chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pyrexia
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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: Injection site reaction: hard, painful red lump that showed up overnight; Arm hurts to move/ very painful to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 30Sep2021 07:00 (Batch/Lot Number: ER8733) at the age of 39 years old, as dose number unknown, single for COVID-19 immunization. Medical history included migraine and known allergies included sensitive to some adhesives. Patient was not pregnant. Concomitant medication(s) included topiramate taken for an unspecified indication, start and stop date were not reported; influenza vaccine (FLU) taken for an unspecified indication on 22Sep2021. No COVID prior vaccination and not COVID tested post vaccination. On 01Oct2021 05:30, the patient experienced injection site reaction: hard, painful red lump that showed up overnight and arm hurts to move as expected from any injection, but was very painful to the touch. No treatment provided for events. Outcome of the events were not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Palpitations
Clinical narrative: heart fluttering; dizzy; heart was racing like she was running; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 14Jul2021 19:30 (lot number: 9W0170; as reported; at the age of 64 years old) as dose 1, single and then via an unspecified route of administration, administered in the right arm on 04Aug2021 19:30 (lot number: 9W0170; as reported; at the age of 64 years old) as dose 2, single for COVID-19 immunization. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included duloxetine taken for anxiety from an unspecified start date and ongoing. The patient experienced heart fluttering, dizzy and heart was racing like she was running on an unspecified date in 2021. It was reported that the patient had her first dose and after had heart fluttering, and she read it was more common with the second but had it with the first one as well and continues to have it sporadically. Specifically, the heart fluttering happened after both doses, but the second one wasn't as bad it didn't wake her up in the morning like the first. She got dizzy and laid there like she had been running and running forever heart pounding fast, but that it subsided after a while when she got herself calm. She has not had a lot of side effects. She also added that after the first shot she woke up at about 3 o'clock the next morning and her heart was racing like she was running. The severe racing part lasted about a couple of hours and then eased off. Now it is sporadic. After the second shot it has mainly stayed sporadic heart flutters. There were no prior vaccinations (within 4 weeks). The outcome of all events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fibrin D dimer, Fibrin D dimer increased, SARS-CoV-2 test
Clinical narrative: her brother who got fully vaccinated in May, now has covid; her brother who got fully vaccinated in May, now has covid.; stated that his D-dimer is tripling; This is a spontaneous report from a contactable consumer (patient sister). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), first dose and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got fully vaccinated in May2021, now had covid. The reporter stated that her brother got the Pfizer vaccine at the beginning of May2021 and was currently in ICU with Covid. Stated that his condition was getting worst. His D-dimer was tripling. Stated that he was fully vaccinated in May 2021 and was fully vaccinated in Sep2021(as reported). Stated that this was not an adverse event due to the vaccine because it was almost four months after the vaccine. Stated that she read that that the Pfizer vaccine should be stored in certain storage conditions. Wanted to know how to ensure get to end user in the correct form. Stated that when it is exposed to higher temperatures for a longer time that it effects the efficacy. Stated that she was in the process of getting the vaccine. Stated that she was not sure that the Pfizer Covid vaccine was effective when he got it. She inquired how Pfizer ensure that the vaccine it reaches its end user are under proper storage temperatures and in its correct form. The patient underwent lab tests and procedures which included fibrin d dimer: d-dimer is tripling, Covid-19 test: positive on unknown date. Outcome of event covid was not recovered, D-dimer was tripling was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: ~~~
Sex: U
Vaccine: COVID19
Symptoms: Allergy test, Anaphylactic reaction
