chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair falling out on two days of receiving the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 11:30 (Lot number: Ff2568) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to Penicillin" (unspecified if ongoing), notes: Past drug event and known allergies: Penicillin; "Allergy to Cecile" (unspecified if ongoing), notes: Past drug event and known allergies: Cecile; "Allergy to Sulfonamide" (unspecified if ongoing), notes: Past drug event and known allergies: sulfa drugs. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "drug allergy", notes: Past drug event and known allergies: Codeine. The following information was reported: Alopecia(non-serious) with onset 20Sep2021 08:00, outcome "not recovered", described as "Hair falling out on two days of receiving the shot". The event "hair falling out on two days of receiving the shot" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of alopecia.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.  Follow-up (08Oct2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP letter sent   Additional Information:My hair started falling out less than 48 hrs after receiving my 1st shot. It is still falling out. While it is not life threatening it is serious reaction and one that should have been told to me. I don't feel it is in my best interest to take the 2nd dose.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Tinnitus
Clinical narrative: Inappropriate schedule of vaccine administered; I developed tinnitus.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 15:00 (Lot number: EN6207) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild ulcerative colitis" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing), notes: irritable bowel syndrome. The patient took concomitant medications. Past drug history included: Known allergy: codeine, reaction(s): "known allergy: codeine". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Product=COVID 19, Brand=Pfizer,, Lot number=EN6201,, Lot unknown=False,, Administration date=02/Feb/2021,, Administration time=02:00 PM,, Vaccine_location=Left arm), administration date: 02Feb2021, when the patient was 67 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Apr2021 10:00, outcome "not recovered", described as "Inappropriate schedule of vaccine administered"; TINNITUS (non-serious) with onset 04Apr2021 10:00, outcome "not recovered", described as "I developed tinnitus.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inappropriate schedule of product administration, tinnitus. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Eustachian tube dysfunction, Headache, Pain
Clinical narrative: Headache; aching, from back of neck to top of head; Feels pressure on R ear; Tension Headache; Dysfunction of both eustatcian tubes- suspect component of allergic rhinitis-flonase; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 35 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 01Aug2021 03:26 (Lot number: 038B21A) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic lumbar pain", start date: 14Nov2014 (unspecified if ongoing); "Tension headache", start date: 14Nov2014 (unspecified if ongoing); "Latent TB infection", start date: 03Jan2015 (unspecified if ongoing), notes: Latent TB infection; "Over weight", start date: 02Mar2015 (unspecified if ongoing); "H.Pylori infection", start date: 10Aug2017 (unspecified if ongoing), notes: H.Pylori infection. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aching, from back of neck to top of head"; EAR DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Feels pressure on R ear"; TENSION HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Tension Headache"; EUSTACHIAN TUBE DYSFUNCTION (non-serious) with onset 2021, outcome "unknown", described as "Dysfunction of both eustatcian tubes- suspect component of allergic rhinitis-flonase"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness". The events "headache", "aching, from back of neck to top of head", "feels pressure on r ear", "tension headache" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tension headache.  Additional information: History of tension HA noted. No history of migraine, Denies vision changes, balance concerns, head trauma, and parasthesias. Tension Headache - demonstrated neck stretches and exercises to improve pain, decreases tension. Advised heat, stretching, hydration. Patient was seen in clinic today 14Sep to follow up with provider along with professional medical interpreter, and accompanied by family member (on phone) for dizziness and headache.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: Headache; aching, from back of neck to top of head; Feels pressure on R ear; Tension Headache; Dysfunction of both eustatcian tubes- suspect component of allergic rhinitis-flonase; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 35 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 01Aug2021 03:26 (Lot number: 038B21A) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic lumbar pain", start date: 14Nov2014 (unspecified if ongoing); "Tension headache", start date: 14Nov2014 (unspecified if ongoing); "Latent TB infection", start date: 03Jan2015 (unspecified if ongoing), notes: Latent TB infection; "Over weight", start date: 02Mar2015 (unspecified if ongoing); "H.Pylori infection", start date: 10Aug2017 (unspecified if ongoing), notes: H.Pylori infection. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aching, from back of neck to top of head"; EAR DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Feels pressure on R ear"; TENSION HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Tension Headache"; EUSTACHIAN TUBE DYSFUNCTION (non-serious) with onset 2021, outcome "unknown", described as "Dysfunction of both eustatcian tubes- suspect component of allergic rhinitis-flonase"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness". The events "headache", "aching, from back of neck to top of head", "feels pressure on r ear", "tension headache" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tension headache.  Additional information: History of tension HA noted. No history of migraine, Denies vision changes, balance concerns, head trauma, and parasthesias. Tension Headache - demonstrated neck stretches and exercises to improve pain, decreases tension. Advised heat, stretching, hydration. Patient was seen in clinic today 14Sep to follow up with provider along with professional medical interpreter, and accompanied by family member (on phone) for dizziness and headache.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: got this soreness and it's getting better but the people call it COVID arm; 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 67 year-old patient received bnt162b2 (BNT162B2), administration date Sep2021 (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 "got this soreness and it's getting better but the people call it COVID arm".  Additional information: Patient called in with questions about a letter that patient received regarding the medication Zoloft. And with a question about The Pfizer-BioNTech COVID-19 vaccine. During the call patient stated patient took the Pfizer COVID shot 10 days, lets see 12 not this Monday but the week before Monday its been 8, 9, 10, 11 days and now patient got this soreness and its getting better but the people call it COVID arm where after the shot patient have a sore arm. But it started getting sore 7 or 8 days after the shot, its getting better but patient didn't know if they knew about that or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache
Clinical narrative: Headaches and sore eyes when turning for 3-4 days straight.; Headaches and sore eyes when turning for 3-4 days straight.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Sep2021 19:30 (Lot number: FC3183) at the age of 25 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 number=1,, administration time=07:30 PM,, vaccine location=Left arm, lot number=FD8448,), administration date: 25Aug2021, when the patient was 25 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), EYE PAIN (non-serious) all with onset 19Sep2021 22:00, outcome "not recovered" and all described as "Headaches and sore eyes when turning for 3-4 days straight.". Therapeutic measures were not taken as a result of headache, eye pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store, patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to vaccination patient was not diagnosed or tested with covid-19, race and ethnicity information was available.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the spot where they gave the shot was sore like it was with the 1st dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Aug2021 11:20 (Lot number: EW0168) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: Pertinent Details: Take a 12.5 mg tablet of Hydrochlorothiazide Daily.; "Cholesterol" (ongoing), notes: Pertinent Details: Take a 40 mg tablet of Pravastatin Daily. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LOSARTAN; PRAVASTATIN; VITAMIN D NOS. Vaccination history included: Flu shot, for Vaccination site pain; Flu shot, for Appetite lost; Flu shot, for Woozy. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "the spot where they gave the shot was sore like it was with the 1st dose".  Additional information: The spot where they gave the shot was sore like it was with the 1st dose but she was feeling ok. Caller stated she had nothing like this with the 1st her arm was sore the next day and she did not walk anywhere. Patient had no prior vaccinations (within 4 weeks). Relevant Tests: None. Vaccine administered at a facility: No. Vaccination facility type: Other. No test were given for adverse effect experienced after receiving second Covid-19 vaccine. Patient took a 25 mg tablet of Losartan Daily. Patient took blood pressure medication, cholesterol medication and over the counter Vitamin D. Investigation Assessment: No.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, C-reactive protein, HIV test, Pain in extremity, Thyroid function test
Clinical narrative: Sore arm after both doses Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 02May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seizures" (unspecified if ongoing); "Bowel obstruction", start date: 2017 (unspecified if ongoing); "sinus tach" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "high blood pressure readings" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing); "G-tube" (unspecified if ongoing); "Fast heart rate" (unspecified if ongoing). Concomitant medication(s) included: ONFI taken for seizure, start date: 2018 (ongoing); METOPROLOL taken for heart rate increased, sinus tachycardia, start date: 2014 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm after both doses Covid-19 vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vitamin B12, Weight
