chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Vaccination site pain
Clinical narrative: injection site tenderness; chills; injection site tenderness that progressed causing repeated awakening during the night; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 06Jan2021 (Lot number: EL1283) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2019 (ongoing); "Polycythaemia vera", start date: 2020 (ongoing); "depression" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Rhinorrhea" (unspecified if ongoing); "anemia" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR taken for asthma, start date: 2020 (ongoing); HYDREA taken for polycythaemia vera, start date: Oct2020 (ongoing); SYMBICORT taken for asthma, start date: 2019 (ongoing); VENLAFAXINE taken for depression, start date: 2010 (ongoing); AZELASTINE HCL taken for hypersensitivity, start date: 2019 (ongoing); IPRATROPIUM taken for rhinorrhoea, start date: 2019 (ongoing); IRON taken for anaemia, start date: 2015 (ongoing); ASA taken for anticoagulant therapy, start date: 2019 (ongoing); NASONEX taken for hypersensitivity, start date: 2019 (ongoing). Vaccination history included: Bnt162b2 (Dose:1st, Date/Time: 16Dec2021 Time: 09:30, Site and Route of injection:, Anatomical site of injection: Left Deltoid , Route of administration: Intramuscular, Batch/Lot number: EH9899), administration date: 16Dec2020, when the patient was 63 years old, for COVID-19 immunisation. The following information was reported: INJECTION SITE PAIN (non-serious) with onset Jan2021, outcome "unknown", described as "injection site tenderness"; CHILLS (non-serious) with onset Jan2021, outcome "unknown", described as "chills"; INSOMNIA (non-serious) with onset Jan2021, outcome "unknown", described as "injection site tenderness that progressed causing repeated awakening during the night".   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Post-traumatic stress disorder
Clinical narrative: Booster; severe PTSD; 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 parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization; Bnt162b2 (2nd Dose), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; POST-TRAUMATIC STRESS DISORDER (non-serious), outcome "unknown", described as "severe PTSD".  Additional Information: She was worried about the injection site because the person who administered the booster shot to her son accidentally rubbed it.  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-202101655501 Same reporter different patient
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "headache" (unspecified if ongoing); "found tumors" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Covid shots made her sick.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity
Clinical narrative: Dose Number: 3; Arm pain; fatigure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date Nov2021 (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: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Dose Number: 3"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovering", described as "Arm pain"; FATIGUE (non-serious) with onset Nov2021, outcome "recovering", described as "fatigure". It was unknown if therapeutic measures were taken as a result of pain in extremity, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown prior to vaccination, if the patient diagnosed with COVID-19 and has been tested for COVID-19 since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Lymph node pain, Rash, SARS-CoV-2 test
Clinical narrative: Painful lymph nodes on the armpit and neck 24 hrs after the vaccine; rash on the left flank within 48 hrs that later on diagnosed as shingles; rash on the left flank within 48 hrs that later on diagnosed as shingles; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 10:00 (Lot number: 30155BA) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chicken Pox" (unspecified if ongoing); "Post Partum Depression" (unspecified if ongoing); "Epicarditis" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 20Nov2021 10:00, outcome "recovering", described as "Painful lymph nodes on the armpit and neck 24 hrs after the vaccine"; HERPES ZOSTER (non-serious), RASH (non-serious) all with onset 20Nov2021 10:00, outcome "recovering" and all described as "rash on the left flank within 48 hrs that later on diagnosed as shingles". The events "painful lymph nodes on the armpit and neck 24 hrs after the vaccine", "rash on the left flank within 48 hrs that later on diagnosed as shingles" and "rash on the left flank within 48 hrs that later on diagnosed as shingles" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymph node pain, herpes zoster, rash.  Additional information: The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient did not have any known allergies. The patient was tested for covid-19 since vaccination and results were unknown. The patient received treatment with Valtrex, Norco, Gabapentin, Prednisone, Advil for reported events.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site nodule
Clinical narrative: 4 nodules to the injection areas; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): GL-111621-26885 (RA).  A 66-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Feb2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation; hyaluronic acid, lidocaine hydrochloride (RESTYLANE DEFYNE), since 23Sep2021 (Batch/Lot number: unknown) at 1 mL. Relevant medical history included: "osteoporosis" (unspecified if ongoing), notes: Med history of osteoporosis. Concomitant medication(s) included: FOSAMAX taken for bone disorder. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown.), administration date: Jan2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: INJECTION SITE NODULE (non-serious) with onset 15Oct2021, outcome "unknown", described as "4 nodules to the injection areas". The action taken for hyaluronic acid, lidocaine hydrochloride was unknown. Therapeutic measures were not taken as a result of injection site nodule.  Additional information: Patient was injected with Defyne to both marionette lines. About a month ago on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Immunisation, Malaise, Pain
