chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Rash, Rash pruritic
Clinical narrative: developed a itchy bumpy rash on her torso,; developed a itchy bumpy rash on her torso,; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a non-contactable consumer or other non hcp (Patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Dec2020 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she took 1st dose of Covid vaccine on 30Dec and developed a itchy bumpy rash on her torso, that was lasted a month. Patient wondering what she should do now as far as getting the vaccine again and wondering if she has some level of protection after the 1st dose. She took an antibody test and it was negative. The patient underwent lab tests and procedures which included antibody test: negative. The outcome for the event was unknown.   No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: pain at injection site; joint ache; 101 temperature; This is a spontaneous report from a non-contactable consumer (Patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 05Feb2021, patient reported pain at injection site, and then in next 24 hours he was reported joint aches and pain at injection site to touch. Upon follow up he reported that, patient previously reported below now has a 101 temperature (date unspecified). The patient underwent lab tests and procedures which included body temperature of 101 on an unspecified date. Outcome of all the event were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: possible UTI; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect (Patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), 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. On an unspecified date, the patient experienced possible UTI (Urinary tract infection). The patient was prescribed an antibiotic for a possible UTI and wants to know if he can take the antibiotic or will it interfere with his second dose on Thursday. The outcome of the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she felt stinging; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer or non-health care professional (patient) of unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration on 02Feb2021 as 1st dose, single for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient received the first dose on 02Feb201 and said while they're injecting the vaccine, she felt stinging. Caller asked if it was normal since her friend did not experienced it. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Illness
Clinical narrative: I feel sick, I have problems with my stomach.; I feel sick, I have problems with my stomach.; This is a spontaneous report from a non-contactable consumer (Patient reported for self). A patient of unspecified age and gender received first 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 a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient has had to get second vaccine 'today', but the patient cannot go because, the patient was feeling sick, had problems with stomach. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: knee pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a 93-year-old female patient (mother) that A 93-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that that the reporter's mother got the 1st dose on Covid-19 vaccine recently. her mother might need cortazone shot next week and wants to know if her mother can take tylenol for knee pain. Read the literature Gave the caller the number and transferred to (Name) in Faxing to for potential AE as not known if knee pain is worse or not after first vaccine. Outcome of the event was unknown.  Follow-up (05Feb2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a patient that:Her mother got her first covid vaccine shot yesterday and is scheduled to get her cortisone shot for her knee next week. Also will be taking Tylenol Wanted to know if these will interfere with the vaccine.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had very minimal sore in the arm after the vaccine; This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer sponsored program.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very minimal sore in the arm after the vaccine on an unspecified date. Patient stated that he already took the first dose and will be having an appointment with his knee doctor and might get a few injections during that time. Patient was asking if he can take the injections on his knee appointment. Clinical outcome for the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feel extremely tired.; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (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 on 02Feb2021 as unknown,single for covid-19 immunisation.The patient medical history and concomitant medications were not reported.The patient experienced feel extremely tired on an unspecified date. The outcome of the event fatigue was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pyrexia, Vaccination site discomfort
