chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Angiotensin converting enzyme, Biopsy skin, Blood gases, Chest X-ray, Computerised tomogram thorax
Clinical narrative: Non-granulomatous bilateral anterior uveitis; This is a literature report from Chest, 2021, Vol 160 (4 Suppl), Pgs A1233-A1234 (DOI: 10.1016/j.chest.2021.07.1134), entitled "RARE EXPRESSION OF SYSTEMIC SARCOIDOSIS AFTER A NOVEL RNA VACCINE".  Here is a rare presentation of a (Ethnic Group) male with sarcoidosis after exposure to an unusual antigen. CASE PRESENTATION: A 32-year-old man came to the emergency department with dyspnea, dry cough, and bilateral eye redness of one week of evolution and ten days after the second dose of the SARS-CoV-2 vaccine. Before these symptoms, the patient experienced multiple desquamating tattoos and bilateral eye redness after the first dose of the vaccine, which presumed that resolved with tobramycin and dexamethasone eye drops. Physical examination was notable for tattoo peeling with surrounding erythematous papules and tenderness to palpation. Eye examination revealed an intact visual acuity bilaterally with hyperemia and conjunctival injection. Ophthalmology made the diagnosis of non- granulomatous bilateral anterior uveitis. Routine laboratories were unremarkable including angiotensin-converting enzyme levels except for erythrocyte sedimentation rate on 32mm/Hr and arterial blood gas with a partial pressure of oxygen of 72 mmHg. Chest radiograph revealed innumerable bilateral centrilobular nodules. Chest Computerized tomography showed bilateral centrilobular diffuse pulmonary nodules with associated mediastinal paratracheal and mediastinal lymphadenopathy. Skin biopsy revealed a nodular infiltrate of histiocytes with black foreign body deposits with non-caseating sarcoid granulomas. Treatment consisted of prednisone and azathioprine resulting in an improvement of symptoms the following days. DISCUSSION: The side effects of this novel ribonucleic acid vaccine are not well described yet, but the authors' case raises the suspicion if the vaccine arouses or unmask autoimmune diseases like the one previously described. CONCLUSION(S): More studies and data are required on side effects to assess other possible complications, response to the vaccine, and which patients are at risk of developing autoimmune or serious health conditions.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Iridocyclitis and 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.
Sex: M
Vaccine: COVID19
Symptoms: Iridocyclitis, Laboratory test, Ophthalmological examination, PO2, Physical examination
Clinical narrative: Non-granulomatous bilateral anterior uveitis; This is a literature report from Chest, 2021, Vol 160 (4 Suppl), Pgs A1233-A1234 (DOI: 10.1016/j.chest.2021.07.1134), entitled "RARE EXPRESSION OF SYSTEMIC SARCOIDOSIS AFTER A NOVEL RNA VACCINE".  Here is a rare presentation of a (Ethnic Group) male with sarcoidosis after exposure to an unusual antigen. CASE PRESENTATION: A 32-year-old man came to the emergency department with dyspnea, dry cough, and bilateral eye redness of one week of evolution and ten days after the second dose of the SARS-CoV-2 vaccine. Before these symptoms, the patient experienced multiple desquamating tattoos and bilateral eye redness after the first dose of the vaccine, which presumed that resolved with tobramycin and dexamethasone eye drops. Physical examination was notable for tattoo peeling with surrounding erythematous papules and tenderness to palpation. Eye examination revealed an intact visual acuity bilaterally with hyperemia and conjunctival injection. Ophthalmology made the diagnosis of non- granulomatous bilateral anterior uveitis. Routine laboratories were unremarkable including angiotensin-converting enzyme levels except for erythrocyte sedimentation rate on 32mm/Hr and arterial blood gas with a partial pressure of oxygen of 72 mmHg. Chest radiograph revealed innumerable bilateral centrilobular nodules. Chest Computerized tomography showed bilateral centrilobular diffuse pulmonary nodules with associated mediastinal paratracheal and mediastinal lymphadenopathy. Skin biopsy revealed a nodular infiltrate of histiocytes with black foreign body deposits with non-caseating sarcoid granulomas. Treatment consisted of prednisone and azathioprine resulting in an improvement of symptoms the following days. DISCUSSION: The side effects of this novel ribonucleic acid vaccine are not well described yet, but the authors' case raises the suspicion if the vaccine arouses or unmask autoimmune diseases like the one previously described. CONCLUSION(S): More studies and data are required on side effects to assess other possible complications, response to the vaccine, and which patients are at risk of developing autoimmune or serious health conditions.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Iridocyclitis and 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.
