chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Increased appetite, Psychomotor hyperactivity
Clinical narrative: hyperactivity; increased appetite/ Voracious appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 9 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Dec2021 14:15 (Lot number: FK5127) at the age of 9 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "autism" (ongoing), notes: Onset Date: Birth; "GI Reflux", start date: Aug2013 (ongoing). Concomitant medication(s) included: PREVACID taken for gastrooesophageal reflux disease, start date: Sep2013 (ongoing); CLONIDINE taken for autism spectrum disorder, start date: Oct2021 (ongoing); RISPERDON taken for autism spectrum disorder, start date: Sep2019 (ongoing); FAMOTIDINE taken for gastrooesophageal reflux disease, start date: Sep2013 (ongoing). Vaccination history included: Bnt162b2 (Dose:1st, Time: 16:45, Site and Route of injection:, Anatomical site of injection: Left arm, Batch/Lot number: FK5127), administration date: 18Nov2021, for COVID-19 Immunization. The following information was reported: PSYCHOMOTOR HYPERACTIVITY (non-serious) with onset 28Dec2021 22:00, outcome "recovered", described as "hyperactivity"; INCREASED APPETITE (non-serious) with onset 28Dec2021 19:00, outcome "recovered", described as "increased appetite/ Voracious appetite". Therapeutic measures were not taken as a result of psychomotor hyperactivity, increased appetite.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fear of falling, Vertigo
Clinical narrative: Vertigo daily since vaccine / I get vertigo when I lay down, bend over, and stand up. I have to hold onto something to keep from falling.; dizziness; I cannot keep my balance; I have to hold onto something to keep from falling.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 13:15 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. Past drug history included: Adhesive tape, reaction(s): "Allergy". The following information was reported: VERTIGO (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Vertigo daily since vaccine / I get vertigo when I lay down, bend over, and stand up. I have to hold onto something to keep from falling."; DIZZINESS (non-serious) with onset 07Dec2021, outcome "not recovered", described as "dizziness"; BALANCE DISORDER (non-serious) with onset 07Dec2021, outcome "not recovered", described as "I cannot keep my balance"; FEAR OF FALLING (non-serious) with onset 07Dec2021, outcome "not recovered", described as "I have to hold onto something to keep from falling.". It was unknown if therapeutic measures were taken as a result of vertigo, dizziness, balance disorder, fear of falling.  The lot number for bnt162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo twelve hours after receiving the first shot and it lasted about ten hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "recovered", described as "vertigo twelve hours after receiving the first shot and it lasted about ten hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Complaining of headache since receiving last vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 13:00 (Lot number: FD7218) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "Ache" (unspecified if ongoing). Concomitant medication(s) included: MINOCYCLINE taken for acne, start date: Sep2021 (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0181), administration date: 15Jun2021, when the patient was 15 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW1080), administration date: 21May2021, when the patient was 15 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 27Dec2021, outcome "not recovered", described as "Complaining of headache since receiving last vaccine.". Therapeutic measures were taken as a result of headache.  Additional information:The patient received treatment with Tylenol and Advil.The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-2 test, Taste disorder
Clinical narrative: a distorted sense of taste and smell; a distorted sense of taste and smell; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 15:00 (Lot number: PE3590) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy to mollusks (clams, scallops, abalone)" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 02Nov2021 14:00, outcome "not recovered" and all described as "a distorted sense of taste and smell". The event "a distorted sense of taste and smell" and "a distorted sense of taste and smell" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder, parosmia.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications the within 2 weeks of vaccination. Reported that, approximately 4 days post vaccine patient noticed a distorted sense of taste and smell.  Fresh fruit (apples, plums, grapes) taste rotten. Many foods have a very muted taste or do not taste anything like patient recall. Many things have a chemical-type smell like faint gasoline or did not smell like patient recall. Her favorite candle, body lotion, some foods, some surfaces (such as car leather) smell like very strong chemical. Patient has been diagnosed with COVID-19 prior to vaccination and has been tested since the vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 67 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash on his face".  Additional information: on behalf of his husband and he was 67 years old. She mentioned that he already got his first and second dose of Pfizer Vaccine however he found a rash on his face but he's about to get a booster shot. His doctor told him to get the Moderna booster shot. Pt.'s wife is asking if it is safe to mix the Pfizer vaccine and the Moderna Vaccine.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.  Follow-up (20Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills; headache; body aches; This is a spontaneous report received from noncontactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Lot number: EP6955) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MOMETASONE; FEXOFENADINE. Vaccination history included: Bnt162b2 (lot number=EP6955,, administration ime=09:00 AM,, anatomical location: left arm, dose umber: 1), administration date: 23Mar2021, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 12Apr2021 22:00, outcome "recovered" (2021), described as "Chills"; HEADACHE (non-serious) with onset 12Apr2021 22:00, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 12Apr2021 22:00, outcome "recovered" (2021), described as "body aches". Therapeutic measures were not taken as a result of chills, headache, pain. Additional information: the patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Arm pain fromthe vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingrix vaccine and experienced arm pain. The patient asked should he/she put hot or cold compresses on vaccinated arm to relieve arm pain from the vaccine. The follow-up would not possible as no contact details were available.