chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Glossodynia, Pain
Clinical narrative: pain under my tongue on the right side; canker sore formed in the same area / another canker sore formed on the left under side of my tongue a few days after that, as well as sores on the inside of my cheeks; sores were very painful and made it difficult to eat; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: EP6955) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: JUNEL FE 1/20. Vaccination history included: Bnt162b2 (1st dose, lot number: EN6202, vaccine location: left arm), administration date: 12Mar2021, when the patient was 26 years old, for Covid-19 immunisation, reaction(s): "pain under my tongue". The following information was reported: GLOSSODYNIA (non-serious) with onset 06Apr2021, outcome "recovering", described as "pain under my tongue on the right side"; APHTHOUS ULCER (non-serious) with onset 06Apr2021, outcome "recovering", described as "canker sore formed in the same area / another canker sore formed on the left under side of my tongue a few days after that, as well as sores on the inside of my cheeks"; PAIN (non-serious) with onset 06Apr2021, outcome "recovering", described as "sores were very painful and made it difficult to eat". The events "pain under my tongue on the right side", "canker sore formed in the same area / another canker sore formed on the left under side of my tongue a few days after that, as well as sores on the inside of my cheeks" and "sores were very painful and made it difficult to eat" were evaluated at the physician office visit. Therapeutic measures were taken as a result of glossodynia, aphthous ulcer, pain.  Additional information: The patient did not receive any other vaccines within 4 week prior vaccination. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination. The patient had steroid (dexamethasone) swish and spit to help speed up the healing process.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: With my first vaccine the only adverse reaction was insomnia. I could not sleep at all the first night. I even had trouble sleeping the 2nd night after the shot.; I could not sleep at all the first night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 16:30 (Lot number: ER8732) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PAXIL [PIROXICAM]; TOPAMAX. The following information was reported: INSOMNIA (non-serious) with onset 01Apr2021, outcome "recovered" (Apr2021), described as "With my first vaccine the only adverse reaction was insomnia. I could not sleep at all the first night. I even had trouble sleeping the 2nd night after the shot."; INSOMNIA (non-serious) with onset 01Apr2021, outcome "recovered" (Apr2021), described as "I could not sleep at all the first night". Therapeutic measures were not taken as a result of insomnia, insomnia.  Additional Information: With patient's first vaccine the only adverse reaction was insomnia. she could not sleep at all the first night. She even had trouble sleeping the 2nd night after the shot. she had no other ill effects. The 2nd shot though was much different. She actually blacked out. She got up at 4am running a fever. She took tylenol. She threw up the tylenol a short time later. She then don't remember anything. The next thing She remember was her dog waking him up by licking his face about 20 mins later. She was laying face down in the hallway between the bathroom and the bedroom. Other than some scratches, She didn't get hurt. She also could not form coherent sentences while trying to call her husband to tell him to come home from work. She don't remember much from Friday morning at all. It was all a fog. But the blackout was scary. She was fevered and sick feeling for 24 hours and then was fine again. The Patient reported that she did not affected with Covid 19 prior to vaccination and post vaccination. Patient was not having with any known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm is aching and it is feeling that my arm is squeezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm is aching and it is feeling that my arm is squeezing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: 1st shot bad head ache and chills.; 1st shot bad head ache and chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 08:15 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: Covid prior vaccination: Yes. Concomitant medication(s) included: INSULIN. Past drug history included: Ibuprofen, reaction(s): "allergy"; Zpack, reaction(s): "Allergy". The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "1st shot bad head ache and chills."; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "1st shot bad head ache and chills".  Additional information: the patient did not receive any other vaccine in four weeks. Other medications in two weeks: Insulin. The patient had not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills for 24 hours; Aches and pains for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: CHILLS (non-serious), outcome "recovered", described as "Chills for 24 hours"; PAIN (non-serious), outcome "recovered", described as "Aches and pains for 24 hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021459175 same reporter/vaccine, similar event, and different patient.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 13:45 (Lot number: EV8732) 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: PALPITATIONS (non-serious) with onset 19Apr2021 10:00, outcome "recovering", described as "palpitations". The event "palpitations" was evaluated at the physician office visit. Therapeutic measures were taken as a result of palpitations.  Additional Information: The patient experienced similar symptoms of palpitations on 19Apr2021 at 10:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. The AE was treated with High strength Advil recommended by MD. It was reported that the patient had covid prior to vaccination but was not tested for covid post vaccination. The patient had no Allergies or other medical history  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experiencing pain in the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "experiencing pain in the injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Lymphadenopathy