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Non-granulomatous bilateral anterior uveitis; This is a literature report from Chest, 2021, Vol 160 (4 Suppl), Pgs A1233-A1234 (DOI: 10.1016/j.chest.2021.07.1134), entitled "RARE EXPRESSION OF SYSTEMIC SARCOIDOSIS AFTER A NOVEL RNA VACCINE".  Here is a rare presentation of a (Ethnic Group) male with sarcoidosis after exposure to an unusual antigen. CASE PRESENTATION: A 32-year-old man came to the emergency department with dyspnea, dry cough, and bilateral eye redness of one week of evolution and ten days after the second dose of the SARS-CoV-2 vaccine. Before these symptoms, the patient experienced multiple desquamating tattoos and bilateral eye redness after the first dose of the vaccine, which presumed that resolved with tobramycin and dexamethasone eye drops. Physical examination was notable for tattoo peeling with surrounding erythematous papules and tenderness to palpation. Eye examination revealed an intact visual acuity bilaterally with hyperemia and conjunctival injection. Ophthalmology made the diagnosis of non- granulomatous bilateral anterior uveitis. Routine laboratories were unremarkable including angiotensin-converting enzyme levels except for erythrocyte sedimentation rate on 32mm/Hr and arterial blood gas with a partial pressure of oxygen of 72 mmHg. Chest radiograph revealed innumerable bilateral centrilobular nodules. Chest Computerized tomography showed bilateral centrilobular diffuse pulmonary nodules with associated mediastinal paratracheal and mediastinal lymphadenopathy. Skin biopsy revealed a nodular infiltrate of histiocytes with black foreign body deposits with non-caseating sarcoid granulomas. Treatment consisted of prednisone and azathioprine resulting in an improvement of symptoms the following days. DISCUSSION: The side effects of this novel ribonucleic acid vaccine are not well described yet, but the authors' case raises the suspicion if the vaccine arouses or unmask autoimmune diseases like the one previously described. CONCLUSION(S): More studies and data are required on side effects to assess other possible complications, response to the vaccine, and which patients are at risk of developing autoimmune or serious health conditions.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Iridocyclitis and 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.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Illness, SARS-CoV-2 test
Clinical narrative: been ill; symptoms were getting worse; This is a spontaneous report from a contactable consumer reported different events under the same suspect product for 5 patients. This is one of 5 patients. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, COVID 19 Vaccine, mRNA), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had been experiencing the side effects, that were life threatening. The patient had been ill. Tested for COVID many many times. Had worked with COVID patients for a long time. The patient's symptoms were getting worse. The outcome of ill was unknown, while of symptoms were getting worse was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test, Weight decreased
Clinical narrative: weight loss; loss of taste smell probably; loss of taste smell probably; This is a spontaneous report from a contactable consumer reporting on behalf of the patients. This consumer reported same events under the same suspect product for two patients. This is second of 2 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single  for covid-19 immunisation.  Medical history included exposure to sars-cov-2. The patient's concomitant medications were not reported. The patient experienced weight loss, loss of taste smell probably, loss of taste smell probably, all on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included CPVID test: negative on an unknown date. Clinical course: In reporter's circle, 5 people including her and her doctor had been experiencing the same side effect, that were life threatening. 2 friends the reporter only found today in at withheld was also sick. A friend she met 4-5 months ago had the same problem and same long experience. All tested for COVID many many times. All of them had worked with COVID patients for a long time. Her friend had each experience in a hospital. They had symptom including weight loss, loss of taste smell probably but all of their tested result were negative. All of the symptoms are escalating and getting worse. Her friends and doctors symptoms were also getting worse.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383019 same reporter, product, event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Cough, Drug ineffective
Clinical narrative: test positive for COVID; test positive for COVID; 101 fever; chills; headache; coughing; congestion; fatigue; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as dose 2, single and dose 1 via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient was tested positive for covid and was exposed to drug ineffective. The patient also experienced, 101 fever, chills, headache, coughing, congestion and fatigue on an unspecified date in 2021. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date in 2021, sars-cov-2 test: positive on an unspecified date in 2021. Outcome of all the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: test positive for COVID; test positive for COVID; 101 fever; chills; headache; coughing; congestion; fatigue; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as dose 2, single and dose 1 via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient was tested positive for covid and was exposed to drug ineffective. The patient also experienced, 101 fever, chills, headache, coughing, congestion and fatigue on an unspecified date in 2021. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date in 2021, sars-cov-2 test: positive on an unspecified date in 2021. Outcome of all the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Developed Blood clot in right leg; This is a spontaneous report from a contactable consumer or other non-HCP (patient wife). This is the 2nd case out of 2 cases.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Solution for injection, Batch/Lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 13Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single COVID-19 immunization. The patient developed blood clot in right leg last Friday on 15Oct2021. The report is not related to a study. Patient wanted to know whether the Pfizer is having any reports of Blood clot from the Pfizer Covid Vaccine. The clinical outcome of the event blood clot in right leg was unknown.   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-202101383426 same reporter/drug/AE, different patient
