chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Insomnia, Pain, Pain in extremity
Clinical narrative: pain on one side of his body; he could not sleep; he experienced numbness; first dose of the vaccine just hurt the caller's arm and he was in pain; It felt like something was crawling inside of the caller; This is a spontaneous report from a contactable consumer(patient) via Pfizer-sponsored program COVAX US Support. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for covid-19 immunisation. Medical history included chronic sinusitis (he experiences it year round everyday). The patient's concomitant medications were not reported. On an unspecified date the patient experienced pain on one side of his body, he could not sleep, he experienced numbness, first dose of the vaccine just hurt the caller's arm and he was in pain, it felt like something was crawling inside of the caller. Patient stated, His doctor advised him not to take the second dose. He received his second dose on 20Jul2021 and is scheduled for a third dose on 10Aug2021. He is to receive the third dose because we are restarting. The patient took the second shot on 20Jul2021. It has been so long they scheduled the caller for a third dose on 10Aug2021. Should the patient do that since he's already had two doses? He thinks it was more scaring him and he's not trying to blame Pfizer. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: She went to see her doctor who prescribed her prednisone tablets for her knee; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unknown date in 2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that She went to see her doctor who prescribed her prednisone tablets for her knee. She has taken 1 dose. she got the Pfizer COVID-19 vaccine first dose two weeks ago and she just went to the doctor who prescribed her Prednisone. Sher says she would like to know, will that mess with the vaccine in her body? She says she only took one dose of it, could it do anything to her? She says that she heard it can take away if take steroids, that it can downplay vaccine. Caller would like to know if prednisone PO would interfere with the Pfizer COVID-19 vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Malaise, Nausea
Clinical narrative: felt very unwell; discomfort; dizziness; Nausea; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration in left arm on 07Apr2021 as dose 1, single (at the age of 52 years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, on an unspecified date after the first dose, the patient experienced felt very unwell, discomfort, dizziness, nausea. Upon follow-up (04Aug2021); patient stated she got her first shot in April, but never got the second shot. She doesn't remember the anatomical location she received her first dose in, but she thinks it was in her left arm. She would like to know, since it has been so long since her first dose, if she has to start with the vaccination series from scratch. Clinical outcome of the events was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-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 left arm on 19Apr2021 (at the age of 34-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021, a few days after the first dose the patient began to experience symptoms of UTI (Urinary Tract Infection). The UTI was non responsive to antibiotics for almost 4 months. It finally went away. The patient went to the emergency room (ER) several times and saw several different doctors and was prescribed several different antibiotics. The patient had no history of UTIs, it was very out of the ordinary for the patient. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included antibiotics. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event UTI (Urinary Tract Infection) was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Inappropriate schedule of product administration, Laboratory test, Peripheral swelling, Vaccination site erythema
Clinical narrative: Frustrated; next day her palm was big as her arms; Date of 2st Shot: Consumer Stated, "2 August, 2021; arm is hot and red and itchy around where the shot was; arm is hot and red and itchy around where the shot was; arm is hot and red and itchy around where the shot was; This is a spontaneous report from a contactable consumer (Patient).   A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, in left arm on 02Aug2021 (at the age of 59-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medication of the patient included levothyroxine sodium (SYNTHROID). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown) via unspecified route of administration, on 17Apr2021 as a dose 1, single for COVID-19 immunization. On 02Aug2021 the patient experienced arm was hot and red and itchy around where the shot was and bigger than it was on Monday night. Three days ago, the patient had redness. Patient was frustrated. Patient reported that her palm was big as her arms, and she was very swollen and patient stills feels it warm to the touch. Patient was informed about Pfizer Medical Information Department. Patient stated that she will call her doctor because she had already talked to three people, and it was not getting patient anywhere. So, patient was okay to not going to call anybody else. Patient had lab test 2 twice 2 weeks ago. Patient stated that she was pretty healthy. The patient received the treatment of Advil 200 mg. Outcome of all the reported events was unknown.  Information about Lot/Batch has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Frustrated; next day her palm was big as her arms; Date of 2st Shot: Consumer Stated, "2 August, 2021; arm is hot and red and itchy around where the shot was; arm is hot and red and itchy around where the shot was; arm is hot and red and itchy around where the shot was; This is a spontaneous report from a contactable consumer (Patient).   