chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Swelling on right leg below the knee and its painful off and on with discoloration; Swelling on right leg below the knee and its painful off and on with discoloration; Swelling on right leg below the knee and its painful off and on with discoloration; 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 male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Apr2021 10:00 (Lot number: EW0170) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, SINGLE, COVID-19 Vaccine (Pfizer), Lot number: ER8730, Administration date: 29Mar2021, Administration time: 10:00 AM, Location: Right arm), administration date: 29Mar2021, when the patient was 57 years old, for COVID-19 immunization.  The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), SKIN DISCOLOURATION (non-serious) all with onset 20Apr2021, outcome "not recovered" and all described as "Swelling on right leg below the knee and its painful off and on with discoloration". Therapeutic measures were taken as a result of peripheral swelling. Therapeutic measures were not taken as a result of pain in extremity, skin discolouration.   Additional information: Patient did not receive other vaccine in four weeks. He did not receive other mediations within 2 weeks of vaccination. He was not diagnosed with COVID-19 prior to vaccination and had not been tested positive since the vaccination. He does not have allergies to medications, food or other products.    No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Lot number: ER9731) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (Lot No: EN6207)), administration date: 01Apr2021, when the patient was 30 years old, for COVID-19 Immunisation, reaction(s): "Brief spells of fever like warming of body multiple times throughout day.". The following information was reported: FATIGUE (non-serious) with onset 21Apr2021, outcome "unknown", described as "Fatigue".  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: 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 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "vitamin d deficient" (unspecified if ongoing). Concomitant medication(s) included: XYZAL. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Facility type vaccine was other. No other vaccine in four weeks. Other medications in two weeks was Xyzal and multivitamins. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: Yesterday, I took 20,000 steps and my second shot feels like I'm on a caffeine buzz of energy.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 10:00 (Lot number: Er8727) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: PROPOFOL; PROZAC; LISINOPRIL. The following information was reported: ENERGY INCREASED (non-serious) with onset 01Apr2021 12:00, outcome "not recovered", described as "Yesterday, I took 20,000 steps and my second shot feels like I'm on a caffeine buzz of energy."; WEIGHT INCREASED (non-serious), outcome "unknown", described as "My leg skin is starting to sag from losing weight quickly". Therapeutic measures were not taken as a result of energy increased.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site (similar to first vaccine); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 15:45 (Lot number: ER8734) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MIRENA. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Pain at injection site (similar to first vaccine)". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks was Mirena IUD, Women's Multi. No covid prior vaccination. Not tested for COVID post vaccination. There were no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia, Paraesthesia
Clinical narrative: Metal/tin taste in mouth immediately after, for about 10 minutes; Tingling and numbness on left side of mouth and face immediately after; Tingling and numbness on left side of mouth and face immediately after; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 15:45 (Lot number: ER8734) at the age of 26 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: DYSGEUSIA (non-serious) with onset 10Apr2021 15:45, outcome "recovered" (2021), described as "Metal/tin taste in mouth immediately after, for about 10 minutes"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 10Apr2021 15:45, outcome "recovered" (2021) and all described as "Tingling and numbness on left side of mouth and face immediately after". Therapeutic measures were not taken as a result of dysgeusia, paraesthesia, hypoaesthesia.  Additional information: The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Mar2021, outcome "recovered" (27Mar2021), described as "Slight soreness at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Iron overload
Clinical narrative: iron overload; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male 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: IRON OVERLOAD (non-serious), outcome "unknown", described as "iron overload". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Only a sore arm the day of and after; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021 US085199_NS (Novartis Pharmaceuticals Corporation).  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 65 years 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 "recovered", described as "Only a sore arm the day of and after". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Paraesthesia, Vaccination site warmth