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Tested positive for Covid 19; Tested positive for Covid 19; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Right on 22Feb2021 (at the age of 50 years) (Batch/Lot Number: EL3247) as DOSE 1, SINGLE, dose 2 intramuscular, administered in Arm Left on 15Mar2021 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunization at Workplace clinic. Medical history included hypertension (Under control), cholesterol from an unknown date and unknown if ongoing). Concomitant medication included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; quinapril hydrochloride (ACCUPRIL) taken for an unspecified indication, start and stop date were not reported; chlorthalidone taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Oct2021 07:00 the patient experienced tested positive for covid 19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Oct2021 Nasal Swab. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Glaucoma, Pain, Pruritus
Clinical narrative: severe itching; rashes; Very sharp needle like pain/needle-like pain all over her body; severe back ache; I just get stress feels in me; I have got glaucoma in both my eyes; This is a spontaneous report from a contactable consumer(patient) or other non HCP. A 72-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number: EL8982) via an unspecified route of administration, administered in Arm Left on 06Feb2021(at the age of 72-years old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypertension and patient was not on any medications for hypertension. The historical vaccines include bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number: EL8982), via an unspecified route of administration, administered in Arm Left on 16Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient reported she was taking an eye drop and was taking Gabapentin' (Further not clarified) for pain and was just, the doctor had given steroids (Methyl prednisolone) but they did not help so she stopped. It may be bad effect, so she stopped. The patient got glaucoma in both her eyes (Further clarification unknown). So, she had a trusopt procedure, they injected Trusopt medication in her eye and that was done in May and then in June. The patient had two shots of steroids one in April and one in May because of severe back ache and then after this itching and rashes became nearly bad. Since Jul2021 the patient had severe itching and rashes all over her body. She had sharp pain all over her body. At first it was just on the back of her neck. Then, it went to her genitals, and it has slowly spread all over. Now every time it shows up in a different spot on her body. The itch and the rash were very severe. She was put on steroids and steroid cream, but she stopped that because it made the rash and itching worse. It was a 6 day course. She did two doses of that. All she knows is it was Methylprednisolone. The patient has been to doctors including dermatologist and an allergist, No one could determine the cause of it. The doctors put her on steroid medications, but those seemed to make it worse. She was concerned it was a delayed reaction to the vaccine. The patient reported she just gets stress feel. The event glaucoma was assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood test and results are unknown.  The events outcome for Glaucoma and she just get stress feels was reported as unknown. The event outcome for rashes, severe itching, very sharp needle like pain/needle-like pain all over her body and severe back ache was reported as not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Stress
Clinical narrative: severe itching; rashes; Very sharp needle like pain/needle-like pain all over her body; severe back ache; I just get stress feels in me; I have got glaucoma in both my eyes; This is a spontaneous report from a contactable consumer(patient) or other non HCP. A 72-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number: EL8982) via an unspecified route of administration, administered in Arm Left on 06Feb2021(at the age of 72-years old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypertension and patient was not on any medications for hypertension. The historical vaccines include bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number: EL8982), via an unspecified route of administration, administered in Arm Left on 16Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient reported she was taking an eye drop and was taking Gabapentin' (Further not clarified) for pain and was just, the doctor had given steroids (Methyl prednisolone) but they did not help so she stopped. It may be bad effect, so she stopped. The patient got glaucoma in both her eyes (Further clarification unknown). So, she had a trusopt procedure, they injected Trusopt medication in her eye and that was done in May and then in June. The patient had two shots of steroids one in April and one in May because of severe back ache and then after this itching and rashes became nearly bad. Since Jul2021 the patient had severe itching and rashes all over her body. She had sharp pain all over her body. At first it was just on the back of her neck. Then, it went to her genitals, and it has slowly spread all over. Now every time it shows up in a different spot on her body. The itch and the rash were very severe. She was put on steroids and steroid cream, but she stopped that because it made the rash and itching worse. It was a 6 day course. She did two doses of that. All she knows is it was Methylprednisolone. The patient has been to doctors including dermatologist and an allergist, No one could determine the cause of it. The doctors put her on steroid medications, but those seemed to make it worse. She was concerned it was a delayed reaction to the vaccine. The patient reported she just gets stress feel. The event glaucoma was assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood test and results are unknown.  