chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: First dose caused him a lot of pain; Pain generally all over his body but mostly joint pain; 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) (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 (non-serious), outcome "unknown", described as "First dose caused him a lot of pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Pain generally all over his body but mostly joint pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: his shoulder was sore; 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 male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Jan2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 21Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Nov2020 (unspecified if ongoing), notes: COVID as he tested positive for COVID-19 in Nov. The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "his shoulder was sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received his first dose of the Pfizer COVID-19 vaccine last 21Dec2020 where "his shoulder was sore". Caller received his second dose of the vaccine last 08Jan2021 and mentioned that "the nurse injected it in his shoulder IM and that his shoulder was very sore and needed ice to relieve it". Caller received his booster dose of the Pfizer COVID-19 vaccine last 29Sep2021 "first thing in the morning and he felt good, but late night to early morning at around 1 or 3 or 4 am, his knuckles hurt, he had a fast heartbeat, had chills, had headache and it hit him harder than the actual COVID as he tested positive for COVID-19 in Nov where he got tested for work". Caller wanted to know why he sad such an effect with the booster dose.  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: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2021US151492_NC.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "not recovered", described as "fever".  Additional Information: Patient stated that the day prior to starting Entresto she got COVID-19 booster and had developed fever which is still continuing.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Nausea
Clinical narrative: nauseous; weirdness in chest goes from left to right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (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 (First dose), for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "weirdness in chest goes from left to right".  Additional information: During the call, caller mentions he had a truck driver come in who stated his sister also had weirdness in her chest after the second shot. This sister did not have phlegm after her first shot. Wants to know if the weirdness in his chest has been reported before. Maybe it is just him and this truck driver's sister who are experiencing this. Stated the weirdness in chest goes from left to right. It is just strange.   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-202101325402 same reporter/product/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Heart rate, Heart rate increased
Clinical narrative: his knuckles hurt; a fast heartbeat; chills; 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 male patient received bnt162b2 (COMIRNATY), administration date 29Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing), notes: he tested positive for COVID-19 in November where he got tested for work. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 21Dec2020, for Covid-19 Immunization, reaction(s): "his shoulder was sore"; Bnt162b2 (DOSE 2), administration date: 08Jan2021, for Covid-19 Immunization, reaction(s): "his shoulder was very sore".  The following information was reported: ARTHRALGIA (non-serious) with onset Sep2021, outcome "unknown", described as "his knuckles hurt"; HEART RATE INCREASED (non-serious) with onset Sep2021, outcome "unknown", described as "a fast heartbeat"; CHILLS (non-serious) with onset Sep2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset Sep2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that he received his first dose of the Pfizer COVID-19 vaccine last 21Dec2020 where "his shoulder was sore". Caller received his second dose of the vaccine last 08Jan2021 and mentioned that "the nurse injected it in his shoulder IM and that his shoulder was very sore and needed ice to relieve it". Caller received his booster dose of the Pfizer COVID-19 vaccine last 29Sep2021 "first thing in the morning and he felt good, but late night to early morning at around 1 or 3 or 4 am, his knuckles hurt, he had a fast heartbeat, had chills, had headache and it hit him harder than the actual COVID as he tested positive for COVID-19 in November where he got tested for work". Caller wanted to know why he sad such an effect with the booster 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: SARS-CoV-2 test