Clinical narrative: Left axillary lymphadenopathy; headache; letarghy; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 08:30 (Lot number: ER87310) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Polycystic ovary" (unspecified if ongoing); "congenital neutropenia" (unspecified if ongoing); "contraception" (unspecified if ongoing), notes: Contraceptive. The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 20Apr2021 18:00, outcome "recovering", described as "Left axillary lymphadenopathy"; HEADACHE (non-serious) with onset 20Apr2021 18:00, outcome "recovering", described as "headache"; LETHARGY (non-serious) with onset 20Apr2021 18:00, outcome "recovering", described as "letarghy". Therapeutic measures were not taken as a result of lymphadenopathy, headache, lethargy.  Additional information: No known allergies reported. No covid prior vaccination and not tested for covid post vaccination. Patient did not take other vaccine in 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: but the pain is gone; 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 male patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: ER8733) as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild osteoarthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Mar2021, for Covid-19 immunization, reaction(s): "After my first shot, the next mornng, no pain". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "but the pain is gone". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional Information: There was no other vaccine in four weeks. Patient have a mild case of osteo-arthritis, so, in the morning, he usually wake up with a little joint pain which takes about 1/2 to 1 hour to go away. After the second dose, and it still has not come back. The joints are still old and stiff, but the pain is gone. He hope this side effect continues. He wanted to know if he was the only one who has reported this result. No treatment for AE. No covid prior vaccination. Did not tested covid  post vaccination. There was no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: Nausea; felt very hot; sweats; very bad headache; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 16 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 19Apr2021 (Lot number: EW0169) at the age of 16 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (ongoing). Concomitant medication(s) included: ESCITALOPRAM taken for anxiety (ongoing).  The following information was reported: NAUSEA (non-serious) with onset 20Apr2021, outcome "recovered", described as "Nausea"; FEELING HOT (non-serious) with onset 19Apr2021, outcome "recovering", described as "felt very hot"; HYPERHIDROSIS (non-serious) with onset 19Apr2021, outcome "recovering", described as "sweats"; HEADACHE (non-serious) with onset 19Apr2021, outcome "not recovered", described as "very bad headache"; PAIN IN EXTREMITY (non-serious) with onset 19Apr2021, outcome "not recovered", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: After my first dose of the vaccine my right eye twitched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2021 10:15 (Lot number: EN6202) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTIC [BIFIDOBACTERIUM LACTIS]. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "recovering", described as "After my first dose of the vaccine my right eye twitched". The event "after my first dose of the vaccine my right eye twitched" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of muscle twitching.  Additional information: Patient did not receive any other vaccines in four weeks prior to the COVID vaccine. The patient receive other medications in two weeks was Probiotic, Vitamin. Facility type vaccine: Other. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: General body aches - first dose; Sore throat - first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: EK5730, Expiration Date: Mar2021) at the age of 23 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: OROPHARYNGEAL PAIN (non-serious) with onset 30Mar2021, outcome "recovered" (Apr2021), described as "Sore throat - first dose"; PAIN (non-serious) with onset 31Mar2021, outcome "recovered" (01Apr2021), described as "General body aches - first dose". The event "sore throat - first dose" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No prior vaccinations within 4 weeks. No AE following prior vaccinations. The patient was not visited physician office for AE. The patient's reaction started with a sore throat and aches following the first dose of the Covid-19 vaccine. Sore throat started about 30 minutes after her first dose of the Covid-19 vaccine. The sore throat went away in 36 hours. When she went to the emergency room, she got 2 bags of fluids and was sent home. The emergency room staff instructed her to stay hydrated and hang out at home.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: After my second dose, 5 hours later I began to see things. Large Black circles, small dots, floaters.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 10:15 (Lot number: EP7534) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product:COVID 19, brand: Phizer, lot number: EN6202, lot unknown: False, administration time:10:15 AM, dose number:1, Vaccine location=Right arm), administration date: 24Feb2021, when the patient was 66 years old, for COVID-19 immunisation, reaction(s): "My right eye twitched". The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 18Mar2021 15:00, outcome "recovering", described as "After my second dose, 5 hours later I began to see things. Large Black circles, small dots, floaters.". The event "after my second dose, 5 hours later i began to see things. large black circles, small dots, floaters." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of visual impairment.  Additional information: It was reported that, the patient was not pregnant at the time of vaccination. The patient had no known allergies. Other vaccine in four weeks was reported as no. Other medications in two weeks included Probiotic, Vitamin. No covid prior vaccination and no covid tested post vaccination. Stated that, after her second dose, 5 hours later she began to see things, large black circles, small dots, floaters. Stated that, that was in her right eye.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm with first and second; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 10:00 (Lot number: Ew0150) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma, possible fibromyalgia; "Possible Fibromyalgia" (unspecified if ongoing), notes: Asthma, possible fibromyalgia; "Known allergies: Sulpha antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies, codeine", notes: Sulpha antibiotics, codeine. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Sore arm with first and second".  Additional information: Patient did not recieved any treatment. Patient did not had covid prior to vaccination and not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Feeling hot, Off label use, Product use issue
Clinical narrative: strong metallic taste in my mouth; felt warm; very lightheaded; Breastfeeding; Breastfeeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 (Lot number: Unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breastfeeding" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Foods-oral allergy syndrome" (unspecified if ongoing). Concomitant medication(s) included: TOPICAL [CLOBETASOL PROPIONATE]; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Vaccination history included: Bnt162b2 (1ST DOSE), for COVID-19 IMMUNIZATION. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Apr2021, outcome "unknown" and all described as "Breastfeeding"; DYSGEUSIA (non-serious) with onset 23Apr2021 09:00, outcome "recovered", described as "strong metallic taste in my mouth"; FEELING HOT (non-serious) with onset 23Apr2021 09:00, outcome "recovered", described as "felt warm"; DIZZINESS (non-serious) with onset 23Apr2021 09:00, outcome "recovered", described as "very lightheaded". Therapeutic measures were not taken as a result of dysgeusia, feeling hot, dizziness.  Additional information: patient received other medications within 2 weeks of vaccinations like Topical creams and prenatal vitamins. patient reported she received her second shot she got strong metallic taste in her mouth, felt warm, and very lightheaded. the feeling disappeared within 5 minutes but was very disconcerting. She did not test since the vaccination, and she did not diagnose as COVID-19 prior to vaccination. No covid prior vaccination. Device Date was 25Apr2021. She had chicken pox booster left arm injection for vaccine received within 4 weeks prior. The most recent COVID-19 vaccine was administered was hospital. No treatment AE.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia more than 4 days; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 15:45 (Batch/Lot number: unknown) at the age of 45 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: INSOMNIA (non-serious) with onset 20Apr2021 21:00, outcome "not recovered", described as "Insomnia more than 4 days". Therapeutic measures were not taken as a result of insomnia.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Patient reported she had a sore arm after the vaccine. Patient stated that this was just from the vaccine, it is just one of the things that go along with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Physical examination, Tremor
Clinical narrative: Shaking uncontrollably; Some times have harder tremors in chest and back; Internal shaking that feels like sitting on a message chair set to level 5, its constant and all over body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 08:30 (Lot number: EW0161) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXAMETHASONE; MONTELUKAST; FLUTICASONE. Past drug history included: Erythromycin, reaction(s): "Drug allergy". The following information was reported: TREMOR (non-serious) with onset 13Apr2021 08:45, outcome "recovered" (13Apr2021), described as "Shaking uncontrollably"; TREMOR (non-serious) with onset 13Apr2021 08:45, outcome "not recovered", described as "Some times have harder tremors in chest and back"; NERVOUSNESS (non-serious) with onset 13Apr2021 08:45, outcome "not recovered", described as "Internal shaking that feels like sitting on a message chair set to level 5, its constant and all over body". The events "shaking uncontrollably", "some times have harder tremors in chest and back" and "internal shaking that feels like sitting on a message chair set to level 5, its constant and all over body" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tremor, tremor, nervousness.   Additional information: Onset date of event shaking uncontrollably was 13Apr2021 08:45. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The paramedics were called, they took her vitals, told her to monitor the shaking. The patient felt better, after at hour the visible shaking stopped, but the patient had an internal shaking that felt like she was sitting on a message chair set to level 5, it was constant and all over her body. The patient went to urgent care they gave her Benadryl, it did not help. It had been non-stop since the vaccine. Therapeutic measures were taken as a result of reported events and included treatment with Benadryl. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Night sweats, Rhinorrhoea
