain.". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Oct2021, outcome "unknown", described as "their first dose was 11Aug2021 and their second dose was 12Oct2021"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Just a little pain". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200317235 same reporter/different patient/same AE;US-PFIZER INC-202200323190 same reporter/different patient/same AE
Sex: M
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: Developed neuro deficits starting in lower extremities within 2 weeks from vaccine #1; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 51 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (ongoing); "Hyperlipidemia" (ongoing); "Sinus tachycardia" (unspecified if ongoing); "Esophagitis" (unspecified if ongoing). Concomitant medication(s) included: HCTZ taken for hypertension. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "Developed neuro deficits starting in lower extremities within 2 weeks from vaccine #1". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I was very tired for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 09:00 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 64 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "I was very tired for 2 days". Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient stated that With First dose I was very tired for 2 days. With Second dose I felt in a fog or hangover for a week. My hot flashes returned for couple months. They did stop. With booster, had fever 100.4 and chills for 3 days. Hot flashes came back and still have then today arm was sore.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hot flush
Clinical narrative: i felt in a fog or hangover; my hot flashes returned for a couple months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 17Apr2021 09:00 (Lot number: ER8731, Expiration Date: 31Jul2021) at the age of 64 years 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, Single, Time: 09:00 AM, Batch Number: ER8733, Expiry Date: 31Jul2021), administration date: 27Mar2021, when the patient was 64 years old, for covid-19 immunization, reaction(s): "I was very tired for 2 days". The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Apr2021, outcome "recovered" (2021), described as "i felt in a fog or hangover"; HOT FLUSH (non-serious) with onset 17Apr2021, outcome "recovered" (2021), described as "my hot flashes returned for a couple months". Therapeutic measures were not taken as a result of feeling abnormal, hot flush.  Additional information: Patient with first dose I was very tired for 2 days. Patient with second dose I felt in a fog or hangover for a week. My hot flashes returned for couple months, they did stop. With booster, had fever 100.4 chills, hot flashes came back and still have then today arm was sore  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: The finger tips getting numb was with the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FMWBO) at the age of 20 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: HYPOAESTHESIA (non-serious) with onset Nov2021, outcome "unknown", described as "The finger tips getting numb was with the first dose". Additional information: In the beginning the patient finger tips were getting numb. She has had two doses. The finger tips getting numb was with the first dose and they did not think anything about it and over looked it. After the second dose is when other side effects started and the finger tips getting numb increased really bad. Caller unable to provide specific date on when her daughter finger tips were getting numb. The second dose was on 05Dec2021. Her daughter did not start having side effects or did not mention it to caller until the beginning of Jan2022. Prior Vaccinations (within 4 weeks), and other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were none. AE(s) following prior vaccinations were none. Family Medical History Relevant to AE(s) was not provided.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had pain on his left hand/his wife had the same problem when she took the vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had pain on his left hand/his wife had the same problem when she took the vaccines".   Additional information: Consumer called about the Pfizer COVID-19 vaccine who said he took the first and second one and since he took that he has had pain on his left hand. Caller said the left hand pain started after his second dose, about 3-4 days later. Caller said his wife had the same problem when she took the vaccines. Caller declines to complete a report on his wife without her permission.  The lot number for bnt162b2 was not provided and will be requested during follow up.