chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had the delta-variant; Had the delta-variant; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports. A 69-year-old female patient (reporter's sister) received the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at left arm on 26Feb2021 (Lot Number: EL9266) at the age of 68 years as single dose and dose 1 via an unspecified route of administration at left arm on 05Feb2021 (Lot Number: EL9269) at the age of 68 years as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer explained her sister (patient) who also got the Covid-19 vaccine the same days she did have the same symptoms she did. Her sister (patient) had the delta-variant from Sep2021. Consumer started to have covid symptoms on 08Sep2021 she had a stuffy nose, stuffy ears, slight fever, drainage, and sore throat. At first she thought it was just sinus issues, but the covid test had come back positive. She had tiredness, loose stools, headache, stuffiness, stuffiness in nose and ears really bad. Her twin sister (patient) had all these covid symptoms along with a lost of taste. Outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101294617 same reporter/drug/AE, different patient.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: This is a spontaneous report from a contactable consumer. A 66-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (vaccinated at 66-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included cataracts. Patient received first dose on an unspecified date. The patient's concomitant medications were not reported. The patient experienced cataracts got worse after second dose. Unknown if treatment received. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This consumer reported for two patients. This is the first of two reports. A 55-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0170), at the age of 55, via an unspecified route of administration, in right arm, on Apr 23, 2021, at 15:45, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine , solution for injection, batch/lot# EW8377), at the age of 55, in right arm, on Apr 2, 2021, 16:00, single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had erectile dysfunction on Apr 26, 2021, at 08:00, with outcome of not recovered. Patient never had an issue like this ever in his life. Patient was physically fit, in great health, and do not smoke or drink. This also happened to his son 2-3 days after receiving his second Pfizer shot. This was not a mental issue or coincidence. It was a physical issue, and would be nice if someone in would start investigating what the vaccine did. This was causing extreme mental distress for his family. It has been 4 months and it is not resolved. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event: not recovered. No treatment used for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts needed. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-202101300543 same reporter/drug/event, different patient.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Depression, Erectile dysfunction, Loss of libido
Clinical narrative: Erectile dysfunction and very low libido.  My father is experiencing the exact same problem after his 2nd Pfizer shot.  I am 19, in great physical shape, work out every day, in perfect health.  This i; extreme depression.; very low libido.; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 01Jun2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no previous COVID-19 prior to vaccination and not COVID-19 tested post vaccination. The patient received the first dose of bnt162b2 on 11May2021 16:00 in the right arm for COVID-19 immunization. The patient reported of Erectile dysfunction and very low libido on 03Jun2021, 08:00 AM. The patient added that: "My father is experiencing the exact same problem after his 2nd Pfizer shot.  I am 19, in great physical shape, work out every day, in perfect health.  This issue has been ongoing for 4 months now and is causing extreme depression (as reported).  Please start investigating what the vaccine is doing to cause this.  I keep hearing that the vaccine doesn't cause ED, but it did for both me and my father.  This is not being caused by any mental duress.  It is a physical problem. " Treatment includes Viagra, Cialis (both did not work). The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile dysfunction and very low libido.  My father is experiencing the exact same problem after his 2nd Pfizer shot.  I am 19, in great physical shape, work out every day, in perfect health.  This i; extreme depression.; very low libido.; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 01Jun2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no previous COVID-19 prior to vaccination and not COVID-19 tested post vaccination. The patient received the first dose of bnt162b2 on 11May2021 16:00 in the right arm for COVID-19 immunization. The patient reported of Erectile dysfunction and very low libido on 03Jun2021, 08:00 AM. The patient added that: "My father is experiencing the exact same problem after his 2nd Pfizer shot.  I am 19, in great physical shape, work out every day, in perfect health.  This issue has been ongoing for 4 months now and is causing extreme depression (as reported).  Please start investigating what the vaccine is doing to cause this.  I keep hearing that the vaccine doesn't cause ED, but it did for both me and my father.  This is not being caused by any mental duress.  It is a physical problem. " Treatment includes Viagra, Cialis (both did not work). The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Depression, Erectile dysfunction, Loss of libido