Clinical narrative: feels weak; fever; chills; headache; slight discomfort to injection site; This is a spontaneous report from a contactable consumer (patient herself) received from Pfizer-sponsored program. An 82-years-old female patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 03Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 04Feb2021 she experienced fever, chills, headache, slight discomfort to injection site, on 05Feb2021 she felt weak, caller received an appointment for her second dose on 03Mar2021 which is 4 weeks out rather than 3. The outcome of all events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: yesterday severe pain on her shoulder; This is a spontaneous report from a Pfizer-sponsored program via a contactable female consumer.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot/Batch number: unknown), via an unspecified route of administration on an unspecified date in Jan2021 (a week ago) as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced severe pain on her shoulder on 04Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: It is stated she had her second dose on Monday and ever since then she has not had night sweats or hot flashes/after getting her 2nd dose she had no night sweats or hot flashes; It is stated she had her second dose on Monday and ever since then she has not had night sweats or hot flashes/after getting her 2nd dose she had no night sweats or hot flashes; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported that a 53-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EL3302; Expiration Date: May2021), dose 2 via an unspecified route of administration on left shoulder 01Feb2021as 2nd dose single for covid-19 Immunization.  Medical history and concomitant medications were reported as none. Patient Previously took, first dose of vaccine on 11Jan2021 with a Lot number: EJ1685 and Expiry: 30Mar2021.It was reported that, caller stated she had her second dose on Monday and ever since then she has not had night sweats or hot flashes. She wanted to go online and report this, but it kept asking about adverse effects and this is not a bad effect. It is explained that after the second shot, that night. When she woke on the 20Feb2021 she realized that she was not soaking wet and didn't get up in the middle of the night for water. This week she couldn't remember using desk fan for when she gets hot, at work. Caller clarifies these were experiences prior to taking the vaccine and related to menopause. There has been no new medications started, she has not been exercising, there has been nothing that has changed in what she doing. Both shots were given in the left shoulder area. The outcome of the events was not recovered.  Follow-up (05Feb2021): This is a follow-up spontaneous report from a contactable consumer. added lot number, patient details, onset dates, outcome, first dose details.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, Inappropriate schedule of product administration, Mammogram
Clinical narrative: administration date: dose 2: 21Jan2021, dose1: 14Jan2021; Lateral left breast simple cyst and simple cyst cluster, benign; This is a spontaneous report received from a contactable consumer (patient). A 44-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EK9231), via an unspecified route of administration in left arm on 21Jan2021 at 10:30 as second dose, single (age at vaccination was 44 years) for COVID-19 immunization. Medical history included nickel topical allergy. Concomitant medication included valacyclovir [VALACICLOVIR], received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EK 9231) via an unspecified route of administration in left deltoid on 14Jan2021 as first dose, single for COVID-19 immunization and experienced lateral left breast simple cyst and simple cyst cluster, benign. Patient received second dose on 21Jan2021 and first dose on 14Jan2021. On 02Feb2021, the patient experienced lateral left breast simple cyst and simple cyst cluster, benign. The patient underwent lab tests and procedures which included mammogram on 19Jan2021 and showed impression: lateral left breast asymmetries-CC view only. Assessment: BI-RADS assessment category 0- incomplete: need additional imaging evaluation; recommendation: left diagnostic mammogram. Targeted ultrasound if needed. The patient had another mammogram on 02Feb2021 and showed impression: Lateral left breast simple cyst and simple cyst cluster, benign-accounting for the mammographic appearance. BI-RADS assessment category 2 benign. The event resulted doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event lateral left breast simple cyst and simple cyst cluster, benign was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Tremor
Clinical narrative: headache; 102 deg fever; chills; Violent shaking; This is a spontaneous report from a non-contactable consumer or other non hcp.   An adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on 30Jan2021 at 13:00 as 2nd dose, single for covid-19 immunisation. Patient no known allergies. The patient medical history and concomitant medications were not reported. It was unknown if patient was covid prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on an unknown date in Jan2021 at 13:00 as 1st dose, single for covid-19 immunization.It was reported after receiving the second dose at 1 pm, started chills at 10 pm. Violent shaking and 102 degree fever 11 pm - 4 am, then she took ibuprofen. Low grade fever and headache the next day (minor chills but no shaking). Following day woke up with headache; fine after taking Tylenol. Symptoms much worse after second dose than first dose. It was unknown if patient tested for covid-19 post vaccination. Outcome of the events were recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills after taking the 2nd shot; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program.  A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. No medical history and concomitant medication were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. On an unspecified date, the patient experienced chills after taking the second shot. The patient wanted to know if she was immune to COVID now. The outcome of the event chills was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Nasopharyngitis