The events outcome for Glaucoma and she just get stress feels was reported as unknown. The event outcome for rashes, severe itching, very sharp needle like pain/needle-like pain all over her body and severe back ache was reported as not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, Suspected COVID-19
Clinical narrative: Showed symptoms of Covid; Showed symptoms of Covid; Showed symptoms of Covid and was really sick for 36 hours; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 57-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 17Sep2021 (at the age of 57-year-old) (Batch/Lot Number: 30130BA) as dose 1, single for covid-19 immunisation at a clinic. Medical history included none. The patient's concomitant medications were not reported. Patient previously took tetanus shot on an unspecified date in Aug2021 and states that he experienced events which was described as he had nausea, and a super, super sore arm for from that.The patient received the Moderna shot as the second dose. On 01Oct2021 the patient experienced symptoms of covid. Where the patient states that he got Covid between the 2 shots, stating that he got Covid on 01Oct2021. When attempting to clarify if 01Oct2021 was the date he had a positive test result for Covid, the patient states that he does not have a positive test result. He states that his wife has positive test results for Covid and that he showed symptoms and was really sick for 36 hours. Then, he was fine. It was also reported that family medical history was none.He just got it pumped into him about 15 minutes ago, well, He is really freaked out, they put the wrong crap in him and he wants to get it out. He is just really upset and is freaking out. He has had 2 Covid vaccines but because they are 2 different vaccines, he still can't go anywhere. Outcome of all the events was recovered on an unspecified date in Oct2021.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Doctor diagnosed potential pericarditis; This is a spontaneous report from a non-contactable consumer or other non hcp via a sales representative. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine concluded bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunization. Patient was diagnosed with potential pericarditis (medically significant) on an unspecified date. Patient went to emergency room about two weeks post second covid vaccine dose. Event took place after use of product. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: She took the vaccine and 4-5 hours later she went into Afib/ she still has Afib right now; sweating; pulse went up; This is a spontaneous report from a contactable consumer (patient) reported that. A female patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing and her heart has been regular for at least 4 weeks, she went to the doctor on Thursday and everything was okay, no irregularities, no missed beats. The patient concomitant medications were not reported. The patient historical vaccine includes bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. On an unspecified date of 2021, patient experienced AFIB after 4-5 hours later vaccination, was sweating and her pulse went up. She went to see the doctor on Friday, and he sent her to the ER to get her checked out, she still has Afib right now. The patient underwent lab tests and procedures which included heart rate went up on an unspecified date of 2021. Outcome of the events AFIB was not recovered, and other events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: So far four people who were vaccinated in Jan and has already COVID; So far four people who were vaccinated in Jan and has already COVID; This is a spontaneous report from a non-contactable other healthcare professional. This other healthcare professional reported similar events for four patients. This is the first of four reports. An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that the patient was vaccinated in Jan2021 and already had COVID. The reporter stated that they don't think they have, they are associating to it at the hospital, but patient was symptomatic. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101392304 different patient, same event and dose;US-PFIZER INC-202101392306 different patient, same event and dose;US-PFIZER INC-202101392305 different patient, same event and dose
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: reports four PTs caught COVID after vaccine; reports four PTs caught COVID after vaccine; This is a spontaneous report from a non-contactable other healthcare professional. This other healthcare professional reported similar events for four patients. This is the second of four reports. An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Jan2021 (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that the patient was vaccinated in Jan2021 and already had COVID. The reporter stated that they don't think they have, they are associating to it at the hospital, but patient was symptomatic. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events Drug ineffective, Covid19  and the administration of the vaccine cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101392305 different patient, same event and dose;US-PFIZER INC-202101392306 different patient, same event and dose;US-PFIZER INC-202101392297 different patient, same event and dose