Clinical narrative: Sore arm after both doses Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 02May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seizures" (unspecified if ongoing); "Bowel obstruction", start date: 2017 (unspecified if ongoing); "sinus tach" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "high blood pressure readings" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing); "G-tube" (unspecified if ongoing); "Fast heart rate" (unspecified if ongoing). Concomitant medication(s) included: ONFI taken for seizure, start date: 2018 (ongoing); METOPROLOL taken for heart rate increased, sinus tachycardia, start date: 2014 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm after both doses Covid-19 vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Off label use, Product use issue, Suppressed lactation
Clinical narrative: Decreased Milk Production; Decreased Milk Production; Decreased Milk Production; fatigue; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Sep2021 (Batch/Lot number: unknown) at the age of 33 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Heart murmur" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination,  the patient was diagnosed with COVID-19. Concomitant medication(s) included: TYLENOL; IRON; PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]. Past drug history included: Penicillin, reaction(s): "Known allergies Penicillin", notes: Penicillin, Sulfa; Sulfa, reaction(s): "Known allergies Sulfa", notes: Penicillin, Sulfa. The following information was reported: SUPPRESSED LACTATION (non-serious), OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 22Sep2021, outcome "unknown" and all described as "Decreased Milk Production"; FATIGUE (non-serious) with onset 22Sep2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 22Sep2021, outcome "unknown", described as "headache". Therapeutic measures were not taken as a result of suppressed lactation, off label use, product use issue, fatigue, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Prolonged Hospitalization. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101268645 mother/baby
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Exposure via breast milk, Fatigue, Jaundice neonatal
Clinical narrative: fatigue; decreased appetite; possible reoccurance of jaundice; Decreased Milk Production; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transmammary, administration date 22Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The mother of the patient was 33 years old at the time of vaccination. The mother's relevant medical history included: "Heart murmur" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; IRON; PRENATAL [FOLIC ACID;IRON]. The following information was reported: FATIGUE (non-serious) with onset 22Sep2021, outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious) with onset 22Sep2021, outcome "unknown", described as "decreased appetite"; JAUNDICE NEONATAL (non-serious) with onset 22Sep2021, outcome "unknown", described as "possible reoccurance of jaundice"; EXPOSURE VIA BREAST MILK (non-serious) with onset 22Sep2021, outcome "unknown", described as "Decreased Milk Production". Therapeutic measures were not taken as a result of fatigue, decreased appetite, jaundice neonatal, exposure via breast milk.  Additional information: The patient mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Prolonged Hospitalization. Since the vaccination, the patient mother had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101268502 mother/baby
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: first dose: sore achy arm/ sore arm; 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. Other Case identifier(s): US-PFIZER INC-202101863766 (Pfizer).  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2021 (Lot number: EM9809) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "heart condition" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Augmentin for tooth infection, reaction(s): "anaphylaxis", notes: a negative reaction to a medicine is a couple years ago he developed an infection, a tooth infection maybe, he can't remember, and a doctor prescribed Augmentin, an antibiotic he has taken a number of times over the decades Augmentin, an antibiotic he has taken a number of times over the decades, but this one time, he almost went into anaphylaxis, he had finally caught his breath by the time; Augmentin for tooth infection, reaction(s): "finally caught his breath". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Feb2021, outcome "recovered" (07Feb2021), described as "first dose: sore achy arm/ sore arm". No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Polymerase chain reaction
