chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mass, Speech disorder, Swelling face
Clinical narrative: Numbness; Swelling occurred in the area between my mouth and chin on the left side of my face; When touching the area there is a lump that measures between an inch and two; Speech is weird; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 04:00 PM in the left arm at 2nd dose, single for COVID-19 immunisation. The patient age at vaccination was 57 Years. Medical history included IBS (inflammatory bowel disease) and recently the patient was developed a sensitivity to shrimp that results in hives. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number: EL9282) received in left arm on 10Feb2021 05:00 PM for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and not received other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination and after the vaccination. On 05Mar2021 7:15 AM, the patient had swelling occurred in the area between my mouth and chin on the left side of my face up and my speech is weird. It almost feels like I went to the dentist and got a shot of novocaine in that area. When touching the area there is a lump that measures between an inch and two. I took two Benadryl at 7:35 or so and the swelling has started to decrease but is still there, as well as the numbness. Therapeutic measures were taken as a result of numbness (hypoaesthesia), swelling occurred in the area between my mouth and chin on the left side of my face (swelling face), when touching the area there is a lump that measures between an inch and two (mass) with Benadryl and novocaine. The patient reported that she do not know if this was happened before but potentially having a reaction to the vaccine that she got on Wednesday part of face has swelled up. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Erythema, Inappropriate schedule of product administration, Off label use, Pruritus
Clinical narrative: Head & neck all red, itchy; Head & neck all red, itchy; I'm scratching; my left ear was itching super bad; I almost felt like I was sun burned from my neck and head up, my thighs, my abdomen it was like super itchy; she received both her first and second dose; she received both her first and second dose; This is a spontaneous report from a contactable consumer.   This 61-year-old (non-pregnant) female consumer (patient) reported that she received both her first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) intramuscularly into the right arm on 09Mar2021 15:00 (at the age of 61-year-old) as single dose for COVID-19 immunisation. The patient medical history included hypertension, cancer and overweight. Concomitant medications included Xanax, Synthroid and Estratest (Female hormone). Blood Pressure medication, that was the only prescription she took. On 09Mar2021, she reported that she got her Covid shot about 3O Clock that day and about 8:30 that evening, she kind of itching some and scratching so she was going to bath and her left ear was itching super bad. She was itching and all red and had welch. So, she called her sister who was in the medical field too and that time what was going on and she took a couple of Benadryl and had some and then took a 10 mg of Prednisone and it calmed down but she almost felt like she was sun burned from her neck and head up, her thighs, her abdomen and it was like super itchy. She could not believe how red she was, looked like she have been in the sun. That was it. No investigation assessment done. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. She was treated with Benadry and prednisone. Prior to vaccination, she was not diagnosed with COVID-19 nor had been tested since the vaccination. She has allergies to medications, food or other products. She was a cancer survivor and considered herself a little over-weight, was not obese. Outcome for events was itching and all red was recovering and unknown for rest of the events.  Follow-up(10Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This 61-year-old female consumer (patient) reported which included   Information related lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sunburn
Clinical narrative: Head & neck all red, itchy; Head & neck all red, itchy; I'm scratching; my left ear was itching super bad; I almost felt like I was sun burned from my neck and head up, my thighs, my abdomen it was like super itchy; she received both her first and second dose; she received both her first and second dose; This is a spontaneous report from a contactable consumer.   This 61-year-old (non-pregnant) female consumer (patient) reported that she received both her first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) intramuscularly into the right arm on 09Mar2021 15:00 (at the age of 61-year-old) as single dose for COVID-19 immunisation. The patient medical history included hypertension, cancer and overweight. Concomitant medications included Xanax, Synthroid and Estratest (Female hormone). Blood Pressure medication, that was the only prescription she took. On 09Mar2021, she reported that she got her Covid shot about 3O Clock that day and about 8:30 that evening, she kind of itching some and scratching so she was going to bath and her left ear was itching super bad. She was itching and all red and had welch. So, she called her sister who was in the medical field too and that time what was going on and she took a couple of Benadryl and had some and then took a 10 mg of Prednisone and it calmed down but she almost felt like she was sun burned from her neck and head up, her thighs, her abdomen and it was like super itchy. She could not believe how red she was, looked like she have been in the sun. That was it. No investigation assessment done. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. She was treated with Benadry and prednisone. Prior to vaccination, she was not diagnosed with COVID-19 nor had been tested since the vaccination. She has allergies to medications, food or other products. She was a cancer survivor and considered herself a little over-weight, was not obese. Outcome for events was itching and all red was recovering and unknown for rest of the events.  Follow-up(10Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This 61-year-old female consumer (patient) reported which included   Information related lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test