Clinical narrative: Tingling and burning up and down back/for Tingling in face, side of right cheek; Tingling and burning up and down back; Headache; Warm at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 09:30 (Lot number: EW0162, Expiration Date: 31Jul2021) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing), notes: Tylenol every once in while for headaches in the last 2 week. Concomitant medication(s) included: TYLENOL taken for headache. Vaccination history included: Meningitis a (Route: injection, Anatomical Location: right arm), for immunisation. The following information was reported: PARAESTHESIA (non-serious) with onset 22Apr2021 09:45, outcome "not recovered", described as "Tingling and burning up and down back/for Tingling in face, side of right cheek"; BURNING SENSATION (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Tingling and burning up and down back"; HEADACHE (non-serious) with onset 22Apr2021, outcome "recovered" (22Apr2021), described as "Headache"; VACCINATION SITE WARMTH (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Warm at injection site". Therapeutic measures were not taken as a result of paraesthesia, burning sensation, headache, vaccination site warmth.  Additional information: The patient had tingling and burning up and down her back, neck and tingling in her face. Had the vaccine 9:30 this morning. It started almost as soon as she had it. Also had a headache that went away. The patient was told to wait the 15 minutes to see if there were any side effects. When she left, she started feeling the burning sensation in her back. When she got home, she felt the tingling, like acupuncture. It was still burning and felt the same way. Has not gotten any worse, its the same. Tingling in face, side of right cheek: Is by her nose on the right side. Started about an hour or 2 ago. Still feels the same.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysphagia, Tenderness, Vaccination site pain
Clinical narrative: Soreness in arm at injection site; It was like getting dry mouth really bad; Area was a little tender; hard to swallow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 14:00 (Lot number: EW0169) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN taken for depression; PROPRANOLOL taken for anxiety; CITALOPRAM taken for anxiety. Past drug history included: Codeine, reaction(s): "Allergy", notes: verbatim: Is allergic to Codeine. Vaccination history included: Flu vaccine (verbatim: she had the flu shot), for Immunisation. The following information was reported: DYSPHAGIA (non-serious) with onset 20Apr2021, outcome "recovered" (21Apr2021), described as "hard to swallow"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in arm at injection site"; DRY MOUTH (non-serious), outcome "unknown", described as "It was like getting dry mouth really bad"; TENDERNESS (non-serious), outcome "unknown", described as "Area was a little tender". Therapeutic measures were not taken as a result of dysphagia, vaccination site pain, dry mouth, tenderness.  Additional information:When reporting symptoms about her daughter, had mentioned that she had experienced sore arm at the site and having a hard time swallowing after the vaccine. After the shot, was drinking stuff constantly because she felt thirsty. Additional Vaccines Administered on same date was no.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not visited emergency room or physician office due to events.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear disorder, Feeling abnormal, Tinnitus
Clinical narrative: She is getting problems, it is like a rushing noise but it is not necessary ringing;; Head has been fuzzy; Dizzy; Ear trouble; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol; "Heart issues" (unspecified if ongoing), notes: Verbatim: Heart issues. The patient took concomitant medications. Vaccination history included: Bnt162b2, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "She is getting problems, it is like a rushing noise but it is not necessary ringing;"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Head has been fuzzy"; DIZZINESS (non-serious), outcome "not recovered", described as "Dizzy"; EAR DISORDER (non-serious), outcome "not recovered", described as "Ear trouble". Therapeutic measures were not taken as a result of tinnitus, feeling abnormal, dizziness, ear disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose increased, Fatigue
Clinical narrative: blood sugar went higher; tiredness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  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 was not reported. Concomitant medication(s) included: NOVOLOG. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar went higher"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  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: Chills, Diarrhoea, Headache, Oropharyngeal pain, Pain
Clinical narrative: headache; chills; slight sore throat; body ache; loose stools; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 21-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 21 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 Number: Not provided)), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "headache"; CHILLS (non-serious), outcome "recovered", described as "chills"; OROPHARYNGEAL PAIN (non-serious), outcome "recovered", described as "slight sore throat"; PAIN (non-serious), outcome "recovered", described as "body ache"; DIARRHOEA (non-serious), outcome "unknown", described as "loose stools".  Additional Information: The patient received the second dose around 10:30 AM. At 20:00, she started to have a headache. At 22:00, she experienced chills. The next morning, she had a headache, slight sore throat, and body ache. These resolved by that afternoon. The next day, she experienced loose stools.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Head discomfort, Ocular discomfort
Clinical narrative: Pressure headaches; Eye pressure pain; Eye pressure pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An 81 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer", start date: 2020, stop date: Nov2020, notes: cancer free since November of 2020.; "Chemotherapy", start date: 2020 (unspecified if ongoing); "Radiation", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "Pressure headaches"; OCULAR DISCOMFORT (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "Eye pressure pain".  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: Abdominal pain, Condition aggravated, Off label use, Product use issue
