chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; 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. Other Case identifier(s): US-PFIZER INC-202101225741 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 17Sep2021 07:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 17Sep2021 13:00, outcome "unknown", described as "chills".  Additional information-It was reported that she took the 2nd shot this morning, around 07:30, and she takes care of kids after school and its noon, 1pm where she was, and she's starting to get the chills, she really doesn't feel bad. Her concern is can she have an effect on the kids around her after having the second dose? She just started with the chills about an hour a go, she's been fine until then, she's just concerned about the kids and the people she works with. She just wants to know even if she does have chills, they don't have them going to work if they have Covid, they check them, so it kind of gave her Covid right. She just wanted to find out if she should go to work today or stay home. She also has an aging mother, that's why she got the darn thing. She's been healthy  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This is a spontaneous report received from a contactable pharmacist. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0187, expiration date: Sep 13, 2021), on Sep 16, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient administered expired product (expired beyond recommended storage and handling), onset Sep 16, 2021, with outcome of unknown. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired beyond their storage and handling recommendation; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Sep2021 (Batch/Lot number: unknown, Expiration Date: Aug2021) 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: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset Sep2021, outcome "unknown", described as "expired beyond their storage and handling recommendation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Experiencing muscle twitching in his right arm; muscle spasm; 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 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Sep2021 10:00 (Lot number: FC3182) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to shellfish" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing); TAMSULOSIN taken for diuretic therapy (ongoing). The following information was reported: MUSCLE TWITCHING (non-serious) with onset 02Sep2021, outcome "not recovered", described as "Experiencing muscle twitching in his right arm"; MUSCLE SPASMS (non-serious) with onset Sep2021, outcome "unknown", described as "muscle spasm".  Additional information: It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on vaccination day evening he started experiencing muscle twitching in his right arm which was the arm he was vaccinated it had stayed the same, occurring 3-4 times a day.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: tired/ tiredness; Body aches/ achey; Arm pain at the site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Jan2021 16:40 (Lot number: EL3247) as dose 1, single and administered in arm left, administration date 08Feb2021 08:30 (Lot number: EM9810) 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: FATIGUE (non-serious), outcome "recovered", described as "tired/ tiredness"; PAIN (non-serious), outcome "recovered", described as "Body aches/ achey"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Arm pain at the site". Therapeutic measures were not taken as a result of fatigue, pain, vaccination site pain.  Additional information: The patient reported that the first two vaccines left patient very tired, body aches and arm pain at the site for a few days - 4.5.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: where the needle actually hits, it was a little sore/tenderness at the injection site; 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 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (ongoing), notes: she had MS for seven years now and takes infusions for MS. Concomitant medication(s) included: RITUXAN taken for multiple sclerosis. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "where the needle actually hits, it was a little sore/tenderness at the injection site".  Additional information: The patient received the first dose of the BNT162B2 in Feb2021. She received dose in the left arm and had complaints of tenderness at the injection site, where the needle actually hits, it was a little sore. Vaccination facility type was pharmacy. No prior vaccinations (within 4 weeks).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Oropharyngeal pain
Clinical narrative: throat pain; neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 11:00 (Lot number: EW0173) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed with COVID-19:Yes" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "known_allergies: Augmentin". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 14Sep2021 08:00, outcome "not recovered", described as "throat pain"; NECK PAIN (non-serious) with onset 14Sep2021 08:00, outcome "not recovered", described as "neck pain". Therapeutic measures were not taken as a result of oropharyngeal pain, neck pain.  Additional information: Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any medication within 2 weeks of vaccination. Since the vaccination, the patient had not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Memory impairment, Mood swings, Night sweats, SARS-CoV-2 test