Clinical narrative: 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 fourth 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 EHCPs self-reported adverse reactions to a centralized COVID-19 command center (CCC). The CCC screened and collected information on the quality of reaction, symptoms, and timing of the onset of the reaction. Results: Of 1253 calls to the CCC, 113 were identified as requiring consideration by a panel of three (Board of Allergy and Immunology) 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 EHCPs 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 ECHPs 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-202101300055 Same article/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 fifth 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 at a large health-care system to consider administration of future dosing. Methods: There were 28,544 providers who received their first dose of COVID-19 vaccines between December 15, 2020, and March 8, 2021. The providers self-reported adverse reactions to a centralized COVID-19 AGENCY center. The AGENCY screened and collected information on the quality of reaction, symptoms, and timing of the onset of the reaction. Results: Of 1253 calls to the agency, 113 were identified as requiring consideration by a panel of three certified allergists for future dosing or formal in-person assessment. Of the 113 cases, 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 cases 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 providers 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-202101300055 Same article/drug/event; Different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, Menstruation irregular, Vaginal haemorrhage
Clinical narrative: Abnormal vaginal bleeding at unexpected times / gush of blood; abnormal vaginal bleeding at unexpected times. Large clots and gush of blood; Irregular menses; worsened cramps; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Right on 12Jun2021 (at the age of 34 years old) (Lot Number: EW0186) as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing (COVID prior vaccination: yes). The patient was not pregnant at the time of vaccination. Patient has no known allergies. No other vaccine in four weeks. There were no concomitant medications. No other medications in two weeks. The patient took the first dose of BNT162B2 (Lot number: EW0176) administered to right arm on 15May2021 (at the age of 34 years old) for COVID-19 Immunization. On 16Jun2021, the patient experienced abnormal vaginal bleeding at unexpected times. Large clots and gush of blood was experienced after receiving the second dose. Patient has been experiencing irregular menses and worsened cramps since 16Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures of tranexamic acid were taken as a result of the events. Patient has not been tested for COVID post vaccination. The outcome of the events was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: Caller also stated that she "had shingles at the time of her second dose of the Pfizer COVID-19 vaccine; tingling; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration, administered on 21Feb2021 (age at vaccination 69 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9263) via an unspecified route of administration, administered on 31Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The caller stated that she had shingles at the time of her second dose of the pfizer covid-19 vaccine and tingling on Feb2021. It was reported that she got shingles the same day as her second dose of Pfizer COVID-19 vaccine. Caller stated that she had the first 2 doses of the Pfizer COVID-19 vaccine and is planning to get a third or a booster dose. Caller is also planning to get a flu shot and a Shingles shot and wanted to know in which order should she get the vaccines. Caller also stated that she "had shingles at the time of her second dose of the Pfizer COVID-19 vaccine but was not sure if it was simultaneous with the dose or which came in first. Caller clarifies that she is not sure when she had shingles because it came on over a few days as tingling, which she is not sure which day it started, it was within a day or two before or after her second Pfizer COVID-19 shot, immediately in the vicinity. Caller says she didn't realize it was shingles, it felt like the label on her shirt was rubbing or something. As a treatment she received Zovirax 20mg four times a day by mouth. She says she took it three times later than she was supposed to have taken it, she took it for 5 days. The outcome of the event was unknown.  Follow-up activities closed as follow-up attempts are completed.
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: first shot caused white blood cells to drop by 50% and then they came back up and then after the second dose the white blood cells dropped by 25%.; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program with Regulatory Authority Support. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced first shot caused white blood cells to drop by 50% and then they came back up and then after the second dose the white blood cells dropped by 25%. The patient underwent lab tests and procedures which included white blood cell: drop by 50%, white blood cell: dropped by 25%. The outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Insomnia