Clinical narrative: After 2nd dose, the pain is worse; I had a baby via c-section in March 2020, I am still lactating; I had a baby via c-section in March 2020, I am still lactating; cramping in my lower abdomen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 10:00 (Lot number: er8731) as dose 2, single and administered in arm left, administration date 24Mar2021 09:30 (Lot number: er8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "c-section", start date: Mar2020 (unspecified if ongoing), notes: I had a baby via c-section in March, 2020. The patient took concomitant medications. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 24Mar2021 10:00, outcome "recovered", described as "cramping in my lower abdomen"; CONDITION AGGRAVATED (non-serious), outcome "recovered", described as "After 2nd dose, the pain is worse"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious), outcome "recovered" and all described as "I had a baby via c-section in March 2020, I am still lactating". Therapeutic measures were taken as a result of abdominal pain, condition aggravated.  Additional Information: Other medications in two weeks: Soloxine 0.1 once daily. After each shot, within 8-10 minutes she had cramping in her lower abdomen, as if she were getting her period. It wasn't as painful as her period, but enough to remember and send you all a note. It happened each time. After the first vaccine, the pain lasted only about an hour, and it was not as painful as after the second vaccine. After the second vaccine, the pain was worse, almost like period cramping. It lasted all day. She took Advil and it went way at night. Other medical history: She had a baby via c-section in March 2020. She was still lactating. Her periods have come back, but are not horrible.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021473742 same report/drug, mother/child case
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: has been feeling tired over a week; This is a spontaneous report received from a contactable consumer from medical information team.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 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: FATIGUE (non-serious), outcome "unknown", described as "has been feeling tired over a week".  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: Limb discomfort, SARS-CoV-2 test
Clinical narrative: Sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Mar2021 19:30 (Lot number: ER8733) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gallbladder removal", start date: 2008, stop date: 2008, notes: Pertinent Details: Organ removal; "gestational diabetes", start date: 2013, stop date: 2013, notes: Pertinent Details: stopped after birth; "gestational diabetes", start date: 2016, stop date: 2016, notes: Pertinent Details: stopped after birth; "Ablation", start date: 2020, stop date: 2020, notes: Pertinent Details: Done. Family history included: "breast cancer" (unspecified if ongoing), notes: Mother died at breast cancer at age 50; "diabetes" (unspecified if ongoing), notes: Father had history of diabetes and heart issues died at age of 76; "heart issues" (unspecified if ongoing), notes: Father had history of diabetes and heart issues died at age of 76. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time (24hr): 07:30 pm, Anatomical site of injection: upper left Arm, Route of Administration: Intramuscular, Batch/lot number: EN6204), administration date: 10Mar2021, when the patient was 43 years old, for COVID-19 immunisation, reaction(s): "Minor heart flutter". The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Sore left arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that she only had heart flutters with the first vaccine. Dr. later said it was most likely anxiety induced and not from the vaccine. Second dose of vaccine was given on 31Mar2021 with no side effects except a sore, left arm.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: felt a bit of soreness; soreness on right side where she got vaccine; felt tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (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 (non-serious), outcome "unknown", described as "felt a bit of soreness"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness on right side where she got vaccine"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Therapeutic measures were taken as a result of pain, vaccination site pain, fatigue include two Tylenol.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Woke up morning after vaccine with strong dizziness...sporadic. Bouts of dizziness seemed to subside after 90 minutes.; Arm where shot taken is quite sore; 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 male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Apr2021 09:30 (Lot number: EL3247, Expiration Date: May2021) at the age of 45 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 (product=COVID 19, brand=Pfizer, lot unknown=True , lot unknown reason=Not available/provided to reporter at the time of report completion, administrator route=Intramuscular , administration date=06Apr2021, administration time=11:00 AM, dose number=1 , vaccine location=Right arm, Lot no: EL3247,), administration date: 06Apr2021, when the patient was 45 years old, for covid 19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 28Apr2021 06:45, outcome "recovering", described as "Woke up morning after vaccine with strong dizziness...sporadic. Bouts of dizziness seemed to subside after 90 minutes."; VACCINATION SITE PAIN (non-serious) with onset 28Apr2021 06:45, outcome "recovering", described as "Arm where shot taken is quite sore". Therapeutic measures were not taken as a result of dizziness, vaccination site pain.  Additional information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not covid tested post vaccination. No known allergies. No prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No concomitant drugs taken within two weeks before the event onset. Exclude all drugs only administered more than two weeks before the event, and any drug used to treat the event or taken after event onset. No other medical history or family history reported. No other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest X-ray, MRI). If COVID-19 testing has been conducted, provide test dates and results. Still alive only felt symptoms day AE reported.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Neck pain