A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, in left arm on 02Aug2021 (at the age of 59-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medication of the patient included levothyroxine sodium (SYNTHROID). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown) via unspecified route of administration, on 17Apr2021 as a dose 1, single for COVID-19 immunization. On 02Aug2021 the patient experienced arm was hot and red and itchy around where the shot was and bigger than it was on Monday night. Three days ago, the patient had redness. Patient was frustrated. Patient reported that her palm was big as her arms, and she was very swollen and patient stills feels it warm to the touch. Patient was informed about Pfizer Medical Information Department. Patient stated that she will call her doctor because she had already talked to three people, and it was not getting patient anywhere. So, patient was okay to not going to call anybody else. Patient had lab test 2 twice 2 weeks ago. Patient stated that she was pretty healthy. The patient received the treatment of Advil 200 mg. Outcome of all the reported events was unknown.  Information about Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Off label use, Product use issue
Clinical narrative: got the covid Pfizer plus they gave me the shingles; got the covid Pfizer plus they gave me the shingles; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, 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 was not reported. Concomitant vaccine included varicella zoster vaccine (SHINGLE VACCINE) via an unspecified route of administration from an unspecified date for immunization. The patient went this past Monday he went to get the covid Pfizer plus they gave him the shingles, they said it was ok and everything. As soon Monday came he had a little bit of chills but that went away, and he had had a headache ever since Monday and that's been 6 days now. The outcome of the event chills was recovered and the outcome of the other events was unknown.  The lot number for the BNT162B2, was not provided and will be requested during follow up.  Follow up (26Aug2021): New information received from a contactable consumer (patient) includes reporter information.  Follow-up (07Aug2021): This case is being submitted to notify that the initial information for this case was first received by the Company on 07Aug2021 and not on 26Aug2021 as previously reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Nausea, Vomiting, Water pollution
Clinical narrative: feeling uneasy; I couldn't get down water; I woke up nauseous; started vomiting violently; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 33-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 03Aug2021 18:00 (age at vaccination: 33 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included immune thrombocytopenia (ITP) , splenectomy which was recovered , cerebrovascular accident from Aug2012, gastrectomy from Feb2019, covid-19 prior vaccination. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC); aspirin (acetylsalicylic acid); esomeprazole magnesium (NEXIUM); risankizumab rzaa (SKYRIZI) and sertraline hydrochloride (ZOLOFT). The patient did not have any other vaccine in four weeks. It was unknown if patient had any known allergies. On 04Aug2021 02:00, the patient woke up nauseous, started vomiting violently approximately 6 to 8 times, diarrhea and couldn't get down water. The patient was prescribed zofran for nausea and it stopped 04Aug around 8pm. I had diarrhea and nausea through 06Aug. On 08Aug2021, the patient was feeling uneasy. Still was feeling uneasy on 08Aug2021. The adverse events resulted in physicians office visit. The patient was not tested for covid post vaccination. The outcome of all the events was recovering with sequalae.   The lot number for the vaccine was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Bright red discharge from vagina; This is a spontaneous report from a contactable consumer or other non hcp reported for herself. A 40-years-old non-pregnant female patient received BNT162B2 (BNT162B2, Pfizer-BioNTech COVID 19 vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 06Aug2021 09:30 as dose1, single (age at vaccination 40 years) for covid-19 immunisation (At Pharmacy or Drug Store). The patient medical history was not reported. Concomitant medication included prednisone (other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. The patient experienced bright red discharge from vagina on 08Aug2021 12:00. Patient was not received any treatment for the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding following the vaccine for 2 days; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 21Jul2021 11:00 (at the age of 30-year-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Patient took Prenatal vitamins in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Jul2021 18:00, the patient experienced vaginal bleeding following the vaccine for 2 days. No treatment was taken as a result of events. The outcome of the event was recovered on an unspecified date in Jul2021.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Fatigue; Arm was sore; Headache; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer reported for herself. A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown), via an unspecified route of administration, administered in the left arm on 29Jul2021 (age at vaccination was 22 years) as dose 1, single for COVID-19 immunization. The patient's medical history included none from an unknown date. There were no concomitant medications reported. On 30Jul2021, after the first dose the patient experienced fatigue, arm was sore, headache, nausea and diarrhea. The side effects went away on 01Aug2021. Patient started having side effects again on 05Aug2021. Patient began with a headache yesterday. Then on 06Aug2021, Patient started having headache, nausea, diarrhea, and fatigue. They all came back the same. Patient was on no other medications. Patient has not gone to the doctor, but she was going to call the doctor after this. The outcome of event arm was sore was unknown. The outcome of event fatigue, headache, nausea and diarrhea was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Peripheral swelling, Rash, Respiratory rate decreased, Urticaria
