chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache 5days following 1st vaccine; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 57-year-old female patient received the first dose of bnt162b2 ((PFIZER BIONTECH COVID-19 VACCINE)) intramuscular, administered in the left arm on 23Dec2020 (batch/lot number: EK5730) at the age of 57 years old, as DOSE 1, SINGLE for COVID-19 immunization. Relevant medical history included: "Endometrial PolyP", start date: 29Nov2012 (unspecified if ongoing), notes: with Laparoscopic Supracervical Hysterectomy; "Adenomyosis", start date: 29Nov2012 (unspecified if ongoing), notes: with Laparoscopic Supracervical Hysterectomy; "Laparoscopic Supracervical Hysterectomy" (unspecified if ongoing); "Intermittent A-Fib", stop date: 29Apr2014, notes: with successful A-Fib ablation; "A-Fib ablation" (unspecified if ongoing); "Hypothyroid", start date: 18Nov2019 (unspecified if ongoing), notes: Started oral Synthroid; "High blood pressure" (unspecified if ongoing). There was no family medical history relevant to the adverse event. Concomitant medication included: LISINOPRIL taken for hypertension. The following information was reported: HEADACHE (non-serious) with onset 28Dec2020, outcome "unknown" described as "headache 5days following 1st vaccine."  No follow-up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Wrong Route (SC, IM, etc.)-, Additional Details: Selection based on what I was told by staff who observed injection site on 10/16.
I RECEIVED PHONE CALL FROM HER PHYSICIAN ON REPORTING THAT SHE HAS ADVERSE EVENT FROM VACCINATION THAT SHE RECEIVED ON SATURDAY, 9/23/2017. PER PHYSICIAN, IT IS RED AND HER UPPER ARM IS SWOLLEN. PATIENT RECEIVED BOTH VACCINATION ON RIGHT ARM AND TOP INJECTION SITE WAS LITTLE PUSSY WHERE SHE RECEIVED FLU SHOT. I AM TRYING TO GET HOLD OFF PATIENT BUT NO LUCK.  I CALLED HER 3 TIMES AND ALSO LEFT MASSAGE TO CALL ME BACK.  I HAVE NOT HEARD BACK YET.
Lt upper arm affected by 2nd Anthrax, erythema present. Circular area measuring 1 1/2 x 2 cm. Soldier stated that the area was much bigger in diameter. (+) pain.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient received 2nd dose of moderna 2/10/2021. Patient has PMH significant for malignant tumor of urinary bladder, Ischemic heart death, t2dm, AF. Patient passed away on 3/19/2021 under hospice care.
This spontaneous report as received from a nurse refers to a patient of unknown age. On unknown dates the patient were vaccinated with a dose of 0.5 ml LIQUID PEDVAXHIB (lot#, expiration date unspecified), intramuscular at 2 months of age, 4 months of age and 7 months of age. No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Lymphedema after vaccine / Lymphedema got worst after the second dose; she started the lymphedema therapy, and for her second dose; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema after vaccine / Lymphedema got worst after the second dose) and CONDITION AGGRAVATED (she started the lymphedema therapy, and for her second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (Lymphedema after vaccine / Lymphedema got worst after the second dose) and CONDITION AGGRAVATED (she started the lymphedema therapy, and for her second dose). At the time of the report, LYMPHOEDEMA (Lymphedema after vaccine / Lymphedema got worst after the second dose) and CONDITION AGGRAVATED (she started the lymphedema therapy, and for her second dose) outcome was unknown.            concomitant medications include - Blood pressure medication . No treatment medications provided. patient stated that- she did manual therapy after second dose, so the arm did not blow up.   This case was linked to MOD-2021-292373 (Patient Link).
Arm became extremely red, hot, swollen and painful and continued for about 8 days, diminishing slightly each day after about 5 days. I had alternating chills and sweats for about 3 days. Felt tired and lacked energy for about 3 days.
