chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Skin indentation
Clinical narrative: Severe indentation on the arm that shot was delivered.; Severe indentation on the arm that shot was delivered.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 30 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: SKIN INDENTATION (non-serious), LIMB DISCOMFORT (non-serious), outcome "not recovered" and all described as "Severe indentation on the arm that shot was delivered.". Therapeutic measures were not taken as a result of skin indentation, limb discomfort.  Additional Information: Patient had no other vaccine in four- weeks and no Other medications in two weeks. Patient had no covid prior to vaccination and was not tested to covid post vaccination   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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to device use error, Pain in extremity, Wrong technique in product usage process
Clinical narrative: Extreme arm pain was noted at time of injection.; patient was told by the Pharmacist that he accidently injected her with nothing in the syringe.; Patient is concerned of potentially being dosed twice in same arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Aug2021 (Batch/Lot number: unknown) at the age of 50 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, product: COVID 19, brand: Pfizer, lot unknown reason: Not available/provided to reporter at the time of report completion), when the patient was 50 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Aug2021, outcome "unknown", described as "Extreme arm pain was noted at time of injection."; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 11Aug2021, outcome "unknown", described as "patient was told by the Pharmacist that he accidently injected her with nothing in the syringe."; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO DEVICE USE ERROR (non-serious) with onset 11Aug2021, outcome "unknown", described as "Patient is concerned of potentially being dosed twice in same arm.". Therapeutic measures were not taken as a result of pain in extremity, wrong technique in product usage process, circumstance or information capable of leading to device use error.  Additional information: Patient was injected with an empty syringe of what was thought to be Pfizer COVID-19 vaccine. Pharmacist immediately noticed this and told patient that he would be right back. Upon further questioning, patient was told by the Pharmacist that he accidently injected her with nothing in the syringe. He apologized for the mistake and then dosed her with the Pfizer COVID-19 vaccine. Patient is concerned of potentially being dosed twice in same arm. Extreme arm pain was noted at time of injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Limb discomfort, Paraesthesia
Clinical narrative: I just feel very heavy legs; It's like in waves, it comes and goes; experiencing weight, tingling; It's like in waves, it comes and goes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 15:00 (Batch/Lot number: unknown) at the age of 45 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: LIMB DISCOMFORT (non-serious) with onset 12Aug2021, outcome "unknown", described as "I just feel very heavy legs; It's like in waves, it comes and goes"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "experiencing weight, tingling; It's like in waves, it comes and goes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of limb discomfort, paraesthesia.  Additional information: Consumer got Covid vaccine 2 days ago and the patient just feel very heavy legs, I just want to know if it's normal. Consumer stated, " I believe the LOT # is FC3181. The patient experiencied weight, tingling, heavy legs and I want to know if it's normal or not."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: She is feeling ill right now; I blow my nose I blinked my eyes; started to really hurt; 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 43-year-old female patient received bnt162b2 (BNT162B2), administration date 13Aug2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Ear Infection" (unspecified if ongoing), notes: wants to know if she can take her antibiotic for chronic ear infection (Intent: Medical history). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 13Aug2021, outcome "unknown", described as "She is feeling ill right now"; PAIN (non-serious) with onset 13Aug2021, outcome "unknown", described as "I blow my nose I blinked my eyes; started to really hurt".  Additional information: Expiry date of COVID-19 Vaccine was unknown. She wanted to know if she could take her antibiotic for her chronic ear infection (Intent: Medical history) since she was feeling ill right now, feels like a normal infection as what she said earlier. She said that she felt it after getting the first dose. She had her first dose earlier today. She stated that she usually gets on 2 or 3 times a year and when she went and got her shot today. Her very first one it wasn't bothering but as the nights were on, she blows her nose, blinked her eyes. It started to really hurt, and she had antibiotics ('Erythromycin' (Further not clarified)) but was scared to take them because she did not want to mess up with vaccine. She further clarified that it is not a side effect of vaccine. She gets Chronic Ear infection and already have an antibiotic prescribed. She wanted to know if she could take it on top of the vaccine or if they are fine to wait. What if there a drug interaction that is what she was checking on. Reporter seriousness for events was unspecified.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: she did get dizzy with the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "she did get dizzy with the first shot".  