Clinical narrative: After receiving both doses, I have been feeling fatigued; and extremely dizzy; sometimes I get nauseous from the dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Aug2021 06:00 (Lot number: EW0179) at the age of 32 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: FATIGUE (non-serious), outcome "not recovered", described as "After receiving both doses, I have been feeling fatigued"; DIZZINESS (non-serious), outcome "not recovered", described as "and extremely dizzy"; NAUSEA (non-serious), outcome "not recovered", described as "sometimes I get nauseous from the dizziness". The events "after receiving both doses, i have been feeling fatigued", "and extremely dizzy" and "sometimes i get nauseous from the dizziness" 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 fatigue, dizziness, nausea.  Additional information: Most recent COVID-19 vaccine was administered at Hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Jul2021 (Lot number: FA7484) at the age of 49 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pain in extremity.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Limb discomfort, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Feeling kind of weird my arm; Barely can use my arm, my arm is like it''s popping; I could barely use this arm; Can''t even use my arm; her arm is "popping", cramping and aching; sometimes she feels a sudden pain in the arm similar to a "shock"; she cannot work properly because of the side effects; 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 female patient received bnt162b2 (BNT162B2), administration date Aug2021 (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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Feeling kind of weird my arm"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "Barely can use my arm, my arm is like it''s popping; I could barely use this arm; Can''t even use my arm"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm is "popping", cramping and aching"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sometimes she feels a sudden pain in the arm similar to a "shock""; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she cannot work properly because of the side effects".  Additional information:  she mentioned that her arm is "popping", cramping and aching, sometimes she feels a sudden pain in the arm similar to a "shock". She stated that she did not have any health problems. She mentioned that she cannot work properly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: skin condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female 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: SKIN DISORDER (non-serious), outcome "unknown", described as "skin condition". Therapeutic measures were taken as a result of skin disorder. Additional information: The patient said that she already took the first and second doses of the vaccine. The patient had a skin condition and she was using ointment (Corticosteroid) and she was not taking it orally. Patient was asking if she can take the booster shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: "expired" dose of the Pfizer COVID Vaccine this AM; drawn up in the syringe beyond 6 hours per caller; drawn up in the syringe beyond 6 hours per caller; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown, Expiration Date: 23Sep2021) 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: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 27Sep2021, outcome "unknown", described as ""expired" dose of the Pfizer COVID Vaccine this AM"; PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 27Sep2021, outcome "unknown" and all described as "drawn up in the syringe beyond 6 hours per caller".  Additional information: The vaccine was expired after having been drawn up in the syringe beyond 6 hours per caller. Total time in syringes: up to 24 hours at 2 degree C to 30 degree C with no more than 6 hours at room temperature (up to 30 degree C) and the remainder in the refrigerator (2 degree C to 8 degree C).   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, Wrong technique in product usage process
Clinical narrative: caller was drawing up the vaccine into the syringe and it filled really fast so she is not sure if she administered air or the full dose to the patient; The patient felt the poke and felt some pressure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 (Lot number: 301458A, Expiration Date: Nov2021) as dose 3 (booster), 0.3 ml 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: 1st), when the patient was 66 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2nd), when the patient was 66 years old, for Covid-19 immunization. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 25Sep2021, outcome "unknown", described as "caller was drawing up the vaccine into the syringe and it filled really fast so she is not sure if she administered air or the full dose to the patient"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "The patient felt the poke and felt some pressure".  No follow-up attempts are possible. No further information is expected.  Additional Information: It was reported that,the caller is a pharmacist at (withheld) calling about the Pfizer covid 19 vaccine. The caller was drawing up the vaccine into the syringe and it filled really fast so she is not sure if she administered air or the full dose to the patient. The caller felt no pressure when giving the injection but the patient felt the jab or felt something. The caller was preparing two shots side by side and filled up the first one fine but with the second one the caller has a habit up puling it up to the 0.3 ml. The caller administered the one that was not filled with the injection. The patient felt the poke and felt some pressure. The caller is unsure of it was 0.3 ml and how it feels to inject air instead of the medication. When the caller gave the shot it was not normal. The first dose the caller drew up was fine but the second one was in question. The Patient had no medical history.  