chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed period. For the first time since my period began, I missed my monthly period for the first time EVER in eleven years.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 18:00 (Lot number: FC3182) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: ACCUTANE. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Missed period. For the first time since my period began, I missed my monthly period for the first time EVER in eleven years.". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: : Missed period. For the first time since my period began, I missed my monthly period for the first time EVER in eleven years. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Patient received medications within 2 weeks of vaccination: Accutane, hormonal birth control.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Infertility
Clinical narrative: has developed where she can never have children again after getting the vaccine; 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 parent.  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: INFERTILITY (non-serious), outcome "unknown", described as "has developed where she can never have children again after getting the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: I am normally like clockwork on a 4 week cycle, but got my period and then got another period following 2 weeks later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 (Lot number: EW 0169) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibrous dysplasia" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Lot: EW 0169, Location: Arm left), administration date: 19Apr2021, for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 24May2021, outcome "not recovered", described as "I am normally like clockwork on a 4 week cycle, but got my period and then got another period following 2 weeks later". The event "i am normally like clockwork on a 4 week cycle, but got my period and then got another period following 2 weeks later" was 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 menstruation irregular.  Additional information: Her menstrual cycle became irregular immediately following the second shot. She was normally like clockwork on a 4 week cycle, but got her period and then got another period following 2 weeks later. It had been now been 4 months, and things had not evened out. This past month, she slipped her period entirely, with no chance that she was pregnant. She had reported this to her doctor but been waived off, being told that this was not a reported symptom of the vaccine, but several of her female friends had also noted the same they all see a direct link between when we got the vaccine and when things began to go wrong. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Covid tested post vaccination. No known allergies. Facility where the most recent COVID-19 vaccine was administered was Other.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: She is calling about her sister who is biological, has the same problems/palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: PALPITATIONS (non-serious), outcome "unknown", described as "She is calling about her sister who is biological, has the same problems/palpitations".  Additional information: Caller stated that she is a lawyer and she is fed up. She is calling about her sister who is biological, has the same problems. Everybody and her sister knows what is going on behind the scenes. You are hiding a lot of things. She is not anti-vaccine and she has gotten the measles, hepatitis vaccine, and this is not safe. Her sister is having palpitations and is going to see a pathologist.   Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Its affecting my mother and we got some big issue; my mother do not feel well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  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: MALAISE (non-serious), outcome "unknown", described as "Its affecting my mother and we got some big issue; my mother do not feel well".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Nausea
Clinical narrative: Nauseous; Uncomfortable; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (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, Single), for COVID-19 immunization, reaction(s): "Chills", "Persistent cough", "Fever". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; DISCOMFORT (non-serious), outcome "unknown", described as "Uncomfortable".  Follow-up attempts are completed, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: adult female who gets migraines every other day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  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: MIGRAINE (non-serious), outcome "unknown", described as "adult female who gets migraines every other day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Menstrual disorder, X-ray
Clinical narrative: I do not have period for that entire time but on 6th months to the day my periods came back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 25Feb2021 17:15 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 47 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 one EL9269, 1st dose on 04Feb2021 05:15 PM on Right Arm, Batch/Lot number: EL9269, Route of administration: Intramuscular, Amenorrhea onset date-24Feb2021, required visit to Physician Office got recovered on 14Aug2021.), administration date: 04Feb2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "Amenorrhea".  The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "recovered", described as "I do not have period for that entire time but on 6th months to the day my periods came back". The event "i do not have period for that entire time but on 6th months to the day my periods came back" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that she had a side effect that she wanted to or adverse reaction that she wanted to report. Patient periods came back, 11Aug and she thought maybe it was a fluke but now my periods are regular just like they normally have them. So, she thought it might have been the vaccine. she had her period in Feb before her vaccine then she haven't had one in Mar. Patient went to the doctor they told that she was crazy the things that they did not think of and she had some X-ray and lab work done, had a physical, annual checkup. Everything was fine beside the things little bit.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Lethargy, Lymphadenopathy, Nausea