Clinical narrative: Hot flashes; Profuse night sweats; Mood swings; Sleep disturbances; Memory difficulty; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Jan2021 13:06 (Lot number: EK9231) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer", start date: Feb2009 (ongoing), notes: Thyroidectomy, Radioactive, Iodine Tx; "Known allergies: latex" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Thyroid hormone replacement" (unspecified if ongoing). Family history included: "Cancer" (unspecified if ongoing), notes: Hx Cancer; "hypertension" (unspecified if ongoing), notes: Hx hypertension. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid hormone replacement therapy, start date: Feb2009 (ongoing); LORAZEPAM taken for anxiety, start date: Oct2011 (ongoing). Past drug history included: Ancef, reaction(s): "Known allergies: Ancef"; Lamictal, reaction(s): "Known allergies: lamictal"; Doxycycline, reaction(s): "Known allergies: doxycycline". Vaccination history included: Bnt162b2 (Dose number: 1, Time: 15:18, Vaccine location: Left arm, Lot number: EH9899, Route of administration: Intramuscular), administration date: 17Dec2020, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: HOT FLUSH (non-serious) with onset 17Jan2021, outcome "not recovered", described as "Hot flashes"; NIGHT SWEATS (non-serious) with onset 17Jan2021, outcome "not recovered", described as "Profuse night sweats"; MOOD SWINGS (non-serious) with onset 09Jan2021, outcome "not recovered", described as "Mood swings"; SLEEP DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Sleep disturbances"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "Memory difficulty". The events "hot flashes", "profuse night sweats" and "mood swings" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Feb2021) negative, notes: Nasal Swab; (03Mar2021) negative, notes: Other. It was unknown if therapeutic measures were taken as a result of hot flush, night sweats, mood swings.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Hot flashes; Profuse night sweats; Mood swings; Sleep disturbances; Memory difficulty; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Jan2021 13:06 (Lot number: EK9231) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer", start date: Feb2009 (ongoing), notes: Thyroidectomy, Radioactive, Iodine Tx; "Known allergies: latex" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Thyroid hormone replacement" (unspecified if ongoing). Family history included: "Cancer" (unspecified if ongoing), notes: Hx Cancer; "hypertension" (unspecified if ongoing), notes: Hx hypertension. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid hormone replacement therapy, start date: Feb2009 (ongoing); LORAZEPAM taken for anxiety, start date: Oct2011 (ongoing). Past drug history included: Ancef, reaction(s): "Known allergies: Ancef"; Lamictal, reaction(s): "Known allergies: lamictal"; Doxycycline, reaction(s): "Known allergies: doxycycline". Vaccination history included: Bnt162b2 (Dose number: 1, Time: 15:18, Vaccine location: Left arm, Lot number: EH9899, Route of administration: Intramuscular), administration date: 17Dec2020, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: HOT FLUSH (non-serious) with onset 17Jan2021, outcome "not recovered", described as "Hot flashes"; NIGHT SWEATS (non-serious) with onset 17Jan2021, outcome "not recovered", described as "Profuse night sweats"; MOOD SWINGS (non-serious) with onset 09Jan2021, outcome "not recovered", described as "Mood swings"; SLEEP DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Sleep disturbances"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "Memory difficulty". The events "hot flashes", "profuse night sweats" and "mood swings" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Feb2021) negative, notes: Nasal Swab; (03Mar2021) negative, notes: Other. It was unknown if therapeutic measures were taken as a result of hot flush, night sweats, mood swings.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FC3181) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Patient took a took a Naproxen pill.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Hypoaesthesia, Lymphadenopathy, Menstrual disorder, Pain in extremity
Clinical narrative: hair started falling out again like it did first shot/my hair falling out like crazy; Numbness in both arms; ringing in ears(still have); sever pain in arm that lasted for 3 months after shot; Very swallow lymph nodes underarm.; Day 5 my scalp started to feel like it was on fire; Messed up period cycle; 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 23Mar2021 (Lot number: Er8732) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMOTRIGINE. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "recovering", described as "hair started falling out again like it did first shot/my hair falling out like crazy"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "recovering", described as "Numbness in both arms"; TINNITUS (non-serious) with onset 2021, outcome "recovering", described as "ringing in ears(still have)"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "sever pain in arm that lasted for 3 months after shot"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovering", described as "Very swallow lymph nodes underarm."; SKIN BURNING SENSATION (non-serious) with onset 2021, outcome "recovering", described as "Day 5 my scalp started to feel like it was on fire"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovering", described as "Messed up period cycle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia, hypoaesthesia, lymphadenopathy, skin burning sensation, menstrual disorder. Therapeutic measures were taken as a result of tinnitus, pain in extremity.  Additional information: Patient had no known allergies and no other medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Numbness in both arms that lasted about 3 months, hair started falling out again like it did first shot. Patient's hair was still recovering. Therapeutic measures taken for the event included Chiropractor & getting messages, and salt float ta. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Vaccine facility type was reported as Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin burning sensation, Tinnitus
Clinical narrative: hair started falling out again like it did first shot/my hair falling out like crazy; Numbness in both arms; ringing in ears(still have); sever pain in arm that lasted for 3 months after shot; Very swallow lymph nodes underarm.; Day 5 my scalp started to feel like it was on fire; Messed up period cycle; 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 23Mar2021 (Lot number: Er8732) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMOTRIGINE. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "recovering", described as "hair started falling out again like it did first shot/my hair falling out like crazy"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "recovering", described as "Numbness in both arms"; TINNITUS (non-serious) with onset 2021, outcome "recovering", described as "ringing in ears(still have)"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "sever pain in arm that lasted for 3 months after shot"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovering", described as "Very swallow lymph nodes underarm."; SKIN BURNING SENSATION (non-serious) with onset 2021, outcome "recovering", described as "Day 5 my scalp started to feel like it was on fire"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovering", described as "Messed up period cycle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia, hypoaesthesia, lymphadenopathy, skin burning sensation, menstrual disorder. Therapeutic measures were taken as a result of tinnitus, pain in extremity.  Additional information: Patient had no known allergies and no other medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Numbness in both arms that lasted about 3 months, hair started falling out again like it did first shot. Patient's hair was still recovering. Therapeutic measures taken for the event included Chiropractor & getting messages, and salt float ta. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Vaccine facility type was reported as Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia universalis
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 54-year-old female patient (not pregnant) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8730), at the age of 54, in left arm, on Aug 31, 2021, at 16:00, single dose, for COVID-19 immunisation. Medical history included high blood pressure (unspecified if ongoing), and asthma (unspecified if ongoing). The patient took concomitant medications. The patient experienced alopecia (rapid and complete hair loss), and diagnosed with alopecia universalis (all evaluated at a physician office visit), with outcome of not recovered. Therapeutic measures were taken as a result. Additional information: Patient did not take any other vaccine in four weeks. Treatment included corticosteroids injections to scalp and eyebrows. Patient did not have COVID-19 prior to vaccination. Patient has not tested for COVID-19 post vaccination. Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Somnolence
Clinical narrative: Clarified as all of the other COVID shots mad her tired and sleepy; clarified as all of the other COVID shots mad her tired and sleepy; diarrhea; throwing up; headache; feeling queasy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Lot number: EN6204) as dose 1, single and administration date 30Mar2021 (Lot number: ER7833) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Renal transplant", start date: 24Sep2018 (unspecified if ongoing), notes: Verbatim: Kidney transplant, was on dialysis for 7 years. right kidney transplant; "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes, diagnosed about 3 years before she started dialysis; "high blood pressure" (unspecified if ongoing), notes: Verbatim: high blood pressure; "Stroke" (unspecified if ongoing), notes: Verbatim: Stroke, has had 4 strokes, 2012, 2016, 2018 after kidney transplant and then Dec2020.; "Heart attack", start date: 2016 (unspecified if ongoing); "Covid-19", start date: Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), SOMNOLENCE (non-serious) all with onset 2021, outcome "unknown" and all described as "clarified as all of the other COVID shots mad her tired and sleepy"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "diarrhea"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "throwing up"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "feeling queasy".  