chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Chills, Pyrexia
Clinical narrative: Still has a temperature of 99.5 F; Chills; Fever; This is a spontaneous report from a contactable consumer. The consumer reported that an 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Caller states she got her second shot on Wed, 03Feb2021, was sick yesterday with fever and chills, feeling better this morning but still has a temperature of 99.5 F, caller wants to know how long these symptoms will last, wants to know there was anything to do besides take Tylenol. Caller states she was currently treating her symptoms with Tylenol. Caller states she had no issues with the first vaccine except a sore arm, got first vaccine on 13Jan2021, sore arm lasted a couple of days, states it was not too bad, Lot from first vaccine: EL3247, dose: 0.3mL, expiration date: unknown. States the dosage was unknown for second vaccine. The patient underwent lab tests and procedures which included body temperature: 99.5 fahrenheit on unknown date. Outcome of the event was recovering for chills, pyrexia and unknown for body temperature abnormal. The reporter considered the events as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in mouth; This is spontaneous report received from a contactable consumer. A 56-year-old female patient (non-pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9269), via an unspecified route of administration on left arm on 03Feb2021,15:45 at single dose for COVD-19 immunization. The patient medical history included High blood pressure, Allergies: Raw Eggs. Concomitant medication included hydrochlorothiazide taken; verapamil; biotin, calcium pantothenate, chromic chloride, cholecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, sodium ascorbate, sodium molybdate dihydrate, sodium selenate, thiamine mononitrate, zinc oxide (CENTRUM VITAMINTS). The patient previously took prednisone, metoprolol, lisinopril, losartan and all had Allerges. No Covid prior vaccination and no Covid tested post vaccination. It was reported that, the patient experienced metallic taste in mouth on an unspecified date in 2021. The outcome of the event was reported as recovered on 2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Blood test, Computerised tomogram, Hypoaesthesia
Clinical narrative: Her hips and her knees everything was as stiff as a board and she could not bend her knee's; tingling; blood pressure was 169/101; speech was real slurred; numb in her arm and hand; she could not pick up or hold anything; This is a spontaneous report from a contactable consumer (patient herself).A 29-years-old non- female patient received receibed second dose of bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 as intramuscular, administered in Arm Right on 07Jan2021 as SINGLE DOSE for covid-19 immunisation.The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced numb in her arm and hand (hypaesthesia) on 28Jan2021 10:00 and she could not pick up or hold anything on 28Jan2021 and, speech was real slurred on 30Jan2021 and , her hips and her knees everything was as stiff as a board and she could not bend her knee's on an unspecified date  and tingling (paraesthesia), blood pressure was 169/101 (blood pressure abnormal) on an unspecified date and The patient underwent lab tests and procedures which included blood pressure measurement: 169/101 on ,blood test: normal  on 30Jan2021 ,computerised tomogram: no stroke on 30Jan2021 ,urine analysis: normal on 30Jan2021.The events were considered as non-serious by the consumer The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Motor dysfunction, Paraesthesia, Speech disorder, Urine analysis
Clinical narrative: Her hips and her knees everything was as stiff as a board and she could not bend her knee's; tingling; blood pressure was 169/101; speech was real slurred; numb in her arm and hand; she could not pick up or hold anything; This is a spontaneous report from a contactable consumer (patient herself).A 29-years-old non- female patient received receibed second dose of bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 as intramuscular, administered in Arm Right on 07Jan2021 as SINGLE DOSE for covid-19 immunisation.The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced numb in her arm and hand (hypaesthesia) on 28Jan2021 10:00 and she could not pick up or hold anything on 28Jan2021 and, speech was real slurred on 30Jan2021 and , her hips and her knees everything was as stiff as a board and she could not bend her knee's on an unspecified date  and tingling (paraesthesia), blood pressure was 169/101 (blood pressure abnormal) on an unspecified date and The patient underwent lab tests and procedures which included blood pressure measurement: 169/101 on ,blood test: normal  on 30Jan2021 ,computerised tomogram: no stroke on 30Jan2021 ,urine analysis: normal on 30Jan2021.The events were considered as non-serious by the consumer The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Mobility decreased
