chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days after vaccine it feels like a common cold with coughing and with congestion; Two days after vaccine it feels like a common cold with coughing and with congestion; Two days after vaccine it feels like a common cold with coughing and with congestion; Minor dizziness; Minor soreness at the site of injection the day after and continuing; dose number 5; dose number 5; This is a spontaneous report received from non-contactable reporter (Consumer). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN; ATORVASTATIN; THYROXINE. Vaccination history included: Tetanus vaccine (negative reaction to tetanus vaccine 5 weeks earlier); Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022 at 10:00, outcome "unknown" and all described as "dose number 5"; VACCINATION SITE PAIN (non-serious) with onset 01Oct2022 at 22:00, outcome "not recovered", described as "Minor soreness at the site of injection the day after and continuing"; DIZZINESS (non-serious) with onset 02Oct2022 at 22:00, outcome "not recovered", described as "Minor dizziness"; NASOPHARYNGITIS (non-serious), COUGH (non-serious), NASAL CONGESTION (non-serious) all with onset 02Oct2022 at 22:00, outcome "not recovered" and all described as "Two days after vaccine it feels like a common cold with coughing and with congestion". Therapeutic measures were not taken as a result of vaccination site pain, nasopharyngitis, cough, nasal congestion, dizziness.  Additional information: Patent did not have Covid-19 prior vaccination. Patient did not test positive for Covid-19 post vaccination. No known allergies. Thyroid replacement medicine, negative reaction to tetanus vaccine 5 weeks earlier.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
migraines, tingly body, tight left side of face, stiff neck, cloudy mind
I did not have a reaction to the vaccine. On 11/22/2022, I started not feeling well with symptoms like I had a cold. I had congestion, a sore throat, minor cough but no fever. On 11/25/2022, I tested positive for COVID-19 with a home test. I contacted my doctor and was given the prescription PAXLOVID. On 12/01/2022 I tested negative for COVID-19. I continue to have trouble with brain fog and congestion.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      On or around 28-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was hospitalized due to the event. On an unspecified date, the patient was treated by a physician for shingles. At the reporting time, the patient had not recovered from shingles. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
FULL BODY ITCHING, RASH, C/O FEELING LIKE FACE SWELLING.
Unexpected change in menstrual cycle. Breakthrough bleeding beginning 10 days after 2nd covid shot (pfizer)
headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-JAN-2019, the patient was vaccinated with VAQTA 25/0.5 (units not provided),  lot # N023953, which expired on 05-NOV-2018 (dose, route and anatomical location were not reported). No adverse event was reported. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1901USA002589:
No adverse event/ pt is fine; Caller reported administration of PROQUAD after product experienced temperature excursion.; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies.  On 06-OCT-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneously in left vastus lateralis (LVA) (also reported as left vast laterials), lot # T015598, expiry date 02-NOV-2021 (dose was not provided) as immunization for the prevention of measles, mumps, rubella and varicella at public health clinic/ hospital. On the same day, the patient was vaccinated with diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (KINRIX) and influenza virus split virion 3v vaccine inactivated (FLULAVAL). The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced temperature excursion of 23.7 Fahrenheit degrees (range 15 to 46 Fahrenheit degrees) for 2 hours and 19 minutes. There was no previous temperature excursion. Digital data logger was involved. The patient did not sought medical attention and did not receive any treatment (also reported as it was unknown if the patient required any treatment). The patient was fine. No adverse event was reported.
