chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: Site redness and soreness; Site redness and soreness; Body aches; Chills; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 11:30 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic sinusitis" (unspecified if ongoing), notes: Chronic sinusitis; "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: PRAVASTATIN. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 28May2021 23:00, outcome "not recovered" and all described as "Site redness and soreness"; PAIN (non-serious) with onset 28May2021 23:00, outcome "not recovered", described as "Body aches"; CHILLS (non-serious) with onset 28May2021 23:00, outcome "not recovered", described as "Chills"; FATIGUE (non-serious) with onset 28May2021 23:00, outcome "not recovered", described as "Tiredness". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain, pain, chills, fatigue.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Multi vitamin, pravastatin within 2 weeks of vaccination. The AE did not result in emergency room or physician office visit. No hospitalization prolonged. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch, has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Loss of personal independence in daily activities
Clinical narrative: Dizzy; today I feel much dizzy that is kind of worse; Feeling dizzy; dizziness went worse affected my life because I can't focus on my study work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 (Lot number: EW0187, Expiration Date: Aug2021) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "today I feel much dizzy that is kind of worse"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Feeling dizzy; dizziness went worse affected my life because I can't focus on my study work". The action taken for bnt162b2 was unknown. Additional information- It was reported that patient took  first Pfizer shot on May 17th (2021) and she started to feel dizzy she would like to know if the real life do not affect after the vaccine. Yesterday afternoon her dizziness went worse like affected my life because she can't focus on my study work. She was  really feeling dizzy and she thought  she need to take the rest.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle contracture
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 30 year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EP7534), on Mar 23, 2021, for COVID-19 immunization. The patient experienced muscle contracture (two days after second dose: a big contracture of the levator scapulae muscle), with outcome of unknown. Additional information: Two days after second dose, patient experienced a big contracture of the levator scapulae muscle. The next day gone. No headache or fever. Since the vaccination, patient tested for COVID-19. Prior to vaccination, patient was not diagnosed with COVID-19. Patient may have taken Advil and other medications/vitamins within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021621233 same reporter, vaccine and AE; different patient.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He mentioned in passing that he had a sore arm from the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Physician) for a Pfizer sponsored program (164402). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28May2021, outcome "unknown", described as "He mentioned in passing that he had a sore arm from the vaccine".  Additional information: The primary care internist was asked which Covid 19 vaccine he prefers in an individual market research interview. He stated that the Pfizer vaccine was his favorite and that it was the vaccine he had gotten himself. He mentioned in passing that he had a sore arm from the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; body aches; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 08:30 (Batch/Lot number: unknown) at the age of 45 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 SINGLE), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 28May2021 16:45, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 28May2021 16:45, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 28May2021 16:45, outcome "not recovered", described as "Headache". Therapeutic measures were not taken as a result of chills, pain, headache.  Additional Information: The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021 at 16:45, 6 days after second vaccination, the patient began to experience chills, body aches and headache, lasted three days. The events not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen nodule just below armpit; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29May2021 11:45 (Lot number: ew0191) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MONTELUKAST. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: ew0176 , Anatomical Location: Arm Left  , Route of administration: Intramuscular, Time: 11:45 AM), administration date: 08May2021, when the patient was 49 years old, for COVID-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 30May2021 08:00, outcome "not recovered", described as "Swollen nodule just below armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Relevant past drug history: No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if  the patient was diagnosed with COVID-19 prior to vaccination and the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Feeling of despair, Head discomfort, Illness, Sinusitis
