chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Acne, Ear pain, Headache, Lymphadenopathy, Neck pain
Clinical narrative: Head pain on left side lasted 16 days after first shot; Pain in left neck to ear first shot; Pain in left neck to ear first shot; Swollen lymph nodes in neck. Swollen lymph nodes in upper right breast first shot; Upper back leg pain both legs; White pimple on tongue first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Feb2021 13:30 (Lot number: eLB8982) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 15Feb2021, outcome "recovered" (03Mar2021), described as "Head pain on left side lasted 16 days after first shot"; NECK PAIN (non-serious), EAR PAIN (non-serious) all with onset 15Feb2021, outcome "recovering" and all described as "Pain in left neck to ear first shot"; LYMPHADENOPATHY (non-serious) with onset 15Feb2021, outcome "recovering", described as "Swollen lymph nodes in neck. Swollen lymph nodes in upper right breast first shot"; PAIN IN EXTREMITY (non-serious) with onset 15Feb2021, outcome "recovering", described as "Upper back leg pain both legs"; ACNE (non-serious) with onset 15Feb2021, outcome "recovering", described as "White pimple on tongue first shot". Therapeutic measures were not taken as a result of headache, neck pain, ear pain, lymphadenopathy, pain in extremity, acne.  Additional information: The patient did not receive any other vaccines in four weeks. If Covid prior vaccination and covid tested post vaccination was reported as none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Head pain on left side lasted 16 days after first shot; Pain in left neck to ear first shot; Pain in left neck to ear first shot; Swollen lymph nodes in neck. Swollen lymph nodes in upper right breast first shot; Upper back leg pain both legs; White pimple on tongue first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Feb2021 13:30 (Lot number: eLB8982) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 15Feb2021, outcome "recovered" (03Mar2021), described as "Head pain on left side lasted 16 days after first shot"; NECK PAIN (non-serious), EAR PAIN (non-serious) all with onset 15Feb2021, outcome "recovering" and all described as "Pain in left neck to ear first shot"; LYMPHADENOPATHY (non-serious) with onset 15Feb2021, outcome "recovering", described as "Swollen lymph nodes in neck. Swollen lymph nodes in upper right breast first shot"; PAIN IN EXTREMITY (non-serious) with onset 15Feb2021, outcome "recovering", described as "Upper back leg pain both legs"; ACNE (non-serious) with onset 15Feb2021, outcome "recovering", described as "White pimple on tongue first shot". Therapeutic measures were not taken as a result of headache, neck pain, ear pain, lymphadenopathy, pain in extremity, acne.  Additional information: The patient did not receive any other vaccines in four weeks. If Covid prior vaccination and covid tested post vaccination was reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: extreme pain at the injection site; extreme tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) at the age of 43 years 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: VACCINATION SITE PAIN (non-serious) with onset 09Mar2021, outcome "recovered", described as "extreme pain at the injection site"; FATIGUE (non-serious) with onset 09Mar2021, outcome "recovered", described as "extreme tiredness". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient had extreme pain at the injection site and extreme tiredness the following day after first COVID vaccine dose. Events did not result to physician office visit and emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizzy; mild headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: ENS199) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included heart disease (ongoing); triple bypass operation, start date: Oct2017 (unspecified if ongoing); Stents placed, start date: Sep2019 (unspecified if ongoing); dizziness associated with treatment for heart disease as well (unspecified if ongoing); chronic possible dizziness if he stands up too fast (unspecified if ongoing). There were no concomitant medications. The following information was reported DIZZINESS (non-serious) with onset 05Mar2021, outcome recovered (06Mar2021); HEADACHE (non-serious) with onset 05Mar2021, outcome recovered (06Mar2021).  It was reported that he got the vaccine on 05Mar2021 and afterwards he had to sit for 45 minutes because he was dizzy. His dizziness lasted until the next morning. The evening after the shot, he had a mild headache that lasted the whole evening. He never had headaches his whole life.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: tiredness; feeling achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male 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 FATIGUE (non-serious), outcome unknown; PAIN (non-serious), outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: having headaches after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: HEADACHE (non-serious), outcome "unknown", described as "having headaches after getting the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: having headaches after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: HEADACHE (non-serious), outcome "unknown", described as "having headaches after getting 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: Injection site pain, Pain in extremity
