chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Nausea, Pain
Clinical narrative: nausea; severe headache; lethargy; body ached; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 09:15 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shellfish" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing); "iodine" (unspecified if ongoing). Concomitant medication(s) included: NEXPLANON taken for contraception. Past drug history included: Macrobid, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 1, Single, Time: 10:30 AM, Anatomical location : Arm left), administration date: 02Mar2021, when the patient was 26 years old, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "nausea"; HEADACHE (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "severe headache"; LETHARGY (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "lethargy"; PAIN (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "body ached". Therapeutic measures were not taken as a result of nausea, headache, lethargy, pain.  Additional information: Within 3 hours of receiving the second dosage of the Pfizer BioNTech vaccine, the patient experienced nausea, severe headache, lethargy, and body ached. These symptoms persisted for ~30 hours post vaccination. The most recent COVID-19 vaccine was administered at workplace clinic facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received for Nexplanon for Birth Control within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Ethnicity information is available. Race information is available. The patient had allergies to medications, food, or other products which included Macrobid and Pepto Bismuth.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Skin laceration
Clinical narrative: he got  really bad cut and really needs a tetanus vaccine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team for a Pfizer sponsored program.  A 50 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 26Mar2021 (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: SKIN LACERATION (non-serious) with onset 27Mar2021, outcome "unknown", described as "he got really bad cut and really needs a tetanus vaccine". Additional information: The reporter (nurse) would like to know if the patient can receive tetanus vaccine after having the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Nausea, Vomiting
Clinical narrative: bad headache; nausea; vomiting; back pain; 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 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Year ago. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 28Mar2021, outcome "not recovered", described as "bad headache"; NAUSEA (non-serious) with onset 28Mar2021, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 28Mar2021, outcome "not recovered", described as "vomiting"; BACK PAIN (non-serious) with onset 28Mar2021, outcome "not recovered", described as "back pain".  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: Hand/finger swelling/Had arm swelling and couldn't get his wedding band off; normal pain in the arm he got the injection in; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 58 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 28Mar2021 10:30 (Lot number: ER2613) at the age of 58 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: PERIPHERAL SWELLING (non-serious) with onset 28Mar2021 10:45, outcome "not recovered", described as "Hand/finger swelling/Had arm swelling and couldn't get his wedding band off"; VACCINATION SITE PAIN (non-serious) with onset 28Mar2021, outcome "not recovered", described as "normal pain in the arm he got the injection in"; PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "not recovered", described as "arm pain". Therapeutic measures were taken as a result of peripheral swelling, vaccination site pain, pain in extremity.  Additional information: The patient did not undergo any relevant tests. The patient's family medical history included mother was diabetic. The patient had no prior vaccinations (within 4 weeks). The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient had no history of previous imuunization with the Pfizer vaccine considered as suspect. Clinical course: The patient received first dose of vaccine yesterday morning.  Within 15 minutes he developed hand/finger swelling. In the late afternoon he had arm pain, and later had arm swelling and could not get his wedding band off. He took an Aleve last night and this morning. He also had normal pain in the arm he got the injection in. He took Advil for his arm pain and it was the normal pain. Today it was about the same. He was not dying today. Event onset time for normal pain in the arm he got the injection in was 15:00-16:00. The events did not result to emergency room or physician's office visit. The events were reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vertigo
Clinical narrative: vertigo; arm hurt; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Mar2021, outcome "unknown", described as "arm hurt"; VERTIGO (non-serious) with onset 16Mar2021, outcome "not recovered", described as "vertigo". The event "vertigo" was evaluated at the physician office visit.  Additional information: The patient was concerned in taking the second dose of the vaccine since 8 days (also reported as 8-9 days) after she got the first dose of the vaccine, she had some vertigo and it has been on and off since. Her doctor told her to consult a neurologist and her neurologist has said that it is ok to take the vaccine.  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, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: She received the second dose of the Pfizer Covid 19 vaccine, but she later realized it was scheduled earlier than it should have (17 days instead of 21); A little tired; Flu like symptoms; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "She received the second dose of the Pfizer Covid 19 vaccine, but she later realized it was scheduled earlier than it should have (17 days instead of 21)"; FATIGUE (non-serious), outcome "unknown", described as "A little tired"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional information: Caller stated she received the second dose of the Pfizer Covid 19 vaccine, but she later realized it was scheduled earlier than it should have (17 days instead of 21). Caller stated she had experienced the same symptoms from the list, described them as normal, she has been a little tired, and flu like symptoms, but only with the second dose, she didn't have this symptoms after the first 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: Aphthous ulcer