Clinical narrative: Itchy red rash all over chest and left side of neck and left ear.; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN6200, Pfizer NTEC), via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:15 as, 2nd dose, single for covid-19 immunisation. Medical history included eczema, asthma (Patient stated It was Hereditary she was not on medication), penicillin allergy, ongoing blood cholesterol increased (Other Conditions: Yes). The patient previously took 1st dose of bnt162b2 (Lot: EL9264) on 06FEB2021 at 11:00 AM in the Left arm for COVID-19 immunisation and experienced rash near the injection site, amoxicillin and experienced allergic. Concomitant medications included salbutamol (ALBUTEROL), Ethinylestradiol, Norgestimate (TRI-PREVIFEM), Hydroxozine (strength 25 mg), and bupropion (strength 200 mg) taken for an unspecified indication, start and stop date were not reported. The patient experienced itchy red rash all over chest and left side of neck and left ear on 05Mar2021. The events assessed as serious (Medically significant). Treatment was received for the events, patient had allergy medicines, lotions but nothing is really helping and she had been taking BENADRYL, non Pfizer product (Lot Number: 032D9B, Expiry date: Nov 2021) but that hadn't been doing anything and then she was about to take Zyrtec. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 29Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Patient stated she hasn't if it really required me to went to the emergency room because she hasn't knew what they would tell me. I felt liked they'll have been liked took the lotion. No product complaint to be reported and medical information was requested. The outcome of the event was reported as not recovered on unknown date.  Follow-up attempts are needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: just had fever for about 3 times; Covid symptoms are very mild; This is a spontaneous report from a contactable consumer (reporting for herself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated with 1st shot of the Pfizer Covid Vaccine last 24Feb2021 and thinks that he was already infected with Covid even before getting his 1st shot. He said that this is because on 04Mar2021 he started experiencing some symptoms of Covid. He went to the hospital and had a Vamlanidimab infusion today and was advised not to have the vaccine within 90 days. Wants to know if it's safe for him to get the vaccine because he was already scheduled for his 2nd dose. Mentioned that he still has 4 days of required isolation left and his Covid symptoms are very mild and just had fever for about 3 times. 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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report from a contactable consumer. This Consumer reported similar events for 2 patients. This is 2nd of 2 reports. This Consumer reported for a (Age: 21; Unit: Unknown) female patient. A female patient of an unspecified age (age: 21, unit: unknown), received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 10Mar2021 19:31:34 UTC as UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. The reporter on behalf of two college students, who wish to remain anonymous stated the patient has covid (covid positive), however it was not clear whether she received the 1st or 2nd dose of the Pfizer covid vaccine from callers report:  It was reported that 2 college students are in this situation. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021263662 similar report from same reporter
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Scalp begin to itch; Raised hives on my scalp which spread to my face and upper back; This is a spontaneous report from a contactable other HCP. A 45-years-old female patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: EN6205; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 09Mar2021 at 16:00 (at the age of 45-year-old) at a single dose (1ST DOSE,SINGLE) for COVID -19 immunization. The patient medical history and concomitant medications were not reported. No allergies were reported. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No other medications in two weeks.The patient's scalp begin to itch and raised hives on my scalp which spread to her face and upper back within 20 minutes on 09Mar2021 at 19:30. She took a Benadryl and did not get any relief. She said that 30 min later she took another Benadryl and got relief in about 10 minutes. No COVID prior vaccination. No treatment was received. No COVID tested, post vaccination. The outcome of the events was recovered on an unspecified date.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Asthenia, COVID-19, Cough, Fatigue, Nausea
