chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Dysuria, Flatulence, Gastric disorder, Malaise
Clinical narrative: really bad gas/severe amount of gas; pain in lower stomach/brick in his stomach; He felt really sick; it also affected when he went to go urinate/felt a little bit of pressure and almost pain with that; "troubles that night with [his] stomach"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 09Mar2021 09:30 (Lot number: EN6204) at the age of 69 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "He tested positive for covid", start date: 04Jan2021 (unspecified if ongoing); "allergic to shellfish" (ongoing); "He puts his glasses on" (unspecified if ongoing); "He is allergic to topical propylene glycol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "allergic to codeine"; Vitamin e, reaction(s): "allergic to topical vitamin e". The following information was reported: CONTRAINDICATED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "he noticed that one of the ingredients in the vaccine is polyethene glycol. He is wondering if that is his problem."; GASTRIC DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as ""troubles that night with [his] stomach""; FLATULENCE (non-serious) with onset 09Mar2021, outcome "recovering", described as "really bad gas/severe amount of gas"; ABDOMINAL PAIN UPPER (non-serious) with onset 09Mar2021, outcome "recovering", described as "pain in lower stomach/brick in his stomach"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "He felt really sick"; DYSURIA (non-serious) with onset Mar2021, outcome "unknown", described as "it also affected when he went to go urinate/felt a little bit of pressure and almost pain with that". Therapeutic measures were taken as a result of flatulence, abdominal pain upper. Additional information: The patient took Gas X as treatment and it worked. Patient had no prior vaccinations within 4 weeks and had no adverse events following prior vaccinations. Patient is allergic to topical propylene glycol and he noticed that one of the ingredients in the vaccine is polyethene glycol. He wanted to know if that is his problem and is asking if he should take the second dose.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Muscular weakness, Musculoskeletal stiffness, Sluggishness
Clinical narrative: stiffness in his arm; no strength in his arms; felt sluggishness; didnt have the get up and go; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Mar2021, outcome "unknown", described as "stiffness in his arm"; MUSCULAR WEAKNESS (non-serious) with onset 13Mar2021, outcome "unknown", described as "no strength in his arms"; SLUGGISHNESS (non-serious) with onset 13Mar2021, outcome "unknown", described as "felt sluggishness"; ASTHENIA (non-serious) with onset 13Mar2021, outcome "unknown", described as "didnt have the get up and go".  Additional information: Patient last friday had the first pfizer covid vaccine  shot and was given appt for 2nd dose.  However, he wanted to move his appt to a friday. He was asking how to do that. He reported stiffness in his arm; no strength in his arms on saturday and sunday after the shot and felt sluggishness in his movements on saturday and  didnt have the get up and go.   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, Dizziness, Pain
Clinical narrative: chills; Body Aches; A Little Dizzy; 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 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Mar2021 (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: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Body Aches"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "A Little Dizzy".  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: Blood test, Lymphadenopathy, Pain
Clinical narrative: swollen lymph node/right groin lymph node is swollen; when he sits down the pain goes away eventually/he also has a burning pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 24Feb2021 12:00 (Lot number: EN5200, Expiration Date: Jun2021) at the age of 64 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "double bypass surgery" (unspecified if ongoing), notes: has been taking medications since November when he had double bypass surgery. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot: EL9264, Expiration date: 31May2021), administration date: 03Feb2021, when the patient was 64 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 27Feb2021, outcome "not recovered", described as "swollen lymph node/right groin lymph node is swollen"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "when he sits down the pain goes away eventually/he also has a burning pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did not receive prior vaccinations within 4 weeks. The lymph node only bothers the patient when he's standing, he can walk and exercise without a problem. The patient is going to his cardiac doctor on 30Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1 (Lot Number: Not provided)), for COVID-19 immunization. The following information was reported: INJECTION SITE PRURITUS (non-serious), outcome "unknown", described as "her injection area got itchy". Additional Information: The patient stated that her injection area got itchy on the second or third day after the second dose. She mentioned the itchiness to her daughter and said that she did not want to rub the area because her vaccine administrator told her not to rub the area but her daughter's vaccine administrator said that she should rub the area. The patient wanted a clarification on the correct answer and was not wanting to say that the itching was a side effect and the itchiness was part of the healing process. The patient stated that her concern was that no one should be advising patients to rub the area or not rub the area if Pfizer does not have any information about this. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Condition aggravated, Off label use, Product use issue, Ultrasound breast