Clinical narrative: Lymph node swelling in neck/it was very mild/minimal swelling to lymph nodes at the clavicle and axillary areas; Normal Lethargy; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 24Aug2021 13:00 (Lot number: FC3181) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Subclinical hypothyroidism", start date: Jan2020 (unspecified if ongoing). Family history included: "lymphoma" (unspecified if ongoing), notes: No cancer history other than that. . Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Mmr vaccine (She said this happened previously when she had an MMR vaccine. She does not have the date. It was years ago. She was getting into the  program and they said her antibodies were low and she had to get re-dosed. She does not have the manufacturer, lot or expiration. The date would have been around 2014.), for Immunization, reaction(s): "Lymph node swelling in neck the side the dose was on". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Lymph node swelling in neck/it was very mild/minimal swelling to lymph nodes at the clavicle and axillary areas"; LETHARGY (non-serious) with onset 26Aug2021, outcome "recovering", described as "Normal Lethargy"; NAUSEA (non-serious) with onset 26Aug2021, outcome "recovering", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the first dose, Patient had lymph node swelling in neck only and it was very mild. It started after the second day after getting it. But after second dose, it was much more severe. It looked like a baseball is in her armpit. There was a chain of lymph nodes in her neck, and there were like 4 of them, and they are inflamed and were able to see them. Patient took Vitamins and Levothyroxine. Patient did not took many medications. No further details provided.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity
Clinical narrative: Headache; Arm pain; doesn''t feel good/well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 21Sep2021 (Lot number: 301308A) at the age of 50 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: HEADACHE (non-serious) with onset 21Sep2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 21Sep2021, outcome "unknown", described as "Arm pain"; MALAISE (non-serious) with onset 21Sep2021, outcome "unknown", described as "doesn''t feel good/well".  Additional Information: The reporter states he is experiencing a headache, arm pain, and he just doesn't feel good or well. clarifies these symptoms started in evening, 21Sep2021. Patient's height: 5'6'' or 5'7'' and weight: 225-230lbs.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-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 headache (mild headache) and fatigue (tiredness), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Influenza like illness
Clinical narrative: Flu like symptoms; Left arm pit lump; Right hip pain; 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 patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 17:00 (Lot number: EW0180) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Polycystic ovary syndrome" (ongoing), notes: Polycystic ovary syndrome PCOS, Onset date:10+years; "Prediabetic" (ongoing), notes: Onset date:3+years. The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 31Jul2021, outcome "recovered" (02Aug2021), described as "Flu like symptoms"; AXILLARY MASS (non-serious) with onset 2021, outcome "recovered" (03Aug2021), described as "Left arm pit lump"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (24Aug2021), described as "Right hip pain". Therapeutic measures were taken as a result of influenza like illness, axillary mass, arthralgia.  Additional Information: Vaccination Facility type was Pharmacy or Drug Store. The patient received tylonal as treatment for flulike symptoms, left arm pit lump and right hip pain.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; 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 parent.  A female patient received bnt162b2 (BNT162B2), administration date 05Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization; Bnt162b2 (2nd dose), for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes".  Additional Information: She was scheduled to have a mammography on 04Oct and she was calling to see if it's ok for her to go to that appointment."(Further clarification unknown). She developed swollen lymph nodes and she would only give me her name she wouldn't give me her telephone number, address or anything  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was sick for a day in a half; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) for a Pfizer sponsored program. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "respiratory issues" (unspecified if ongoing); "weak immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was sick for a day in a half".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Impaired quality of life, Malaise, Palpitations
Clinical narrative: Fast heart beat; Dizzy; Not feeling well; eyes were blurry; heart is pounding; laying in bed and does not usually do that.  He took off of work because he is not feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), administration date 07Sep2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: took his high blood pressure medication. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number: FC3180, First dose. Injected in Left shoulder), administration date: 17Aug2021. The following information was reported: HEART RATE INCREASED (non-serious), outcome "recovering", described as "Fast heart beat"; DIZZINESS (non-serious), outcome "recovering", described as "Dizzy"; MALAISE (non-serious), outcome "not recovered", described as "Not feeling well"; VISION BLURRED (non-serious), outcome "recovering", described as "eyes were blurry"; PALPITATIONS (non-serious), outcome "unknown", described as "heart is pounding"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "unknown", described as "laying in bed and does not usually do that. He took off of work because he is not feeling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Fast heart beat; Dizzy; Not feeling well; eyes were blurry; heart is pounding; laying in bed and does not usually do that.  