chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: he is struggling right now; Chills; Sweat/legs were sweating; low grade fever; This is a follow-up spontaneous report from a contactable consumer (reported for husband). A 65-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0170 and expiration dates were not reported), via an unspecified route of administration on 30Apr2021 as second dose, single for COVID-19 immunization. Medical history included surgery on his foot. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunization and experienced no adverse event. The patient's concomitant medications were not reported. On an unknown date, the patient was struggling right now. In May2021, the patient experienced chills, sweat/legs were sweating and low grade fever. The outcome of the events was unknown. The Consumer reported that patient was administered with the second dose on 30Apr2021 and felt well after but a couple of days after patient started having chills, fever and sweating. The fever and sweating had persisted since only in the morning and it goes away around 10:00 AM. It was reported that from 2 weeks since patient received the 2nd dose, every day from 6am to 10am patient gets profuse sweating (legs were sweating) and low grade fever and chills. It was reported that due to the sweating patient wets its clothes. The 2 different Physicians recommended the use of Acetaminophen for the management of these symptoms. It was reported that one of patient co-workers got the Moderna vaccine and its affected was hearing. The outcome of the event was unknown.  Follow-up#01(11May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (reporters husband) that: patient events details were updated.  Follow-up(12May2021 and 13May2021):This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (reporters husband) that: no new information was updated.  No follow-up attempts are needed. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report received from a non-contactable consumer (patient). A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07May2021 (at the age of 55 years old) (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history included Systemic lupus, Heart issues, Hypothyroidism. Concomitant medication received within 2 weeks of vaccination included levothyroxine. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced hair loss on 09May2021 12:00. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable Nurse. This contactable Nurse reported for a 65-year-old male friend (patient) that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced shingles. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Product administration error, Underdose
Clinical narrative: few drops of the vaccine dripped from their arms; a few drops fell onto her skin while injecting; few drops of the vaccine dripped from their arms like when they got the vaccine not all of that went in; This is a spontaneous report from a contactable Pharmacist. This pharmacist (reported on behalf of the patient)  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for Injection, Lot number: EW0182; Expiration date: 31Aug2021), via unknown route of administration on an unknown date at an unknown dose as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported.  Reporter informed that after administering the COVID vaccine, few drops of the vaccine dripped from their arms like when they got the vaccine (dripped of the vaccine slide down their arms), not all of that went in. Patient wanted to know what the process to follow. Reporter queried to know if the patient need get their vaccine repeated or what needs to be done. No further probing could be done as the consumer (patient) was unwilling to share any further information. Hence limited information available over the call. Reporter seriousness was Unspecified.    Information on Lot/Batch number was available. Additional information has been requested.  Follow-Up (01Jun2021): Follow-up attempts are completed. No further information is expected.  Amendment (30May2021): This follow-up report is being submitted to amend previously reported Information: Added event, Exposure via skin contact.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Hordeolum, Vaginal infection
Clinical narrative: Left eye got swelled up; Stye; Vaginal infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the first of two reports. This report is for the events related to the first vaccine dose.  A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration in the right arm on 05Apr2021 at 09:45am (Batch/Lot number: Unknown, at the age of 43 years) as a single dose for COVID-19 immunization at a pharmacy drug store. Medical history included migraines. The patient has no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were reported as none. The patient did not receive any other medications within 2 weeks of vaccination. Clinical course included: On 05Apr2021 at 09:45am the patient received the first dose of BNT162B2. On 08Apr2021, 3 days after the first dose of BNT162B2, her left eye swelled up. She went to the ophthalmologist and was told she had a stye. She was prescribed Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic. The same day she woke up with what she thought was a vaginal infection. She went to the gynecologist and was prescribed Diflucan. The patient fulfilled both treatments and was fine. The events resulted in a visit to physician or other health professional office, urgency or emergency room/department. