chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: little nervous; little more scary for her as she is kind of scared of anaphylaxis, normal anxiety range; sensation of throat fullness and tingling with a strange itchy feeling; sensation of throat fullness and tingling with a strange itchy feeling; sensation of throat fullness and tingling with a strange itchy feeling; allergic reaction; This is a spontaneous report from a contactable psychiatrist reported for herself and another physician and consumer. This female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunisation. Medical history included occupational exposure to COVID-19. The patient had been taking care of patients as a psychiatrist throughout this COVID-19 pandemic. Concomitant medications were not reported. The patient experienced a sensation of throat fullness and tingling with a strange itchy feeling about 10 minutes after the vaccine was given on 30Dec2020. The patient was monitored in the emergency room (ER) for six hours and did not need to give epinephrine (EPIPEN) or antihistamines and she was sent home. By the next morning, her throat was back to normal. The patient reported that she knew at least three other people who had the same reaction and had heard others too (AER 2021058666). The patient stated that she had read a bunch and there were differing theories on whether this is complement mediated, IgE or something else. The patient and her immunologist/allergist are trying to figure out how to go about next dose. Her immunologist/allergist wanted to do a skin test but it is impossible to get a sample of the second shot to do that. The patient and her immunologist/allergist were very reluctant for her to get it because of the uncertainty about the possibility of increased allergic reactions from the second shot. The patient is supposed to get next dose tomorrow 22Jan2021, but she is getting a little nervous about how much is unknown. At the same time, she is face-to-face with patients daily and does worry about her exposures. The patient wanted to get Pfizer opinion on all this if company think it would be worthwhile to "risk it" and just get the dose under observation with epinephrine around or if waiting for more information would be better. The patient stated that she was not an anxious person, but this one is a little more scary for her as she is kind of scared of anaphylaxis (which as a psychiatrist, she would put in normal anxiety range). Another reporter also mentioned the allergic reaction and asked if there is any possibility of getting a small sample of the second shot for skin testing and ask for advice on what the patient should do. The outcome of the events sensation of throat fullness and tingling with a strange itchy feeling and allergic reaction was resolved. The outcome of the other events was unknown.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hot flush, Hyperhidrosis, Lethargy, Nausea
Clinical narrative: dizziness. lightheadedness, hot flash, dizzy, shaky. Had similar reaction on 1st vaccine 1/7/2021. BP 137/83 P= 97 16:05      137/86 P=82 16:20     Benadryl 50mg X dose 16:22 Standing after RX BP - 133/92 PR 93
Age: 50.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hot flush, Tremor
Clinical narrative: dizziness. lightheadedness, hot flash, dizzy, shaky. Had similar reaction on 1st vaccine 1/7/2021. BP 137/83 P= 97 16:05      137/86 P=82 16:20     Benadryl 50mg X dose 16:22 Standing after RX BP - 133/92 PR 93
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: After the vaccine was given, Patient stated  her heart became racing. Pulse taken at the time listed it as 180. Patient also said she felt like she could not talk as if the words would not come out. She felt like she could not feel her arms and legs and felt numbness in her chest. Dizziness also occurred.  Vision became blurry. That night after being released from the hospital she still had trouble walking . To this day she suffers from intense brain fog. She says she has so much to say but it wont come out. She still is having trouble walking, her gait is very unsteady. She finds herself unable to work like before and suffers from confusion.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: After the vaccine was given, Patient stated  her heart became racing. Pulse taken at the time listed it as 180. Patient also said she felt like she could not talk as if the words would not come out. She felt like she could not feel her arms and legs and felt numbness in her chest. Dizziness also occurred.  Vision became blurry. That night after being released from the hospital she still had trouble walking . To this day she suffers from intense brain fog. She says she has so much to say but it wont come out. She still is having trouble walking, her gait is very unsteady. She finds herself unable to work like before and suffers from confusion.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF volume, Computerised tomogram, Confusional state, Dizziness, Dysarthria