Clinical narrative: body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Chills; fatigue; general malaise; This is a spontaneous report from a contactable Other HCP, the patient. A 40-year-old non-pregnant female patient first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history included patient was diagnosed with COVID-19 (prior to vaccination). Since the vaccination, the patient had not been tested for COVID-19.The patient had no Known allergies. Concomitant medications included multivitamin and magnesium supplement. On 03Feb2021 at 16:00 the patient expereinced Intense pain at injection site and traveling down to elbow. Unable to raise arm overhead. Chills, body aches, fatigue, prickly skin, general malaise. No treatment was received for the events. Outcome of the events were recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Vaccination site pain
Clinical narrative: body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Chills; fatigue; general malaise; This is a spontaneous report from a contactable Other HCP, the patient. A 40-year-old non-pregnant female patient first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history included patient was diagnosed with COVID-19 (prior to vaccination). Since the vaccination, the patient had not been tested for COVID-19.The patient had no Known allergies. Concomitant medications included multivitamin and magnesium supplement. On 03Feb2021 at 16:00 the patient expereinced Intense pain at injection site and traveling down to elbow. Unable to raise arm overhead. Chills, body aches, fatigue, prickly skin, general malaise. No treatment was received for the events. Outcome of the events were recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: unknown, Formulation: Solution for injection, Lot number: EL3247, expiration date: unknown), via an unspecified route of administration at the age of 83-years, on 13Jan2021, at 0.3 mL, single dose (dose number: 1) for COVID-19 immunization. The patient's medical history and concomitant medications were none. It was reported that she had no issues with the first vaccine except a sore arm on an unknown date in 2021, got first vaccine on 13Jan2021, sore arm lasted a couple of days, states it was not too bad. The outcome of the event was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: pain at injection site/ left arm; pain when raising arm; This is a spontaneous report from a contactable consumer reporting for herself.   A 27-year-old non-pregnant female patient received her first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE),  lot number: 9266, via an unspecified route of administration, administered in left arm on 25Jan2021 at 08:45 (at the age of 27 years old) as a single dose for COVID-19 immunisation.  Medical history included asthma from an unknown date, blood triglycerides increased from an unknown date, and drug allergy to cephalosporins from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Six hours after vaccine administration, the patient experienced pain at injection site/ left arm on 25Jan2021, and pain when raising arm on 25Jan2021. The patient did not receive treatment for the events. The outcome of the events pain at injection site/ left arm, and pain when raising arm was recovered on 26Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Investigation, Lymph node pain, Lymphadenopathy
Clinical narrative: Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen lymph nodes that hurts like crazy; Swollen lymph nodes that hurts like crazy; arm got sore; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31May2021), via an unspecified route of administration on 03Feb2021 (at the age of 75 years) as single dose for covid-19 immunisation; potassium chloride (KLOR-CON M10), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication.  Medical history included ongoing type 2 diabetes and ongoing high blood pressure. Concomitant medications included metformin; atorvastatin; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Consumer stated she got her Covid inoculation last Wednesday and in Feb2021, she was experiencing symptoms, adverse reactions. She had injection site pain still, muscle pain, her lungs are fine but when she breathe her front and back of her chest hurts.  She had chills. She did not think she had a fever but she was definitely feeling unwell and the most difficult thing was swollen lymph nodes that hurts like crazy. She cannot read this too well. Lot was 2CI or EI EL3302 expires 31May2021. Her arm got sore but today she really started may be yesterday experiencing this muscle pain and the lymph stuff going on. Consumer stated she had no treatment. The last time her doctor gave her this new medication because she had run out of her potassium. It was called Klor-con M10 tablet. For lab work, consumer stated she did not know but right before she went there they took some blood and when the doctor gave her the Klor thing, she had a violent reaction to it. she threw up and had a lot of diarrhea and she have not taken it since. Results of lab work was unknown.  The action taken in response to the events for potassium chloride was unknown. Outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen lymph nodes that hurts like crazy; Swollen lymph nodes that hurts like crazy; arm got sore; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31May2021), via an unspecified route of administration on 03Feb2021 (at the age of 75 years) as single dose for covid-19 immunisation; potassium chloride (KLOR-CON M10), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication.  