chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood glucose, Blood test, Breast enlargement, Electrocardiogram
Clinical narrative: light discharge from my vagina; breast seemed to become enlarged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (07Feb2022), this case now contains all required information to be considered valid.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EN6207) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney absent", start date: 02Nov2020, stop date: 02Nov2020, notes: Donated my right kidney to my brother in law; "Laparoscopic surgery", start date: 02Nov2020, stop date: 02Nov2020, notes: Donated my right kidney to my brother in law. Laparoscopic surgery successful procedure.; "Foot surgery", start date: 11Sep2020, stop date: 11Sep2020, notes: Hit on foot by a pickup truck on 30Nov2019.; "Kienbock disease" (unspecified if ongoing), notes: Kienbock disease drought on by being hit by a truck. Surgery was successful.; "ADD" (ongoing). There were no concomitant medications. The following information was reported: VAGINAL DISCHARGE (non-serious) with onset Nov2021, outcome "unknown", described as "light discharge from my vagina"; BREAST ENLARGEMENT (non-serious) with onset Nov2021, outcome "unknown", described as "breast seemed to become enlarged". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received dose 2 on 17Dec2021 Approx 1 PM, Anatomical site of injection: Left arm, Batch/Lot number: 33030BD.Vaccination facility type: Pharmacy or Drug store.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gynaecological examination, Hysteroscopy, Mammogram, Physical breast examination, Smear cervix
Clinical narrative: light discharge from my vagina; breast seemed to become enlarged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (07Feb2022), this case now contains all required information to be considered valid.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EN6207) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney absent", start date: 02Nov2020, stop date: 02Nov2020, notes: Donated my right kidney to my brother in law; "Laparoscopic surgery", start date: 02Nov2020, stop date: 02Nov2020, notes: Donated my right kidney to my brother in law. Laparoscopic surgery successful procedure.; "Foot surgery", start date: 11Sep2020, stop date: 11Sep2020, notes: Hit on foot by a pickup truck on 30Nov2019.; "Kienbock disease" (unspecified if ongoing), notes: Kienbock disease drought on by being hit by a truck. Surgery was successful.; "ADD" (ongoing). There were no concomitant medications. The following information was reported: VAGINAL DISCHARGE (non-serious) with onset Nov2021, outcome "unknown", described as "light discharge from my vagina"; BREAST ENLARGEMENT (non-serious) with onset Nov2021, outcome "unknown", described as "breast seemed to become enlarged". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received dose 2 on 17Dec2021 Approx 1 PM, Anatomical site of injection: Left arm, Batch/Lot number: 33030BD.Vaccination facility type: Pharmacy or Drug store.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan vagina, Vaginal discharge
Clinical narrative: light discharge from my vagina; breast seemed to become enlarged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (07Feb2022), this case now contains all required information to be considered valid.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EN6207) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney absent", start date: 02Nov2020, stop date: 02Nov2020, notes: Donated my right kidney to my brother in law; "Laparoscopic surgery", start date: 02Nov2020, stop date: 02Nov2020, notes: Donated my right kidney to my brother in law. Laparoscopic surgery successful procedure.; "Foot surgery", start date: 11Sep2020, stop date: 11Sep2020, notes: Hit on foot by a pickup truck on 30Nov2019.; "Kienbock disease" (unspecified if ongoing), notes: Kienbock disease drought on by being hit by a truck. Surgery was successful.; "ADD" (ongoing). There were no concomitant medications. The following information was reported: VAGINAL DISCHARGE (non-serious) with onset Nov2021, outcome "unknown", described as "light discharge from my vagina"; BREAST ENLARGEMENT (non-serious) with onset Nov2021, outcome "unknown", described as "breast seemed to become enlarged". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received dose 2 on 17Dec2021 Approx 1 PM, Anatomical site of injection: Left arm, Batch/Lot number: 33030BD.Vaccination facility type: Pharmacy or Drug store.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Thyroid function test, X-ray