Clinical narrative: On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19; On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19; nausea; weakness; extreme fatigue; she had a sore throat and cough but she mentions that this is related to an allergy; she had a sore throat and cough but she mentions that this is related to an allergy; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of unspecified age (age 67,but units were not mentioned) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She was asked on Thursday if in the last 14 days she was exposed to Covid-19, her granddaughter had Covid-19 and she was in contact with her on Saturday, so she answered yes. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 04Mar2021, the next 3 days (until Sunday), experienced nausea, weakness and extreme fatigue, she had no fever or cold, she had a sore throat and cough but she mentions that this was related to an allergy. On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19. She like to know if she could go near her granddaughter and her family who's isolated for care giving reasons or if she has to wait until she receives the second dose of the vaccine (immunity after the first dose). she states she had never had a cold or flu, the CDC call her for blood samples because her AB are so strong and her protection last 6 months, she does not receive any medication. She would also like to know if after the first dose of the vaccine you need to quarantine as much as possible. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Oropharyngeal pain
Clinical narrative: On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19; On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19; nausea; weakness; extreme fatigue; she had a sore throat and cough but she mentions that this is related to an allergy; she had a sore throat and cough but she mentions that this is related to an allergy; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of unspecified age (age 67,but units were not mentioned) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She was asked on Thursday if in the last 14 days she was exposed to Covid-19, her granddaughter had Covid-19 and she was in contact with her on Saturday, so she answered yes. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 04Mar2021, the next 3 days (until Sunday), experienced nausea, weakness and extreme fatigue, she had no fever or cold, she had a sore throat and cough but she mentions that this was related to an allergy. On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19. She like to know if she could go near her granddaughter and her family who's isolated for care giving reasons or if she has to wait until she receives the second dose of the vaccine (immunity after the first dose). she states she had never had a cold or flu, the CDC call her for blood samples because her AB are so strong and her protection last 6 months, she does not receive any medication. She would also like to know if after the first dose of the vaccine you need to quarantine as much as possible. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Feeling abnormal
Clinical narrative: On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19; On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19; nausea; weakness; extreme fatigue; she had a sore throat and cough but she mentions that this is related to an allergy; she had a sore throat and cough but she mentions that this is related to an allergy; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of unspecified age (age 67,but units were not mentioned) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She was asked on Thursday if in the last 14 days she was exposed to Covid-19, her granddaughter had Covid-19 and she was in contact with her on Saturday, so she answered yes. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 04Mar2021, the next 3 days (until Sunday), experienced nausea, weakness and extreme fatigue, she had no fever or cold, she had a sore throat and cough but she mentions that this was related to an allergy. On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19. She like to know if she could go near her granddaughter and her family who's isolated for care giving reasons or if she has to wait until she receives the second dose of the vaccine (immunity after the first dose). she states she had never had a cold or flu, the CDC call her for blood samples because her AB are so strong and her protection last 6 months, she does not receive any medication. She would also like to know if after the first dose of the vaccine you need to quarantine as much as possible. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: I catched the virus (she contracted COVID-19); I catched the virus (she contracted COVID-19); This is a spontaneous report from a contactable consumer or other non-HCP (Patient) via medical information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration on 27Feb2021 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 COVID-19. Reportedly, patient catched the virus, she contracted covid-19. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: catched the virus, she contracted covid-19. Reportedly, the second dose was on 20Mar2021, but patient catched the virus (she contracted COVID-19). she asked should she get the vaccine on 20Mar2021. No PQC was present. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 04Mar2021 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was asking can I received my second vaccine dose if I tested positive for COVID after my first. Patient reported that he received his first vaccine dose last week on 04Mar2021 and since then he had developed COVID, was tested 2 days ago and tested positive. He reported he think he was getting better but asked should I continue on in 2 weeks if he was feeling better to get his second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity, Vaccination site bruising, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 52-years-old female Non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: EL3247) dose1, via an unspecified route of administration in Arm Right on 27Jan2021 11:00 as 1ST DOSE, SINGLE for covid-19 immunization. No prior vaccination and did not tested after post vaccination. Medical history included drug hypersensitivity, known allergies penicillin. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced continue chronic pain in right upper arm where 1st dose vaccine was administered, limited range of motion a large bruise at injection site, a large bruise at injection site, Upon follow-up on 18Mar2021, it was reported that arm pain, lack of mobility occurred about 6 hours after the vaccine was administered on 27Jan2021. Therapeutic measures were taken as a result of continue chronic pain in right upper arm where 1st dose vaccine was administered, limited range of motion, a large bruise at injection site. The clinical outcome of the events were not recovered and arm pain, lack of mobility of the outcome was unknown. Follow-up (18Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Additional events were updated (arm pain, lack of mobility) and updated event onset date. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash macular, Swelling face
