chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I started feeling mildly nauseous and had muscle pains in my wrists and legs. Then the headache rolled in. By 9 PM, everything hurt. I was running a fever of 101.6. Over the next 12 hours it got as high as 102, and then dropped down when I took tylenol. It felt like the worst flu I've ever had. I did not actually vomit, but I didn't eat anything either so that might have helped. The muscle soreness was the worst--it felt like fine grit sandpaper was being rubbed between all of my joints. This went on until around 7 pm on April 7th, when all the symptoms lessened to some extent. I still had everything, it just wasn't quite as bad. As of 4 am on April 8th, the muscle soreness is pretty much gone (though I still feel weak) the fever is gone and all I'm left is this headache.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain, Pyrexia
Clinical narrative: body aches; headache; coughing; fever; This is a spontaneous report from a contactable consumer. A 73-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration on 20Feb2021, at 08:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. The patient medical history included COPD, hypertension, hyperlipidemia, Osteoporosis, Spinal Stenosis, Syncope, tobacco use, neuropathy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included clopidogrel at a dose of 75 mg, irbesartan at a dose of 300mg, metoprolol at a dose of 50mg, pregabalin (LYRICA) at a dose of 100mg thrice a day, hydrochlorothiazide at a dose of 25mg, tramadol at a dose of 50mg, ibuprofen at a dose of 800mg as needed, duloxetine at a dose of 60mg, trazodone at a dose of 50mg, tiotropium at dose of 18ug, and albuterol [salbutamol sulfate] at a dose of (.5 - 2.5mg/3ml) (as reported). The patient previously took Tylenol, Wellbutrin, Steroids (high dose) and experienced allergy. The patient previously took historical vaccine, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration on 30Jan2021 at 07:30 (at the age of 73-year-old) for COVID-19 immunisation. On 21Feb2021, at 04:00 the patient experienced body aches, headache, coughing and fever. The patient received ibuprofen 800mg as treatment medication to all the events. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Severe Lt upper arm and shoulder and Lt neck pain; Severe Lt upper arm and shoulder and Lt neck pain; Severe Lt upper arm and shoulder and Lt neck pain; This is a spontaneous report from a contactable Nurse. A 70-year-old female non-pregnant patient (Nurse) received first dose BNT162B2 (Solution for injection, lot number: EN5318, COVID 19, brand: Pfizer) via an unspecified route of administration in left arm on 01Feb2021 at 12: 30 at single dose for COVID-19 immunisation. Patient medical history included Htn (Hypertension), Depression, Asthma, Ulcer (bleeding ulcers hx), known allergies: Sulfa. Concomitant medications included paroxetine hydrochloride (PAXIL), primidone, gabapentin, lisinopril, trazodone. Patient previously took Wellbutrin and had Known allergies. On 02Feb2021 at 12:30 PM, patient had severe Leftt upper arm and shoulder and Left neck pain since. Not relieved with Voltarin Cream and Tylenol Unable to take NSAIDs due to bleeding ulcers HX. No covid prior vaccination, no covid tested post vaccination. Outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for Covid-19 Virus; she tested positive for Covid-19 Virus; This is a spontaneous report from contactable consumer (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were unknown), via unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that, after getting the first dose of vaccine she tested positive for Covid-19 Virus. She wanted to know if she can still get the 2nd dose of vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on unspecified date. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Headache, Injection site pain
Clinical narrative: however was diagnosed with covid 19 infection yesterday; however was diagnosed with covid 19 infection yesterday; Also reported painful arm on injection site; headache; body ache; feeling very weak and has ' had a bad last couple of days" states she is doing better today but still weak.; This is a spontaneous report received from a Pfizer-sponsored Program COVAX US Support. A Contactable female Consumer (patient) reportedly received first dose of BNT162B2(BNT162B2, Solution for injection,start date/stop date: 01Feb) via unspecified route of administration on 01Feb (Batch/Lot Number: NA) as single dose for covid-19 immunization and she is scheduled for a second dose due on 22Feb. concomitant medications were not reported, she is diabetic and elderly. She was diagnosed with covid 19 infection yesterday.She reports that feeling very weak. The outcome of the events were not recovered, the outcome of the event painful arm on injection site with outcome unknown, headache with outcome unknown and body ache with outcome unknown for a few days after the first shot of the vaccine but went away after 3 days.she is asking if i need second shot of the vaccine since I tested covid positive.