Clinical narrative: severe abdominal pain/abdominal cramping; Lack of appetite and slept; Lack of appetite and slept; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 22Sep2021 17:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization at the age of 56 years old in the Pharmacy or Drug Store. Medical history included migraine headaches and sulpha allergy from an unknown date. The patient was not pregnant at time of vaccination. Concomitant medications included estradiol, zonisamide, sumatriptan, calcium and vitamins. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Sep2021 at 1:00 AM, 8 hrs after injection , the patient experienced severe abdominal pain, the intense pain did not subside for minimum of 8 hrs. Had on/off abdominal cramping for 48 hours after receiving the Pfizer COVID shot. The patient stated, "Lack of appetite and slept when I was not awakened by the intense pain." No treatment was given for the events. The outcome of the events was recovered on unspecified date.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: her father developed Bell's Palsy; This is a spontaneous report from a Pfizer-sponsored program Support from a non-contactable consumer or other non hcp (Reporter's father) Via medical information team. An 88-years-old male patient 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 unspecified date of Mar2021 (age at the time of vaccination 88-years-old), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date of Mar2021, patient experienced her father developed Bell's Palsy. Reporter's father took Pfizer BioNTech COVID-19 vaccine the next day he started experiencing bell's palsy which he is still experiencing, and he didn't get second dose. The outcome of event was not recovered.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex pharyngitis, Herpes zoster, Immune system disorder
Clinical narrative: I am highly certain my immune system turned against me; shingles infection; a severe herpes simplex one outbreak in my throat; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: FC3182; Expiration date was not reported), via an unspecified route of administration in the left arm on 18Sep2021 08:00 AM (at the age of 37-years-old) as dose 2, single for COVID-19 immunization at an administration facility. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: FC3181; Expiration date was not reported), via an unspecified route of administration in the left arm on 28Aug2021 09:00 PM (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. No other vaccine was received by the patient in four weeks. The patient was not tested for COVID post vaccination. On 21Sep2021, the patient went to an urgent care facility unable to swallow with terrible ear and throat pain only to find out that she had a severe herpes simplex one outbreak in her throat. The patient was prescribed with 4x her normal dosage of valaciclovir hydrochloride (VALTREX). It was reported that normally the patient would never get an infection in her throat; never have before. A week later, starting on 28Sep2021, the patient broke out with severe blisters on her spine running up and down left side of her spine and have been told it was a shingles infection. It was reported that she was highly certain her immune system turned against her after the second shot and wanted to report these adverse infections because they have negatively affected her life. Treatment with VALTREX was taken for the events. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report from Pfizer sponsored program COVAX US Support. A non-contactable consumer reported that a female patient of an unspecified age (consumer's friend) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient went in and got the vaccine on behalf of her husband, because he had health issues, she developed blood clots, Consumer didn't know if she still had them, but they happened right away with her. Outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Hypothermia, Immunisation, Off label use
Clinical narrative: Hypothermia (lowest temperature was 95°F); Off-label; booster; This is a spontaneous report from a contactable healthcare professional (patient). A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular, administered in deltoid left on 01Oct2021 15:00 (age at vaccination was 23 years) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history was none (Known allergy: NKA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included buspirone taken for an unspecified indication, start and stop date were not reported; and cyanocobalamin (SUBLINGUAL B12) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 on an unspecified date as dose 1, single and on an unspecified date as dose 2, single for COVID-19 immunization The patient experienced hypothermia (lowest temperature was 95°F) on 01Oct2021 22:00 with outcome of not recovered; off-label and booster on 01Oct2021 15:00. No therapeutic measure was taken as a result of hypothermia. The patient underwent lab tests and procedures which included body temperature: 95 fahrenheit on an unspecified date. The event was hypothermia was reported as serious life-threatening, while the other events were assessed as non-serious.  Information about the lot/batch number for the vaccine was not provided and will be requested during follow-up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events hypothermia,; off-label and booster dose   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: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Bone pain, Hyperaesthesia, Hypoaesthesia, Myalgia
