chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness on arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "soreness on arm". Additional information: Caller wanted to know if it was okay to get eye surgery after getting first and second dose of covid-19 vaccine. Caller also stated she had soreness on arm after getting first dose 15Mar. Caller second dose was appointment on 05Apr, and eye surgery was on 07Apr. Relayed ISI. Caller disconnected during transfer. (Privacy) was not responding on call, so she disconnected due to lack of response. Will fax AE: side effect. There were not any unaddressed medical questions referred or forwarded to Medical Information. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". The reporter wanted to reschedule appointment on 19Mar2021 for second dose as patient is sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia oral
Clinical narrative: her lip and tip of her tongue were tingling; Soreness in arm; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "her lip and tip of her tongue were tingling"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Soreness in arm".  Additional information: on 17Mar2021, was first dose of covid vaccine. Four hours later her lip and tip of her tongue were tingling and lasted for about an hour. Soreness in arm. She wanted to know if she can take the Johnson & Johnson vaccine as her second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue; arm soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid 19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; feeling really tired; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 22Mar2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 22Mar2021, outcome "unknown", described as "feeling really tired".  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Pain at injection site; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 12:15 (Lot number: EL9262) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1,single, Vaccine Name: Pfizer, Lot Number/ Expiry date: EK9231, Route: Arm Left , Date: 07Jan2021), administration date: 07Jan2021, when the patient was 71 years old, for COVID-19 IMMUNIZATION. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Jan2021 05:00, outcome "unknown", described as "Pain at injection site"; DIARRHOEA (non-serious) with onset 29Jan2021 05:00, outcome "unknown", described as "diarrhea".  Additional Information: any AE(s) doesn't require a visit to Emergency Room or Physician Office  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Inappropriate schedule of vaccine administered; body aches; chilling; temperature went up to 103; headache; tired; temperature went up to 103/The next day I ran a low grade temp 100; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Mar2021 08:00 (Lot number: EN6198, Expiration Date: Jun2021) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 18Jan2021, when the patient was 61 years old, for COVID-19 immunisation, reaction(s): "Very sore Painful arm at injection site", "Started chilling", "Ran a fever between 102-103 degrees", "Headache", "Felt nauseous". The following information was reported: PAIN (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "body aches"; CHILLS (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "chilling"; BODY TEMPERATURE INCREASED (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "temperature went up to 103"; HEADACHE (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "headache"; FATIGUE (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "tired"; PYREXIA (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "temperature went up to 103/The next day I ran a low grade temp 100"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Mar2021 08:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, chills, body temperature increased, headache, fatigue, pyrexia.  Additional information: This is a spontaneous report from a contactable nurse. This 61-year-old female nurse (patient) reported in response to HCP follow up letter sent in cross reference case which included. Did reaction(s) recur on re-administration of product: Yes. About 8 hrs after my 2nd vaccine I started chilling again, my temperature went up to 103. I felt terrible headache & body aches, Tired. The next day I ran a low grade temp 100. By second day back to normal. I took Tylenol right after injection.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine administered; body aches; chilling; temperature went up to 103; headache; tired; temperature went up to 103/The next day I ran a low grade temp 100; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Mar2021 08:00 (Lot number: EN6198, Expiration Date: Jun2021) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 18Jan2021, when the patient was 61 years old, for COVID-19 immunisation, reaction(s): "Very sore Painful arm at injection site", "Started chilling", "Ran a fever between 102-103 degrees", "Headache", "Felt nauseous". The following information was reported: PAIN (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "body aches"; CHILLS (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "chilling"; BODY TEMPERATURE INCREASED (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "temperature went up to 103"; HEADACHE (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "headache"; FATIGUE (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "tired"; PYREXIA (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "temperature went up to 103/The next day I ran a low grade temp 100"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Mar2021 08:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, chills, body temperature increased, headache, fatigue, pyrexia.  Additional information: This is a spontaneous report from a contactable nurse. This 61-year-old female nurse (patient) reported in response to HCP follow up letter sent in cross reference case which included. Did reaction(s) recur on re-administration of product: Yes. About 8 hrs after my 2nd vaccine I started chilling again, my temperature went up to 103. I felt terrible headache & body aches, Tired. The next day I ran a low grade temp 100. By second day back to normal. I took Tylenol right after injection.