Medical history included ongoing type 2 diabetes and ongoing high blood pressure. Concomitant medications included metformin; atorvastatin; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Consumer stated she got her Covid inoculation last Wednesday and in Feb2021, she was experiencing symptoms, adverse reactions. She had injection site pain still, muscle pain, her lungs are fine but when she breathe her front and back of her chest hurts.  She had chills. She did not think she had a fever but she was definitely feeling unwell and the most difficult thing was swollen lymph nodes that hurts like crazy. She cannot read this too well. Lot was 2CI or EI EL3302 expires 31May2021. Her arm got sore but today she really started may be yesterday experiencing this muscle pain and the lymph stuff going on. Consumer stated she had no treatment. The last time her doctor gave her this new medication because she had run out of her potassium. It was called Klor-con M10 tablet. For lab work, consumer stated she did not know but right before she went there they took some blood and when the doctor gave her the Klor thing, she had a violent reaction to it. she threw up and had a lot of diarrhea and she have not taken it since. Results of lab work was unknown.  The action taken in response to the events for potassium chloride was unknown. Outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Lymphadenopathy
Clinical narrative: Sore swollen lymph nodes in my underarm left side. Swollen sore lymph nodes groin both sides; This is a spontaneous report from a contactable Other-HCP (patient). A 58-year-old female started to receive dose of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: Ek573), via an unspecified route of administration on 11Jan2021 3:30 Pm in left arm, dose number: 1 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: En5318) on left arm, dose number: 2, on 02 Feb 2021 as single dose. The patient medical history included allergies to Penicillin. The concomitant medications included Estrogen (ESTRADIOL), medroxyprogesterone, venlafaxine, alpraz (ALPRAZOLAM) at an unspecified date at an unknown dose. The patient experienced Sore swollen lymph nodes in her underarm left side. Swollen sore lymph nodes groin both sides on 03Feb2021, 05:00 AM. The outcome of events was recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight pain in left arm of injection site/Sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL9262) via an unspecified route of administration, at the age of 75-year-old, administered in Arm Left on 21Jan2021 10:15 AM, as SINGLE DOSE for covid-19 immunisation.  Medical history included allergy to Penicillin and derivatives. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications.  The patient experienced slight pain in left arm of injection site/sore for 24hrs in 2021. The patient did not receive any treatment in response to the event. Outcome of the event was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling below injection site; Redness and swelling below injection site; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN9581) via an unspecified route of administration in left arm on 07Feb2021 15:00 (at the age of 29-years-old) as single dose for COVID-19 immunisation. Medical history included covid-19. The patient did not receive other vaccine in four weeks prior to vaccination and other medications in two weeks. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3246) in the left arm on 17Jan2021 15:00 for COVID-19 immunisation and amoxicillin and had known allergies. On 08Feb2021 08:00, the patient developed redness and swelling below injection site similar to the "covid arm" from the Moderna vaccine. No treatment was received for the adverse events. The patient did not test COVID post vaccination. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced a positive COVID-19 test on an unknown date after the vaccine. The clinical outcome of the event COVID-19 was unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Chills, Illness, Muscle spasms, Pain
Clinical narrative: cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up; stayed in the bathroom, you know I was just dribbling sometimes; This is a spontaneous report from a contactable consumer for herself. A 68-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269, Expiration date: Unknown) on 08Feb2021 via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history included cholesterol and thyroid from an unknown date and unknown if ongoing. The patient's concomitant medications included vitamins. The patient stated she took medications for her thyroid and cholesterol, and vitamins. On 08Feb2021 at 19:30 the patient had cramping "real bad." The patient was sick all night, had chills, stayed in the bathroom, "you know I was just dribbling sometimes and hurting." The patient could not keep the Tylenol down, it came back up. There was no investigational assessment. The reporter stated she had her first dose of vaccine "yesterday" about 11. The patient was told that the second dose would probably make her sick, but "last night" at about 7:30 she started cramping "real bad," was sick all night, had chills, and just "now" really feeling quite normal. The patient asked if "this in anyway could have affected her kidneys." The patient stayed in the bathroom and "was just dribbling sometimes, was getting normal then she just dribbling and tried Tylenol (taken as treatment) but could not keep the Tylenol." The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Regurgitation
