chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable other HCP. A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced lymphadenopathy (husband had a swollen lymph node in his hand after receiving the vaccine), with outcome of unknown. Additional information: HCP stated she received the 1st dose of the Pfizer COVID-19 vaccine about 2 ½ weeks ago. She experienced swollen lymph nodes, which lasted more than 2 weeks. Her neck was swollen and tight. She couldn't walk. Her husband had a swollen lymph node in his hand after receiving the vaccine. She had to sit after getting the dose. She has an allergy to sulfites. Her heart rate went faster and felt like a rush of blood to head. She had a period (menstrual cycle) twice; and it's been lasting longer than usual. She asked for a letter stating she shouldn't get the 2nd dose. Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Just normal discomfort at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 10:00 (Lot number: FD8448) at the age of 37 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 DISCOMFORT (non-serious) with onset 20Aug2021, outcome "recovered" (2021), described as "Just normal discomfort at the injection site". Therapeutic measures were not taken as a result of vaccination site discomfort.  Additional information: Facility where the most recent COVID-19 vaccine administered was Public Health Clinic/Veterans. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Nausea, SARS-CoV-2 test
Clinical narrative: extreme nausea; extreme fatigue; sleeping 22 hours a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Aug2021 15:45 (Lot number: EW0202) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 12Aug2021 18:00, outcome "not recovered", described as "extreme nausea"; FATIGUE (non-serious) with onset 12Aug2021 18:00, outcome "not recovered", described as "extreme fatigue"; HYPERSOMNIA (non-serious) with onset 12Aug2021 18:00, outcome "not recovered", described as "sleeping 22 hours a day". The events "extreme nausea", "extreme fatigue" and "sleeping 22 hours a day" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, fatigue, hypersomnia.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not have any known allergies. The concomitant medications or other medications the patient received in two weeks included Multivitamin. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. 48 hours after first shot, the patient experienced extreme nausea and sleeping 22 hours a day. She was still sleeping and it has now been 24 days with extreme fatigue.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed tinnitus (got tinnitus in left ear), with outcome of not recovered. The event evaluated at a physician office visit. Additional information: The patient stated she developed tinnitus in her left ear from Pfizer COVID-19 shot. She went to her neurologist/doctors. They said this was not the first time they had heard of it. She wanted to know if there is anything they can do about it. It was driving her nuts. She was told someone was trying to come up with something for it. She developed tinnitus after her first shot. She got second shot because she thought it would go away. She did not know what tinnitus was and did not know it was permanent. She did not know if this was a common occurrence. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Pain
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). Other case identifier: NVSC2020US100435). A 59-year-old female patient received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 59, on Mar 23, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced asthenia (debility with ambulation), felt  abnormal (brain fog) and pain, onset 2021, with outcome of recovered (2021). Follow-up attempts  completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: sweating; Headache; Felt like a freight train hit her; Dizziness; soreness and aching in her body/ Body Aches; chills off and on; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 14:00 (Batch/Lot number: unknown) at the age of 60 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: HYPERHIDROSIS (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "sweating"; HEADACHE (non-serious) with onset 01Sep2021 01:00, outcome "recovering", described as "Headache"; FEELING ABNORMAL (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "Felt like a freight train hit her"; DIZZINESS (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "Dizziness"; PAIN (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "soreness and aching in her body/ Body Aches"; CHILLS (non-serious) with onset 01Sep2021 01:00, outcome "recovering", described as "chills off and on". Therapeutic measures were taken as a result of hyperhidrosis, headache, feeling abnormal, dizziness, pain, chills.  Additional information: This report was not related to a study or program. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that she received the shot on Tuesday, 31AUG2021 and she had a bad reaction on Wednesday and Thursday and today she was feeling better, except for a lingering headache. Patient stated on Tuesday night she felt like a freight train hit her, she was sweating, had chills off and on, body aches, dizziness, soreness and aching in her body.  