Follow-up #01 (27Sep2021): This is a follow-up spontaneous report from a contactable Pharmacist. A Pharmacist reported for 66-year-old male patient that, upon follow up, information included dose was booster, the booster dose administration date was 25Sep2021, Expiry Date was Nov2021 was added. Event verbatim (caller was drawing up the vaccine into the syringe and it filled really fast so she is not sure if she administered air or the full dose to the patient) onset date was 25Sep2021 added. Other medical information was added.  Follow-up #02 (27Sep2021): This is a follow-up spontaneous report from a contactable Pharmacist. A Pharmacist reported for 66-year-old male patient that, Upon follow up, no new event/SD was added.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: 3 spots on lungs; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunization. The following information was reported: LUNG DISORDER (non-serious), outcome "unknown", described as "3 spots on lungs".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: My stomach has been bothering me from this morning; my stomach is doing couple of flips and stuff; 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) (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "My stomach has been bothering me from this morning; my stomach is doing couple of flips and stuff".  Additional information: Consumer stated, took shot, Pfizer shot yesterday. So, patient was wondering, patient take these nauseous pills. So, patient stomach in the morning. So, patient was calling to see if still be able to take the nauseous pill (Unspecified medication) because patient stomach was doing couple of flips and stuff. So, patient want to know if patient can still take the nauseous pill.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up attempts completed.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cardiac disorder, Heart rate
Clinical narrative: Heart problems; Stomach ache after 2nd 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. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 06Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart attack" (unspecified if ongoing), notes: She has heart problems/had a heart attack 4 years ago; "Afib" (unspecified if ongoing), notes: Thought she had AFIB and occasionally it will be 150 times a minutes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart problems"; ABDOMINAL PAIN UPPER (non-serious) with onset 06Feb2021, outcome "unknown", described as "Stomach ache after 2nd dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional info: Patient was advised by her doctor to get the booster dose and wanted to make sure if it was safe for her to have it. Patient stated she had a really bad stomach ache after 2nd dose, It was hours later in the evening after her second dose on 06Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Circumstance or information capable of leading to medication error, Pain in extremity
Clinical narrative: Pain in the left arm; chills; Other vaccine same date vaccine date 21Dec2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Dec2020 (Lot number: EK5730) at the age of 47 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: PAIN IN EXTREMITY (non-serious) with onset 21Dec2020 16:00, outcome "unknown", described as "Pain in the left arm"; CHILLS (non-serious) with onset 21Dec2020 16:00, outcome "unknown", described as "chills"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 21Dec2020 16:00, outcome "unknown", described as "Other vaccine same date vaccine date 21Dec2021". Therapeutic measures were not taken as a result of pain in extremity, chills, circumstance or information capable of leading to medication error. Additional information: At the Hospital facility the patient administered the most recent COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Metformin as other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 27Sep2021 No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Menstrual disorder
Clinical narrative: Menstrual cycle; enlarged lymph node/Painful to touch; 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 patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 12:00 (Lot number: EN6201) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing).  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "enlarged lymph node/Painful to touch"; MENSTRUAL DISORDER (non-serious) with onset 16Mar2021, outcome "recovering", described as "Menstrual cycle". Therapeutic measures were not taken as a result of lymphadenopathy, menstrual disorder.    Additional information: -Enlarged lymph node in groin area for 2 days. Painful to the touch.  -Menstrual cycle affected. started cycle early. 4 month later went almost 2 months without cycle. Cycles are shorter now.  -My workplace required our employees to be vaccinated. All employees received Vaccine at same location. Many have said it has affected their cycle too. Some went from having menstrual cycles to not having them. Some went from not having menstrual cycles to having regular, painful, heavy ones.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Therapeutic response unexpected