Clinical narrative: cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up; stayed in the bathroom, you know I was just dribbling sometimes; This is a spontaneous report from a contactable consumer for herself. A 68-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269, Expiration date: Unknown) on 08Feb2021 via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history included cholesterol and thyroid from an unknown date and unknown if ongoing. The patient's concomitant medications included vitamins. The patient stated she took medications for her thyroid and cholesterol, and vitamins. On 08Feb2021 at 19:30 the patient had cramping "real bad." The patient was sick all night, had chills, stayed in the bathroom, "you know I was just dribbling sometimes and hurting." The patient could not keep the Tylenol down, it came back up. There was no investigational assessment. The reporter stated she had her first dose of vaccine "yesterday" about 11. The patient was told that the second dose would probably make her sick, but "last night" at about 7:30 she started cramping "real bad," was sick all night, had chills, and just "now" really feeling quite normal. The patient asked if "this in anyway could have affected her kidneys." The patient stayed in the bathroom and "was just dribbling sometimes, was getting normal then she just dribbling and tried Tylenol (taken as treatment) but could not keep the Tylenol." The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Mean platelet volume decreased, Red cell distribution width, Red cell distribution width decreased, SARS-CoV-2 test
Clinical narrative: RDW was borderline low at 10.7%; Went to ER with severe vertigo; platelet numbers were within range on the high side (310K) but MPV quite low (7.6 fL on a range of 10.5 fL - 13.6 fL); This is a spontaneous report from a contactable Consumer (patient). A 54-year-old female non pregnant patient received first dose of BNT162B2 (Solution for injection, lot number: EL3248, Expiration date; unknown), via an unspecified route of administration on 23Jan2021, 15:15 at single dose for COVID-19 immunization. The patient's medical history includes bipolar II, left bundle branch block, Known- soya allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 450mg, lamotrigine 200mg, lurasidone hydrochloride (LATUDA) 20 mg. Patient not received other-vaccine-in-four weeks. Other-medications-in-two weeks includes Wellbutrin 450mg, Lamotrigine 200mg, Latuda 20 mg. On 06Feb2021 19 :45, patient went to emergency room with severe vertigo. In CBC taken there, platelet numbers were within range on the high side (310K) but MPV quite low (7.6 fL on a range of 10.5 fL - 13.6 fL). RDW was borderline low at 10.7% (normal range 11%-16% range). No idea when the blood count issues started. Patient received treatment for vertigo, meclizine/PT, for MPV. Patient had covid-prior-vaccination, had covid-tested-post-vaccination. Covid test post vaccination [{covid test type post vaccination=Other, covid test name post vaccination=saliva test, covid test date=28Jan2021, covid test result=Negative}]. The outcome of the event was recovering.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: RDW was borderline low at 10.7%; Went to ER with severe vertigo; platelet numbers were within range on the high side (310K) but MPV quite low (7.6 fL on a range of 10.5 fL - 13.6 fL); This is a spontaneous report from a contactable Consumer (patient). A 54-year-old female non pregnant patient received first dose of BNT162B2 (Solution for injection, lot number: EL3248, Expiration date; unknown), via an unspecified route of administration on 23Jan2021, 15:15 at single dose for COVID-19 immunization. The patient's medical history includes bipolar II, left bundle branch block, Known- soya allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 450mg, lamotrigine 200mg, lurasidone hydrochloride (LATUDA) 20 mg. Patient not received other-vaccine-in-four weeks. Other-medications-in-two weeks includes Wellbutrin 450mg, Lamotrigine 200mg, Latuda 20 mg. On 06Feb2021 19 :45, patient went to emergency room with severe vertigo. In CBC taken there, platelet numbers were within range on the high side (310K) but MPV quite low (7.6 fL on a range of 10.5 fL - 13.6 fL). RDW was borderline low at 10.7% (normal range 11%-16% range). No idea when the blood count issues started. Patient received treatment for vertigo, meclizine/PT, for MPV. Patient had covid-prior-vaccination, had covid-tested-post-vaccination. Covid test post vaccination [{covid test type post vaccination=Other, covid test name post vaccination=saliva test, covid test date=28Jan2021, covid test result=Negative}]. The outcome of the event was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Flushing, Vaccination site pain