Clinical narrative: just a sore arm after; 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 59 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had Covid back in August, mild case, just lost taste and smell." (unspecified if ongoing), notes: I had Covid back in August, mild case, just lost taste and smell.; "just lost taste and smell." (unspecified if ongoing), notes: I had Covid back in August, mild case, just lost taste and smell.; "just lost taste and smell." (unspecified if ongoing), notes: I had Covid back in August, mild case, just lost taste and smell. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "just a sore arm after". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter inquired about side effects for the Pfizer Covid-19 vaccine. He reports that he didnt want to receive the vaccine, but his company mandated it he would get fired or have to quit. He states that he did fine after the first dose, had no side effects, just a sore arm after but after the second dose-4 days or 3 days later, he hasnt felt the same since, his neck feels so sore, stress-feeling sore, sore since Thursday after the shot. Patient had Covid back in August, mild case, just lost taste and smell. Patient went to the doctor this morning, went to his family doctor, he felt patient thyroid and it felt normal, he had blood work done, and just to check he did an x-ray on neck. He was a sales rep and it depressed him and it never happened before. He read about 40 years old, female who had neck pain and got steroids to make it better for neck. The patient got second dose on 29Nov - Monday, then on Thursday it started. The patient stated that he was reading about the lady whos 40 years old had subacute thyroiditis-4 days after second dose severe anterior neck pain for so many weeks treated with Prednisolone which he thinks is a steroid, they scanned her thyroid came back high, thats where her lymph nodes are. He also states that hes not always sore, just when he turns his neck left to right. He also reported that it could be strain, dont think he slept on it, just a coincidence, he went to the chiropractor, but he didnt mess with his neck, but he said the medicine affects the glands in his neck. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Feeding disorder, Lethargy, Vomiting
Clinical narrative: lethargic; couldn't eat; started vomiting and become worse and worse; started vomiting and become worse and worse; 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. The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (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, Single), administration date: 23Nov2021, for COVID-19 immunization. The following information was reported: LETHARGY (non-serious) with onset 18Dec2021, outcome "unknown", described as "lethargic"; FEEDING DISORDER (non-serious) with onset 18Dec2021, outcome "unknown", described as "couldn't eat"; VOMITING (non-serious) with onset Dec2021, outcome "not recovered", CONDITION AGGRAVATED (non-serious) with onset Dec2021, outcome "unknown" and all described as "started vomiting and become worse and worse".  Additional Information: It was reported that as of right now patient has been out on an anti-nausea medication and will be seeking more help from PCP.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 1st one she got dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 (Lot number: EN6199) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st one she got dizzy".  Additional information: It was reported that, her doctor and pharmacist were not sure if she should receive the booster dose and she was told to call us. She was wear a mask everyday until another vaccine comes out because she cannot be dizzy again while driving and going up and down the stairs again.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion
Clinical narrative: cough; nose congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 28-year-old female patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Batch/Lot number: unknown) at the age of 28 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: COUGH (non-serious) with onset 02Jan2022, outcome "unknown", described as "cough"; NASAL CONGESTION (non-serious) with onset 02Jan2022, outcome "unknown", described as "nose congestion".  Additional information: Caller stated she received Pfizer COVID-19 vaccination, first dose on 11Dec2021, however she missed her second dose appointment, and the vaccination site is no longer there. around Sunday 02Jan2022 I started having a little bit of a cough and also kind of nose congestion, can one still get the vaccine while having these symptoms. This case assessed as non-serious by the reporter.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual discomfort
Clinical narrative: That night, after the first shot, I woke up from the pain.; Ever since then my periods have been irregular and painful, last longer and are heavier.; Ever since then my periods have been irregular and painful, last longer and are heavier.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Apr2021 10:45 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single and administered in arm right, administration date 08May2021 10:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; SPIRONOLACTONE. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 17Apr2021 23:45, outcome "not recovered", described as "That night, after the first shot, I woke up from the pain."; MENSTRUAL DISCOMFORT (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 17Apr2021 23:45, outcome "not recovered" and all described as "Ever since then my periods have been irregular and painful, last longer and are heavier.". Therapeutic measures were taken as a result of heavy menstrual bleeding, menstrual discomfort, heavy menstrual bleeding.  Additional information: The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The facility where the most recent COVID-19 vaccine was administered was Hospital.