Clinical narrative: sore spot where he had the vaccine; had a sore arms where he received the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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 INJECTION SITE PAIN (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), outcome unknown.  The patient did not have COVID prior to vaccine.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: Sore arm at site where vaccination was given, Right arm; limited mobility; 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 patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right (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), outcome "unknown", described as "Sore arm at site where vaccination was given, Right arm"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "limited mobility". Therapeutic measures were not taken as a result of vaccination site pain, mobility decreased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Feb2021 11:15 (Lot number: EN6203) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, intramuscular, Batch number: EN5318), administration date: 03Feb2021, when the patient was 66 years old, for covid-19 immunisation, reaction(s): "Injection site muscle pain". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered" (26Feb2021), described as "Injection site muscle pain". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: It was reported as none on the prior patient vaccination within four weeks.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130049 same patient and drug and event, different dose
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: Chills; malaise; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 46 year-old male 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: CHILLS (non-serious), outcome "unknown", described as "Chills"; MALAISE (non-serious), outcome "unknown", described as "malaise".  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-2021263802 Same reporter and drug, similar events, different patient.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Vaccination site pruritus
Clinical narrative: felt tired; Injection site itched; vaccine doses were administered 72 days apart; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 27Mar2021 15:20 (Lot number: EL8982) at the age of 75 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included: VYZULTA (ongoing); LOSARTAN (ongoing); OXYBUTYNIN (ongoing). Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Batch/Lot number: EL3248), administration date: 15Jan2021 15:20, when the patient was 75 years old, for COVID-19 immunisation, reaction: "soreness at injection site". The following information was reported: FATIGUE (non-serious) with onset 28Mar2021, outcome "unknown", described as "felt tired"; VACCINATION SITE PRURITUS (non-serious) with onset 28Mar2021, outcome "unknown", described as "Injection site itched"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Mar2021 15:20, outcome "unknown", described as "vaccine doses were administered 72 days apart".  Additional information: The events did not cause admission to hospital (does not include emergency room visit without further admission.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizzy; Weak; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 08Mar2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing); "Cholesterol" (ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 08Mar2021, outcome "unknown", described as "Dizzy"; ASTHENIA (non-serious) with onset 08Mar2021, outcome "unknown", described as "Weak". Therapeutic measures were not taken as a result of dizziness, asthenia. Additional information: The patient was concomitantly taking unspecified medications for high blood pressure and cholesterol. The patient also reported to experience severe reaction (not specified). Timeframe between vaccination and starting of symptoms was reported as 3 hours and 30 minutes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Food poisoning, Vomiting
Clinical narrative: Food poisoning; vomited three times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6201) 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: FOOD POISONING (non-serious), outcome "unknown", described as "Food poisoning"; VOMITING (non-serious), outcome "unknown", described as "vomited three times".  Additional information: Reporter was calling on behalf of her mother who was 85 years old. Patient had the Pfizer vaccine on Mar2021, sometime 10Mar, not 10Mar2021 earlier, but patient had a scheduled appointment today to do the second dose. But then yesterday, patient had food poisoning and she has vomited three times. Reporter asked if patient can take the vaccine or not.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Malaise, Myalgia, Pain, Vaccination site pain
Clinical narrative: about 2 hours ago, she started to not feel well; all of her body was aching/she had pain in her body; the muscles in her legs were hurting; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 07:30 (Lot number: EN6204) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included Overactive Thyroid (ongoing), had an overactive thyroid for many years. There were no concomitant medications. The following information was reported VACCINATION SITE PAIN (non-serious) with onset 07Mar2021, outcome recovered (09Mar2021); MALAISE (non-serious) with onset 10Mar2021, outcome not recovered; PAIN (non-serious) with onset 10Mar2021, outcome not recovered; MYALGIA (non-serious) with onset 10Mar2021, outcome not recovered. Relevant laboratory tests and procedures are available in the appropriate section.  She had her first Pfizer COVID 19 Vaccine on Sunday (07Mar2021). She said she had pain in arm (left), clarified as injection site, saying the pain was nothing special. She said yesterday (09Mar2021), her injection site pain subsided. She said about 2 hours ago, she started to not feel well. She said all of her body was aching. She did not feel well the whole day, but about 2 to 3 hours ago, she had pain in her body. She said her arms, and the muscles in her legs were hurting. She said she was not feeling well. Treatment, Declined any. She wanted to speak to Pfizer first before taking anything for her symptoms. She said she may take a Tylenol later on. No further details provided. Reporter seriousness for all events were unspecified. Events does not require a visit to emergency room/ physician office. No Prior Vaccinations within 4 weeks. No AE following prior vaccinations. Family Medical History Relevant to AEs was not provided. Relevant tests were none. No history of all previous immunization with the Pfizer vaccine considered as suspect.