chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Constant headache except when he sleeps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 05Jul2021 (Lot number: EW0180) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, single, lot: EW0178, location: arm), administration date: 14Jun2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: HEADACHE (medically significant) with onset Sep2021, outcome "unknown", described as "Constant headache except when he sleeps". The event "constant headache except when he sleeps" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of headache. Clinical course included the patient had been experiencing constant headaches after receiving both doses of the Pfizer Covid vaccine, the mother mentioned that her son had been given IV Toradol, Motrin, Excedrin, Zyrtec allergy medicine, Flonase and another other allergy spray that did not decrease the headaches. The patient had been to the emergency room 2 times, and he had seen his PCP, back and forth, he had been to ID, and nothing. The headache required a visit to Emergency Room and Physician Office (he had been to the primary care and they were trying to get him an appointment with a neurologist).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Vaccination site pain
Clinical narrative: Soreness at injection site; Some fatigue (3rd dose); 3rd dose; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 22 year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19), administered in arm left, administration date 12Dec2021 09:45 (Lot number: FD7218) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "covid prior vaccination" (unspecified if ongoing), notes: Covid prior vaccination: Yes; "Appendectomy", start date: 2004, stop date: 2004; "Oral herpes" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: MG [MAGNESIUM]; ZINC; ASHWAGANDHA ROOT; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM, Soreness at injection site (left arm) (all 3 doses): recovered from first two, injections), administration date: 03May2021, when the patient was 21 years old, for COVID-19 immunization, reaction(s): "Soreness at injection site"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM, Soreness at injection site (left arm) (all 3 doses): recovered from first two, injections), administration date: 12Apr2021, when the patient was 21 years old, for Covid-19 immunization, reaction(s): "Soreness at injection site". The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021 09:45, outcome "unknown", described as "3rd dose"; VACCINATION SITE PAIN (non-serious) with onset 12Dec2021 16:00, outcome "unknown", described as "Soreness at injection site"; FATIGUE (non-serious) with onset 12Dec2021 16:00, outcome "unknown", described as "Some fatigue (3rd dose)". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: patient was not tested for COVID after the vaccination,  None of the known allergies. patient has not received other vaccine in four weeks. other medications in two weeks also include Multi-vitamin.  No follow-up attempts are possible. No further information is expected.  Follow-Up (21Dec2021):Follow-up attempts are completed. No further information is expected
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity
Clinical narrative: Sore arm; Tiredness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Dec2021 13:00 (Lot number: FJ8762) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergies: penicillins" (unspecified if ongoing), notes: known allergies: yes - penicillins, cephalosporins, sulfa, mastisol; "allergies: cephalosporins" (unspecified if ongoing), notes: known allergies: yes - penicillins, cephalosporins, sulfa, mastisol; "allergies: sulfa" (unspecified if ongoing), notes: known allergies: yes - penicillins, cephalosporins, sulfa, mastisol. The patient's concomitant medications were not reported. Past drug history included: Mastisol, reaction(s): "Allergy: mastisol", notes: known allergies: yes - penicillins, cephalosporins, sulfa, mastisol. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 15:45), administration date: 25Mar2021, when the patient was 43 years old, for Covid-19 Immunization, reaction(s): "Soreness at injection site", "Headache"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Left, Vaccine Administration Time: 15:45), administration date: 04Mar2021, when the patient was 43 years old, for Covid-19 Immunization, reaction(s): "Sore left arm at the injection site". The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 13:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021 17:00, outcome "recovering", described as "Sore arm"; FATIGUE (non-serious) with onset 09Dec2021 17:00, outcome "recovering", described as "Tiredness". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional Information: The patient had not received any other vaccinations within 4 weeks. The patient had not received other medication in two weeks. The patient was not diagnosed with COVID prior vaccination and not tested COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Body temperature, Decreased appetite, Headache
Clinical narrative: Swollen and painful armpit (right); Fever over 102; Severe headache; Loss of appetite; Swollen and painful armpit (right); Severe joint and muscle pain; Severe joint and muscle pain; Dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 18:00 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; PRILOSEC [OMEPRAZOLE MAGNESIUM]; ALIGN; CLARITIN [CLARITHROMYCIN]; MINASTRIN 24 FE. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose Administration Time: 05:00 PM, Prev dose vaccine location: Right Arm), administration date: 24Mar2021, when the patient was 39 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Prev dose Administration Time: 05:30 PM, Prev dose vaccine location: Right Arm), administration date: 14Apr2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 18:00, outcome "unknown", described as "Dose number: 3"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 09Dec2021 01:00, outcome "recovering" and all described as "Swollen and painful armpit (right)"; PYREXIA (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Fever over 102"; HEADACHE (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Severe headache"; DECREASED APPETITE (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Loss of appetite"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 09Dec2021 01:00, outcome "recovering" and all described as "Severe joint and muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary pain, pyrexia, headache, decreased appetite, lymphadenopathy, myalgia, arthralgia.   