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Facial numbness; extremely dizzy for 2 weeks; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Lot number: 30145BA) at the age of 41 years as dose 1, single for covid-19 immunization. Relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Back/ gastro issues" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; BUSPAR; XANAX; VIT D [COLECALCIFEROL]; COLACE; SENNA+; PREVACID; PEPCID AC. Past drug history included: Iodine, reaction(s): "Allergies: iodine". The following information was reported: HYPOAESTHESIA (non-serious) with onset 27Sep2021, outcome "recovering", described as "Facial numbness"; DIZZINESS (non-serious) with onset 27Sep2021, outcome "recovering", described as "extremely dizzy for 2 weeks". The events "facial numbness" and "extremely dizzy for 2 weeks" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of hypoaesthesia, dizziness.  Additional information: Patient not had other vaccine in four weeks and no prior Covid vaccination. Patient had not Covid tested post vaccination. Patient provided information to HCP regarding the adverse event(s) after the fact. The reporting Nurse considered the Pfizer product did not have a casual effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Malaise, Pain
Clinical narrative: hot flashes in her back; body pain; feeling unwell; 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 (COMIRNATY), administration date 04Jan2022 (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: HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes in her back"; PAIN (non-serious), outcome "unknown", described as "body pain"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell".  Additional information included: For the last 3 days patient had been experiencing hot flashes in her back and body pain. She was asking what other possible side effect is she to expect with the Pfizer COVID-19 vaccine besides the hot flashes and body pain and what kind of treatment medicine she could take.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (01Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; 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. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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, Manufacturer unknown), administration date: 2021, for Covid-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset Dec2021, outcome "recovering", described as "Shingles". Therapeutic measures were taken as a result of herpes zoster.  Additional information: Caller received her second dose of the Pfizer covid vaccine about 6 months ago and was a due for her booster tomorrow. Caller developed shingles 2 weeks ago and was treated with Valtrex; states the rash has pretty much dried up. Asking if there were any contraindications to getting her booster tomorrow while recovering from shingles. Caller stated that her doctor wasn't sure, because Shingles is a virus, and her doctor was unsure how that would interact with a Covid vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Therapeutic response unexpected
Clinical narrative: numbness is coming back to his foot; headaches; About 10-14 days after the vaccine he was out walking and started to regain the feeling; 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 61 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "automobile accident", start date: 2012 (unspecified if ongoing), notes: loss the feeling in his big toe down to the arch of his foot; "He loss the feeling in his big toe down to the arch of his foot" (unspecified if ongoing), notes: loss the feeling in his big toe down to the arch of his foot; "Surgery on his foot", start date: 2014 (unspecified if ongoing), notes: foot surgery back in 2014 & 2017,regaining feeling for about 45 minutes 1-2 weeks after 2nd surgery. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "About 10-14 days after the vaccine he was out walking and started to regain the feeling"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "numbness is coming back to his foot"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: Patient reported at first it was unbearable and it started to go numb again. Like when you go to the dentist and they numb you and it feels heavy, but you can feel after touching your jaw. He did different was take the covid vaccine and occasionally takes Aleve for headaches.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Affect lability, Bedridden, Body temperature, Chest discomfort, Crying
Clinical narrative: Sleep for the whole day; Lose control of emotions/cry and laugh; Cry and laugh; Cry and laugh; Chest tightness; Breathing difficult; Feel cold and hot at first night; Bedridden; Feel chilly (for 4-5 hrs); Fever (38.5 degrees; treatment received)/Fever (around 38 degrees; treatment received); Sleepy/Feel sleepy; Sore arm (can not lift); Headache; 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), administration date 03Jan2022 (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, SINGLE), administration date: 08Dec2021, for COVID-19 immunization, reaction(s): "No side effects experienced". The following information was reported: AFFECT LABILITY (non-serious) with onset 04Jan2022, outcome "recovering", described as "Lose control of emotions/cry and laugh"; CRYING (non-serious), STRESS URINARY INCONTINENCE (non-serious) all with onset 04Jan2022, outcome "recovering" and all described as "Cry and laugh"; CHEST