He took off of work because he is not feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), administration date 07Sep2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: took his high blood pressure medication. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number: FC3180, First dose. Injected in Left shoulder), administration date: 17Aug2021. The following information was reported: HEART RATE INCREASED (non-serious), outcome "recovering", described as "Fast heart beat"; DIZZINESS (non-serious), outcome "recovering", described as "Dizzy"; MALAISE (non-serious), outcome "not recovered", described as "Not feeling well"; VISION BLURRED (non-serious), outcome "recovering", described as "eyes were blurry"; PALPITATIONS (non-serious), outcome "unknown", described as "heart is pounding"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "unknown", described as "laying in bed and does not usually do that. He took off of work because he is not feeling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: for some reason, under my right arm, my right armpit is swollen; 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 received bnt162b2 (BNT162B2), administered in arm right, administration date 18Sep2021 (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: LYMPHADENOPATHY (non-serious) with onset 18Sep2021, outcome "unknown", described as "for some reason, under my right arm, my right armpit is swollen".  Additional information: After first dose of Pfizer COVID-19 vaccination last Saturday 18Sep2021:   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Breast pain, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: At the moment left armpit lymph node and under jaw are swollen and they hurt; At the moment left armpit lymph node and under jaw are swollen and they hurt; breast pain; right side sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Aug2021 10:15 (Lot number: FC3181) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastritis", start date: 2014 (ongoing); "Dry Scalp" (unspecified if ongoing). Family history included: "Maternal Grandmother: Kidney cancer/Father: Skin cancer" (unspecified if ongoing). Concomitant medication(s) included: KETOCONAZOLE taken for dry skin (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 09:30 AM, Anatomical site of injection:  Left arm, Batch/lot number: EW0198), administration date: 30Jul2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "under jaw are swollen, hurt", "under jaw are swollen, hurt", "armpit got swollen and painful", "armpit got swollen and painful/neck also got swollen", "breast pain". The following information was reported: BREAST PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "breast pain"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "right side sore"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 31Aug2021, outcome "not recovered" and all described as "At the moment left armpit lymph node and under jaw are swollen and they hurt". The events "breast pain", "at the moment left armpit lymph node and under jaw are swollen and they hurt" and "at the moment left armpit lymph node and under jaw are swollen and they hurt" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior vaccination (within 4 weeks) was none. Treatment: Further testing imaging. Lymph node got swollen again after 2nd dose and breast pain 2 weeks after went to PCP on 13Sep2021. Did bloodwork and will schedule ultrasound and mammogram. At the moment left armpit lymph node and under jaw are swollen and they hurt. The right side is just slightly sore.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Product complaint, Product preparation issue, Underdose
Clinical narrative: after improperly diluting the vials with 2mL of the provided diluent rather than the correct amount of 1.8mL; after improperly diluting the vials with 2mL of the provided diluent rather than the correct amount of 1.8mL; complaint is related to lack of instructions; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UNDERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown" and all described as "after improperly diluting the vials with 2mL of the provided diluent rather than the correct amount of 1.8mL"; PRODUCT COMPLAINT (non-serious), outcome "unknown", described as "complaint is related to lack of instructions".  Additional information: Reporter states her office has been administering the Pfizer BioNTech Covid-19 Vaccine after improperly diluting the vials with 2mL of the provided diluent rather than the correct amount of 1.8mL. Reporter states this was not realized until today. States shipments never came with instructions, but that the shipments are from the county and not from Pfizer.   Follow-up attempts completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Vertigo
Clinical narrative: woke up with an extreme case of vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 08:45 (Lot number: ER2615) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; GLIPIZIDE; SYNTHROID; HYDROCHLOROTHIAZID. The following information was reported: VERTIGO (non-serious) with onset 23Mar2021 07:30, outcome "not recovered", described as "woke up with an extreme case of vertigo". The event "woke up with an extreme case of vertigo" was 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 vertigo.  Additional information: The patient did not have any known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Clinical course: It was reported that 4 days after receiving the vaccine, patient woke up with an extreme case of vertigo. It got better over the following 4 to 5 days and became tolerable. Now about 6 months after the initial onset patient still have it especially on standing or rolling over in bed. A month or so after the initial onset a neurologist had and MRI of brain taken which showed nothing unusual.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Papule
