chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm pain at the injection site; arm pain at the injection site; headache; feeling cold; extremely tired; Low grade fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "arm pain at the injection site"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FEELING COLD (non-serious), outcome "unknown", described as "feeling cold"; FATIGUE (non-serious), outcome "unknown", described as "extremely tired"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever".  Additional information: Low grade fever was also present on day 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Oropharyngeal pain, Product administered at inappropriate site, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 6 year-old male patient received bnt162b2 (BNT162B2), administered in leg right, administration date 04Dec2021 16:00 (Lot number: FK5127) at the age of 6 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "constipation" (unspecified if ongoing); "sensory processing disorder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 24Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Leg Right, Vaccine Administration Time: 03:45 PM), administration date: 13Nov2021, when the patient was 6 years old, for Covid-19 Immunization, reaction(s): "vaccine location=Right leg". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 04Dec2021 16:00, outcome "unknown", described as "vaccine location=Right leg"; OROPHARYNGEAL PAIN (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "sore throat"; CHILLS (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "chills"; MYALGIA (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "muscle aches"; PYREXIA (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "low grade fever"; VOMITING (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "vomiting". Therapeutic measures were taken as a result of oropharyngeal pain, chills, myalgia, pyrexia, vomiting. Additional information: Location of injection for vaccine received within 4 weeks PRIOR: dose 1 Flu vaccine in Right leg. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Treatment received for the adverse event was Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 6 year-old male patient received bnt162b2 (BNT162B2), administered in leg right, administration date 04Dec2021 16:00 (Lot number: FK5127) at the age of 6 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "constipation" (unspecified if ongoing); "sensory processing disorder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 24Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Leg Right, Vaccine Administration Time: 03:45 PM), administration date: 13Nov2021, when the patient was 6 years old, for Covid-19 Immunization, reaction(s): "vaccine location=Right leg". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 04Dec2021 16:00, outcome "unknown", described as "vaccine location=Right leg"; OROPHARYNGEAL PAIN (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "sore throat"; CHILLS (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "chills"; MYALGIA (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "muscle aches"; PYREXIA (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "low grade fever"; VOMITING (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "vomiting". Therapeutic measures were taken as a result of oropharyngeal pain, chills, myalgia, pyrexia, vomiting. Additional information: Location of injection for vaccine received within 4 weeks PRIOR: dose 1 Flu vaccine in Right leg. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Treatment received for the adverse event was Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Periorbital swelling, Product use issue, Vertigo
Clinical narrative: Very fatigued; Nausea; Puffy eyes; Spinning sensation; Moderna same date; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 17:45 (Lot number: FJ1620) at the age of 26 years as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), administration date 06Dec2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Dec2021, outcome "unknown", described as "Moderna same date"; FATIGUE (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "Very fatigued"; NAUSEA (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "Nausea"; PERIORBITAL SWELLING (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "Puffy eyes"; VERTIGO (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "Spinning sensation". Therapeutic measures were not taken as a result of fatigue, nausea, periorbital swelling, vertigo.  Additional information: The patient had no other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: have experienced facial twitching that started in my eye and now progressed to my whole side of my face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2 Manufacturer Unknown), for Covid-19 immunization.  The following information was reported: MUSCLE TWITCHING (non-serious) with onset 2021, outcome "not recovered", described as "have experienced facial twitching that started in my eye and now progressed to my whole side of my face".  Additional information: The patient received booster for Covid back in Sep2021 and ever since then have experienced facial twitching that started in eye and now progressed to whole side of face. The patient didn't know to who should report this to or asking had any idea as to how long it would last. The patient just concerned as to whether would be ok to have another booster this was ever needed.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Off label use, Pain in extremity, Product use issue