Clinical narrative: Erectile dysfunction; This is a spontaneous report from a contactable consumer (parent). This consumer reported for two patients. This is the second of the two reports.   A 19-year-old male patient received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced erectile dysfunction on 26Apr2021 08:00 (2-3 days after receiving his second Pfizer shot). This caused extreme mental distress for his family and it has been 4 months and it was not resolved. Had a doctor or other healthcare professional office/clinic visit and no treatment for event.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101299769 Same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile dysfunction; This is a spontaneous report from a contactable consumer (parent). This consumer reported for two patients. This is the second of the two reports.   A 19-year-old male patient received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced erectile dysfunction on 26Apr2021 08:00 (2-3 days after receiving his second Pfizer shot). This caused extreme mental distress for his family and it has been 4 months and it was not resolved. Had a doctor or other healthcare professional office/clinic visit and no treatment for event.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101299769 Same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Allergy test, Anaphylactic reaction
Clinical narrative: symptoms consistent with anaphylaxis; This is a literature report. A health-care system experience. The full publication has been requested. This author reported different events for five patients. This is the first of five reports.  A subject of unspecified age and gender received bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. The subject experienced symptoms consistent with anaphylaxis on an unspecified date with outcome of unknown. The subject underwent lab tests and procedures which included allergy test with unknown results.  Background: Adverse reactions, including anaphylaxis, to messenger RNA coronavirus disease 2019 (COVID-19) vaccines rarely occur. Because of the need to administer a timely second dose in subjects who reported a reaction to their first dose, a panel of health-care professionals developed a safe triage of the employees and health care providers (EHCP) at a large health-care system to consider administration of future dosing. Methods: There were 28,544 EHCPs who received their first dose of COVID-19 vaccines between December 15, 2020, and March 8, 2021. The HCPs self-reported adverse reactions to a regulatory authority. A regulatory authority screened and collected information on the quality of reaction, symptoms, and timing of the onset of the reaction. Results: Of 1253 calls to a regulatory authority, 113 were identified as requiring consideration by a panel of three-certified allergists for future dosing or formal in-person assessment. Of the 113 EHCPs, 94 (83.2%) were recommended to get their second dose. Eighty of 94 received their second planned dose without a severe or immediate reaction. Of the 14 of 113 identified as needing further evaluation, 6 were evaluated by a physician and subsequently received their second dose without a serious adverse reaction. Eight of 14 did not receive their second dose. Only 5 of the 113 HCPs reported reactions (4.4%) were recommended to not take the second dose: 3 (2.6%) because of symptoms consistent with anaphylaxis, and 2 because of neurologic complications (seizure, stroke). Conclusion: The panel demonstrated that, by consideration of reaction history alone, the HCPs could be appropriately triaged to receive scheduled second dosing of COVID-19 vaccines without delays for in-person evaluation and allergy testing.; Sender's Comments: A contributory role of BNT162B2 in triggering the onset of Anaphylaxis cannot be fully excluded, considering the temporal relationship and known adverse event profile of the suspect vaccine,Linked Report(s) : US-PFIZER INC-202101300161 Same article/drug; Different patient/event;US-PFIZER INC-202101300162 Same article/drug; Different patient/event;US-PFIZER INC-202101301646 Same article/drug/event; Different patient;US-PFIZER INC-202101301645 Same article/drug/event; Different patient
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia oral, Insomnia, Joint stiffness, Lymphadenopathy