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 17:45 (Batch/Lot number: unknown) at the age of 35 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "mild pain and soreness due to the breastfeeding" (unspecified if ongoing), notes: mild pain and soreness due to the breastfeeding. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; IRON. The following information was reported: BREAST PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 11Mar2021, outcome "not recovered" and all described as "had mild pain and soreness due to the breastfeeding but after the vaccine, my pain aggravated in both breasts. had constant burning pain in both breasts"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Mar2021 17:45, outcome "unknown" and all described as "Breastfeeding since 4 months". The event "had mild pain and soreness due to the breastfeeding but after the vaccine, my pain aggravated in both breasts. had constant burning pain in both breasts" and "had mild pain and soreness due to the breastfeeding but after the vaccine, my pain aggravated in both breasts. had constant burning pain in both breasts" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast pain, condition aggravated. Additional information: List of any other medications the patient received within 2 weeks of vaccination: Prenatal Multivitamins, Vitamins, Iron 65mg and vitamin C. On an unknown date in Mar2021, the patient's ultrasound of breasts was nothing showed up in the ultrasound. 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-2021308283 baby case.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Soreness in the arm; Tired; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6202) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Dec2020 (unspecified if ongoing); "Bitten by a tick" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in the arm"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  Additional Information: The patient recently was bitten by a tick and has to take high doses of antibiotics for 21 days starting today. The patient has already received the first dose of the Pfizer COVID-19 vaccine and had side effects including soreness in the arm and was tired the next day. The patient was scheduled for the second dose on 24Mar2021. The patient asked if there were any contraindications to taking antibiotics with the vaccine and if she could get the second dose while taking antibiotics. The patient's doctor did not know and told her to call Pfizer.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a little soreness on the arm; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 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 "had a little soreness on the arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Neck pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 15:10 (Lot number: EN6208) at the age of 82 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Lump" (unspecified if ongoing); "Surgery" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN (ongoing); ALPRAZOLAM taken for anxiety, start date: 2012 (ongoing); ATORVASTATIN (ongoing); CARVEDILOL; THYROID (ongoing); CITALOPRAM (ongoing); CENTRUM SILVER [ASCORBIC ACID; BETACAROTENE; BIOTIN; CALCIUM; CHROMIUM; COLECALCIFEROL; COPPER; FOLIC ACID; IODINE; IRON; LYCOPENE; MAGNESIUM; MANGANESE; NICOTINAMIDE; PANTOTHENIC ACID; PHOSPHORUS; PHYTOMENADIONE; POTASSIUM; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN; FOCUS FACTOR; TURMERIC [CURCUMA LONGA]. Vaccination history included: Bnt162b2 (1st dose, Lot number: EN6201, Vaccine location: Left arm), administration date: 11Feb2021, for COVID-19 immunisation. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered", described as "Stiff neck"; NECK PAIN (non-serious), outcome "not recovered", described as "Neck ache"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes". Additional information: The events did not require a visit to physician or ER. Iron pill was also included in the patient's concomitant medications. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Insomnia, Vaccination site pain