Additional information: Prior to getting the 3rd COVID shot yesterday, she felt good. When the caller got home from getting the 3rd COVID shot, she stated that she felt sleepy like she did before; clarified as all of the other COVID shots mad her tired and sleepy. She slept in the chair until 6 o'clock last night. She went upstairs about 9 o'clock and by 11 or 12 o'clock, she was sick as a dog.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Clarified as all of the other COVID shots mad her tired and sleepy; clarified as all of the other COVID shots mad her tired and sleepy; diarrhea; throwing up; headache; feeling queasy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Lot number: EN6204) as dose 1, single and administration date 30Mar2021 (Lot number: ER7833) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Renal transplant", start date: 24Sep2018 (unspecified if ongoing), notes: Verbatim: Kidney transplant, was on dialysis for 7 years. right kidney transplant; "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes, diagnosed about 3 years before she started dialysis; "high blood pressure" (unspecified if ongoing), notes: Verbatim: high blood pressure; "Stroke" (unspecified if ongoing), notes: Verbatim: Stroke, has had 4 strokes, 2012, 2016, 2018 after kidney transplant and then Dec2020.; "Heart attack", start date: 2016 (unspecified if ongoing); "Covid-19", start date: Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), SOMNOLENCE (non-serious) all with onset 2021, outcome "unknown" and all described as "clarified as all of the other COVID shots mad her tired and sleepy"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "diarrhea"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "throwing up"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "feeling queasy".  Additional information: Prior to getting the 3rd COVID shot yesterday, she felt good. When the caller got home from getting the 3rd COVID shot, she stated that she felt sleepy like she did before; clarified as all of the other COVID shots mad her tired and sleepy. She slept in the chair until 6 o'clock last night. She went upstairs about 9 o'clock and by 11 or 12 o'clock, she was sick as a dog.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Nerve compression, Neuralgia, Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Jun2021 16:30 (Lot number: EW0180) at the age of 33 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "unknown digestive issues" (unspecified if ongoing), notes: unknown digestive issues; "intolerance to drinking alcohol" (unspecified if ongoing), notes: known allergies: intolerance to drinking alcohol; "Motion sickness" (unspecified if ongoing). Family history included: "autism" (ongoing), notes: Illness/AE: Autism type 1, Onset Date: Congenital, Stop Date: Ongoing, Both parents undiagnosed but presented signs of autism + anxiety; "anxiety" (ongoing), notes: Illness/AE: Anxiety, Onset Date: Congenital, Stop Date: Ongoing, Both parents undiagnosed but presented signs of autism + anxiety. Concomitant medication(s) included: CANNABIS taken for autism spectrum disorder, anxiety, start date: May2021 (ongoing); CANNABIDIOL taken for autism spectrum disorder, anxiety, start date: May2021 (ongoing); DRAMAMINE taken for motion sickness, start date: 14Jul2021, stop date: 14Jul2021. The following information was reported: NERVE COMPRESSION (non-serious), outcome "unknown", described as "slight nerve pinching on left shoulder and neck"; NEURALGIA (non-serious), outcome "unknown", described as "Neuralgia"; PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "Injected side arm & neck slight cramping". The event "slight nerve pinching on left shoulder and neck" was evaluated at the physician office visit. Additional information: First dose slight nerve pinching on left shoulder and neck. Patient did not received 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 has not been tested for COVID-19.Device Date was 18Sep2021.Prompted testing to affirm (Autism pre-existing). Patient first dose, she had very mild neuralgia from injected side arm & neck slight cramping. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Experienced symptoms of Tinnitus several months after receiving both vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Dec2020 15:45 (Lot number: EL3247) as dose 1, single and administered in arm left (Lot number: EL3247) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 15May2021, outcome "not recovered", described as "Experienced symptoms of Tinnitus several months after receiving both vaccine". The event "experienced symptoms of tinnitus several months after receiving both vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications the patient received within 2 weeks of vaccination. Experienced symptoms of Tinnitus several months after receiving both vaccine. No other cause. Reported to provider. Patient was not covid prior vaccination and did not test for covid post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 28-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# F63180), at the age of 28, in left arm, on Aug 15, 2021, at 15:00, single dose, for COVID-19 immunisation. Medical history included diagnosed with COVID-19, start date: Mar 2021 (unspecified if ongoing), notes: diagnosed in March. No concomitant medications. The patient experienced menstrual disorder (7 days after vaccination, started period again; it lasted 5 days), onset Aug 22, 2021, with outcome of not recovered. No therapeutic measures taken as a result of menstrual disorder. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient was not on any birth control or hormones. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: They did not give her the second shot because she has cold this past Monday; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date Aug2021 (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: NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "They did not give her the second shot because she has cold this past Monday".  Additional information: Further stated that patient missed the second dose kept scheduled last Monday for the second dose (Unspecified Vaccine) and they gave 74 days apart. On past Monday was her 21 days from the first shot. They did not give her the second shot because she has cold this past Monday. Reporter want to know was it too late for her to go and get the second shot now by being 5 days later.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Have been experiencing fatigue few weeks; Along with what would probably be called brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jun2021 18:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "CFS" (unspecified if ongoing), notes: Verbatim:CFS; "ME" (unspecified if ongoing), notes: Verbatim:ME; "Fibro" (unspecified if ongoing), notes: Verbatim:Fibro; "Sensitivities not allergies" (unspecified if ongoing). Concomitant medication(s) included: MAGNESIUM; POTASSIUM; MULTI; SELENIUM; VIT B COMPLEX. The following information was reported: FATIGUE (non-serious) with onset Jun2021, outcome "not recovered", described as "Have been experiencing fatigue few weeks"; FEELING ABNORMAL (non-serious) with onset Jun2021, outcome "not recovered", described as "Along with what would probably be called brain fog". Therapeutic measures were not taken as a result of fatigue, feeling abnormal.  Additional information: 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. Device Date provided as 18Sep2021.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Cognitive disorder, Confusional state, SARS-CoV-2 test
Clinical narrative: he started acting a little goofy laughing; he got confused; he didn't know who his family; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Sep2021 16:00 (Lot number: FC3184) at the age of 15 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. The patient's concomitant medications were not reported. The following information was reported: ABNORMAL BEHAVIOUR (non-serious) with onset 19Sep2021 17:00, outcome "recovered" (19Sep2021 17:20), described as "he started acting a little goofy laughing"; CONFUSIONAL STATE (non-serious) with onset 19Sep2021 17:00, outcome "recovered" (19Sep2021 17:20), described as "he got confused"; COGNITIVE DISORDER (non-serious) with onset 19Sep2021 17:00, outcome "recovered" (19Sep2021 17:20), described as "he didn't know who his family". The events "he started acting a little goofy laughing", "he got confused" and "he didn't know who his family" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abnormal behaviour, confusional state, cognitive disorder.  No follow-up attempts are possible. No further information is expected.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Reported Event: About 20-25 minutes after My son received the Pfizer vaccine, he started acting a little goofy laughing and then about 15-20 minutes after that he got confused he did not know who his family was it lasted for about 20 mins. I became concerned and took him to urgent care. At this time, he was all back to normal the doctor was not concerned and said it was a vaccine reaction. Doctor told me to report this to you guys.  The adverse events resulted in Emergency room/department or urgent care. The patient was not received treatment for the adverse events. Patient was diagnosed with COVID-19 prior vaccination. Patient had not tested for COVID-19 since vaccination  Follow-Up #01 (21Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: More dizzy spells; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 15:00 (Lot number: Ff2588) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Celiacs" (unspecified if ongoing); "primary biliary cirrhosis" (unspecified if ongoing); "lupus" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: IBUP; HYDROXYCHLOROQUINE. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "More dizzy spells". Therapeutic measures were not taken as a result of dizziness.  Additional information: Patient toolk Tyl and Ursodial gabe within two weeks. 1st dose was ok however she did have more dizzy spells than normally do. 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Movement disorder