Clinical narrative: malaise; Fever; aches; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57-year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Prev dose product=COVID 19, prev dose brand unknown=True, prev dose brand name unknown=COVID19 Vaccine, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completio), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Booster"; MALAISE (non-serious) with onset 01Dec2021, outcome "recovering", described as "malaise"; PYREXIA (non-serious) with onset 01Dec2021, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 01Dec2021, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 01Dec2021, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, pyrexia, pain, fatigue.  Additional information: Patient did not have covid prior vaccination and has not been tested for covid post vaccination. No allergies were reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: malaise; Fever; aches; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57-year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Prev dose product=COVID 19, prev dose brand unknown=True, prev dose brand name unknown=COVID19 Vaccine, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completio), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Booster"; MALAISE (non-serious) with onset 01Dec2021, outcome "recovering", described as "malaise"; PYREXIA (non-serious) with onset 01Dec2021, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 01Dec2021, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 01Dec2021, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, pyrexia, pain, fatigue.  Additional information: Patient did not have covid prior vaccination and has not been tested for covid post vaccination. No allergies were reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: after one day on the thirtieth of nov i had swelling under the armpit of my arm right arm with the injection was given swelling under the armpit; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 2, single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "Booster"; SWELLING (non-serious) with onset 30Nov2021, outcome "unknown", described as "after one day on the thirtieth of nov i had swelling under the armpit of my arm right arm with the injection was given swelling under the armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Overdose, Pain in extremity, Product preparation error
Clinical narrative: He was administered with a full undiluted vial of the adult formulation of the Pfizer-BioNTech COVID-19 Vaccine as booster; He was administered with a full undiluted vial of the adult formulation of the Pfizer-BioNTech COVID-19 Vaccine as booster; He was administered with a full undiluted vial of the adult formulation of the Pfizer-BioNTech COVID-19 Vaccine as booster; Sore Arm; Feeling Fatigued; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) from medical information team.  A 48 year-old male patient received bnt162b2 (COMIRNATY), administration date 02Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "fatigue" (ongoing); "myalgia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (first primary dose), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 02Dec2021, outcome "unknown" and all described as "He was administered with a full undiluted vial of the adult formulation of the Pfizer-BioNTech COVID-19 Vaccine as booster"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore Arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Feeling Fatigued". Additional information: It was unknown if patient had any prior vaccinations (within 4 weeks). The stage of medication error (overdose) was preparation and administration. Lack of communication and the RN that administered the dose may have some underlying condition that should have made her not allowed to be administering vaccines. The RN was going out on company to address the condition. Reporter specialty: occupational medicine, physician, MD. Patient was administered with a full undiluted vial of the adult formulation of the Pfizer-BioNTech COVID-19 Vaccine as booster. Caller said that the patient had Moderna as the first primary dose.  She was asking further guidance. Complete only if a 3rd dose was administered. Check one option Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Patient has not reached out to the reporter recently, so she did not have much additional information to provide. She provided the facility information where he was vaccinated and reported that he had a sore arm and was feeling fatigued but could not provide further information as she did not have first-hand knowledge and had only been passed along the information to report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Urinary incontinence
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Thrombosis
Clinical narrative: Irregular menstrual cycle and blood clots. Menstrual cycle has been irregular, lasted longer than ever before in life or absent
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain, Vaccination site pain
Clinical narrative: fatigued; sore arm; chills; body aches; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 01Dec2021 (Lot number: FH8027) at the age of 45 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, Anatomical site: Left arm, Batch number : EL3247), administration date: 18Feb2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, Anatomical site: Left arm, Batch number : EN6203), administration date: 11Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 02Dec2021 10:00, outcome "recovered" (03Dec2021), described as "fatigued"; VACCINATION SITE PAIN (non-serious) with onset 02Dec2021 10:00, outcome "recovered" (03Dec2021), described as "sore arm"; CHILLS (non-serious) with onset 02Dec2021 10:00, outcome "recovered" (03Dec2021), described as "chills"; PAIN (non-serious) with onset 02Dec2021 10:00, outcome "recovered" (03Dec2021), described as "body aches".  Follow-up (09Dec2021): This is follow up spontaneous report from a contactable consumer. This consumer reported in response to Non-Hcp letter sent which included that: Additional information: Lot number for 1st,2nd,3rd are given, anatomical site for both three dose are provided, age of the patient at the time of vaccine is given.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Vaginal haemorrhage