Clinical narrative: The worst sinus infection of my life started 2 days after the vaccine.; I woke up Sunday 3am sick; but it was squeezing my brain and on the back of my head too; desperate; Now, 2 weeks later it started again.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 10:15 (Lot number: Ew0182) at the age of 35 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 (product=COVID 19, brand=Pfizer,, lot_number=EW0171,, administration_time=09:30 AM, dose_number=1,, vaccine_location=Left arm), administration date: 17Apr2021, when the patient was 35 years old, for COVID-19 Imunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: SINUSITIS (non-serious) with onset 11May2021 15:45, outcome "not recovered", described as "The worst sinus infection of my life started 2 days after the vaccine."; ILLNESS (non-serious) with onset 11May2021 15:45, outcome "not recovered", described as "I woke up Sunday 3am sick"; HEAD DISCOMFORT (non-serious) with onset 11May2021 15:45, outcome "not recovered", described as "but it was squeezing my brain and on the back of my head too"; FEELING OF DESPAIR (non-serious) with onset 11May2021 15:45, outcome "not recovered", described as "desperate"; DISEASE RECURRENCE (non-serious) with onset 11May2021 15:45, outcome "not recovered", described as "Now, 2 weeks later it started again.".  Additional Information: Facility where the most recent COVID-19 vaccine was administered:Pharmacy or Drug Store, The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient has not diagnosed with COVID-19 Prior to vaccination. The patient has not tested for COVID-19 since the vaccination. The worst sinus infection of her life started 2 days after the vaccine. She took it on Saturday she woke up Sunday 3 am sick. She was kinda okay too but on Tuesday she had the sinus infection symptoms but it was squeezing her brain and on the back of her head too. She had it for 5 days. Now, 2 weeks later it started again. She was desperate.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Neck pain
Clinical narrative: Server Left side neck pain. The same side I received my vaccine on.; left side headache. The same side I received my vaccine on.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 (Lot number: EN6207) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Server Left side neck pain. The same side I received my vaccine on."; HEADACHE (non-serious) with onset 22Mar2021, outcome "not recovered", described as "left side headache. The same side I received my vaccine on.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information :The patient did not experience covid prior to vaccination and not tested for covid post vaccination and known allergies was reported.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.The patient received BNT162B2 (Pfizer Biontech COVID-19 mRNA vaccine, Lot No:ER2613 ) via intramuscular, administered in left arm on 08Apr2021 as DOSE 2, SINGLE for covid-19 immunization.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: After my second shot, I had a sore arm at the shot of injection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 (Lot number: EPG955) at the age of 27 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 (product=COVID 19, brand=Pfizer, lot number=EL3247, administration date=08Mar2021, dose number=1, vaccine location=Right arm), administration date: 08Mar2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Mar2021, outcome "recovered" (2021), described as "After my second shot, I had a sore arm at the shot of injection.". Therapeutic measures were not 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 and no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: My left leg, arm, and side of my face went numb; Felt like pins and needles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 18:00 (Lot number: Ew0161) at the age of 36 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: HYPOAESTHESIA (non-serious) with onset 03May2021, outcome "recovered with sequelae", described as "My left leg, arm, and side of my face went numb"; PARAESTHESIA (non-serious) with onset 03May2021, outcome "recovered with sequelae", described as "Felt like pins and needles". The events "my left leg, arm, and side of my face went numb" and "felt like pins and needles" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional information: The events lasted constantly for a couple weeks, then slowly tapered off. Still feel it from time to time. Patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Soreness in left arm region three weeks after second dose; painful/stiff when lifting arm up past shoulder; 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 11May2021 09:00 (Lot number: EW0164) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "phantom burning smell" (unspecified if ongoing), notes: Not chronic but after recovering from COVID19 back in January 2021, I periodically smell phantom burning smell. It smells like as if someone lit a match and blew it out but there no one else around smells it.; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: Not chronic but after recovering from COVID 19 back in January 2021, I periodically smell phantom burning smell. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number=EW0164,, administration time=09:00 AM,, dose number=1,, vaccine location=Left arm), administration date: 19Apr2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31May2021 15:00, outcome "not recovered", described as "Soreness in left arm region three weeks after second dose"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 31May2021 15:00, outcome "not recovered", described as "painful/stiff when lifting arm up past shoulder". Therapeutic measures were not taken as a result of pain in extremity, musculoskeletal stiffness.  Additional Information: known allergies were none. The patient has Covid prior vaccination. Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Clinical course was reported as, patient had Soreness in left arm region three weeks after second dose. Onset of side effects are outside expected range and started 31May2021. Could be lymph nodes but not certain. As of right now, soreness is bearable but has increased. It is more pain-ful/stiff when lifting arm up past shoulder. AE treatment was reported as, Birth Control. The patient has not tested for COVID-19 since the vaccination. Device Date was reported as, 01Jun2021.