Clinical narrative: pain at injection sight; Could not sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 23Feb2021 10:00 (Lot number: EN6198, Expiration Date: Jun2021) at the age of 74 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "stung" (unspecified if ongoing), notes: had extreme reactions from yellow jackets in the 90s; "eczema" (unspecified if ongoing), notes: she had eczema all over her back and arms.; "mild allergies to mold" (unspecified if ongoing); "mild allergies to juniper" (unspecified if ongoing); "immune system is sensitive" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Prolia shots for arthritis, notes: she gets Prolia shots twice a year for her arthritis. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Feb2021, outcome "recovered" (23Feb2021), described as "pain at injection sight"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "Could not sleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The events did not require an emergency room or physician's office visit.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: only a little soreness in the arm that went away after taking medication; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing); "hypertense" (unspecified if ongoing); "Swelling in the face" (unspecified if ongoing), notes: before the vaccination. The patient's concomitant medications were not reported. Past drug history included: Epipen for antiallergic. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "only a little soreness in the arm that went away after taking medication". Therapeutic measures were taken as a result of pain in extremity.  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-2021302501 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little soreness in the arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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 "recovered", described as "a little soreness in the arm". Therapeutic measures were taken as a result of pain in extremity. Additional information: The patient received unspecified medication as treatment for the event.  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-2021302500 Same reporter, suspect drug, and event; different patient
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Vertigo, Vision blurred
Clinical narrative: vertigo; blurred vision; sour metalic taste in her mouth; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EN6207) 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: VERTIGO (non-serious), outcome "unknown", described as "vertigo"; VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision"; DYSGEUSIA (non-serious), outcome "unknown", described as "sour metalic taste in her mouth"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  Additional Information: The reporter (patient's husband) was asking what they can do about the patient's symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain, Pain in extremity, X-ray
Clinical narrative: Had a sore arm.; soreness; 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-2021298895.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 16Feb2021 (Batch/Lot number: unknown, Expiration Date: 30Jun2021) at the age of 71 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Had a sore arm."; PAIN (non-serious), outcome "unknown", described as "soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, pain.  Additional information: She stated that she got the first dose and got no problems or side effects, just took an Ibuprofen for the soreness. and sore arm. She also mentioned that she went to get a MRI because she was having shoulder soreness in between of the 2 doses of the covid vaccine and no one told her that she should not because of the vaccine. She was in this study to discover if her soreness was frozen shoulder, but it was not. She stated does having a lab work have anything to do with it because she has a 'frozen shoulder test' to see if she qualified for it because she was a writer, and her shoulder was bothering her and got to do the test to see what it was.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: After Dose 1 - next day if lifted left arm over shoulder had very very mild soar feeling in upper arm at site injection; 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), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 18Mar2021 16:00, outcome "recovering", described as "After Dose 1 - next day if lifted left arm over shoulder had very mild soar feeling in upper arm at site injection". Therapeutic measures were not taken as a result of injection site pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received Hydrochlorothiazide tab 12.5mg;  Lisinopril 20mg within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to and since the vaccination. Patient was not allergic to medications, food, or other products.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Back pain, Blood test, Pain in extremity
Clinical narrative: After Dose 1 - next day if lifted left arm over shoulder had very very mild soar feeling in upper arm at site injection; 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), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 18Mar2021 16:00, outcome "recovering", described as "After Dose 1 - next day if lifted left arm over shoulder had very mild soar feeling in upper arm at site injection". Therapeutic measures were not taken as a result of injection site pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received Hydrochlorothiazide tab 12.5mg;  Lisinopril 20mg within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to and since the vaccination. Patient was not allergic to medications, food, or other products.   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, COVID19
Symptoms: Injection site pain