Clinical narrative: Face got very red; Face got very red, hot; Face got slightly swollen; Face got very red, hot and splotchy; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 05Mar2021 at 09:30 (at the age of 49-years-old), as a first single dose for COVID-19 immunisation. The patient's medical history included asthma. The patient had previously experienced allergy when receiving Zithromax (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Mar2021 at 09:45, the patient's face got very red, hot and splotchy and was slightly swollen. The patient did not receive any treatment for the adverse events. The clinical outcome of face got very red, hot and splotchy and slightly swollen was recovered. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: the COVID test was before getting the vaccine/The caller found out today 10Mar2021 that she was positive for Covid. However, she has not been sick; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 09Mar2021 at 13:45 as single dose for COVID-19 immunization. Patient's medical history and concomitant medication was not reported. The caller had her first shot at 1:45 in the afternoon yesterday 09Mar2021. The caller also had a Covid test on 09Mar2021 at 7:30 in the morning . The caller found out today 10Mar2021 that she was positive for Covid. However, she had not been sick. The caller was scheduled for her second dose of the vaccine on 31Mar2021, and enquiring about should she continue with the second dose. The patient tested positive for SARS-CoV-2 test on 10Mar2021. The outcome of event was unknown.   Investigations: The Covid swab was taken before receiving the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive after the first dose; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer reported for a female patient (Mom). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection),via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient tested positive after the first dose. The reporter mentioned that her mom was due to get her second dose today, but she wants to know if she can reschedule it. The reporter has already spoken with doctor and doctor told her mother that she will be tested for Covid-19 and that if the test is negative, she should wait another week to receive the second dose of the vaccine, also this week she completes her 14-day quarantine. The outcome of events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches in frontal part of head; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), 1st dose on 01Mar2021 at 11:45 am, solution for injection via an unspecified route of administration in the left arm for Covid 19 immunisation (at the age of 38 years). Medical history included daily headaches and neck pain for unknown reasons. The patient also gets Botox for daily headaches every 3 months. The patient had allergies to Topamax (MANUFACTURER UNKNOWN) and Pictocin (MANUFACTURER UNKNOWN). Concomitant medications included T3 (MANUFACTURER UNKNOWN), Skelaxin (MANUFACTURER UNKNOWN), amitriptylin (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN) and prega (MANUFACTURER UNKNOWN for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 02Mar2021 at 09:00 am, the patient experienced continuing headaches in frontal part of head in high forehead and left eye daily headaches. The ache was not debilitating, but nagging. That was new from the daily headaches which tend to occur in occipital area and temporal area. The patient has not recovered from the event of headaches in frontal part of head at the time of reporting. Information about lot number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Extreme tiredness; Headaches; Dizziness; This is a spontaneous report from a contactable patient. A 67-year-old non-pregnant female patient received the 2nd Dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/Batch no: EN6208) solution for injection on her left arm via an unspecified route of administration for Covid 19 immunisation on 12Mar2021 at 12:30 PM. The patient had a medical history of heart issue (past heart attack on an unknown date in 2017 and was on medication) and Colitis. On 19Feb2021 at 10.30 am the patient received her first dose of BNT162B2(BNT162B2) (lot/Batch no: EN6203) solution for injection on her left arm via an unspecified route of administration for Covid-19 immunisation. The patient has not had symptoms associated with COVID-19 and was not tested for covid-19 prior and post vaccination. On 12Mar2021 at 18:30, the patient had experienced extreme tiredness, headaches and dizziness. No therapeutic measures were taken for the reported events. The patient had not recovered from these events at the time of this report. No follow up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Skin hives in my body; This is a spontaneous report from a non-contactable patient. A 70-Year-old non-pregnant female patient received BNT162B2[PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201] 1st dose on 16Feb2021 at 07.00 pm, and BNT162B2[PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208] 2nd dose on 12Mar2021 at 02.00 pm, solution for injection via Right arm and an unspecified route of administration for Covid 19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported as no known allergies. The Concomitant medications included Zolpidem 