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: however was diagnosed with covid 19 infection yesterday; however was diagnosed with covid 19 infection yesterday; Also reported painful arm on injection site; headache; body ache; feeling very weak and has ' had a bad last couple of days" states she is doing better today but still weak.; This is a spontaneous report received from a Pfizer-sponsored Program COVAX US Support. A Contactable female Consumer (patient) reportedly received first dose of BNT162B2(BNT162B2, Solution for injection,start date/stop date: 01Feb) via unspecified route of administration on 01Feb (Batch/Lot Number: NA) as single dose for covid-19 immunization and she is scheduled for a second dose due on 22Feb. concomitant medications were not reported, she is diabetic and elderly. She was diagnosed with covid 19 infection yesterday.She reports that feeling very weak. The outcome of the events were not recovered, the outcome of the event painful arm on injection site with outcome unknown, headache with outcome unknown and body ache with outcome unknown for a few days after the first shot of the vaccine but went away after 3 days.she is asking if i need second shot of the vaccine since I tested covid positive.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Urticaria
Clinical narrative: rash or hives on whole body. Red blotchy marks. felt like pins jabbing; rash or hives on whole body. red blotchy marks. felt like pins jabbing.; rash or hives on whole body. red blotchy marks. felt like pins jabbing.; This is a spontaneous report from a contactable consumer (patient, self-reported). An 83-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN9581 and expiry date was provided), via an unspecified route of administration, in the left arm, on 22Feb2021 at 08:30 AM (at the age of 83-years-old) as a single dose for covid-19 immunisation, at hospital. The patient had no known allergies. Medical history included cancer and finished chemo on 13Jan2021 (start date was unspecified date). The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 22Feb2021 at 13:00 on same day (as reported), the patient experienced rash or hives on whole body, red blotchy marks and felt like pins jabbing. The patient was treated with Cetirizine (ZYRTEC) 1/day, diphenhydramine (BENADRYL) 25mg at bedtime and acetaminophen (TYLENOL). The clinical outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hypersensitivity, Nasopharyngitis, Rhinorrhoea
Clinical narrative: mild breathlessness; allergic reaction; runny nose; cold; feeling tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received 1st dose yesterday, then she experienced an allergic reaction, runny nose, cold, mild breathlessness, and feeling tired in Feb2021. The outcome of ethe events was unknown.  Information about lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Palpitations
Clinical narrative: racing heart; 101 Fever; aches; fatigue; chills; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 18:30 (Batch/Lot Number: EL9266) at a SINGLE DOSE for COVID-19 immunisation. Medical history included bronchiecstasis from an unknown date and unknown if ongoing, patient had COVID-19 prior vaccination. Concomitant medication(s) included progesterone, estradiol, acetylsalicylic acid (BABY ASPIRIN) and zn [zinc] (ZN [ZINC]). The patient previously had allergy to thimerasol which is preservative in shots. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021 12:00, the patient experienced racing heart, 101 fever, aches, fatigue and chills. The events were considered as non-serious. No treatment was given for the event. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of all the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: racing heart; 101 Fever; aches; fatigue; chills; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 18:30 (Batch/Lot Number: EL9266) at a SINGLE DOSE for COVID-19 immunisation. Medical history included bronchiecstasis from an unknown date and unknown if ongoing, patient had COVID-19 prior vaccination. Concomitant medication(s) included progesterone, estradiol, acetylsalicylic acid (BABY ASPIRIN) and zn [zinc] (ZN [ZINC]). The patient previously had allergy to thimerasol which is preservative in shots. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021 12:00, the patient experienced racing heart, 101 fever, aches, fatigue and chills. The events were considered as non-serious. No treatment was given for the event. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of all the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Burning sensation, Full blood count, Lymphadenopathy, Metabolic function test
Clinical narrative: burning; armpit pain; lymph nodes are enlarged bilaterally in both arms; This is a spontaneous report from a contactable nurse. This 29-year-old (at the time of vaccination) female nurse (patient) reported for that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number; unknown, unable to locate or read the details intramuscular on 08Jan2021 at 06:30 pm at single dose on right leg for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient's medical history was not reported (Known allergies: None). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot; unknown, intramuscular on 18Dec2020 at 10:30 am at single dose on right leg for covid-19 immunisation. Vaccine facility was reported as hospital. Concomitant medications in two weeks) included metformin, levothyroxine, loratadine (CLARITINE). If other vaccine in four weeks; no. Nurse reported that At 2 weeks post first vaccine, on 30Jan2021 at 08:00 pm I experienced heart burn for about a week. Not a huge deal. At 3 weeks post the second vaccine, I have severe armpit pain. My lymph nodes are enlarged bilaterally in both arms despite receiving doses in same arm. It feels like a constant burning as if someone injected icy hot into my armpit with a needle. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given for the adverse events. AE treatment: Went to my PCP where additional labs were drawn CBC, CMP, covid antibodies, and covid test with unknown results. Patient did not have covid prior vaccination. Covid test done post vaccination on 09Feb2021 included nasal swab and test resulted as negative. The outcome of events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: burning; armpit pain; lymph nodes are enlarged bilaterally in both arms; This is a spontaneous report from a contactable nurse. This 29-year-old (at the time of vaccination) female nurse (patient) reported for that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number; unknown, unable to locate or read the details intramuscular on 08Jan2021 at 06:30 pm at single dose on right leg for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient's medical history was not reported (Known allergies: None). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot; unknown, intramuscular on 18Dec2020 at 10:30 am at single dose on right leg for covid-19 immunisation. Vaccine facility was reported as hospital. Concomitant medications in two weeks) included metformin, levothyroxine, loratadine (CLARITINE). If other vaccine in four weeks; no. Nurse reported that At 2 weeks post first vaccine, on 30Jan2021 at 08:00 pm I experienced heart burn for about a week. Not a huge deal. At 3 weeks post the second vaccine, I have severe armpit pain. My lymph nodes are enlarged bilaterally in both arms despite receiving doses in same arm. It feels like a constant burning as if someone injected icy hot into my armpit with a needle. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given for the adverse events. AE treatment: Went to my PCP where additional labs were drawn CBC, CMP, covid antibodies, and covid test with unknown results. Patient did not have covid prior vaccination. Covid test done post vaccination on 09Feb2021 included nasal swab and test resulted as negative. The outcome of events was recovering.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Neck pain, Pain in extremity
Clinical narrative: Sore neck was reported as worsened; Sore neck; sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), intramuscular, administered in Arm Left on 17Feb2021 12:08 (Batch/Lot Number: EM9809; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included stiff neck. There were no concomitant medications. The caller explains the arm soreness developed on 17Feb2021 after she got home from receiving the vaccine. She couldn't sleep on her left side, which she is used to doing that. She hasn't slept on her left side still. Right now, where the needle went is a little sore, but her arm is okay. Her neck just hurts. The caller states her neck started to get sore probably last night while she was sleeping. She had a little bit of sore neck yesterday (18Feb2021) and last night. But, she woke up this morning and it was worse. She could move her neck and everything up until this morning. The outcome of the events sore arm was reported as recovering. The outcome of the event Sore neck was reported as not recovered. The outcome of the event Sore neck was reported as worsened was reported as unknown.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Sore neck was reported as worsened; Sore neck; sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), intramuscular, administered in Arm Left on 17Feb2021 12:08 (Batch/Lot Number: EM9809; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included stiff neck. There were no concomitant medications. The caller explains the arm soreness developed on 17Feb2021 after she got home from receiving the vaccine. She couldn't sleep on her left side, which she is used to doing that. She hasn't slept on her left side still. Right now, where the needle went is a little sore, but her arm is okay. Her neck just hurts. The caller states her neck started to get sore probably last night while she was sleeping. She had a little bit of sore neck yesterday (18Feb2021) and last night. But, she woke up this morning and it was worse. She could move her neck and everything up until this morning. The outcome of the events sore arm was reported as recovering. The outcome of the event Sore neck was reported as not recovered. The outcome of the event Sore neck was reported as worsened was reported as unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Sleep disorder
Clinical narrative: At about 6pm, started feeling run down and not good; had a fever of 100; Could only sleep off and on; chills; This is a spontaneous report from a contactable consumer. A 48-Year-Old female non-pregnant patient (consumer) received second dose BNT162B2 (Solution for injection, EN5318, COVID19, Brand: Pfizer) via an unspecified route of administration in right arm on 18Feb2021 at 10:00 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (COVID19, Brand: Pfizer, Lot number: EN5318) on right arm on 28Jan2021 at 10:00 AM for COVID19 immunization. On 18Feb2021, at about 6pm, started feeling run down and not good. Took 2 Advil Liquid Gels. Woke up at about 2am and took temperature and had a fever of 100. Could only sleep off and on, had chills and fever persisted until about 7am. No covid prior vaccination and no covid tested post vaccination. Outcome of events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary Tract Infection; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced urinary tract infection (non-serious) on an unspecified date. It was reported that Caller will take the 2nd dose on 19Feb2021. As per the caller he has been diagnosed with Urinary Tract Infection (UTI) and advised to take medication today or tomorrow. Caller would like to know if she can take the medication before the 2nd dose. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Gait disturbance, Insomnia, Pain, Sciatica