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events left eye swelled up, stye and vaginal infection was recovered.  Information on the lot/batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021577114 same report/patient/vaccine, different dose/AE.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: coughing a lot; small mild cold when he got the shot; This is a spontaneous report from a contactable consumer reporting for himself. This 39 years old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in May2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had a reaction from the vaccine. He had a small mild cold when he got the shot, on an unspecified date in May2021. From 17May2021, on 18May2021 and on 19May2021 the patient had been coughing a lot and it was not going away. He needed to take a deep breath to get the cough out. He was going back on 02Jun2021 for the second dose. Coughing had not yet resolved at the time of report. The outcome of cold was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Hypoaesthesia
Clinical narrative: Left side facial numbness starting with the left tip of tongue spreading to left side of lips, then left cheek, then left forehead.  Continues to intensify and spread.  Now surrounds left eye; extremely concerned as I am blind in my right eye.; This is a spontaneous report from a contactable consumer. This 74-year-old male consumer reported for himself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 02Feb2021 09:00 (Batch/Lot Number: EN5318) as 2ND DOSE, SINGLE DOSE, and via an unspecified route of administration, administered in Arm Right on 12Jan2021 09:00 (Batch/Lot Number: EL1283) as 1ST DOSE, SINGLE  DOSE for covid-19 immunisation.  Medical history was none. Concomitant medication(s) included latanoprost taken for an unspecified indication, start and stop date were not reported; donepezil hydrochloride (ARICEPT) taken for an unspecified indication, start and stop date were not reported.  The patient stated of experiencing "left side facial numbness starting with the left tip of tongue spreading to left side of lips, then left cheek, then left forehead. It continues to intensify and spread and now surrounds left eye" and stated that he "extremely concerned as I am blind in my right eye). Onset date for events was 1Feb2021. Events reported as medically significant . Outcome of events was not recovered.  Patient had ongoing consult neurologist and was scheduled for MRI. Patient did not have covid or tested positive prior to vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Balance disorder, Deafness unilateral, Ear disorder, Tinnitus
Clinical narrative: feels like there is water inside my ear; impacted my equilibrium; I can't hear from left ear; tinnitus; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in right arm on 18May2021 11:30 (Lot number: ER8735 7/21) at single dose for COVID-19 immunization. Medical history included allergy with Vitamin E oil and Hair dyes. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  In the afternoon of the day she had received the vaccine (18May2021) she got ringing (tinnitus) in ears which is unusual for her.  It went away by the evening time but when she woke up the next morning (day after the vaccine, 19May2021 07:00) she noticed that she can't hear from her left ear. It almost felt like there was water inside her ear but not quite really. It's a strange sensation that she had never felt before. She also felt that it had impacted her equilibrium somewhat. No treatment received for events tinnitus and can't hear from left ear. Lab data included antibody (blood test) on 30Apr2021: negative.  Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  The outcome of tinnitus was recovered on 18May2021, outcome of she can't hear from her left ear was not recovered, outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Electrocardiogram, Stress, Tachycardia
Clinical narrative: tachycardia; in a lot of stress; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm on May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included family history of high blood pressure. The patient's concomitant medications were not reported. The patient experienced tachycardia on an unspecified date, the patient was in a lot of stress in May2021. The patient did not get admitted to the hospital and that the patient was released from the emergency room. The cardiologist has done a couple of EKGs and a heart monitor and nothing has shown up so far. Outcome of event tachycardia was recovered, in a lot of stress was recovered in May2021. Event tachycardia required Emergency Room Visit. Event tachycardia was reported as serious due to medically significant.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported tachycardia cannot be excluded based on temporal relationship. The patient's stress might also have contributed to the event. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm pain; This is a spontaneous report from a contactable consumer reported for himself.  A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 (at age of 45 years old) 09:00AM (Lot Number: EW0179) as 1st dose, single for covid-19 immunisation.  Medical history included covid-19, No known allergies.  The patient's concomitant medications received within 2 weeks of vaccination were none.  The patient experienced muscle pain, joint pain, headache, fever, injection site swelling, nausea, diarrhea, vomiting and arm pain, all on 19May2021 11:00 PM, no treatment received for events, and patient was not recovered from events. Adverse events result in Congenital anomaly or birth defect and Seriousness criteria reported as Congenital anomaly/birth defect (pending clarification). Prior to vaccination, the patient was diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts possible. No further information expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site swelling, Vomiting