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Sweet taste in her mouth/ salty taste/ metallic taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious), outcome "unknown", described as "Sweet taste in her mouth/ salty taste/ metallic taste".  Additional Information: Caller received the covid vaccine and within 5 minutes had a Sweet taste in her mouth. Then it switched to a salty taste and now a metallic taste. Caller would like to know how long this will last. Provided number to PMI and transferred to Pfizer DSU but more than 7 calls holding so transferred to PMI but transferred to hold queue due to long hold time from support. Any unaddressed medical questions were not referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: light headed; my arms hurts a little; This is a spontaneous report received from contactable reporter (Consumer) for a Pfizer sponsored program (002591). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "light headed"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arms hurts a little".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Vaccine seems to have helped my sinusitis/since my 2 vaccinations my breathing is much much better almost perfect; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sinusitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Vaccine seems to have helped my sinusitis/since my 2 vaccinations my breathing is much much better almost perfect".  Additional details: This is a spontaneous report from Pfizer. Patient got vaccinated and felt fine. Patient reported that the vaccine seemed to help with sinusitis. For many years patient was not able to breathe well through nose and since 2 vaccinations patient described that breathing was much better and almost perfect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen neck gland; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen neck gland".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature fluctuation, Chills, Discomfort, Fatigue
Clinical narrative: Arm Pain at the Injection Site which seems to be lessening somewhat; Chills; Fatigue/Tiredness; Slight headache; My body feels heavy, as if I am carrying a weight, but no muscle pain; Temperature fluctuates, goes up and down 100.3, 99.4, 98.6, now it is at 100.9; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE:1, MANUFACTURER UNKNOWN, formulation: Solution for injection, Lot Number: not reported; Expiration Date: not reported), for covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "recovering", described as "Arm Pain at the Injection Site which seems to be lessening somewhat"; CHILLS (non-serious) with onset 18Mar2021, outcome "unknown", described as "Chills"; FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Fatigue/Tiredness"; HEADACHE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Slight headache"; DISCOMFORT (non-serious) with onset 18Mar2021, outcome "unknown", described as "My body feels heavy, as if I am carrying a weight, but no muscle pain"; BODY TEMPERATURE FLUCTUATION (non-serious) with onset 18Mar2021, outcome "unknown", described as "Temperature fluctuates, goes up and down 100.3, 99.4, 98.6, now it is at 100.9". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that side effects, which began yesterday evening, to the COVID-19 Vaccine Pfizer-BioNTech, 2nd Dose, Lot#EL3247, Taken at (name), yesterday, 18Mar2021Arm Pain at the Injection Site which seems to be lessening somewhat, Chills, Fatigue/Tiredness, Slight headache, Patient body feels heavy, as carrying a weight, but no muscle pain. Temperature fluctuates, goes up and down 100.3, 99.4, 98.6, now it is at 100.9. Patient realize these are common reactions, but must be reported nonetheless.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Arm Pain at the Injection Site which seems to be lessening somewhat; Chills; Fatigue/Tiredness; Slight headache; My body feels heavy, as if I am carrying a weight, but no muscle pain; Temperature fluctuates, goes up and down 100.3, 99.4, 98.6, now it is at 100.9; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE:1, MANUFACTURER UNKNOWN, formulation: Solution for injection, Lot Number: not reported; Expiration Date: not reported), for covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "recovering", described as "Arm Pain at the Injection Site which seems to be lessening somewhat"; CHILLS (non-serious) with onset 18Mar2021, outcome "unknown", described as "Chills"; FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Fatigue/Tiredness"; HEADACHE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Slight headache"; DISCOMFORT (non-serious) with onset 18Mar2021, outcome "unknown", described as "My body feels heavy, as if I am carrying a weight, but no muscle pain"; BODY TEMPERATURE FLUCTUATION (non-serious) with onset 18Mar2021, outcome "unknown", described as "Temperature fluctuates, goes up and down 100.3, 99.4, 98.6, now it is at 100.9". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that side effects, which began yesterday evening, to the COVID-19 Vaccine Pfizer-BioNTech, 2nd Dose, Lot#EL3247, Taken at (name), yesterday, 18Mar2021Arm Pain at the Injection Site which seems to be lessening somewhat, Chills, Fatigue/Tiredness, Slight headache, Patient body feels heavy, as carrying a weight, but no muscle pain. Temperature fluctuates, goes up and down 100.3, 99.4, 98.6, now it is at 100.9. Patient realize these are common reactions, but must be reported nonetheless.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Intense headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Intense headache".  Additional Information: The patient received her first dose of the vaccine in (place name) or (place name) on either Friday 05Mar or Friday 12Mar. Reporter was not sure of the exact date but recall her appointment being a Friday in the last week or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377195 same patient, different dose/AE