Clinical narrative: 3 hours after injection, experienced pain and tenderness at injection site; facial flushing that persisted for 3 days; This is a spontaneous report from a contactable 75-year-old non-pregnant female nurse (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Feb2021 at 09:15 am at single dose for covid-19 immunization on left arm. The patient's medical history included hypothyroidism, breast cancer and known allergies: Shrimp, cilantro, contrast dye, gadolinium. Concomitant drugs included Levothyroxine sodium, ciclosporin (RESTASIS), multiple vitamins. On 05Feb2021, 3 hours after injection (12:00 PM), the patient experienced pain and tenderness at injection site, facial flushing that persisted for 3 days. Benadryl 25mg taken every 4 hours for 2 days for flushing. The laboratory test included temperature taken and WNL (within normal limits) 97.2 during flushing period. The outcome of the events was recovered.   Information about Lot/Batch number is requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache; fatigue; muscle aches; This is a spontaneous report received from contactable consumer, the mother of the patient. A 29-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot EN6200 expiry not provided) as a single dose via unspecified route on 19Feb2021 (at the age of 29-years-old) for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications reported. The patient previously received COVID-19 immunisation with BNT162b2 (first dose; Lot EL9262 expiry information not provided) on 29Jan2021 (at the age of 29-years-old). The consumer reported that the patient had not received any other vaccinations within four weeks prior to the COVID vaccine. The consumer also reported that the patient had no known allergies and was not diagnosed with COVID prior to the vaccination. On 20Feb2021 after his second injection, the patient experienced a headache, fatigue and muscle aches. There was no laboratory testing reported. There was no treatment received for the events. The outcome of the events, headache, fatigue and muscle aches was recovered on 21Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: 17Jan2021 was the first dose of the covid vaccine. 07Feb2021 she had a positive covid test; 17Jan2021 was the first dose of the covid vaccine. 07Feb2021 she had a positive covid test; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. A female patient of an unspecified age (reported as 68 with no units) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 17Jan2021 as a single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported.  On 07Feb2021, the patient had a positive COVID test.  The patient was inquiring when she should go back for her second dose. The patient was treated for the event and received 'BAM' (as reported) intravenously at the hospital and was encouraged to receive her 2nd dose nonetheless. The clinical outcome of the patient had a positive COVID test after the 1st dose of the vaccine was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Neck pain
Clinical narrative: I'm now 23 days post my 2nd Pfizer Covid19 injection and I still have neck discomfort and soreness.; I'm now 23 days post my 2nd Pfizer Covid19 injection and I still have neck discomfort and soreness.; This is a spontaneous report from a contactable Nurse (patient). A 56-years-old non pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 18Jan2021 (Batch/Lot Number: EJ1686) as single dose for covid-19 immunisation. Medical history included Graves Disease, supraventricular tachycardia and vertigo from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) verapamil and piroxicam (MAXIDENE) via unspecified route of administration, unspecified date, dose, unit, frequency and indication. The patient previously took first dose (56-years) BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE,) on30Dec2020 at10:00AM administered in right arm and doxycycline and experienced allergies. The reporter stated that I'm now 23 days post my 2nd Pfizer Covid19 injection and I still have neck discomfort and soreness on 20Jan2021. The patient did not received prior and covid tested post vaccination. Therapeutic measures were taken as a result of I'm now 23 days post my 2nd Pfizer Covid19 injection and I still have neck discomfort and soreness and included treatment with inflammatory and heat applications. The outcome of the events was reported as Not recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: aches; Chills; Fever; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing Patient History: No. There were no concomitant medications. The patient experienced aches (pain) (non-serious) on 10Feb2021, chills (chills) (non-serious) on 10Feb2021, fever (pyrexia) (non-serious) on 10Feb2021. The outcome of the events aches and chills were reported as recovering. The outcome of the event fever was reported as not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported) first dose on 05Jan2021 and second dose on 26Jan2021 both via an unspecified route of administration as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. First, the patient was getting tested twice a week at the hospital where the patient work. The patient had been negative since starting this back in Aug2020. After the first dose on 05Jan2021, the patient was still get tested on Sunday and Wednesday. On Sunday 24Jan2021, patient was negative and on Tuesday 26Jan2021, patient received the second dose. On Wednesday 27Jan2021, the patient got tested again, but this time it came back positive. Patient got sick after the second dose. The patient had to be self-quarantine for ten days and had no symptoms at all which the patient did not understand. Patient was told could not get tested for three months what could patient do to make sure that patient did not have COVID-19 at this time. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter asked if her husband could have the 2nd dose since he had been tested positive for Covid-19. The patient experienced fever, chills, malaise. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021191296 same reporter and drug, similar event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was due to get her second dose of BNT162b2 the day after the report. She was on an antibiotic for sinus infection. The reporter asked if it was okay for her to take it. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable nurse. A 92-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 30Jan2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included blood pressure. Concomitant medications included rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported and an unspecified blood pressure medication.  The patient experienced shingles on an unspecified date too weeks later; he never had shingles before. The outcome of event was unknown. Therapeutic measures were taken as a result of shingles included "some cream".  Follow-up attempts are completed. The following information on the batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Received the first shot; I currently have Covid; Received the first shot; I currently have Covid; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 24Jan2021 as a single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported.  The patient reported they received the first dose and they now currently have COVID. The patient stated they were to receive the second dose on 14Feb2021 and they contracted COVID and currently have COVID and they do not feel well. The patient inquired if they can still get the second dose if they still have COVID and if not, how long do they have to wait to get the second shot or do they have to start the whole series over again. The clinical outcome of the patient had COVID after the 1st dose of the vaccine was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Limb discomfort, Myocardial infarction, Palpitations, Vomiting
Clinical narrative: heart was palpitating like having a heart attack; heart was palpitating like having a heart attack; throwing up; very weak; her legs won't work; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient also received first dose of BNT162B2 (unknown lot number and expiration) on unspecified date for COVID-19 immunization. The patient experienced relatively severe reaction to the second dose. The patient mentioned that she couldn't get out of bed for 5 days, was throwing up, very weak, her legs won't work, and mentioned that her heart was palpitating like having a heart attack. The patient is feeling okay now. The patient is recovering from the events.   Information on the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Erythema multiforme, Weight
Clinical narrative: "very dark red, big, angry rash" on the back of both of his hands that is moving up his arms, which the caller describes as "erythema multiform"; This is a spontaneous report from contactable consumers (one is the caregiver). An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 23Feb2021 (at the age of 82-year-old) at single dose for COVID-19 immunization. Medical history included cancer, stage 4 renal cancer with metastasis to the lung, kidney failure and being dialyzed, electrolyte imbalance, prostate infection, blood pressure abnormal. Concomitant medications included prednisone for kidney failure; sevelamer carbonate (RENVELA) to regulates his electrolytes; hydralazine (HYDRALAZINE) for blood pressure; candesartan for blood pressure; metoprolol succinate (TOPROL) for blood pressure; finasteride for prostate; and amlodipine. The patient developed a very dark red, big, angry rash on the back of both of his hands that is moving up his arms (reported as worsened), which the consumer describes as "erythema multiforme".  