I woke up in the middle of the night with some weird burning pain throughout my body. Like a rush of heat from head to toe. After that I started getting really bad tachycardia. I could not get back to sleep that night. The following day I started having the burning pain again. Like a sunburn but its not there. That lasted for about a week. Then it slowly went away. It came back maybe about 1 week or 2 weeks later. With that I started having nausea, diarrhea, and vomiting along with the pain. I had a really bad headache especially on the right side of my head. When I would stand up I would feel pressure in my head. I became very dehydrated with the vomiting and diarrhea. I had to go to the ER and get fluids. They ran blood work and chest x-ray. Everything came back normal. Since then I have been having the pain in my arms and my body along with elevated heartrate and heart palpitation. I am going to see my PCP on Friday for everything.
Feeling sick, chills, cold sweats, fatigue, irregular  heartbeat,  loss of appetite.
A large red circle grew around the injection site, swelled, then became hot and itchy. Continued to grow over next days. Largest diameter so far is 4 inches. Treated with Benadryl at home because no access to weekend healthcare.
Pt's mother called our phone center seeking advice because pt had a fever, was having some jerking of extremities and wouldn't walk. Referred to ER by triage nurse. Found to have a temperature of 106F and rigors. Treated with antipyretic with symptom resolution.
Positive for COVID; Positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "anxiety and depression" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "macular degenerative" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE oral taken for hypertension; LISINOPRIL oral taken for blood pressure abnormal; AMLODIPINE oral taken for blood pressure abnormal; FLUOXETINE oral taken for depression; CARVIDIL oral taken for blood pressure abnormal; METFORMIN oral taken for diabetes mellitus; ROSUVASTATIN taken for blood cholesterol abnormal; NOVOLOG; PRESERVISION AREDS 2 oral taken for macular degeneration. Vaccination history included: shingles shot, administration date: 21Oct2021, when the patient was 63-year-old, for Immunization; flu shot, administration date: 21Oct2021, when the patient was 63-year-old, for Immunization; 2nd shingles, administration date: 26Oct2021, when the patient was 63-year-old, for Immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "unknown" and all described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive, notes: Result: positive; Unit: Not Provided; (18Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Tested positive Monday, 18Jul2022. Clarifies she tested positive for COVID on 20Jul2022. She woke up Monday with a bad sore throat and chest was hurting, pain. Thought she had bronchitis and her sore throat was less and thought it was allergies because she was sneezing. Tuesday was not feeling better by Wednesday and doctor wouldn't let her go in. Hasn't been anywhere since Monday. She did a home COVID test. No AE(s) require a visit to Emergency Room and Physician Office. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations: None. No Family Medical History Relevant to AE(s). She has never had this taste with any medication. She has had a metal taste but not like this was. Clarifies this was years ago and recalls it because she was raising kids. Doesn't recall name of medication, NDC, lot or expiry. Patient took Paxlovid.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID-19 Treatment; COVID-19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Lot number: 032M20A), in right arm, on 05Apr2021 as dose 2, single (Lot number: 019B21A), in right arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 011F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "bronchitis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX SINUS [OXYMETAZOLINE HYDROCHLORIDE]; NIGHTTIME COLD & FLU RELIEF. Past drug history included: Clindamycin, reaction(s): "Allergy"; Gantrisin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (08Jan2023) Negative, notes: Tested negative 08Jan2023; (10Jan2023) Positive, notes: Runny nose, sneezing, cough , congestion tarted again 10Jan2023; (11Jan2023) Positive, notes: Tested positive for Covid 11Jan2023. Therapeutic measures were taken as a result of vaccination failure, covid-19, which includes Paxlovid (lot: GF9573) from 31Dec2022 to 04Jan2023.