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: I just had this terrible nauseousness; 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 2021 (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: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "I just had this terrible nauseousness".  Additional Information: The patient was asking if it was common for the event to last so long.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: fatigue; loss of appetite; Slight sore arm; headache; my pulse went up 139; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 16Feb2021 (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: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Slight sore arm"; HEADACHE (non-serious), outcome "unknown", described as "headache"; HEART RATE INCREASED (non-serious), outcome "recovered" (2021), described as "my pulse went up 139". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: This 65 plus year-old female patient received first shot February 16: Slight sore arm headache February 9, next day total fatigue, loss of appetite, my pulse went up 139. Called (Doctor) he said see how day goes, pulse went down to normal by late afternoon.  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: fatigue; loss of appetite; Slight sore arm; headache; my pulse went up 139; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 16Feb2021 (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: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Slight sore arm"; HEADACHE (non-serious), outcome "unknown", described as "headache"; HEART RATE INCREASED (non-serious), outcome "recovered" (2021), described as "my pulse went up 139". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: This 65 plus year-old female patient received first shot February 16: Slight sore arm headache February 9, next day total fatigue, loss of appetite, my pulse went up 139. Called (Doctor) he said see how day goes, pulse went down to normal by late afternoon.  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
Clinical narrative: was really bad, very bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACCINE) (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, reaction(s): "no adverse event". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "was really bad, very bad".  Additional information: The reporter's first sister-in-law (patient) gotten the COVID vaccine and with the first they did okay but not with the second. The reporter's first sister-in-law was really bad and the caller was not even going to venture into what to say but her first sister-in-law was very bad.   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, Pain
Clinical narrative: fatigue; aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN (non-serious), outcome "unknown", described as "aches". Additional information: The patient had no fever and was scheduled to receive dose 2 on 23Mar2021. The events took place after use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Polymerase chain reaction
Clinical narrative: Yesterday I received the second shot, and this time my sore throat started 12 hours after the shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 10:00 (Lot number: EN6208) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies; Yes" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE; PROPRANOLOL; PANTOPRAZOLE; FAMOTIDINE. Vaccination history included: Comirnaty (dose 1, lot number: EN6200, administration time: 12:00 PM, vaccine location: Right arm), administration date: 15Feb2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 08Mar2021 22:00, outcome "unknown", described as "Yesterday I received the second shot, and this time my sore throat started 12 hours after the shot.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain. Additional information: Patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was COVID tested post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021276546 Same patient/drug/event, different dose
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Peripheral coldness
Clinical narrative: was very cold from 10PM to 3AM / felt like bones were cold; extremities were very cold to the touch; 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 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING COLD (non-serious) with onset 10Mar2021 22:00, outcome "unknown", described as "was very cold from 10PM to 3AM / felt like bones were cold"; PERIPHERAL COLDNESS (non-serious) with onset 10Mar2021 22:00, outcome "unknown", described as "extremities were very cold to the touch". Additional information: Event was described as follows: The patient was given the Pfizer COVID 19 vaccine on 23Feb. The patient felt fine until March 10, 2021 at 10PM (reported as last night). The patient was very cold from 10PM to 3AM; The patient's extremities were very cold to the touch and it felt like bones were cold. The patient just couldn't warm up for 5 hours. 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: Asthenia, Dizziness, Malaise, Tremor, Vertigo