Clinical narrative: muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm pain; This is a spontaneous report from a contactable consumer reported for himself.  A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 (at age of 45 years old) 09:00AM (Lot Number: EW0179) as 1st dose, single for covid-19 immunisation.  Medical history included covid-19, No known allergies.  The patient's concomitant medications received within 2 weeks of vaccination were none.  The patient experienced muscle pain, joint pain, headache, fever, injection site swelling, nausea, diarrhea, vomiting and arm pain, all on 19May2021 11:00 PM, no treatment received for events, and patient was not recovered from events. Adverse events result in Congenital anomaly or birth defect and Seriousness criteria reported as Congenital anomaly/birth defect (pending clarification). Prior to vaccination, the patient was diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Peripheral swelling, Product preparation issue
Clinical narrative: receive 0.3ml of undiluted Pfizer COVID 19 vaccine; 0.3 ml of undiluted vaccine administered; swelling in his arm; This is a spontaneous report from a sponsored program via a contactable pharmacist. A 14-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as 0.3ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller who states that they have a patient who is a 14 year old male who receive 0.3ml of undiluted Pfizer COVID 19 vaccine. He is having swelling in his arm and is now in the ER. She states that AE has already been reported via VAERS. She would like to know if there is any information on this occurring with others? Dosage Higher-than-authorized dose volume administered. Diluent (Pfizer-BioNTech COVID-19 Vaccine only). No diluent, resulting in higher than authorized dose (i.e., 0.3 ml of undiluted vaccine administered). The second dose of vaccine should still be given as per the recommended. Event outcome was unknown. The trial showed that although a stronger dose (100 micrograms) was not harmful, the recipients experienced more local reactions with very painful arms being reported. Participants who received 58 micrograms of COVID-19 mRNA Vaccine [the product currently marketed in the U.S. as Pfizer-BioNTech COVID-19 Vaccine] in clinical trials did not report an increase in reactogenicity or adverse events. If a person is given more than the recommended dose, they should be monitored and treated for any symptoms as required. They should be reassured that this is not harmful but that they may be more likely to experience pain in their injected arm.   Information on the lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: there are raised bumps on the instep part of the foot below the ankle. Some are raised and some are under the skin/ it could be considered a rash; This is a spontaneous report from a contactable consumer (the patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176) via an unspecified route of administration in left upper arm on 19May2021 at age of 56-year-old at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications (reported as no other products). The patient received the first dose of the Pfizer COVID vaccine from Pfizer. He didn't know if it was related or not. But this was the only thing that is different. He just sat down and was looking at his feet, and on his left foot there are about 12 bumps raised on the instep part of the foot, below the ankle. Some were raised and some were under the skin on 20May2021.  When he looked at the pink part of his foot on the bottom side, he could see raised bumps underneath. He just noticed this. The patient asked if this could be a reaction. He had never had anything like this before. Some of the bumps were above the skin, and some of the bumps were under the skin. He could see them protruding out of the bottom/side of foot. Most of it was on his left foot. There looked like there might be a couple on his right foot. He has a couple raised ones on his right foot, and 2-3 under the skin. Caller stated he hadn't thought of it before but it could be considered a rash. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Atelectasis, Back pain, Chest pain, Dyspnoea, Erythema
Clinical narrative: her lungs looked scarred on both sides.; partial collapsing in the bottom and upper lung known as atelectasis; she had sharp pains in her chest, back, and in different parts of her body.; she had sharp pains in her chest, back, and in different parts of her body.; she had sharp pains in her chest, back, and in different parts of her body.; headaches; a blood spot" on her arm near the injection site, described as a "blood circle."; ashortness of breath; redness around her nose, eyes; redness around her nose, eyes; pain in her eyes; her lungs looked scarred on both sides. Caller states that "one doctor felt like a nodule, but another doctor didn't feel it."; inflammation; This is a spontaneous report from a contactable consumer (the patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included rare lung disease, in