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: reports four PTs caught COVID after vaccine, they are symptomatic; reports four PTs caught COVID after vaccine; This is a spontaneous report from a contactable other health care professional. This other health care professional reported similar event for 4 patients. This is one of the 4 reports. A 67-year-old female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration in Jan2021 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported. It was reported that, four people who were vaccinated in January and had already COVID in 2021. The reporter did not think the patients were associating to it at the hospital, but they were symptomatic. The outcome was unknown for the reported event.  Causality: Not reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE (Drug ineffective,Covid-19),Linked Report(s) : US-PFIZER INC-202101392304 different patient, same event and dose;US-PFIZER INC-202101392297 different patient, same event and dose;US-PFIZER INC-202101392305 different patient, same event and dose
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Lipoma, Magnetic resonance imaging
Clinical narrative: She felt a lump under her right armpit; has gotten an MRI and was told it was a lipoma; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, and received dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received two doses of the Pfizer BioNTech Covid 19 vaccine, the first dose was in the right arm, and the second in her left. She was not sure when she noticed it, but she felt a lump under her right armpit, and had read that swollen lymph nodes can be a side effect of the vaccine, and she wanted to know if that was still true. She was not absolutely sure and not positive that it came from the vaccine, but she noticed it after she got her 2nd dose. She had her 1st dose in her right arm, and this lump is under her right arm pit, and then she got her 2nd dose in her left arm. She clarified and said that she was wondering if the location of the vaccine affects the location of the lump under the arm pit. Caller mentioned that she had been to a breast specialist and has gotten an MRI and was told it was a lipoma. The patient underwent lab tests and procedures which included MRI: was told it was a lipoma on an unspecified date. The outcome of events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Myalgia, Nausea, Off label use
Clinical narrative: Fever; muscle aches; nausea; vomiting; sore arm; headache; dose received: 3; dose received: 3; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Oct2021 (at the age of 29-years-old) as dose 3 (Booster), single for covid-19 immunization at pharmacy or drug store. The patient medical history was not reported.  Concomitant medications included escitalopram, lamotrigine, paracetamol (TYLENOL), all taken for unknown indications from an unknown date. Other medications the patient received in two weeks included escitalopram, lamotrigine, tylenol. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was unknown, expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 (at the age of 29-years-old) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was unknown, expiration date was not reported), via an unspecified route of administration, administered in left arm on 07Apr2021 (at the age of 29-years-old) as dose 2, single for covid-19 immunization at pharmacy or drug store. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 18Oct2021 the patient experienced fever, muscle aches, nausea, vomiting, sore arm, headache. Tylenol was received as treatment for the adverse events. Therapeutic measures were taken as a result of fever, muscle aches, nausea, vomiting, sore arm, headache. The outcome of the events fever, muscle aches, nausea, vomiting, sore arm, headache was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever; muscle aches; nausea; vomiting; sore arm; headache; dose received: 3; dose received: 3; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Oct2021 (at the age of 29-years-old) as dose 3 (Booster), single for covid-19 immunization at pharmacy or drug store. The patient medical history was not reported.  Concomitant medications included escitalopram, lamotrigine, paracetamol (TYLENOL), all taken for unknown indications from an unknown date. Other medications the patient received in two weeks included escitalopram, lamotrigine, tylenol. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was unknown, expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 (at the age of 29-years-old) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was unknown, expiration date was not reported), via an unspecified route of administration, administered in left arm on 07Apr2021 (at the age of 29-years-old) as dose 2, single for covid-19 immunization at pharmacy or drug store. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 18Oct2021 the patient experienced fever, muscle aches, nausea, vomiting, sore arm, headache. Tylenol was received as treatment for the adverse events. Therapeutic measures were taken as a result of fever, muscle aches, nausea, vomiting, sore arm, headache. The outcome of the events fever, muscle aches, nausea, vomiting, sore arm, headache was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy, Pain
