chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Nausea, Paraesthesia, Pulmonary pain, Vision blurred
Clinical narrative: Headache; Chills; Hot flashes; Blurred vision; Tingling in hands; Nausea; Head feels fuzzy at times thinking takes a few moments/ Felt foggy when I woke up; Emotional; Slept alot first 2 days; My lungs seem sore; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 55-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 26Nov2021 at 14:00 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient did not receive other medications within two weeks of vaccination. The following information was reported: HEADACHE (non-serious), CHILLS (non-serious), HOT FLUSH (non-serious), VISION BLURRED (non-serious), PARAESTHESIA (non-serious), NAUSEA (non-serious), FEELING ABNORMAL (non-serious), EMOTIONAL DISORDER (non-serious), PULMONARY PAIN (non-serious), all with onset 26Nov2021, outcome "recovering", described as "headache, chills, hot flashes, blurred vision, tingling in hands, nausea, head felt fuzzy at times thinking took a few moments, emotional, felt foggy when she woke up, lungs seemed sore"; HYPERSOMNIA (non-serious) with onset 26Nov2021, outcome "recovered" (28Nov2021), described as "slept a lot first 2 days". The events "headache, chills, hot flashes, blurred vision, tingling in hands, nausea, head felt fuzzy at times thinking took a few moments, emotional, slept a lot first 2 days, felt foggy when she woke up, lungs seemed sore" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache, chills, hot flush, vision blurred, paraesthesia, nausea, feeling abnormal, emotional disorder, hypersomnia and pulmonary pain.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pain
Clinical narrative: Pink spot on arm close to injection site about 2 inches wide; Pink spot on arm close to injection site about 2 inches wide only slightly tender; Received 3rd dose of BNT162B2 Pfizer vaccine; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 26Nov2021 at 11:15 (Batch/Lot number: 33030BD) at the age of 42 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VENLAFAXINE and ADDERALL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: ER8730, Anatomical location: Left arm, Route of administration: Unspecified), administration date: 31Mar2021, when the patient was 41 year(s) old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot Number: EW0153, Anatomical location: Left arm, Route of administration: Unspecified), administration date: 21Apr2021, when the patient was 41 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 at 11:15, outcome "unknown", described as "Received 3rd dose of BNT162B2 Pfizer vaccine"; VACCINATION SITE ERYTHEMA (non-serious) and VACCINATION SITE PAIN (non-serious), both described as "Pink spot on arm close to injection site about 2 inches wide only slightly tender", with onset 28Nov2021, outcome "not recovered". Therapeutic measures were not taken as a result of the events vaccination site erythema and vaccination site pain.   Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that the pink spot on arm which was slightly tender might have been there earlier, but the patient didn't look; had been wearing long sleeves. The patient reported that this wasn't a problem but figured it was worth reporting just for the information; the patient realized it wasn't dangerous or harmful (as reported). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid after both vaccines; Tested positive for Covid after both vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 24Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Nov2021, outcome "unknown" and all described as "Tested positive for Covid after both vaccines". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive.  Additional information: There was no predisposing factors reported for the patient. The patient did not receive any specific antipyretics around the dates of vaccination.  No follow-up attempts are needed. No further information was expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid after both vaccines.; Tested positive for Covid after both vaccines.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) at the age of 42 years as dose 1, single and administered in arm left, administration date 16Apr2021 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2021, outcome "not recovered" and all described as "Tested positive for Covid after both vaccines." The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Muscular weakness, Paraesthesia
Clinical narrative: Dose received: 3; I have weakness in my left arm; I still feel the pinching as though the needle is in my arm; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 64-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 04Nov2021 at 13:00 (Batch/Lot number: FF2587) at the age of 64 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Thyroid cancer" start date: an unknown date in 2017 (unspecified if ongoing) and "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; CARVEDILOL; LEVOTHYROXINE and OMEPRAZOLE. Past drug history included: Levofloxacin, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: ER8733, Anatomical site: left arm, Administration time: 11:00, Route of administration: unspecified), administration date: 29Mar2021 and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: EN6203, Anatomical site: left arm, Administration time: 11:00, Route of administration: unspecified), administration date: 05Mar2021, both when the patient was 63 years old, for COVID-19 immunisation  The following information was reported: MUSCULAR WEAKNESS (non-serious), PARAESTHESIA (non-serious), with onset an unknown date in Nov2021, outcome "not recovered" described as "I have weakness in my left arm, I still feel the pinching as though the needle is in my arm". Therapeutic measures were not taken as a result of muscular weakness and paraesthesia.   Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered with sequelae", described as "headaches". The event "headaches" was evaluated at the physician office visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: Prior to vaccination, whether the patient was diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19 were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Drug ineffective, Gait disturbance, Grip strength