Clinical narrative: Vertigo; Dizziness; Weakness; Trembling in the leg; I still feel weak; Shakiness in my hand; I am not feeling too well; 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 09Feb2021 (Lot number: EL9269) 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: VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizziness"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "Weakness"; TREMOR (non-serious) with onset 2021, outcome "not recovered", described as "Trembling in the leg"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "I still feel weak"; TREMOR (non-serious) with onset 2021, outcome "not recovered", described as "Shakiness in my hand"; MALAISE (non-serious) with onset 2021, outcome "not recovered", described as "I am not feeling too well".  Additional Information: It was reported that NDC number and UPC number of Covid 19 vaccine was unknown. Patient did not have any reaction right away but patient think like sometime around the weekend patient started getting vertigo and dizziness, weakness, trembling in the leg and it has been stopped patient meant it comes and go, symptoms are coming and going and patient was looking at the papers and saw there was symptoms of dizziness, patient thought it might be something related, it didn't happened right away, it happened by weekend so now it's really almost a month and patient still feel weak and dizzy every now and then. Patient registered for second dose because patient was still weak and do not feel normal right now.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: headache/ dull; unsteadiness; wouldn't say it's vertigo, but kind of dizziness; had a fog thing; sore at the injection site; tired; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 01Mar2021 (Lot number: EN6198) at the age of 70 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, administered in the right arm, Lot number: EM9809), administration date: 08Feb2021 12:00, when the patient was 70 years old, for COVID-19 immunisation, reactions: "entire arm was aching", "arm/ trouble lifting it", "dull headache", "flushing", "getting really hot/ warmth", "unsteadiness", "dizziness". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache/ dull"; BALANCE DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "unsteadiness"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "wouldn't say it's vertigo, but kind of dizziness"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "had a fog thing"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore at the injection site"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired".  Additional information: The patient stated she was in a cold climate where vertigo and variables happen. Stated she knows everyone will be needing a booster shot. The patient stated she was tired too, but she exercises and walks five miles a day so maybe she was just getting old. The patient was getting a blood test and would report if she had any abnormal results.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: headache/ dull; unsteadiness; wouldn't say it's vertigo, but kind of dizziness; had a fog thing; sore at the injection site; tired; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 01Mar2021 (Lot number: EN6198) at the age of 70 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, administered in the right arm, Lot number: EM9809), administration date: 08Feb2021 12:00, when the patient was 70 years old, for COVID-19 immunisation, reactions: "entire arm was aching", "arm/ trouble lifting it", "dull headache", "flushing", "getting really hot/ warmth", "unsteadiness", "dizziness". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache/ dull"; BALANCE DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "unsteadiness"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "wouldn't say it's vertigo, but kind of dizziness"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "had a fog thing"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore at the injection site"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired".  Additional information: The patient stated she was in a cold climate where vertigo and variables happen. Stated she knows everyone will be needing a booster shot. The patient stated she was tired too, but she exercises and walks five miles a day so maybe she was just getting old. The patient was getting a blood test and would report if she had any abnormal results.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling hot, Flushing, Headache
Clinical narrative: This is a spontaneous report received from contactable consumer. The reporter is the patient. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 08Feb2021 12:00 (Lot number: EM9809) at the age of 70 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Feb2021 23:00, outcome "recovered" (Feb2021), described as "entire arm was aching"; MOBILITY DECREASED (non-serious) with onset 08Feb2021 23:00, outcome "unknown", described as "arm/ trouble lifting it"; HEADACHE (non-serious) with onset 08Feb2021 23:00, outcome "recovered" (13Feb2021 23:00), described as "dull headache"; FLUSHING (non-serious) with onset 08Feb2021 23:00, outcome "unknown", described as "flushing"; FEELING HOT (non-serious) with onset 08Feb2021 23:00, outcome "recovered" (09Feb2021 23:00), described as "getting really hot/ warmth"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "unsteadiness"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness". Additional information: Arm aching lasted four to five days. The patient didn't normally get any shots, even the flu shot. The warmth she felt was gone within a day. She didn't take her temperature but didn't think she had a fever. The dull headache lasted for five days. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable consumer. The reporter is the patient. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 08Feb2021 12:00 (Lot number: EM9809) at the age of 70 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Feb2021 23:00, outcome "recovered" (Feb2021), described as "entire arm was aching"; MOBILITY DECREASED (non-serious) with onset 08Feb2021 23:00, outcome "unknown", described as "arm/ trouble lifting it"; HEADACHE (non-serious) with onset 08Feb2021 23:00, outcome "recovered" (13Feb2021 23:00), described as "dull headache"; FLUSHING (non-serious) with onset 08Feb2021 23:00, outcome "unknown", described as "flushing"; FEELING HOT (non-serious) with onset 08Feb2021 23:00, outcome "recovered" (09Feb2021 23:00), described as "getting really hot/ warmth"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "unsteadiness"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness". Additional information: Arm aching lasted four to five days. The patient didn't normally get any shots, even the flu shot. The warmth she felt was gone within a day. She didn't take her temperature but didn't think she had a fever. The dull headache lasted for five days. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Slow speech