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Eructation, Hyperaesthesia, Pruritus
Clinical narrative: burp; was hypersensitive in the area which lasted until 2 days after the 2nd dose/is still having hypersensitivity in the right side of my face; itchy arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 11:48 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoinmune Hashimoto" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Right Eye Proptosis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "she had a similar sensation in her face approximately 11 year ago" (unspecified if ongoing). Family history included: "Prostate Cancer" (unspecified if ongoing), notes: Father had Prostate Cancer & Heart Disease; "Heart Disease" (unspecified if ongoing), notes: Father had Prostate Cancer & Heart Disease. The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "Could not go to the bathroom (childhood)", notes: Benadryl Side Effect Could not go, to the bathroom (childhood). Vaccination history included: Bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE DETAILS:, Dose: 1st, Time (24hr): 11:25 AM., Anatomical Site of injection: Left Arm, Batch/Lot number: EL9266), administration date: 18Feb2021, for covid-19 immunisation.  The following information was reported: HYPERAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "was hypersensitive in the area which lasted until 2 days after the 2nd dose/is still having hypersensitivity in the right side of my face"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itchy arm"; ERUCTATION (non-serious) with onset Mar2021, outcome "unknown", described as "burp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, eructation.  Additional Information: The patient had not received any other vaccine within 4 weeks prior to the vaccination. Relevant tests: Test: BW prior 1-2 weeks before the vaccine. BW 8 days after. Narrative: Consumer stated 15 minutes after the 1st dose she started with numbness sensation on the right side of my neck and face. It then started to go away, but she was hypersensitive in the area which lasted until 2 days after the 2nd dose. She mentioned she started to burp within 5 minutes after the 2nd dose and therefore she was administered Pepcid. She also experienced itchy arm which normal.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: Enlarged lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 19Mar2021, outcome "unknown", described as "Enlarged lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). This consumer reported similar events for 2 patients. The reporter is the patient. A male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (unknown manufacturer), for immunisation. The patient developed pain/body ache, and headache, with  outcome of unknown. Additional information: Upon follow-up, patient got the 2nd shot yesterday had a body ache and headache. He asked was it ok to take Tylenol and received response as correct. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021304328 same reporter/drug/AE, different patients.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 28Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Chemical taste in throat; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EP6955) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; DYSGEUSIA (non-serious), outcome "unknown", described as "Chemical taste in throat".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Covid vaccine soreness and muscle ache at injection site; Covid vaccine soreness and muscle ache at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "Covid vaccine soreness and muscle ache at injection site".  Additional Information: No underlying conditions. No allergies. No previous COVID-19. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph node swelling on collar bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Mar2021, outcome "unknown", described as "lymph node swelling on collar bone".  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lethargy, Nausea, Pain in extremity
Clinical narrative: Headache; Nausea; Lightheadedness; Lethargy; Sore arm; This is a spontaneous report received from non-contactable consumer from a sales representative. The reporter is the patient.  A 75-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) at the age of 75 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; DIZZINESS (non-serious), outcome "recovered", described as "Lightheadedness"; LETHARGY (non-serious), outcome "recovered", described as "Lethargy"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm". Therapeutic measures were taken as a result of nausea, pain in extremity.  Additional Information: Events took place after use of product. The patient had headache, nausea, lightheadedness, lethargy, and sore arm after both COVID-19 vaccine shots. The adverse events set in hours after shots. Symptoms lasted 24 to 36 hours. Paracetamol (TYLENOL) helped relieve sore arm and famotidine (PEPCID) was used for nausea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), in arm, on Mar 21, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain in extremity/her arm started to feel a little bit sore, onset Mar 21, 2021, with outcome of unknown. Additional information: The patient received her 1st dose of vaccine yesterday afternoon Mar 21, 2021. The night after getting the 1st dose, her arm started to feel a little bit sore. She would like to confirm if this is normal and how long will she feel the sore. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache/had a massive headache for a couple hours; This is a spontaneous report from a contactable reporter Physician. This Physician (patient) reported that-  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "severe headache/had a massive headache for a couple hours".  