Clinical narrative: She was like having mini stroke; her left jaw was tighten up where could not sleep; her left jaw was tighten up where could not sleep; left lymph node was swollen; the left side of my tongue was numb; had  burning feeling in back of head; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received bnt162b2 (BNT162B2), vaccinated at the same age, via an unspecified route of administration, administered in left arm on 17Sep2021 (Batch/Lot Number: 301130BA) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Relevant medical history included lymphedema, vitamin b1 deficiency (take Vitamin B for low deficiency). Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for lymphoedema; vitamin b [vitamin b nos] (VITAMIN B [VITAMIN B NOS]) taken for low deficiency; anastrozole (ANASTROL). On an unspecified date, patient got the shot on the left side, her left jaw was tighten up where could not sleep, her left lymph node was swollen, the left side of tongue was numb. She was like having mini stroke and then had burning feeling in back of head like its burning in the middle of head. Patient received lab test at the hospital since Monday (unspecified date) due to neurological issues with unknown results (Further not clarified). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, Transient ischaemic attack
Clinical narrative: She was like having mini stroke; her left jaw was tighten up where could not sleep; her left jaw was tighten up where could not sleep; left lymph node was swollen; the left side of my tongue was numb; had  burning feeling in back of head; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received bnt162b2 (BNT162B2), vaccinated at the same age, via an unspecified route of administration, administered in left arm on 17Sep2021 (Batch/Lot Number: 301130BA) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Relevant medical history included lymphedema, vitamin b1 deficiency (take Vitamin B for low deficiency). Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for lymphoedema; vitamin b [vitamin b nos] (VITAMIN B [VITAMIN B NOS]) taken for low deficiency; anastrozole (ANASTROL). On an unspecified date, patient got the shot on the left side, her left jaw was tighten up where could not sleep, her left lymph node was swollen, the left side of tongue was numb. She was like having mini stroke and then had burning feeling in back of head like its burning in the middle of head. Patient received lab test at the hospital since Monday (unspecified date) due to neurological issues with unknown results (Further not clarified). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Vaccination site reaction
Clinical narrative: Moderna shot on February 5th. Because we had 4 weeks of travel planned we got a Pfizer shot on September 1st; Moderna shot on February 5th. Because we had 4 weeks of travel planned we got a Pfizer shot on September 1st; Small reaction; This is a spontaneous report from a contactable consumer. A contactable male consumer (patient) reported for himself that who received bnt162b2 (BNT162B2) formulation solution for injection, dose 3 (Lot number and expiry date was not reported) via an unspecified route of administration on 01Sep2021 as dose 3 booster single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine dose 1 Moderna formulation solution for injection, (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as first dose single for COVID-19 immunisation, historical Vaccine dose 2 formulation solution for injection, (Lot number and expiry date was not reported) via an unspecified route of administration on 05Feb2021 as second dose single dose for COVID-19 immunisation. His wife and he received our 2nd Moderna shot on 05Feb. Because they had 4 weeks of travel planned, we got a Pfizer shot on 01Sep. They had very small reaction. He feels that the mixture may give more immunity, (Interchange of vaccine products, Off label use). Outcome of the events was unknown.    The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101300168 Different patient, same drug and event
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Interchange of vaccine products, Off label use
Clinical narrative: we got a Pfizer shot on 01Sep. We had very small reaction; received our 2nd Moderna shot on 05Feb. Because we had 4 weeks of travel planned we got a Pfizer shot on 01Sep; received our 2nd Moderna shot on 05Feb. Because we had 4 weeks of travel planned we got a Pfizer shot on 01Sep; This is a spontaneous report from a contactable consumer reporter for wife via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), third dose via an unspecified route of administration on 01Sep2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient previously was MODERNA (MODERNA COVID-19 VACCINE Batch/Lot number was not reported), second dose via an unspecified route of administration on 05Feb2021 as dose 2, single for COVID-19 immunization; MODERNA (MODERNA COVID-19 VACCINE Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that patient's wife and patient received their 2nd Moderna shot on 05Feb2021. Because they had 4 weeks of travel planned, they got a Pfizer shot on 01Sep2021. They had very small reaction. The patient feels that the mixture may give more immunity. The outcome of adverse event NOS was reported as unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101300166 Different patient, same drug and event
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Libido decreased
