chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: just fatigue and sore arm; just fatigue and sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 11:00 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, patient was diagnosed with COVID-19,; "Hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA; SINGULAIR; LOSARTAN; HCTZ. Past drug history included: Erythromycin, reaction(s): "Drug allergy", notes: Known allergies: Erythromycin. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Mar2021, outcome "unknown" and all described as "just fatigue and sore arm".  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. 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: Headache
Clinical narrative: headache; 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 female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (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: HEADACHE (non-serious) with onset 06Apr2021, outcome "unknown", described as "headache".  Additional information: Callback to a consumer who stated "I just wanted to know if I can take Tylenol or Advil for a headache?".  Reporter stated that she received her first dose of Pfizer-Biontech Covid19 vaccine today. PQC was not present. AE present was reported as yes.  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: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 25, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain in extremity, onset 2021, with outcome of unknown. Additional information: The patient received the 1st dose of the Pfizer COVID-19 vaccine on Mar 25, 2021; and due for the 2nd dose this Thursday (at the time of report). She mentioned she had no reactions to the vaccine except for maybe a little soreness in the arm. She asked if it would still be safe for her to accommodate a friend who got vaccinated with her 2nd dose of the Moderna vaccine. She mentioned her friend had COVID-19 three months ago, and had a reaction to her 2nd dose. Her friend plans to visits her from an area that withdrew their mask policies and allows people to go without masks; so she was really concerned about her friend's situation. Patient questioned if it is true you have to get a booster after 6 months; and if the vaccine protects against the other variants. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Influenza like illness
Clinical narrative: weakness; headache; flu-like symptoms; 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), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: 11Mar2021, for Covid-19 Immunisation, reaction(s): "weakness", "sore arm". The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "weakness"; HEADACHE (non-serious), outcome "unknown", described as "headache"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms".  Additional Information: Caller (Name withheld) reports symptoms experienced by her and her husband while taking the vaccine. 1st dose taken on 11Mar and 2nd dose on 01Apr. Caller has experienced weakness sore arm after the 1st dose and weakness, headache and flu-like symptoms after the 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 11, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache, with outcome of unknown. Additional information: It was reported the patient received second dose on Apr 1, 2021. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Hyperhidrosis, Tinnitus
Clinical narrative: ringing in one ear for 12-18 hours; states a week later the ringing began again; woke up drenched in sweat that night for an hour.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021376518 (Pfizer).  A 62 year-old male 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 "ringing in one ear for 12-18 hours"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "states a week later the ringing began again"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "woke up drenched in sweat that night for an hour.".  Additional information: Caller states he is calling about the Pfizer COVID19 vaccine and states he wanted guidance on the vaccine; states he had the 1st dose administered 2 weeks ago and then three days later he had ringing in one ear that lasted about 12 hours and then went away; states a week later the ringing began again for probably 4-5 hours and with the first occurrence of the ringing that night he started having ringing and woke up at 4:00am sweating and that went away in about an hour. States then the next morning the ringing was gone, and he was fine and then a week after that he had ringing for about 4-5 hours and then it went away. Caller states he is supposed to get his 2nd dose of the Pfizer COVID Vaccine this Friday and wants to know if he should go with it or not; caller aware that the company and Pfizer not able to offer treatment recommendations or medical advice.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Viral test
Clinical narrative: increased urinary frequency; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Benign Prostatic Hyperplasia", start date: Sep2020 (unspecified if ongoing); "Green Light Laser surgery" (unspecified if ongoing), notes: on my prostate.; "Non-Hodgkins B-cell Follicular Lymphoma Grades 1-2", start date: Aug2017 (unspecified if ongoing), notes: Diagnosed with Non-Hodgkins B-Cell Follicular Lymphoma Grades 1-2 in August 2017.; "Lymphoma has been in remission", start date: Feb2018 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Treanda for Chemo, notes: I had 6 months of chemo with Rituxin and Treanda. The following information was reported: POLLAKIURIA (non-serious) with onset 09Mar2021, outcome "unknown", described as "increased urinary frequency". The event "increased urinary frequency" was evaluated at the physician office visit. 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: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: I started feeling fatigued/but I thought the same when you got yours; slightly achey/but I thought the same when you got yours.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I started feeling fatigued/but I thought the same when you got yours"; PAIN (non-serious), outcome "unknown", described as "slightly achey/but I thought the same when you got yours.". Additional information: My husband got the his #2 vaccine and I started feeling fatigued and slightly achey two days later. When I mentioned it he said, funny but I thought the same when you got yours. Seemed to be more than coincidence or sympathetic reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperkeratosis, SARS-CoV-2 test, Vaccination site pruritus