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: given a dose of Engerix-B though the doctor had ordered HPV vaccine.; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 36-year-old female patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th March 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 11th March 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was inadvertently given a dose of Engerix-B though the doctor had ordered a dose of the HPV vaccine, which led to wrong vaccine administered. The reporter reported that it was unknown which site the dose had been administered in; as of the time of reporting the Medical Assistant who administered the dose had not documented site of administration. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: gave expired Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 8th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received dose of Twinrix that was already expired on 28th February 2022, which led to expired vaccine used. The reporter enquired that what he/she need to tell a patient as he/she gave an expired Twinrix vaccine. The reporter consented to follow up via postal.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Inappropriate schedule of product administration, Injection site pain, Pruritus, Rash
Clinical narrative: Intense pain at the injection site, worse than 1st dose; Rash on lower back; Blisters on lower back; Is very itchy, asks if this could be Shingles; 1st dose few years ago, 2nd dose a year ago; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose few years ago (date unknown), for tolerance of 1st dose refer case US2022AMR046812).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, rash, blister, pruritus and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the rash, blister and pruritus were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, rash, blister and pruritus to be related to Shingrix.     Additional details reported were as follows: A year ago, the patient went back to the pharmacy and received a second dose of Shingrix, as the pharmacist stated it was late for second dose but she should take it as soon as possible.  The patient received 2nd dose of Shingrix, late than recommended time frame, which led to lengthening of interval between vaccine doses. On the date of her vaccination the patient felt intense pain at the injection site which did resolve in a few days. Less than a year after receiving Shingrix, for the last few months the patient noticed a rash or blisters on her lower back near the coccyx which was very itchy and had not resolved.  The patient asked if this could be the Shingles.  The patient provided medical advice disclaimer and referred to healthcare professional.  The consent to follow up was given. The Permission to contact healthcare and pharmacy was provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046812:Same reporter
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Vaccination site pain, Weight increased
Clinical narrative: Weight gain after first shot; Lethargy after first shot; After the first dose, her left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain after first shot), LETHARGY (Lethargy after first shot) and VACCINATION SITE PAIN (After the first dose, her left arm was sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thalassemia (She has had Thalassemia for many years).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (After the first dose, her left arm was sore). On 14-Mar-2021, the patient experienced WEIGHT INCREASED (Weight gain after first shot) and LETHARGY (Lethargy after first shot). On 17-Mar-2021, VACCINATION SITE PAIN (After the first dose, her left arm was sore) had resolved. On 18-Mar-2021, LETHARGY (Lethargy after first shot) had resolved. At the time of the report, WEIGHT INCREASED (Weight gain after first shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were mentioned.  Patient reported that the symptoms, sore left arm and lethargy lasted for 2-4 days.  No treatment details were reported.   This case was linked to MOD-2022-511431, MOD-2022-511425 (Patient Link).   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture) and ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5 ml and is not immunocompromised) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer vaccine (from lot FF2589) on 16-Sep-2021 and Pfizer vaccine (from lot FF8841) on 08-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture) and ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5 ml and is not immunocompromised). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture) and ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5 ml and is not immunocompromised) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication were provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Follow up contains patient identifiers.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: got 50 mcg instead of 100 mcg; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (got 50 mcg instead of 100 mcg) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (18 years ago), Sleep apnea (for 4 years), Hypothyroidism (for 4 years) and Ringing in ears (for 4 years). Concurrent medical conditions included Immunocompromised (his immune system is probably compromised,).   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 50 microgram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (got 50 mcg instead of 100 mcg). At the time of the report, ACCIDENTAL UNDERDOSE (got 50 mcg instead of 100 mcg) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported. Patient asked the local pharmacist who gave him third dose and pharmacist said patient can get a 4th dose, after 5 month which is on 2APR-2022. Patient reports no side effects.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: 2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2022 and was forwarded to Moderna on 15-Mar-2022.    This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On 25-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Serious itching on the skin on lower legs after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Serious itching on the skin on lower legs after 2nd dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Serious itching on the skin on lower legs after 2nd dose). On 12-Jul-2021, PRURITUS (Serious itching on the skin on lower legs after 2nd dose) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-512258, MOD-2022-512313 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 11:00 (Lot number: EN6207) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 12Mar2021, outcome "recovered" (12Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 12Mar2021, outcome "recovered" (12Mar2021), described as "Fatigue".  Additional information: The reporter stated that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. All symptoms Lasting over 24 hrs. After 24 hrs, severe joint pain remains. First dose had a headache and fatigue for a few hrs. 2nd dose fever, headache, fatigue for 6-8 hrs. 3rd dose makes me never want to get a 4th if recommended. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, SARS-CoV-2 test