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Swollen and painful armpit (right); Fever over 102; Severe headache; Loss of appetite; Swollen and painful armpit (right); Severe joint and muscle pain; Severe joint and muscle pain; Dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 18:00 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; PRILOSEC [OMEPRAZOLE MAGNESIUM]; ALIGN; CLARITIN [CLARITHROMYCIN]; MINASTRIN 24 FE. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose Administration Time: 05:00 PM, Prev dose vaccine location: Right Arm), administration date: 24Mar2021, when the patient was 39 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Prev dose Administration Time: 05:30 PM, Prev dose vaccine location: Right Arm), administration date: 14Apr2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 18:00, outcome "unknown", described as "Dose number: 3"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 09Dec2021 01:00, outcome "recovering" and all described as "Swollen and painful armpit (right)"; PYREXIA (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Fever over 102"; HEADACHE (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Severe headache"; DECREASED APPETITE (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Loss of appetite"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 09Dec2021 01:00, outcome "recovering" and all described as "Severe joint and muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary pain, pyrexia, headache, decreased appetite, lymphadenopathy, myalgia, arthralgia.   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Myalgia, Pyrexia
Clinical narrative: Symptoms following booster shot; fever; headache; joint and muscle ache for >24hr; joint and muscle ache for >24hr; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2) (Lot number: 33030BD) 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 number unknown, Unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Symptoms following booster shot"; PYREXIA (non-serious), outcome "unknown", described as "fever"; HEADACHE (non-serious), outcome "unknown", described as "headache"; ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "joint and muscle ache for >24hr".  No follow-up attempts are possible. No further information is expected.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Rash
Clinical narrative: Flat red rash from neck to abdomen on the front of my body; Rash; Dose number: 3, product: COVID 19, brand: Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 15:45 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2), when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1), when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 15:45, outcome "unknown", described as "Dose number: 3, product: COVID 19, brand: Pfizer"; ERYTHEMA (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Flat red rash from neck to abdomen on the front of my body"; RASH (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Rash". Therapeutic measures were not taken as a result of erythema, rash.  Additional information: No other vaccine in fourweeks. No covid prior vaccination. No covid tested post vaccination. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Immediately after first 2 doses my periods skipped every other month; Immediately after first 2 doses my periods skipped every other month; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2021 11:00 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single and administered in arm left, administration date 26Jan2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: Verbatim: Hashimotos. Concomitant medication(s) included: ARMOUR THYROID. Past drug history included: Amoxicillan, reaction(s): "known_allergies: Amoxicillan", notes: known_allergies: Amoxicillan. The following information was reported: MENSTRUAL DISORDER (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset 05Jan2021, outcome "not recovered" and all described as "Immediately after first 2 doses my periods skipped every other month". The event "immediately after first 2 doses my periods skipped every other month" and "immediately after first 2 doses my periods skipped every other month" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of menstrual disorder, menstruation irregular.  Additional information: The patient had not received any other vaccine within 4 weeks. Patient have always been regular, since her period started. Her booster shot was on the 25Oct2021. The 26Oct2021 she had her period for 5 weeks. Patient received estrogen and progesterone treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Nausea
Clinical narrative: Acute headache; chills; nausea; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 15:30 (Lot number: FJ8757) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA taken for immunisation, administration date 21Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0153, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 13Apr2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6199, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 22Mar2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 15:30, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 09Dec2021 03:00, outcome "recovered" (Dec2021), described as "Acute headache"; CHILLS (non-serious) with onset 09Dec2021 03:00, outcome "recovered" (Dec2021), described as "chills"; NAUSEA (non-serious) with onset 09Dec2021 03:00, outcome "recovered" (Dec2021), described as "nausea". Therapeutic measures were not taken as a result of headache, chills, nausea.  Additional information: yes patient took other vaccine in four weeks. Other vaccine 4 weeks details: other vaccine 4weeks product was Influenza. The patient did not have covid prior to vaccination and did not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Flatulence, Gastritis, Helicobacter test