Clinical narrative: canker sores; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: APHTHOUS ULCER (non-serious) with onset 29Mar2021, outcome "unknown", described as "canker sores".  Additional information: Caller mentioned that she just received her 2nd dose of the Pfizer covid19 vaccine 2 days ago. She was calling to check if she could take an antiviral, Valtrex (valaciclovir) for canker sores. She had coffee this morning and could feel the onset of canker sores. She called her local pharmacist and was referred to Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 94-year-old female patient received BNT162B2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "Systemic mastocytosis" (unspecified if ongoing); "Coronary artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset Mar2021, outcome "unknown", described as "Urinary tract infection".  Additional Information: The patient received the first dose of the COVID-19 vaccine 05Mar2021 and was scheduled for her second dose on this upcoming Friday, 4 weeks later. The patient would like to know whether that is okay. Following the first dose of the vaccine, the patient had a urinary tract infection (UTI). The patient has had it for about 10 days. The patient was set to start her prescription of antibiotics today or tomorrow; would like to know whether she can start her antibiotics today or tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Somnolence, Speech disorder
Clinical narrative: real drowsy; fatigued; talking and not making any sense/babble like talk; little weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 94 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 24Mar2021 14:30 (Batch/Lot number: unknown) at the age of 94 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "patient was up in age, and with her mind, was kind of losing it" (ongoing). The patient's concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 24Mar2021, outcome "recovering", described as "real drowsy"; FATIGUE (non-serious) with onset 24Mar2021, outcome "recovering", described as "fatigued"; SPEECH DISORDER (non-serious) with onset 24Mar2021, outcome "recovering", described as "talking and not making any sense/babble like talk"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovering", described as "little weak".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: experiencing numbness in her hands; tingling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. 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: HYPOAESTHESIA (non-serious), outcome "unknown", described as "experiencing numbness in her hands"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: had a sore arm; having soreness and pain under my armpit in the arm where I received the vaccine.; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 56-year-old 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm"; AXILLARY PAIN (non-serious), outcome "unknown", described as "having soreness and pain under my armpit in the arm where I received the vaccine.".  Additional Information: After the first dose, the patient had a sore arm at first. On the third day, she started having soreness and pain under her armpit in the arm where she received the vaccine. The patient was asking if this was a side effect and if she should receive 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: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: runny nose; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), administration date 12Mar2021 (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: RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  The reporter considered "runny nose" and "sore throat" not related to bnt162b2.  Additional information: Reporter is calling on behalf of his wife. She received her 1st dose on 12Mar2021 and was scheduled to receive the 2nd dose on 02Apr2021. She has a runny nose and sore throat. Reported asked if patient can she take OTC product like Cepacol. The reporter does not think the sore throat and runny nose was from the vaccine. According to the reporter their daughter currently has a cough and sore throat and they all live in the same house.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events running nose and sore throat cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue
Clinical narrative: he had an equilibrium issue; lightheaded; he was wiped out; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 07:00 (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) with onset 26Mar2021 12:00, outcome "unknown", described as "he was wiped out"; BALANCE DISORDER (non-serious) with onset 29Mar2021, outcome "unknown", described as "he had an equilibrium issue"; DIZZINESS (non-serious) with onset 29Mar2021, outcome "unknown", described as "lightheaded". Additional Information: He had his vaccine first dose on Friday 26Mar2021 at 7 AM and by 12PM he was "wiped out." He felt like he had an equilibrium issue starting on 29Mar2021 and was feeling lightheaded. He wanted to know if these are normal side effects of 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: Sinusitis