Clinical narrative: Shortly after vaccination small raised bumps formed on both forearms; 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 received bnt162b2 (BNT162B2), administration date 02Sep2021 (Lot number: EW0185) at the age of 26 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Sensitive skin" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing), notes: eczema (usually form hives versus small bumps). There were no concomitant medications.  The following information was reported: PAPULE (non-serious) with onset 06Sep2021, outcome "not recovered", described as "Shortly after vaccination small raised bumps formed on both forearms". Therapeutic measures were not taken as a result of papule.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash developed around the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): 20210916000674, 2021SA308621.  A 12 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Drug hypersensitivity" (ongoing), notes: Ongoing, historical condition, drug hypersensitivity; "ongoing allergies" (ongoing), notes: At the time of the event, the patient had ongoing allergies: Lanolin 100% cream, sorbitan monoluarate. Concomitant medication(s) included: DIPHENHYDRAMINE HYDROCHLORIDE; XYZAL; VITAMIN D3; DUPIXENT. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "recovering", described as "rash developed around the injection site". Therapeutic measures were taken as a result of vaccination site rash. Patient used PRM eczema cream to treat and is slowly resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: After 2nd 1st day migrain again; 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 22Sep2021 15:00 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical location: Arm left, Administration time: 15:00), administration date: 01Sep2021, when the patient was 42 years old, for COVID-19 immunization, reaction(s): "Shoulder pain", "left knee feel sore", "Migrain turned to headache", "Migrain turned to headache", "Heart piercing 1st two weeks". The following information was reported: MIGRAINE (non-serious) with onset Sep2021, outcome "unknown", described as "After 2nd 1st day migrain again".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no Known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The first vaccine caused pain 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 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Jun2021 14:00 (Lot number: EW01A1) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic fatigue" (unspecified if ongoing); "tinnitus" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; MONTELUKAST; ATORVASTATIN; ZOLPIDEM. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Jun2021, outcome "recovering", described as "The first vaccine caused pain at the injection site". The event "the first vaccine caused pain at the injection site" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Tramadol and Pregabalin for the pain for the adverse event as treatment. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  Follow-Up (28 Sep2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: Felt sick; Tired; Extreme headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 (Lot number: FA6780) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Grass" (unspecified if ongoing); "Known allergy: Pollen" (unspecified if ongoing); "Known allergy: Dust" (unspecified if ongoing); "Known allergy: Mite" (unspecified if ongoing); "Known allergy: Animals" (unspecified if ongoing); "Hodgkin's lymphoma" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL. The following information was reported: MALAISE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Felt sick"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Tired"; HEADACHE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Extreme headache". Therapeutic measures were taken as a result of malaise, fatigue, headache.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was other. Prior to vaccination, patient had not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-1 test, Taste disorder
Clinical narrative: There is a lot of foods I can't eat anymore because they taste and smell bad; There is a lot of foods I can't eat anymore because they taste and smell bad; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jul2021 (Lot number: EW0198) as dose 1, single and administered in arm right, administration date Aug2021 (Lot number: EW0183) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: May2021 (unspecified if ongoing), notes: I had COVID-19; "High blood pressure" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: DICYCLOMINE. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 21Aug2021, outcome "not recovered" and all described as "There is a lot of foods I can't eat anymore because they taste and smell bad". Relevant laboratory tests and procedures are available in the appropriate section, which included SARS-CoV-1 test, results: positive ( I had covid-19) on an unspecified date in May2021. Therapeutic measures were not taken as a result of taste disorder, parosmia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Patient mentioned that she lost taste and smell after she had COVID-19 IN May2021, she mentioned that It was coming back by the time I got the vaccine. But after the second vaccine it got worse again. Patient had not taken any other vaccines within 4 weeks prior to the COVID vaccine. patient mentioned that she is unable to eat meat and mentioned as "No matter what kind it is. They all smell they same. This terrible smell that is hard to describe". Since vaccine patient had not been tested for covid-19.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Energy increased, Heart rate increased, Panic attack, Vision blurred