Clinical narrative: Golf ball sized knot; Swelling of arm; hives; rash; Slow Breathing.; This is a spontaneous report from a contactable consumer. A 35-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 21Jul2021 11:00 (age at vaccination 35 years) as dose 1, single for covid-19 immunisation. Medical history included known allergies: Latex. There were no concomitant medications. The patient previously took codeine and experienced drug hypersensitivity, historical vaccine flu vaccine vii and experienced drug hypersensitivity. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jul2021 the patient experienced golf ball sized knot, swelling of arm, purple colour hives, rash, slow breathing. Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient received treatment of 40Mg prednisone, benadryl every 3 hours, zyrtec 2x. The outcome of events was recovered with sequelae.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron decreased, Menstrual disorder, Menstruation irregular, Oligomenorrhoea
Clinical narrative: After I got the vaccine my period came three days after but it was a week and a half early and I have never had that with my cycle; Then after the first shot my period went away for two and a half months; Then came back and I have been bleeding for 16 days straight.; My period is still flowing and my iron is very low due to how heavy it is.; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old female patient received bnt162b2 (BNT162B2) Solution for injection, dose 1 (Lot number expiry date was not reported) via an unspecified route of administration at arm right on 21May2021 14:00 (at the age of 29-years-old) as a single dose, dose 2 (Lot number expiry date was not reported) via an unspecified route of administration at arm right on 06Jul2021 as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient did not have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After she got the vaccine her period came three days after, but it was a week and a half early and she have never had that with her cycle. Then after the first shot her period went away for two and a half months. Then came back and she have been bleeding for 16 days straight. she went to the doctor and they can't find any reason why her period was doing this as they checked her hormone levels and did a pap. Her period was still flowing, and her iron was very low due to how heavy it was. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Post-vaccination she experienced numbness on her face; This is a spontaneous report from report from Pfizer-sponsored program Support via a contactable consumer or other non HCP (Patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation solution for injection), dose 1 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included bell's palsy (when she was younger) from an unknown date and unknown if ongoing. The patient's concomitant medications were not provided. Post-vaccination on an unknown date, the patient experienced numbness on her face. It was reported that she experienced these AEs post-vaccination of her 1st dose, caller decided not to get her 2nd dose. In line with this, caller would like to know if, if she decides to get her 2nd dose , in terms of efficacy, does she need to restart her whole 2 dose series or can she proceed in getting her 2nd dose as is. The patient decided not to get her second dose and she want to know if she decides to get her second dose, in terms of efficacy, does she need to restart her whole 2 dose series or she proceed in getting her second dose. The outcome of event was unknown.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the injection site in his left arm/shoulder; This is a spontaneous report from a contactable consumer or other non-health care professional. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 05Aug2021 (at the age of 73-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced pain in his left shoulder at the injection site and asked if it was normal to feel this pain. Among the Pfizer-BioNTech COVID-19 Vaccine recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction", that approximately 84% of clinical trial recipients experienced pain at the injection site as well. Patient wanted to know why was that he still felt the pain in the injection site in his left arm/shoulder in his first dose. Outcome of the event was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: headache that would come and go; a little bit of chest pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on Apr2021 as dose 1, single for covid-19 immunisation and experienced headache. On an unspecified date in 2021, the patient experienced headache and chest pain. It was reported that after shot 1 Patient experienced headache that would come and go After shot 2 Patient also experienced a headache that would come and go and a little bit of chest pain after the second shot. Event took place after use of product. She received both shots in Apr2021. The outcome of the event headache was not recovered while the outcome of the other event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: No longer lactose intolerant; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included lactose intolerance from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was no longer lactose intolerant after receiving COVID-19 vaccine. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (17Sep2021): Follow-up attempts completed. information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Palpitations, Tremor