Clinical narrative: his knuckles hurt; a fast heartbeat; chills; 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 male patient received bnt162b2 (COMIRNATY), administration date 29Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing), notes: he tested positive for COVID-19 in November where he got tested for work. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 21Dec2020, for Covid-19 Immunization, reaction(s): "his shoulder was sore"; Bnt162b2 (DOSE 2), administration date: 08Jan2021, for Covid-19 Immunization, reaction(s): "his shoulder was very sore".  The following information was reported: ARTHRALGIA (non-serious) with onset Sep2021, outcome "unknown", described as "his knuckles hurt"; HEART RATE INCREASED (non-serious) with onset Sep2021, outcome "unknown", described as "a fast heartbeat"; CHILLS (non-serious) with onset Sep2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset Sep2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that he received his first dose of the Pfizer COVID-19 vaccine last 21Dec2020 where "his shoulder was sore". Caller received his second dose of the vaccine last 08Jan2021 and mentioned that "the nurse injected it in his shoulder IM and that his shoulder was very sore and needed ice to relieve it". Caller received his booster dose of the Pfizer COVID-19 vaccine last 29Sep2021 "first thing in the morning and he felt good, but late night to early morning at around 1 or 3 or 4 am, his knuckles hurt, he had a fast heartbeat, had chills, had headache and it hit him harder than the actual COVID as he tested positive for COVID-19 in November where he got tested for work". Caller wanted to know why he sad such an effect with the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Investigation, Pyrexia
Clinical narrative: fever of 102 for 2 days after getting the Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (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: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever of 102 for 2 days after getting the Covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: she got the Pfizer vaccine back in May and now she cannot get the flu, shingles. and the pneumonia shot because she is a servivor of GBS. She wants to know if Pfizer is making those vaccines with the MRNA rather then the virus so she can get the other vaccines. She also said she had a fever of 102 for 2 days after getting the Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chills, Hyperhidrosis, Lymphadenopathy
Clinical narrative: swollen; painful stiff neck; painful stiff neck; swollen, tender, sore arm pits; swollen, tender, sore arm pits; swollen, tender, sore arm pits; chills; soaking wet; fever; 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 55 year-old male patient received bnt162b2 (BNT162B2), administration date 03Oct2021 (Batch/Lot number: unknown) at the age of 55 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 1), for COVID-19 Immunization, reaction(s): "he was diagnosed with Covid-19 infection three weeks after receiving his first dose/contracted the Covid virus", "he was diagnosed with Covid-19 infection three weeks after receiving his first dose/contracted the Covid virus", "sick for a month", "high fevers coming and going". The following information was reported: PYREXIA (non-serious) with onset 04Oct2021, outcome "unknown", described as "fever"; SWELLING (non-serious) with onset 05Oct2021, outcome "unknown", described as "swollen"; MUSCULOSKELETAL STIFFNESS (non-serious), NECK PAIN (non-serious) all with onset 05Oct2021, outcome "unknown" and all described as "painful stiff neck"; LYMPHADENOPATHY (non-serious), TENDERNESS (non-serious), AXILLARY PAIN (non-serious) all with onset 05Oct2021, outcome "unknown" and all described as "swollen, tender, sore arm pits"; CHILLS (non-serious) with onset 05Oct2021, outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious) with onset 04Oct2021, outcome "unknown", described as "soaking wet". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 102; (unspecified date) 100.1; (04Oct2021) 100.2.  Additional information: Patient was looking for insights as he had no health issues. He also states that he was in great health and had never had this experience. His pain had subsided in his neck, but under his arms was still store.  Follow-up (11Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pyrexia, Swelling, Tenderness
Clinical narrative: swollen; painful stiff neck; painful stiff neck; swollen, tender, sore arm pits; swollen, tender, sore arm pits; swollen, tender, sore arm pits; chills; soaking wet; fever; 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 55 year-old male patient received bnt162b2 (BNT162B2), administration date 03Oct2021 (Batch/Lot number: unknown) at the age of 55 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 1), for COVID-19 Immunization, reaction(s): "he was diagnosed with Covid-19 infection three weeks after receiving his first dose/contracted the Covid virus", "he was diagnosed with Covid-19 infection three weeks after receiving his first dose/contracted the Covid virus", "sick for a month", "high fevers coming and going". The following information was reported: PYREXIA (non-serious) with onset 04Oct2021, outcome "unknown", described as "fever"; SWELLING (non-serious) with onset 05Oct2021, outcome "unknown", described as "swollen"; MUSCULOSKELETAL STIFFNESS (non-serious), NECK PAIN (non-serious) all with onset 05Oct2021, outcome "unknown" and all described as "painful stiff neck"; LYMPHADENOPATHY (non-serious), TENDERNESS (non-serious), AXILLARY PAIN (non-serious) all with onset 05Oct2021, outcome "unknown" and all described as "swollen, tender, sore arm pits"; CHILLS (non-serious) with onset 05Oct2021, outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious) with onset 04Oct2021, outcome "unknown", described as "soaking wet". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 102; (unspecified date) 100.1; (04Oct2021) 100.2.  