Looks like erythema multiform is this rash associated with the product very dark red, big angry splotches very large. He was told he should get the vaccination, his oncologist and his nephrologist said he should get it so he got the vaccination last Tuesday and then he woke up either the next day or the day after that and her mother said he had a very severe rash on his hands and now it is climbing up his arms. It almost looks like erythema multiforme but it has no bulls eye, It is dark red and ugly looking it is rough, it is not really raised. They went to the oncologist and they took blood work to make sure his platelets were okay and they were normal so his doctors are baffled with this. She is calling from her husband's surgery office and they are disgusted with the healthcare he is receiving there but she wants to know if there is any data with cancer patients taking the vaccine or with people that have developed a rash like she is describing. His weight has dropped a lot since she last saw him he is 5'10", now he is probably about 150 or 160 lbs. That is an estimate. He developed the rash either 24Feb2021 or 25Feb2021, she is not sure which. It was ongoing and it is actually spreading up his arms so she would say it is worsened. He is on a slew of medications, but she doesn't know if they want all of them. It could be an interaction with medication, he is a really sick person. The outcome of the event was not recovered.  Information on lot number/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration, Loss of consciousness
Clinical narrative: passed out; Did not get second Covid 19 vaccine when scheduled; 50 days since las shot; first Covid 19 vaccination lot number says RL3246; This is a spontaneous report from a contactable consumer, the patient via the Pfizer sponsored program.   A 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on  07Jan2021 at 12:00 (at the age of 80-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included ovarian and endometrial cancer. Concomitant medications were not provided. The patient did not receive any other vaccinations within four weeks of immunization. On 07Jan2021,  the patient received the first Pfizer shot. When she went for the second shot, she was waiting outside in the heat (she is a cancer victim) and she passed out so they wouldn't give her the second shot. She mentioned that, then, she couldn't go back because of cancer treatments she was being given and the facility was only open in that community for a certain amount of time.  She finally went for a second shot at a different facility ("Institute") but she was told that she couldn't get the shot because "they didn't know if the first shot was real" as they had a different lot number than the Pfizer lot number that she had. She explained further that her first COVID 19 vaccination lot number is recorded on her vaccination card as "RL3246." Her husband's COVID 19 vaccination card says "EL3246" for lot number and they received injections on the same day. The caller believes her lot number should also say "EL3246" -  she thinks it's a small written 'e.'  The patient added that, as of the reporting date,  "It is 50 days since I had the last shot." She also asked if she has to retake the vaccines or if she can just take the second dose. The clinical outcomes of the event "passed out" was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fall, Feeling hot, Hot flush, Loss of consciousness
Clinical narrative: blackout/ I wasn't able to see him only hear his voice; panicking sensation; mild pain in the administration spot; then I vomited; excessive heat coming out of my body like hot flash; fell on my face; like excessive heat coming out of my body like hot flash , when my husband touched me it became worse I'm talking about the heat; This is a spontaneous report from a contactable consumer, the patient.  A 38-years-old (also reported as 45 years old)  non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration, in the right arm on 01Mar2021 at 13:30 (at the age of 38-years-old) as a single dose,  for covid-19 immunization. The facility in which the vaccine was given was Doctor's office/urgent care  The patient had no known medical history or allergies.  Concomitant medication were reported as yes but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 02Mar2021 04:00, the patient experienced  blackout/ I wasn't able to see him only hear his voice   (medically significant),  panicking sensation, , mild pain in the administration spot, vomited,  like excessive heat coming out of my body like hot flash,  fell on my face, when my husband touched me it became worse I'm talking about the heat. The reporter explained on mild pain in the administration spot, but after I went to bed I woke up to use the restroom and suddenly I had blackout and fell on my face It was panicking sensation my husband rushed for help he was talking to me but I wasn't able to see him only hear his voice then I vomited and there was like excessive heat coming out of my body like hot flash , when my husband touched me it became worse I'm talking about the heat and my eyes were widely open in a scary way. Body temperature was checked with a thermometer and it was 98.1. The patient went back to bed was feeling the same blackout sensation. Consumer stated she is a healthy person in all means and never had such thing before. The patient underwent lab tests and procedures which included body temperature: 98.1 on Mar2021. No treatment was given for the events. The clinical outcome of the events Blackout, Vaccination site pain, fell on face, panicking sensation, vomited, hot flash and Feeling hot was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.