chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: eyes are swollen and itchy; eyes are swollen and itchy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at a single dose as a COVID-19 vaccine. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine) on an unspecified date. The patient just got the second vaccine and experienced side effects as eyes were swollen and itchy on an unspecified date and had to take Claritin and Benadryl. There was no swelling of the face/tongue. The patient was asking if this was normal and what should they do. Outcome of the events was unknown.  Information about the lot/batch has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache; extreme fatigue; all over body aches; stomach pain; diarrhea; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; This is a spontaneous report from a contactable healthcare professional (patient).  A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK-9231 and expiration date not reported), intramuscular on the right arm, on 07Jan2021 at 07:15 at a single dose for Covid-19 immunization. Medical history included fibromyalgia and chronic fatigue syndrome. The patient has no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. Concomitant medications included vitamin D, niacin, hydrocodone bitartrate, paracetamol (NORCO), and paracetamol (TYLENOL). On 07Jan2021 at 11:00AM, the patient experienced headache, extreme fatigue, all over body aches, stomach pain, diarrhea, and unable to move R arm due pain and swelling. The patient did not receive treatment for the adverse events. The patient underwent Covid test post vaccination (Antigen and PCR) and result was SARS-CoV-2 test negative on 11Jan2021. The outcome of the events was recovered/resolved in Jan2021. The reporter assessed the events as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Headache; extreme fatigue; all over body aches; stomach pain; diarrhea; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; This is a spontaneous report from a contactable healthcare professional (patient).  A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK-9231 and expiration date not reported), intramuscular on the right arm, on 07Jan2021 at 07:15 at a single dose for Covid-19 immunization. Medical history included fibromyalgia and chronic fatigue syndrome. The patient has no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. Concomitant medications included vitamin D, niacin, hydrocodone bitartrate, paracetamol (NORCO), and paracetamol (TYLENOL). On 07Jan2021 at 11:00AM, the patient experienced headache, extreme fatigue, all over body aches, stomach pain, diarrhea, and unable to move R arm due pain and swelling. The patient did not receive treatment for the adverse events. The patient underwent Covid test post vaccination (Antigen and PCR) and result was SARS-CoV-2 test negative on 11Jan2021. The outcome of the events was recovered/resolved in Jan2021. The reporter assessed the events as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Headache; extreme fatigue; all over body aches; stomach pain; diarrhea; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; This is a spontaneous report from a contactable healthcare professional (patient).  A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK-9231 and expiration date not reported), intramuscular on the right arm, on 07Jan2021 at 07:15 at a single dose for Covid-19 immunization. Medical history included fibromyalgia and chronic fatigue syndrome. The patient has no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. Concomitant medications included vitamin D, niacin, hydrocodone bitartrate, paracetamol (NORCO), and paracetamol (TYLENOL). On 07Jan2021 at 11:00AM, the patient experienced headache, extreme fatigue, all over body aches, stomach pain, diarrhea, and unable to move R arm due pain and swelling. The patient did not receive treatment for the adverse events. The patient underwent Covid test post vaccination (Antigen and PCR) and result was SARS-CoV-2 test negative on 11Jan2021. The outcome of the events was recovered/resolved in Jan2021. The reporter assessed the events as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Smear test, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Headache; extreme fatigue; all over body aches; stomach pain; diarrhea; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; This is a spontaneous report from a contactable healthcare professional (patient).  A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK-9231 and expiration date not reported), intramuscular on the right arm, on 07Jan2021 at 07:15 at a single dose for Covid-19 immunization. Medical history included fibromyalgia and chronic fatigue syndrome. The patient has no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. Concomitant medications included vitamin D, niacin, hydrocodone bitartrate, paracetamol (NORCO), and paracetamol (TYLENOL). On 07Jan2021 at 11:00AM, the patient experienced headache, extreme fatigue, all over body aches, stomach pain, diarrhea, and unable to move R arm due pain and swelling. The patient did not receive treatment for the adverse events. The patient underwent Covid test post vaccination (Antigen and PCR) and result was SARS-CoV-2 test negative on 11Jan2021. The outcome of the events was recovered/resolved in Jan2021. The reporter assessed the events as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Headache; extreme fatigue; all over body aches; stomach pain; diarrhea; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; This is a spontaneous report from a contactable healthcare professional (patient).  