Clinical narrative: Other vaccine same date vacine date 04Dec2021; Other vaccine same date vacine date 04Dec2021; Big red welt on the injection site; Big red welt on the injection site; arm pain; Swollen lymph node in the left armpit; redness; It is hot and itchy; It is hot and itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Dec2021 15:45 (Lot number: 331308A) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 04Dec2021 (Batch/Lot number: unknown) as dose 1, single. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: ER8736, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Dec2021, outcome "unknown" and all described as "Other vaccine same date vacine date 04Dec2021"; VACCINATION SITE REACTION (non-serious), URTICARIA (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "Big red welt on the injection site"; PAIN IN EXTREMITY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "arm pain"; LYMPHADENOPATHY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Swollen lymph node in the left armpit"; ERYTHEMA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "redness"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 04Dec2021, outcome "unknown" and all described as "It is hot and itchy". Therapeutic measures were not taken as a result of vaccination site reaction, urticaria, pain in extremity, lymphadenopathy, erythema.  Additional information: Big red welt on the injection site and arm pain. It was hot and itchy. Swollen lymph node in the left armpit. This redness had lasted for 3-4 days (and may continue). The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID-19 prior and post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Other vaccine same date vacine date 04Dec2021; Other vaccine same date vacine date 04Dec2021; Big red welt on the injection site; Big red welt on the injection site; arm pain; Swollen lymph node in the left armpit; redness; It is hot and itchy; It is hot and itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Dec2021 15:45 (Lot number: 331308A) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 04Dec2021 (Batch/Lot number: unknown) as dose 1, single. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: ER8736, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Dec2021, outcome "unknown" and all described as "Other vaccine same date vacine date 04Dec2021"; VACCINATION SITE REACTION (non-serious), URTICARIA (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "Big red welt on the injection site"; PAIN IN EXTREMITY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "arm pain"; LYMPHADENOPATHY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Swollen lymph node in the left armpit"; ERYTHEMA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "redness"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 04Dec2021, outcome "unknown" and all described as "It is hot and itchy". Therapeutic measures were not taken as a result of vaccination site reaction, urticaria, pain in extremity, lymphadenopathy, erythema.  Additional information: Big red welt on the injection site and arm pain. It was hot and itchy. Swollen lymph node in the left armpit. This redness had lasted for 3-4 days (and may continue). The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID-19 prior and post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Off label use, Product use issue, Pruritus, Skin disorder
Clinical narrative: itchy hands and feet; Her skin is like she is digging in her skin; Left arm hurting at injection; Caller reports having her first dose of the vaccine on 07DEC2021. Caller reports on 08DEC2021 having itchiness; Caller reports having her first dose of the vaccine on 07DEC2021. Caller reports on 08DEC2021 having itchiness; 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 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 10:30 (Lot number: FD0809) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic", start date: 2019 (unspecified if ongoing). There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Dec2021, outcome "unknown" and all described as "Caller reports having her first dose of the vaccine on 07DEC2021. Caller reports on 08DEC2021 having itchiness"; PRURITUS (non-serious) with onset 08Dec2021 12:00, outcome "not recovered", described as "itchy hands and feet"; SKIN DISORDER (non-serious) with onset 08Dec2021, outcome "unknown", described as "Her skin is like she is digging in her skin"; INJECTION SITE PAIN (non-serious) with onset 08Dec2021, outcome "not recovered", described as "Left arm hurting at injection". The patient had itchy hands and feet. Her skin was like the patient was digging in her skin. The patient had the first dose on 07Dec2021 and just had a baby so she got it for prevention. The patient normally did not get vaccines, but got it because of her daughter. The patient then asked if they can pass antibodies through breast milk. The patient was breastfeeding her daughter. Since then, her daughter had been extremely fussy. The patient was crying all day yesterday and today and then stated she cries all the time anyway. Separate report created for her daughter.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101761084 maternal/child case
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Last two weeks she got exposed to a person with covid; she never felt this way with the first two doses. She had no reaction aside from soreness where shots was given.; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2021 (Lot number: EL0142) at the age of 47 years as dose 2 , single and administered in arm left, administration date 18Dec2020 (Lot number: EK5730) as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2018 (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "Last two weeks she got exposed to a person with covid"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "she never felt this way with the first two doses. She had no reaction aside from soreness where shots was given.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No reaction aside from soreness where shot was given with first two doses. Last two weeks she got exposed to a person with COVID and she had a COVID PCR test and it was negative. No family medical history relevant to adverse event. No Emergency Room or physician Office visit. She has an oncologist as well and just finished treatment in 2020 for her chemo. She was immunocompromised.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Skin discolouration, Urticaria