Clinical narrative: Sinus infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUSITIS (non-serious) with onset Mar2021, outcome "unknown", described as "Sinus infection".  Additional information: The reporter wanted to know if an antibiotic would interfere with the patient on getting the vaccine on Friday (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: Disturbance in attention, Fatigue, Feeling abnormal, Headache, Insomnia
Clinical narrative: Fatigue/ exhaustion; Brain fog; Memory issues; Attentions issued (she cannot concentrate enough to watch a video or processing a lot of video or a lot of light); Severe headaches; Migraine; Light sensitivity; Difficulty sleeping; 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 64 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Concussion", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 03Mar2021, outcome "unknown", described as "Fatigue/ exhaustion"; FEELING ABNORMAL (non-serious) with onset 03Mar2021, outcome "unknown", described as "Brain fog"; MEMORY IMPAIRMENT (non-serious) with onset 03Mar2021, outcome "unknown", described as "Memory issues"; DISTURBANCE IN ATTENTION (non-serious) with onset 03Mar2021, outcome "unknown", described as "Attentions issued (she cannot concentrate enough to watch a video or processing a lot of video or a lot of light)"; HEADACHE (non-serious) with onset 03Mar2021, outcome "unknown", described as "Severe headaches"; MIGRAINE (non-serious) with onset 03Mar2021, outcome "unknown", described as "Migraine"; PHOTOPHOBIA (non-serious) with onset 03Mar2021, outcome "unknown", described as "Light sensitivity"; INSOMNIA (non-serious) with onset 03Mar2021, outcome "unknown", described as "Difficulty sleeping". The events "fatigue/ exhaustion", "brain fog", "memory issues", "attentions issued (she cannot concentrate enough to watch a video or processing a lot of video or a lot of light)", "severe headaches", "migraine", "light sensitivity" and "difficulty sleeping" were evaluated at the physician office visit and emergency room visit.  Additional Information: The patient reported the events she was experiencing was almost the same symptoms as when she had a concussion on 2019. Since the first week after the administration of the vaccine, the patient had spoken with her Physician for more information and management. The week before the day of report, the patient had to be admitted into the Emergency Room for the management of the symptoms reported. It was further reported that she has now an appointment with her Neurologist.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Migraine, Photophobia
Clinical narrative: Fatigue/ exhaustion; Brain fog; Memory issues; Attentions issued (she cannot concentrate enough to watch a video or processing a lot of video or a lot of light); Severe headaches; Migraine; Light sensitivity; Difficulty sleeping; 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 64 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Concussion", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 03Mar2021, outcome "unknown", described as "Fatigue/ exhaustion"; FEELING ABNORMAL (non-serious) with onset 03Mar2021, outcome "unknown", described as "Brain fog"; MEMORY IMPAIRMENT (non-serious) with onset 03Mar2021, outcome "unknown", described as "Memory issues"; DISTURBANCE IN ATTENTION (non-serious) with onset 03Mar2021, outcome "unknown", described as "Attentions issued (she cannot concentrate enough to watch a video or processing a lot of video or a lot of light)"; HEADACHE (non-serious) with onset 03Mar2021, outcome "unknown", described as "Severe headaches"; MIGRAINE (non-serious) with onset 03Mar2021, outcome "unknown", described as "Migraine"; PHOTOPHOBIA (non-serious) with onset 03Mar2021, outcome "unknown", described as "Light sensitivity"; INSOMNIA (non-serious) with onset 03Mar2021, outcome "unknown", described as "Difficulty sleeping". The events "fatigue/ exhaustion", "brain fog", "memory issues", "attentions issued (she cannot concentrate enough to watch a video or processing a lot of video or a lot of light)", "severe headaches", "migraine", "light sensitivity" and "difficulty sleeping" were evaluated at the physician office visit and emergency room visit.  Additional Information: The patient reported the events she was experiencing was almost the same symptoms as when she had a concussion on 2019. Since the first week after the administration of the vaccine, the patient had spoken with her Physician for more information and management. The week before the day of report, the patient had to be admitted into the Emergency Room for the management of the symptoms reported. It was further reported that she has now an appointment with her Neurologist.   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, Headache, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: Funky feeling; headache feeling; My symptoms seems like it could have been just allergies; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (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 21Mar2021, outcome "unknown", described as "Funky feeling"; HEADACHE (non-serious) with onset 21Mar2021, outcome "unknown", described as "headache feeling"; HYPERSENSITIVITY (non-serious) with onset Mar2021, outcome "unknown", described as "My symptoms seems like it could have been just allergies". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient got the vaccine on 11Mar2021 and nothing bad had happened to her. On Saturday 20Mar2021, she started getting some funky, headache feeling. Her work made her get a COVID test on the 21st of the month. She had been hanging out with about eight people including her partner but no one had shown symptoms. Her symptoms seemed like it could have been just allergies. She got another test on Thursday (2021) and it came back negative. She understood that polymerase chain reaction (PCR) test pick up tiny traces of genetic material and the vaccine, the spike protein is genetic protein. The patient was asking if there was a paperwork saying it may possible cause a false positive.