Clinical narrative: red bumps and itchiness at the site of the second shot (right arm); red bumps and itchiness at the site of the second shot (right arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 14:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, other vaccine same date vaccine , location: Left arm), administration date: 10Mar2021, when the patient was 53 years old, for Covid-19 immunisation. The following information was reported: VACCINATION SITE PRURITUS (non-serious), HYPERKERATOSIS (non-serious) all with onset 03Apr2021, outcome "unknown" and all described as "red bumps and itchiness at the site of the second shot (right arm)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pruritus, hyperkeratosis.  Additional information: No treatment received, no covid prior to vaccination, covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Stress
Clinical narrative: Had a migraine for days after the vaccine, but not certain if related to vaccine or stress. Went away 02April2021 afternoon.; related to Stress; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; MELATONIN. The following information was reported: MIGRAINE (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "Had a migraine for days after the vaccine, but not certain if related to vaccine or stress. Went away 02April2021 afternoon."; STRESS (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "related to Stress". Therapeutic measures were not taken as a result of migraine, stress.  Additional Information: The 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, the patient was not 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: Chills, Fatigue, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced vaccination site pain (pain at injection site), with outcome of not recovered; chills (non-serious) and fatigue, with outcome of unknown. Additional information: The female patient experienced pain at injection site, along with chills and fatigue about 36 hours after her dose. She stated she was still experiencing pain at injection site. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (005570). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included interstitial cystitis (unspecified if ongoing). The patient's concomitant medications not reported. The patient experienced unexpected therapeutic response, and improved pre-existing condition, with outcome of unknown. The patient stated, "I have interstitial cystitis. Since my vaccine, I haven't had any pain or flare-ups." Additional information: The patient just wanted to report a positive effect of the Pfizer COVID-19 vaccine they received. The patient also knew a few other patients that expressed this happening to them as well/also expressed this happening to them in an open forum. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Pain in extremity
Clinical narrative: arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021252141 (same vaccine, different dose, similar event).  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Feb2021 09:50 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes 1" (ongoing); "Diabetes 2" (ongoing); "muscle spasticity" (ongoing); "High blood pressure" (ongoing). Concomitant medication(s) included: INSULIN taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; BACLOFEN taken for muscle spasticity; LISINOPRIL taken for hypertension; METOPROLOL taken for hypertension; CALCIUM PLUS VITAMIN D (ongoing); TYLENOL; PANTOPRAZOLE taken for gastrooesophageal reflux disease, gastrooesophageal reflux disease (ongoing); FUROSEMIDE (ongoing); ELIQUIS taken for anticoagulant therapy (ongoing).  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was a little sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No prior vaccination within 4 weeks. Concomitant therapy included Multivitamins also.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: pain throughout the body; chattering chills; This is a spontaneous report received from a 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 25Mar2021 10:15 (Lot number: ep6955) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: COPAXONE. Vaccination history included: Bnt162b2 (Product: COVID 19, Lot number: en6199, Administration date: 04Mar2021, Administration time: 11:15AM, Vaccine location: Left arm, Dose number: 1), administration date: 04Mar2021, when the patient was 52 years old, for Covid-19 immunisation, reaction(s): "My face got tight", "Got very hot", "Sharp pain down spine", "Hard to breath", "Racing heart lasting about 3-4 minutes", "Pain throughout the body", "Teeth chattering chills (over 2 hours)". The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain throughout the body"; CHILLS (non-serious), outcome "unknown", described as "chattering chills". Additional information: No treatment given for AE. Covid prior vaccination was no. Covid tested post vaccination was no. Known allergies was no. No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen lymph node; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Environmental Allergies" (unspecified if ongoing), notes: Environmental Allergies; "GERD" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: PANTOPRAZOLE; PREDNISONE; PHENTERMINE. Past drug history included: Nasonex, reaction(s): "allergies: nasonex", notes: known allergies: nasonex; Omnaris, reaction(s): "allergies: omnaris", notes: known allergies: omnaris. Vaccination history included: Bnt162b2 (product= COVID 19,, lot unknown reason= Other,, lot unknown reason other= Public health event,, administration time= 03:15 PM,, vaccine location= Left arm,, dose number= 1, Cellulitis- 10 days (10Mar21) following first dose on 26Feb21), administration date: 26Feb2021, when the patient was 47 years old, for Covid-19 Immunization, reaction(s): "Cellulitis". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Swollen lymph node". The event "swollen lymph node" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Mar2021) negative, notes: Nasal swab. Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: It was reported that the patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had been tested for COVID-19. It was reported that patient had received Pantoprazalol, prednisone, phenteromine, and more medications within 2 weeks of vaccination. Patient had received treatment of Keflex then Doxycycline. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 09:30 (Lot number: EL9267, Expiration Date: 05Mar2021) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "UTI", start date: 23Feb2021, stop date: 03Apr2021; "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: LEVOFLOXACIN taken for urinary tract infection, start date: 23Feb2021, stop date: 24Feb2021; PANTOPRAZOLE taken for gastrooesophageal reflux disease (ongoing); CEPHALEXIN [CEFALEXIN] taken for urinary tract infection, start date: 26Feb2021, stop date: 04Mar2021. Vaccination history included: Bnt162b2 (1st dose, Time: 09:30 AM, Anatomical Site of injection: Right arm, Batch/Lot number: EN5318, Exp.Date: 12Feb2021), administration date: 12Feb2021, for COVID-19 immunisation; Shingles zoster (shingles zoster, Anatomical Site of injection: Right arm, No. of previous dose: 1), administration date: 21Jan2021, for immunization. The following information was reported: HEADACHE (non-serious) with onset 06Mar2021, outcome "recovered" (2021), described as "headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient received treatment drug Advil/ Tylenol for an event headache.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: This is a spontaneous report received from a contactable physician. A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had chills (non-serious), with outcome of unknown. Additional information: Patient got chills 8 hours later. 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-2021379915 same reporter/drug/AE, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: One of the nurses, I had that administered the vaccine said she also had the chills/her nurse that gave her shot had the chills 6 hours later; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. This Physician reported similar events for 2 patients. This is second of two reports. This Physician reported for a female patient that:  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: CHILLS (non-serious), outcome "unknown", described as "One of the nurses, I had that administered the vaccine said she also had the chills/her nurse that gave her shot had the chills 6 hours later".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021379914 Same reporter/Drug/AE, Different patient
Sex: M
Vaccine: COVID19
Symptoms: Ear disorder
Clinical narrative: Ear problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR DISORDER (non-serious), outcome "unknown", described as "Ear problems".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. 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: FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional Information: I had fatigue after first and second shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: [arm pain] is messing with her sleep.; Sharp pain in Right Arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: EN6203) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: Verbatim: Arthritis. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Apr2021, outcome "not recovered", described as "Sharp pain in Right Arm"; SLEEP DISORDER (non-serious), outcome "unknown", described as "[arm pain] is messing with her sleep.". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Stated that she talked to one of her family members, her niece, and she said the pain should only last a few days and go away. Stated but she had her shot on the first, does not know if this is a side effect or what. States the pain should last a while and go away but she still has this, the patient enquired does she need to go be seen coming from the shot because the pain was sharp where she got the shot at. Stated she was hoping it would go away and she would not have to go to the doctor. The patient received treatment with Tylenol and Witch Hazel and Rubbing on it.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in ear, like tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 09:15 (Lot number: ER8727) as dose 2, single and administration date 02Mar2021 09:15 (Lot number: EN6205) 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: TINNITUS (non-serious) with onset 22Mar2021, outcome "not recovered", described as "ringing in ear, like tinnitus".  Additional information: After the second dose vaccine on 23Mar2021, the ringing was very much louder in the ear. Prior vaccination within 4 weeks: No. AEs following prior vaccinations: not provided. Family medical history: no. Relevant tests: no. The ENT industry looking at the fact that they are having many patients coming in with this condition. They don't know if this was because of the vaccine or the fact that so many people are getting the vaccine. They are seeing an up rise in this condition and are dealing with it.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Mobility decreased, Muscle tightness