DISCOMFORT (non-serious) with onset 04Jan2022, outcome "recovering", described as "Chest tightness"; DYSPNOEA (non-serious) with onset 04Jan2022, outcome "recovering", described as "Breathing difficult"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 04Jan2022, outcome "recovering", described as "Feel cold and hot at first night"; BEDRIDDEN (non-serious) with onset 04Jan2022, outcome "recovering", described as "Bedridden"; FEELING COLD (non-serious) with onset 04Jan2022, outcome "recovering", described as "Feel chilly (for 4-5 hrs)"; PYREXIA (non-serious) with onset 04Jan2022, outcome "recovered" (07Jan2022), described as "Fever (38.5 degrees; treatment received)/Fever (around 38 degrees; treatment received)"; SOMNOLENCE (non-serious) with onset 04Jan2022, outcome "recovering", described as "Sleepy/Feel sleepy"; SOMNOLENCE (non-serious) with onset 05Jan2022, outcome "recovering", described as "Sleep for the whole day"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Sore arm (can not lift)"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Fourth day after vaccination: Feeling well and temperature became normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling cold, Feeling of body temperature change, Headache, Pain in extremity
Clinical narrative: Sleep for the whole day; Lose control of emotions/cry and laugh; Cry and laugh; Cry and laugh; Chest tightness; Breathing difficult; Feel cold and hot at first night; Bedridden; Feel chilly (for 4-5 hrs); Fever (38.5 degrees; treatment received)/Fever (around 38 degrees; treatment received); Sleepy/Feel sleepy; Sore arm (can not lift); Headache; 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), administration date 03Jan2022 (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, SINGLE), administration date: 08Dec2021, for COVID-19 immunization, reaction(s): "No side effects experienced". The following information was reported: AFFECT LABILITY (non-serious) with onset 04Jan2022, outcome "recovering", described as "Lose control of emotions/cry and laugh"; CRYING (non-serious), STRESS URINARY INCONTINENCE (non-serious) all with onset 04Jan2022, outcome "recovering" and all described as "Cry and laugh"; CHEST DISCOMFORT (non-serious) with onset 04Jan2022, outcome "recovering", described as "Chest tightness"; DYSPNOEA (non-serious) with onset 04Jan2022, outcome "recovering", described as "Breathing difficult"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 04Jan2022, outcome "recovering", described as "Feel cold and hot at first night"; BEDRIDDEN (non-serious) with onset 04Jan2022, outcome "recovering", described as "Bedridden"; FEELING COLD (non-serious) with onset 04Jan2022, outcome "recovering", described as "Feel chilly (for 4-5 hrs)"; PYREXIA (non-serious) with onset 04Jan2022, outcome "recovered" (07Jan2022), described as "Fever (38.5 degrees; treatment received)/Fever (around 38 degrees; treatment received)"; SOMNOLENCE (non-serious) with onset 04Jan2022, outcome "recovering", described as "Sleepy/Feel sleepy"; SOMNOLENCE (non-serious) with onset 05Jan2022, outcome "recovering", described as "Sleep for the whole day"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Sore arm (can not lift)"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Fourth day after vaccination: Feeling well and temperature became normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Stress urinary incontinence
Clinical narrative: Sleep for the whole day; Lose control of emotions/cry and laugh; Cry and laugh; Cry and laugh; Chest tightness; Breathing difficult; Feel cold and hot at first night; Bedridden; Feel chilly (for 4-5 hrs); Fever (38.5 degrees; treatment received)/Fever (around 38 degrees; treatment received); Sleepy/Feel sleepy; Sore arm (can not lift); Headache; 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), administration date 03Jan2022 (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, SINGLE), administration date: 08Dec2021, for COVID-19 immunization, reaction(s): "No side effects experienced". The following information was reported: AFFECT LABILITY (non-serious) with onset 04Jan2022, outcome "recovering", described as "Lose control of emotions/cry and laugh"; CRYING (non-serious), STRESS URINARY INCONTINENCE (non-serious) all with onset 04Jan2022, outcome "recovering" and all described as "Cry and laugh"; CHEST DISCOMFORT (non-serious) with onset 04Jan2022, outcome "recovering", described as "Chest tightness"; DYSPNOEA (non-serious) with onset 04Jan2022, outcome "recovering", described as "Breathing difficult"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 04Jan2022, outcome "recovering", described as "Feel cold and hot at first night"; BEDRIDDEN (non-serious) with onset 04Jan2022, outcome "recovering", described as "Bedridden"; FEELING COLD (non-serious) with onset 04Jan2022, outcome "recovering", described as "Feel chilly (for 4-5 hrs)"; PYREXIA (non-serious) with onset 04Jan2022, outcome "recovered" (07Jan2022), described as "Fever (38.5 degrees; treatment received)/Fever (around 38 degrees; treatment received)"; SOMNOLENCE (non-serious) with onset 04Jan2022, outcome "recovering", described as "Sleepy/Feel sleepy"; SOMNOLENCE (non-serious) with onset 05Jan2022, outcome "recovering", described as "Sleep for the whole day"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Sore arm (can not lift)"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Fourth day after vaccination: Feeling well and temperature became normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Histamine level, Histamine level increased