Clinical narrative: Diagnosed with COVID; Diagnosed with COVID; pain and muscle spasms down her leg; pain and muscle spasms down her leg; prevented her from walking sometimes; lot of pain in her back and neck; lot of pain in her back and neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 23Aug2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Diagnosed with COVID". The patient underwent the following laboratory tests and procedures: grip strength: (unspecified date) had a problem gripping the pfs; (23Aug2021) unknown results; sars-cov-1 test: (23Aug2021) positive, notes: she was diagnosed with COVID. Therapeutic measures were taken as a result of covid-19 which included treatment with a prednisone pack but that did not help her at all. Clinical course: The patient was vaccinated. However, on 23Aug2021, she was diagnosed with COVID. Her symptoms included pain and muscle spasms down her leg that prevented her from walking sometimes.Since getting COVID she had a lot of pain in her back and neck. She was treated She stated she had an appointment in the near future with a pain clinic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neck pain, Pain in extremity, SARS-CoV-1 test
Clinical narrative: Diagnosed with COVID; Diagnosed with COVID; pain and muscle spasms down her leg; pain and muscle spasms down her leg; prevented her from walking sometimes; lot of pain in her back and neck; lot of pain in her back and neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 23Aug2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Diagnosed with COVID". The patient underwent the following laboratory tests and procedures: grip strength: (unspecified date) had a problem gripping the pfs; (23Aug2021) unknown results; sars-cov-1 test: (23Aug2021) positive, notes: she was diagnosed with COVID. Therapeutic measures were taken as a result of covid-19 which included treatment with a prednisone pack but that did not help her at all. Clinical course: The patient was vaccinated. However, on 23Aug2021, she was diagnosed with COVID. Her symptoms included pain and muscle spasms down her leg that prevented her from walking sometimes.Since getting COVID she had a lot of pain in her back and neck. She was treated She stated she had an appointment in the near future with a pain clinic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: had a dream that someone or something had ahold of him three different times trying to pull him somewhere he didn't want to go; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 05Feb2021 08:00 (Lot number: EJ1686) at the age of 82 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, administered in the left arm), administration date: 15Jan2021 08:00, when the patient was 82 years old, for COVID-19 immunisation. The following information was reported: ABNORMAL DREAMS (non-serious) with onset 07Feb2021 01:00, outcome "unknown", described as "had a dream that someone or something had ahold of him three different times trying to pull him somewhere he didn't want to go". Therapeutic measures were not taken as a result of abnormal dreams.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. He had no known allergies.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021236488 Same reporter, suspect drug, and event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Vomiting
Clinical narrative: vaccine doses were administered 20 days apart; chills; vomiting; This is a spontaneous report received from a non-contactable reporter consumer. The reporter is the patient.  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 25Feb2021 10:30 (Lot number: Em6198) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medications included: ATENOLOL; ROSUVASTATIN; VITAMIN C [ASCORBIC ACID]; FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EM9810), administration date: 06Feb2021 15:15, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 25Feb2021 23:45, outcome "recovered" (26Feb2021 11:45), described as "chills"; VOMITING (non-serious) with onset 25Feb2021 23:45, outcome "recovered" (Feb2021), described as "vomiting"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "vaccine doses were administered 20 days apart". Therapeutic measures were taken as a result of chills, vomiting.  Additional information: Therapeutic measures included naproxen sodium (ALEVE) and went to bed. The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. He did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient has no known allergies.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Limb discomfort, Pain
Clinical narrative: severe pain; not been able to walk.; Arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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), when the patient was 67 years old, for Covid-19 immunization.  The following information was reported: PAIN (non-serious), outcome "recovering", described as "severe pain"; LIMB DISCOMFORT (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Arm sore"; GAIT DISTURBANCE (non-serious), outcome "recovering", described as "not been able to walk.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: body aches; headache; nausea; vomiting; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Feb2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "laryngitis" (unspecified if ongoing), notes: for about a month and the patient was seeking treatment. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 01Mar2021, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset 01Mar2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 01Mar2021, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset 01Mar2021, outcome "unknown", described as "vomiting".  Additional information: The patient wanted to know if it's "normal" for side effects to begin almost a week after receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: hoarse voice; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 24Feb2021 (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: DYSPHONIA (non-serious) with onset 26Feb2021, outcome "unknown", described as "hoarse voice".