Follow-up attempts completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sweating; Headache; Felt like a freight train hit her; Dizziness; soreness and aching in her body/ Body Aches; chills off and on; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 14:00 (Batch/Lot number: unknown) at the age of 60 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: HYPERHIDROSIS (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "sweating"; HEADACHE (non-serious) with onset 01Sep2021 01:00, outcome "recovering", described as "Headache"; FEELING ABNORMAL (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "Felt like a freight train hit her"; DIZZINESS (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "Dizziness"; PAIN (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "soreness and aching in her body/ Body Aches"; CHILLS (non-serious) with onset 01Sep2021 01:00, outcome "recovering", described as "chills off and on". Therapeutic measures were taken as a result of hyperhidrosis, headache, feeling abnormal, dizziness, pain, chills.  Additional information: This report was not related to a study or program. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that she received the shot on Tuesday, 31AUG2021 and she had a bad reaction on Wednesday and Thursday and today she was feeling better, except for a lingering headache. Patient stated on Tuesday night she felt like a freight train hit her, she was sweating, had chills off and on, body aches, dizziness, soreness and aching in her body.  Follow-up attempts completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A 60-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8730), at the age of 59, in left arm, on Apr 29, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER2613), in left arm, on Apr 7, 2021, for COVID-19 immunisation. The patient experienced  myalgia (muscle pain) and oropharyngeal pain (sore throat), with outcome of unknown. Additional information: The patient experienced muscle pain and sore throat after they wake up every morning. She wondered if that's to be expected with the COVID-19 vaccine, and if it will go away or anything. This LRN W2021394316 crosslinked with LRN W2021394310. Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: This is a spontaneous report received from contactable other HCP (patient). A 28-year-old female patient (not pregnant) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 28, in right arm, on Aug 31, 2021, at 20:30, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had tremor (shaking hands, appearing randomly through the day for several days), onset Sep 2, 2021, with outcome of not recovered. No therapeutic measures taken as a result of tremor. Additional information: The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Hospital. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: He gets confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Lot number: ER8732) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "disability" (unspecified if ongoing), notes: He has been on disability for 8 or 9 years., Caller clarified that he was disabled and had diabetes prior to receiving the vaccine.; "Diabetic" (unspecified if ongoing), notes: He is a diabetic., Caller clarified that he was disabled and had diabetes prior to receiving the vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose , Lot number: it is either ENB206 or EN0206.), administration date: 10Mar2021, when the patient was 64 years old, for COVID-19 Immunization. The following information was reported: CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "He gets confused".  Additional Information: He was calling to check. He did his vaccine. He was not sure if he was calling the right place. He gets confused. When can he get the other one. They said he could make another appointment. He got the first one on 10Mar2021 and the second one on 31Mar2021. Now, he had got to get another one. Reporter states he doesn't have a side effect or product complaint. He called up because they said he could do it already. He was on disability. He has a lot of problems. He was a diabetic. He has been on disability for 8 or 9 years. Reporter clarified that he was disabled and had diabetes prior to receiving the vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Migraine
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA7485), single dose, for COVID-19 immunisation. Medical history included migraine sufferer (unspecified if ongoing). The patient's concomitant medications not reported. The patient had a rash, fatigue/lot of fatigue and migraine (migraine; "I'm a migraine sufferer but it threw me straight into a headache"), with outcome of unknown. Additional information: Patient was fine after the vaccination and fine for 24 hours thereafter. The pharmacist said "if you are going to have a reaction, would happen 24 hours after." After the first shot, patient had a lot of fatigue and got a migraine. Patient was a migraine sufferer. It went straight into a headache. Then yesterday a rash popped up all over their body and had fatigue. The rash persisted for a full 24 hours now. The only thing that seems to be kind of keeping this under control was Benadryl treatment. Follow-up (Sep 10, 2021): Follow-up attempts  completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunization. The patient experienced a headache (outcome unknown). Additional information: Patient stated, "I