Clinical narrative: Welts on her face; Dark spots on her face where her skin has turned totally darker than what it was; Face is itching; Can hardly sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (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: URTICARIA (non-serious), outcome "not recovered", described as "Welts on her face"; SKIN DISCOLOURATION (non-serious), outcome "not recovered", described as "Dark spots on her face where her skin has turned totally darker than what it was"; PRURITUS (non-serious), outcome "not recovered", described as "Face is itching"; INSOMNIA (non-serious), outcome "not recovered", described as "Can hardly sleep".  Additional information: Patient had 2 of the Pfizer Covid Shots and she called for medical advisement on what to do about her current ongoing symptoms. She states that her face has broken out, including welts and dark spots on her face where her skin has turned totally darker than what it was, and her face was itching. Patient was advised to seek medical help if she was experiencing swelling and numbness of the face. Patient clarified that she was not having numbness but dark patches of itchiness. She also adds that she can hardly sleep. The reporter was advised to contact HCP or initiate emergency services due to ongoing potentially emergent events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: pain, stiffness and joint swelling (hands and lower legs ); pain, stiffness and joint swelling; pain, stiffness and joint swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 08Aug2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bilateral Carpal Tunnel Syndrome" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Recurrent Headache" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "Chronic pain of multiple joints" (unspecified if ongoing); "Trigger Ring Finger of Right Hand" (unspecified if ongoing). Concomitant medication(s) included: TORSEMIDE; FLONASE [FLUTICASONE PROPIONATE]; PROPANOLOL HYDROCHLORIDE. Past drug history included: Erythromycin, reaction(s): "Known allergies". The following information was reported: ARTHRALGIA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "pain, stiffness and joint swelling (hands and lower legs )"; JOINT STIFFNESS (non-serious), JOINT SWELLING (non-serious) all with onset 05Sep2021, outcome "not recovered" and all described as "pain, stiffness and joint swelling". The events "pain, stiffness and joint swelling (hands and lower legs )", "pain, stiffness and joint swelling" and "pain, stiffness and joint swelling" were evaluated at the physician office visit. Therapeutic measures were taken as a result of arthralgia, joint stiffness, joint swelling. Additional information: If Covid prior vaccination: No, If covid tested post vaccination: No, If other vaccine in four weeks: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: little bump at the injection site; swollen lump; 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 58 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious) with onset Dec2021, outcome "unknown", described as "little bump at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset Dec2021, outcome "unknown", described as "swollen lump".  Additional information: Patient asked had anyone else reported a little bump at the injection site. How long will it last. Caller further describes that as a swollen lump. Patient received her 1st Pfizer BTC vaccine (12 and older, purple cap formula) dose last week. It was reported that Across both age groups, 18 through 55 years of age and 56 years of age and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the Pfizer-BioNTech COVID-19 Vaccine group.  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, Fatigue, Myalgia, Vaccination site pain, Weight
Clinical narrative: tiredness; muscle pain in the arm where he got the shot; muscle pain has turned more to soreness; lost about 14 lbs; 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 65 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm right, administration date 22Mar2021 (Lot number: ER2613) at the age of 64 years as dose 1, single and administered in arm right, administration date 19Apr2021 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost about 14 lbs"; FATIGUE (non-serious) with onset Apr2021, outcome "recovering", described as "tiredness"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "muscle pain in the arm where he got the shot"; MYALGIA (non-serious) with onset Mar2021, outcome "not recovered", described as "muscle pain has turned more to soreness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter seriousness for lost about 14lbs, Tiredness, Arm pain is unspecified. .The arm pain has lingered since receiving his doses of the vaccine which is still sore. He asked for the booster dose in the left arm. He has not had any problems with the booster dose (Lot number: FJ8762; expiration date: unknown) yet. He had pain in his arm with the first dose, but more pain with the second dose. He stated that the muscle pain has turned more to soreness and is still ongoing. Tiredness is improved and he has only sometimes. Patient received Flu shot one month ago in Nov2021.   Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: tiredness; muscle pain in the arm where he got the shot; muscle pain has turned more to soreness; lost about 14 lbs; 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 65 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm right, administration date 22Mar2021 (Lot number: ER2613) at the age of 64 years as dose 1, single and administered in arm right, administration date 19Apr2021 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost about 14 lbs"; FATIGUE (non-serious) with onset Apr2021, outcome "recovering", described as "tiredness"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "muscle pain in the arm where he got the shot"; MYALGIA (non-serious) with onset Mar2021, outcome "not recovered", described as "muscle pain has turned more to soreness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter seriousness for lost about 14lbs, Tiredness, Arm pain is unspecified. .The arm pain has lingered since receiving his doses of the vaccine which is still sore. He asked for the booster dose in the left arm. He has not had any problems with the booster dose (Lot number: FJ8762; expiration date: unknown) yet. He had pain in his arm with the first dose, but more pain with the second dose. He stated that the muscle pain has turned more to soreness and is still ongoing. Tiredness is improved and he has only sometimes. Patient received Flu shot one month ago in Nov2021.