which her right lung is attached to her rib cage. The patient's concomitant medications were not reported. Caller stated that she was having a hard time finding a place that would administer the second dose to her. She did not want to go back to the original site. Caller was worried about receiving left over Pfizer Covid-19 vaccines from an original site. Caller stated that the vaccine was being stored in a refrigerator around "7 degrees" but she wasn't sure that is a guaranteed temperature. Caller received the first dose of the Pfizer Covid-19 vaccine and stated that she had sharp pains in her chest, back, and in different parts of her body. She also had headaches, "a blood spot" on her arm near/under the injection site, described as a "blood circle." She experienced shortness of breath, redness around her nose, eyes, and pain in her eyes. She went to the emergency room/ hospital three times within three months. She just went to the ER, she was never admitted. A doctor said her lungs looked scarred on both sides. Caller stated that "one doctor felt like a nodule, but another doctor didn't feel it." She was told she had partial collapsing in the bottom and upper lung known as atelectasis. She was "high risk due to a pre-existing rare lung disease, in which her right lung is attached to her rib cage." Caller asked if her reactions have been reported, caller asked if any rare reactions have been reported, Caller asked if her reaction would be considered an allergic reaction or hypersensitivity reaction, Caller asked if any ingredient of the vaccine would produce inflammation or pain that she has experienced. Caller stated the leaflet on some medications states to not take the vaccine or any vaccines while taking the medication. Caller asked, "Can you be on certain medications that may react with the vaccine?" Caller was referring to any antibiotics and prednisone. Caller also asked if the Covid virus was always present with a fever. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Inflammation, Ocular hyperaemia, Pain
Clinical narrative: her lungs looked scarred on both sides.; partial collapsing in the bottom and upper lung known as atelectasis; she had sharp pains in her chest, back, and in different parts of her body.; she had sharp pains in her chest, back, and in different parts of her body.; she had sharp pains in her chest, back, and in different parts of her body.; headaches; a blood spot" on her arm near the injection site, described as a "blood circle."; ashortness of breath; redness around her nose, eyes; redness around her nose, eyes; pain in her eyes; her lungs looked scarred on both sides. Caller states that "one doctor felt like a nodule, but another doctor didn't feel it."; inflammation; This is a spontaneous report from a contactable consumer (the patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included rare lung disease, in which her right lung is attached to her rib cage. The patient's concomitant medications were not reported. Caller stated that she was having a hard time finding a place that would administer the second dose to her. She did not want to go back to the original site. Caller was worried about receiving left over Pfizer Covid-19 vaccines from an original site. Caller stated that the vaccine was being stored in a refrigerator around "7 degrees" but she wasn't sure that is a guaranteed temperature. Caller received the first dose of the Pfizer Covid-19 vaccine and stated that she had sharp pains in her chest, back, and in different parts of her body. She also had headaches, "a blood spot" on her arm near/under the injection site, described as a "blood circle." She experienced shortness of breath, redness around her nose, eyes, and pain in her eyes. She went to the emergency room/ hospital three times within three months. She just went to the ER, she was never admitted. A doctor said her lungs looked scarred on both sides. Caller stated that "one doctor felt like a nodule, but another doctor didn't feel it." She was told she had partial collapsing in the bottom and upper lung known as atelectasis. She was "high risk due to a pre-existing rare lung disease, in which her right lung is attached to her rib cage." Caller asked if her reactions have been reported, caller asked if any rare reactions have been reported, Caller asked if her reaction would be considered an allergic reaction or hypersensitivity reaction, Caller asked if any ingredient of the vaccine would produce inflammation or pain that she has experienced. Caller stated the leaflet on some medications states to not take the vaccine or any vaccines while taking the medication. Caller asked, "Can you be on certain medications that may react with the vaccine?" Caller was referring to any antibiotics and prednisone. Caller also asked if the Covid virus was always present with a fever. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary fibrosis, Pulmonary mass, Vaccination site haemorrhage