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: she started experiencing cramps in her stomach it hurt so; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: she was infected with Covid. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "she started experiencing cramps in her stomach it hurt so". Additional Information: She was infected with Covid and waited to get the vaccine. She received the Pfizer Covid 19 vaccine and waited 30 minutes in the vaccination center. She was okay so she left, when she came home, she started experiencing cramps in her stomach and she described them "like having a baby". It hurt so she sat down for 15 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: Throat irritation
Clinical narrative: itchy throat; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient (Age: 51; Unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Mar2021 (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: THROAT IRRITATION (non-serious), outcome "unknown", described as "itchy throat". Therapeutic measures were taken as a result of throat irritation. Clinical course: The patient reported she felt an itchy throat when she got home, and she actually took Benadryl as treatment. She was asking if she can take another Benadryl before or after taking the 2nd dose.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: sore arm; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovering", described as "sore arm"; NAUSEA (non-serious) with onset Mar2021, outcome "recovering", described as "nausea".  Additional information: The reporter stated that the patient received her first does of the Pfizer covid-19 vaccine on 27Mar2021, and experienced a sore arm and nausea afterwards but she was better at the time of the report. The reporter asked the ingredients of the Pfizer COVID-19 vaccine and what are they used for; also asked if the ingredients were shown to be safe; and how effective the vaccine is.  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: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: whole left arm hurt including the top of the shoulder/ the whole Left arm, shoulder and wrist, is sore; whole left arm hurt including the top of the shoulder/ the whole Left arm, shoulder and wrist, is sore; a little pain at the site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Batch/Lot number: unknown) at the age of 74 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 Feb2021, outcome "unknown", described as "a little pain at the site"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset Mar2021, outcome "unknown" and all described as "whole left arm hurt including the top of the shoulder/ the whole Left arm, shoulder and wrist, is sore". The events "a little pain at the site", "whole left arm hurt including the top of the shoulder/ the whole left arm, shoulder and wrist, is sore" and "whole left arm hurt including the top of the shoulder/ the whole left arm, shoulder and wrist, is sore" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain, pain in extremity, arthralgia; patient was given gabapentin and a topical cream .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain at the injection site".  Additional Information: The patient wanted to know how long the pain would last at the injection site. She mentioned that her arm pain was gone the next day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Sciatica
Clinical narrative: sciatica pain; sciatica pain; This is a spontaneous report received from a non-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) (Batch/Lot number: unknown) as dose 1, single and administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "sciatica pain" (unspecified if ongoing); "bulging disk" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SCIATICA (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "sciatica pain". Additional information: The patient says she is in pain but was told by the pharmacist that she cannot take ibuprofen (ADVIL) for 2 weeks after the vaccine or it would decreased the efficacy of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 04Mar2021 09:15 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.   The following information was reported: DIARRHOEA (non-serious), outcome "recovered", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient did not have COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to cats" (unspecified if ongoing), notes: highly allergic to cats; "allergic to holm oak" (unspecified if ongoing), notes: moderately to holm oak; "allergic to almonds" (unspecified if ongoing), notes: mildly to almonds. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain in the injection site".  Additional information: The patient reported she did not have an allergic reaction to vaccine administration but a pain in the injection site for a couple of days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Nausea, Pain in extremity
Clinical narrative: sore arm; headache; nausea; chills; she is still sick; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "sore arm"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "headache"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "nausea"; CHILLS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "chills"; ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "she is still sick".  Additional information: The patient had her first dose of the Pfizer Covid 19 vaccine last 23Mar2020 and experienced sore arm, headache, nausea, chills for 2 days. On the 3rd day, she is still sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Paraesthesia oral, Salivary hypersecretion