Additional information: The first shot she got was fine, she had no pain, nothing. The patient clarified that she did get dizzy with the first shot and it passed in one or two hours and was not concerned about that part. She was diabetic and had Crohn's disease and she was not sure if that has anything to do with it. She got the shots through her doctor and that has been her doctor for seven years. She declined to complete report. She just wants her question answered. If it was normal then stated that Pfizer need add to the sheet as a side effect if it was normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in left arm, single dose, for COVID-19 immunisation. Medical history scar (unspecified if ongoing); cancer (unspecified if ongoing); and tumor (unspecified if ongoing). The patient's concomitant medications not reported. The patient experienced vaccination site swelling ("it's like a lot of fluid is just pooled-up underneath; it's the size of a golf ball or a tennis ball/it's all around the scar/it's all under my left arm where I had my shot"), with outcome of unknown. No follow-up attempts possible. Information about batch/lot  number cannot be obtained. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Discomfort, Insomnia, Pain
Clinical narrative: A lot of shooting pains in my back near my shoulder blade, it almost feels like how shin splints feels but it's in my back; Body aches; Chills; Couldn't sleep I kept tossing and turning, I couldn't get comfortable; It's very uncomfortable, I could not sleep last night, I'm just a little worried; Couldn't sleep I kept tossing and turning, I couldn't get comfortable; It's very uncomfortable, I could not sleep last night, I'm just a little worried; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administration date 14Aug2021 (Batch/Lot number: unknown) at the age of 36 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, LOT: EA7485), administration date: 24Jul2021, when the patient was 36 years old, for Covid-19 immunisation. The following information was reported: BACK PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "A lot of shooting pains in my back near my shoulder blade, it almost feels like how shin splints feels but it's in my back"; PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "Body aches"; CHILLS (non-serious) with onset Aug2021, outcome "unknown", described as "Chills"; INSOMNIA (non-serious), DISCOMFORT (non-serious) all with onset Aug2021, outcome "unknown" and all described as "Couldn't sleep I kept tossing and turning, I couldn't get comfortable; It's very uncomfortable, I could not sleep last night, I'm just a little worried". Therapeutic measures were taken as a result of back pain, pain.  Additional information: Patient had no history. Consumer stated, calling to report a side-effect that having from the vaccine (Pfizer COVID 19 Vaccine), had received second dose yesterday and patient experiencing a side-effect. Patient did take Tylenol last night also before bed and it just didn't seem to help the pain. Patient also experienced the other symptoms the body aches, chills, all that other stuff but the shooting pains was something that wasn't prepared for. LOT for Tylenol: SMC133. NDC: 50580-414-04, UPC: 0045055024 and Dosage: 325 mg, patient took 2, it's a pack of 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A bit sore in her 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 parent.  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 14Aug2021 (Batch/Lot number: unknown) at the age of 21 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 14Aug2021, outcome "unknown", described as "A bit sore in her arm".   Follow-up (27Sep2021)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: Heart rate increased, Hypertension
Clinical narrative: Rapid heart rate; Elevated blood pressure; 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 parent.  An adult 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: HEART RATE INCREASED (non-serious), outcome "unknown", described as "Rapid heart rate"; HYPERTENSION (non-serious), outcome "unknown", described as "Elevated blood pressure". Additional information- It was reported that My adult daughter received her 1st dose of the Pfizer Vaccine and the next day she began to develop a rapid heart rate elevated blood pressure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Upon receiving my first dose I had a fever and very sore arm but that was the extent of it.; Upon receiving my first dose I had a fever and very sore arm but that was the extent of it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Jul2021 16:00 (Batch/Lot number: unknown) at the age of 22 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Celiac" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Gluten, reaction(s): "known allergies: Gluten". The following information was reported: PAIN IN EXTREMITY (non-serious), PYREXIA (non-serious) all with onset 15Aug2021 03:00, outcome "recovered" and all described as "Upon receiving my first dose I had a fever and very sore arm but that was the extent of it.". The event "upon receiving my first dose I had a fever and very sore arm but that was the extent of it." and "upon receiving my first dose I had a fever and very sore arm but that was the extent of it." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, pyrexia.  Additional information: Takes a women's multivitamin once a day. Upon receiving first dose she had a fever and very sore arm but that was the extent of it. Patient had covid prior to vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Sweating, I like drip water; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): AE-2021-12948.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating, I like drip water".  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fall