Clinical narrative: severe soreness; developed a lump under the arm/it was like a golf ball; couldn''t put her arm down because of how large the lump was; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported different events for 3 patients. This is 1 of 3 reports.    A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 06May2021 ((Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, on unknown date of 2021 Caller reports she had the Pfizer Covid vaccine on 06May2021 and then had the second shot and had severe soreness, but then she developed a lump under the arm. Thought that maybe it had nothing to do with the vaccine and had hoped it wasn't breast cancer and so she went to the doctor. Doctor informed her that it is a known side effect of the Pfizer vaccine and it's the lymph nodes building antibodies to the virus from the vaccine. She had no idea and it would have not been so alarming had she known and she wouldn't have gone to the doctor. Only went because she thought it was breast cancer.  Now she has a medical bill and would like a member advocate to help with the bill. Knows that the shot was free, but she received a bill from the doctor that was $257.68 and she needs help with it because she is unemployed right now. States the area went down and it was like a golf ball and really sore and that's why she went to the doctor. It's fine now and knows it's a known side effect and it did subside just like they said 3-4 days after the second shot. At the time she couldn't put her arm down because of how large the lump was. This information was never been advertised and she spoke to another lady who said she had a lump under the arm the size of an orange, but she may have been exaggerating about the size, and she said she didn't see it anywhere about being a known side effect. Then some other lady said she had a lump under her arm also and it went down. Pfizer should have something put out saying it should be something that is known especially in women. Even her doctor says its recommended for women not to have a mammogram at least 6 weeks after the vaccine. The patient experienced severe soreness, developed a lump under the arm/it was like a golf ball, couldn't put her arm down because of how large the lump was  on 2021 with outcome of recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. This is report 2 of 3. A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The caller stated she spoke to a lady who said she had an underarm lump the size of an orange. She may have been exaggerating about the size. She said she did not see it anywhere about being a known side effect. Then another lady said she also had a lump under her arm and it went down. The caller  believes Pfizer should have something put out saying it should be known especially in women. Even her doctor says its recommended for women not to have a mammogram at least 6 weeks after the vaccine. No further details provided. The lot number for the vaccine BNT162B2, not provided and will be requested during follow-up.
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash left arm; This is a spontaneous report from a contactable consumer (patient). A 84-years-old patient of unspecified gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262), via an intramuscular route on 17Feb2021 at 14:30 (at the age of 84-years) as dose 2, single in the right arm for covid-19 immunisation. The patient medical history included low heartbeat from 06Jan2021 to 07Jan2021 and pace-maker implanted. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1283, Exp date: 30Apr2021), via an intramuscular route on 27Jan2021 at 14:00 as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced rash left arm on 19Feb2021. The patient did not receive treatment for events. The outcome of the events was recovered on Feb2021. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; fatigue; This is a spontaneous report from a contactable consumer(parent) via medical information team.A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FF2595 and expiry date was not reported) via an unspecified route of administration, on an unknown date, as Dose 3(Booster), single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers and expiry dates were not reported) via an unspecified route of administration, on an unknown date, as Dose 1 and Dose 2, single, for covid-19 immunisation. The patient experienced headache and fatigue on an unspecified date. The outcome of the event was unknown at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a solicited report from a non-Pfizer sponsored program (marketing program name FACILITATED COLLECT) received from a contactable consumer (patient's caregiver), based on information received by Pfizer from the (manufacturer control number 21K-163-4121505-00).  An 81-year-old elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number, expiration date was not reported) as single dose for COVID-19 Vaccination; and adalimumab (HUMIRA, Solution for injection in pre-filled pen), Subcutaneous from an unspecified date (Batch/Lot number, expiration date was not reported) to an unspecified date, at unspecified dose for Moderate to severe adult Crohn's disease. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced fatal COVID-19. On unknown date, the patient died. The cause of death was reported as COVID-19. It is unknown if an autopsy was performed. The patient's caregiver reported that patient died of COVID-19. The action taken in response to the event for adalimumab was Not Applicable. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's Causality for adalimumab with the event was a reasonable possibility. The reporter's Causality for bnt162b2 with the event was possible.   The lot number for the vaccine bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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; Reported Cause(s) of Death: COVID-19; COVID-19
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 38-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, solution for injection; batch/lot# and expiry dates not reported), via unspecified route of administration, on unknown date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On unknown date, patient experienced metallic taste in his mouth, which lasted for 24 hours after he received the 1st dose. The patient was about to get the 2nd dose of the Pfizer-BioNTech COVID-19 vaccine. The pharmacist would like to know whether it is safe for the patient to take 2nd dose despite the reaction he had with the 1st dose. The outcome of the event recovered (at the time of report). The batch/lot number for BNT162B2 not provided and will be requested during follow-up.