Clinical narrative: He had sciatica for 10-12 days; He was unable to stand or walk.; He was worse when he was lying in bed; It was impossible to get into bed without having pain.; It was impossible to get into bed without having pain.; This is a spontaneous report from a contactable other-HCP (patient reported himself). A male patient of an unspecified age received second dose of BNT162B2 (Covid-19 vaccine, Formulation: Solution for injection, Lot Number: EL3302, NDC number/Expiry date: Unknown) via an unspecified route of administration on 12Feb2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medication was not reported. Historical vaccine details included first dose of BNT162B2 (Covid-19 vaccine, Lot Number: EL3302) via an unspecified route of administration on 22Jan2021 at single dose for Covid-19 immunization. Caller previously reported side effects with the Covid-19 vaccine on 25Jan2021 or 26Jan2021. He received the first dose on 22Jan2021. He received a form with some follow up questions on it. The form was requesting the batch or lot number. He might have provided it with the first call. The lot from the first vaccine is EL3302. He added that the handwriting was sloppy. He received the second dose on 12Feb2021. Lot EL3302. He added that the lot for the first dose could have been EL3302, but it was written sloppy. The form was also asking if the patient provided information regarding the reported adverse events with the use of the product. Caller is an Optometrist. He was reporting on himself. Caller confirmed there were no new events. Caller added that maybe some of the side effects were still lingering. He had sciatica for 10-12 days. He was unable to stand or walk. He was worse when he was lying in bed. It was impossible to get into bed without having pain. He was unsure if dozens of people had this or just him. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received 1st dose of vaccine on 27Jan2021. Daughter tested positive for covid 19 on "valentines day" (14Feb2021).; received 1st dose of vaccine on 27Jan2021. Daughter tested positive for covid 19 on "valentines day" (14Feb2021).; This is a spontaneous report from a contactable consumer reported for patient (Daughter). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient tested positive for covid 19 on valentines day (14Feb2021). Patient was supposed to get 2nd dose today. Caller asking if her daughter can get the 2nd dose today or if she needs to wait 90 days. Caller says she had also tested positive for covid but has not received a dose of vaccine and will be waiting 90 days. Caller asks, can she have good days and bad days after covid (symptoms improve and then get worse). The outcome for the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Illness, Joint lock, Pain in extremity
Clinical narrative: Pain in hands and shoulders,or knees with her knees "locking up"; Pain in hands and shoulders,or knees with her knees "locking up"; Pain in hands and shoulders,or knees with her knees "locking up"; sick; Extreme Fatigue; This is a spontaneous report from a contactable Nurse. A 45-year-old female patient received BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Dec2020 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. It was unknown whether patient was pregnant at time of event or not. Medical history included rheumatoid arthritis. The patient received 1st covid vaccine on 26Dec2020 and diagnosed with covid19 on 05Jan2021. Patient reported while sick "no significance changes with rheumatoid arthritis symptoms just extreme fatigue". 2nd covid vaccine was received on 20Jan2021. Patient reported "no significant side effects with vaccine". Patient also reported that in the last 6 months when there was any significant change in the weather she experienced pain in hands or shoulders or knees with her Knees "locking up". Patient also received tofacitinib citrate (XELJANZ XR, strength: 11 mg, Manufacturer: Pfizer labs) tablet (30's) orally from 25May2020 at 11 mg daily for rheumatoid arthritis and hydroxychloroquine sulfate (PLAQUENIL) started from 29Aug2020. The outcome of events was unknown.  Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: received the first dose of the pfizer covid 19 vaccine and then got covid 7-8 days after; This is a spontaneous report from a contactable consumer (patient himself). A 70-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unknown date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, 7 to 8 days after therapy with suspect product, experienced COVID-19 infection. It was reported that the patient and his wife received a viral cocktail and wanted to know the impact the covid virus and the viral cocktail had on the vaccine. Caller wanted to know if it is recommended to wait 90 days for the second dose. Outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller stated that she had the first dose of the pfizer covid 19 on 13Feb2021 and then on Tuesday tested positive for covid; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of age 38 (units unknown) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 13Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient had the first dose of the pfizer covid 19 on 13Feb2021 and then on Tuesday (Feb2021) tested positive for covid. Caller wanted to know she should get the second dose on schedule. The event was assessed as non-serious. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Vaccination site pain