PT C/O PAIN IN BOTH ARMS THEN CHEST PAIN, NO CHEST PAIN ON FRIDAY OR SATURDAY, THEN CHEST PAIN RETURNED ON SUNDAY RETURNED TO CLINIC ON 5-13-19 WITH CONTINUED INTERMITTENT CHEST PAIN
He also had some mild lightheadedness and felt a little flushed after the second shot; He also had some mild lightheadedness and felt a little flushed after the second shot; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (He also had some mild lightheadedness and felt a little flushed after the second shot) and DIZZINESS (He also had some mild lightheadedness and felt a little flushed after the second shot) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 prophylaxis.     The patient's past medical history included Stroke in 2001. Previously administered products included for Product used for unknown indication: Influenza shot. Past adverse reactions to the above products included No adverse event with Influenza shot. Concomitant products included LOSARTAN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-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 FLUSHING (He also had some mild lightheadedness and felt a little flushed after the second shot) and DIZZINESS (He also had some mild lightheadedness and felt a little flushed after the second shot). At the time of the report, FLUSHING (He also had some mild lightheadedness and felt a little flushed after the second shot) and DIZZINESS (He also had some mild lightheadedness and felt a little flushed after the second shot) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 18-Nov-2021, the patient received third booster dose of Moderna monovalent vaccine of batch number 069F21A. On 18-Aug-2022, the patient received fourth booster dose of Moderna monovalent vaccine of batch number 011B22A.  No treatment medications was reported.   This case was linked to MOD-2023-710973 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 27Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 13Jul2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Currently treating kidney stone" (ongoing), notes: Currently treating kidney stone and also enlarged prostate; "enlarged prostate" (ongoing), notes: Currently treating kidney stone and also enlarged prostate; "known allergies Sea food" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with PF-07321332, ritonavir (PAXLOVID).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient received two doses of GARDASIL 9 on 5/12/2020; patient received two doses of GARDASIL 9 on 5/12/2020; patient received two doses of GARDASIL 9 on 5/12/2020; This spontaneous report was received from a physician and refers to a 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 12-MAY-2020, the patient received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (the second dose with lot #1621934 verified to be a valid lot number for syringe and expiration date 29-JAN-2022) (lot # and expiration date for the first dose, strength, exact doses, site of administration were not provided) for prophylaxis (overdose and inappropriate schedule of product administration). No additional adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
He got his vaccine, sister talked to him the night before and he complained of a soreness in the arm and achiness, and said he was going to bed.  She made plans to take him to lunch the next day and it had been a month since she saw him.   She went to see him on 2/2/22 at 11:00 AM and found him on his stomach purple and he was dead.  She called 911 who called the coroner and he was determined to have died from cardiac dysrhythmia, MI and diabetes type I.   After MI interval was minutes, diabetes was years, and cardiac dysrhythmia was seconds.    He had recent had a cardiac work up within the last year including stress test and nothing was abnormal.  He also had a TEE which was also negative for any heart problems.   He has never had any cardiac issues other than having low blood pressure which was due to medication which was discontinued and his BP came back to normal.  He did have some episodes of tachycardia but was septic at that time in the hospital and once the infection cleared up he was fine.    He did have COVID last spring and did have the antimicrobial infusion.  He did not have a lot of symptoms from the COVID.  His sister didn't think he had COVID and went to the doctor who swabbed him and it was positive and she ordered the infusion.  Due to his health issues the infusion was ordered and had no reactions and was fine.
Patient received COVID Pfizer vaccine at approximately 0955 and reported back to unit. Medical was called to unit at approximately 1030. Upon arrival to unit patient was laying down on floor and stated she felt hot and achy all over.  Patient's  vitals in unit: bp 156/126, hr 135, R 22, 02 sat 98% on room air. Patient has strong history of anxiety.   Patient brought to medical for further evaluation: Face/chest flushed, hyperventilation, tachycardia, skin diaphoresis/clammy. No skin hives. No  wheezing. No vomiting/diarrhea No swelling lips/face. 02 @ 2 L given, blood sugar 126, last bp 129/77-hr 109 EPIPEN given via R thigh, EKG shows sinus tachycardia, possible inferior infarct, Abnormal ECG. Will send pt to local ED.   *Report from ED received: indeterminate troponin and elevated WBC count, also with elevated BUN and creatinine.  Pt will likely be held overnight for observation for suspected cardiac issues. Vaccine reaction not suspected at this time.
I received my covid vaccine on Saturday January 16, 2021, at 9:30am.  On Saturday January 23, 2021, at 1:00pm I noticed a lump appear by my left collar bone.  I went to a doctor on Monday 2/1/21, at 8:45am.  The doctor at the walk in clinic told me I needed to report this to the hotline as a adverse effect to the vaccine.  The doctor stated it was a swollen lymph node.  This swollen lymph node is on the same side as the injection was administered.  The doctor is calling it lymphadenopathy supraclavicular.  I am waiting to have a sonogram done on the lymph node.  I have been extremely fatigued and my appetite has been off since having this vaccine as well.