Clinical narrative: My daughter also had a histamine reaction, wish you made better product.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: My entire family got COVID including my kids. The patient's concomitant medications were not reported. The following information was reported: HISTAMINE LEVEL INCREASED (non-serious), outcome "unknown", described as "My daughter also had a histamine reaction, wish you made better product.". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pyrexia
Clinical narrative: Headache; Fever; They felt like poo poo. They felt really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "They felt like poo poo. They felt really bad". Patient had a headache and fever. The next morning, he felt like poo poo and felt really bad.  Follow-up (21Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asphyxia, Head discomfort, Hypotension, Lymphadenopathy, Ocular discomfort
Clinical narrative: Swollen lymph node on the left side of neck. Feeling pressure in the head and eyes as if I was being asphyxiated. Blood pressure was a lot lower than my usual.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: coughing; viscous cold/ got the same cold again. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Sep2021 (Batch/Lot number: unknown) at the age of 80 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), administration date: 11Aug2021, when the patient was 80 years old, for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 11Sep2021, outcome "not recovered", described as "viscous cold/ got the same cold again."; COUGH (non-serious), outcome "unknown", described as "coughing". The event "viscous cold/ got the same cold again." was evaluated at the physician office visit. Therapeutic measures were taken as a result of nasopharyngitis.  Additional information: It was reported that, he has had two colds, one lasted 2 months, after being vaccinated with Pfizer's Covid19 vaccine. One started last week and he had to have it treated by his doctor. It might be leaving the body in cold. He is getting very viscous colds that he had never had before. He got vaccinated on 11Aug2021 and got second shot three or four weeks later on 11Sep2021. Then he had a cold from 11Sep2021 to 07Dec2021. Then it lifted off. He had to be treated with antibiotics and typical cold remedies. Then it vanished and he felt really great. Then at the first of the year he took a local trip and came back and got the same cold again. When he says same cold he didn't check, but it was viscous and he was coughing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; vomiting; Fever on and off for 4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in leg left, administration date 15Jan2022 09:00 (Batch/Lot number: unknown) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 16Jan2022, outcome "recovered" (Jan2022), described as "Nausea"; VOMITING (non-serious) with onset 16Jan2022, outcome "recovered" (Jan2022), described as "vomiting"; PYREXIA (non-serious) with onset 16Jan2022, outcome "recovered" (Jan2022), described as "Fever on and off for 4 days". Therapeutic measures were not taken as a result of nausea, vomiting, pyrexia.  Follow-up (21Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; fever; chills; sweats; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 15 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat". This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension
Clinical narrative: 3 pant sizes up in a week/Still up 3 due to the bloat; 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 (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (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: Jul2021, for COVID-19 immunization, reaction(s): "severe bloating"; Bnt162b2 (Dose 1, Verbatim: Within a day severe bloating and stomach distention began), administration date: Jul2021, for COVID-19 immunization, reaction(s): "stomach distention". The following information was reported: ABDOMINAL DISTENSION (non-serious) with onset 2021, outcome "not recovered", described as "3 pant sizes up in a week/Still up 3 due to the bloat".  Additional information: The patient stated that today I received my Pfizer Covid booster. Within an hour my stomach ballooned by 5 inches. It was then it all came flooding back to me. Patient asked Why it was I have been fighting severe bloating and stomach distention for 6 months. In Jul2021 I received my first Pfizer Covid vaccine. Within a day the severe bloating and stomach distention began. In Aug2021 the second dose and oh so much worse. 3 pant sizes up in a week. Still up 3 due to the bloat. They enquired What, how and why What is in this thing to do that.  Follow-up attempts completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling drunk, Libido increased