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: I'm still dealing with mass nerve pain in my shoulder all around where I received my shots.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: NEURALGIA (non-serious) with onset Jun2021, outcome "not recovered", described as "I'm still dealing with mass nerve pain in my shoulder all around where I received my shots.".  Additional information: The pharmacist told to patient to exercise shoulder.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: have flu like symptoms but no positive test results; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (ongoing), notes: m also type 1 diabetic but yet never contracted the disease. The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "have flu like symptoms but no positive test results".   Additional information: Customer Verbatim "How do I sign up to be studied or compensated for covid-19 trial study. I work in a highly contagious environment yet I Tve never tested positive through both outbreaks. I Tm currently vaccinated and I Tm also type 1 diabetic but yet never contractedthe disease. I Tve have flu like symptoms but no positive test results".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: high grade fever; chills; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high grade fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "body ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: got a heart condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "got a heart condition".  Additional information: The report was not related to a study or programme. Consumer works in a hospital and majority 90 percent of patients took our covid vaccine. He had a friend's child took the vaccine and got a heart condition. Stated that we are hiding the side effects and it is a junk vaccine. Stated that we are saying the heart condition is from smoking weed and we are making excuses since we are making a junk vaccine. Investigation Assessment was not Provided.  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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchial hyperreactivity, Condition aggravated, Cough, Lung disorder, Lymphadenopathy
Clinical narrative: pulmonary inflammation; swelling of the lymph nodes in his arms; pulmonary distress; triggering an underlying condition of reactive airway disease; triggering an underlying condition of reactive airway disease; constant need to cough; felt like he had fluid on his lungs; swelling under the arms/swelling of the arms; body aches; Fever; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 28Jan2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "reactive airway disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PNEUMONITIS (medically significant), outcome "unknown", described as "pulmonary inflammation"; PULMONARY OEDEMA (medically significant) with onset 30Dec2021, outcome "unknown", described as "felt like he had fluid on his lungs"; PERIPHERAL SWELLING (non-serious) with onset 29Dec2021, outcome "not recovered", described as "swelling under the arms/swelling of the arms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling of the lymph nodes in his arms"; PAIN (non-serious) with onset 29Dec2021, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 29Dec2021, outcome "unknown", described as "Fever"; LUNG DISORDER (non-serious), outcome "unknown", described as "pulmonary distress"; BRONCHIAL HYPERREACTIVITY (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 30Dec2021, outcome "unknown" and all described as "triggering an underlying condition of reactive airway disease"; COUGH (non-serious) with onset 30Dec2021, outcome "unknown", described as "constant need to cough". Clinical course: The patient stated that he is reporting a negative experience with the Pfizer vaccine. He took the vaccine on 29Dec2021 and that night had a standard more intense reaction relative to what is possible like swelling of the arms, body aches and fever. The next day it attacked his lungs with the swelling and it felt like he had fluid on his lungs triggering an underlying condition of reactive airway disease and the constant need to cough. The patient reported that the shot he had triggered pulmonary distress and pulmonary inflammation. Later clarified that he had swelling under the arms and swelling of the lymph nodes in his arms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pneumonitis, Pulmonary oedema, Pyrexia
Clinical narrative: pulmonary inflammation; swelling of the lymph nodes in his arms; pulmonary distress; triggering an underlying condition of reactive airway disease; triggering an underlying condition of reactive airway disease; constant need to cough; felt like he had fluid on his lungs; swelling under the arms/swelling of the arms; body aches; Fever; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 28Jan2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "reactive airway disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PNEUMONITIS (medically significant), outcome "unknown", described as "pulmonary inflammation"; PULMONARY OEDEMA (medically significant) with onset 30Dec2021, outcome "unknown", described as "felt like he had fluid on his lungs"; PERIPHERAL SWELLING (non-serious) with onset 29Dec2021, outcome "not recovered", described as "swelling under the arms/swelling of the arms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling of the lymph nodes in his arms"; PAIN (non-serious) with onset 29Dec2021, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 29Dec2021, outcome "unknown", described as "Fever"; LUNG DISORDER (non-serious), outcome "unknown", described as "pulmonary distress"; BRONCHIAL HYPERREACTIVITY (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 30Dec2021, outcome "unknown" and all described as "triggering an underlying condition of reactive airway disease"; COUGH (non-serious) with onset 30Dec2021, outcome "unknown", described as "constant need to cough". Clinical course: The patient stated that he is reporting a negative experience with the Pfizer vaccine. He took the vaccine on 29Dec2021 and that night had a standard more intense reaction relative to what is possible like swelling of the arms, body aches and fever. The next day it attacked his lungs with the swelling and it felt like he had fluid on his lungs triggering an underlying condition of reactive airway disease and the constant need to cough. The patient reported that the shot he had triggered pulmonary distress and pulmonary inflammation. Later clarified that he had swelling under the arms and swelling of the lymph nodes in his arms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: she is suspecting that she had covid.; she is suspecting that she had covid.; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she is suspecting that she had covid.