Clinical narrative: lips started to feel like it was stretching; mouth was watering; she felt as if her tongue did not want to sit in her mouth; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Mar2021 (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: ORAL DISCOMFORT (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "lips started to feel like it was stretching"; SALIVARY HYPERSECRETION (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "mouth was watering"; PARAESTHESIA ORAL (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "she felt as if her tongue did not want to sit in her mouth".  Additional information: Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Monday. While she was driving home, her lips started to feel like it was stretching, but when she checked, it was not swollen. She said her mouth was watering, and she felt as if her tongue did not want to sit in her mouth. Consumer said it eventually went away after 2 hours so she never sought medical attention. She was querying if she should still receive the second dose. She also wanted to know what are considered as mild reactions to the vaccine.  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
Clinical narrative: soreness; 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 female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (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: PAIN (non-serious) with onset 29Mar2021, outcome "unknown", described as "soreness".  Additional information: The patient would like to know if it is okay to take aspirin for soreness afterwards.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder, Malaise, Oropharyngeal pain
Clinical narrative: congestion; mild sore throat; not feeling well; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Mar2021 (Batch/Lot number: unknown) 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: OROPHARYNGEAL PAIN (non-serious) with onset 22Mar2021, outcome "not recovered", described as "mild sore throat"; MALAISE (non-serious) with onset 22Mar2021, outcome "not recovered", described as "not feeling well"; ILL-DEFINED DISORDER (non-serious) with onset 25Mar2021, outcome "not recovered", described as "congestion". Therapeutic measures were not taken as a result of oropharyngeal pain, malaise, ill-defined disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Dizziness; weak; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 57 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: DIZZINESS (non-serious) with onset 25Mar2021, outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious) with onset 25Mar2021, outcome "unknown", described as "weak"; HEADACHE (non-serious) with onset 25Mar2021, outcome "unknown", described as "Headache". Additional information: The patient was waiting to see if she had a reaction. After an hour, she got dizzy. The patient had a headache, dizziness, weak, and hard to get out of bed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection
Clinical narrative: Bacterial infection; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 29Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 76-year-old female 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: BACTERIAL INFECTION (non-serious), outcome "unknown", described as "Bacterial infection". Therapeutic measures were taken as a result of bacterial infection.  Additional Information: The patient was calling about the COVID-19 vaccine. The patient was scheduled to receive the second dose of the Pfizer-BioNTech COVID-19 vaccine tomorrow, 30Mar2021. The patient was currently taking 1000 mg of cefalexin (KEFLEX) for a bacterial infection after the first dose of her vaccine. The patient was concerned if this would have a possible interaction with the vaccine and if this would make her sick if she gets the second vaccine. The patient asked when is the latest she can get the second dose if she doesn't get the second dose tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue
Clinical narrative: loss of appetite; stomach pain; tiredness; 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 male patient (Age: 71; Unit: Unknown) received bnt162b2 (BNT162B2), administration date 20Mar2021 (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: DECREASED APPETITE (non-serious) with onset Mar2021, outcome "unknown", described as "loss of appetite"; ABDOMINAL PAIN UPPER (non-serious) with onset Mar2021, outcome "unknown", described as "stomach pain"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain assessment, Pain in extremity
Clinical narrative: Extreme pain in my arm/ It started on my under arm, and now my whole upper arm is extremely painful; Painful swollen gland under arm; This is a spontaneous report received from a contactable reporter (consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Feb2021 (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 (as dose 1, single), administration date: 02Feb2021, for COVID-19 immunisation, reaction: "No side after 1st." The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "not recovered", described as "Extreme pain in my arm/ It started on my under arm, and now my whole upper arm is extremely painful" and LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "not recovered", described as "Painful swollen gland under arm." Relevant laboratory tests and procedures are available in the appropriate section. Additional information: She had no side effect or pain at all after the first shot, but after the second shot, she experienced little pain on her upper arm, but it went away (as reported). It has already been a month later and her arm was really sore to touch. The pain was a 9 when she touched it. She also experienced a painful swollen gland under her arm a month later. She reported that she could take the pain, but it was extremely painful when touched. Now, she has this pain going down her arm a week later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.