Clinical narrative: possible gastritis; Abdominal Pain worsened immediately after second dose/Pain was always constant and would get extremely painful at times.More pain in the morning and night.; Lots of gas is associated with the pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Sep2021 09:13 (Lot number: FD0809) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Lot No: FD0809), administration date: 25Aug2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Abdominal pain".  The following information was reported: GASTRITIS (non-serious), outcome "unknown", described as "possible gastritis"; ABDOMINAL PAIN (non-serious), outcome "not recovered", described as "Abdominal Pain worsened immediately after second dose/Pain was always constant and would get extremely painful at times.More pain in the morning and night."; FLATULENCE (non-serious), outcome "not recovered", described as "Lots of gas is associated with the pain". The events "possible gastritis", "abdominal pain worsened immediately after second dose/pain was always constant and would get extremely painful at times. more pain in the morning and night." and "lots of gas is associated with the pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastritis, abdominal pain, flatulence.  Additional information: The patient provided information regarding the reported adverse events with the use of the product and reporter consider the Pfizer product had a casual effect to the adverse event and was willing to be contacted again by Pfizer on the reported adverse event. The patient took PRILOSEC [OMEPRAZOLE] tablet orally from 13Oct2021 to 30Oct2021 for abdominal pain and possible gastritis. The patient went to see physician on 29Oct2021, and started possibly gastritis. The patient was given Rx for gastritis and did an H.pylori test which was negative. Took Rx for two weeks which did not seem to help too much. Pain was still there with no current definition of cause or diagnosis. Will be following of with treating MD on Monday 13Dec2021.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (Comirnaty, batch/lot# FJ1620), at the vaccination age of 50, right arm, on Dec 2, 2021, at 15:00, single dose, for COVID-19 immunization. Medical history included hypertension, acid reflux (unspecified if ongoing); and COVID-19 (unspecified if ongoing). Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Concomitant medication(s) included telmisartan and pantoprazole. The patient reported lymph node pain/arm pit lymph node pain, onset Dec 4, 2021, at 06:00, with outcome of not recovered; and arthralgia/elbow pain, onset Dec 5, 2021, with outcome of not recovered. No therapeutic measures were taken as a result of lymph node pain and arthralgia. Additional Information: Two days post injection, patient had arm pit lymph node pain. Now, had extreme elbow pain (day 3 through present day 9). The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Lymphadenopathy
Clinical narrative: Swollen lymph node in left arm pit; extreme fatigue; dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 13:00 (Lot number: Fj1620) at the age of 43 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 Number: 2, Batch/Lot No: Er8727, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 24Mar2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6205, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 04Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 13:00, outcome "unknown", described as "dose_number=3"; LYMPHADENOPATHY (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Swollen lymph node in left arm pit"; FATIGUE (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "extreme fatigue". It was unknown if therapeutic measures were taken as a result of lymphadenopathy, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID results; Positive COVID results; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL3247) at the age of 39 years as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) 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: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 10Dec2021, outcome "unknown" and all described as "Positive COVID results". The patient underwent the following laboratory tests and procedures: body temperature: (08Dec2021) 99 Fahrenheit, notes: Low grade fever of 99F; sars-cov-2 test: (10Dec2021) positive, notes: Nasal Swab, Covid tested post vaccination and Covid tested post vaccination.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: I had really bad joint pain that is intermittently continuing.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 39 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Phenobarbital, reaction(s): "known allergies Phenobarbital"; Dilantin, reaction(s): "known allergies: Dilantin". The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "I had really bad joint pain that is intermittently continuing.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 but the result was unknown. Device date was reported as 11Dec2021. The case was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Pain armpit pain; 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 (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, administered in arm left, administration date 08Dec2021 16:15 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported.The following information was reported: AXILLARY PAIN (non-serious) with onset 09Dec2021 02:00, outcome "unknown", described as "Pain armpit pain". It was unknown if therapeutic measures were taken as a result of axillary pain. The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation
Clinical narrative: This is a spontaneous report received from noncontactable consumer or other non-healthcare professional. A 56-year-old female patient received the third (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Comirnaty), for COVID-19 immunisation; and had reaction(s) of chills, total body aches and shaking. The patient reported immunization/booster shot, chills/feeling chilly and  fatigue, all with outcome of unknown. Additional information: The patient shared that after second Pfizer COVID-19 shot, she experienced shaking chills and total body aches and milder symptoms (feeling chilly, fatigue) after Pfizer COVID-19 third (booster) shot. Optional information: Unknown patient history, medications and underlying conditions. Adverse events took place after use of product. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-202101772839 same patient and drug, different dose and similar event.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pyrexia
Clinical narrative: This is a spontaneous report received from noncontactable consumer or other non-HCP. A 60-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included unknown dose number of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. The patient reported immunisation/booster, pyrexia/fever and chills (non-serious), all with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Immunisation, Pain in extremity, Peripheral swelling
Clinical narrative: Booster; Pain/swelling at the site of the injection; Pain/swelling at the site of the injection; Numbness of the arm all the way through the end and fingers; Extreme fatigue; Selling under the armpit, nera the collarbone on the side of my breast; This was painful in the first few days; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Dec2021 16:30 (Lot number: FJ8757) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; PROGESTERONE; LINZESS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0176, Vaccine Administration Time: 10:00 AM), administration date: 08May2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0169, Vaccine Administration Time: 10:00 AM), administration date: 17Apr2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 12:00, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 09Dec2021 12:00, outcome "recovering", VACCINATION SITE SWELLING (non-serious) with onset 09Dec2021 12:00, outcome "not recovered" and all described as "Pain/swelling at the site of the injection"; HYPOAESTHESIA (non-serious) with onset 09Dec2021 12:00, outcome "recovered" (Dec2021), described as "Numbness of the arm all the way through the end and fingers"; FATIGUE (non-serious) with onset 09Dec2021 12:00, outcome "recovering", described as "Extreme fatigue"; PERIPHERAL SWELLING (non-serious) with onset 09Dec2021 12:00, outcome "recovering", described as "Selling under the armpit, nera the collarbone on the side of my breast"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021 12:00, outcome "recovering", described as "This was painful in the first few days". Therapeutic measures were not taken as a result of immunisation, vaccination site pain, vaccination site swelling, hypoaesthesia, fatigue, peripheral swelling, pain in extremity.  Additional information: The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post the vaccination.  No follow-up attempts possible. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Booster; Pain/swelling at the site of the injection; Pain/swelling at the site of the injection; Numbness of the arm all the way through the end and fingers; Extreme fatigue; Selling under the armpit, nera the collarbone on the side of my breast; This was painful in the first few days; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Dec2021 16:30 (Lot number: FJ8757) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; PROGESTERONE; LINZESS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0176, Vaccine Administration Time: 10:00 AM), administration date: 08May2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0169, Vaccine Administration Time: 10:00 AM), administration date: 17Apr2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 12:00, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 09Dec2021 12:00, outcome "recovering", VACCINATION SITE SWELLING (non-serious) with onset 09Dec2021 12:00, outcome "not recovered" and all described as "Pain/swelling at the site of the injection"; HYPOAESTHESIA (non-serious) with onset 09Dec2021 12:00, outcome "recovered" (Dec2021), described as "Numbness of the arm all the way through the end and fingers"; FATIGUE (non-serious) with onset 09Dec2021 12:00, outcome "recovering", described as "Extreme fatigue"; PERIPHERAL SWELLING (non-serious) with onset 09Dec2021 12:00, outcome "recovering", described as "Selling under the armpit, nera the collarbone on the side of my breast"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021 12:00, outcome "recovering", described as "This was painful in the first few days". Therapeutic measures were not taken as a result of immunisation, vaccination site pain, vaccination site swelling, hypoaesthesia, fatigue, peripheral swelling, pain in extremity.  Additional information: The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post the vaccination.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation, Malaise, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot; Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot; Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot; I am not feeling well; I am feeling bad; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Dec2021 (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: VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I am feeling bad"; IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Booster".  Additional information:  QR Comment: Reporter type was not available over the call as the consumer was unwilling to answer further questions hence, reporter type captured as consumer or non-healthcare professional by default.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot; Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot; Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot; I am not feeling well; I am feeling bad; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Dec2021 (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: VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I am feeling bad"; IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Booster".  Additional information:  QR Comment: Reporter type was not available over the call as the consumer was unwilling to answer further questions hence, reporter type captured as consumer or non-healthcare professional by default.