Clinical narrative: dizziness/lightheadedness; his sense of balance and equilibrium were not the same/loses his balance; fell on his face; 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 79 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date Mar2021 (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: DIZZINESS (non-serious), outcome "unknown", described as "dizziness/lightheadedness"; BALANCE DISORDER (non-serious), outcome "unknown", described as "his sense of balance and equilibrium were not the same/loses his balance"; FALL (non-serious), outcome "unknown", described as "fell on his face".  Additional information: Caller said he just wanted to know if he's the only one who experienced this and how long this might last. He added he doesn't remember ever having this experience. Caller asked if he can get a 3rd dose of the vaccine. He said "I probably will be given because of my age." He said he has a concern in taking the 3rd shot because of his symptoms and said this might be a coincidence but he doesn't know for sure. He added that if the time comes and they say he's eligible for the 3rd shot, he wants to feel comfortable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Infection
Clinical narrative: Patient got COVID-19 Vaccine and was sick with infection after first shot.; Patient got COVID-19 Vaccine and was sick with infection after first shot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 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: ILLNESS (non-serious), INFECTION (non-serious), outcome "unknown" and all described as "Patient got COVID-19 Vaccine and was sick with infection after first shot.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sinus disorder
Clinical narrative: knocked her out; sinus issues; 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) (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: FATIGUE (non-serious), outcome "unknown", described as "knocked her out"; SINUS DISORDER (non-serious), outcome "unknown", described as "sinus issues".  Additional Information: It was reported that the patient received the first dose of the vaccine and it knocked her out. She also had sinus issues.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: My neck felt warm and fuzzy; My neck felt warm and fuzzy; Oddly pleasant/I felt... high; Some arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jul2021 13:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "anaplasmosis" (unspecified if ongoing), notes: I, unknowingly, lived with anaplasmosis (a tick borne illness) for several years. Concomitant medication(s) included: PRAZOSIN; TOPIRAMATE; BUPROPION. The following information was reported: FEELING HOT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 2021, outcome "not recovered" and all described as "My neck felt warm and fuzzy"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "Oddly pleasant/I felt... high"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Some arm pain". Therapeutic measures were not taken as a result of feeling hot, musculoskeletal discomfort, feeling abnormal, pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination: Clonidinramelteon.   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: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: The pain she had was so intense that by the 2nd day she wanted her arm to be amputated; The pain she had was so intense that by the 2nd day she wanted her arm to be amputated ans she lost 9 days of work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (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), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "The pain she had was so intense that by the 2nd day she wanted her arm to be amputated"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Mar2021, outcome "unknown", described as "The pain she had was so intense that by the 2nd day she wanted her arm to be amputated ans she lost 9 days of work".  Additional information: A contactable consumer reported different events for 2 patients. This is 2 of 2 reports. the reporter is not related to a study or programme. patient is the (Privacy) for the reporter. Reporter seriousness for the pain she had was so intense that by the 2nd day she wanted her arm to be amputated and she lost 9 days of work: Unspecified. the reporter stated that his (Privacy) got her 2nd dose of the Pfizer COVID Vaccine at a different location on the same day and told him the pain she had was so intense that by the 2nd day she wanted her arm to be amputated and she lost 9 days of work; reporter states he does not know if she reported this and he has no other information to provide including the lot, expiry date or NDC of her vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Stomach pain; nausea.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08May2021 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 12Aug2021, outcome "not recovered", described as "Stomach pain"; NAUSEA (non-serious) with onset 12Aug2021, outcome "not recovered", described as "nausea.". Therapeutic measures were taken as a result of abdominal pain upper, nausea.  Additional information: Patient had administered vaccine Facility at Pharmacy or Drug Store. Patient had not received other vaccine in four weeks. Patient had not received other medications in two weeks. Patient had not covid prior vaccination. Patient had not covid tested post vaccination. Patient had received OTC meds for Ae treatment.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (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: URINARY TRACT INFECTION (non-serious) with onset Feb2021, outcome "unknown", described as "UTI". The event "uti" was evaluated at the emergency room visit.  Additional information: PQC was not present. This report was not related to a study or programme. NDC number of covid vaccine was not provided. Other Products was not provided. Investigation assessment was not provided.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070859 same reporter/drug/AE with different patient;US-PFIZER INC-202101069940 same reporter/drug/AE with different patient
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Left arm involuntary tremor; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 12:00 (Batch/Lot number: unknown) at the age of 35 years as dose, 1 single for covid-19 immunisation. Relevant medical history included: "Graves Disease" (unspecified if ongoing). Concomitant medication(s) included: PROPYLTHIOURACIL. The following information was reported: TREMOR (non-serious) with onset 02Aug2021 12:00, outcome "not recovered", described as "Left arm involuntary tremor". Therapeutic measures were not taken as a result of tremor.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up (27Sep2021)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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Nausea, Pain