A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK-9231 and expiration date not reported), intramuscular on the right arm, on 07Jan2021 at 07:15 at a single dose for Covid-19 immunization. Medical history included fibromyalgia and chronic fatigue syndrome. The patient has no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. Concomitant medications included vitamin D, niacin, hydrocodone bitartrate, paracetamol (NORCO), and paracetamol (TYLENOL). On 07Jan2021 at 11:00AM, the patient experienced headache, extreme fatigue, all over body aches, stomach pain, diarrhea, and unable to move R arm due pain and swelling. The patient did not receive treatment for the adverse events. The patient underwent Covid test post vaccination (Antigen and PCR) and result was SARS-CoV-2 test negative on 11Jan2021. The outcome of the events was recovered/resolved in Jan2021. The reporter assessed the events as non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood magnesium normal, Blood potassium decreased, Chest X-ray normal, Dyspnoea
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable nurse (patient) reported that a 43-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EK5730, expiration date: not reported), on 18Dec2020 16:30 then received the second dose on 08Jan2021 12:00 (lot number: EL3246, expiration date: not reported) both via an unspecified route of administration in the left arm at a single dose for covid-19 immunisation. Medical history included asthma, non-systemic vasculitic neuropathy left foot, seasonal allergies, allergies to tree nuts, peanuts, CT dye; all from unknown dates. Concomitant medications included prednisone, omeprazole, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and montelukast sodium (SINGULAIR).  The patient previously took compazine [prochlorperazine maleate] and experienced drug allergy. On 11Jan2021 09:00, the patient experienced anaphylaxis. The patient was required 11 hours in ER then ICU on epinephrine drip after 2 epinephrine IM shots, steroids, fluids, albuterol, oxygen, Pepcid, Benadryl. The reported event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021 covid test type post vaccination is Nasal Swab. The outcome of the event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. 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: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer normal, Full blood count, Headache, Human chorionic gonadotropin negative, Intensive care
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable nurse (patient) reported that a 43-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EK5730, expiration date: not reported), on 18Dec2020 16:30 then received the second dose on 08Jan2021 12:00 (lot number: EL3246, expiration date: not reported) both via an unspecified route of administration in the left arm at a single dose for covid-19 immunisation. Medical history included asthma, non-systemic vasculitic neuropathy left foot, seasonal allergies, allergies to tree nuts, peanuts, CT dye; all from unknown dates. Concomitant medications included prednisone, omeprazole, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and montelukast sodium (SINGULAIR).  The patient previously took compazine [prochlorperazine maleate] and experienced drug allergy. On 11Jan2021 09:00, the patient experienced anaphylaxis. The patient was required 11 hours in ER then ICU on epinephrine drip after 2 epinephrine IM shots, steroids, fluids, albuterol, oxygen, Pepcid, Benadryl. The reported event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021 covid test type post vaccination is Nasal Swab. The outcome of the event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. 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: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test abnormal, Nausea, Pain, Procalcitonin normal, Pruritus
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable nurse (patient) reported that a 43-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EK5730, expiration date: not reported), on 18Dec2020 16:30 then received the second dose on 08Jan2021 12:00 (lot number: EL3246, expiration date: not reported) both via an unspecified route of administration in the left arm at a single dose for covid-19 immunisation. Medical history included asthma, non-systemic vasculitic neuropathy left foot, seasonal allergies, allergies to tree nuts, peanuts, CT dye; all from unknown dates. Concomitant medications included prednisone, omeprazole, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and montelukast sodium (SINGULAIR).  The patient previously took compazine [prochlorperazine maleate] and experienced drug allergy. On 11Jan2021 09:00, the patient experienced anaphylaxis. The patient was required 11 hours in ER then ICU on epinephrine drip after 2 epinephrine IM shots, steroids, fluids, albuterol, oxygen, Pepcid, Benadryl. The reported event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021 covid test type post vaccination is Nasal Swab. The outcome of the event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. 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: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia, Urticaria, White blood cell count increased