Clinical narrative: Patient experienced on second shot (vaccine) left arm hurt got it in t's a little warm and it was red around and itches; Patient experienced on second shot (vaccine) left arm hurt got it in t's a little warm and it was red around and itches; This is a spontaneous report from a contactable consumer. A 73-Year-Old female consumer (patient) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in left arm on 18Feb2021, as single dose for covid-19 Immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for covid-19 immunization. Relevant medical history included Diabetic (From: Dec 2005 to: Unspecified), CPAP from an unspecified date to unspecified date, Asthma from an unspecified date to unspecified date and Cholesterol from an unspecified date to unspecified date. The patient concomitant medication included started on unspecified date Dulaglutide(TRULICITY) took for Diabetes, Budesonide (BUDESONIDE) took for Asthma, Metformin (METFORMIN) (500 mg tablet), twice a day took for unspecified indication, Pravastatin (PRAVASTATIN) (40mg) Indication used for Cholesterol, Lisinopril (LISINOPRIL) (5 mg, once a day), Aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) (82 mg, Once a day), Multivitamins, (2 pills, once a day), Aminobenzoic Acid, Calcium Pantothenate, Cyanocobalamin, Nicotinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Hydrochloride (B-COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE; CYANOCOBALAMIN; NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), Vitamin d (VITAMIN D [VITAMIN D NOS]) (200 IU and took 2 (tablet) of those daily), Omega Fish Oil (FISH OIL) (1200 mg, (2 dose) once a day) Ubidecarenone (COQ-10) (100 mg, once a day) stopped if unspecified date. Patient experienced on second shot (vaccine) left arm hurt got it in t's a little warm and it was red around and itches. The outcome of the event was not unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test
Clinical narrative: itchy bumps/Now the outbreak is on stomach, chest, left arm, and both legs; This is a spontaneous report from a contactable other Health Care Professional (Patient, self-reported). A 54-years-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot Number and expiry dates were not provided), via an unspecified route of administration, in Arm Right, on 05Feb2021 08:30 AM (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation and experienced itchy bumps on 20Jan2021. The patient did not receive any other vaccine within 4 weeks of the vaccine. The patient reported that Singular itchy bumps within 5-7 days after the initial injection, these shows up on stomach area and left leg on 20Jan2021. They started to dry up, however, after the second dose (as prescribed) and after 5-7 days another outbreak. Now the outbreak is on stomach, chest, left arm, and both legs on an unknown date in Feb2021. Patient underwent, nasal swab test on 12Jan2021, 26Jan2021, 10Feb2021 and 16Feb2021 respectively; resulted as negative on all dates. No treatment was received for the event. Outcome of the event was reported as not recovered.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Slight fever; body aches; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received bnt162b2, dose 1 via an unspecified route of administration on 25Jan2021 at 4:00 pm (Batch/Lot Number: EL9267) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medication was not reported. On 28Jan2021 at 01:00 AM the patient experienced slight fever and body aches several days after administration increasing in severity for the following week. Body aches, fever of 101.5. Symptoms lasted a week. Similar experience after vaccine 2. On 15Feb2021, Nasal swab covid test was done. The result was negative. No known allergies reported for patient. Over the counter analgesics was administered for treatment. The outcome of the events was Recovering.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Gait disturbance