10mg (Manufacturer unknown), and Escitalopram 10 mg (Manufacturer unknown) for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced skin hives on her body on 16Feb2021 at 10.00 am. Therapeutic measures were taken as a result of Hives and included treatment with Cetirizine Hydrochloride from an unknown date. The patient has recovering from the event of skin hives on her body at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: pain at injection site; Fever; Fatigue; Dizziness/lightheadedness; Difficulty reading; Chills; I experienced side effects of headache, fatigue, fever, chills, difficulty reading/slow to comprehend, dizziness/lightheadedness, pain at injection site, loss of appetite, and swollen lymph nodes in n; Swollen lymph nodes in neck; Loss in appetite; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), dose number 2, via an unspecified route of administration in the left arm on 14Mar2021 at 09:45 (at the age of 34-year-old at vaccination) as a single dose for COVID-19 vaccination. Medical history and concomitant medications of the patient were not reported. The patient did not have allergy to medications, food or other products. Past drug history of the patient included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose number 1, via an unspecified route of administration in the left arm on 20Feb2021 (at the age of 34-year-old at vaccination) as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 14Mar2021 at 18:00, the patient experienced side effects of headache, fatigue, fever, chills, difficulty reading/slow to comprehend, dizziness/lightheadedness, pain at injection site, loss of appetite and swollen lymph nodes in neck. The patient recovered from headache, fever/chills, swollen nodes, site pain and body aches within 48 hours but the difficulty reading and comprehending and dizziness/ lightheadedness remained. Dehydration was not an issue as the patient drank bottle of water every 2 hours. The patient found herself needing to hold a railing when on stairs and move slowly when getting up and walking. No therapeutic measures were taken for the event. The outcome of the events were recovered with sequel at an unknown date and the events difficulty reading and dizziness was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Pyrexia, Reading disorder
Clinical narrative: pain at injection site; Fever; Fatigue; Dizziness/lightheadedness; Difficulty reading; Chills; I experienced side effects of headache, fatigue, fever, chills, difficulty reading/slow to comprehend, dizziness/lightheadedness, pain at injection site, loss of appetite, and swollen lymph nodes in n; Swollen lymph nodes in neck; Loss in appetite; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), dose number 2, via an unspecified route of administration in the left arm on 14Mar2021 at 09:45 (at the age of 34-year-old at vaccination) as a single dose for COVID-19 vaccination. Medical history and concomitant medications of the patient were not reported. The patient did not have allergy to medications, food or other products. Past drug history of the patient included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose number 1, via an unspecified route of administration in the left arm on 20Feb2021 (at the age of 34-year-old at vaccination) as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 14Mar2021 at 18:00, the patient experienced side effects of headache, fatigue, fever, chills, difficulty reading/slow to comprehend, dizziness/lightheadedness, pain at injection site, loss of appetite and swollen lymph nodes in neck. The patient recovered from headache, fever/chills, swollen nodes, site pain and body aches within 48 hours but the difficulty reading and comprehending and dizziness/ lightheadedness remained. Dehydration was not an issue as the patient drank bottle of water every 2 hours. The patient found herself needing to hold a railing when on stairs and move slowly when getting up and walking. No therapeutic measures were taken for the event. The outcome of the events were recovered with sequel at an unknown date and the events difficulty reading and dizziness was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: mild nausea; dizziness; sweating; Little appetite or desire for food; Head feels "off" or slightly foggy; chills; This is a spontaneous report received from a contactable consumer, the patient.  A 73-years-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch/lot number: EN 6201) via an unknown route in left arm on 04Mar2021 at 12:15 PM for COVID-19 immunization (at the age of 73-years). The patient did not have any medical history and the patient was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient was not tested for COVID-19 since the vaccination. Concomitant medication included Naproxin (MANUFACTURER UNKNOWN) for an unknown indication. The patient received this medication within 2 weeks of vaccination and the exact therapy dates were not provided. The patient woke up at morning on 16Mar2021 (12 days after 1st dose) at 08:30 AM with dizziness, sweating and mild nausea. The patient's temperature was normal. The patient felt fine the night before and slept well. The nausea continued for 3 hours. The patient developed chills after sweating subsided and the chills have continued for the past six hours. The patient was having little appetite or desire for food. The patient's head did not hurt but felt "off" or slightly foggy. No therapeutic measures were taken as a result of these events. On 16Mar2021, the events dizziness and sweating resolved within 30 minutes of waking. The patient was recovering from the events mild nausea, chills, little appetite or desire for food and head did not hurt but felt "off" or slightly foggy. No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: mild nausea; dizziness; sweating; Little appetite or desire for food; Head feels "off" or slightly foggy; chills; This is a spontaneous report received from a contactable consumer, the patient.  