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt under the weather for 12-15 hours; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient of an unspecified age (reported as patient's age: above 65; unit: unspecified) 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: MALAISE (non-serious), outcome "recovered", described as "felt under the weather for 12-15 hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling a little rough; 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 male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 27Feb2021 (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: FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "unknown", described as "Feeling a little rough".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: severe back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "severe back pain".  Additional information: Caller asked if he could take hydrocodone after taking the first dose.   No follow up attempts were possible. Information about Lot/batch number could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Gout, Pain
Clinical narrative: gout flare up; severe pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Daughter) reported.  A 63-year-old male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "gout" (unspecified if ongoing), notes: long before the vaccine his dad has issues with his gout. The patient's concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown", described as "gout flare up"; PAIN (non-serious), outcome "unknown", described as "severe pain". The patient was treated with Prednisone. Therapeutic measures were taken as a result of gout.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diplopia, Neck pain
Clinical narrative: double vision in one eye; soreness in his neck and shoulders; soreness in his neck and shoulders; This is a spontaneous report received from a contactable nurse from medical information team.  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 14Jan2021 13:15 (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: NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Jan2021, outcome "unknown" and all described as "soreness in his neck and shoulders"; DIPLOPIA (non-serious) with onset 25Jan2021, outcome "recovered" (28Jan2021), described as "double vision in one eye".  Additional information: The patient had his first Pfizer COVID-19 vaccination on 14Jan2021 at 1315 and second on 04Feb2021 at 1315.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP patient's granddaughter).  A 83 year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 20:45 (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: VOMITING (non-serious) with onset 25Mar2021, outcome "not recovered", described as "severe vomiting".  Additional information: Report is not related to a study or programme. When ask to report caller states she would rather spend that time calling the doctor and she doesn't have time right now to report. No further information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Nasopharyngitis, Nausea, Pain in extremity
Clinical narrative: severe fatigue; Nausea/felt yuck; a little sluggish; sore arm; she was out cold; slept for 24 hours off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 16:30 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 47 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis; "Renal disorder" (unspecified if ongoing), notes: Verbatim: Kidney disorder; "immunocompromised" (unspecified if ongoing); "she was a cancer patient" (unspecified if ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis Dosage text: once a week injection. The patient stated stating her reaction to the vaccine is a little abnormal or out of what she is expecting. She never has issues with vaccines, she gets all of her flu vaccines every year. She takes a biologic for rheumatoid arthritis and has kidney issues as well. Her main concern is the severe fatigue she experienced after the first shot. She actually did get corona. However, she doesn't have any fever. She's been checking her temperature- no fever, no swelling of lymph nodes, it's definitely not coronavirus, she is very sure of that. States that she was a cancer patient. When speaking of her kidney disorder, she clarifies she has an inability to process electrolytes. Kidney disease was one of the qualifying factors for receiving the COVID-19 vaccine. States that it is kidney damage and that it is a tubule processing thing. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "severe fatigue"; NAUSEA (non-serious), outcome "recovering", described as "Nausea/felt yuck"; SLUGGISHNESS (non-serious), outcome "recovering", described as "a little sluggish"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she was out cold"; HYPERSOMNIA (non-serious), outcome "unknown", described as "slept for 24 hours off". The patient was treated with Pepto on hand and Ondansetron. Therapeutic measures were taken as a result of nausea.  No follow-up attempts are possible. No further information is expected
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: severe fatigue; Nausea/felt yuck; a little sluggish; sore arm; she was out cold; slept for 24 hours off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 16:30 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 47 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis; "Renal disorder" (unspecified if ongoing), notes: Verbatim: Kidney disorder; "immunocompromised" (unspecified if ongoing); "she was a cancer patient" (unspecified if ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis Dosage text: once a week injection. The patient stated stating her reaction to the vaccine is a little abnormal or out of what she is expecting. She never has issues with vaccines, she gets all of her flu vaccines every year. She takes a biologic for rheumatoid arthritis and has kidney issues as well. Her main concern is the severe fatigue she experienced after the first shot. She actually did get corona. However, she doesn't have any fever. She's been checking her temperature- no fever, no swelling of lymph nodes, it's definitely not coronavirus, she is very sure of that. States that she was a cancer patient. When speaking of her kidney disorder, she clarifies she has an inability to process electrolytes. Kidney disease was one of the qualifying factors for receiving the COVID-19 vaccine. States that it is kidney damage and that it is a tubule processing thing. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "severe fatigue"; NAUSEA (non-serious), outcome "recovering", described as "Nausea/felt yuck"; SLUGGISHNESS (non-serious), outcome "recovering", described as "a little sluggish"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she was out cold"; HYPERSOMNIA (non-serious), outcome "unknown", described as "slept for 24 hours off". The patient was treated with Pepto on hand and Ondansetron. Therapeutic measures were taken as a result of nausea.  No follow-up attempts are possible. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Pain, Proctalgia
Clinical narrative: loose stools; less severe rectal irritation and pain; less severe rectal irritation and pain; bloating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: ER8737) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "SIBO" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known allergies: tomatoes, chili peppers" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN; PROGESTONE; PREGNENOLONE. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EN6208, lot unknown=False, administration date=15Mar2021, administration time=12:15 PM, vaccine location=Left arm, dose number=1), administration date: 15Mar2021, when the patient was 52 years old, for Covid-19 immunisation, reaction(s): "severe stomach pain", "cramping", "gas", "diarrhea", "headache", "bloating", "rectal irritation and pain", "rectal irritation and pain". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "loose stools"; PROCTALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "less severe rectal irritation and pain"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "bloating". Additional information: Symptoms lasted 24-36 hours after each injection. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable other healthcare professional for a Pfizer sponsored program (60820).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 19Feb2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing). Concomitant medication included: IBRANCE taken for breast cancer, start date: Sep2016, stop date: 19Feb2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: The patient has stopped taking IBRANCE since receiving the first dose of BNT162B2. The patient would get the second on 12Mar2021 and she was to call physician after second one and see when she is to restart IBRANCE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Myalgia, Vaccination site pain
Clinical narrative: 2nd dose: pain in the site of injection, first after 1 hour mild muscle pain and contractions; 2nd dose: pain in the site of injection, first after 1 hour mild muscle pain and contractions; while in bed I have a severe muscle contractions in both legs; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EW0172) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "penicillin" (unspecified if ongoing), notes: known allergies penicillin. Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN; CALCIUM; MAGNESIUM. Vaccination history included: Bnt162b2 (product: COVID 19 , brand: Pfizer , lot number: ER8134 , lot unknown: False , administration date: 01Apr2021 , administration time: 10:30 AM , vaccine location: Right arm, dose number: 1, 1st dose: pain in the site of injection, mild muscle contractions in one leg (left)), administration date: 01Apr2021, when the patient was 60 years old, for covid 19 immunization, reaction(s): "1st dose: pain in the site of injection", "mild muscle contractions in one leg (left)". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Apr2021 16:00, outcome "recovering", MYALGIA (non-serious) with onset 22Apr2021, outcome "recovering" and all described as "2nd dose: pain in the site of injection, first after 1 hour mild muscle pain and contractions"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) with onset 22Apr2021, outcome "recovered" (23Apr2021), described as "while in bed I have a severe muscle contractions in both legs". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, muscle contractions involuntary.  Additional information: 2nd dose: pain in the site of injection, first after 1 hour mild muscle pain and contractions, after eating I was watching TV, then I decided to rest even thought I was not feeling tire from the vaccine (I was sleeping only 5 or 6 hours only ) it was about after 5 hours from the shot, while in bed I have a severe muscle contractions in both legs. I could not stop it massaging them, still with pain I stood up and decided to ride my bike, I rode about 10 miles total. Why? because when I have the first vaccine I went next day to a doctor's appointment and the pain went away with movement. I rode about 9 miles total. Few Months ago I have muscle contractions but when I started taking magnesium went away. When I have them after the 1st dose I thought it was the cold weather but then I was not having them until I have the second dose. It was an excruciating pain that I have never experienced before.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Heat at injection site; Fever; Chills; Severe fatigue; Nausea; Swelling at injection site; Muscle pain surrounding injection site to elbow; Tingling from elbow to fingertips; Headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: IR8729) via an unspecified route of administration in the arm right on 03May2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilia gastroenteritis, asthma, menorrhagia, dysmenorrhea, arthritis, depression and anxiety. The patient had history of allergies to latex, paper medical tape, various household cleaning agents, green bell pepper. Concomitant medications included duloxetine hydrochloride (CYMBALTA), trazodone (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN), multivi and ibuprofen (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm right on 10Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 10:30, the patient experienced fever, chills, severe fatigue, nausea, headache, heat and swelling at injection site, muscle pain surrounding injection site to elbow, tingling from elbow to fingertips. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of fever, chills, severe fatigue, nausea, headache, heat and swelling at injection site, muscle pain surrounding injection site to elbow, tingling from elbow to fingertips were unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended narrative data and added No therapeutic measures were taken as a result of the reported events. and Treatment Received was ticked no for all events.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Heat at injection site; Fever; Chills; Severe fatigue; Nausea; Swelling at injection site; Muscle pain surrounding injection site to elbow; Tingling from elbow to fingertips; Headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: IR8729) via an unspecified route of administration in the arm right on 03May2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilia gastroenteritis, asthma, menorrhagia, dysmenorrhea, arthritis, depression and anxiety. The patient had history of allergies to latex, paper medical tape, various household cleaning agents, green bell pepper. Concomitant medications included duloxetine hydrochloride (CYMBALTA), trazodone (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN), multivi and ibuprofen (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm right on 10Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 10:30, the patient experienced fever, chills, severe fatigue, nausea, headache, heat and swelling at injection site, muscle pain surrounding injection site to elbow, tingling from elbow to fingertips. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of fever, chills, severe fatigue, nausea, headache, heat and swelling at injection site, muscle pain surrounding injection site to elbow, tingling from elbow to fingertips were unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended narrative data and added No therapeutic measures were taken as a result of the reported events. and Treatment Received was ticked no for all events.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 29Apr2021 at 12:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021, about 10-12 hours after the second shot, the patient was weak, tired and had to stay in bed for the entirety of the day. The patient remained tired the 48 hours after the vaccine but was able to go on with day. On 03May2021, the fourth day after the second shot, the patient developed a severe headache, slight nausea and a dizzy feeling. Therapeutic measures were taken as a result of headache and included treatment with TYLENOL. The clinical outcome of the events had to stay in bed for the entirety of the next day, weak, tired, dizzy feeling, slight nausea and severe headache were recovering. No follow-up attempts are possible. No further information is expected.Amendment: This follow-up report is being submitted to amend previously reported information: Amended narrative data in final sentence to No follow-up attempts are possible. No further information is expected and for events (except headache), treatment received updated to No. Initial information needs to be reviewed:Covid_vaccine_details [{product=COVID 19, brand=Pfizer,lot_number=EW0171, lot_unknown=False,administration_date=29Apr2021,administration_time=12:00 PM, dose_number=2,vaccine_location=Left arm},{product=COVID 19, brand=Pfizer, lot_number=EW0158,lot_unknown=False,administration_date=08Apr2021,administration_time=01:30 PM,dose_number=1,vaccine_location=Left arm}]facility_type_vaccine Other if_other_vaccine_in_fourweeks Noother_medications_in_twoweeks no adverse_event About 10 - 12 hours after the second shot, I was weak and tired, and had to stay in bed for the entirety of the next day. I remained tired the 48 hours after the vaccine but was able to go on with my day. On the 4th day after the second shot, I developed a severe headache, slight nausea, and a dizzy feeling. The headache only slightly subsided after taking Tylenol. adverse_event_start_date 30Apr2021;adverse_event_country; ae_resulted_in [None of the above] if_patient_recovered Recovering;if_treatment_ae; No if_covid_prior_vaccination; No if_covid_tested_post_vaccination; No known_allergies; No other_medical_history None
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Fatigue, Headache, Hyperhidrosis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13May2021 14:00 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PMDD" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing), notes: cipro, tequin, seasonal and other allergies like ingredients in makeup; "other allergies like ingredients in makeup" (unspecified if ongoing), notes: cipro, tequin, seasonal and other allergies like ingredients in makeup; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination. The patient took concomitant medications. Past drug history included: Ciprofloxacin, reaction(s): "Allergy", notes: cipro, tequin, seasonal and other allergies like ingredients in makeup; Tequin, reaction(s): "Allergy", notes: cipro, tequin, seasonal and other allergies like ingredients in makeup. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation. The following information was reported: HYPERHIDROSIS (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "sweating profusely"; PAIN (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "body aches"; CHILLS (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "chills"; FATIGUE (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "severe tiredness"; HEADACHE (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "headache"; LETHARGY (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "lethargic"; CONFUSIONAL STATE (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "confusion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: diagnosed with covid-19, notes: Prior to vaccination. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.