Clinical narrative: experiencing colds; head was stuffy; This is a spontaneous report from a contactable consumer (patient) to report from a Pfizer sponsored program.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the second dose was due for tomorrow but currently (as reported) the patient experiencing colds and head was stuffy on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: experienced side effects like chills; fever; headache; body aches; This is a spontaneous report received from a contactable male consumer (patient) via Pfizer-sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced side effects like chills, fever, headache and body aches but they're gone already. He's feeling good. Reporter was querying for if he can resume his normal activities/life now. Outcome of events was recovered on unspecified date.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain on his arm; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (Wife) reported for a male patient (Husband). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on unspecified date (lot number: not reported), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced pain on his arm after the first dose of the covid-19 vaccine. The outcome of the event was unknown.  Information on the Lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: the vaccine has helped get rid of my headaches; This is a spontaneous report from a Contactable consumer (patient) via Pfizer sponsored program. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), dose 1 via unspecified route of administration on an unspecified date as a 1st dose, single and dose 2 via unspecified route of administration on an unspecified date as a 2nd dose, single both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient was working in healthcare and had both doses. For some reason the vaccine had helped patient to get rid of headaches that patient had every single day. Patient stated that even with all the stress of everything in the world today, patient have not had a headache since the first vaccine. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Illness, Influenza like illness
Clinical narrative: Little bit weak today; sore muscle; body ache; had chills too; I would feel bad.; if I smell food, it would you know kind of sickening but I ate,; I had unwell feeling, like you getting the flu; This is a spontaneous report received from a contactable consumer (patient). A 77-years-old (reported currently 77 and half, 78 in august so) female patient received first dose of bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 22Jan2021 (age at vaccination: 77 years) as single dose for covid-19 immunisation. Medical history was not reported. The patient's height is about 5 (feet) 3 (inches) and right now her weight this morning was 116.7 (pounds), closer to 117 (pounds) (not captured in tab). Concomitant medications included vitamins once a day (multiple vitamins), calcium plus D (calcium, colecalciferol) per day, ciclosporin (RESTASIS) for dry eyes (in eye twice a day). On 22Jan2021, the patient had first shot and started having a sore muscle and the body ache and everything; on the same night she had little bit chills too, but side effects were mostly at night and then about (incomplete sentence). And then during the day she was fine, and it was just during the evening when she would feel bad. And then about Thursday (dates unspecified) when she woke up and she had unwell feeling, like getting the flu. And then at times like if she smells food, kind of sickening, but ate, had a good appetite. Sometimes she would get up and would feel better. The symptoms had gradually gotten better and went to a grocery shopping in-between the time, but it was sick, but now she would not be sick again and she was almost back to normal today. She was wondering is this normal to have this kind of symptoms for 2 weeks. When questioned about stop date of events, she reported that she was not feeling really bad right now, she just feels, just a little bit weak today (05Feb2021), feel like everything's going away. When questioned about outcome of event: consumer stated, she thinks she was recovering. The patient did not take any treatment. She did call her doctor and didn't seem to be concerned. She didn't take any Tylenol or anything else. She did not have the seizure; she did not have injection site swelling or redness or so. She reported alright and was going to have her next one. The outcome of event asthenia was unknown and for other events it was resolving.  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Little bit weak today; sore muscle; body ache; had chills too; I would feel bad.; if I smell food, it would you know kind of sickening but I ate,; I had unwell feeling, like you getting the flu; This is a spontaneous report received from a contactable consumer (patient). A 77-years-old (reported currently 77 and half, 78 in august so) female patient received first dose of bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 22Jan2021 (age at vaccination: 77 years) as single dose for covid-19 immunisation. Medical history was not reported. The patient's height is about 5 (feet) 3 (inches) and right now her weight this morning was 116.7 (pounds), closer to 117 (pounds) (not captured in tab). Concomitant medications included vitamins once a day (multiple vitamins), calcium plus D (calcium, colecalciferol) per day, ciclosporin (RESTASIS) for dry eyes (in eye twice a day). On 22Jan2021, the patient had first shot and started having a sore muscle