Clinical narrative: After the vaccine was given, Patient stated  her heart became racing. Pulse taken at the time listed it as 180. Patient also said she felt like she could not talk as if the words would not come out. She felt like she could not feel her arms and legs and felt numbness in her chest. Dizziness also occurred.  Vision became blurry. That night after being released from the hospital she still had trouble walking . To this day she suffers from intense brain fog. She says she has so much to say but it wont come out. She still is having trouble walking, her gait is very unsteady. She finds herself unable to work like before and suffers from confusion.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Gait disturbance, Heart rate increased, Hypoaesthesia, Impaired work ability
Clinical narrative: After the vaccine was given, Patient stated  her heart became racing. Pulse taken at the time listed it as 180. Patient also said she felt like she could not talk as if the words would not come out. She felt like she could not feel her arms and legs and felt numbness in her chest. Dizziness also occurred.  Vision became blurry. That night after being released from the hospital she still had trouble walking . To this day she suffers from intense brain fog. She says she has so much to say but it wont come out. She still is having trouble walking, her gait is very unsteady. She finds herself unable to work like before and suffers from confusion.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Palpitations, Vision blurred
Clinical narrative: After the vaccine was given, Patient stated  her heart became racing. Pulse taken at the time listed it as 180. Patient also said she felt like she could not talk as if the words would not come out. She felt like she could not feel her arms and legs and felt numbness in her chest. Dizziness also occurred.  Vision became blurry. That night after being released from the hospital she still had trouble walking . To this day she suffers from intense brain fog. She says she has so much to say but it wont come out. She still is having trouble walking, her gait is very unsteady. She finds herself unable to work like before and suffers from confusion.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood blister, Contusion, Rash
Clinical narrative: Thrombocytopenia/lowplatelet; A spontaneous report was received from a caregiver concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombocytopenia/low platelet count.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 18 Jan 2021 at 04:00 pm, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient was hospitalized for thrombocytopenia/low platelet count, the patient was in emergency room and was given a strong dose of steroid. Her body did not react to it and she was then given a platelet transfusion. The doctors have given her steroids, immunoglobulin and aminocaproic acid during the hospitalization. They were discussing the next steps of therapy and plan to try rituximab.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event thrombocytopenia/low platelet count was unknown.; Reporter's Comments: This case concerns a 72-year-old, female patient, who experienced a serious unexpected event of thrombocytopenia. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included steroids, platelet transfusion, immunoglobulin, Amicar and pending treatment with Rituximab. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Platelet count decreased, Thrombocytopenia
Clinical narrative: Thrombocytopenia/lowplatelet; A spontaneous report was received from a caregiver concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombocytopenia/low platelet count.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 18 Jan 2021 at 04:00 pm, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient was hospitalized for thrombocytopenia/low platelet count, the patient was in emergency room and was given a strong dose of steroid. Her body did not react to it and she was then given a platelet transfusion. The doctors have given her steroids, immunoglobulin and aminocaproic acid during the hospitalization. They were discussing the next steps of therapy and plan to try rituximab.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event thrombocytopenia/low platelet count was unknown.; Reporter's Comments: This case concerns a 72-year-old, female patient, who experienced a serious unexpected event of thrombocytopenia. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included steroids, platelet transfusion, immunoglobulin, Amicar and pending treatment with Rituximab. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Platelet transfusion, Thrombocytopenia
Clinical narrative: Thrombocytopenia/lowplatelet; A spontaneous report was received from a caregiver concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombocytopenia/low platelet count.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 18 Jan 2021 at 04:00 pm, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient was hospitalized for thrombocytopenia/low platelet count, the patient was in emergency room and was given a strong dose of steroid. Her body did not react to it and she was then given a platelet transfusion. The doctors have given her steroids, immunoglobulin and aminocaproic acid during the hospitalization. They were discussing the next steps of therapy and plan to try rituximab.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event thrombocytopenia/low platelet count was unknown.; Reporter's Comments: This case concerns a 72-year-old, female patient, who experienced a serious unexpected event of thrombocytopenia. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included steroids, platelet transfusion, immunoglobulin, Amicar and pending treatment with Rituximab. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling cold, Nausea, Paraesthesia