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable nurse (patient) reported that a 43-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EK5730, expiration date: not reported), on 18Dec2020 16:30 then received the second dose on 08Jan2021 12:00 (lot number: EL3246, expiration date: not reported) both via an unspecified route of administration in the left arm at a single dose for covid-19 immunisation. Medical history included asthma, non-systemic vasculitic neuropathy left foot, seasonal allergies, allergies to tree nuts, peanuts, CT dye; all from unknown dates. Concomitant medications included prednisone, omeprazole, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and montelukast sodium (SINGULAIR).  The patient previously took compazine [prochlorperazine maleate] and experienced drug allergy. On 11Jan2021 09:00, the patient experienced anaphylaxis. The patient was required 11 hours in ER then ICU on epinephrine drip after 2 epinephrine IM shots, steroids, fluids, albuterol, oxygen, Pepcid, Benadryl. The reported event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021 covid test type post vaccination is Nasal Swab. The outcome of the event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. 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: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Intensive care, SARS-CoV-2 test negative
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable nurse (patient) reported that a 43-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EK5730, expiration date: not reported), on 18Dec2020 16:30 then received the second dose on 08Jan2021 12:00 (lot number: EL3246, expiration date: not reported) both via an unspecified route of administration in the left arm at a single dose for covid-19 immunisation. Medical history included asthma, non-systemic vasculitic neuropathy left foot, seasonal allergies, allergies to tree nuts, peanuts, CT dye; all from unknown dates. Concomitant medications included prednisone, omeprazole, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and montelukast sodium (SINGULAIR).  The patient previously took compazine [prochlorperazine maleate] and experienced drug allergy. On 11Jan2021 09:00, the patient experienced anaphylaxis. The patient was required 11 hours in ER then ICU on epinephrine drip after 2 epinephrine IM shots, steroids, fluids, albuterol, oxygen, Pepcid, Benadryl. The reported event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021 covid test type post vaccination is Nasal Swab. The outcome of the event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. 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: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Chest X-ray normal, Contusion, Dizziness
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable nurse (patient) reported that a 43-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EK5730, expiration date: not reported), on 18Dec2020 16:30 then received the second dose on 08Jan2021 12:00 (lot number: EL3246, expiration date: not reported) both via an unspecified route of administration in the left arm at a single dose for covid-19 immunisation. Medical history included asthma, non-systemic vasculitic neuropathy left foot, seasonal allergies, allergies to tree nuts, peanuts, CT dye; all from unknown dates. Concomitant medications included prednisone, omeprazole, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and montelukast sodium (SINGULAIR).  The patient previously took compazine [prochlorperazine maleate] and experienced drug allergy. On 11Jan2021 09:00, the patient experienced anaphylaxis. The patient was required 11 hours in ER then ICU on epinephrine drip after 2 epinephrine IM shots, steroids, fluids, albuterol, oxygen, Pepcid, Benadryl. The reported event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021 covid test type post vaccination is Nasal Swab. The outcome of the event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. 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: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Erythema, Headache, Hyperhidrosis
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable nurse (patient) reported that a 43-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EK5730, expiration date: not reported), on 18Dec2020 16:30 then received the second dose on 08Jan2021 12:00 (lot number: EL3246, expiration date: not reported) both via an unspecified route of administration in the left arm at a single dose for covid-19 immunisation. Medical history included asthma, non-systemic vasculitic neuropathy left foot, seasonal allergies, allergies to tree nuts, peanuts, CT dye; all from unknown dates. Concomitant medications included prednisone, omeprazole, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and montelukast sodium (SINGULAIR).  The patient previously took compazine [prochlorperazine maleate] and experienced drug allergy. On 11Jan2021 09:00, the patient experienced anaphylaxis. The patient was required 11 hours in ER then ICU on epinephrine drip after 2 epinephrine IM shots, steroids, fluids, albuterol, oxygen, Pepcid, Benadryl. The reported event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021 covid test type post vaccination is Nasal Swab. The outcome of the event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. 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: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oropharyngeal discomfort, Pain, Pruritus