Additional information: Patient was looking for insights as he had no health issues. He also states that he was in great health and had never had this experience. His pain had subsided in his neck, but under his arms was still store.  Follow-up (11Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruise on the knuckle of my middle finger; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Oct2021 12:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: CONTUSION (non-serious) with onset 09Oct2021, outcome "recovered" (12Oct2021), described as "Bruise on the knuckle of my middle finger".  Additional information: Patient had third COVID shot this '12' around noon today and a few hours go, by 2 hours ago noticed a significant bruise on the knuckle of middle finger. She don't remember by hitting it or hurting it and just see this bruise. she was fully recovered after 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose was bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (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: EPISTAXIS (non-serious) with onset 09Oct2021, outcome "unknown", described as "Nose was bleeding".  Additional information: After two days of first dose of vaccine in the morning her nose was bleeding.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: fever/fever 102 Extreme exhaustion; hand, arm, leg pain; fever/fever 102 Extreme exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Mar2021 11:00 (Lot number: EP7534) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: EN6203 , Location of injection: Arm Left , Vaccine Administration Time: 11:00 AM, Route of administration: Intramuscular), administration date: 28Feb2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), FATIGUE (non-serious) all with onset 08Oct2021, outcome "recovered" (Oct2021) and all described as "fever/fever 102 Extreme exhaustion"; PAIN IN EXTREMITY (non-serious) with onset 08Oct2021, outcome "recovered" (Oct2021), described as "hand, arm, leg pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. No specific relevant test for thromboembolic events with thrombocytopenia. The case assessed as non-serious by the reporter.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test
Clinical narrative: large swelling beneath armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Oct2021 08:30 (Lot number: FD0809) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3249, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Feb2021, when the patient was 62 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3246, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 13Jan2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 08Oct2021 08:30, outcome "not recovered", described as "large swelling beneath armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of peripheral swelling.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: The rash is located on his chest, back, buttocks, rear thighs, rear knees, his arms ,and some on his/a skin rash that is deteriorating; 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 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 11:00 (Lot number: EW0179) at the age of 72 years as dose 1, single and administered in arm right, administration date 05Jun2021 (Lot number: EW0182) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 12May2021, outcome "not recovered", described as "The rash is located on his chest, back, buttocks, rear thighs, rear knees, his arms ,and some on his/a skin rash that is deteriorating". Therapeutic measures were taken as a result of rash.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Mass, Pain
Clinical narrative: severe flu-like symptoms; fever; headache; body aches and pains; painful and uncomfortable skin; painful and uncomfortable skin; grape-sized lump appeared on same-side over clavicle and blueberry-sized lump on same-side neck; Still extremely fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Oct2021 05:15 (Lot number: FF2588) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergy:Doxycycline". Vaccination history included: Pfizer (Dose Number: 1, Lot Number: FC3183, prev dose vaccine_location: Right Arm), administration date: 14Sep2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 06Oct2021 05:00, outcome "not recovered", described as "severe flu-like symptoms"; PYREXIA (non-serious) with onset 06Oct2021 05:00, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 06Oct2021 05:00, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 06Oct2021 05:00, outcome "not recovered", described as "body aches and pains"; PAIN OF SKIN (non-serious), SKIN DISCOMFORT (non-serious) all with onset 06Oct2021 05:00, outcome "not recovered" and all described as "painful and uncomfortable skin"; MASS (non-serious) with onset 06Oct2021, outcome "not recovered", described as "grape-sized lump appeared on same-side over clavicle and blueberry-sized lump on same-side neck"; FATIGUE (non-serious) with onset 06Oct2021, outcome "not recovered", described as "Still extremely fatigued". Therapeutic measures were not taken as a result of influenza like illness, pyrexia, headache, pain, pain of skin, skin discomfort, mass, fatigue.  Additional information: No other vaccine in four weeks and no Covid prior vaccination. 12 hours later, severe flu-like symptoms. 24 hours later, grape-sized lump appeared on same side over clavicle and blueberry-sized lump on same-side neck. Both lumps still present, 6 days later. No Covid tested post vaccination.  Follow-Up (22Oct2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pyrexia, Skin discomfort