Clinical narrative: Erectile dysfunction; very low libido; This is a spontaneous report from a contactable consumer (patient's son). The consumer reported similar events for two patients. This is the second of two reports. A male patient of unspecified age received second dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced erectile dysfunction and very low libido on an unspecified date. He was experiencing the exact same problem after his 2nd Pfizer shot. The outcome of the events was unknown.  Information about the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101299845 Same reporter/vaccine, similar events, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had the 2 doses of the vaccine/tested positive; had the 2 doses of the vaccine/tested positive; This is a spontaneous report from a Program from a Non-contactable Female consumer (patient).  A female patient of unspecified age received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via Unspecified route of administration, on unspecified date (Batch/Lot Number: Not provided) as dose 2, Single and first dose of (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via Unspecified route of administration, on unspecified date (Batch/Lot Number: Not provided) as dose 1, Single for COVID-19 immunization. Reporter, had the 2 doses of the vaccine, she is wondering about the booster shot. Her friend also had the 1st 2 doses and was tested positive, also tested positive. Would like to ask if she got the booster shot, would it be different from the 1st doses, and how soon can she get it. She asked if the booster is the same medication as the first 2 doses.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Her friend also had the 1st 2 doses and was tested positive; Her friend also had the 1st 2 doses and was tested positive; This is a spontaneous report from a non-contactable consumer or other non hcp via a program. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single and second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date a consumer friend experienced that friend also had the 1st 2 doses and was tested positive. She wanted to know ask if she got the booster shot, would it be different from the 1st doses, and how soon can she get it. Consumer asked In the original statement the protection of the vaccine was for at least 6 months, asked if it was true, and asked if the booster was the same medication as the first 2 doses. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. The outcome of events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a Program from a non-contactable consumer, reported similar events for two patients. This is the first of two reports. A patient (consumer) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's friend was tested positive even after having the 2 doses of the vaccine. Patient was just calling to ask about the booster shot if it was the same as the 1st 2 doses as patient was also tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test positive on unspecified date. Outcome of events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-202101300598 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had mentioned that her friend was tested positive even after having the 2 doses of the vaccine.; had mentioned that her friend was tested positive even after having the 2 doses of the vaccine.; This is a spontaneous report from a Program. A non-contactable consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer had mentioned that her friend (patient) was tested positive even after having the 2 doses of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive on unspecified date. Outcome of events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-202101300582 same reporter/drug/event, different patient.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Illness, Nausea, Panic attack
Clinical narrative: I did have reaction that wasn''t so pleasant; make me little concern; It was more extreme than panic attack; I couldn''t for a second bare what I looked out; when I looked basically all I thought was white.; I felt sick; where I was gonna throw up twice; and then I thought I was  gonna passed out and faint.; This is a spontaneous report from a contactable consumer (patient) reported for herself that.   A 31-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: 30155BA; Expiration Date: 31Dec2021), via an unspecified route of administration, administered in right deltoid on an unspecified date (at the age of 31-years) as dose 1, single for covid-19 immunization. The patient medical history included Psoriatic arthritis. The patient's concomitant medications were not reported. On an unspecified date after vaccination, the patient stated that she had a reaction that was not so pleasant and did make her little concerned. The patient also stated that was more extreme than panic attack and she could not for a second bare what she looked out and when she looked basically all she thought was white. The patient also felt sick, was going to throw up twice and also was then going to pass out and faint. The patient queried if that happened to anyone else and why was that happening to her. Also stated that seeing white for a good two minutes had cured and was enquiring whether she had to visit emergency room as she was feeling fine that time. The patient had not received any treatment for the events. The outcome of the events was recovered on an unspecified date at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: I did have reaction that wasn''t so pleasant; make me little concern; It was more extreme than panic attack; I couldn''t for a second bare what I looked out; when I looked basically all I thought was white.; I felt sick; where I was gonna throw up twice; and then I thought I was  gonna passed out and faint.; This is a spontaneous report from a contactable consumer (patient) reported for herself that.   