Clinical narrative: feel very weak; unstable walking; I am wondering; feel very weak, unstable walking and I don't know if it may be in my stomach too, I am feeling upset feeling in my stomach; This is a spontaneous report from a contactable consumer (Patient herself). A 90-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not reported, Expiration date: 31May2021) via unspecified route of administration on 02Feb2021 at SINGLE DOSE for COVID-19 Immunization. The patients medical history was not reported. Concomitant medication included vitamins. The patient stated I am wondering; feel very weak, unstable walking and I don't know if it may be in my stomach too, I am feeling upset feeling in my stomach. The patient did not receive treatment medication. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: I experienced red rash around where I got the Injection; got the Injection and it was about 2 inches long and 1 inch wide and I still have the itchiness; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 20Feb2021 (Batch/Lot Number: EN9810; 79-year at the time vaccination) as single dose for covid-19 immunisation. Medical history included cholesterol; blood pressure. Concomitant medications included losartan 50 mg; rosuvastatin 5 mg; ezetimibe 10 mg. The patient previously received first single dose of bnt162b2 for Covid-19 immunization. It was reported " I got the Pfizer second vaccine on the 20Feb2021 and I experienced red rash around where I got the Injection and it was about 2 inches long and 1 inch wide and I still have the itchiness." Consumer stated, "No I went on (Search engine) and wash it with soap and water, I have been taking it what you call it Advil or Tylenol. Today the itching is not as bad and pain is gone." The outcome of the events recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Ache; fatigue; chills; This is a spontaneous report from a contactable 56-Year-old non-pregnant female physician reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3249), via an unspecified route of administration on 08Jan2021 at 08:30 as single dose in right arm for covid-19 immunization. The patient medical history was not reported and known allergies included Keflex had allergy. Historical vaccine included bnt162b2 for covid-19 immunization on 17Dec2020 (Lot number: EL0140, administration time: 15:30 PM, vaccine location: right arm and dose number: 1). Concomitant medications were not reported. On 08Feb2021 at 21:45, the patient experienced ache, fatigued and chills. The patient did not take treatment for the events. The outcome of the events was recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain, Pyrexia
Clinical narrative: Fever; aches; Trigger finger in right thumb day after 1st vaccine, worse after 2nd vaccine; This is a spontaneous report from a contactable consumer (patient reported herself). A 67-year-old non-pregnant female patient received second dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EL9261) via an unspecified route of administration to her right arm on 18Feb2021 09:00 AM at single dose for Covid-19 immunization. The patient's medical history included mild asthma. Known allergies: None. Historical vaccine details included first dose of BNT162B2 (COVID 19, Pfizer, Lot number: EL8982, Expiration date: May2021) via an unspecified route of administration to her right arm on 28Jan2021 16:30 PM at single dose for Covid-19 immunization. Concomitant medications (other medications in two weeks) included levothyroxine and meloxicam. On an unspecified date in Feb2021 21:00 PM, the patient experienced trigger finger in right thumb day after first vaccine, worse after second vaccine fever and aches day after second vaccine fever for seven hours five days after vaccine. The patient did not receive any treatment in response to the events. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart strain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced heart strain on an unspecified date. It was reported that the patient was supposed to take the second shot tomorrow, however the patient is experiencing heart strain. Wanted to know if taking aspirin is fine or if we have a protocol in taking medicine in between doses. The outcome of the event was unknown.  No follow-up attempts are needed; information about batch/ lot number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue; Pain in arm; This is a spontaneous report from a contactable consumer (patient's wife). A 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration in right arm on 23Jan2021 at 10:30 as a single dose for COVID-19 immunisation. The patient's medical history included diabetic type 2, stent from an unspecified date in Dec2019, sulfa allergies. Concomitant medications included metformin (Strength: 500 mg) at four times a day, buspirone (Strength: 10 mg) at thrice a day, sitagliptin phosphate (JANUVIA, Strength: 50 mg), hyoscyamine sulfate (OSCIMIN, Strength: 0.125 mg), lisinopril (Strength: 5 mg) at once a day (bedtime) for BP (blood pressure), silodosin (Strength: 8 mg) at once a day (bedtime), simvastatin (ZOCOR, Strength: 40 mg) at once a day (bedtime), fish oil (Strength: 1000 mg) at twice a day, zinc (Formulation: Tablet) at once a day (in the morning), vitamin D3, cyanocobalamin (B12 20 MIL, Strength: 1000 mg) at once a day, allium sativum bulb (GARLIC EXTRACT) at 1 DF (Dosage Form), once a day (1 pill, once a day), ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 NOS, vitamin d NOS, vitamin e NOS, vitamin k NOS, xantofyl, zinc (MEN 50+) at once a day, ubidecarenone (COQ-10, Strength: 200 mg) at once a day, exenatide (BYDUREON PEN, Formulation: Injection) at weekly (once a week on Monday) for diabetes, doxepin (Strength: 10 mg) at twice a day (bedtime). Family history was none. The patient did not receive prior vaccinations (within 4 weeks). The patient experienced pain in arm on 23Jan2021, fatigue on 24Jan2021. The patient did not require the initiation of new medication / other treatment / procedure for the events. Relevant tests was none. The outcome of the event fatigue was not recovered and recovered on an unspecified date in 2021 for the other event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a contactable other HCP (patient). A 60-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included (BNT162B2, covid vaccine) via unspecified route and unspecified date for covid-19 immunisation and experienced fatigue. Patient states that she is having occasional fatigue. Patient did have a Covid vaccine and the first injection she took during her on week and just had fatigue. The second dose was during her off week and she states she slept for three days and had nausea on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch no. cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rhinorrhoea