and the body ache and everything; on the same night she had little bit chills too, but side effects were mostly at night and then about (incomplete sentence). And then during the day she was fine, and it was just during the evening when she would feel bad. And then about Thursday (dates unspecified) when she woke up and she had unwell feeling, like getting the flu. And then at times like if she smells food, kind of sickening, but ate, had a good appetite. Sometimes she would get up and would feel better. The symptoms had gradually gotten better and went to a grocery shopping in-between the time, but it was sick, but now she would not be sick again and she was almost back to normal today. She was wondering is this normal to have this kind of symptoms for 2 weeks. When questioned about stop date of events, she reported that she was not feeling really bad right now, she just feels, just a little bit weak today (05Feb2021), feel like everything's going away. When questioned about outcome of event: consumer stated, she thinks she was recovering. The patient did not take any treatment. She did call her doctor and didn't seem to be concerned. She didn't take any Tylenol or anything else. She did not have the seizure; she did not have injection site swelling or redness or so. She reported alright and was going to have her next one. The outcome of event asthenia was unknown and for other events it was resolving.  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: a little discomfort around injection site; injection site pain; This is a spontaneous report from a Pfizer Sponsored program. A contactable male consumer reported for himself. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date, as SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications took Tylenol 2 hours before vaccine. On an unspecified date patient received first dose of BNT162b2 as single dose for covid-19 immunization. On an unspecified date, the patient experienced a little discomfort around injection site, and injection site pain. Patient stated that he did not see in the guidance prior to vaccine not to take tylenol, caller took tylenol 2 hours before vaccine. Patient wanted to know if there is any info on the specific effects that might have happen as he said he is now aware that people should not take pain killers before getting the covid vaccine. The outcome of the events was unknown.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, X-ray
Clinical narrative: sore throat; his upper arm started to hurt really bad; This is a spontaneous report from a contactable consumer reported for his  father via Pfizer-sponsored program. A 91-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 25Jan2021 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 29Jan2021 (day 4), patient experienced sore throat and his upper arm started to hurt really bad. He was not sure if it's because of the Covid vaccine or because his dad lifts very small weights. They did take Xrays, nothing was broken, but he wanted to know if the Covid vaccine could cause his dad's upper arm area to become super painful and then also he is supposed to get a Cortisone injection today and he wanted to know if that is alright to do or not as well, since reporter's dad developed a sore throat and a upper sore area after getting the Covid vaccine. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. The outcome of the events was unknown.   Information of lot/batch no has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fatigue; headache; body ache; My temperature hovered arouund 101.0 F; This is a spontaneous report from a contactable other hcp (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date (at the age of 64-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Covid-19 from Mar2020. The patient's concomitant medications were not reported. Historical vaccine information included bnt162b2 (COMIRNATY, Solution for injection) 1st dose on 17Dec2020 (at the age 64-years-old) for Covid-19 Immunization and experienced temperature up to 102.2/quite ill with a temperature of 105.1 F, Chills, Numbness in fingertips, Nausea, Soreness in arm, Shaking too badly, Dehydration. The patient experienced fatigue, headache, body ache, my temperature hovered around 101.0 f on an unspecified date. For the second vaccine, patient pre-medicated with Ibuprofen, every 4 hours after the Vaccine patient took TYLENOL or IBUPROFEN. Her temperature hovered around 101.1 F and she continued this for 48 hours and then her temperature started to drop. The other usual complaints of headache, body ache, and fatigue were also present. Again, she was completely well in four days. In her professional opinion, as she was a nurse practitioner, she did not consider this an adverse drug reaction, but just her own body doing what it needed to do. If it was of any interest, she did have Covid in Mar2020. The patient underwent lab tests and procedures which included body temperature resulted in 101.0 fahrenheit on unknown date. Therapeutic measures were taken as a result of events include TYLENOL or IBUPROFEN. The clinical outcome for events was recovered on an unspecified date.