Clinical narrative: the vaccine helped with his allergies; just a little fatigue; 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 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 (Lot number: EW0170, Expiration Date: Aug2021) at the age of 52 years as dose 2, 0.3 ml single and administered in arm right, administration date 13Apr2021 (Lot number: ER8731, Expiration Date: Jul2021) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "severe latex allergy" (unspecified if ongoing), notes: He has a severe latex allergy; "Allergy to nickel" (unspecified if ongoing), notes: He also has a allergy to nickel; "Lymphoma" (unspecified if ongoing), notes: Diagnosed in 1984-1985.; "chicken pox virus" (unspecified if ongoing), notes: He could not finish his Senior year because the chicken pox virus came back and it attacked his legs and he was on crutches. He had chemo and radiation treatments.; "Blisters" (unspecified if ongoing), notes: did not get any blisters this summer for almost the first time in 30 years. Concomitant medication(s) included: DIPHENHYDRAMINE HCL taken for blister. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "the vaccine helped with his allergies"; FATIGUE (non-serious), outcome "unknown", described as "just a little fatigue".  Additional Information-Caller reported that he used to wear latex for his job but later on developed poisoning and allergy, had blisters and from contact. After receiving both doses of the Comirnaty he had no outbreak during this summer from the vaccine. Department called it an AE. Caller stated he wanted to give a heads up that the vaccine helped with his allergies. He said that this can be ironic that the first time in years his hands had not broken out during summer. He added that this even happened during winter but more during the summer because of the heat. Caller added that he called because this was something that Pfizer might want to look in to. Caller said that he'll be monitoring his condition because at this point, he had zero outbreaks. He added he thought there would be something from Pfizer because there are people who have latex allergy. He said that what he took when he does have outbreaks was diphenhydramine. He said that he would take 25mg tablets. He said that when he had a doctor and he needed to get his outbreaks under control, they would prescribe him 180mg prescription strength.  He said that he would buy it OTC and he would took 4 of them at a time. He said that they are basically tranquilizers. Patient did not had any other vaccinations within four weeks prior to the first  administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 56-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced pain in extremity (sore arm), with outcome of unknown. Additional information: Patient has long standing arthritis for which he takes Tylenol. He denied any improvement or worsening of his arthritis since his first or second vaccine doses. He didn't take any ahead of the 2nd vaccine shot. He reported having concerns because he didn't have any soreness before either the first or second dose of the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysgeusia, Eye disorder, Facial pain
Clinical narrative: Mild nausea; Weird odor in her nose that smells like gasoline; Mouth food tasted sour; Dizzy; Black dot in her right eye; Muscle face ache; Chills; Toothache; Generalized muscle ache; 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 41 year-old female patient received bnt162b2 (BNT162B2), administration date 24Sep2021 (Lot number: 30145BA) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Black dot in her right eye" (ongoing), notes: in the past she has had complaints of a black dot in her right eye. There were no concomitant medications. The following information was reported: NAUSEA (non-serious), outcome "not recovered", described as "Mild nausea"; NASAL ODOUR (non-serious), outcome "unknown", described as "Weird odor in her nose that smells like gasoline"; DYSGEUSIA (non-serious), outcome "recovered", described as "Mouth food tasted sour"; DIZZINESS (non-serious), outcome "not recovered", described as "Dizzy"; EYE DISORDER (non-serious), outcome "unknown", described as "Black dot in her right eye"; FACIAL PAIN (non-serious), outcome "recovered", described as "Muscle face ache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; TOOTHACHE (non-serious), outcome "recovering", described as "Toothache"; MYALGIA (non-serious), outcome "unknown", described as "Generalized muscle ache".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal odour, Nausea, Toothache
Clinical narrative: Mild nausea; Weird odor in her nose that smells like gasoline; Mouth food tasted sour; Dizzy; Black dot in her right eye; Muscle face ache; Chills; Toothache; Generalized muscle ache; 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 41 year-old female patient received bnt162b2 (BNT162B2), administration date 24Sep2021 (Lot number: 30145BA) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Black dot in her right eye" (ongoing), notes: in the past she has had complaints of a black dot in her right eye. There were no concomitant medications. The following information was reported: NAUSEA (non-serious), outcome "not recovered", described as "Mild nausea"; NASAL ODOUR (non-serious), outcome "unknown", described as "Weird odor in her nose that smells like gasoline"; DYSGEUSIA (non-serious), outcome "recovered", described as "Mouth food tasted sour"; DIZZINESS (non-serious), outcome "not recovered", described as "Dizzy"; EYE DISORDER (non-serious), outcome "unknown", described as "Black dot in her right eye"; FACIAL PAIN (non-serious), outcome "recovered", described as "Muscle face ache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; TOOTHACHE (non-serious), outcome "recovering", described as "Toothache"; MYALGIA (non-serious), outcome "unknown", described as "Generalized muscle ache".  No follow-up attempts are possible. No further information is expected.