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable nurse (patient) reported that a 43-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EK5730, expiration date: not reported), on 18Dec2020 16:30 then received the second dose on 08Jan2021 12:00 (lot number: EL3246, expiration date: not reported) both via an unspecified route of administration in the left arm at a single dose for covid-19 immunisation. Medical history included asthma, non-systemic vasculitic neuropathy left foot, seasonal allergies, allergies to tree nuts, peanuts, CT dye; all from unknown dates. Concomitant medications included prednisone, omeprazole, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and montelukast sodium (SINGULAIR).  The patient previously took compazine [prochlorperazine maleate] and experienced drug allergy. On 11Jan2021 09:00, the patient experienced anaphylaxis. The patient was required 11 hours in ER then ICU on epinephrine drip after 2 epinephrine IM shots, steroids, fluids, albuterol, oxygen, Pepcid, Benadryl. The reported event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021 covid test type post vaccination is Nasal Swab. The outcome of the event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. 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: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Rash, Tenderness
Clinical narrative: Diffuse rash and left supraclavicular lymphadenopathy; Diffuse rash and left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EL0142) via an unspecified route of administration into the left arm on 09Jan2021 08:45 at a single dose for covid-19 immunisation. Medical history was reported as non. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:ES1685) via an unspecified route of administration into the left arm on 19Dec2020 08:45 at a single dose for covid-19 immunization. On 09Jan2021 20:00, it was reported that the patient experienced diffuse rash and left supraclavicular lymphadenopathy. It was also reported that the events reported was treated with loratadine (CLARITIN). Patient was not pregnant. Outcome of events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Diffuse rash and left supraclavicular lymphadenopathy; Diffuse rash and left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EL0142) via an unspecified route of administration into the left arm on 09Jan2021 08:45 at a single dose for covid-19 immunisation. Medical history was reported as non. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:ES1685) via an unspecified route of administration into the left arm on 19Dec2020 08:45 at a single dose for covid-19 immunization. On 09Jan2021 20:00, it was reported that the patient experienced diffuse rash and left supraclavicular lymphadenopathy. It was also reported that the events reported was treated with loratadine (CLARITIN). Patient was not pregnant. Outcome of events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Erythema, Fatigue, Hypoaesthesia, Influenza like illness
Clinical narrative: Flu-like symptoms; Bilateral cheek numbness; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: El0140), intramuscular in right arm, on 18Dec2020 at 14:30, at a single dose, for COVID-19 immunization. The patient's medical history included was not reported. The patient's concomitant medication included ascorbic acid (VITAMIN C). The patient previously took benzoyl peroxide and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital facility. On an unspecified date after the first dose, the patient experienced flu-like symptoms for 48 hours plus bilateral cheek numbness for two weeks. The events were considered non-serious. No treatment was received for the adverse events. The patient underwent laboratory tests and procedures which included nasal swab for Coronavirus Pandemic 2019-NCOV (NAA) that was negative on 04Jan2021. The patient recovered from the events on an unspecified date.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Flu-like symptoms; Bilateral cheek numbness; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: El0140), intramuscular in right arm, on 18Dec2020 at 14:30, at a single dose, for COVID-19 immunization. The patient's medical history included was not reported. The patient's concomitant medication included ascorbic acid (VITAMIN C). The patient previously took benzoyl peroxide and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital facility. On an unspecified date after the first dose, the patient experienced flu-like symptoms for 48 hours plus bilateral cheek numbness for two weeks. The events were considered non-serious. No treatment was received for the adverse events. The patient underwent laboratory tests and procedures which included nasal swab for Coronavirus Pandemic 2019-NCOV (NAA) that was negative on 04Jan2021. The patient recovered from the events on an unspecified date.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Influenza like illness, SARS-CoV-2 test
Clinical narrative: Flu-like symptoms; Bilateral cheek numbness; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: El0140), intramuscular in right arm, on 18Dec2020 at 14:30, at a single dose, for COVID-19 immunization. The patient's medical history included was not reported. The patient's concomitant medication included ascorbic acid (VITAMIN C). The patient previously took benzoyl peroxide and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital facility. On an unspecified date after the first dose, the patient experienced flu-like symptoms for 48 hours plus bilateral cheek numbness for two weeks. The events were considered non-serious. No treatment was received for the adverse events. The patient underwent laboratory tests and procedures which included nasal swab for Coronavirus Pandemic 2019-NCOV (NAA) that was negative on 04Jan2021. The patient recovered from the events on an unspecified date.
Age: 40.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Flushing, Myalgia, Nausea, Pruritus, Rash
Clinical narrative: Rash, hives, itching, tingly lips, heat, nausea. Benadryl and claritin. Hives and tingly lips went down after 1hr. Itching lasted 5 days.