Clinical narrative: severe flu-like symptoms; fever; headache; body aches and pains; painful and uncomfortable skin; painful and uncomfortable skin; grape-sized lump appeared on same-side over clavicle and blueberry-sized lump on same-side neck; Still extremely fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Oct2021 05:15 (Lot number: FF2588) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergy:Doxycycline". Vaccination history included: Pfizer (Dose Number: 1, Lot Number: FC3183, prev dose vaccine_location: Right Arm), administration date: 14Sep2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 06Oct2021 05:00, outcome "not recovered", described as "severe flu-like symptoms"; PYREXIA (non-serious) with onset 06Oct2021 05:00, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 06Oct2021 05:00, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 06Oct2021 05:00, outcome "not recovered", described as "body aches and pains"; PAIN OF SKIN (non-serious), SKIN DISCOMFORT (non-serious) all with onset 06Oct2021 05:00, outcome "not recovered" and all described as "painful and uncomfortable skin"; MASS (non-serious) with onset 06Oct2021, outcome "not recovered", described as "grape-sized lump appeared on same-side over clavicle and blueberry-sized lump on same-side neck"; FATIGUE (non-serious) with onset 06Oct2021, outcome "not recovered", described as "Still extremely fatigued". Therapeutic measures were not taken as a result of influenza like illness, pyrexia, headache, pain, pain of skin, skin discomfort, mass, fatigue.  Additional information: No other vaccine in four weeks and no Covid prior vaccination. 12 hours later, severe flu-like symptoms. 24 hours later, grape-sized lump appeared on same side over clavicle and blueberry-sized lump on same-side neck. Both lumps still present, 6 days later. No Covid tested post vaccination.  Follow-Up (22Oct2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity
Clinical narrative: She also shared with agent that she previously had an allergic reaction with the Pfizer-BioNTech COVID-19 Vaccine.; The first vaccine made her feel a little bad; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EN6198) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing); "trouble walking" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Family history included: "heart failure" (unspecified if ongoing), notes: Husband; "Multiple Sclerosis" (unspecified if ongoing), notes: daughter. There were no concomitant medications. Vaccination history included: Flu vaccine (Location: right arm). The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "The first vaccine made her feel a little bad"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "She also shared with agent that she previously had an allergic reaction with the Pfizer-BioNTech COVID-19 Vaccine."  Additional information: The first vaccine made her feel a little bad, but nothing like the second vaccine. She has fibromyalgia, and has a lot of pain anyway and she doesn't know whether there is any information about patients with Fibromyalgia, and the vaccine hitting them harder and laid in bed for 2 days. She was in so much pain that she couldn't move.She had hydrocodone pain medicine for her Fibromyalgia.She thinks her first dose was on 25Mar2021 she did get it in her left arm. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: He feels unbearable pain from the place of the injection down his arm, past his elbow; He feels unbearable pain from the place of the injection down his arm, past his elbow; He feels unbearable pain from the place of the injection down his arm, past his elbow; 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 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 (Lot number: 30145BA) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Received 1st dose on 19Feb2021 in left arm. , Lot: EM9809, NDC/Expiry: Unknown.), administration date: 19Feb2021, when the patient was 66 years old, for COVID-19 immunisation; Bnt162b2 (Received 2nd dose on 26Mar2021 in Right arm. , Lot: ER8727, Expiry: 31Jul2021, NDC: Unknown.), administration date: 26Mar2021, when the patient was 66 years old, for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 26Sep2021, outcome "not recovered" and all described as "He feels unbearable pain from the place of the injection down his arm, past his elbow". The event "he feels unbearable pain from the place of the injection down his arm, past his elbow", "he feels unbearable pain from the place of the injection down his arm, past his elbow" and "he feels unbearable pain from the place of the injection down his arm, past his elbow" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain, pain in extremity, arthralgia.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: bad rashes; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 09Sep2021 (Lot number: EW0191, Expiration Date(30Sep2021) at the age of 41 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.The following information was reported: RASH (non-serious) with onset Sep2021, outcome "unknown", described as "bad rashes".  