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood test, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Shortness of breath; racing heartbeat; feeling over heated; elevated blood sugar; This is a spontaneous report from a contactable other health care professional (patient). A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9267), via an intramuscular route of administration, administered in arm right on 11Feb2021 13:30 (age at vaccination 52-years) as single doe for COVID-19 immunization. Medical history included a reaction to epinephrine, even a tiny amount results, causing feeling overheated, racing heart back, slight difficulty breathing, and elevated blood sugar. Concomitant medication included lispro insulin vial taken for an unspecified indication, start and stop date were not reported. The patient was not had COVID prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccine within four weeks. On 11Feb2021 01:30, the patient experienced shortness of breath, racing heartbeat, feeling over heated, elevated blood sugar and it was lasted about 30-45 minutes. The treatment was received for the adverse events and reported that needed to take additional insulin. The patient underwent lab tests and procedures which included blood test: elevated, heart rate: racing on an unspecified date. The vaccination facility type was reported as hospital. The clinical outcome of the events was reported as recovered on an unspecified date in 2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Shortness of breath; racing heartbeat; feeling over heated; elevated blood sugar; This is a spontaneous report from a contactable other health care professional (patient). A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9267), via an intramuscular route of administration, administered in arm right on 11Feb2021 13:30 (age at vaccination 52-years) as single doe for COVID-19 immunization. Medical history included a reaction to epinephrine, even a tiny amount results, causing feeling overheated, racing heart back, slight difficulty breathing, and elevated blood sugar. Concomitant medication included lispro insulin vial taken for an unspecified indication, start and stop date were not reported. The patient was not had COVID prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccine within four weeks. On 11Feb2021 01:30, the patient experienced shortness of breath, racing heartbeat, feeling over heated, elevated blood sugar and it was lasted about 30-45 minutes. The treatment was received for the adverse events and reported that needed to take additional insulin. The patient underwent lab tests and procedures which included blood test: elevated, heart rate: racing on an unspecified date. The vaccination facility type was reported as hospital. The clinical outcome of the events was reported as recovered on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This is a spontaneous report from a Pfizer sponsored program. A contactable Female consumer reported for herself that a female patient with unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/ batch number; not provided) via an unspecified route of administration on 18Jan2021 at 1st dose, single for covid-19 immunization. Patient's medical history and concomitant medications were not reported. The patient received her 1st dose of Covid vaccine on 18Jan2021 and was told to call Pfizer as she was experiencing joint pain on an unspecified date. She called to see if joint pain was a side affect. She received a letter asking her to fill out a form about the joint pain. She is wondering if she needs to fill out form or not.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: tiredness; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced tiredness and muscle aches. Patient experiencing like muscle aches and tiredness after she took the first dose of the covid-19 vaccine. The action taken in response to the events for bnt162b2 was not applicable. The outcome of all the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Dental caries
Clinical narrative: Had cavities in his teeth after covax vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp via Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 03Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced had cavities in his teeth after covax vaccine on an unspecified date. On 03Feb, received covid vaccine. Went to the dentist, has a cavity. Prescribed an antibiotic for cavities. Inquiring if that would have an effect on his vaccine. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of had cavities in his teeth after covax vaccine (dental caries). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: bladder infection; This is a spontaneous report from a Pfizer-sponsored program. A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration on 14Jan2021 (at the age of 79-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her first covid-19 vaccine 2 weeks ago. The patient experienced bladder infection last week (on 2021). She was seen by her doctor last Friday. Her second dose scheduled, and she was inquiring if she should have her second dose of the covid-19 vaccine today on 08Feb2021. Her husband was asking if it ok to take shot with the vaccine with being on an antibiotic. Her husband does not feel the vaccine caused the bladder infection. She was currently taking Unspecified antibiotic the last 2 weeks. The outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: I've had high blood pressure for two weeks since I had the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that I had high blood pressure for two weeks since I had the vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: She developed a rash at the injection site yesterday.; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on unspecified date of Feb2021 as unknown, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received vaccine two weeks ago. On 04Feb2021 the patient developed a rash at the injection site yesterday. Patient took Benadryl for the rash. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Insomnia, Pain in extremity