Clinical narrative: It seem to really aggravate weak spots in body. Felt like a horse kicked me in back of neck where I had spinal stenosis surgery.; It seem to really aggravate weak spots in body. Felt like a horse kicked me in back of neck where I had spinal stenosis surgery.; Just tired; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 15:15 (Lot number: EB6203) at the age of 67 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Azythromycin, reaction(s): "azithromycin allergy", notes: Yes, arithomyacin. The following information was reported: FEELING ABNORMAL (non-serious), NECK PAIN (non-serious) all with onset 20Feb2021 20:00, outcome "recovered" (21Feb2021) and all described as "It seem to really aggravate weak spots in body. Felt like a horse kicked me in back of neck where I had spinal stenosis surgery."; FATIGUE (non-serious) with onset 20Feb2021 20:00, outcome "unknown", described as "Just tired". Therapeutic measures were taken as a result of feeling abnormal, neck pain included Ibuprofen and it was fine next day. Therapeutic measures were not taken as a result of fatigue.  Additional information: Patient had no covid prior vaccination and did not take any vaccine with in the four week of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: sore at the injection site; Extreme tiredness; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Mar2021 09:42 (Lot number: EN6205) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Overactive Bladder" (unspecified if ongoing); "Estrogen Since hysterectomy" (unspecified if ongoing); "Estrogen Since hysterectomy" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "vascular Problem in lower legs & ankles" (unspecified if ongoing). Concomitant medication(s) included: MYRBETRIQ taken for hypertonic bladder (ongoing); ESTRADIOL taken for blood oestrogen (ongoing); FEXOFENADINE taken for hypersensitivity (ongoing); FAMOTIDINE taken for gastrooesophageal reflux disease (ongoing); FLONASE SENSIMIST ALLERGY RELIEF taken for hypersensitivity (ongoing); VASCULERA taken for vascular pain (ongoing). Vaccination history included: Bnt162b2 (1st Dose, Anatomical Site of Injection: Left Arm,, Route of administration: Intramuscular, Batch/Lot Number: EL3247), administration date: 09Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "couldn't move arm out to side", "extreme headache", "extreme tiredness". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore at the injection site"; FATIGUE (non-serious), outcome "unknown", described as "Extreme tiredness"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: The patient believe the error uses in the administration of the vaccine. She jabbed me quite firmly and it may have not been quite in the right placed. It was extremely pain full and felt all the vaccine going into my arm. After ward realized I couldn't move my arm away from body more than it has lasted 5 days also had severe headache, tiredness. In comparison, when I got my 2nd vaccine, never felt the injection and I could move my arm in all direction. It was just sore at the injection site like a Flu shot was. I did have the extreme tiredness and headache as I did with 1st vaccination for several days.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: She is not feeling well; This is a spontaneous report received from a non-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: MALAISE (non-serious), outcome "unknown", described as "She is not feeling well".  Additional Information: Reporter said, that she has today her appointment to get the second dose of the Pfizer covid vaccine and she is not feeling well so she would like to change her appointment. PQC was not present. AE Present was reported as yes. Case was reported as non-serious. Possible AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 female patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (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: HEADACHE (non-serious) with onset 24Apr2021, outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity
Clinical narrative: migraine; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 30's received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 4 decade as dose 1, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing), notes: patient get migraines when patient have anxiety and when about to get my period; "migraine" (unspecified if ongoing), notes: but it's not related to that, it is related to my feminine cycle. The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "migraine"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "sore arm".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Somnolence
Clinical narrative: Drowsiness; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset Apr2021, outcome "unknown", described as "Drowsiness"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache".  Additional Information: After the 2nd dose, patient is having drowsiness and a headache. Patient asked if he can take Tylenol or Advil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: rashes all over the body due to poison ivy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (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: DERMATITIS CONTACT (non-serious) with onset 26Apr2021, outcome "unknown", described as "rashes all over the body due to poison ivy". The event "rashes all over the body due to poison ivy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of dermatitis contact. Additional information: The patient received loratadine (CLARITIN) as treatment for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Therapeutic response unexpected
Clinical narrative: Two hours after my second injection my balance was restored to normal; My legs still don't work very well but my balance has been restored.; 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 2, single for covid-19 immunisation. Relevant medical history included: "MS" (unspecified if ongoing), notes: I have had MS for 20 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Two hours after my second injection my balance was restored to normal"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "My legs still don't work very well but my balance has been restored.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm with her first and second vaccination; 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm with her first and second 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: Asthenia, COVID-19 pneumonia, Confusional state, Dysstasia, Fatigue