Clinical narrative: her lungs looked scarred on both sides.; partial collapsing in the bottom and upper lung known as atelectasis; she had sharp pains in her chest, back, and in different parts of her body.; she had sharp pains in her chest, back, and in different parts of her body.; she had sharp pains in her chest, back, and in different parts of her body.; headaches; a blood spot" on her arm near the injection site, described as a "blood circle."; ashortness of breath; redness around her nose, eyes; redness around her nose, eyes; pain in her eyes; her lungs looked scarred on both sides. Caller states that "one doctor felt like a nodule, but another doctor didn't feel it."; inflammation; This is a spontaneous report from a contactable consumer (the patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included rare lung disease, in which her right lung is attached to her rib cage. The patient's concomitant medications were not reported. Caller stated that she was having a hard time finding a place that would administer the second dose to her. She did not want to go back to the original site. Caller was worried about receiving left over Pfizer Covid-19 vaccines from an original site. Caller stated that the vaccine was being stored in a refrigerator around "7 degrees" but she wasn't sure that is a guaranteed temperature. Caller received the first dose of the Pfizer Covid-19 vaccine and stated that she had sharp pains in her chest, back, and in different parts of her body. She also had headaches, "a blood spot" on her arm near/under the injection site, described as a "blood circle." She experienced shortness of breath, redness around her nose, eyes, and pain in her eyes. She went to the emergency room/ hospital three times within three months. She just went to the ER, she was never admitted. A doctor said her lungs looked scarred on both sides. Caller stated that "one doctor felt like a nodule, but another doctor didn't feel it." She was told she had partial collapsing in the bottom and upper lung known as atelectasis. She was "high risk due to a pre-existing rare lung disease, in which her right lung is attached to her rib cage." Caller asked if her reactions have been reported, caller asked if any rare reactions have been reported, Caller asked if her reaction would be considered an allergic reaction or hypersensitivity reaction, Caller asked if any ingredient of the vaccine would produce inflammation or pain that she has experienced. Caller stated the leaflet on some medications states to not take the vaccine or any vaccines while taking the medication. Caller asked, "Can you be on certain medications that may react with the vaccine?" Caller was referring to any antibiotics and prednisone. Caller also asked if the Covid virus was always present with a fever. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: cellulitis; This is a spontaneous report from a contactable pharmacist (patient). This 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced cellulitis (hospitalization) on an unspecified date in 2021. The patient received the first dose of the Pfizer Covid 19 vaccine on 28Mar2021. The second dose was due on 18Apr2021. He was hospitalized due to cellulitis and missed the second dose. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Limited information can not support a complete medical assessment. A possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of cellulitis due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Dysstasia, Fatigue, Feeling abnormal
Clinical narrative: Fatigue; Her "stomach feels like there's a knife",; She feels like she's "about to die", "I feel awful".; Wasn't feeling well; She "can't stand up straight", she's not been out of the house since Tuesday; Not eating; Vomiting; has Arm pain; Can't get up hardly; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (at the age of 54-year-old) (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date for covid-19 immunisation and she was sick pretty bad too. The patient reported that she received the second dose of the vaccine on Tuesday and she felt like she was "about to die" and felt awful in 2021. She was not transferred to Safety since she wasn't feeling well. She stated since the second dose, she cannot stand up straight, she had not been out of the house since Tuesday, she was not eating, was vomiting, fatigue, her stomach felt like there was a knife, has arm pain, and she can't get up hardly. She was referred to her healthcare provider. Outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Pain in extremity, Vomiting
Clinical narrative: Fatigue; Her "stomach feels like there's a knife",; She feels like she's "about to die", "I feel awful".; Wasn't feeling well; She "can't stand up straight", she's not been out of the house since Tuesday; Not eating; Vomiting; has Arm pain; Can't get up hardly; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (at the age of 54-year-old) (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date for covid-19 immunisation and she was sick pretty bad too. The patient reported that she received the second dose of the vaccine on Tuesday and she felt like she was "about to die" and felt awful in 2021. She was not transferred to Safety since she wasn't feeling well. She stated since the second dose, she cannot stand up straight, she had not been out of the house since Tuesday, she was not eating, was vomiting, fatigue, her stomach felt like there was a knife, has arm pain, and she can't get up hardly. She was referred to her healthcare provider. Outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Loss of libido