Clinical narrative: I was super tired and achy; I was super tired and achy; Sweaty; Nauseated; Dizzy; The site pain was about half what I had before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Aug2021 11:30 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; CRESTOR; SYNTHROID; LITHIUM; PRISTIQ. Vaccination history included: Bnt162b2 (Dose number=1,, Administration time=11:00 AM,, Vaccine location=Left arm), administration date: 25Jul2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "I rubbed my arm a few hrs after injection to ease the pain I had with the 1st shot & that seemed to work". The following information was reported: HYPERHIDROSIS (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "Sweaty"; NAUSEA (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "Nauseated"; DIZZINESS (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "Dizzy"; VACCINATION SITE PAIN (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "The site pain was about half what I had before"; FATIGUE (non-serious), PAIN (non-serious) all with onset 16Aug2021, outcome "recovered" (17Aug2021) and all described as "I was super tired and achy". Therapeutic measures were not taken as a result of hyperhidrosis, nausea, dizziness, vaccination site pain, fatigue, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination were atenolol, crestor, synthroid, lithium, Pristiq. Reported that, for 2nd shot, patient rubbed arm a few hrs after injection to ease the pain had with the 1st shot & that seemed to work - the site pain was about half what she had before; in the first 15 mins after injection, Patient was dizzy, sweaty and nauseated, but that passed pretty quick; after that, patient was super tired and achy the next day but that only lasted the one day. Patient has been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Follow-up attempts completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I was super tired and achy; I was super tired and achy; Sweaty; Nauseated; Dizzy; The site pain was about half what I had before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Aug2021 11:30 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; CRESTOR; SYNTHROID; LITHIUM; PRISTIQ. Vaccination history included: Bnt162b2 (Dose number=1,, Administration time=11:00 AM,, Vaccine location=Left arm), administration date: 25Jul2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "I rubbed my arm a few hrs after injection to ease the pain I had with the 1st shot & that seemed to work". The following information was reported: HYPERHIDROSIS (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "Sweaty"; NAUSEA (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "Nauseated"; DIZZINESS (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "Dizzy"; VACCINATION SITE PAIN (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "The site pain was about half what I had before"; FATIGUE (non-serious), PAIN (non-serious) all with onset 16Aug2021, outcome "recovered" (17Aug2021) and all described as "I was super tired and achy". Therapeutic measures were not taken as a result of hyperhidrosis, nausea, dizziness, vaccination site pain, fatigue, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination were atenolol, crestor, synthroid, lithium, Pristiq. Reported that, for 2nd shot, patient rubbed arm a few hrs after injection to ease the pain had with the 1st shot & that seemed to work - the site pain was about half what she had before; in the first 15 mins after injection, Patient was dizzy, sweaty and nauseated, but that passed pretty quick; after that, patient was super tired and achy the next day but that only lasted the one day. Patient has been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Follow-up attempts completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain to COVID vaccination; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 20Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Feb2021 13:30 (Lot number: EN6200) at the age of 73 years as dose 2, single and intramuscular, administered in arm left, administration date 27Jan2021 13:30 (Lot number: ELA265) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain to COVID vaccination".  Additional information: Prior vaccinations-None, Concomitant drugs: None  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: Immune system is low; This is a spontaneous report from a contactable consumer (patient's husband) from a Pfizer-sponsored program. The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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: 05Feb2021, for COVID-19 Immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Immune system is low".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms
Clinical narrative: struggling with this significant and continuous involuntary muscle spasms.; legs and feet are constantly tired from these spasms; 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 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: MUSCLE SPASMS (non-serious), outcome "unknown", described as "struggling with this significant and continuous involuntary muscle spasms."; FATIGUE (non-serious), outcome "unknown", described as "legs and feet are constantly tired from these spasms".  