Clinical narrative: Scalp psoriasis flare-up; Psoriasis flare-up; Throat tightness; Numbness of lower extremities; Bone pain; Paraesthesia lower limb/tingling on legs and feet; Joint pain; Increased skin sensitivity; Muscle pain; Psoriatic arthritis aggravated/psoriatic arthritis flare up; This is a solicited report based on information received by Pfizer from AbbVie (Mfr. Control No.: 21K-163-4096772-00). A contactable 36-year-old female consumer reported that:  Solicited report from the USA by a consumer of a 36 year old female with events of non-serious throat tightness, skin sensitivity, numbness on legs and feet, psoriatic arthritis flare up, muscle pains, bone and joint pain if bumps into. Things which was different from psoriatic arthritis pain, tingling on legs and feet and scalp psoriasis flare up with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced throat tightness, numbness on legs and feet, bone and joint pain if bumps into things which was different from psoriatic arthritis pain, tingling on legs and feet and scalp psoriasis flare up. In 2021, the patient experienced psoriatic arthritis flare up and muscle pains. In Jun2021, the patient experienced skin sensitivity. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 19Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer Biontech. On 09Apr2021, patient received second dose COVID-19 Vaccine manufactured by Pfizer Biontech. Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of throat tightness, skin sensitivity, numbness on legs and feet, psoriatic arthritis flare up, muscle pains, bone and joint pain if bumps into things which was different from psoriatic arthritis pain unknown onset, tingling on legs and feet, scalp psoriasis flare up and bone and joint pain if bumps into things which was different from psoriatic arthritis pain unknown onset with Humira (Adalimumab) was a reasonable possibility. Causality as per reporter for the events with bnt162b2 was probable.  The lot number for the vaccine bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events Psoriatic arthropathy, Psoriasis, Throat tightness, Hyperaesthesia, Hypo aesthesia, Myalgia, Bone pain, Paraesthesia, Athralgia. 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: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Paraesthesia, Psoriasis, Psoriatic arthropathy, Throat tightness
Clinical narrative: Scalp psoriasis flare-up; Psoriasis flare-up; Throat tightness; Numbness of lower extremities; Bone pain; Paraesthesia lower limb/tingling on legs and feet; Joint pain; Increased skin sensitivity; Muscle pain; Psoriatic arthritis aggravated/psoriatic arthritis flare up; This is a solicited report based on information received by Pfizer from AbbVie (Mfr. Control No.: 21K-163-4096772-00). A contactable 36-year-old female consumer reported that:  Solicited report from the USA by a consumer of a 36 year old female with events of non-serious throat tightness, skin sensitivity, numbness on legs and feet, psoriatic arthritis flare up, muscle pains, bone and joint pain if bumps into. Things which was different from psoriatic arthritis pain, tingling on legs and feet and scalp psoriasis flare up with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced throat tightness, numbness on legs and feet, bone and joint pain if bumps into things which was different from psoriatic arthritis pain, tingling on legs and feet and scalp psoriasis flare up. In 2021, the patient experienced psoriatic arthritis flare up and muscle pains. In Jun2021, the patient experienced skin sensitivity. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 19Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer Biontech. On 09Apr2021, patient received second dose COVID-19 Vaccine manufactured by Pfizer Biontech. Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of throat tightness, skin sensitivity, numbness on legs and feet, psoriatic arthritis flare up, muscle pains, bone and joint pain if bumps into things which was different from psoriatic arthritis pain unknown onset, tingling on legs and feet, scalp psoriasis flare up and bone and joint pain if bumps into things which was different from psoriatic arthritis pain unknown onset with Humira (Adalimumab) was a reasonable possibility. Causality as per reporter for the events with bnt162b2 was probable.  The lot number for the vaccine bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events Psoriatic arthropathy, Psoriasis, Throat tightness, Hyperaesthesia, Hypo aesthesia, Myalgia, Bone pain, Paraesthesia, Athralgia. 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: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Nasopharyngitis, Rheumatoid arthritis, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Rheumatoid arthritis flare up; Cold; This is a solicited report based on the information received by Pfizer from AbbVie (Mfr. Control No.: 21K-163-4014885-00). A contactable consumer (patient) reported that a 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular on Feb2021 (at age of 52 years old, Batch/Lot number was not reported) as a single dose, dose 1 intramuscular on Feb2021 (at age of 52 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Lot Number: 1153187) to Jul2021, at Citrate Free for moderate to severe rheumatoid arthritis. The patient medical history was not reported. Concomitant medication(s) included methotrexate taken for an unspecified indication from an unspecified start date to Jul2021. In Apr2021, the patient experienced Cold with Humira (Adalimumab). In Jul2021, the patient experienced rheumatoid arthritis flare up with Humira (Adalimumab). On 16Jul2021, the patient experienced COVID-19 with Humira (Adalimumab). In 2021, the COVID-19 and rheumatoid arthritis flare up resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient underwent lab tests and procedures which included COVID-19 Virus Test: positive on 16Jul2021. The action taken in response to the events for adalimumab was permanently withdrawn on Jul2021. The outcome of the event Cold was unknown. The outcome of the other events was recovered in 2021.  