Clinical narrative: right arm is unbearably painful after injection/My arm is hurting so bad; didn't sleep all night because of the pain/I really can't sleep enough, I mean it's hurting; This is a spontaneous report from a contactable consumer. This 77-year-old female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiry date not reported) via unspecified route of administration in right arm on 03Feb2021 (at age of 77-years old) as single dose for Covid-19 Immunization. Patient medical history includes high blood pressure. Patient concomitant medications include Amlodipine (once a day) used for blood pressure from unknown date and ongoing, Hydrochlorothiazide, lisinopril (once a day) used for high blood pressure from unknown date and ongoing. Patient previously received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:EK9231, Expiry date not reported) via unspecified route of administration on 15Jan2021 as single dose for COVID-19 Immunization. On 03Feb2021, patient had shot at noon, she got the injection in her right arm, she developed the arm pain last night about 8 or 9 pm. She said it will feel better one minute, and then she will have a sharp pain going through her arm again. Patient experienced like her arm is hurting so bad; patient stated that I really cannot sleep all night because of the pain/I really cant sleep enough, I mean it is hurting. Patient right arm is unbearably painful after injection and stated that she did not let nothing get around the injection area and she rubbed her arm with alcohol.Caller verifies she talked with a man yesterday and reported this information and gave information on what was on her vaccine record card. Caller verifies she was not provided with any type of reference number.Upon follow up reporter stated that the reason she got it because she works at the hospital, what mandated, and she got it. Patient stated that, I am having a problem so I could get the paid today, okay but look can I rub my arm with some alcohol. Consumer was informed about Pfizer Medical information department.Treatment received for event by taking Tylenol. Patient underwent lab test and procedures include blood pressure measurement is high on unspecified date. The outcome of events was not recovered.   Follow-up (04Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (mom) that: new information include vaccination at right arm and updated age 77years on onset of reaction, concomitant medications,Treatment received for event.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: She has UTI; This is a spontaneous report from a Pfizer Sponsored Program. A Non contactable consumer reported for a female patient (mother).  A female 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 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient discovered that she has Urinary tract infection (UTI). The patient stated that She was currently taking antibiotics as treatment medication for the event. The patient wanted to know if it was okay to get her second dose scheduled tomorrow. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Blood test, Illness, Infection, Weight
Clinical narrative: Come down with an infection, she is almost bed ridden; sick/his wife is sick/My wife is down with a sickness; Come down with an infection, she is almost bed ridden; She has lost some weight in the last couple of weeks; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient's husband) reported for a female patient. An 84-year-old female patient received first dose of BNT162B2 (Solution for injection, Lot number: EL9261 expiration date: unknown) via an unspecified route of administration on 21Jan2021, as a single dose for Covid-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. On an unspecified date, the patient fell sick (reported as "My wife is down with a sickness"). On 04Feb2021, she was diagnosed with an infection (reported as come down with an infection). It was stated that she was almost bed ridden and on an unknown date in 2021, she had lost some weight in the couple of weeks prior to this report. It was stated that she had an appointment for second dose of vaccine scheduled on 09Feb2021, unfortunately she had come down with an infection 'chronic' (further not clarified), she had received the diagnosis from her doctor. She was almost bed ridden at the time of this report, hopefully improving. It was also stated that she would not be able to go for that second session on 09Feb2021, and needed to reschedule appointment a little later, the reporter asked could she go as far as a week beyond such as like 15Feb2021 or 16Feb2021. The reporter stated that do not know her weight, she has lost some weight in the couple of weeks but that was okay. She was taking an antibiotic Bactrim (Further clarified as treatment) for this infection, on a 5 day schedule which would end on a day next to this report. The patient went to the doctor on 04Feb2021 Thursday, underwent laboratory test blood work on 04Feb2021 the result showed the infection (unspecified). The reporter did not think this was a side effect from the vaccine, and stated this was, could be, reporter was guessing it could be. It was reported that, "I am going to say it's very much in the vicinity of 145 pounds. She has lost some weight in the last couple of weeks but that's okay, I would say that 140, I am going to say 140 instead of 145". The outcome of the events of fell sick, come down with an infection, almost bed ridden and lost some weight was unknown.    Follow-up attempts completed. No further information expected.