Clinical narrative: Mild headaches; Night sweat; Nose running; I didn't have appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Lot number: EN6205) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinus Trouble" (unspecified if ongoing), notes: sinus trouble from past 4-5 years; "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for blood cholesterol abnormal; AMLODIPINE taken for blood pressure abnormal. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Mild headaches"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Night sweat"; RHINORRHOEA (non-serious), outcome "unknown", described as "Nose running"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I didn't have appetite".  Additional Information: Patient has taken first dose around 5Apr2021 and second shot on 28Apr2021.she is having little mild headaches and sweat at night but then she do have kind of trouble and stuff. she have been taking little over counter medication and one time I was sick and prescribed medication. So, she is feeling okay, but last night I had little mild headache and my nose running but she have been dealing with sinus trouble from past 4-5 years. So, she is asking that is the symptom of the virus or not.Patient stated before virus came she was getting little mild headaches and her doctor told her that sometime when sinus trouble they have little mild headaches and before the virus came, I did have that at night when air conditioner is on. Patient stated after About 2 days ago and she is feeling fine but they she didn't have appetite.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Hyperhidrosis, Nausea
Clinical narrative: started having some sweats; started having diarrhea; feeling a little weak; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "recovered", described as "started having some sweats"; DIARRHOEA (non-serious), outcome "unknown", described as "started having diarrhea"; ASTHENIA (non-serious), outcome "unknown", described as "feeling a little weak"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Therapeutic measures were taken as a result of diarrhoea.  Additional Context: Caller states after the vaccine she started having some sweats and that was fine and after a while the sweats went away; states after she got the Pfizer vaccine she went to eat some chicken and started having diarrhea; states she has gone up to the bathroom today 10 times already and is feeling a little weak; states she is drinking Pedialyte to get better and is wanting to know if this is normal or is a regular that happens and she does not know what to do. States she ate an apple, some beef broth or soup and tried to do that and has not thrown up but started having some kind of nausea and has not eaten and has no temperature and no fever but does feel sort of weak. Caller states she was not specifically trying to do the medical part regarding the report and is taking Pepto Bismol trying to stop the diarrhea and is diabetic and states she has taken other things; no further details provided as caller then states she is feeling a little weak and is very weak and was thinking of telling her son to call an ambulance to take her somewhere and was thinking about getting some IV fluids and states she might faint out.  Caller verified she needs urgent medical attention at this point in the call. Caller asks if agent is unable to tell her if this is normal or if the diarrhea is a normal thing;   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: He did not feel good/ he was definitely sick; He did not feel good/ he was definitely sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in leg left, administration date 25Apr2021 11:15 (Batch/Lot number: unknown) at the age of 20 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: ILLNESS (non-serious), MALAISE (non-serious), outcome "not recovered" and all described as "He did not feel good/ he was definitely sick". The event "he did not feel good/ he was definitely sick" and "he did not feel good/ he was definitely sick" was evaluated at the physician office visit. Therapeutic measures were taken as a result of illness, malaise.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not receive medications in two weeks. It was reported that he had pretty much of septum and needed a doctor. The patient did not have COVID prior vaccination. The patient had not been tested post-vaccination. The patient had not known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Magnetic resonance imaging, Positron emission tomogram
Clinical narrative: her sister had high blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer (5 years ago)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose vaccine). The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "her sister had high blood sugar". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arms after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arms after the first dose".  Additional information: Patient was due to get her second dose of Pfizer Covid-19 vaccine tomorrow (23Apr2021) but she wanted to know if the first and second dose of the Pfizer Covid-19 vaccine has the same efficacy and what are the side effects of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: She experienced an enhanced ringing in the ear after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "She experienced an enhanced ringing in the ear after the first dose".  