The reporter's causality for all events with BNT162B2 was assessed as possible.  The reporter's causality for the events of "COVID-19 and rheumatoid arthritis flare up" with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event of "Cold" with Humira (Adalimumab) was not provided.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure COVID-19, Rheumatoid arthritis flare up and Nasopharyngitis cannot be totally excluded. However, due to co-suspect Humira, role of BNT162B2 cannot be assessed in isolation. 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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Crohn's Disease Flare; Crohn's Disease Flare/Related It to Stress after Losing Grandmother; Temperature elevation; Stress; Fatigue; Muscle pain; This is a solicited report based on information received by Pfizer from (Mfr. Control No.: 21K-163-3846093-00). A contactable consumer (patient) reported that a 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular on Mar2021 (at age of 32 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate free, then via subcutaneous from 18Dec2020 (Batch/Lot number was not reported) to an unspecified date, at Increased dosage Citrate free (1 in 1 wk) for Moderate to Severe Adult Crohn's Disease. Medical history included cerebral palsy. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular on Feb2021 (at age of 32 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. In 2021, the patient experienced Stress, Fatigue, Muscle Pain and Temperature elevation after Got Covid Vaccine. On 21Mar2021, the patient experienced Crohn's Disease Flare/Related It to Stress after Losing Grandmother with HUMIRA (ADALIMUMAB). In 2021, The Crohn's Disease Flare/Related It to Stress after Losing Grandmother resolved. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. On 21Aug2021, the patient experienced Crohn's Disease Flare with HUMIRA (ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The outcome of the event "Crohn's disease aggravated (onset date 21Mar2021)" was recovered in 2021. The outcome of other events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product ADALIMUMAB and BNT162B2 was not provided at the time of this report. Since no determination has been received, the case was managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events Crohn's disease flare up and other reported events and the suspect drug BNT162B2.   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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chest pain, Drug ineffective, Echocardiogram
Clinical narrative: On 05Apr2021 the COVID test result positive; On 05Apr2021 the COVID test result positive; muscle pain in my left arm; two days the pain radiated into my anterior chest wall which increased by activity; The pain then radiated to my elbow, forearm, and both of my lower extremities.; The pain then radiated to my elbow, forearm, and both of my lower extremities.; The pain then radiated to my elbow, forearm, and both of my lower extremities.; Dose 1 and dose 2 administered on 27Jan2021; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration at the left arm, on 27Jan2021 at 03:15 PM (age at the time of vaccination was 52-year-old), as a dose 1, single for COVID-19 immunization and BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration at the right arm, on 27Jan2021, as a dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient concomitant medications include unspecified prescribed medication for diabatic and hypotension. It was reported that the patient did not have any allergies. Reportedly the patient tested for COVID post vaccination. On 27Jan2021, at 05:00 PM the patient experience muscle pain in his left arm and after two days the pain radiated into his anterior chest wall which increased by activity. Reportedly the patient visited his primary physician regarding the pain, he then referred him to a cardiologist, who conducted an EKG and echocardiogram. An X-Ray of his left shoulder was also taken, and his carotid ultrasounds were normal. The pain then radiated to his elbow, forearm, and both of his lower extremities. On 05Apr2021 the patient was tested for COVID-19 (drug ineffective). On 05Apr2021, the patient underwent lab tests and procedures which included SARS-CoV-2 (COVID19) (Nasal Swab) resulted positive. Outcome of the event was not recovered for muscle pain in my left arm, two days the pain radiated into my anterior chest wall which increased by activity, the pain then radiated to my elbow, forearm, and both of my lower extremities. Outcome was unknown for rest of the event.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Inappropriate schedule of product administration, Myalgia, Pain, Pain in extremity