have had a headache ever since I got the second dose of Pfizer; so what do you recommend?" No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information  expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: arm has been hurting ever since receiving the second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 15:00 (Lot number: EP7534) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "anti-inflammatory" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN taken for blood pressure measurement (ongoing); MELOXICAM taken for antiinflammatory therapy (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Lot: EN6198, NDC: Unknown , Expiration: Unknown , Anatomical location: left arm), administration date: 24Feb2021, when the patient was 80 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Mar2021, outcome "not recovered", described as "arm has been hurting ever since receiving the second dose". The event "arm has been hurting ever since receiving the second dose" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: It was reported that patient had a reaction and is still having a problem after receiving the second dose Pfizer Covid 19 Vaccine. He went to the doctor about the arm hurting and he went to the orthopedic doctor and the family doctor. The orthopedic doctor took x-rays. He was sent to rehab section, did rehab exercise stuff and believe it or not it may have helped a little, doing exercise and went to physical therapy, everything and not seen a lot of improvement. Reporter stated figured the arm pain would go away. The patient is worried about, it has been 4 months since the caller received the Pfizer Covid 19 Vaccine. Some days the arm pain does not bother the caller as much and only hurts when moves arm or not normal, lifting arm above head, trying to put on his belt or something like that, raising his arms above his head, brushing his hair or pulling his hair, sticks arm behind back or something like that. If the caller has his hands Infront he feels the arm pain but it does not hurt that bad. Sometimes the arm hurts worse than others. He clarifies the arm pain is in his left arm, not his primary arm. The patient is not overweight and takes a little bit of blood pressure medicine, a low dose and also takes an anti-inflammatory medicine. No additional Vaccines administered on same date of the Pfizer Suspect and no prior Vaccinations (within 4 weeks).   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cushingoid
Clinical narrative: goid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EN6206) 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, Lot# EN6203), for Covid-19 immunization. The following information was reported: CUSHINGOID (non-serious) with onset 21Feb2021, outcome "unknown", described as "goid".  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Change in menstrual cycle after both first and second dose/Period occurred 5 days after 1st only 10 days after the previous menstruation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 13:00 (Lot number: FC3180) at the age of 42 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: MENSTRUAL DISORDER (non-serious) with onset Aug2021, outcome "unknown", described as "Change in menstrual cycle after both first and second dose/Period occurred 5 days after 1st only 10 days after the previous menstruation".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown that the patient diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. Device Date: 03Sep2021  Follow-up attempts are completed. No further information is expected
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Euphoric mood, Insomnia
Clinical narrative: Euphoria; Insomnia; he is wide awake/it is like an unusual energy boost, like he drank a bunch of; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2020 (Lot number: EJ1685) at the age of 35 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: EUPHORIC MOOD (non-serious) with onset 22Dec2020, outcome "unknown", described as "Euphoria"; INSOMNIA (non-serious) with onset 22Dec2020, outcome "unknown", described as "Insomnia"; ENERGY INCREASED (non-serious) with onset 22Dec2020, outcome "unknown", described as "he is wide awake/it is like an unusual energy boost, like he drank a bunch of". Therapeutic measures were not taken as a result of euphoric mood, insomnia, energy increased.  Additional information: Caller stated that after the one dose of the vaccine he had so much energy he hiked 7 miles. Caller said his vaccine card has a mix of stickers and handwritten information. He said that the euphoria and insomnia begins 30-45 minutes after each dose. He said that there has been no treatment done, he just enjoys it, to be honest. He said he believe all those times he received his vaccine doses it was after work, and he works night shift so he was normally very tired after work. He said he knows it cause insomnia because he was normally extra tired after work, and usually falls asleep right away. He said he has had no coffee and done nothing different and he was wide awake which was the same feeling as had those other times. He said it was like an unusual energy boost, like he drank a bunch of caffeine or coffee. Seriousness: Caller said it was not serious, he was curious to hear what someone might think about it, he was not really sure, anyone he mentions it to like physicians he basically got laughter for it.