Age: 40.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Feeling hot, Nausea, Paraesthesia oral, Pruritus, Rash
Clinical narrative: Rash, hives, itching, tingly lips, heat, nausea. Benadryl and claritin. Hives and tingly lips went down after 1hr. Itching lasted 5 days.
Age: 40.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Urticaria
Clinical narrative: Rash, hives, itching, tingly lips, heat, nausea. Benadryl and claritin. Hives and tingly lips went down after 1hr. Itching lasted 5 days.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Myalgias; fatigue; sweats; headache; chills; Fever/T max 102.6; This is a spontaneous report from a contactable physician. This 32-year-old male physician (patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1283), via unspecified route at left arm on 08Jan2021 04:45 pm at single dose for COVID-19 immunization. Medical history and concomitant drugs were not reported. Historical vaccine included the first dose of BNT162B2 (lot number= EK5730) for COVID-19 immunization on 18Dec2020 04:45 pm at left arm. Facility type vaccine was hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. On 09Jan2021 04:15 am, patient experienced fever/T max 102.6, myalgias, fatigue, sweats, headache and chills. No treatment was received for events. Outcome of events was recovering.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Myalgias; fatigue; sweats; headache; chills; Fever/T max 102.6; This is a spontaneous report from a contactable physician. This 32-year-old male physician (patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1283), via unspecified route at left arm on 08Jan2021 04:45 pm at single dose for COVID-19 immunization. Medical history and concomitant drugs were not reported. Historical vaccine included the first dose of BNT162B2 (lot number= EK5730) for COVID-19 immunization on 18Dec2020 04:45 pm at left arm. Facility type vaccine was hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. On 09Jan2021 04:15 am, patient experienced fever/T max 102.6, myalgias, fatigue, sweats, headache and chills. No treatment was received for events. Outcome of events was recovering.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgias; fatigue; sweats; headache; chills; Fever/T max 102.6; This is a spontaneous report from a contactable physician. This 32-year-old male physician (patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1283), via unspecified route at left arm on 08Jan2021 04:45 pm at single dose for COVID-19 immunization. Medical history and concomitant drugs were not reported. Historical vaccine included the first dose of BNT162B2 (lot number= EK5730) for COVID-19 immunization on 18Dec2020 04:45 pm at left arm. Facility type vaccine was hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. On 09Jan2021 04:15 am, patient experienced fever/T max 102.6, myalgias, fatigue, sweats, headache and chills. No treatment was received for events. Outcome of events was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Paraesthesia
Clinical narrative: after sleeping with her neck completely craned; paresthesia in the fingers of her left hand/right paresthesia on the sole of her foot; shock-like symptoms in both hands; Fever; Malaise; This is a spontaneous report from a contactable physician (patient). A female patient of unspecified age received BNT162B2 on 22Dec2020 first dose at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She had the first vaccination on 22Dec2020. Caller states she had a fever, malaise for 2 days afterwards (24Dec2020). Around Day 4 (26Dec2020), she developed paresthesia in the fingers of her left hand and stimulation in her left hand, there was quite a lot of involvement with her hand. She also developed right paresthesia on the sole of her foot which lasted a couple of days. She states she has never experienced the hand thing completely, for such an extensive time. She has experienced stuff before, but milder. She has never had paresthesia in 2 different places. It seems she was experiencing shock-like symptoms in both hands, that lasted about a week. She did have a neurologic assessment, just as exam, not a testing. But, she confirms the testing was fine. She experienced re-occurring paresthesia in her left hand this morning, but it was after sleeping with her neck completely craned. Caller stated she doesn't know if its vaccine related. Also, her second vaccine is due this week and she doesn't want it be worse. The outcome of event shock-like symptoms in both hands was recovered on 02Jan2021. The outcome of event paresthesia in the fingers of her left hand/right paresthesia on the sole of her foot was recovered. The outcome of other events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported "shock-like symptoms" cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Neurological examination normal, Paraesthesia, Posture abnormal, Pyrexia