Clinical narrative: I do breastfeeding, my doter is 3 month. After vaccine next day I had Vaginal bleeding.; I do breastfeeding, my doter is 3 month. After vaccine next day I had Vaginal bleeding.; I do breastfeeding, my doter is 3 month. After vaccine next day I had Vaginal bleeding.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 12:45 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 04Dec2021 12:00, outcome "recovering", OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Dec2021 12:45, outcome "unknown" and all described as "I do breastfeeding, my doter is 3 month. After vaccine next day I had Vaginal bleeding.". The event "i do breastfeeding, my doter is 3 month. after vaccine next day i had vaginal bleeding." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaginal haemorrhage.  Additional information: Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101725297 baby case
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: Quarter sized spot of Alopecia Areata on Childs upper right lobe of head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 16:15 (Lot number: FK5618) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 04:15 PM), administration date: 15Nov2021, when the patient was 9 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA AREATA (non-serious), outcome "not recovered", described as "Quarter sized spot of Alopecia Areata on Childs upper right lobe of head". The event "quarter sized spot of alopecia areata on childs upper right lobe of head" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of alopecia areata.  Additional information: The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device time stamp was 07Dec2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cyst, Immunisation, Interchange of vaccine products, Lymph node pain, Lymphadenopathy
Clinical narrative: watery bag under his arm; painful lymph nodes; swollen lymph nodes; his left arm has swollen; painful lymph node around the injection site; painful lymph node around the injection site; booster; received the first two doses of the Moderna Covid-19 vaccine and Pfizer Covid-19 booster dose last Monday; received the first two doses of the Moderna Covid-19 vaccine and Pfizer Covid-19 booster dose last Monday; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non- health care professional) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): PFIZER INC-202101751445.  A 56-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 (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: MODERNA COVID-19 vaccine (first dose of the MODERNA COVID-19 vaccine), for COVID-19 immunization; MODERNA COVID-19 vaccine (2nd dose of the MODERNA COVID-19 vaccine), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 06Dec2021, outcome "unknown" and all described as "received the first two doses of the MODERNA COVID-19 vaccine and Pfizer Covid-19 booster dose last Monday"; LYMPH NODE PAIN (non-serious) with onset 08Dec2021, outcome "unknown", described as "painful lymph nodes"; LYMPHADENOPATHY (non-serious) with onset 08Dec2021, outcome "unknown", described as "swollen lymph nodes"; CYST (non-serious), outcome "unknown", described as "watery bag under his arm"; PERIPHERAL SWELLING (non-serious) with onset 07Dec2021, outcome "unknown", described as "his left arm has swollen"; VACCINATION SITE LYMPHADENOPATHY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 07Dec2021, outcome "unknown" and all described as "painful lymph node around the injection site".  Additional information: Caller received the first two doses of the MODERNA COVID-19 vaccine and PFIZER COVID-19 booster dose last Monday. He stated that his left arm had swollen, painful lymph node around the injection site. He mentioned that it was swollen yesterday and he got it on Monday. This Wednesday would be the second day, he said that he woke up with a lot of swelling under the arm, lymph nodes under the arm, it was just somewhat painful. He mentioned that he looked it and it sounds like it was normal. He wants to know if this was normal or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Peripheral swelling, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: watery bag under his arm; painful lymph nodes; swollen lymph nodes; his left arm has swollen; painful lymph node around the injection site; painful lymph node around the injection site; booster; received the first two doses of the Moderna Covid-19 vaccine and Pfizer Covid-19 booster dose last Monday; received the first two doses of the Moderna Covid-19 vaccine and Pfizer Covid-19 booster dose last Monday; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non- health care professional) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): PFIZER INC-202101751445.  A 56-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 (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: MODERNA COVID-19 vaccine (first dose of the MODERNA COVID-19 vaccine), for COVID-19 immunization; MODERNA COVID-19 vaccine (2nd dose of the MODERNA COVID-19 vaccine), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 06Dec2021, outcome "unknown" and all described as "received the first two doses of the MODERNA COVID-19 vaccine and Pfizer Covid-19 booster dose last Monday"; LYMPH NODE PAIN (non-serious) with onset 08Dec2021, outcome "unknown", described as "painful lymph nodes"; LYMPHADENOPATHY (non-serious) with onset 08Dec2021, outcome "unknown", described as "swollen lymph nodes"; CYST (non-serious), outcome "unknown", described as "watery bag under his arm"; PERIPHERAL SWELLING (non-serious) with onset 07Dec2021, outcome "unknown", described as "his left arm has swollen"; VACCINATION SITE LYMPHADENOPATHY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 07Dec2021, outcome "unknown" and all described as "painful lymph node around the injection site".  Additional information: Caller received the first two doses of the MODERNA COVID-19 vaccine and PFIZER COVID-19 booster dose last Monday. He stated that his left arm had swollen, painful lymph node around the injection site. He mentioned that it was swollen yesterday and he got it on Monday. This Wednesday would be the second day, he said that he woke up with a lot of swelling under the arm, lymph nodes under the arm, it was just somewhat painful. He mentioned that he looked it and it sounds like it was normal. He wants to know if this was normal or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: break through bleeding; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "menopause" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "break through bleeding".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Pruritus, Rash