Clinical narrative: got aches in arms, stomach side/lower back - not horrible - still working and moving; got aches in arms, stomach side/lower back - not horrible - still working and moving; got aches in arms, stomach side/lower back - not horrible - still working and moving; 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), administered in arm left, administration date 18Mar2021 14:30 (Lot number: EN6203) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL. Vaccination history included: Bnt162b2 (product=COVID 19 Vaccine, brand=Pfizer,, DOSE 1, lot number=EN6203, vaccine location=Left arm), for COVID-19 immunisation, reaction(s): "After Dose 1 - next day if lifted left arm over shoulder had very very mild sore feeling in upper arm at site injection"; Flue shot (After Dose 1 - next day if lifted left arm, over shoulder had very very mild soar, feeling in upper arm at site injection (I, have this with flue shot in past too)), for Flu prevention, reaction(s): "if lifted left arm over shoulder had very very mild sore feeling in upper arm at site injection". The following information was reported: ABDOMINAL PAIN UPPER (non-serious), BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Mar2021 16:00, outcome "recovering" and all described as "got aches in arms, stomach side/lower back - not horrible - still working and moving". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain upper, back pain, pain in extremity.  Additional information: The patient received vaccine at facility work place clinic. The patient had no other vaccine within 4 weeks prior the vaccination. 2 hours after 2nd dose, patient got aches in arms, stomach side/lower back - not horrible - still working and moving. The patient had full blood work between dosages and everything in ranges per Doctor no concerns/changes.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Back pain, Blood test, Pain in extremity
Clinical narrative: got aches in arms, stomach side/lower back - not horrible - still working and moving; got aches in arms, stomach side/lower back - not horrible - still working and moving; got aches in arms, stomach side/lower back - not horrible - still working and moving; 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), administered in arm left, administration date 18Mar2021 14:30 (Lot number: EN6203) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL. Vaccination history included: Bnt162b2 (product=COVID 19 Vaccine, brand=Pfizer,, DOSE 1, lot number=EN6203, vaccine location=Left arm), for COVID-19 immunisation, reaction(s): "After Dose 1 - next day if lifted left arm over shoulder had very very mild sore feeling in upper arm at site injection"; Flue shot (After Dose 1 - next day if lifted left arm, over shoulder had very very mild soar, feeling in upper arm at site injection (I, have this with flue shot in past too)), for Flu prevention, reaction(s): "if lifted left arm over shoulder had very very mild sore feeling in upper arm at site injection". The following information was reported: ABDOMINAL PAIN UPPER (non-serious), BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Mar2021 16:00, outcome "recovering" and all described as "got aches in arms, stomach side/lower back - not horrible - still working and moving". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain upper, back pain, pain in extremity.  Additional information: The patient received vaccine at facility work place clinic. The patient had no other vaccine within 4 weeks prior the vaccination. 2 hours after 2nd dose, patient got aches in arms, stomach side/lower back - not horrible - still working and moving. The patient had full blood work between dosages and everything in ranges per Doctor no concerns/changes.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Poor quality sleep
Clinical narrative: Restless sleep; achy muscles; Felt very tired after the 2nd; 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 (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 12:00 (Lot number: EP6955) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "some medicines give me a rash" (unspecified if ongoing), notes: known allergies: yes - some medicines give me a rash. Concomitant medication(s) included: AMLODIPINE; MULTIVITAMIN & MINERAL; ELDERBERRY [RUBUS IDAEUS LEAF;SAMBUCUS NIGRA FLOWER;SAMBUCUS NIGRA FRUIT]. Vaccination history included: Bnt162b2 (Dose No. 1), for Covid-19 Immunization. The following information was reported: POOR QUALITY SLEEP (non-serious) with onset 18Mar2021 21:00, outcome "recovering", described as "Restless sleep"; MYALGIA (non-serious) with onset 18Mar2021 21:00, outcome "recovering", described as "achy muscles"; FATIGUE (non-serious) with onset 18Mar2021 12:30, outcome "recovered" (Mar2021), described as "Felt very tired after the 2nd". Therapeutic measures were not taken as a result of poor quality sleep, myalgia. It was unknown if therapeutic measures were taken as a result of fatigue.  Additional information- It was unknown if COVID tested post or prior to vaccination. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had been tested for COVID-19 was unknown. Patient became aware of the events reported on the same day March 18 as her vaccine shot.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Pain in extremity