Additional information: Patient received the first dose and second dose of Covid-19 vaccine. She experienced an enhanced ringing in the ear after the first dose, but forgot to report about it. Asked if this has anything to do with the Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; mild headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "mild headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: developed tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 09:00 (Batch/Lot number: unknown) at the age of 64 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: TINNITUS (non-serious) with onset 16Mar2021 16:00, outcome "not recovered", described as "developed tinnitus".  Additional information: The caller reported, that was really bad for 1-2 days then subsided nothing that it was still at a persistent level as they spoke. The caller asked, had tinnitus been reported and was Pfizer recommended a treatment for it. Stated that, he had talked to other people in conversations and they said that, some people get tinnitus from the vaccine. Stated that, upon calling back, caller stated he had seen three HCP for the tinnitus. The caller reported the AE and stated that, he reported the date of his first dose and reported that he has not had his second dose yet. Enquired, the caller asked, what percentage of protection did he had from the first vaccine. The caller asked, how long did the antibodies continue to show up. What are the 6 months topline analysis results of the Pfizer-BioNTech COVID-19 Vaccine. Enquired that, the caller asked, whether he was still showing antibodies, could he donate plasma to himself instead of getting a second shot. The caller asked that, could he forget about the second shot altogether and just get the third shot. Also, the caller asked, when was the third shot coming out. Stated that, he was past 21 days and asked how much further out he could still get it. Caller stated that, the 6 week mark was tomorrow. The caller asked, could he go 3 to 4 months.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: pain to injection site arm; pain to injection site arm, which feels swollen and tender; nausea; vomiting; 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 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 18Apr2021 (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: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "pain to injection site arm"; VACCINATION SITE SWELLING (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "pain to injection site arm, which feels swollen and tender"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset Apr2021, outcome "unknown", described as "vomiting".  Additional Information: In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: Let caller know that there is no information regarding a potential interaction between the vaccine and having someone's eyes dilated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 11May2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "oral surgery", start date: 06May2021 (unspecified if ongoing); "will be undergoing arterial surgery", start date: 06May2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1st), administration date: 20Apr2021, for Covid-19 immunization. The following information was reported: EYE DISORDER (non-serious), outcome "unknown", described as "Let caller know that there is no information regarding a potential interaction between the vaccine and having someone's eyes dilated".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Bursitis, Chills, Fatigue, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 22Jan2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "immunosuppressed" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE. Past drug history included: Antibiotics, reaction(s): "Reaction", notes: Reaction to an antibiotic 5 years ago.The following information was reported: CHILLS (non-serious) with onset Jan2021, outcome "unknown", described as "Chills"; FATIGUE (non-serious) with onset Jan2021, outcome "unknown", described as "Fatigue"; HEADACHE (non-serious) with onset Jan2021, outcome "unknown", described as "Headache"; NECK PAIN (non-serious) with onset Jan2021, outcome "unknown", described as "Neckache"; LYMPHADENOPATHY (non-serious) with onset 22Jan2021, outcome "recovered" (23Jan2021), described as "Pain under her arm which she believes was a swollen lymph node"; BURSITIS (non-serious) with onset Jan2021, outcome "recovered" (Feb2021), described as "Hip bursitis"; MOVEMENT DISORDER (non-serious) with onset Jan2021, outcome "unknown", described as "She had difficulty moving in and out of bed". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was concerned and upset that the vaccine may not work for her because she is immunosuppressed. She wants Pfizer to know that this information should be "out there" more and it creates a "false sense of security" in individuals who are on immunosuppressants. Patient was upset that she tested negative for antibodies after the vaccine series. Patient received several weeks of physical therapy after the 1st Pfizer shot. She is on an immunosuppressant drug. Patient began taking immunosuppressant medication BEFORE receiving the Pfizer Covid vaccines. She states she will be going back to her MD for another test to determine if she has immunity against Covid. Caller upset that information about immunosuppressed individuals and the Covid vaccine is not more "out there" for the public to know. She is upset that this population was not included in the clinical trials and is upset that she has been told to proceed with her life as if she wasn't vaccinated. Patient wanted to know if Pfizer will be studying the vaccine with immunosuppressed individuals. Patient stated no one is giving clear warnings that the vaccine may or may not work including her doctor at (withheld). Went for antibody test which came back negative. Doctor told her it does not mean the vaccine did not work but that they do not know how effective it may be. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.