Clinical narrative: developed Erectile Dysfunction; lost all desire for sex; This is a spontaneous report from a contactable consumer (the patient). A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173) via an unspecified route of administration in right arm on 01May2021 14:45 at age of 50-year-old at single dose for COVID-19 immunisation. Medical history included high cholesterol, headaches and chronic pain. Concomitant medications received within 2 weeks of vaccination included oxycodone, topiramate and metoclopramide, all taken for an unspecified indication from an unspecified date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) in right arm on 03Apr2021 02:45 PM at age of 50-year-old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. After the 2nd dose, the developed erectile dysfunction and lost all desire for sex on 02May2021. He had not been able to have sex and all desire has disappeared. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was not recovered. The case was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Disturbance in attention, Dizziness, Feeling abnormal
Clinical narrative: decreased ability to make decisions; Dizziness similar to vertigo;dizziness set in maybe 48 hours after my second dose and worsened over the following week; Dizziness similar to vertigo;dizziness set in maybe 48 hours after my second dose and worsened over the following week; was stimulated by movement, visual changes, and sounds independent of each other; was stimulated by movement, visual changes, and sounds independent of each other; Brain fog; inability to focus my attention; confusion as well as decreased ability to make decisions; Anxiety that was severe/Heightened anxiety levels have remained for almost a week; describe as a severe panic attack; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0179) as single dose for covid-19 immunisation at the age of 34-year-old.  Medical history included ADHD, allergy to Bactrim. She has felt dizziness when had the middle ear suctioned out while having a tympanostomy. The patient previously received the dose 1 administered in Arm Left on 16Apr2021 (Batch/Lot Number: EW0161) as single dose for covid-19 immunisation at the age of 34-year-old. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and sertraline hydrochloride (ZOLOFT). On 09May2021, the patient experienced dizziness that similar to vertigo, that was stimulated by movement, visual changes, and sounds independent of each other. The only time I've felt similar dizziness is when I've had my middle ear suctioned out while having a tympanostomy. The dizziness set in maybe 48 hours after my second dose and worsened over the following week and then started to lessen; also felt brain fog that included inability to focus my attention, switch between tasks effectively, and confusion as well as decreased ability to make decisions. This brain fog has lasted well over a week now but is starting to abate; and also experienced anxiety that was severe. A week after my second dose, I had what I can only describe as a severe panic attack. I have never had one this severe and have not had a panic attack in well over a decade. The panic attack was not preceded by any event that I would characterize as outside the realm of normal levels of stress. Heightened anxiety levels have remained for almost a week now but are slowly dissipating. The outcome of the events was recovering. No treatment received for the events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired healing, Mental impairment, Panic attack, Vertigo, Visual impairment
Clinical narrative: decreased ability to make decisions; Dizziness similar to vertigo;dizziness set in maybe 48 hours after my second dose and worsened over the following week; Dizziness similar to vertigo;dizziness set in maybe 48 hours after my second dose and worsened over the following week; was stimulated by movement, visual changes, and sounds independent of each other; was stimulated by movement, visual changes, and sounds independent of each other; Brain fog; inability to focus my attention; confusion as well as decreased ability to make decisions; Anxiety that was severe/Heightened anxiety levels have remained for almost a week; describe as a severe panic attack; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0179) as single dose for covid-19 immunisation at the age of 34-year-old.  Medical history included ADHD, allergy to Bactrim. She has felt dizziness when had the middle ear suctioned out while having a tympanostomy. The patient previously received the dose 1 administered in Arm Left on 16Apr2021 (Batch/Lot Number: EW0161) as single dose for covid-19 immunisation at the age of 34-year-old. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and sertraline hydrochloride (ZOLOFT). On 09May2021, the patient experienced dizziness that similar to vertigo, that was stimulated by movement, visual changes, and sounds independent of each other. The only time I've felt similar dizziness is when I've had my middle ear suctioned out while having a tympanostomy. The dizziness set in maybe 48 hours after my second dose and worsened over the following week and then started to lessen; also felt brain fog that included inability to focus my attention, switch between tasks effectively, and confusion as well as decreased ability to make decisions. This brain fog has lasted well over a week now but is starting to abate; and also experienced anxiety that was severe. A week after my second dose, I had what I can only describe as a severe panic attack. I have never had one this severe and have not had a panic attack in well over a decade. The panic attack was not preceded by any event that I would characterize as outside the realm of normal levels of stress. Heightened anxiety levels have remained for almost a week now but are slowly dissipating. The outcome of the events was recovering. No treatment received for the events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: have intense joint pain that I've never experienced before in my hands and feet; This is a spontaneous report from a contactable other hcp (consumer). A 42-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Feb2021 15:00 (Batch/Lot Number: En6203) as single for covid-19 immunisation at the age of 41-year-old. Medical history included allergies to gluten, soy, dairy, penicillin. The patient previously received the dose 1 (Batch/Lot Number: EL9265) as single for covid-19 immunisation at the age of 41-year-old. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. The patient reported I have intense joint pain that I've never experienced before in my hands and feet. The events started on 12Mar2021 and not recovered. No treatment received for the event. The event was reported as resulting in disability or permanent damage. The patient was not diagnosed with COVID-19 prior to vaccination and underwent Nasal Swab test on 16Apr2021 with result of negative.; Sender's Comments: The causal association between the reported event joint pain and vaccine administered cannot be excluded based on known drug profile and plausible temporal association.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Post menopause bleeding; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 15Mar2021 (Batch/Lot Number: EP7534) as single dose for covid-19 immunisation at the age of 55-year-old. Medical history included ongoing high blood pressure, Allergies shrimps. Concomitant medications included lisinopril and lovastatin. The patient experienced post menopause bleeding on 19May2021 with outcome of not recovered. No treatment received for the event. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination.  Information about lot/batch number was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itchy; hives all over her body/welts/Multiple whelps; This is a spontaneous report from a contactable nurse (patient's mother). A 15-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16May2021 (at the age of 15-years-old) (Lot Number: EW0161) as single dose for covid-19 immunisation.  Medical history included mensuration cramps. Concomitant medications included ibuprofen (MOTRIN) taken for mensuration cramps; paracetamol (TYLENOL) taken for mensuration cramps; ibuprofen taken for mensuration cramps. She was taking Motrin and Tylenol. Motrin was 200mg and she was taking, she didn't start Motrin until Wednesday, that would have been 18th and in 24hr. On Tuesday she took 400mg Motrin for the whole day and Yesterday she took about a 1000mg of Motrin in the 24 hour period. So she took it may be 3 times, so each pill is 200mg. She had her period and she was getting mensuration cramps, so that's why she was taking it. It's a gel cap. The Tylenol she was taking, she took on Wednesday that would have been the 17th she was taking Tylenol, so she was taking about a 1000mg coz they are 550mg per tablet and she was taking two times, may be three times. The patient received first of the vaccine on 16May2021. Last night 19May2021 around 11pm she was very itchy with hives/welts but then went away. Then at 4am extremely itchy on thighs stomach back, and then again today on wrist as well on thighs, stomach and back, down to her knees. She had been taking Benadryl and Zyrtec. She also got her period on 16May2021 and had been taking mostly TYLENOL and some ibuprofen. She usually took MOTRIN during her period and had no problems. The nurse stated "My daughter took the Pfizer vaccine on Sunday, 16May2021 and last night 19May2021 she developed multiple whelps, hives all over her body, her abdomen, her legs, very itchy and it still continued on today. Now, she's 15, I have not taken her to doctor but I do plan to do that tomorrow but since you have a calling number for adverse reaction then I'm thinking this might be a delayed reaction to the vaccine, I'm not sure. Does that spell familiar?" Nurse stated "I have given her Benadryl and Zyrtec, only 25mg she got one last night that may be 5 in the morning and then she took another one about an hour ago 25mg. Two Benadryl 25 & 25 today and last night and she took one Zyrtec. The Benadryl is in 25mg tablet orally. She took Zyrtec now, she took one its 10mg oral." The outcome of the events was not recovered. For Causality, Nurse stated, "That's what I'm thinking. She has not taken anything out of the normal, that the only thing I can think of. It could be."
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: throwing up non stop/throwing up all fluids now; feeling really woozy; Nauseous; Diarrhea; Sluggish; she broke out in a sweat; all her energy went away; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 20May2021 at 11:15 (Lot Number: EW0168) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she just got her first dose of Pfizer COVID vaccine at 11:15 am on 20May2021. At around 12:30 or 1pm, she started feeling really woozy and nauseous. Since 2:3 or 3:00pm, she has been throwing up non-stop. She stated that all her energy went away, felt sluggish was nauseous and she broke out in a sweat. She even had diarrhea a few times and that threw her off. She was throwing up all fluids now and she was scared to drink anything. The patient did not receive treatment for the events. the events did not require a visit to emergency room or physician office. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.