Clinical narrative: My legs would not move correct I was matching as walking and I could not walk straight I was walking diagle; My legs would not move correct I was matching as walking and I could not walk straight I was walking diagle; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Aug2021 15:30 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Kiwi" (unspecified if ongoing); "Known allergies: Tape" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MOVEMENT DISORDER (non-serious), GAIT DISTURBANCE (non-serious) all with onset 27Aug2021 15:30, outcome "recovered" (2021) and all described as "My legs would not move correct I was matching as walking and I could not walk straight I was walking diagle". Therapeutic measures were not taken as a result of movement disorder, gait disturbance.  Additional information: Prior to vaccination, the patient  was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Horrible headache lasting 6 days; Sore arm; Chills; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 (Lot number: FA7484) at the age of 34 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: HEADACHE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Horrible headache lasting 6 days"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Sore arm"; CHILLS (non-serious) with onset Aug2021, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset Aug2021, outcome "unknown", described as "Nausea". Therapeutic measures were not taken as a result of headache, pain in extremity, chills, nausea.  Additional information: No known allergies. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Vertigo
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Aug2021 12:00 (Batch/Lot number: unknown) as dose 1, single and administered in arm, administration date 12Aug2021 (Lot number: Ew0183) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: EAR DISCOMFORT (non-serious), VERTIGO (non-serious) all with onset 19Aug2021 12:00, outcome "recovering" and all described as "Vertigo, re occurs Vertigo with left ear discomfort". The event "vertigo, re occurs vertigo with left ear discomfort" and "vertigo, re occurs vertigo with left ear discomfort" was evaluated at the physician office visit. Therapeutic measures were taken as a result of ear discomfort, vertigo.  Additional information: 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 was not tested for COVID-19. Device Date: 19Sep2021. The treatment received for the adverse event was Anniversary and deltasone.   Follow-up attempts completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain; Injection site swelling; Injection site redness; Arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Sep2021 14:30 (Lot number: FC3182) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. Concomitant medication(s) included: EMOQUETTE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Injection site pain"; VACCINATION SITE SWELLING (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Injection site swelling"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Injection site redness"; PAIN IN EXTREMITY (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Arm pain". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema, pain in extremity. Additional information: The patient was administered the most recent COVID-19 vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 19Sep2021. The patient do not have Known allergies and Other medical history. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I have been getting headaches daily; This is a spontaneous report received from a non-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 06Jun2021 15:00 (Lot number: EW0191) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Drug allergy", notes: Known allergies: Sulfur; Naproxen, reaction(s): "Drug allergy", notes: Known allergies: Naproxen. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0171; Anatomical site: Arm Left; Administration time:15:30), administration date: 16May2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 06Jun2021 16:00, outcome "not recovered", described as "I have been getting headaches daily". The event "i have been getting headaches daily" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional Information: Patient stated that she was thinking she should buy stock in paracetamol, acetylsalicylic acid, caffeine (EXCEDRIN) since she had to take that daily to help with the headaches. She stated that she refused to be on narcotics, so hopefully, they will stop eventually. Therapeutic measure was taken as a result of the event which included treatment with paracetamol, acetylsalicylic acid, caffeine (EXCEDRIN).   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An elderly female patient 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 (1st dose), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Dizzy". Additional Context: She is in the over 65 age group. According to what she is seeing they are next in line for 3rd dose. She reports being dizzy for a few hours in the evening after getting her second dose and was fine the next day. She would like to know if she should get a similar reaction after the third dose or can she take something to prevent it like Dramamine? Follow-up attempts completed, lot/batch number is not available despite the follow-up attempts made. No further information is expected.