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: poison ivy is drying up within hours of outbreak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Apr2021 09:00 (Lot number: EL 3247) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulpha" (unspecified if ongoing); "Known allergies: ceftin based antiobitics" (unspecified if ongoing), notes: ceftin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: EP6955, Route of administration: Intramuscular, Anatomical Location: Arm Left, Time: 09:00), administration date: 11Mar2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: DERMATITIS CONTACT (non-serious) with onset 31May2021, outcome "recovered" (2021), described as "poison ivy is drying up within hours of outbreak". Therapeutic measures were not taken as a result of dermatitis contact.  Additional information: Patient reported that poison ivy is drying up within hours of outbreak and normally get poison ivy on my feet in the spring but I have had one outbreak and it has gone away within a day with no treatment. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not diagnosed with COVID-19 prior to vaccination and had not tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered was workplace clinic  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Nausea
Clinical narrative: Headache; Fatigue; Nausea; Metallic taste; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient reporting for himself.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30May2021 16:00 (Lot number: EW0177) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies Tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 30May2021 20:00, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 30May2021 20:00, outcome "not recovered", described as "Fatigue"; NAUSEA (non-serious) with onset 30May2021 20:00, outcome "not recovered", described as "Nausea"; DYSGEUSIA (non-serious) with onset 30May2021 20:00, outcome "not recovered", described as "Metallic taste". Therapeutic measures were not taken as a result of headache, fatigue, nausea, dysgeusia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medical history was none. Adverse events resulted in none of the above. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Headache, Thinking abnormal
Clinical narrative: Very high anxiety; abdominal pain; foggy thought process; Daily headaches; This is a spontaneous report from a contactable consumer (Patient). An 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 18:00 (Lot number: EW0182) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ABILIFY; WELLBUTRIN; TRAZODONE; HYDROXYZINE; VYVANSE. Vaccination history included: Bnt162b2 (Covid vaccine details: Product COVID 19, Brand: Pfizer, Lot number: EWO172, Administration time: 06:00 PM, Vaccine location: Left arm, Dose number 1), administration date: 28Apr2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "No reaction reported". The following information was reported: ANXIETY (non-serious) with onset 20May2021, outcome "not recovered", described as "Very high anxiety"; ABDOMINAL PAIN (non-serious) with onset 20May2021, outcome "not recovered", described as "abdominal pain"; THINKING ABNORMAL (non-serious) with onset 20May2021, outcome "not recovered", described as "foggy thought process"; HEADACHE (non-serious) with onset 20May2021, outcome "not recovered", described as "Daily headaches". Therapeutic measures were not taken as a result of anxiety, abdominal pain, thinking abnormal, headache.  Additional information: Facility type vaccine: Hospital. If other vaccine in four weeks: No. Adverse event: Very high anxiety, abdominal pain, foggy thought process. Daily headaches. Had been extremely well controlled until 2nd vaccine. If covid prior vaccination: No. If covid tested post vaccination: No. Device time stamp: 01Jun2021.Facility where the most recent COVID-19 vaccine was administered: Hospital. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. No new medically significant information.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Yawning
Clinical narrative: slight headache; yawning; all he just wanted to do is sleep  ; it just he is sleeping a lot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Jun2021 10:15 (Lot number: EW0178) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Lot Number "EW0171"), for covid -19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "slight headache"; YAWNING (non-serious), outcome "unknown", described as "yawning"; HYPERSOMNIA (non-serious), outcome "unknown", described as "all he just wanted to do is sleep; it just he is sleeping a lot".  Additional information: Caller stated that her husband received the second dose of the Pfizer covid 19 vaccine today. Caller reported that he had a slight headache, and it went away as fast as it came. Caller stated that 1/2 hour to 1 hour after the vaccine he started yawning and could not stop and then went to sleep when he got home. Caller stated she woke him up to eat and he then went back to sleep.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: feel vertigo; lightheaded; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 35 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination : Yes. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset Apr2021, outcome "unknown", described as "feel vertigo"; DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "lightheaded". Therapeutic measures were not taken as a result of vertigo, dizziness. Additional information: The patient had no known allergies to medications, foods or other products. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. After 3 weeks the patient started adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in ears; 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 male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 12:00 (Lot number: ER2613) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "drug allergy", notes: known allergies: Augmentin. The following information was reported: TINNITUS (non-serious) with onset 20Mar2021 12:15, outcome "not recovered", described as "Tinnitus in ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: With 1st dose I had an enormous lymph node under my arm for a few wks; This is a spontaneous report received from a contactable reporter (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 02Apr2021 16:00 (Lot number: EW0150) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Drug allergy;Erythromycin", notes: known_allergies Erythromycin. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "With 1st dose I had an enormous lymph node under my arm for a few wks". The event "with 1st dose i had an enormous lymph node under my arm for a few wks" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Reported Event: With 1st dose I had an enormous lymph node under my arm for a few wks. 2nd dose I was sick in bed for 3 days and have been sick with headache, slight fever, extreme fatigue. I went to urgent care. Tested for Covid, mono, UTI, etc. Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Since the vaccination, has the patient been tested for COVID-19?:Yes  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on May 8, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had illness, onset May 9, 2021, at 03:00, with outcome of recovered (May 10, 2021). Patient stated, "We took it on Saturday. Both my husband and I woke up Sunday 3 am sick." Additional information: This report is for a male patient (reporter's husband). Adverse event: The worst sinus infection of my life started 2 days after the vaccine. We took it on Saturday. Both my husband and I woke up Sunday 3 am sick. On Monday he was okay. I was kinda okay too; but on Tuesday, I had sinus infection symptoms. It felt like  squeezing on my brain and on the back of my head too. I had it for 5 days. Now, 2 weeks later it started again. I'm desperate. Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: First dose had moderate migraine headache started 18hrs after dose through third day following dose with some nausea and vomiting.; First dose had moderate migraine headache started 18hrs after dose through third day following dose with some nausea and vomiting.; First dose had moderate migraine headache started 18hrs after dose through third day following dose with some nausea and vomiting.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 14:00 (Lot number: EW0170) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gilbert's syndrome" (unspecified if ongoing); "Rosacea" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing); "Known Allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. Past drug history included: Cephalexin, reaction(s): "Allergies". The following information was report-ed: MIGRAINE (non-serious) with onset 08May2021, outcome "unknown", NAUSEA (non-serious), VOMITING (non-serious) all with onset May2021, outcome "unknown" and all described as "First dose had moderate migraine headache started 18hrs after dose through third day following dose with some nausea and vomiting.". Therapeutic measures were taken as a result of migraine, nausea.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was only omeprazole 20mg and multivitamin daily. The patient other medical history was Gilberts syndrome, Rosacea, irritable, bowel syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. First dose had moderate migraine headache started 18hrs after dose through third day following dose with some nausea and vomiting. Second Dose had severe debilitating migraine headache 12hrs after dose with severe nausea and vomiting through 72hrs following dose. Experienced severe muscle pain during 12-30hrs post dose with temp 101, which eased off with only migraine and nausea remaining through 72hrs. adverse event start date was 29May2021. Adverse event start time was 07:00 AM  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Inflammation, Muscle spasms, Pain in extremity
Clinical narrative: Had tje typical sore arm; headache; later that night I got a muscle spasm in my lower back; My entire back was inflamed; My back still hurts but not as bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10May2021 12:00 (Lot number: EW0165) at the age of 64 years (not pregnant) as dose 1, single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing), notes: Years ago when I got the shingles vaccine it took me 3 years to get the inflammation to settle down. Concomitant medication(s) included: AMBIEN; XANAX; VICTOZA; BASAGLAR; CLONIDINE.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "Had tje typical sore arm"; HEADACHE (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "headache"; MUSCLE SPASMS (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "later that night I got a muscle spasm in my lower back"; INFLAMMATION (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "My entire back was inflamed"; BACK PAIN (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "My back still hurts but not as bad". The events "had tje typical sore arm", "headache", "later that night i got a muscle spasm in my lower back", "my entire back was inflamed" and "my back still hurts but not as bad" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, headache, muscle spasms, inflammation, back pain.  Additional Information: Route of administration for Dose 1 was intramuscular in Arm right. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the 1st vaccine at noon. Had tje typical sore arm and headache but later that night she got a muscle spasm in her lower back which she could not get rid of with muscle relaxers. Her entire back was inflamed. She called her doctor and doctor put her on a steroid dose pack for a week. Her back still hurts but not as bad. She is really scared to get the 2nd one because she heard that the 2nd one has worse side effects. Years ago when she got the shingles vaccine it took her 3 years to get the inflammation to settle down. Treatment received for the adverse event was Steroid pack. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 on 28May2021 saliva was tested with results negative.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Had tje typical sore arm; headache; later that night I got a muscle spasm in my lower back; My entire back was inflamed; My back still hurts but not as bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10May2021 12:00 (Lot number: EW0165) at the age of 64 years (not pregnant) as dose 1, single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing), notes: Years ago when I got the shingles vaccine it took me 3 years to get the inflammation to settle down. Concomitant medication(s) included: AMBIEN; XANAX; VICTOZA; BASAGLAR; CLONIDINE.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "Had tje typical sore arm"; HEADACHE (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "headache"; MUSCLE SPASMS (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "later that night I got a muscle spasm in my lower back"; INFLAMMATION (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "My entire back was inflamed"; BACK PAIN (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "My back still hurts but not as bad". The events "had tje typical sore arm", "headache", "later that night i got a muscle spasm in my lower back", "my entire back was inflamed" and "my back still hurts but not as bad" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, headache, muscle spasms, inflammation, back pain.  Additional Information: Route of administration for Dose 1 was intramuscular in Arm right. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the 1st vaccine at noon. Had tje typical sore arm and headache but later that night she got a muscle spasm in her lower back which she could not get rid of with muscle relaxers. Her entire back was inflamed. She called her doctor and doctor put her on a steroid dose pack for a week. Her back still hurts but not as bad. She is really scared to get the 2nd one because she heard that the 2nd one has worse side effects. Years ago when she got the shingles vaccine it took her 3 years to get the inflammation to settle down. Treatment received for the adverse event was Steroid pack. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 on 28May2021 saliva was tested with results negative.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: 4 days after shot experienced nausea and diahreah; 4 days after shot experienced nausea and Diarrhoea; This is a spontaneous report received from 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 27May2021 10:45 (Lot number: Ew0172) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 01Jun2021, outcome "recovering", described as "4 days after shot experienced nausea and Diarrhoea"; DIARRHOEA (non-serious) with onset 01Jun2021, outcome "recovering", described as "4 days after shot experienced nausea and Diarrhoea". Therapeutic measures were not taken as a result of nausea, diarrhoea.   Additional information; The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Yes. Prior to vaccination,  the patient was not d 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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at site of injection (right arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Jun2021 (Lot number: EWO171) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Jun2021, outcome "not recovered", described as "Pain at site of injection (right arm)". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19, since the vaccination, patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Computerised tomogram, Echocardiogram, Fatigue
Clinical narrative: Tiredness; headache; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 10:24 (Lot number: EN6201) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Open Heart Surgery", start date: 18Dec2013 (unspecified if ongoing), notes: Bicuspid valve; "Aortic Aneurysm", start date: 2013 (unspecified if ongoing), notes: Open heart Surgery, repaired.; "Total Knee Replacement", start date: 2011, stop date: 2015, notes: Total knee replaced Left Knee; "Thyroidectomy", start date: 2003, stop date: Aug2018, notes: Thyroid removed Aug2018; "High blood pressure" (ongoing); "AFIB" (ongoing); "Thyroid" (ongoing); "Heart" (ongoing). Concomitant medication(s) included: SOTALOL taken for hypertension, start date: 2017 (ongoing); METOPROLOL taken for atrial fibrillation, start date: 2013 (ongoing); LOSARTAN taken for hypertension, start date: 2015 (ongoing); SYNTHROID taken for thyroid disorder, start date: 2018 (ongoing); ASPIRIN 81 taken for cardiac disorder, start date: 2013 (ongoing); VITAMIN D3, start date: 2015 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date/Time:, Date: 16Feb2021, Time: 10:08AM, Site and Route of Injection: , Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN-6201), administration date: 16Feb2021, for COVID-19 Immunization, reaction(s): "Chills", "aches", "Headache", "Stomach Upset", "Tiredness", "Arm Swelling". The following information was reported: FATIGUE (non-serious) with onset 09Mar2021 18:00, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset 09Mar2021 18:00, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, headache.  Additional information: no prior vaccinations within 4 weeks. Relevant Tests: the patient had blood work done 3x a year due to heart and thyroid issues. She also had an echocardiogram done yearly since 2013. She had (6) stress tests since 2008. She had numerous MRI's and CT scans due to various issues. There was not enough room to list all of it on this page. This Questionnaire was not for the average person to complete. Most doctors will charge a fee to complete this form and the pharmacists say to see your doctor about this form. You people are not in the real world. Most people would become frustrated and throw this in the trash. Get real. What a joke.   Follow-up attempts completed. No further information expected.