Clinical narrative: her heart was racing and she was having an anxiety attack and started shaking; her heart was racing and she was having an anxiety attack and started shaking; her heart was racing and she was having an anxiety attack and started shaking; This is a spontaneous report from Pfizer-sponsored program from a contactable female consumer (patient). A female patient of over 65-year of age (exact age: not specified) received first dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, Solution for injection, Batch/lot number: Not Provided, Expiry date: Not provided), via an unspecified route on an unspecified date in Jan2021 and second dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, Solution for injection, Batch/lot number: Not Provided, Expiry date: Not provided), via an unspecified route on an unspecified date in Feb2021, both as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient heart was racing, and she was having an anxiety attack and started shaking. Her question was that she wanted to make sure she was fully vaccinated, and it was still effective after so much time had passed or if she needed to be revaccinated. The clinical outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Feeling abnormal, Pyrexia, Speech disorder
Clinical narrative: experiencing a fever that is continually rising and is up to 101.1 degrees Fahrenheit; Feels bad; hard to talk because of the fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date: not reported), via an unspecified route of administration on 09Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced, a fever that was continually rising and is up to 101.1 degrees Fahrenheit, hard to talk because of fever, and feels bad on an unspecified date in 2021. She reported that, since 4 AM today, she had been experiencing a fever that was continually rising, and was up to 101.1 degrees Fahrenheit. She also reported it was hard to talk because of the fever. Referred caller to HCP (healthcare professional) for treatment. The patient was seeking information about this side effect. Yesterday she got her 1st injection of the Pfizer BioNtech Covid Vaccine (09Aug2021). Today (10Aug2021) her temperature kept going up and up, right now it was 101.1. Caller began to say something about her head but did not complete the sentence. Stated only that she felt bad. The patient underwent lab tests and procedures which included body temperature increased 101.1 on an unspecified date temperature keeps goes up and up, right now it is 101.1. Reason for no lot number of Pfizer BioNtech Covid Vaccine. Caller unwilling to complete the report. The outcome of the events was not recovered at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: redness on the injection site and soreness in the arm where she got the shot; redness on the injection site and soreness in the arm where she got the shot; Redness and soreness in left arm; This is a spontaneous report from a contactable consumer or other non-Health Care Professional from a Pfizer sponsored program. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date at the age of 63-years-old as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported.There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 04Aug2021 the patient experienced redness on the injection site and soreness in the arm where she got the shot, redness and soreness in left arm.The outcome of events was unknown.  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain, Peripheral swelling, Skin discolouration
Clinical narrative: Had a bruise for 7 days and it hurt a lot for several days; Had a bruise for 7 days and it hurt a lot for several days; swelling on the arm; The first time it was only purple/purple stain on her arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in arm on an unspecified date in 2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had the first vaccine three or four months ago, 4 hours later she had a bruise for 7 days and it hurt a lot for several days not where the vaccine was applied but in the middle of the injection arm on an unspecified date in 2021. Had like a bruise, purple stain on her arm. It was very hard. The first time it was only purple on an unspecified date in 2021. All around the arm there was swelling on the arm on an unspecified date in 2021. The patient stated that the swelling was not too much. It was the color purple. It was on the middle. The patient stated that it was just after the first dose. It was not where the vaccine was applied, it is in the middle of the injection arm. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in arm on an unspecified date in 2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The case was assessed as non-serious. The outcome of the events had a bruise for 7 days and it hurt a lot for several days was resolved on an unspecified date in 2021. The outcome of the other events was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: didn't have any side effects except at most a sore arm for a few days; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Jan2021 (at the age of 73 years old) as dose 1, single for COVID-19 immunisation. Medical history included smoking for 50 years and was up to two packs a day, spot on her lung. Concomitant medication(s) included varenicline tartrate (CHANTIX) taken for smoking cessation therapy from 01Jul2021 to 20Jul2021. Historical vaccine included FLU on an unspecified date for immunisation and experienced sore arm. Patient got her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 for COVID-19 immunisation. The patient experienced as, "didn't have any side effects except at most a sore arm for a few days" on 15Jan2021. Reported as, she got the Pfizer COVID vaccine and all of her friends did, and they all did great with no side effects. At most they had sore arms like a flu shot. Outcome of the event was recovered on 16Jul2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: WBC was low; felt lethargic; This is a spontaneous report from a contactable consumer. This 61-year-old female consumer (patient) reported for herself. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported she is taking 125mg tablets for two weeks on followed by two week off, then starting Ibrance 100mg after September 1st due to chronically low WBC count. Reported after her first Covid vaccine, her WBC was low and she felt lethargic, but it did not occur with 2nd vaccine. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had soreness to her arm like the first, which she had gotten in her right arm; This is a spontaneous report from a contactable consumer. This consumer reported for 26-year-old female patient.  A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via unknown route of administration, administered in right arm on unspecified date in Jul2021, as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications included Products ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), colecalciferol (VITAMIN D), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN), sambucus nigra (ELDERBERRY) on unspecified date and took two Tylenol two days ago for her cycle, because she was aching from her cycle. It was reported patient received her first dose was in July, it was like a two-week period between them, so she thought it was on 30Jul or 26Jul. She reported that the ache or tired like feeling just started around 3:30PM, afternoon. She reported she kept checking on her yesterday and last night to make sure she was not feverish or feeling bad, and morning she had soreness to her arm like the first, which she had gotten in her right arm, then got the second in her left arm since they told her she couldn't take both shots in same arm. She said her daughter was fine when she left here outside of the soreness of the arm and redness at the injection site and complaining of hurting. An hour ago, she had aching to the bend of her knee like a tired feeling like she has been walking too much. She said her daughter had not treated the ache or tired feeling because it just started about an hour ago. At the time of this report the outcome of the events was unknown.  The lot number for the vaccine was not provided and would be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: A bump at the injection site; large round welt appeared at the injection site raised red hot to the touch and sore; large round welt appeared at the injection site raised red hot to the touch and sore; large round welt appeared at the injection site raised red hot to the touch and sore; This is a spontaneous report from a contactable consumer (patient herself). A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Jul2021 14:00 (age at vaccination: 46 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included giant cell tumour of tendon sheath, PVNS in my right knee, knee arthroplasty and high blood pressure. Concomitant medication(s) included olmesartan. The patient had no known allergies. The patient had covid prior to vaccination. On 02Aug2021 19:00, slightly over 24 hours of receiving the vaccination, the patient started to have a bump at the injection site, large round welt appeared at the injection site raised red hot to the touch and sore. On 03Aug2021 at around 11AM (Tuesday morning) a large round welt appeared at the injection site raised red. The patient did not receive any treatment for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted in physician's office visit. The patient was not diagnosed with covi-19 prior to vaccination nor was tested since vaccination. The outcome of all the events was unknown. The device date was 10Aug2021.   The lot number for the vaccine was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Decreased appetite, Dizziness, Headache, Hyperhidrosis
Clinical narrative: sore and swollen arm for three days; sore and swollen arm for three days; severe headaches; clammy skin; blood pressure has been low; has no appetite; vertigo; having sweating; dizziness; This is a spontaneous report from a contactable consumer (patient mother) or other non-healthcare professional. A 47-year-old male patient received BNT162B2 (COMIRNATY; Solution for injection; Lot number, Expiry date: Unknown), via an unspecified route of administration on 06Aug2021 (at the age of 47-year-old) as dose 1 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Aug2021 the patient experienced severe headaches, clammy skin, vertigo, his blood pressure has been low and has no appetite. The patient received the first dose of the vaccine Pfizer since the patient been experiencing sweating and having headache and something that did not realize dizziness, the patient had dizziness where he's spinning the room is not spinning it is preventing him from going to work because he drives, now is this a possible side effect of the medication. Initially the patient experienced a sore and swollen arm for three days but that has now (at the time of report) subsided. The patient received Tylenol, 500 MG each, two tablets (twice a day) as a therapeutic measure for the events. The patient did not receive any treatment Prior Vaccination. The event sore and swollen arm was recovered, the events severe headaches, clammy skin, vertigo, his blood pressure has been low and has no appetite was not recovered and outcome of the events sweating, dizziness was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Limb discomfort, Peripheral swelling, Vertigo