Clinical narrative: very cold; nausea; weak; light headed; tingly sensation in my limbs (like little needles); This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: EL3247), via an unspecified route of administration at the right arm on 19Jan2021 08:00 AM (as reported) at a single dose for covid-19 immunization. Medical history included sarcoid and premature heart disease. The patient was not pregnant at the time of vaccination. Concomitant medication included atorvastatin, rabeprazole, acetylsalicylic acid (ASPRIN) and chlorthalidone. On 12Jan2021 10:30 pm, the patient experienced very cold, nausea, weak, light-headed, tingly sensation in my limbs (like little needles). The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Feeling cold, Nausea, Paraesthesia
Clinical narrative: very cold; nausea; weak; light headed; tingly sensation in my limbs (like little needles); This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: EL3247), via an unspecified route of administration at the right arm on 19Jan2021 08:00 AM (as reported) at a single dose for covid-19 immunization. Medical history included sarcoid and premature heart disease. The patient was not pregnant at the time of vaccination. Concomitant medication included atorvastatin, rabeprazole, acetylsalicylic acid (ASPRIN) and chlorthalidone. On 12Jan2021 10:30 pm, the patient experienced very cold, nausea, weak, light-headed, tingly sensation in my limbs (like little needles). The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: arm pain; fatigue; beginning 1/13 a constant high pitch whine in whole head; probably tinnitus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Jan2021 at 07:30, at a single dose, for COVID-19 immunization. Medical history included seasonal allergies and mild jackfruit allergy. Concomitant medications included testosterone, finasteride, and unspecified vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 21Dec2020, at 07:30 AM, in the left arm, for COVID-19 immunization and experienced arm pain and fatigue. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On an unspecified date, the patient had arm pain and fatigue from second dose but milder. On 13Jan2021, at 07:00 AM, the patient experienced a constant high pitch whine in whole head, probably tinnitus. The patient has not sought medical attention yet. The events were considered non-serious. Outcome of the events "beginning 1/13 a constant high pitch whine in whole head" and tinnitus was not recovered, while outcome of the other events was unknown. The patient has not been tested for COVID-19 since vaccination.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Head discomfort, Pain in extremity, Tinnitus
Clinical narrative: arm pain; fatigue; beginning 1/13 a constant high pitch whine in whole head; probably tinnitus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Jan2021 at 07:30, at a single dose, for COVID-19 immunization. Medical history included seasonal allergies and mild jackfruit allergy. Concomitant medications included testosterone, finasteride, and unspecified vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 21Dec2020, at 07:30 AM, in the left arm, for COVID-19 immunization and experienced arm pain and fatigue. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On an unspecified date, the patient had arm pain and fatigue from second dose but milder. On 13Jan2021, at 07:00 AM, the patient experienced a constant high pitch whine in whole head, probably tinnitus. The patient has not sought medical attention yet. The events were considered non-serious. Outcome of the events "beginning 1/13 a constant high pitch whine in whole head" and tinnitus was not recovered, while outcome of the other events was unknown. The patient has not been tested for COVID-19 since vaccination.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; headache; fever; body aches; This is a spontaneous report from a contactable other Healthcare professional reporting for himself. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1283), via an unspecified route of administration on 20Jan2021 10:00 at SINGLE DOSE (left arm) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccines were taken in four weeks. Patient did not have COVID-19 prior vaccination and patient was not tested for COVID-19 post vaccination. The patient previously look the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (Lot number: Ek5730) on 28Dec2020, 10:00 AM, left arm for covid-19 immunisation. The patient experienced chills, headache, fever, body aches on 20Jan2021 22:00. Treatment was not given. Outcome of the event was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Nausea, Palpitations