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: I was diagnosed with premature menopause at age 30. Shortly after second dose, I had a heavy menstrual period. I haven't had one in years. Especially while taking hormone replacement regularly.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: second dose: real bad headache; second dose: fever; second dose: chills; second dose: real bad body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: EM9809) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: 27Mar2020, stop date: 20Apr2020, notes: He had on Covid 27Mar2020 and was cleared on 20Apr2020 prior to the shot. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL3249), administration date: 15Feb2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "felt like they had stuck Covid in him", "head pain", "pain all over body", "diarrhea", "nose stopped up", "nose running", "sore throat", "sick". The following information was reported: HEADACHE (non-serious) with onset 08Mar2021, outcome "recovered" (Mar2021), described as "second dose: real bad headache"; PYREXIA (non-serious) with onset 08Mar2021, outcome "recovered" (Mar2021), described as "second dose: fever"; CHILLS (non-serious) with onset 08Mar2021, outcome "recovered" (Mar2021), described as "second dose: chills"; PAIN (non-serious) with onset 08Mar2021, outcome "recovered" (11Mar2021), described as "second dose: real bad body aches". Therapeutic measures were not taken as a result of headache, chills, pain. Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient stated that he had the second shot and it lasted 2.5-3 days. He had real bad headache, chills, fever and real bad body aches. He had been in the hospital for COVID prior to the first dose. He had on COVID on 27Mar2020 and was cleared on 20Apr2020 prior to the shot. He knew what COVID felt like. He wanted to know how to get through this pain. The patient stated that he recovered completely from real bad headache from the second dose in about three days. The fever from the second dose lasted for about two days and he recovered completely. He took Aleve for the fever. It took about two days to recover completely from chills from second dose. He recovered completely from real bad body aches on third day.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. This consumer reported for 2 patients (Herself and Husband). This is 1st of 2 reports. This female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an intramuscular route of administration in left arm on 19Jan2021 01:30 PM (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were none. Prior vaccination was none. The following information was reported: FATIGUE (non-serious) with onset 19Jan2021, described as "Fatigue". Patient stated that they were not able to schedule the second dose until 3 weeks and 6 days later. The caller said there was no available appointment in 3 weeks and asked if this will affect the efficacy of the vaccine. The reporter also mentioned that she read from Israel that one dose of Pfizer's COVID vaccine was lasting a lot longer and could go 9 weeks out while the UK has moved the second dose to 12 weeks. Relevant tests were none. Therapeutic measures were not taken as a result of fatigue. The clinical outcome for the event was unknown.  Follow-up (05Feb2021): This is a follow-up spontaneous report from a Pfizer-sponsored program Pfizer First Connect. It was unknown if the reporter was a health care professional. The Occupation/Specialty was Unknown. The Reporter's contact information available to you or a sub-contracted party. The reporter was the prescribing HCP.   Follow-up (13Apr2021 and 10May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to non-hcp letter sent via follow-up letter which included: route of administration, anatomical site, vaccination time and dosage details of Dose 1 added, Event fatigue added.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021143240 different patient, same drug/AE
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Headache; Chills; fatigue; Body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Feb2021 09:45 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (brand=Pfizer, Lot number=EL3247, Lot unknown=False, Administration date=20Jan2021, Administration time=12:00 AM, Vaccine location=Left arm, Dose number=1, Route of administration: Intramuscular), administration date: 20Jan2021, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 10Feb2021 01:00, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 10Feb2021 01:00, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 10Feb2021 01:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 10Feb2021 01:00, outcome "unknown", described as "Body ache". Therapeutic measures were not taken as a result of headache, chills, fatigue, pain.  Additional Information: Patient did not receive any other vaccines within 4 weeks. Patient has not COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Vaccination facility type: Workplace clinic.  No follow-up attempts are possible. No further information is expected.  Follow-up (16Apr2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: Route of administration was captured. Vaccine facility information was updated. New event body ache was coded to ache.  Follow-up (07May2021): Follow-up attempts completed. No further information expected