A 31-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: 30155BA; Expiration Date: 31Dec2021), via an unspecified route of administration, administered in right deltoid on an unspecified date (at the age of 31-years) as dose 1, single for covid-19 immunization. The patient medical history included Psoriatic arthritis. The patient's concomitant medications were not reported. On an unspecified date after vaccination, the patient stated that she had a reaction that was not so pleasant and did make her little concerned. The patient also stated that was more extreme than panic attack and she could not for a second bare what she looked out and when she looked basically all she thought was white. The patient also felt sick, was going to throw up twice and also was then going to pass out and faint. The patient queried if that happened to anyone else and why was that happening to her. Also stated that seeing white for a good two minutes had cured and was enquiring whether she had to visit emergency room as she was feeling fine that time. The patient had not received any treatment for the events. The outcome of the events was recovered on an unspecified date at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: one month and 4 weeks after the second shot i contracted covid and pneumonia; pneumonia; one month and 4 weeks after the second shot i contracted covid and pneumonia; This is a spontaneous report from a contactable consumer (patient) from epsilon escalation team. A patient of unspecified age and gender received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on Mar2021 ad dose 1 single and second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. On Aug2021 (one month and 4 weeks after the second shot), patient contracted covid and pneumonia and patient wondering how it is that this happened in such a short time after the vaccinations. Patient still on oxygen. The outcome of the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Limb injury, Off label use
Clinical narrative: received her booster shot of the covid-19 vaccine; received her booster shot of the covid-19 vaccine; injured on her foot; This is a spontaneous report from a contactable consumer (patient) from the Pfizer sponsored program. A female patient of an unknown age received 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 26Sep2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. She received her booster shot of the covid-19 vaccine on 26Sep2021. She got injured on her foot on an unknown date in Sep2021 and her doctor put her on a 6-day regimen for Prednisone. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Epistaxis, Fatigue, Joint swelling, Lethargy
Clinical narrative: Nausea within 48 hours - subsided; Nosebleed x 1 at 48 hours (5 in my lifetime 3 related to injury); Right knee swelling and discomfort at 5 days subsided 3 days; Right knee swelling and discomfort at 5 days subsided 3 days; new symptom Lethargy; exhaustion; muscle weakness; sedation/I felt like I was drugged.; She said I might have had Covid and not known it.; muscle ache; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 17Sep2021 10:00AM (at the age of 58 years old) (Lot Number: FC3183) as dose 1, single for covid-19 immunisation. Medical history included allergies to poppy seeds, mushrooms, sarcoidosis, thyroid nodule (benign), nosebleed at 48 hours. Concomitant medications included VITAMIN C; VITAMIN D3; ZINC; CoQ10; VITAMIN C, VITAMIN D3, VITAMIN B, Zinc, Reservatrol, CoQ10, Hair Skin Nails, all were taken for an unspecified indication, start and stop date were not reported. The patient previously took CODEINE and CIPRO, and experienced allergies. The patient was not pregnant at time of vaccination. The patient experienced nausea within 48 hours - subsided, nosebleed at 48 hours, right knee swelling, and discomfort at 5 days subsided 3 days, new symptom lethargy, exhaustion, muscle weakness, sedation/ felt like she was drugged, she said she might have had covid, and not known it, and muscle ache, all on 18Sep2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported events were nausea within 48 hours - subsided, nosebleed at 48 hours, right knee swelling, and discomfort at 5 days subsided 3 days - new symptom, lethargy, exhaustion, muscle weakness, and sedation started 24 hours after 14 days. Patient felt like she was drugged. She called the pharmacist at RA. She said she might have had Covid and not known it. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient said she received the 1st dose of the Pfizer- BioNTech Covid-19 Vaccine on 17Sep2021. Afterwards, she experienced severe lethargy, exhaustion, muscle ache, and muscle weakness. She said she felt like she was drugged. She said there was a "sedated feeling." She also said she had a nose bleed, right knee pain which lasted for a couple of days, and nausea which has already subsided. HCP said she is more concerned with the lethargy, and wants to know how long it lasts. She also wants to know if the 2nd dose would be worse or better. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Nausea, Sedation, Suspected COVID-19