Clinical narrative: runny nose; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, Expiration date unknown), via an unspecified route of administration on 06Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had her 1st dose on 06Feb2021 and 2nd dose is scheduled on 27Feb2021. She wanted to know more information about the 2nd dose. Patient experienced a runny nose and chills yesterday on 23Feb2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 2 doses of the Pfizer Covid Vaccine and 3 weeks later tested positive for Covid; 2 doses of the Pfizer Covid Vaccine and 3 weeks later tested positive for Covid; This is a spontaneous report from a contactable consumer reporting for a patient. A 44-years-old male patient received second dose of BNT162B2(Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 2 doses of the Pfizer covid vaccine and 3 weeks later tested positive for covid (vaccination failure) on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch cannot be obtained.(Reporter does not wish to be contacted for follow-up.).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid after the vaccine; mild cold symptoms; runny nose; This is a spontaneous report from a contactable consumer (patient itself). A 63-years-old male patient received BNT162B2(Solution for injection, Lot Number: EL1283 and Expiration date was unknown), via an unspecified route of administration, administered in Arm Left on 19Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included type 2 diabetes mellitus from 2011 and ongoing as he was diagnosed with type II diabetes 10 years ago. The patient's concomitant medications were not reported. Patient stated that he is on other medications for diabetes and that he is due for second shot in two weeks and does not know what to do when it comes. The patient tested positive for covid after the vaccine on 25Feb2021 , mild cold symptoms and runny nose on 19Feb2021. Seriousness of all the events were resported as non-serious. The patient underwent lab tests and procedures which included covid test: positive on 25Feb2021. Outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got the Covid around the same time you know he received the vaccine; This is a spontaneous report from a contactable pharmacist. A male patient of unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got the Covid around the same time you know he received the vaccine. Pharmacist reported that their technician who received first Covid vaccine and pretty much developed Covid 19. Pharmacist wanted to see and check what was the proper follow through on that. Pharmacist knew one supposed to wait for 90 days and then start administering the first dose and then second dose is in 21 days or wanted to know there was been any changes in that. He just got the Covid around the same time, he received the vaccine. The pharmacist did not know which Lot number he received. When probed for the Causality, Pharmacist stated, "No it was due to exposure to someone who had Covid." Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested positive after the 1st dose.; he tested positive after the 1st dose.; This is a spontaneous report from a Pfizer-sponsored program.  A contactable Consumer reported for his father.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Solution for injection, (Lot number and Expiration dates were unknown), via an unspecified route of administration on an unknown date, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter reported that, his father (patient) has an appointment tomorrow for the 2nd shot of the vaccine. The patient had a COVID test yesterday and tested positive after the 1st dose. The reporter is asking to reschedule the 2nd dose of the vaccine. The patient underwent SARS-COV-2 test and resulted positive on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection; This is a spontaneous report from a contactable consumer based on information received by Pfizer from agency (manufacturer control number: EC-2020-083296).  A 76-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Relevant history includes endometrial carcinoma, pembrolizumab (KEYTRUDA) infusions. Patient continues to take Lenvima 10 mg once daily. Stated "I'm doing okay with it." Received second COVID vaccine (Pfizer) and noted with soreness at injection site. Diagnosis Endometrial carcinoma, Lenvima 20 mg once daily, start date 11/2/20 and temporary stop date 11/6/20 and resumed Lenvima 14 mg once daily on 11/9/20, stopped Lenvima 14 mg once daily temporarily for one week and resumed Lenvima 10 mg once daily on 12/26/20, stopped Lenvima temporarily for 10 days and resumed Lenvima 10 mg on 1/31/21. The clinical outcome of soreness at injection site was unknown.   Follow-up attempts completed. No further information expected. Information about lot number cannot be obtained.