Clinical narrative: Very confused; Couldn't be stand; Arm Sore; Very weak; Din't feel good; Tired for several days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Feb2021 14:15 (Lot number: EM9810) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid Pneumonia both lungs" (unspecified if ongoing), notes: Covid Pneumonia both lungs, Date-21Dec2020 to 24Dec2020, Result-positive; "ICU", start date: 21Dec2020, stop date: 24Dec2020, notes: Covid Pneumonia both lungs, Date-21Dec2020 to 24Dec2020, Result-positive, Hospitalized ICU 4 days; "covid virus", start date: 09Dec2020, stop date: Jan2021, notes: onset date-09Dec2020, stop date-Jan2021. There were no concomitant medications. Vaccination history included: Bnt162b2 (Time: 2:15 PM, Anatomical site of Injection-Left Arm, Route of Administration-Intramuscular, Lot# -EL3249), administration date: 21Jan2021, for Covid-19 immunization, reaction(s): "Run a 103 fever", "Arm sore", "Tired for several days", "didn't feel good". The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Very confused"; DYSSTASIA (non-serious), outcome "unknown", described as "Couldn't be stand"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm Sore"; ASTHENIA (non-serious), outcome "unknown", described as "Very weak"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Din't feel good"; FATIGUE (non-serious), outcome "recovering", described as "Tired for several days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Arm sore-got up around 8AM. by 10:00AM could not stand, very weak. very confused. Thought he had a stroke. he kept trying to get up, walked to kitchen, had to sit down at table. stay there till 4:30 begin to get where he could stand by6:00PM, could walk. next day, tired, but better, didn't feel good for several days.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Very confused; Couldn't be stand; Arm Sore; Very weak; Din't feel good; Tired for several days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Feb2021 14:15 (Lot number: EM9810) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid Pneumonia both lungs" (unspecified if ongoing), notes: Covid Pneumonia both lungs, Date-21Dec2020 to 24Dec2020, Result-positive; "ICU", start date: 21Dec2020, stop date: 24Dec2020, notes: Covid Pneumonia both lungs, Date-21Dec2020 to 24Dec2020, Result-positive, Hospitalized ICU 4 days; "covid virus", start date: 09Dec2020, stop date: Jan2021, notes: onset date-09Dec2020, stop date-Jan2021. There were no concomitant medications. Vaccination history included: Bnt162b2 (Time: 2:15 PM, Anatomical site of Injection-Left Arm, Route of Administration-Intramuscular, Lot# -EL3249), administration date: 21Jan2021, for Covid-19 immunization, reaction(s): "Run a 103 fever", "Arm sore", "Tired for several days", "didn't feel good". The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Very confused"; DYSSTASIA (non-serious), outcome "unknown", described as "Couldn't be stand"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm Sore"; ASTHENIA (non-serious), outcome "unknown", described as "Very weak"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Din't feel good"; FATIGUE (non-serious), outcome "recovering", described as "Tired for several days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Arm sore-got up around 8AM. by 10:00AM could not stand, very weak. very confused. Thought he had a stroke. he kept trying to get up, walked to kitchen, had to sit down at table. stay there till 4:30 begin to get where he could stand by6:00PM, could walk. next day, tired, but better, didn't feel good for several days.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: Had missed the 2nd dose appointment due on April 21st; Not feeling well; 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 female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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: PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "Had missed the 2nd dose appointment due on April 21st"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well".  Additional information: The patient had missed the 2nd dose appointment due on 21Apr because she was not feeling well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Nausea
Clinical narrative: About half of a milliliter came out of the patient's arm; Nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A female patient in her late 20s received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot no: unknown) via an unspecified route of administration on an unspecified date, at a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 07Apr2021, for COVID-19 Immunization. The patient was administered the vaccine on an unspecified date wherein about half of a milliliter came out of the patients arm. The patient experienced nausea on 28Apr2021. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Additional information: Instructed patient to take the rest of the day off and drink a lot of water and BRAT diet.   Follow-up (28Apr2021): This is a Follow-up spontaneous report from a contactable nurse. Updated information: Event "upon administering the vaccine, about half of a milliliter of the dose came out of the patient's arm" onset date was added, Event "Nausea" was added with onset date and outcome, Expiry date of Covid vaccine, Historical vaccine dose1 of Covid vaccine, Medical relevant history (none) was captured.      No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: his wife experianced fatigue after the injection but that was it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Takes methotrexate(stopped for 2 weeks prior to vaccine),Advil for rheumatoid arthritis in joints. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "his wife experianced fatigue after the injection but that was it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.