Additional information: Reporter called to ask if a patient who was complaining of rash after taking 1st dose of the Pfizer COVID vaccine on 09Sep2021, should take the second dose.Wants to know if they should get the second dose and if Pfizer has any suggestion about the rash itself. Wants to know if they should get the second dose and if Pfizer has any suggestion about the rash itself.Reporter explained to the patient that patient should not get the COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of this vaccine or if you had a severe allergic reaction to any ingredient of this vaccine. Pharmacist stated that patient would report, but it depends on the information. The patient didn't show up at the pharmacy, she just called. She stated event was not life threatening and it was not requiring hospitalization. She did not think it was disabling. The patient just said when she ate, and she got an outbreak. It was reported that the onset and outcome of the event rashes was unknown. It was reported either EW0191 or EWO191 was the lot number. The patient did not read it from vial instead. Previous immunization, additional vaccines administered on same date were none, adverse event following prior vaccination was none.   Follow-up (11Oct2021): This is a follow-up spontaneous report from a Pfizer-sponsored program, a contactable pharmacist reported for a 41-year-old female patient about the NDC number of Pfizer COVID vaccine (59267100002), Dosage text (0.3 right deltoid), expiry date (30Sep2021).  Follow-up (12Oct2021, 12Oct2021): Confirmation on Reporter's occupation was received as new information.  Follow-up (18Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: Pain in her arm; Developed little and itchy bumps on her arm and legs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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) with onset 2021, outcome "unknown", described as "Pain in her arm"; RASH PRURITIC (non-serious) with onset 2021, outcome "unknown", described as "Developed little and itchy bumps on her arm and legs".  Additional information: She reported that after getting her first 2 doses she experienced pain in her arm and then 5 months later she mentioned that she developed little and itchy bumps on her arm and legs. But she is not particular if this has been caused by the vaccine per se. The reporter wanted to know if she did not had any severe AEs on her first 2 doses. Is it possible that she will not have any AEs on the 3rd dose too. The reporter wanted to know how long does she need to wait to get the shingles/flu vaccine after she got the booster dose and vice versa.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin disorder, Swelling
Clinical narrative: and then she had bumps under her arm; arm got really, really red; then there was a lot of swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101352721 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date Oct2021 (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: ERYTHEMA (non-serious) with onset Oct2021, outcome "unknown", described as "arm got really, really red"; SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "then there was a lot of swelling"; SKIN DISORDER (non-serious), outcome "unknown", described as "and then she had bumps under her arm".  Additional information: Caller says that she was calling because her cousin did not have a cell phone number and later noted that she was not sure if her cousin had the Moderna or the Pfizer-BioNTech COVID-19 Vaccine, past weekend on the west side of town, she believes  and her cousin really had some side effects from it. Her arm got really, really red and then there was a lot of swelling and then she had bumps under her arm, it was under the same arm that she had gotten the vaccine in. There was a lot of redness, swelling and bumps. Caller says it was very frustrating for her cousin because she was going to go out of town and then she could not travel and she had to stay home because she did not know what to do. Phone out at 14:27 PM , 1st attempt by phone to Consumer to obtain contact information. Call answered by Consumer who refused to provide contact information. Consumer does not wish to be contacted any further.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bundle branch block right, Chest pain, Computerised tomogram, Condition aggravated, Dyspnoea
Clinical narrative: Went to ER on 24Sep due to worsening of symptoms; Nowhas a incomplete Right Bundle Branch Block on EKG; had elevated D-dimer; SOB tachycardia with exertion.; SOB tachycardia with exertion.; Intermittent CP.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Aug2021 14:00 (Lot number: EW0175) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Renal cell carcinoma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Cipro, reaction(s): "known allergies: Cipro". The following information was reported: DYSPNOEA (non-serious), TACHYCARDIA (non-serious) all with onset 03Sep2021 08:00, outcome "unknown" and all described as "SOB tachycardia with exertion."; CHEST PAIN (non-serious) with onset 03Sep2021 08:00, outcome "unknown", described as "Intermittent CP."; CONDITION AGGRAVATED (non-serious) with onset 24Sep2021, outcome "unknown", described as "Went to ER on 24Sep due to worsening of symptoms"; BUNDLE BRANCH BLOCK RIGHT (non-serious) with onset 03Sep2021 08:00, outcome "unknown", described as "Nowhas a incomplete Right Bundle Branch Block on EKG"; FIBRIN D DIMER INCREASED (non-serious) with onset 03Sep2021 08:00, outcome "unknown", described as "had elevated D-dimer". The events "sob tachycardia with exertion.", "sob tachycardia with exertion.", "intermittent cp.", "went to er on 24sep due to worsening of symptoms", "nowhas a incomplete right bundle branch block on ekg" and "had elevated d-dimer" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, tachycardia, chest pain, condition aggravated, bundle branch block right, fibrin d dimer increased.  