Clinical narrative: after sleeping with her neck completely craned; paresthesia in the fingers of her left hand/right paresthesia on the sole of her foot; shock-like symptoms in both hands; Fever; Malaise; This is a spontaneous report from a contactable physician (patient). A female patient of unspecified age received BNT162B2 on 22Dec2020 first dose at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She had the first vaccination on 22Dec2020. Caller states she had a fever, malaise for 2 days afterwards (24Dec2020). Around Day 4 (26Dec2020), she developed paresthesia in the fingers of her left hand and stimulation in her left hand, there was quite a lot of involvement with her hand. She also developed right paresthesia on the sole of her foot which lasted a couple of days. She states she has never experienced the hand thing completely, for such an extensive time. She has experienced stuff before, but milder. She has never had paresthesia in 2 different places. It seems she was experiencing shock-like symptoms in both hands, that lasted about a week. She did have a neurologic assessment, just as exam, not a testing. But, she confirms the testing was fine. She experienced re-occurring paresthesia in her left hand this morning, but it was after sleeping with her neck completely craned. Caller stated she doesn't know if its vaccine related. Also, her second vaccine is due this week and she doesn't want it be worse. The outcome of event shock-like symptoms in both hands was recovered on 02Jan2021. The outcome of event paresthesia in the fingers of her left hand/right paresthesia on the sole of her foot was recovered. The outcome of other events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported "shock-like symptoms" cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Shock symptom
Clinical narrative: after sleeping with her neck completely craned; paresthesia in the fingers of her left hand/right paresthesia on the sole of her foot; shock-like symptoms in both hands; Fever; Malaise; This is a spontaneous report from a contactable physician (patient). A female patient of unspecified age received BNT162B2 on 22Dec2020 first dose at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She had the first vaccination on 22Dec2020. Caller states she had a fever, malaise for 2 days afterwards (24Dec2020). Around Day 4 (26Dec2020), she developed paresthesia in the fingers of her left hand and stimulation in her left hand, there was quite a lot of involvement with her hand. She also developed right paresthesia on the sole of her foot which lasted a couple of days. She states she has never experienced the hand thing completely, for such an extensive time. She has experienced stuff before, but milder. She has never had paresthesia in 2 different places. It seems she was experiencing shock-like symptoms in both hands, that lasted about a week. She did have a neurologic assessment, just as exam, not a testing. But, she confirms the testing was fine. She experienced re-occurring paresthesia in her left hand this morning, but it was after sleeping with her neck completely craned. Caller stated she doesn't know if its vaccine related. Also, her second vaccine is due this week and she doesn't want it be worse. The outcome of event shock-like symptoms in both hands was recovered on 02Jan2021. The outcome of event paresthesia in the fingers of her left hand/right paresthesia on the sole of her foot was recovered. The outcome of other events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported "shock-like symptoms" cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Migraine, Nausea
Clinical narrative: Patient reports she received the Moderna Covid 19 vaccine lot #039K20A on 12/31/2020. Patient reports on 1/08/2021 she developed a severe headache that continued for 3 days. Patient reports she self managed with Imitrex which was ineffective. Patient reports symptoms have since resolved. VAERS completed. D/c from EHS.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Patient reports she received the Moderna Covid 19 vaccine lot #039K20A on 12/31/2020. Patient reports on 1/08/2021 she developed a severe headache that continued for 3 days. Patient reports she self managed with Imitrex which was ineffective. Patient reports symptoms have since resolved. VAERS completed. D/c from EHS.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report from a contactable nurse.  A 44-year-old female nurse (Patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular at single dose into the left arm on an unknown date for COVID-19 immunization. The patient received second dose on 08Jan2021. Medical history included heart condition called Wolff-Parkinson-White but it happens once in a blue moon, like her heart rate goes fast but happens once in a blue moon. Concomitant drugs included Vitamin C, Iron, Vitamin D. The patient reported got her first and second shot, the only side effect was the soreness in the arm. She had slightly sore arm which you get normally from any vaccine. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021017999 Same patient/drug, different event seperated in time
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report from a contactable nurse.  A 44-year-old female nurse (Patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular at single dose into the left arm on an unknown date for COVID-19 immunization. The patient received second dose on 08Jan2021. Medical history included heart condition called Wolff-Parkinson-White but it happens once in a blue moon, like her heart rate goes fast but happens once in a blue moon. Concomitant drugs included Vitamin C, Iron, Vitamin D. The patient reported got her first and second shot, the only side effect was the soreness in the arm. She had slightly sore arm which you get normally from any vaccine. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021017999 Same patient/drug, different event seperated in time