Clinical narrative: Felt inebriated; Increased libido; Fatigue towards sundown; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 10:45 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COLLAGEN; VITAMIN C [ASCORBIC ACID]; PROBIOTICS. Past drug history included: Amoxicillin, reaction(s): "allergies: amoxicillin". The following information was reported: FEELING DRUNK (non-serious) with onset 04Jan2022 12:15, outcome "not recovered", described as "Felt inebriated"; LIBIDO INCREASED (non-serious) with onset 04Jan2022 12:15, outcome "not recovered", described as "Increased libido"; FATIGUE (non-serious) with onset 04Jan2022 12:15, outcome "not recovered", described as "Fatigue towards sundown". The events "felt inebriated", "increased libido" and "fatigue towards sundown" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of feeling drunk, libido increased, fatigue.  Additional information : No other vaccine in four weeks of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Other medications in two weeks: multivitamin. Device Date was noted as 22Jan2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: we are all sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient. A patient (no qualifiers provided) 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: ILLNESS (non-serious), outcome "unknown", described as "we are all sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: after each vaccine my platelet count went down into the 20000 range; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Apr2021 11:45 (Lot number: ER8731) at the age of 74 years as dose 2, single and intramuscular, administered in arm left, administration date 31Mar2021 11:45 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thrombocytopenia", start date: 2019 (ongoing), notes: Pertinent details: Rituximab Infusions 01Mar2021- 08Mar2021- 15Mar2021, 22Mar2021 (All in Mar2021). The patient's concomitant medications were not reported.  The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "after each vaccine my platelet count went down into the 20000 range". The event "after each vaccine my platelet count went down into the 20000 range" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of platelet count decreased.  Additional information: ThPlatelet factor IV after each vaccine my platelet count went down into the 20,000 range at which point the hematologist prescribed prednisolone which would bring the platelet count up somewhat around the 50,000 range.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Overdose, Product preparation error
Clinical narrative: He gave a Pfizer shot to a child and forgot to dilute it; He gave a Pfizer shot to a child and forgot to dilute it; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 7 year-old male patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 29Jan2022 11:00 (Lot number: FL0007, Expiration Date: Sep2021) at the age of 7 years as dose 1, 0.2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 29Jan2022 11:00, outcome "unknown" and all described as "He gave a Pfizer shot to a child and forgot to dilute it"; OROPHARYNGEAL PAIN (non-serious) with onset 29Jan2022, outcome "not recovered", described as "Sore throat".  Additional information: The reported confirmed the patient was administered with the Pfizer COVID19 vaccine, the paediatric formulation with an orange cap. The patient had a sore throat which didn't need to be sent to a doctor or anything. The patient's sore throat began later on during the day on 29Jan2022. The reporter confirmed the expiration date on the bottle is Sep2021 but mentions there was an extended expiration date which says 08Mar2022. The patient did not visit emergency room or physician office.Patient's Medical History was none (no allergies, nothing).Other Products was reported as no  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: feeling weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220122000095.  A male patient received bnt162b2 (BNT162B2) (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: ASTHENIA (non-serious), outcome "recovered", described as "feeling weak".  Additional Information: Patient reports he received 2 Pfizer covid-19 vaccination doses & experienced feeling weak for a couple of days after the vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: sore arm; not mixed and the whole 0.2 mL of concentration was administered to the patients; not mixed and the whole 0.2 mL of concentration was administered to the patients; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 10 year-old male patient received bnt162b2 (BNT162B2), administration date 01Feb2022 12:58 (Lot number: FL0007, Expiration Date: 2022) at the age of 10 years as dose number unknown (tris), 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 01Feb2022 12:58, outcome "unknown" and all described as "not mixed and the whole 0.2 mL of concentration was administered to the patients"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The adverse event was non-serious. AE required visit was not applicable. Vial was not reconstituted. Communication error between pharmacist & tech. Only a sore arm. No other side effect.  No follow-up attempts are possible. No further information is expected.  Follow-up (23Feb2022): This is a follow-up spontaneous report from a contactable pharmacist. This pharmacist reported for the patient in response to HCP letter sent which included: Updated Information included: New event (sore arm) added. Event onset date updated for overdose and product preparation error.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200186001 Same reporter/drug/event, different patient.