Clinical narrative: Nausea within 48 hours - subsided; Nosebleed x 1 at 48 hours (5 in my lifetime 3 related to injury); Right knee swelling and discomfort at 5 days subsided 3 days; Right knee swelling and discomfort at 5 days subsided 3 days; new symptom Lethargy; exhaustion; muscle weakness; sedation/I felt like I was drugged.; She said I might have had Covid and not known it.; muscle ache; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 17Sep2021 10:00AM (at the age of 58 years old) (Lot Number: FC3183) as dose 1, single for covid-19 immunisation. Medical history included allergies to poppy seeds, mushrooms, sarcoidosis, thyroid nodule (benign), nosebleed at 48 hours. Concomitant medications included VITAMIN C; VITAMIN D3; ZINC; CoQ10; VITAMIN C, VITAMIN D3, VITAMIN B, Zinc, Reservatrol, CoQ10, Hair Skin Nails, all were taken for an unspecified indication, start and stop date were not reported. The patient previously took CODEINE and CIPRO, and experienced allergies. The patient was not pregnant at time of vaccination. The patient experienced nausea within 48 hours - subsided, nosebleed at 48 hours, right knee swelling, and discomfort at 5 days subsided 3 days, new symptom lethargy, exhaustion, muscle weakness, sedation/ felt like she was drugged, she said she might have had covid, and not known it, and muscle ache, all on 18Sep2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported events were nausea within 48 hours - subsided, nosebleed at 48 hours, right knee swelling, and discomfort at 5 days subsided 3 days - new symptom, lethargy, exhaustion, muscle weakness, and sedation started 24 hours after 14 days. Patient felt like she was drugged. She called the pharmacist at RA. She said she might have had Covid and not known it. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient said she received the 1st dose of the Pfizer- BioNTech Covid-19 Vaccine on 17Sep2021. Afterwards, she experienced severe lethargy, exhaustion, muscle ache, and muscle weakness. She said she felt like she was drugged. She said there was a "sedated feeling." She also said she had a nose bleed, right knee pain which lasted for a couple of days, and nausea which has already subsided. HCP said she is more concerned with the lethargy, and wants to know how long it lasts. She also wants to know if the 2nd dose would be worse or better. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, SARS-CoV-2 test
Clinical narrative: Terrible arthritis flare up in knees and back.; having bad arthritic pain; This is a spontaneous report from a contactable consumer (reported for himself). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on an unspecified date in Mar2021 (seven months prior at the time of report; also reported on "08Feb2021"; pending clarification) (at the age of 71-year-old) (Lot Number: En6201) as dose 2, single for COVID-19 immunization. Medical history included diabetes. No known allergies. The patient's concomitant medications were not reported. The patient previously administered BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 08Feb2021 at 03:30 PM (at the age of 71-year-old) (Lot Number: EI9265) as dose 1, single for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient no COVID prior to vaccination and was tested for COVID post vaccination with molecular nasal swab on 21Sep2021: unknown results. On 15Mar2021 at 12:00 PM, the patient experienced terrible arthritis flare up in knees and back. Still not able to walk or stand more than 5 minutes. Seven months after the second shot (Mar2021) and still having bad arthritic pain. These events resulted in Doctor or other healthcare professional office/clinic visit and disability or permanent damage. Treatment was received with prednisone, gabapentin, and spinal physical therapy. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site movement impairment, Feeling hot, Hypersensitivity, Magnetic resonance imaging, Pruritus