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 56-year-old male patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# 330308D), at the age of 56, on Dec 8, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (primary immunization series complete but unknown manufacturer), for COVID-19 immunization. The patient reported peripheral swelling/arm is swollen up/swelling on the left arm, pain in extremity/arm is hurting/really painful, axillary mass/lump under arm, swelling and painful, swelling/swelling under armpit, axillary pain/under my arm pit is painful and decreased joint range of motion/patient doesn't think arm is working, all onset Dec 8, 2021, with outcome of unknown. No therapeutic measures taken as a result of the adverse events. Additional information: I took a booster shot on Friday (as reported, pending clarification) and my arm is swollen up right now and it is hurting me. After Friday I got the shot, I have a lump under my arm, swelling and it is painful. There is swelling under my armpit after I take the vaccination. Right now, it is very painful. Friday, Saturday and Sunday. Today is the second day and it is very painful and right now. My wife is supposed to do it my family and I am going to advise them not to do it. This thing it is not good. I mean I got two vaccination I was fine, now I have got the booster shot and I am not okay. I took picture of it, my arm, under my arm pit is swollen and painful. He got the booster shot and has swelling on the left arm. The arm is really painful and he doesn't think it's working. No follow-up attempts possible. No further information expected. Follow-up (Dec 24, 2021): Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 56-year-old male patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# 330308D), at the age of 56, on Dec 8, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (primary immunization series complete but unknown manufacturer), for COVID-19 immunization. The patient reported peripheral swelling/arm is swollen up/swelling on the left arm, pain in extremity/arm is hurting/really painful, axillary mass/lump under arm, swelling and painful, swelling/swelling under armpit, axillary pain/under my arm pit is painful and decreased joint range of motion/patient doesn't think arm is working, all onset Dec 8, 2021, with outcome of unknown. No therapeutic measures taken as a result of the adverse events. Additional information: I took a booster shot on Friday (as reported, pending clarification) and my arm is swollen up right now and it is hurting me. After Friday I got the shot, I have a lump under my arm, swelling and it is painful. There is swelling under my armpit after I take the vaccination. Right now, it is very painful. Friday, Saturday and Sunday. Today is the second day and it is very painful and right now. My wife is supposed to do it my family and I am going to advise them not to do it. This thing it is not good. I mean I got two vaccination I was fine, now I have got the booster shot and I am not okay. I took picture of it, my arm, under my arm pit is swollen and painful. He got the booster shot and has swelling on the left arm. The arm is really painful and he doesn't think it's working. No follow-up attempts possible. No further information expected. Follow-up (Dec 24, 2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Lymphadenopathy, Pain in extremity
Clinical narrative: Yes, so I got the Pfizer booster; Underneath my arm and my armpit was sore; its very swollen like in the lymph nodes; its only in one side of my arm or one arm that I got the shot in; Underneath my arm and my armpit was sore; its only in one side of my arm or one arm that I got the shot in; Underneath my arm and my armpit was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Dec2021 (Lot number: FD0809) as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization; Bnt162b2 (Dose:2), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Yes, so I got the Pfizer booster"; LYMPHADENOPATHY (non-serious) with onset 11Dec2021, outcome "unknown", described as "Underneath my arm and my armpit was sore; its very swollen like in the lymph nodes; its only in one side of my arm or one arm that I got the shot in"; PAIN IN EXTREMITY (non-serious) with onset 11Dec2021, outcome "unknown", described as "Underneath my arm and my armpit was sore; its only in one side of my arm or one arm that I got the shot in"; AXILLARY PAIN (non-serious) with onset 11Dec2021, outcome "unknown", described as "Underneath my arm and my armpit was sore".  Additional information: The patient got the Pfizer booster on the 09Dec2021 and the day before reporting on 11Dec2021 the patient woke up and underneath patient's arm and armpit was sore and so, the following morning on 12Dec2021 which was on the day of reporting morning the patient woke up and its very swollen like in the lymph nodes the patient mentioned. So, the patient was assuming this was a side effect because its only in one side of my arm or one arm that I got the shot in. So, the patient was wondering what should be the next course of action.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Chest pain
Clinical narrative: I am having a lot of pain under my armpit and my chest; I am having a lot of pain under my armpit and my chest; pain, not even on my arm, it's just under my armpit and not my whole breast it's just on my breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: CHEST PAIN (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "I am having a lot of pain under my armpit and my chest"; BREAST PAIN (non-serious), outcome "unknown", described as "pain, not even on my arm, it's just under my armpit and not my whole breast it's just on my breast".  Additional information: Patient stated I took Pfizer vaccine (later clarified as Pfizer Covid-19 vaccine) this Wednesday. I was having a lot of pain under my armpit and my chest. Like pain, not even on my arm, it's just under my armpit and not my whole breast it's just on my breast.  The lot number for bnt162b2 was not provided and will be requested during follow up.