Customer Verbatim: Have you had any cases of involuntary muscle spasms in the legs, feet, toes,and thighs from weeks to months after taking the COVID-19 vaccine. Consumer considering taking the booster but still struggling with this significant and continuous involuntary muscle spasms. Consumer's legs and feet are constantly tired from these spasms. They started about 6 weeks after taking the COVID-19 shot and the doctors can not find any other cause for it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: She experienced a rapid heart beat with an onset of 20 minutes after vaccination lasting 1.5 hours; 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 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Jul2021 18:30 (Lot number: EW0186) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ventricular septal defect" (ongoing), notes: She was born with it.; "Heart murmur" (ongoing), notes: She was born with it.; "Diabetes" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Cancer " (unspecified if ongoing), notes: Cancer 2 generations ago. Family history included: "Heart cath" (unspecified if ongoing), notes: dad had a heart cath. The patient's concomitant medications were not reported. Vaccination history included: Flu shot, for Immunization, reaction(s): "she felt draggy", "Arm sore". The following information was reported: HEART RATE INCREASED (non-serious) with onset 27Jul2021 18:50, outcome "recovered" (27Jul2021 20:20), described as "She experienced a rapid heart beat with an onset of 20 minutes after vaccination lasting 1.5 hours". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Receiving her first dose of the Pfizer covid 19 vaccine three weeks ago; after receiving the dose, she experienced a rapid heart beat with an onset of 20 minutes after vaccination lasting 1.5 hours. She has not had any more bouts of it like she did that day. Family medical history relevant to event were reported as diabetes, high cholesterol, high blood pressure and her dad had a heart cath.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Thirst
Clinical narrative: Very strong metallic taste; feel the tip of the tongue a little numb; feel very thirsty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Aug2021 15:30 (Batch/Lot number: unknown) at the age of 48 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 21Aug2021 23:00, outcome "not recovered", described as "Very strong metallic taste"; HYPOAESTHESIA ORAL (non-serious) with onset 21Aug2021 23:00, outcome "not recovered", described as "feel the tip of the tongue a little numb"; THIRST (non-serious) with onset 21Aug2021 23:00, outcome "not recovered", described as "feel very thirsty". Therapeutic measures were not taken as a result of dysgeusia, hypoaesthesia oral, thirst.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: She is still feeling really fatigued; She is still feeling fatigued; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 14Aug2021 (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: FATIGUE (non-serious), outcome "unknown", described as "She is still feeling really fatigued; She is still feeling fatigued".  Additional Information: Reporter calling on behalf of the patient. so this was about patient, 'that the only' fatigued. So, she got it on Saturday, Patient was still feeling fatigued. Reporter just wanted to make sure that this was a normal side effect for patient.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had fatigue (tiredness) and pain (aches), onset 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: 29Apr2021/08Aug2021; Sick for about 30 days after 2nd; This is a spontaneous report received from 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 left, administration date 08Aug2021 11:00 (Lot number: EW0158) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Penicillin" (unspecified if ongoing), notes: Known allergy: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer, Lot number=EW0172, Lot unknown=False, Administration date=29Apr2021, Administration time 11:00 AM, Vaccine location= Left arm, Dose number=1), administration date: 29Apr2021, when the patient was 34 years old, for COVID-19 immunisation, reaction(s): "Heart racing often", "shortness of breath", "lethargic", "extreme brain fog", "weight gain", "body aches"; Bnt162b2 (Product=COVID 19, brand=Pfizer, Lot number=EW0172, Lot unknown=False, Administration date=29Apr2021, Administration time 11:00 AM, Vaccine location= Left arm, Dose number=1), administration date: 29Apr2021, for COVID-19 immunisation, reaction(s): "muscle fatigue", "headaches". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Aug2021, outcome "unknown", described as "29Apr2021/08Aug2021"; ILLNESS (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Sick for about 30 days after 2nd". Therapeutic measures were not taken as a result of illness.  Additional information: Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage was not reported. Patient recovered with lasting effects. Patient did not have Covid prior to vaccination. Patient did not tested Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: who suffers from tinnitus and got the Pfizer COVID-19 vaccine and had elevated tinnitus.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "who suffers from tinnitus and got the Pfizer COVID-19 vaccine and had elevated tinnitus.".  Additional information: Caller who does not want to provide any information at all and has three concerns. Agent reports reporter said patient had tinnitus and said patient does not want what happened to a friend of hers, who suffers from tinnitus and got the Pfizer COVID-19 vaccine and had elevated tinnitus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Headache, Pain in extremity
Clinical narrative: Headache; Arm is sore; Arm pain; Body temperature is low; Took my temperature, my body temperature is 73.8; 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) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is sore; Arm pain"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "Body temperature is low; Took my temperature, my body temperature is 73.8". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient had the second shot (Pfizer COVID 19 Vaccine) and is looking at the side effects. Patient have headache and the arm is sore. Feel like patient want to 'run it' but and have a arm pain. One of the concern was that when patient took temperature, patient's body temperature is 73.8. Patient wants to know if that is a reason for concern. Patient just took it the previous day and do not have the card. Patient wants to know why body temperature is low.   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 have been completed and no further information is expected.