Clinical narrative: fatigue; dizziness; 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 received bnt162b2 (BNT162B2), administration date 21May2021 (Lot number: EW0187) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood Pressure" (unspecified if ongoing), notes: Other medical history: Blood pressure, weight; "Weight" (unspecified if ongoing), notes: Other medical history: Blood pressure, weight; "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 21May2021, outcome "not recovered", described as "fatigue"; DIZZINESS (non-serious) with onset 21May2021, outcome "not recovered", described as "dizziness". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, dizziness.  Additional information: 1st shot dizziness and fatigue within 10 min of shot reported to provider. No other vaccine in four weeks: No Covid prior vaccination. Patient tested Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, SARS-CoV-1 test
Clinical narrative: heartrate at over 100; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jun2021 (Batch/Lot number: unknown) at the age of 15 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 , single, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 21May2021, when the patient was 15 years old, for Covid-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "recovered" (2021), described as "heartrate at over 100". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient heartrate at over 100 resting for a few hours slowly coming back to normal overnight after second dose. No received other vaccine in 4 weeks. Patient had not covid-19 prior vaccination and post vaccination not tested covid-19. On 19Dec2021, patient received Pfizer covid-19 booster at 12pm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: developed swelling in his normal arthritic area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "developed swelling in his normal arthritic area".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes under armpit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 54 years 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: LYMPHADENOPATHY (non-serious) with onset 29Dec2021, outcome "unknown", described as "swollen lymph nodes under armpit".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain of right deltoid since injection, still ongoing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Oct2021 (Lot number: ff2590) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Pain of right deltoid since injection, still ongoing". The event "pain of right deltoid since injection, still ongoing" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: It was reported that the patient did not administer other vaccine in four weeks, and no other mediation administered in two weeks. Patient never had Covid prior vaccination and not tested for Covid post vaccination. No known allergies were reported. The AE resulted in Emergency room/department or urgent care]]. Facility type vaccine was Pharmacy or Drug Store  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy, SARS-CoV-2 test, Ultrasound scan, X-ray
Clinical narrative: swelling in the area of both my left and right supraclavicular nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 10:30 (Lot number: EP7534) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure - controlled with medication" (unspecified if ongoing), notes: Verbatim: High blood pressure - controlled with medication. Concomitant medication(s) included: LOSARTAN; AMLODIPINE. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25Mar2021 14:00, outcome "not recovered", described as "swelling in the area of both my left and right supraclavicular nodes". The event "swelling in the area of both my left and right supraclavicular nodes" 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 lymphadenopathy.  Additional Information: Patient did not receive other vaccine in four weeks. Patient received Losartan, Amlodipine medications in two weeks. Somewhere between his 1st and 2nd dose patient noticed a significant swelling in the area of both his left and right supraclavicular nodes. At first he was not sure what the significance was as he had no pain. The swelling continued and he saw his primary doctor in August. He was not sure what was happening so he ordered an ultrasound, bloodwork and a lung xray to rule out lymphoma and explained to him the timing of when it happened and we both suspected it could be from the vaccines. All of his tests showed nothing remarkable or concerning. He was put on Amoxicillin and Prednisone. As he was sending this information he still have the same large swelling in both nodes. Nothing has changed in almost 10 months. he contacted the CDC with this same information but was never given a response. he would like to know what possible recourse as to what type of specialist to see for any type of remedy for his situation. Patient received AE treatment of Ultrasound, bloodwork, x-ray, antibiotics, prednisone. Patient did not had covid prior vaccination. Patient had tested covid post vaccination. patient had none known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging, Mass, SARS-CoV-2 test
Clinical narrative: I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen; I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8729) at the age of 41 years as dose 2, single and administered in arm left, administration date 12Mar2021 (Lot number: EN6306) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROBIOTICS; DIGESTIVE ENZYMES; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]. The following information was reported: LYMPHADENOPATHY (non-serious), MASS (non-serious) all with onset 12Mar2021, outcome "recovered with sequelae" and all described as "I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen". The event "i have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen" and "i have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient had no other medical history and no known allergies. The patient had not received any other vaccine in four weeks prior to vaccination. Adverse event reported after each Covid vaccine. Lump took weeks to go down. Recovered with lasting effects. Prior vaccination, the patient was not diagnosed with Covid. Post vaccination the patient was tested for Covid-19 through nasal swab, result was negative. Got an MRI of the area in Aug2021, no cancer detected.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, SARS-CoV-2 test