Clinical narrative: had MRI with contrast- had severe allergic reaction; Red huge welt at injection site/Rash and hives developed on torso; Red huge welt at injection site.; Red, hot, swollen, itchy.; Red, hot, swollen, itchy.; Red, hot, swollen, itchy/right upper leg- very itchy; Couldn't move arm; Rash and hives developed on torso; right upper leg- very itchy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-years-old, via an unspecified route of administration, administered in Arm Left on 13Sep2021 12:15 (Batch/Lot Number: FC3183) as dose 1, single for COVID-19 immunization. Medical history included multiple sclerosis. Concomitant medications included levothyroxine sodium (SYNTHROID); estradiol (ESTROGEN); progesterone; vaccinium macrocarpon (ELLURA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Copaxone and clarithromycin (KETEK) and experienced allergies to both. The patient had no other vaccine in four weeks. No COVID prior vaccination and was not tested post vaccination. On 17Sep2021, the patient had a red huge welt at injection site. It was red, hot, swollen, itchy. She could not move an arm, rash and hives developed on torso; right upper leg was very itchy. Days later she had MRI with contrast and had a severe allergic reaction. Never in 20 years she had a reaction to MRI dye before. It was believed that the vaccine caused the allergy. She had a reaction twice, once after first dose and again on 20Sep2021 the day of her MRI. The patient took high dose Benadryl as treatment. The outcome of the events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: had MRI with contrast- had severe allergic reaction; Red huge welt at injection site/Rash and hives developed on torso; Red huge welt at injection site.; Red, hot, swollen, itchy.; Red, hot, swollen, itchy.; Red, hot, swollen, itchy/right upper leg- very itchy; Couldn't move arm; Rash and hives developed on torso; right upper leg- very itchy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-years-old, via an unspecified route of administration, administered in Arm Left on 13Sep2021 12:15 (Batch/Lot Number: FC3183) as dose 1, single for COVID-19 immunization. Medical history included multiple sclerosis. Concomitant medications included levothyroxine sodium (SYNTHROID); estradiol (ESTROGEN); progesterone; vaccinium macrocarpon (ELLURA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Copaxone and clarithromycin (KETEK) and experienced allergies to both. The patient had no other vaccine in four weeks. No COVID prior vaccination and was not tested post vaccination. On 17Sep2021, the patient had a red huge welt at injection site. It was red, hot, swollen, itchy. She could not move an arm, rash and hives developed on torso; right upper leg was very itchy. Days later she had MRI with contrast and had a severe allergic reaction. Never in 20 years she had a reaction to MRI dye before. It was believed that the vaccine caused the allergy. She had a reaction twice, once after first dose and again on 20Sep2021 the day of her MRI. The patient took high dose Benadryl as treatment. The outcome of the events was recovering.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Tenderness
Clinical narrative: significant nodular swelling up to 4-5cm; Axillary pain; tenderness; This is a spontaneous report from a Non-contactable Other HCP (Patient). A 26-years-old non pregnant female patient received bnt162b2 (Solution injection; Batch/Lot Number: Ff8841), via an unspecified route of administration, administered in Arm Left on 30Sep2021 at 08:00 (at the age of 26-years-old) as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Sep2021 at 20:00, patient experienced axillary pain, tenderness, and significant nodular swelling up to 4-5cm. Therapeutic measures were not taken due to the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Scan
Clinical narrative: She developed allergic reactions from taking Butalbital; This is a spontaneous report from a program support. A contactable consumer (patient) reported that a 52-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EN6201) as dose 1, single, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Batch/Lot Number: EN6202) as dose 2, single for covid-19 immunisation. BUTALBITAL SODIUM, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included migraine (has migraine ever since she was a child). On 30Sep2021, she took a dose of Butalbital for the first time since she was administered Pfizer Covid Vaccine and experienced an allergic reaction to the Butalbital because of the Pfizer Covid Vaccine. The patient received Benadryl as treatment. Event was serious, medically significant. The outcome of the events not recovered. The action taken in response to the events for butalbital sodium was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 29Sep2021 14:00 (at the age of 70 years old) (Lot Number: FE3592) as dose 3 (booster), single for covid-19 immunisation. The patient has no medical history. Patient was not pregnant  time of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known allergies.  Concomitant medication included regular low dose hormone replacement. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EL9262) and second dose of BNT162B2 (lot number: EN6205) in left arm for covid-19 immunization on an unknown date in 2021 (also reported as 29Sep2021 for both doses). The patient experienced aches, 100.4 (pyrexia), headache, nausea, extreme tiredness, on 30Sep2021 04:00. Reported Event: 100.4, headache, nausea, extreme tiredness, aches, in bed for 18 hours. The patient underwent lab tests and procedures which included body temperature: 100.4 on 30Sep2021. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.