Clinical narrative: Increased heart rate; Blurred vision; Panic; a feeling of adrenaline rushing through my body; a feeling of adrenaline rushing through my body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Sep2021 17:15 (Lot number: FF2587) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Food allergy onion" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Tetracyclines, reaction(s): "Medication allergy tetracyclines", notes: Medication allergy tetracyclines, paraxetine, hydrocodone; Hydrocodone, reaction(s): "Medication allergy Hydrocodone"; Paraxetine, reaction(s): "Medication allergy paraxetine". The following information was reported: HEART RATE INCREASED (non-serious) with onset 23Sep2021 17:15, outcome "recovering", described as "Increased heart rate"; VISION BLURRED (non-serious) with onset 23Sep2021 17:15, outcome "recovering", described as "Blurred vision"; PANIC ATTACK (non-serious) with onset 23Sep2021 17:15, outcome "recovering", described as "Panic"; AGITATION (non-serious), ENERGY INCREASED (non-serious) all with onset 23Sep2021 17:15, outcome "recovering" and all described as "a feeling of adrenaline rushing through my body". Therapeutic measures were not taken as a result of heart rate increased, vision blurred, panic attack, agitation, energy increased.  Additional Information: The case reported as non-serious. Facility type vaccine was reported as Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. COVID prior vaccination was reported as no. COVID tested post vaccination reported as no.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: It has cause my warts to recede and skin seems smother. Great side affect; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 12:00 (Lot number: EN6198) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "heart" (unspecified if ongoing), notes: Event verbatim: heart, diabetic kidney stones gall stones fatty liver, etc; "diabetic" (unspecified if ongoing), notes: Event verbatim: heart, diabetic kidney stones gall stones fatty liver, etc; "kidney stones" (unspecified if ongoing), notes: Event verbatim: heart, diabetic kidney stones gall stones fatty liver, etc; "gallstones" (unspecified if ongoing), notes: Event verbatim: heart, diabetic kidney stones gall stones fatty liver, etc; "fatty liver" (unspecified if ongoing), notes: Event verbatim: heart, diabetic kidney stones gall stones fatty liver, etc. The patient took concomitant medications. Vaccination history included: Bnt162b2 (administration time:12:00 AM,, dose number:1,, vaccine location: Right arm), administration date: 02Feb2021, when the patient was 70 years old, for COVID-19 immunisation.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 24Sep2021, outcome "unknown", described as "It has cause my warts to recede and skin seems smother. Great side affect". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: The patient reported side effect, he had noticed since he had two shots It has cause his warts to recede and skin seems smother. Great side effect. May have other uses. Great work After all they are virus related. The vaccine was administered at Hospital. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. was not result in emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling abnormal, Headache, Malaise
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 16:00 (Lot number: EW0196) at the age of 51 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 28Aug2021, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 22Sep2021, outcome "recovered", described as "I felt very nauseous"; FEELING ABNORMAL (non-serious) with onset 22Sep2021, outcome "recovered", described as "I could not get out of bed; I felt really bad"; SLUGGISHNESS (non-serious) with onset 22Sep2021, outcome "recovered", described as "I still feel little sluggish; I really was having a hard time this morning"; HEADACHE (non-serious) with onset 22Sep2021, outcome "recovered", described as "I had a terrible headache"; MALAISE (non-serious) with onset 22Sep2021, outcome "recovered", described as "I felt like, I am going to get sick"; ANXIETY (non-serious) with onset 22Sep2021, outcome "recovered", described as "I was concerned"; DIZZINESS (non-serious) with onset 22Sep2021, outcome "recovered", described as "dizzy". Additional information: The patient had received second dose of the vaccine at one of the churches and patient was concerned because when patient got the first vaccine on 28Aug patient was okay, but the second one all on 22Sep2021, patient got it about 4 O'clock and last night and early this morning she is felt very nauseous. The patient felt like, patient was going to get sick, patient had a terrible headache, it is that she could not get out of bed, but after that she is fine because right now she is fine. Is that normal to have a reaction like that, after because patient did not had after the first one but the second one she felt really, really bad. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Sluggishness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 16:00 (Lot number: EW0196) at the age of 51 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 28Aug2021, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 22Sep2021, outcome "recovered", described as "I felt very nauseous"; FEELING ABNORMAL (non-serious) with onset 22Sep2021, outcome "recovered", described as "I could not get out of bed; I felt really bad"; SLUGGISHNESS (non-serious) with onset 22Sep2021, outcome "recovered", described as "I still feel little sluggish; I really was having a hard time this morning"; HEADACHE (non-serious) with onset 22Sep2021, outcome "recovered", described as "I had a terrible headache"; MALAISE (non-serious) with onset 22Sep2021, outcome "recovered", described as "I felt like, I am going to get sick"; ANXIETY (non-serious) with onset 22Sep2021, outcome "recovered", described as "I was concerned"; DIZZINESS (non-serious) with onset 22Sep2021, outcome "recovered", described as "dizzy". Additional information: The patient had received second dose of the vaccine at one of the churches and patient was concerned because when patient got the first vaccine on 28Aug patient was okay, but the second one all on 22Sep2021, patient got it about 4 O'clock and last night and early this morning she is felt very nauseous. The patient felt like, patient was going to get sick, patient had a terrible headache, it is that she could not get out of bed, but after that she is fine because right now she is fine. Is that normal to have a reaction like that, after because patient did not had after the first one but the second one she felt really, really bad. No follow-up attempts are possible. No further information is expected.