Prior to vaccination on 6/12/21 patient had received Moderna Vaccination on 5/15/21. Patient arrived at clinic on 6/12/21 and received Pfizer vaccination. Both vaccine card and registration were overlooked during procedure and patient was incorrectly given second dose.
some kind of pain; rash is still there; spread even more down her arm; left arm started to swell up; small rash; was itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm started to swell up), RASH (small rash), PRURITUS (was itchy), PAIN (some kind of pain) and RASH (rash is still there) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (left arm started to swell up), RASH (small rash) and PRURITUS (was itchy). On 18-Apr-2021, the patient experienced RASH (spread even more down her arm). On 19-Apr-2021, the patient experienced PAIN (some kind of pain) and RASH (rash is still there). At the time of the report, PERIPHERAL SWELLING (left arm started to swell up), RASH (small rash), PRURITUS (was itchy), PAIN (some kind of pain), RASH (rash is still there) and RASH (spread even more down her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On 01-APR-2021, the subject experienced chest pain. On 01-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and shortness of breath. This report was non-serious.
Pt was given her Covid Booster and immediately became weak, dizzy and unresponsive Pt was unresponsive to sternal rub.  No rhythmic body movements, incontinence, other sx of seizure activity.  After a few minutes, pt began moving eyes somewhat and was able to blink on command.  Not able to follow any other commands.  911 called, EMS arrived to transport pt to hospital to r/o seizure.  Thought to be less likely vagal response to inj given normal HR and BP while unresponsive.
pt slept for an hr p/returning home when awoke began a cont high-pitched screaming which lasted until 5AM the next morning; refused to eat & could not be comforted; had a fever but mom doesn't remember how high temp was;
Entire shoulder, upper arm grossly swollen, very hard, painful to touch and unable to move arm,  shoulder without excrutiating pain.
Site: Pain at Injection Site-Mild, Systemic: Nausea-Mild
Patient presented to clinic for an RSV vaccine. Arexvy was given. Patient should have received Abrysvo, which is approved for pregnant women. Abrysvo was not available in clinic. Post vaccine symptoms include headache, muscle aches, soreness at injection site. 36 weeks gestation in pregnancy, due date is November 25, 2023
A report has been received from a Physician concerning, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST started on 24-Sep-2013. The patient experienced tested positive for Influenza A and B, positive for flu B which started on 27-Sep-2013. The outcome of the event of tested positive for influenza A and B, positive for flu B is unknown. The report was considered to be non-serious.
On 9/17/22 I received the vaccine booster.  On 10/22/22 I tested positive for COVID.  I was prescribed Paxlovid.  It seemed to be a mild case.  On 12/08/22, my blood pressure began to drop.  On 12/09/22 I felt very lethargic and was advised to go to the emergency room.  I was diagnosed with new onset diabetes with diabetic ketoacidosis.  My blood sugar was brought under control and I was released on 12/14/22.  I do not know if my diabetes has anything to do with the vaccination, with my COVID illness or possibly getting COVID after the vaccination.  I have been participating in a program to monitor my health after vaccination and they suggested I report it here.
This spontaneous report was received from a consumer refers to 2 children of unknown age. On an unknown date, the patients were vaccinated with VARIVAX. Concomitant medications not reported. On an unknown date, the patients experienced rash at the injection site. They were also coughing and congested and had a fever. It was confirmed that they had experienced a mild case of chicken pox and a double ear infection. The outcome of the adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Today is May 13, 2021 and I have not had a menstrual period since I received the second COVID vaccine on February 19, 2021.
Injection sight pain onset soon after shot lasted 2 days, fever and headache occurred that evening had subsided by next morning, trouble swallowing occurred a few minutes after vaccination lasted for 1/2 hour.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:31 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 39.33 for dose administered on 15-Apr-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
17 year old received the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the vaccine) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Was administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment medications reported.   This case was linked to MOD21-148609, MOD21-148614, MOD21-148534, MOD21-148595 (Patient Link).
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored PROQUAD (Merck) lot# L014401, expiration date 23-OCT-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
15 X 8-1/2 cm erythematous slightly raised injection site on anterior left thigh.
Scores of non erythematous papular itchy lesions, waist on lower extremities and face, as of my exam 6/30/14. No fever.
pt recv vax & devel an inj site rxn characterized by erythema, induration & tenderness;
This spontaneous reports as received from a licensed practical nurse (also reported as registered nurse), refers to a 20 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 27-FEB-2014, the patient was vaccinated with M-M-R II (Lot number reported as J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.