Clinical narrative: felt "winded"/Increasing shortness of breath; nauseous; This is a spontaneous report from a contactable nurse (patient). This 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3248) via an unspecified route of administration in the left arm on 19Jan2021 at 12:30 at the age of 54-year-old at single dose for COVID-19 immunisation. The patient was not pregnant.  Relevant medical history included hypertension and obesity. Concomitant medication included vitamin C. The patient had a past drug history of allergy with hydromorphone hydrochloride (DILAUDID); she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231) on 29Dec2020 at 08:30 in the left arm and she experienced nausea and palpitations. On 20Jan2021 at 19:00, the patient felt "winded" and nauseous with increasing shortness of breath, particularly with having to apply mask. The patient did not receive corrective treatments. The patient did not have COVID-19 prior to vaccination, and she had not been tested for COVID-19 post vaccination. She was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057652 Same patient, same drug, different dose/event
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Nausea
Clinical narrative: felt "winded"/Increasing shortness of breath; nauseous; This is a spontaneous report from a contactable nurse (patient). This 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3248) via an unspecified route of administration in the left arm on 19Jan2021 at 12:30 at the age of 54-year-old at single dose for COVID-19 immunisation. The patient was not pregnant.  Relevant medical history included hypertension and obesity. Concomitant medication included vitamin C. The patient had a past drug history of allergy with hydromorphone hydrochloride (DILAUDID); she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231) on 29Dec2020 at 08:30 in the left arm and she experienced nausea and palpitations. On 20Jan2021 at 19:00, the patient felt "winded" and nauseous with increasing shortness of breath, particularly with having to apply mask. The patient did not receive corrective treatments. The patient did not have COVID-19 prior to vaccination, and she had not been tested for COVID-19 post vaccination. She was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057652 Same patient, same drug, different dose/event
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Herpes zoster, Imaging procedure, Ocular hyperaemia, Pruritus
Clinical narrative: Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. 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: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. 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: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema of eyelid, Eye pain, Herpes zoster, Ophthalmological examination abnormal, Tenderness
Clinical narrative: Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. 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: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: left arm numbness; lightheadedness; This is a spontaneous report from a contactable pharmacist. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), intramuscular on 22Dec2020 10:15 AM at single dose on left arm for COVID-19 immunization. Vaccine facility type is hospital. Patient is not pregnant. Medical history included latex allergies. The patient's concomitant medications were not reported (unknown if there are other medications in two weeks). The patient previously took codeine, ibuprofen and prednisone and experienced allergies. No other vaccines in four weeks. No COVID prior vaccination.  The patient experienced left arm numbness and lightheadedness on 22Dec2020 at 10:15 AM. Patient was awake, alert and oriented to date, place and person (AAOx3). Rapid response arrived and offered a snack and a drink. Patient was released after brief monitoring. No treatment was given for the events. Outcome of the events was recovered on an unspecified date. Patient was not tested for COVID post vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: nausea; lightheaded; heart pounding that went away and returned; HA; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1284, expiry: unknown), intramuscular in the right arm on 23Dec2020 17:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient had not covid prior to vaccination and no other vaccine in four weeks. The patient previously took ibuprofen and naproxen and experienced allergies. On 23Dec2020 at 17:00, the patient started having nausea, lightheaded and heart pounding that went away and returned. Patient also reported headache (HA). Rapid Response was called and patient was discharged. The events were not treated. The patient was not tested for Covid post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Nausea, Palpitations