Additional information: The vaccination location was also reported as right shoulder. Patient did not take any other vaccine in four weeks and also event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient also reported not tested covid post vaccination or having covid prior to vaccination. He also did not take covid test post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fibrin D dimer, Fibrin D dimer increased, Tachycardia
Clinical narrative: Went to ER on 24Sep due to worsening of symptoms; Nowhas a incomplete Right Bundle Branch Block on EKG; had elevated D-dimer; SOB tachycardia with exertion.; SOB tachycardia with exertion.; Intermittent CP.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Aug2021 14:00 (Lot number: EW0175) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Renal cell carcinoma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Cipro, reaction(s): "known allergies: Cipro". The following information was reported: DYSPNOEA (non-serious), TACHYCARDIA (non-serious) all with onset 03Sep2021 08:00, outcome "unknown" and all described as "SOB tachycardia with exertion."; CHEST PAIN (non-serious) with onset 03Sep2021 08:00, outcome "unknown", described as "Intermittent CP."; CONDITION AGGRAVATED (non-serious) with onset 24Sep2021, outcome "unknown", described as "Went to ER on 24Sep due to worsening of symptoms"; BUNDLE BRANCH BLOCK RIGHT (non-serious) with onset 03Sep2021 08:00, outcome "unknown", described as "Nowhas a incomplete Right Bundle Branch Block on EKG"; FIBRIN D DIMER INCREASED (non-serious) with onset 03Sep2021 08:00, outcome "unknown", described as "had elevated D-dimer". The events "sob tachycardia with exertion.", "sob tachycardia with exertion.", "intermittent cp.", "went to er on 24sep due to worsening of symptoms", "nowhas a incomplete right bundle branch block on ekg" and "had elevated d-dimer" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, tachycardia, chest pain, condition aggravated, bundle branch block right, fibrin d dimer increased.  Additional information: The vaccination location was also reported as right shoulder. Patient did not take any other vaccine in four weeks and also event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient also reported not tested covid post vaccination or having covid prior to vaccination. He also did not take covid test post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Inflammation, Influenza like illness, Limb discomfort, Rash
Clinical narrative: flu-like symptoms/ felt like he had the flu; arm is very inflamed (which is his initial concern) and hot to touch; redness tripled in size on Saturday on the injection site; His arm is not as hard around the injection site but still has a bit of feeling from the arm; arm was really inflamed; there was a patchy area an inch to an inch and a half circumference around the shot area; 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 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: FC3184) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (ongoing), notes: diagnosed in the 90s. Concomitant medication(s) included: CIMZIA taken for crohn's disease (ongoing). Vaccination history included: Bnt162b2 (1st dose, LOT: EN6204, left arm, injection, unknown dosage), administration date: 11Mar2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (2st dose,LOT: EP6955, left arm, unknown dosage, injection), administration date: 01Apr2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 06Oct2021, outcome "recovered" (07Oct2021), described as "flu-like symptoms/ felt like he had the flu"; FEELING HOT (non-serious) with onset 06Oct2021, outcome "unknown", described as "arm is very inflamed (which is his initial concern) and hot to touch"; VACCINATION SITE ERYTHEMA (non-serious) with onset 06Oct2021, outcome "unknown", described as "redness tripled in size on Saturday on the injection site"; LIMB DISCOMFORT (non-serious) with onset 06Oct2021, outcome "not recovered", described as "His arm is not as hard around the injection site but still has a bit of feeling from the arm"; INFLAMMATION (non-serious) with onset 06Oct2021, outcome "unknown", described as "arm was really inflamed"; RASH (non-serious) with onset 06Oct2021, outcome "not recovered", described as "there was a patchy area an inch to an inch and a half circumference around the shot area".  Additional Information: The patient did not received any other vaccination prior to Pfizer covid vaccine, Caller states he was going to get the flu shot too but then the pharmacist said that his recommendation was to wait, if he has a reaction to he won't know which one, so caller states he's going to wait a couple weeks until he gets his flu shot. Caller states he just wants to know if his arm is going to fall off.  No follow-up attempts are possible. No further information is expected.