Clinical narrative: On 05Apr2021 the COVID test result positive; On 05Apr2021 the COVID test result positive; muscle pain in my left arm; two days the pain radiated into my anterior chest wall which increased by activity; The pain then radiated to my elbow, forearm, and both of my lower extremities.; The pain then radiated to my elbow, forearm, and both of my lower extremities.; The pain then radiated to my elbow, forearm, and both of my lower extremities.; Dose 1 and dose 2 administered on 27Jan2021; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration at the left arm, on 27Jan2021 at 03:15 PM (age at the time of vaccination was 52-year-old), as a dose 1, single for COVID-19 immunization and BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration at the right arm, on 27Jan2021, as a dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient concomitant medications include unspecified prescribed medication for diabatic and hypotension. It was reported that the patient did not have any allergies. Reportedly the patient tested for COVID post vaccination. On 27Jan2021, at 05:00 PM the patient experience muscle pain in his left arm and after two days the pain radiated into his anterior chest wall which increased by activity. Reportedly the patient visited his primary physician regarding the pain, he then referred him to a cardiologist, who conducted an EKG and echocardiogram. An X-Ray of his left shoulder was also taken, and his carotid ultrasounds were normal. The pain then radiated to his elbow, forearm, and both of his lower extremities. On 05Apr2021 the patient was tested for COVID-19 (drug ineffective). On 05Apr2021, the patient underwent lab tests and procedures which included SARS-CoV-2 (COVID19) (Nasal Swab) resulted positive. Outcome of the event was not recovered for muscle pain in my left arm, two days the pain radiated into my anterior chest wall which increased by activity, the pain then radiated to my elbow, forearm, and both of my lower extremities. Outcome was unknown for rest of the event.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination failure
Clinical narrative: Tested Positive for COVID-19; Tested Positive for COVID-19; stuffy nose; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0179) via an unspecified route of administration, administered anatomical location not reported, on 11May2021 (at the age of 58 years), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170) via an unspecified route of administration, administered anatomical location not reported, on 20Apr2021 (at the age of 58 years), as a single dose for COVID-19 immunization. Prior vaccination, the patient does not have COVID-19. Post vaccination, the patient tested for COVID-19. On 01Oct2021, the patient experienced Tested Positive for COVID-19, and on 30Sep2021 stuffy nose. The patient stated, Fiance had symptoms earlier and tested positive for COVID-19 (Moderna vaccine) on 29Sep2021. On 01Oct2021, the patient underwent lab tests and procedures which included PSA, SARS-CoV-2 test: Positive, Nasal Swab. The patient did not received treatment for the events. The outcome of the events was recovering.  No Follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis reactive, Investigation
Clinical narrative: I have reactive arthritis; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant) received the first dose of BNT162B2 (Pfizer COVID 19) via an unspecified route of administration on the right arm on 11Aug2021 at 12:00 PM (Lot Number: EN0198) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs. COVID prior vaccination was unknown. COVID tested post vaccination was none. The patient didn't received other vaccine in four weeks. Concomitant medication was received (not specified). On 30Aug2021, the patient had reactive arthritis. Ankles, feet , hands, back and wrists. The patient blood work twice. The government should push to check for Covid antibodies PRIOR to giving a shot. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included 2 different doctors visits, blood work twice. The outcome of events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Muscle spasms, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Extremely painful menstruation. Large clots.; Extremely painful menstruation; Severe cramping; Left arm pain; This is a spontaneous report from a contactable consumer (patient).   A 40-year-old female patient received the third dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in the left arm  on 30Sep2021 19:00 (Batch/Lot Number: FF2589) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), ascorbic acid (VIT C), and multivitamins, taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in the left arm  on 21Dec2020  (Batch/Lot Number: EK5731) as DOSE 1, SINGLE; the second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in the left arm  on 11Jan2021  (Batch/Lot Number: EL3249) as DOSE 2, SINGLE and experienced left arm pain with the second shot; both given  for COVID-19 immunization. The patient was not pregnant at time of vaccination. Facility where vaccine was administered was a pharmacy or dug store. There were no other medications received in two weeks. The patient did not have COVID-19 prior to vaccination. On 01Oct2021, the patient  experienced extremely painful menstruation. large clots, severe cramping, and left arm pain. The patient underwent lab tests and procedures which included COVID test nasal swab: negative  on 01Oct2021 Nasal Swab per test weekly. The events did not require treatment. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.