Clinical narrative: left shoulder and neck muscles were incredibly tight; left shoulder and neck muscles were incredibly tight; left shoulder and neck muscles were incredibly tight and were restricting movement; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 06Apr2021 at 12:30 (at the age of 32-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included ADHD, oral herpes. Concomitant medications included methylphenidate hydrochloride (RITALIN), valaciclovir hydrochloride (VALTREX), lysine (L-LYSINE), and calcium pantothenate; nicotinamide; procaine hydrochloride; pyridoxine hydrochloride; riboflavin; thiamine hydrochloride (VITAMIN B COMPLEX) and FIS; all from an unknown date for an unspecified indication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 05:00, the patient experienced left shoulder and neck muscles were incredibly tight and were restricting movement. Patient took 800mg of Ibuprofen to try to soften the side effects 18 hours after the injection, and it was not changing anything. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events was resolving.    No follow-up attempts are needed. No further information is expected.   Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added. In addition, concomitant medication: "vitamin b complex" and events "left shoulder and neck muscles were incredibly tight and were restricting movement" were recoded.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: felt excessively tired the next morning for about 1/2 the day; 12 hours after injection he had extreme cold chills for about 2 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for covid-19 immunisation. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "12 hours after injection he had extreme cold chills for about 2 hours"; FATIGUE (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "felt excessively tired the next morning for about 1/2 the day". Felt fine after midday.  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: Nasal congestion, Rhinorrhoea, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Red, swollen and painful injection site; Red, swollen and painful injection site; red, swollen and painful injection site; Stuffy,runny nose; Stuffy,runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EL9262, Expiration Date: May2021) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number :1), when the patient was 70 years old, for Covid-19 Immunization, reaction(s): "red, swollen and painful injection site", "red, swollen and painful injection site"; Bnt162b2 (Dose number :1), for Covid-19 Immunization, reaction(s): "red, swollen and painful injection site". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Red, swollen and painful injection site"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "red, swollen and painful injection site"; NASAL CONGESTION (non-serious), RHINORRHOEA (non-serious), outcome "unknown" and all described as "Stuffy,runny nose".  Additional information: Time the Vaccination was given as 7:15 AM  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood, Paraesthesia, Thirst
Clinical narrative: I was tingly; felt overcaffeinated; was extremely thirsty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: EN6208) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing); "Allergies: Sulfas" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "I was tingly"; EUPHORIC MOOD (non-serious) with onset 2021, outcome "unknown", described as "felt overcaffeinated"; THIRST (non-serious) with onset 2021, outcome "unknown", described as "was extremely thirsty".  Additional information: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Administration time of dose 1 was provided as 10:30. After the first dose, the patient was tingly, felt overcaffeinated and was extremely thirsty.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: pain has gone down has been away;  no neck pain/ no issues with my collar bone my shoulder; my shoulder I can move my arm up and down and everything; 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), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "neuropathy" (unspecified if ongoing); "my shoulder I broke my collar bone" (unspecified if ongoing); "neck pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 05Mar2021, for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "pain has gone down has been away;  no neck pain/ no issues with my collar bone my shoulder; my shoulder I can move my arm up and down and everything".  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-2021381420 Same reporter, drug, and event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunization. The following information was reported: SINUSITIS (non-serious) with onset 02Apr2021, outcome "unknown", described as "sinus infection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: not have any effects to the vaccine,other than a sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male 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 "not have any effects to the vaccine,other than a sore arm.".  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Fatigue, Nausea, SARS-CoV-2 test