Clinical narrative: Left arm is achy and weak; Left arm is achy and weak; Mild headache located in both temples. 2 on standard 10 point pain scale; 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), administered in arm left, administration date 18Mar2021 01:00 (Lot number: EP6955) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergy to Non-shellfish seafood" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Vaccination history included: Bnt162b2 (First Dose, Administration time: 12:15Pm, Vaccine location: Left arm), administration date: 26Feb2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 19Mar2021 07:00, outcome "recovering" and all described as "Left arm is achy and weak"; HEADACHE (non-serious) with onset 19Mar2021 07:00, outcome "recovering", described as "Mild headache located in both temples. 2 on standard 10 point pain scale". Therapeutic measures were taken as a result of pain in extremity, muscular weakness, headache.  Additional information: Woke up at 7am on 19Mar2021. Left arm is achy and weak. Mild headache located in both temples. 2 on standard 10 point pain scale. Patient did not receive any other vaccines in four weeks prior to the COVID vaccine. He received concomitant medication within 2 weeks of vaccination includes Vitamin D3 125mcg (5,000 IU) - daily. He has taken Acetaminophen 1000 mg for the adverse event. He was not tested covid positive prior to vaccination and was not tested positive since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: sore arm, nausea, fatiguesymptoms disappeared after 24 hours; sore arm, nausea, fatiguesymptoms disappeared after 24 hours; sore arm, nausea, fatiguesymptoms disappeared after 24 hours; This is a spontaneous report received from 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 right, administration date 17Mar2021 14:30 (Lot number: 3247) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, lot_number=3247,, lot_unknown=False,, administration_date=24Feb2021,, administration_time=02:00 PM,, vaccine_location=Right arm,, dose_number=1), administration date: 24Feb2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), NAUSEA (non-serious) all with onset 18Mar2021 09:00, outcome "recovered" (2021) and all described as "sore arm, nausea, fatiguesymptoms disappeared after 24 hours". Therapeutic measures were not taken as a result of fatigue, pain in extremity, nausea.  Additional information: Adverse event sore arm, nausea, fatigue symptoms disappeared after 24 hours. No covid prior vaccination. Not tested covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 94 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "chills". Therapeutic measures were taken as a result of headache, chills.  Additional Information: Patient's caregiver (who was not nurse) stated that events was possible side effects of second dose of the vaccine. She didn't want to call 911 because she did not feel it was that big of an emergency. It was not easing up. Caller gave her a Tylenol.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Crying, Decreased appetite, Depression, Feeling abnormal
Clinical narrative: depression; haven't stopped crying; have no appetite; it feels like a tomb is sitting on my head; feels like you don't want to wake up, if you can even get to sleep; concerned; 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 88 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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), when the patient was 88 years old, for COVID-19 immunisation. The following information was reported: DEPRESSION (non-serious), outcome "unknown", described as "depression"; CRYING (non-serious), outcome "unknown", described as "haven't stopped crying"; DECREASED APPETITE (non-serious), outcome "unknown", described as "have no appetite"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it feels like a tomb is sitting on my head"; SLEEP DISORDER (non-serious), outcome "unknown", described as "feels like you don't want to wake up, if you can even get to sleep"; ANXIETY (non-serious), outcome "unknown", described as "concerned". Additional information: she states that since receiving her second dose she has been suffering from depression and states "[I] haven't stopped crying, have no appetite", that it "feels like a tomb is sitting on my head", and "feels like you don't want to wake up if you can even get to sleep!".  She was concerned because it showed up after the second dose and she "didn't sign up for this". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: depression; haven't stopped crying; have no appetite; it feels like a tomb is sitting on my head; feels like you don't want to wake up, if you can even get to sleep; concerned; 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 88 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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), when the patient was 88 years old, for COVID-19 immunisation. The following information was reported: DEPRESSION (non-serious), outcome "unknown", described as "depression"; CRYING (non-serious), outcome "unknown", described as "haven't stopped crying"; DECREASED APPETITE (non-serious), outcome "unknown", described as "have no appetite"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it feels like a tomb is sitting on my head"; SLEEP DISORDER (non-serious), outcome "unknown", described as "feels like you don't want to wake up, if you can even get to sleep"; ANXIETY (non-serious), outcome "unknown", described as "concerned". Additional information: she states that since receiving her second dose she has been suffering from depression and states "[I] haven't stopped crying, have no appetite", that it "feels like a tomb is sitting on my head", and "feels like you don't want to wake up if you can even get to sleep!".  She was concerned because it showed up after the second dose and she "didn't sign up for this". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm soreness, no other clinical symptoms; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 09:15 (Lot number: EP6955) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Mar2021 16:00, outcome "recovering", described as "Left arm soreness, no other clinical symptoms". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Concomitant medications in two weeks included Multi-vitamin. Patient administered no other vaccine in four weeks. Patient not had covid prior to vaccination and not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight soreness in upper left arm near injection site.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 09:00 (Lot number: EP6955) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: verbatim:High blood pressure. Concomitant medication(s) included: ACCUPRIL; NORVASC. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Mar2021 13:00, outcome "recovered" (Mar2021), described as "Slight soreness in upper left arm near injection site.". Therapeutic measures were not taken as a result of vaccination site pain.   Additional information: Patient did not receive any other vaccines in 4 week, Prior to vaccination and post vaccination, the patient was not diagnosed with COVID-19 and patient had no allergy to medications, food, or other products. Soreness aware on March 18, 2021  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: the first dose was not the easiest on my body; 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 (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "the first dose was not the easiest on my body".  Additional information: Caller received her 1st dose of the vaccine 26Feb2021 and was scheduled for the second dose on 22Mar2021 (24 days away from first one), however she received a call from the pharmacy today telling her that she would need to come in today to get the second dose otherwise she will have to start the series again, but she is out of town and will be back on Sunday.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Myalgia, Pain, Pain in extremity
Clinical narrative: Muscle pain; couldn't run or walk without terrible pain; left arm is still sore; Headache; pain everywhere in her body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Feb2021 12:10 (Lot number: EN6200) at the age of 68 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, lot no. EL9261), administration date: 26Jan2021, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious) with onset 16Feb2021, outcome "not recovered", described as "Muscle pain"; GAIT DISTURBANCE (non-serious) with onset 16Feb2021, outcome "not recovered", described as "could not run or walk without terrible pain"; PAIN IN EXTREMITY (non-serious) with onset 16Feb2021, outcome "not recovered", described as "left arm is still sore"; HEADACHE (non-serious) with onset 16Feb2021, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset 16Feb2021, outcome "not recovered", described as "pain everywhere in her body". Therapeutic measures were not taken as a result of myalgia, gait disturbance, pain in extremity, headache, pain.  Additional information: Clinical course: Patient said her side effects began 4-5 hours later. She said that the questionnaire she answered asked about side effects for the first hour or so, but that did not happen. She said that her side effect was that she was curled up on the floor in a little ball in pain, that was not muscle aches like what is listed as a potential side effect, this was muscle pain, really bad pain. She said that this persisted, and she was a runner and a couple weeks later she could not run or walk without terrible pain. She said her left arm was still sore, and she has done no treatment. She said she wonders if she was going to have to put up with this pain for the rest of her life. She said that she has the pain when she was active, a month later, and she would like to know what would cause pain like this. She said who knew, but she can tell that was related to the vaccine as it started 4-5 hours later that she was in pain everywhere in her body; headache and body. She said that the next day she was obviously functioning, and she was a runner so a week or two later when she goes to run or walk she had terrible pain that showed up again and again. She said she was assuming eventually it will go away.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Depressed mood, Electrocardiogram, Malaise
Clinical narrative: kind of feeling low, not good; kind of feeling low, not good; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 12Mar2021 14:00 (Lot number: EN6204, Expiration Date: 31Jul2021) at the age of 48 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious), DEPRESSED MOOD (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "kind of feeling low, not good". The event "kind of feeling low, not good" and "kind of feeling low, not good" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). Patient stated that he had never been vaccinated before (only as a kid) and had no adverse reactions. Clinical course: he got the shot 5 days ago and he is still kind of feeling low and not good.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; 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 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "not recovered", described as "arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.