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Euphoric mood, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Euphoria; Insomnia; he is wide awake/it is like an unusual energy boost, like he drank a bunch of; first dose: 22Dec2020/second dose this dose was provided 09Jan2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2021 (Lot number: EL3249) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: EJ1685, he believes all three of his doses were given in his left arm), administration date: 22Dec2020, when the patient was 35 years old, for Covid-19 Immunization, reaction(s): "Euphoria", "Insomnia", "he is wide awake/it is like an unusual energy boost, like he drank a bunch of". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Jan2021, outcome "unknown", described as "first dose: 22Dec2020/second dose this dose was provided 09Jan2021"; EUPHORIC MOOD (non-serious), outcome "unknown", described as "Euphoria"; INSOMNIA (non-serious), outcome "unknown", described as "Insomnia"; ENERGY INCREASED (non-serious), outcome "unknown", described as "he is wide awake/it is like an unusual energy boost, like he drank a bunch of". Therapeutic measures were not taken as a result of euphoric mood, insomnia, energy increased.  Additional information: Caller says his vaccine card has a mix of stickers and handwritten information. He says the NDC/EXP were not provided for any of his three doses of Pfizer-BioNTech COVID-19 vaccine/Comirnaty. He provides LOT: EJ1685 for his first dose and says he believes all three of his doses were given in his left arm. He says his second dose was LOT: EL3249 and this dose was provided 09Jan2021. Caller says his third dose was today 02Sep2021, of LOT: EW0185. He says that the euphoria and insomnia begins 30-45 minutes after each dose. He says that there has been no treatment done, he just enjoys it, to be honest. He says he believe all those times he received his vaccine doses it was after work, and he works night shift so he was normally very tired after work. He says he knows it cause insomnia because he was normally extra tired after work, and usually falls asleep right away. He says he has had no coffee and done nothing different and he was wide awake which was the same feeling as had those other times. He says it was like an unusual energy boost, like he drank a bunch of caffeine or coffee. Seriousness: Caller says it was not serious, he was curious to hear what someone might think about it, he was not really sure, anyone he mentions it to like physicians he basically got laughter for it.  Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: first dose: arm hurt, hurt to lift it up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Aug2021 14:00 (Lot number: FC3181) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Digestive issues" (ongoing), notes: Verbatim: digestive issues; "Menopause" (ongoing), notes: in menopause, she has not had a period since she was, probably 3 years, 3.5 years; "Migraines" (ongoing), notes: she does migraines, she doesn't know if she is ever been technically diagnosed, but the first time she ever had one was after she had her 2nd child, so probably 29 years ago,. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE MAGNESIUM] taken for dyspepsia (ongoing); ALKA-SELTZER HEARTBURN RELIEF taken for dyspepsia (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Aug2021, outcome "recovered" (09Aug2021), described as "first dose: arm hurt, hurt to lift it up".  Additional information: No vaccinations within four weeks prior to the first administration date of the suspect vaccine  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My right arm was sore, more so then the 1st 2 shots.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose 1, single and administered in arm right (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Immune deficiency" (unspecified if ongoing), notes: Immune deficiency; "Exercise induced asthma" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: Post-traumatic stress disorder; "Depression" (unspecified if ongoing); "Panic disorder" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My right arm was sore, more so then the 1st 2 shots.".  Additional information: Reaction(s)/Event(s): 3rd dose of vaccine was administered in the right arm. Her right arm was sore, more so then the 1st 2 shots. She had a few light heart flutters the 1st 2 days, but nothing serious. She had moments of feeling flush to the skin, but not feverish. 3 day. Date of start of reaction/event: 31Aug2021. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date: 03Sep2021. Reported Event:  She had moments of feeling flush to the skin, but not feverish. 3 days ago, it felt like she was starting to break out on her right cheek and just thought of it as a possible acne reaction to stress. Yesterday, the lesion started on my right side and the bumps felt blotchy vice like acne. Yesterday, she had tenderness under my armpit and outer part of her boob and took it as the soreness from her arm was spreading and prolonged wear of her bra. This morning, her arm hurt less, but under her arm and near her outer boob area it was a little tender. Some tenderness on the right side of her throat, like the lymph nodes might have been swollen in those 2 areas. Tonight she looked online to see if bupropion could be causing this. It was possible, but the symptoms didn't start until after the 3rd Pfizer shot. Left side was fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Feeling hot, Therapeutic response unexpected