Clinical narrative: few itching spots; a rash all over her body; Diarrhea; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 07Dec2021 (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: Covid-19 vaccine (Dose 1; MANUFACTERER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2; MANUFACTERER: UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "booster"; PRURITUS (non-serious) with onset 08Dec2021, outcome "not recovered", described as "few itching spots"; RASH (non-serious) with onset 07Dec2021, outcome "recovering", described as "a rash all over her body"; DIARRHOEA (non-serious) with onset 07Dec2021, outcome "unknown", described as "Diarrhea". Additional information: The caller was a consumer, she got the Pfizer covid 19 booster shot yesterday morning and by night she developed a rash all over her body and diarrhea. This morning the rash was almost gone, just few itching spots. Was that normal or should be worried about. Follow-up attempts completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Slight sore shoulder at injection site; Dose 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Nov2021 09:15 (Lot number: FF8839) at the age of 54 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 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM, Route of Administration: Intramuscular), administration date: 01Mar2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 09:15, outcome "unknown", described as "Dose 3"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021 22:00, outcome "recovered" (2021), described as "Slight sore shoulder at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: problems with sleeping; weird noises that she was hearing; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8730) at the age of 71 years as dose 2, single and administration date 05Mar2021 (Lot number: EN6206) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: SLEEP DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "problems with sleeping"; TINNITUS (non-serious) with onset Oct2021, outcome "unknown", described as "weird noises that she was hearing".  Additional information: The reporter had been taking daily medications that she had never had a reaction to them before or after she got the vaccine. The reporter declined to provide this information at the time of reporting. The patient clarified that she received the vaccine last Mar2021. These events started happening after both of the dose that the reporter had. The reporter's symptoms began about 2 months ago, about Oct2021. The reporter thought she had a reaction to the graphine oxide nanoparticles, which were in the vaccine. The patient stated that the sleeping problems came from the graphene oxide nanoparticles found in the vaccine that was causing a weird electroactivity with the internet. The reporter started noticing some odd things going on. The reporter had internet in her home and she was wondering if this had anything to do with that. The caller also had her meter changed from a smart meter to a normal analog meter and she was still having weird noises that she was hearing and she thought it was from the graphine oxide nanoparticles in the vaccine. The reporter had never experienced any of this. This was causing problems with the reporter's sleeping. The patient wanted to know if graphene oxide was part of the ingredients of the vaccine and was actually causing her sleep problems. Graphene oxide was not used during the manufacturing of the vaccine and the vaccine did not contain. The patient took bnt162b2 because the reporter's doctor recommended it and when she usually got a virus, it got right to lungs. The caller had the influenza vaccine in Sep2021, the one for people over 65 years old, and she never had a reaction to them.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation
Clinical narrative: Got sick again with the booster dose; Got sick again with the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "patient got Covid back in the beginning, before Delta" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "Got sick again with the booster dose".  Follow-up attempts completed. No further information is expected.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Gastric disorder, Headache
Clinical narrative: Head ach; dizziness; stomach issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 11:00 (Lot number: ER8730) at the age of 61 years as dose 1, single and administered in arm right, administration date 19Apr2021 (Lot number: EW0162) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Head ach"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "stomach issues". Additional information: The patient had headache, dizziness and stomach issues for all three shots.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : 202101766389 same reporter/product/ patient, different dose, similar event
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Condition aggravated, Headache, Immunisation, Pain