Additional information: Description of Event: Patient reported during a virtual meeting that he received the Pfizer BioNTech Covid 19. Vaccine recently and after the 2nd dose he had a severe headache which resolved. After the second dose of Covid vaccine he had a massive headache for a couple hours. Optional Information: Didn't have a headache after first dose but had one after second. Event took place after use of product. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: Felt awful; Like hit with ton of bricks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 19Mar2021, outcome "unknown", described as "Felt awful"; PAIN (non-serious) with onset 19Mar2021, outcome "unknown", described as "Like hit with ton of bricks".  Additional information: Pfizer vaccine 2nd dose on 18Mar2021. Felt 'awful' and 'like hit with ton of bricks' the following day. Awareness Date: 19Mar2021. Country of Occurrence. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Have several reaction; got severely sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Have several reaction; got severely sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vaccination site swelling
Clinical narrative: mild soreness; a little swelling at the shot location; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "diverticulitis" (ongoing); "stress" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose-1 single), for Covid-19 immunisation, reaction(s): "not had any problems after that initial shot". The following information was reported: PAIN (non-serious), outcome "unknown", described as "mild soreness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "a little swelling at the shot location".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Exhaustion; massive headache; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EP6955) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication included: LISINOPRIL AND HYDROCHLORTIAZIDE; NUVARING; GAVISCON ES; PEPTID. The patient had no known allergy (NKA). was the patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination. The patient was vaccinated in other facility. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: FATIGUE (non-serious) with onset 22Mar2021, outcome "recovering", described as "Exhaustion"; HEADACHE (non-serious) with onset 22Mar2021, outcome "recovering", described as "massive headache". Therapeutic measures were not taken as a result of fatigue, headache.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: woke up with severe tiredness; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Mar2021 14:40 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN, Batch/lot number: Unknown), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "woke up with severe tiredness"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness".  Additional information: Got the second COVID vaccine yesterday at 240 pm (18Mar2021) and woke up with severe tiredness and dizziness. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "extreme fatigue". Additional information: the patient experienced extreme fatigue 2 days after receiving the 2nd dose of the COVID-19 vaccine and it lasted less than 12 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Vomited twice; Body chills; Bad headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Mar2021 15:30 (Batch/Lot number: unknown) at the age of 49 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Bad headache"; VOMITING (non-serious), outcome "unknown", described as "Vomited twice"; CHILLS (non-serious), outcome "unknown", described as "Body chills". Therapeutic measures were taken as a result of headache.  Additional information: Reason why batch-lot is unknown was misplaced-discarded. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID- 19. Allergies to medications, food, or other products was none. Vaccine facility information available. Bad headache 24 hours later. Took Tylenol and vomited twice. Drank more water and slept. Body chills and light headache persistence throughout day but getting better. Doing light house chores today. No treatment was received for the adverse event.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "soreness at the injection site".  Additional Information: Gender: Female, Verbatim & Event Terms: (Withheld) received her COVID-19 vaccine on Saturday evening, 20Mar. She reported severe soreness at the injection site on her arm yesterday afternoon (Sunday, 21Mar).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: soreness at the injection site on his arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "soreness at the injection site on his arm"; FATIGUE (non-serious) with onset 21Mar2021, outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tired; little headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 26-year-old male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tired"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "little headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: both Pfizer vaccines I have recently received made the pain in my ankle go down a lot!; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Active diffuse lymphoma" (unspecified if ongoing), notes: I have active diffuse lymphoma in my right ankle, waiting for chemo and radiation. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "both Pfizer vaccines I have recently received made the pain in my ankle go down a lot!".  Additional information: A Doctor of Chiropractic, but also a non-Hodgkin's lymphoma survivor and patient for 20 years. First diagnosed elsewhere. I have active diffuse lymphoma in my right ankle, waiting for chemo and radiation. Funny part is though, both Pfizer vaccines I have recently received made the pain in my ankle go down a lot! I'm wondering, are any of the markers targeted for Covid 19 the same as for potential cancer gene therapies? I'd be very curious, also if this is relevant to possible coming cancer treatments from BioNTech.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.