Clinical narrative: extremely tired; Slow speech; walking like a drunk; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 04Mar2021 (Lot number: EN6202) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 08Mar2021, outcome "recovering", described as "extremely tired"; SLOW SPEECH (non-serious) with onset 08Mar2021, outcome "recovering", described as "Slow speech"; GAIT DISTURBANCE (non-serious) with onset 08Mar2021, outcome "recovering", described as "walking like a drunk".  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jan2021 (Lot number: EL9264) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 1988 (unspecified if ongoing); "Ovarian cancer", start date: 2015 (unspecified if ongoing), notes: went into remission and came out of it and now she is on a maintenance drug; "lymph nodes removed from left arm 30 years ago" (unspecified if ongoing). Concomitant medication(s) included: LYNPARZA taken for ovarian cancer (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "slight sore arm".  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 43-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 43 years 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), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Sore arm and sore shoulder on same side as injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: sweats; tingles in her left arm; nausea; 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 female patient received bnt162b2 (BNT162B2), administration date 15Feb2021 (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), administration date: 19Jan2021, for COVID-19 immunisation. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingles in her left arm"; NAUSEA (non-serious), outcome "unknown", described as "nausea". The events "sweats", "tingles in her left arm" and "nausea" were evaluated at the emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity
Clinical narrative: tiredness; leg and shoulder ache; leg and shoulder ache; a little headache; 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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 04Mar2021 (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 10Mar2021, outcome "unknown", described as "tiredness"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 10Mar2021, outcome "unknown" and all described as "leg and shoulder ache"; HEADACHE (non-serious) with onset 10Mar2021, outcome "unknown", described as "a little headache".  Additional information: The patient was asking how could there be side effects after the 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: Limb operation
Clinical narrative: leg surgery; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 10Mar2021 (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: LIMB OPERATION (medically significant) with onset 10Mar2021, described as "leg surgery". The patient was taking a pain reliever for her leg surgery after the 1st dose last 10Mar2021 and asked about the vaccination card since she lost it.  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, Headache, Nausea
Clinical narrative: nausea; headache; physically tired; This is a spontaneous report received from a 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 10Mar2021 (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: NAUSEA (non-serious) with onset 10Mar2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 10Mar2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "physically tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: extremely lethargic; sore all over; 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 male 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: LETHARGY (non-serious), outcome "unknown", described as "extremely lethargic"; PAIN (non-serious), outcome "unknown", described as "sore all over".  Additional information: The patient stated that he walks 2-3 miles a day and can't do that right now.  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-2021282812 same reporter, drug and events; different patient
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: extremely lethargic; sore all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female 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: LETHARGY (non-serious), outcome "unknown", described as "extremely lethargic"; PAIN (non-serious), outcome "unknown", described as "sore all over".  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-2021282786 Same reporter and drug, similar events, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Joint swelling, Peripheral swelling
Clinical narrative: swelling left arm, shoulder and hand; swelling left arm, shoulder and hand; pain in right breast but moved to left breast; 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 female 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: PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "swelling left arm, shoulder and hand"; BREAST PAIN (non-serious), outcome "unknown", described as "pain in right breast but moved to left breast".  Additional information: Patient had 1st Covid vaccine last Friday. Having side effects and would like to talk to someone about them. Having swelling left arm, shoulder and hand. Also had pain in right breast but moved to left breast.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.