Clinical narrative: granuloma annulare; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 (Lot number: FF2690) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose 2, Single, Lot No: EN6 200, Location of injection: Arm Left), administration date: 19Feb2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Single, Lot No: EL8982, Location of injection: Arm Left), administration date: 20Jan2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: GRANULOMA ANNULARE (non-serious) with onset 24Oct2021, outcome "recovering", described as "granuloma annulare". The event "granuloma annulare" 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 granuloma annulare.  Additional information: No other vaccine in four weeks. Other medications in two weeks: Only multi vitamins and Zyrtec antihistamine. No Covid prior vaccination. Covid tested post vaccination. No Known allergies. Ae treatment: Skin lesion biopsy and then high dosage cortisone.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: tingling in hands/ feet- worse in the mornings.; Intermittent tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient was 29 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 15Dec2021. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; FISH OIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown.), administration date: 20Jan2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), administration date: 30Dec2020, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 15Oct2021, outcome "recovering", described as "tingling in hands/ feet- worse in the mornings."; TINNITUS (non-serious) with onset 15Oct2021, outcome "recovering", described as "Intermittent tinnitus". Therapeutic measures were not taken as a result of paraesthesia, tinnitus.  Additional information: patient did not have covid prior vaccination. patient did not have covid tested post vaccination. Known allergies reported as No. Patient did not received other vaccine in four weeks .Other medications in two weeks reported as Prenatal, fish oil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 10Apr2021 (Lot number: EW0151) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose 1, Single, product COVID 19, brand Pfizer, lot number EP7534,), administration date: 20Mar2021, when the patient was 64 years old, for COVID-19 immunization, reaction(s): "No issues w/1st dose".  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional information: No issues w/1st dose, tiredness the day following 2nd dose.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Shots 1 & 2 only gave me sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01May2021 (Lot number: EW0173) at the age of 44 years as dose 2, single and intramuscular, administered in arm left, administration date 12Apr2021 (Lot number: EW0158) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shell fish" (unspecified if ongoing), notes: known allergies: shell fish; "Cow dairy milk" (unspecified if ongoing), notes: known allergies: cow dairy milk; "Gluten" (unspecified if ongoing), notes: known allergies:gluten. Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; CALCIUM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Shots 1 & 2 only gave me sore arm". The event "shots 1 & 2 only gave me sore arm" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: No other vaccines were received within 4 weeks prior to the COVID vaccine by patient. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been not tested for COVID-19.Patient received multi vitamin within 2 weeks of vaccination. Vaccine was not administered at Facility. No Relevant tests or specific relevant for Thromboembolic events with Thrombocytopenia test was done. No seriousness criteria was reported by patient which could result in death/Life threatening/prolonged hospitalization /Disabling/Incapacitating or Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 14:30 (Lot number: EW0164) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cat allergy" (unspecified if ongoing), notes: Cat allergy. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity. Additional information: No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. Covid tested post vaccination. The patient had no known allergies. The patient had received dose 2 COVID 19 Pfizer vaccine. First Vaccine, the patient had a sore left arm for the first few days. Second Vaccine the patient experienced a sore left arm, sore lymph nodes/armpit (left side), fever, fatigue for 2 days after vaccine (01May to 02May); sore lymph nodes lasted about a week.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015297 Same reporter and product; different events and dose
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Computerised tomogram, Disorientation, Dizziness
Clinical narrative: 3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet; 3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet; 3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP, Physician and Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 10Sep2021 12:30 (Lot number: FC3183) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Tramadol, reaction(s): "Known allergies: Tramadol". The following information was reported: DIZZINESS (non-serious), DISORIENTATION (non-serious), BALANCE DISORDER (non-serious) all with onset 02Oct2021 12:00, outcome "not recovered" and all described as "3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet". The event "3.5 hours after first pfizer vaccine i became extremely dizzy, disoriented and unstable on my feet", "3.5 hours after first pfizer vaccine i became extremely dizzy, disoriented and unstable on my feet" and "3.5 hours after first pfizer vaccine i became extremely dizzy, disoriented and unstable on my feet" 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 dizziness, disorientation, balance disorder.  Additional information: The patient was treated with Steroid for 1 day 26Jan2022 unable to take. The seriousness criteria was provided as persistent. The patient neither have Covid prior vaccination not had tested positive post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks.  No follow-up attempts are possible. No further information is expected