Clinical narrative: I was given my shot, I had this warm feeling in my head, migraine left and I have not had one since; I was given my shot, I had this warm feeling in my head, migraine left and I have not had one since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "had terrible migraines", start date: Jan2021 (unspecified if ongoing), notes: lasting everyday for weeks. My doctor thought it might be iritis but, the steroid drops did not help. I tried a new migraine medicine and it did nothing. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "I was given my shot, I had this warm feeling in my head, migraine left and I have not had one since". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Last January patient had terrible migraines lasting everyday for weeks. Sunglasses in house and windows and door covered. Patient doctor thought it might be iritis but the steroid drops did not help. Patient tried a new migraine medicine and it did nothing. Patient went the next day for blood work and was given a different medicine. Patient told doctor patient was getting Covid shot next day so patient would take it after 3 days. Patient was given shot, patient had this warm feeling in patient head, migraine left and patient have not had one since.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed nasopharyngitis (a cold) and nasal congestion (stuffy nose), with outcome of not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: Sinus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "Sinus". Therapeutic measures were taken as a result of sinus disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Had a mild headache after receiving  the 1st and 2nd dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 12:00 (Lot number: EW0198) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I am currently breastfeeding", start date: 25Apr2021 (ongoing), notes: Other medical history: Had 2nd child and I am currently breastfeeding. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: HEADACHE (non-serious) with onset 01Sep2021 07:30, outcome "not recovered", described as "Had a mild headache after receiving  the 1st and 2nd dose of the vaccine". Therapeutic measures were not taken as a result of headache.  Additional information: It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store Facility.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: turned blue Not at the injection site, but in general; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 14 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: SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "recovered" (2021), described as "turned blue Not at the injection site, but in general".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, 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 "sore arm after getting the vaccine".  Additional information: Reporter husband took both doses of the Pfizer Covid19 vaccine and doesn't have a reaction aside from a little sore arm.   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: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Influenza like illness
Clinical narrative: Headache; Tiredness; bad stomach ache; nausea; Vomited; really bad diarrhea; flu like; Insomnia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 03Sep2021 (Lot number: FC3184) 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: VOMITING (non-serious) with onset 06Sep2021, outcome "recovered" (06Sep2021), described as "Vomited"; DIARRHOEA (non-serious) with onset 06Sep2021, outcome "not recovered", described as "really bad diarrhea"; INFLUENZA LIKE ILLNESS (non-serious) with onset 06Sep2021, outcome "not recovered", described as "flu like"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; FATIGUE (non-serious), outcome "recovered", described as "Tiredness"; INSOMNIA (non-serious) with onset 03Sep2021, outcome "recovered" (2021), described as "Insomnia"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "bad stomach ache"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Therapeutic measures were taken as a result of insomnia.  Additional information: . Caller reported that her side effects started yesterday. Caller stated she vomited and had really bad diarrhea describing the diarrhea as yellow and flu like. Caller reported that she had headache and tiredness. Caller stated she did not see sore throat as a side effect to the vaccine . No Other Products. No Investigation Assessment.Her and her son had the COVID vaccine on Friday. 3 days after the COVID vaccine side effects started . Caller says that all of her side effects began yesterday, confirmed to 06Sep2021. She then clarifies and says that she felt the tiredness and the headache days before but they were not severe and even yesterday they were not severe, but she had the bad stomach ache and the diarrhea and then vomiting, she only threw up once. She says that she was not having the headache and the tiredness today and when inquired when it ended she states that she still doesn't feel top notch. She was still having the diarrhea and the headache has gone away and the nausea was not as bad today but the stomach ache was still there a little bit. The vomited ended yesterday, she only threw up once. Insomnia was began on 03Sep2021. She took this thing that she has called sleep sense and it has melatonin in it. Pretty much she slept all day yesterday. She didn't move much from either the bed or the toilet.She was feeling fine before the COVID vaccine. She has O+ blood type and she knows that you can have no symptoms at all and be carrying it, she doesn't know if that's true or if it's just rumors going around.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Vomiting