Clinical narrative: nausea; lightheaded; heart pounding that went away and returned; HA; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1284, expiry: unknown), intramuscular in the right arm on 23Dec2020 17:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient had not covid prior to vaccination and no other vaccine in four weeks. The patient previously took ibuprofen and naproxen and experienced allergies. On 23Dec2020 at 17:00, the patient started having nausea, lightheaded and heart pounding that went away and returned. Patient also reported headache (HA). Rapid Response was called and patient was discharged. The events were not treated. The patient was not tested for Covid post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia, Pain, Pyrexia
Clinical narrative: Headache; Body aches; Fever; Insomnia; This is a spontaneous report from a contactable healthcare professional (reported for himself). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), intramuscular in the left arm on 19Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 on 29Dec2020 16:30 in the left arm for COVID-19 immunization. No other vaccines received within prior to COVID vaccine and no other medications received within 2 weeks of vaccination. The patient experienced headache, body aches, fever, and insomnia on 21Jan2021 07:30. The reported events were non-serious. No treatment received for reported events. The outcome of the events was recovered on 21Jan2021.   Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Headache, Periorbital swelling, Throat irritation
Clinical narrative: feeling some increasing shortness of breath; feeling some increasing shortness of breath; scratchy throat; some swelling in her bilateral periorbital area; have a mild headache; This is a spontaneous report from a contactable Pharmacist.  A 38-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL3302) intramuscular at single dose at right arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital.  Medical history included, chronic headaches and vertigo, depression, type 2 diabetes mellitus (DMT2), hypertension, vitamin d deficiency, sleep apnoea syndrome (OSA), chronic pain, psoriatic arthropathy, allergies: ACE inhibtors, gabapentin, lisinopril, Lyrica, milk products, nuts. Patient was not pregnant.  The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: amlodipine (manufacturer unknown) 2.5mg, apremilast (manufacturer unknown), bupropion (manufacturer unknown) 150mg bid, calcipotriene (manufacturer unknown) topical, carvedilol (manufacturer unknown) 12.5mg bid, ergocalciferol (VIT D, manufacturer unknown) 1000 units, duloxetine (manufacturer unknown) 20mg bid, dicyclomine (manufacturer unknown) 20mg qid, losartan (manufacturer unknown) 50mg qday.  The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) intramuscular at single dose at left arm on 23Dec2020 12:30 PM for Covid-19 immunisation, administered at hospital. Patient denied any allergic reaction to the initial dose of Covid vaccine. No other vaccine has been received in 4 weeks. On 14Jan2021 12:00 PM after vaccination, she has being monitored for the mandatory 15-30 minute period, when she started feeling some increasing shortness of breath, scratchy throat, some swelling in her bilateral periorbital area. She was then taken to the ED for further evaluation. Patient denied any allergic reaction to the initial Covid vaccine 3 weeks before. She denied any abdominal pain, diarrhea, nausea, vomiting, chest pain, shortness of breath. She had a mild headache. In ED, patient received treatment with diphenhydramine 25mg IV, epinephrine 0.3mg IM, famotidine 20mg IV and dexamethasone 10mg IV, and LR 1,000mL bolus @ 1228, ketorolac 15mg @1312, ondansetron 4mg @1312. Patient monitored and discharged at 1530. Post vaccination, the patient has been tested with nasal swab for COVID-19 and resulted negative on 15Jan2021. Therapeutic measures were taken as a result of events. The outcome of recovered in Jan2021.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Periorbital swelling, SARS-CoV-2 test negative, Throat irritation
Clinical narrative: feeling some increasing shortness of breath; feeling some increasing shortness of breath; scratchy throat; some swelling in her bilateral periorbital area; have a mild headache; This is a spontaneous report from a contactable Pharmacist.  A 38-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL3302) intramuscular at single dose at right arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital.  Medical history included, chronic headaches and vertigo, depression, type 2 diabetes mellitus (DMT2), hypertension, vitamin d deficiency, sleep apnoea syndrome (OSA), chronic pain, psoriatic arthropathy, allergies: ACE inhibtors, gabapentin, lisinopril, Lyrica, milk products, nuts. Patient was not pregnant.  The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: amlodipine (manufacturer unknown) 2.5mg, apremilast (manufacturer unknown), bupropion (manufacturer unknown) 150mg bid, calcipotriene (manufacturer unknown) topical, carvedilol (manufacturer unknown) 12.5mg bid, ergocalciferol (VIT D, manufacturer unknown) 1000 units, duloxetine (manufacturer unknown) 20mg bid, dicyclomine (manufacturer unknown) 20mg qid, losartan (manufacturer unknown) 50mg qday.  