Clinical narrative: sore and swollen arm for three days; sore and swollen arm for three days; severe headaches; clammy skin; blood pressure has been low; has no appetite; vertigo; having sweating; dizziness; This is a spontaneous report from a contactable consumer (patient mother) or other non-healthcare professional. A 47-year-old male patient received BNT162B2 (COMIRNATY; Solution for injection; Lot number, Expiry date: Unknown), via an unspecified route of administration on 06Aug2021 (at the age of 47-year-old) as dose 1 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Aug2021 the patient experienced severe headaches, clammy skin, vertigo, his blood pressure has been low and has no appetite. The patient received the first dose of the vaccine Pfizer since the patient been experiencing sweating and having headache and something that did not realize dizziness, the patient had dizziness where he's spinning the room is not spinning it is preventing him from going to work because he drives, now is this a possible side effect of the medication. Initially the patient experienced a sore and swollen arm for three days but that has now (at the time of report) subsided. The patient received Tylenol, 500 MG each, two tablets (twice a day) as a therapeutic measure for the events. The patient did not receive any treatment Prior Vaccination. The event sore and swollen arm was recovered, the events severe headaches, clammy skin, vertigo, his blood pressure has been low and has no appetite was not recovered and outcome of the events sweating, dizziness was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza like illness
Clinical narrative: She wanted to know if she can take over-the-counter medications for her symptoms. (like Tamiflu and cough medications); She wanted to know if she can take over-the-counter medications for her symptoms. (like Tamiflu and cough medications); This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she wanted to know if she can take over-the-counter medications for her symptoms (like tamiflu and cough medications). The clinical outcome of the events was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Nausea, Vomiting
Clinical narrative: Nauseous; throwing up; little bit of diarrhea; I am going on a week of feeling awful.; really run down/ tired; This is a spontaneous report from a contactable consumer (patient). A 26-year-old-female (patient) reported herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 04Aug2021 (Batch/Lot number was not reported) as dose 1, single for (at the age of 26-year-old) covid-19 immunisation. The patient medical history and was not reported. The patient was on other medication (Birth control). Consumer stated, she got her first shot a week ago last Wednesday (04Aug2021) and she felt pretty good on Wednesday just like tired and 'out a bit' which was excepted. She woke up last Thursday morning (05Aug2021), super nauseous and throwing up and little bit of diarrhea and then and she have been nauseous ever since last Thursday. So, she was going on a week of feeling awful. Therapeutic measures were taken as a result of nauseous, she had taken over the counter nausea medicine Zofran. The clinical outcome of events nauseous and feeling awful were not recovered, events really run down/ tired, throwing up and little bit of diarrhea were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Neuralgia, Pain in extremity
Clinical narrative: extreme fatigue; aching nerve pain in hands and calves; aching nerve pain in hands and calves; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer or other non hcp reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration in May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2, via an unspecified route of administration, administered on an unspecified date as dose 1, single for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced extreme fatigue, aching nerve pain in hands and calves on Jul2021. It was stated that, had pfizer second shot in may. Now since July extreme fatigue and aching nerve pain in hands and calves. Outcome of the events was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Tinnitus, Urticaria
Clinical narrative: Itchy hives developed near my lower part body near leg and but tuck 24-32 hours after vaccine. I woke up 4 AM due to itch, and took zyrtec for the hives. Hives went away in the morning when I woke up; Itchy hives developed near my lower part body near leg and but tuck 24-32 hours after vaccine. I woke up 4 AM due to itch, and took zyrtec for the hives. Hives went away in the morning when I woke up; started to notice tinnitus or ringing in my ear as well.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 06Aug2021 11:45 AM (at the age of 41-years-old) as dose 1, single for covid-19 immunization at Doctor's office/urgent care. Medical history included known allergies to pollen, dust mite, tumble weeds, cat, dog all from an unknown date to unknown if ongoing and No spleen and only one kidney due to an accident, single functional kidney. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]), tocopherol (VITAMIN E [TOCOPHEROL]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), ubidecarenone (COQ10 [UBIDECARENONE]), turmeric [curcuma longa rhizome] (TURMERIC [CURCUMA LONGA RHIZOME]) all were taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccines within four weeks of vaccination. Patient had no covid prior vaccination and has been tested for covid post vaccination. On 08Aug2021, at 02:00Am patient developed Itchy hives near his lower part body near leg and but tuck 24-32 hours after vaccine. He woke up 4 AM due to itch and took zyrtec for the hives. Hives went away in the morning when he woke up. And also started to notice tinnitus or ringing in his ear as well, it was developed a day after vaccine, and he still have it so patient reporting the side effects. Not sure if tinnitus going to go away. That was the two side effects that are obvious to him so far. The patient underwent lab tests and procedures which included sars-cov-2 Nasal Swab test results negative for Covid-19 on an unknown date in Jun2021. Patient did not receive any treatment for the events itchy and Tinnitus and took Zyrtec for Hives. Outcome of the event hives was recovered on an unknown date in Aug2021 and not recovered for Itchy and Tinnitus.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.