Clinical narrative: Headache; Tiredness; bad stomach ache; nausea; Vomited; really bad diarrhea; flu like; Insomnia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 03Sep2021 (Lot number: FC3184) 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: VOMITING (non-serious) with onset 06Sep2021, outcome "recovered" (06Sep2021), described as "Vomited"; DIARRHOEA (non-serious) with onset 06Sep2021, outcome "not recovered", described as "really bad diarrhea"; INFLUENZA LIKE ILLNESS (non-serious) with onset 06Sep2021, outcome "not recovered", described as "flu like"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; FATIGUE (non-serious), outcome "recovered", described as "Tiredness"; INSOMNIA (non-serious) with onset 03Sep2021, outcome "recovered" (2021), described as "Insomnia"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "bad stomach ache"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Therapeutic measures were taken as a result of insomnia.  Additional information: . Caller reported that her side effects started yesterday. Caller stated she vomited and had really bad diarrhea describing the diarrhea as yellow and flu like. Caller reported that she had headache and tiredness. Caller stated she did not see sore throat as a side effect to the vaccine . No Other Products. No Investigation Assessment.Her and her son had the COVID vaccine on Friday. 3 days after the COVID vaccine side effects started . Caller says that all of her side effects began yesterday, confirmed to 06Sep2021. She then clarifies and says that she felt the tiredness and the headache days before but they were not severe and even yesterday they were not severe, but she had the bad stomach ache and the diarrhea and then vomiting, she only threw up once. She says that she was not having the headache and the tiredness today and when inquired when it ended she states that she still doesn't feel top notch. She was still having the diarrhea and the headache has gone away and the nausea was not as bad today but the stomach ache was still there a little bit. The vomited ended yesterday, she only threw up once. Insomnia was began on 03Sep2021. She took this thing that she has called sleep sense and it has melatonin in it. Pretty much she slept all day yesterday. She didn't move much from either the bed or the toilet.She was feeling fine before the COVID vaccine. She has O+ blood type and she knows that you can have no symptoms at all and be carrying it, she doesn't know if that's true or if it's just rumors going around.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 12:00 (Lot number: FC3182) at the age of 33 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "I am currently breastfeeding", start date: 25Apr2021 (ongoing), notes: Had 2nd child on 25Apr2021 and, I am currently breastfeeding. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. Vaccination history included: Bnt162b2 (Product: COVID 19, brand: Pfizer, Lot number: EW0198, Lot unknown: False, Administration date: 09Aug2021, Administration time: 12:00 PM, Dose number: 1, Vaccine location=Left arm), administration date: 19Jan1988, when the patient was 33 years old, for COVID-19 immunization, reaction(s): "Headache". The following information was reported: DIZZINESS (non-serious) with onset 01Sep2021 07:30, outcome "not recovered", described as "Feelings of dizziness/vertigo in the morning hour"; VERTIGO (non-serious) with onset 01Sep2021 07:30, outcome "not recovered", described as "Feelings of dizziness/vertigo in the morning hours"; HEADACHE (non-serious) with onset 01Sep2021 07:30, outcome "not recovered", described as "Had a mild headache after receiving the 1st and 2nd dose of the vaccine". Therapeutic measures were not taken as a result of dizziness, vertigo, headache. Additional information: Patient did not received any other vaccine in four weeks. Patient was not tested for Covid post vaccination. It was unknown that if patient had Covid prior to vaccination. There were no known allergies. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick from the side effects; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). 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: ILLNESS (non-serious), outcome "unknown", described as "Sick from the side effects".  Additional information: This report is not related to a study or programme. Patient mentioned he took the vaccine for Covid, the Pfizer COVID vaccine and initially stated he wanted to report an event. He then went on to state he is sick from the side effects and wanted to speak to someone on about it. He confirmed he has not reported these events to our safety department previously.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.