The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) intramuscular at single dose at left arm on 23Dec2020 12:30 PM for Covid-19 immunisation, administered at hospital. Patient denied any allergic reaction to the initial dose of Covid vaccine. No other vaccine has been received in 4 weeks. On 14Jan2021 12:00 PM after vaccination, she has being monitored for the mandatory 15-30 minute period, when she started feeling some increasing shortness of breath, scratchy throat, some swelling in her bilateral periorbital area. She was then taken to the ED for further evaluation. Patient denied any allergic reaction to the initial Covid vaccine 3 weeks before. She denied any abdominal pain, diarrhea, nausea, vomiting, chest pain, shortness of breath. She had a mild headache. In ED, patient received treatment with diphenhydramine 25mg IV, epinephrine 0.3mg IM, famotidine 20mg IV and dexamethasone 10mg IV, and LR 1,000mL bolus @ 1228, ketorolac 15mg @1312, ondansetron 4mg @1312. Patient monitored and discharged at 1530. Post vaccination, the patient has been tested with nasal swab for COVID-19 and resulted negative on 15Jan2021. Therapeutic measures were taken as a result of events. The outcome of recovered in Jan2021.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Bilirubin conjugated, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: Acute hemolytic anemia; Felt pale and tachycardic; Felt pale and tachycardic; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscularly on 06Jan2021 12:30 on Left arm at single dose for COVID-19 immunization, facility where the most recent COVID-19 vaccine was administered in Hospital; pembrolizumab (KEYTRUDA), via unspecified route of administration from 01Dec2020 and from 22Dec2020 at unspecified dosage for unspecified indication. Medical history included thymic carcinoma stage IV, Allergy to adhesive tape. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number=EJ1685) intramuscularly on 18Dec2020 14:15 on Left arm for COVID-19 immunization. It was reported that patient was receiving Keytruda (01Dec2020 and 22Dec2020) which could cause hemolytic anemia. Labs were stable on 22Dec2020. Patient felt pale and tachycardic the next day (07Jan2021) but didn't notify us. He had follow-up on 1/12/2021 at the cancer center. The labs were consistent with acute hemolytic anemia (12Jan2021 at 08:00 AM), and patient was closely followed by hematology. He was on immunotherapy for cancer treatment, but there was concern for COVID vaccine contributing the hemolytic anemia. Events were result in doctor or other healthcare professional office/clinic visit. Treatment received for acute hemolytic anemia included blood transfusion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The action taken for pembrolizumab was unknown. The outcome of the events were not resolved.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events acute hemolytic anemia, pallor and tachycardia cannot be completely excluded. concomitant use of KEYTRUDA and patient's underlying medical condition may have also contributed to reported events. The case will be reevaluated should additional information become available. 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: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood bilirubin increased, Blood bilirubin unconjugated increased, Blood chloride increased, Blood creatinine decreased, Blood glucose normal
Clinical narrative: Acute hemolytic anemia; Felt pale and tachycardic; Felt pale and tachycardic; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscularly on 06Jan2021 12:30 on Left arm at single dose for COVID-19 immunization, facility where the most recent COVID-19 vaccine was administered in Hospital; pembrolizumab (KEYTRUDA), via unspecified route of administration from 01Dec2020 and from 22Dec2020 at unspecified dosage for unspecified indication. Medical history included thymic carcinoma stage IV, Allergy to adhesive tape. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number=EJ1685) intramuscularly on 18Dec2020 14:15 on Left arm for COVID-19 immunization. It was reported that patient was receiving Keytruda (01Dec2020 and 22Dec2020) which could cause hemolytic anemia. Labs were stable on 22Dec2020. Patient felt pale and tachycardic the next day (07Jan2021) but didn't notify us. He had follow-up on 1/12/2021 at the cancer center. The labs were consistent with acute hemolytic anemia (12Jan2021 at 08:00 AM), and patient was closely followed by hematology. He was on immunotherapy for cancer treatment, but there was concern for COVID vaccine contributing the hemolytic anemia. Events were result in doctor or other healthcare professional office/clinic visit. Treatment received for acute hemolytic anemia included blood transfusion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The action taken for pembrolizumab was unknown. The outcome of the events were not resolved.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events acute hemolytic anemia, pallor and tachycardia cannot be completely excluded. concomitant use of KEYTRUDA and patient's underlying medical condition may have also contributed to reported events. The case will be reevaluated should additional information become available. 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.