Clinical narrative: Booster; I am also experiencing headache pretty bad headache; It seems to be sustaining or worsening; I have got a really large swollen area like a big lump under my arm pit and it''s really painful; I have got a really large swollen area like a big lump under my arm pit and it''s really painful; I have got a really large swollen area like a big lump under my arm pit and it''s really painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FD7218) at the age of 27 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "sleeping" (unspecified if ongoing), notes: I have a sleeping medication Zolpidem. Concomitant medication(s) included: VENLAFAXINE taken for depression; ARIPIPRAZOLE taken for depression; ZOLPIDEM taken for sleep disorder. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; , MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; SWELLING (non-serious), AXILLARY MASS (non-serious), PAIN (non-serious) all with onset 07Dec2021, outcome "not recovered" and all described as "I have got a really large swollen area like a big lump under my arm pit and it''s really painful"; HEADACHE (non-serious), outcome "unknown", described as "I am also experiencing headache pretty bad headache"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "It seems to be sustaining or worsening". Therapeutic measures were taken as a result of swelling, axillary mass, pain, headache.  Additional information: The patient received a Pfizer booster dose (Unspecified Shot) a few days ago and had a large swollen area like a big lump under her arm pit and which was painful. Patient guessed, she started at the night of 7th and really on the 8th of this month Dec. Patient received a shot around 48 hours ago and so may be 12 hours after she received the booster shot, she woke up and she was having lot of she was experiencing a lot of pain in her underarm that was continued she did not notice, when she went to shower, she noticed. The patient did take some Tylenol, so it didn't helped too much yesterday, she was also experiencing headache pretty bad headache but she was not sure if that was related, since the lump was right under the injection site so it was probably from that, she was also experiencing headache so all she was taking was Tylenol. It seemed to be sustaining or worsening. The patient's top of arm felt better like she would be able to, but the thing under her arm was very painful but otherwise the injection site felt like it got better.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Booster; I am also experiencing headache pretty bad headache; It seems to be sustaining or worsening; I have got a really large swollen area like a big lump under my arm pit and it''s really painful; I have got a really large swollen area like a big lump under my arm pit and it''s really painful; I have got a really large swollen area like a big lump under my arm pit and it''s really painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FD7218) at the age of 27 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "sleeping" (unspecified if ongoing), notes: I have a sleeping medication Zolpidem. Concomitant medication(s) included: VENLAFAXINE taken for depression; ARIPIPRAZOLE taken for depression; ZOLPIDEM taken for sleep disorder. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; , MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; SWELLING (non-serious), AXILLARY MASS (non-serious), PAIN (non-serious) all with onset 07Dec2021, outcome "not recovered" and all described as "I have got a really large swollen area like a big lump under my arm pit and it''s really painful"; HEADACHE (non-serious), outcome "unknown", described as "I am also experiencing headache pretty bad headache"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "It seems to be sustaining or worsening". Therapeutic measures were taken as a result of swelling, axillary mass, pain, headache.  Additional information: The patient received a Pfizer booster dose (Unspecified Shot) a few days ago and had a large swollen area like a big lump under her arm pit and which was painful. Patient guessed, she started at the night of 7th and really on the 8th of this month Dec. Patient received a shot around 48 hours ago and so may be 12 hours after she received the booster shot, she woke up and she was having lot of she was experiencing a lot of pain in her underarm that was continued she did not notice, when she went to shower, she noticed. The patient did take some Tylenol, so it didn't helped too much yesterday, she was also experiencing headache pretty bad headache but she was not sure if that was related, since the lump was right under the injection site so it was probably from that, she was also experiencing headache so all she was taking was Tylenol. It seemed to be sustaining or worsening. The patient's top of arm felt better like she would be able to, but the thing under her arm was very painful but otherwise the injection site felt like it got better.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Immunisation, Pain, Pain in extremity
Clinical narrative: Booster; Stated she had trouble to walk/hard to stand up and walk on; States that she had her booster dose yesterday and apart from feeling a sore arm,; she woke up in the middle of the night with a mayor pain in her feet and ankles/Woke up to ankle and foot throbbing and stabbing with pain; she woke up in the middle of the night with a mayor pain in her feet and ankles/Woke up to ankle and foot throbbing and stabbing with pain; throbbing and shooting; 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 54 year-old female patient received bnt162b2 (BNT162B2) (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: 2), for COVID-19 Immunization; Bnt162b2 (DOSE: 1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; GAIT DISTURBANCE (non-serious) with onset 09Dec2021, outcome "unknown", described as "Stated she had trouble to walk/hard to stand up and walk on"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021, outcome "unknown", described as "States that she had her booster dose yesterday and apart from feeling a sore arm,"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 09Dec2021, outcome "unknown" and all described as "she woke up in the middle of the night with a mayor pain in her feet and ankles/Woke up to ankle and foot throbbing and stabbing with pain"; PAIN (non-serious) with onset 09Dec2021, outcome "unknown", described as "throbbing and shooting". Therapeutic measures were taken as a result of gait disturbance, pain in extremity, pain in extremity, arthralgia, pain. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza, Malaise, Pyrexia
Clinical narrative: ill; fever; flu symptoms; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (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: MALAISE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "ill"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "fever"; INFLUENZA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "flu symptoms"; ILLNESS (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "sick". The lot number for bnt162b2 was not provided and will be requested during follow up.