Patient vaccinated 2/26/2008-that night at 11:30 pm she got dizzy, weak, sweaty she just went to bed.  The next morning she went to work, could not concentrate had trouble entering data and broke out in hives.  Today she has a raised red area at injection site and redness to the elbow the confusion has almost resolved she complains of fatigue and muscle aches she did not work today. No Benadryl was taken due to sedation.
lower dose administered; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (lower dose administered) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   In February 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In February 2022, the patient experienced ACCIDENTAL UNDERDOSE (lower dose administered). At the time of the report, ACCIDENTAL UNDERDOSE (lower dose administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
had shots, still get them / suspected vaccination failure; had shots, still get them; hurt; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media.  The patient get them, but not like these folks. The patient reported that as he/she got older he/she would. The patient had his/her shots, but patient still got them and hurt no lie. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE, PANTOPRAZOLE, METOPROLOL and AMITRIPTYLINE for an unknown indication.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable Concomitant medications included statin Treatment medication included antibiotics and steroid injection
Urticaria and joint pain since flu shot in 10/13. She was seen in our office after seeing doctor at clinic. Steroids Rx'd orally, IM, and also antihist. given.
p/vax pt began to exp soreness & pain to lt flank & kidney area;no fever, no hematuria;no rx given;
Painful injection reported by patient. Patient presented back to the clinic 3 days later reporting continuous pain with difficulty sleeping at night. Difficulty moving right arm. No obvious redness or swelling noted by provider. Treatment with FLEXERIL, LODINE, TYLENOL.
Tremendous amount of fatigue, could not get out of bed; flu like symptoms; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tremendous amount of fatigue, could not get out of bed), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (Tremendous amount of fatigue, could not get out of bed), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache). On 11-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. On 22-Mar-2021, FATIGUE (Tremendous amount of fatigue, could not get out of bed) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment with Tylenol.
Sore, swollen left arm. Fever, nausea, headache. Symptoms developed 24 hours after injection and continued for 48 more hours. Patient was unable to use left arm due to pain and missed 2 days of work. Fever, nausea, headache resolved, but pain in arm continues 4 days post-vaccine administration.
Muscles around hip replacement were affected for 2-3 days. Sore muscles in the buttocks, hip and quad. It only affected this site.  It went away but I found it odd.  I got the usual bit of nausea, wooziness, fatigue and sore arm, but those were expected
nausea; back pain; low energy; Fatigue; muscles pain; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), BACK PAIN (back pain), ASTHENIA (low energy), FATIGUE (Fatigue) and MYALGIA (muscles pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and LISINOPRIL for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced NAUSEA (nausea), BACK PAIN (back pain), ASTHENIA (low energy), FATIGUE (Fatigue) and MYALGIA (muscles pain). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), BACK PAIN (back pain), ASTHENIA (low energy), FATIGUE (Fatigue) and MYALGIA (muscles pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
REDNESS AND MUSCLE PAIN IN THE RIGHT ARM (ADMINISTRATION SITE), FLU-LIKE SYMPTOMS, BODYACHE.
This spontaneous report as received from a pharmacist refers to a 62 years old female patient with no known drug allergies. On 23-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as H012579, exp date 28-SEP-2013) subcutaneously in the "back of the arm in the axilla space, the part of the arm that jiggles." No other co-suspects were reported. No concomitant medications were reported. On 25-OCT-2012 the patient developed "a red, raised, itchy area about the size of her palm at the injection site". The patient called the pharmacist to seek medical attention. No treatment was given for the events. No lab diagnostics studies were performed. At the time of the report, the outcome of a red, raised, itchy area about the size of her palm at the injection site was reported as not recovered. The outcome of "Received ZOSTAVAX subcutaneously in the back of the arm in the axilla space the part of the arm that jiggles" was unknown. Additional information is not expected.