Clinical narrative: First Dose: Nausea; First Dose: Diarrhea; First Dose: Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 09:00 (Lot number: EM9810) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: Had 10-15 years; "degenerative arthritis" (ongoing), notes: Diagnosed 2010; "Rheumatoid arthritis" (ongoing), notes: Diagnosed around 2015; "pneumonia", start date: Sep2020 (unspecified if ongoing). Concomitant medication(s) included: HUMIRA (ongoing); METHOTREXATE (ongoing); HYDROCODONE taken for pain (ongoing). The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "First Dose: Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "First Dose: Diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "First Dose: Tired". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: she said I don't need my walker so she was walking without her walker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing), notes: my roommate has A Fib; "Diabetic" (unspecified if ongoing), notes: she is diabetic; "lung cancer surgery" (unspecified if ongoing), notes: she had three lung cancer surgery; "requires a walker to walk" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "she said I don't need my walker so she was walking without her walker".  Additional information: Reporter noted that patient had issues walking with her knees, hips and whatever and requires a walker to walk. Patient had been able to walk without her walker without any pain after 6-7 hours of receiving the second dose. Reporter confirmed that patient had no adverse effect with the vaccine.  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-2021381311 Same reporter, drug, and event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arms were sore; 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 male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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 "arms were sore". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient took two TYLENOL as treatment of the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Insomnia
Clinical narrative: chills; hot flashes; insomnia; headache; night sweats; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jan2021 11:00 (Batch/Lot number: unknown) at the age of 50 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: NIGHT SWEATS (non-serious) with onset 21Jan2021 07:00, outcome "recovered" (2021), described as "night sweats"; FATIGUE (non-serious) with onset 21Jan2021 07:00, outcome "recovered" (2021), described as "fatigue"; CHILLS (non-serious) with onset 22Jan2021 07:00, outcome "recovered" (2021), described as "chills"; HOT FLUSH (non-serious) with onset 22Jan2021 07:00, outcome "recovered" (2021), described as "hot flashes"; INSOMNIA (non-serious) with onset 22Jan2021 07:00, outcome "recovered" (2021), described as "insomnia"; HEADACHE (non-serious) with onset 22Jan2021 07:00, outcome "recovered" (2021), described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: chills; hot flashes; insomnia; headache; night sweats; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jan2021 11:00 (Batch/Lot number: unknown) at the age of 50 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: NIGHT SWEATS (non-serious) with onset 21Jan2021 07:00, outcome "recovered" (2021), described as "night sweats"; FATIGUE (non-serious) with onset 21Jan2021 07:00, outcome "recovered" (2021), described as "fatigue"; CHILLS (non-serious) with onset 22Jan2021 07:00, outcome "recovered" (2021), described as "chills"; HOT FLUSH (non-serious) with onset 22Jan2021 07:00, outcome "recovered" (2021), described as "hot flashes"; INSOMNIA (non-serious) with onset 22Jan2021 07:00, outcome "recovered" (2021), described as "insomnia"; HEADACHE (non-serious) with onset 22Jan2021 07:00, outcome "recovered" (2021), described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar rises and went higher; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient's wife) for a sponsored program (002191).  A male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (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: BLOOD GLUCOSE INCREASED (non-serious) with onset Apr2021, outcome "unknown", described as "blood sugar rises and went higher". Relevant laboratory tests and procedures are Blood glucose with result of rises available in the appropriate section.  Additional information: Reporter wanted to know what's with the Covid19 vaccine that can cause them to have these reactions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Headache/migraine started 2 weeks after vaccination; 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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "Headache/migraine started 2 weeks after vaccination". The event "headache/migraine started 2 weeks after vaccination" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of migraine.  Additional information: The event took place after use of product and ER visit was required for fluids.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: 2nd shot made him off on every bone like he has a flu; fatigue; Every part of his body hurts even his toe nails hurt; 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 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for Covid-19 immunization, reaction(s): "1st dose didn't feel anything". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "2nd shot made him off on every bone like he has a flu"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN (non-serious), outcome "unknown", described as "Every part of his body hurts even his toe nails hurt".  Additional Information: Pfizer 2nd shot made him off on every bone like he has a flu and fatigue. Every part of his body hurts even his toenails hurt. 1st dose didn't feel anything. Spoke to his Dr and told him to call Pfizer. Is this something common? PQC was not present. AE present was reported as yes. Case was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.