A 73-years-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch/lot number: EN 6201) via an unknown route in left arm on 04Mar2021 at 12:15 PM for COVID-19 immunization (at the age of 73-years). The patient did not have any medical history and the patient was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient was not tested for COVID-19 since the vaccination. Concomitant medication included Naproxin (MANUFACTURER UNKNOWN) for an unknown indication. The patient received this medication within 2 weeks of vaccination and the exact therapy dates were not provided. The patient woke up at morning on 16Mar2021 (12 days after 1st dose) at 08:30 AM with dizziness, sweating and mild nausea. The patient's temperature was normal. The patient felt fine the night before and slept well. The nausea continued for 3 hours. The patient developed chills after sweating subsided and the chills have continued for the past six hours. The patient was having little appetite or desire for food. The patient's head did not hurt but felt "off" or slightly foggy. No therapeutic measures were taken as a result of these events. On 16Mar2021, the events dizziness and sweating resolved within 30 minutes of waking. The patient was recovering from the events mild nausea, chills, little appetite or desire for food and head did not hurt but felt "off" or slightly foggy. No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Herpes zoster, Pain in extremity, Rash
Clinical narrative: rash; Chills; Fatigue; Sharp pains in back of legs/shooting pain on the legs; Shingles; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID- 19 VACCINE), via an unspecified route of administration, administered in left arm on 05Feb2021 14:00 (Batch/Lot Number: EL3249) at the age of 74 years old as 1st dose, single for COVID-19 immunization. Medical history included ulcerative colitis (autoimmune disease) and high blood pressure. The patient was not pregnant at the time 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. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included sulfasalazine (AZULFIDINE), hydrochlorothiazide and nadolol, all taken for unspecified indications, start and stop dates were not reported. The patient previously took cipro and sulfa antibiotics and had known allergies. The patient got her first dose on 05Feb2021. She stated that she had side effects the next day (on 06Feb2021) including chills, fatigue, and sharp pains down her legs, shooting pain on the legs after a few hours (as reported). She stated that 4-5 days later (on Feb2021), she had a pretty severe case of shingles. The patient would like to know if the shingles could have been a possible side effect or a coincidence since her doctor couldn't answer that. Her real question was if she should get the second dose while she has shingles as she already missed her second dose appointment because she was still recovering, and she still has a rash (unknown date), but she was past due for her second shot. Patient was advised not to get the 2nd dose of the PFIZER-BIONTECH COVID- 19 VACCINE until she recovered from shingles. Events resulted in Emergency room/department or urgent care and therapeutic measures were taken. Outcome of events were recovering. The case was assessed by the reporter as not serious.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain
Clinical narrative: Severe muscle aches beginning in left arm and spreading both down to wrist/hand, and up into shoulder, neck and down back. Dull throbbing ache that is much more painful when moving. Headache. Chills.; Dull throbbing ache; Headache; Chills; This is a spontaneous report from a contactable Non health care professional, the patient. A 31-year-old non pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot/Batch no: Not available, Dose number:1) solution for injection via unspecified route of administration in the left arm on 16Mar2021 at 15 hrs 45 min for Covid-19 immunization. Medical history included Lupus, post-traumatic stress disorder  and allergy to Sulfa. Concomitant medication(s) were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19 prior to vaccination and was neither tested positive since the vaccination. The patient experienced chills, headache, throbbing pain and muscle ache beginning in left arm and spreading both down to wrist/hand, and up into shoulder, neck and down back on 16Mar2021 at 16 00hrs. Therapeutic measures were not taken The patient was not recovered from the events chills, headache, throbbing pain and muscle ache. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Costochondritis, Headache, Nausea, Vomiting
Clinical narrative: headache; Burning in rib cartilage swellings (fromTietze Syndrome); nauseas; vomiting; Low back pain; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old non-pregnant female patient received a single dose of BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine; Lot/batch no: EN6208) via an unspecified route of administration on 15Mar2021, at 14:30 (at the age of 43-year-old) for COVID-19 immunisation. Medical history of the patient included hemochromatosis, CPPD (Calcium pyrophosphate dihydrate crystal deposition disease), Tietze Syndrome, Reynaud's syndrome and autoimmune disorder. The patient was not pregnant at the time of vaccination. The patient was allergic to medications, food or other products. Concomitant medications included magnesium, lysine and multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, at 15:00, the patient experienced burning in rib cartilage swellings (from Tietze Syndrome). She also had low back pain, nauseas, headache and vomiting. No therapeutic measures were taken as a result of those events. The clinical outcome of the events burning in rib cartilage swellings (from Tietze Syndrome), low back pain, nauseas, headache and vomiting was not recovered.