chrisvoncsefalvay/vaers-outcomes huggingface dataset:
called 05/03/2007 complaining of tongue swelling and rash.  Was told to go to emergency room.  I called on 05/04/07 for follow up and was told by father that patient was fine, only complained of "tongue heaviness and had a few pimples", did not go to er.  Again was called 05/09/2007 when physician not in office, with arm swelling, was told to go to emergency room since there was no physician available for 24 hours to examine patient.
Approximately 10-14 days after receiving the Pfizer 2nd Covid Vaccine a 64 year old male developed constant dizziness with any type of movement and constant ringing in the ear which as of 5/12/23 have NOT subsided. Actually symptoms have gotten worse. He has seen his primary care physician twice, seen an Ear/Nose/Throat doctor, Opthamoligist, went to balance therapy, and seen a neurologist. No one can find anything medically wrong. He has had hearing testing, blood work, and MRI on brain. Both the balance therapist and neurologist claim they see people on a regular basis that have these same symptoms soon after they received the Covid vaccine. My dear friend asked the neurologist if they would go away and the response was "you will know in 20 years". The neurologist recommended Hyperbaric Oxygen treatment which is not covered by insurance. Need 20 treatments at approx. $500 per treatment and only comes with 50% success rate. We tried getting him an appointment at the Clinic and it will be 1 year to see a neurologist. We are trying to determine if any research has been done on the side effects from the vaccine since there are people struggling on a daily basis, or, is there anything to counter the vaccine. My friend has terrible balance due to the dizziness and is afraid to do anything. He was prescribed Meclizine for the dizziness and that makes him very sleepy and does not help the dizziness. We are at wits end. I have contacted the CDC, Health Dept., State Health Dept (Can't get to speak with anyone or leave a message), County, Health Dept., and Pfizer. All just say you need to see your primary care physician. No one seems to care that people are suffering on a daily basis. It is not fair they need to suffer so. No one states whether anything is being researched or if there are any known resolutions . You are our last resort other than going to the news media. Nothing medically wrong. Has high blood pressure that is being treated
extremely cold for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (extremely cold for 1 day) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FEELING COLD (extremely cold for 1 day). At the time of the report, FEELING COLD (extremely cold for 1 day) outcome was unknown.            No Treatment information was reported.
granuloma annular/on both arms, hands, neck and face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for Covid-19 immunization. The following information was reported: GRANULOMA ANNULARE (non-serious), outcome "not recovered", described as "granuloma annular/on both arms, hands, neck and face". Therapeutic measures were taken as a result of granuloma annulare.  Additional information: The patient has a generalized case of granuloma annular after receiving (Pfizer) COVID-19 booster shot. She has been receiving treatment (unspecified) for the past 10 months with only slight improvement. It was on both arms, hands, neck and face. Patient asked if she should be reporting this reaction in another way.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient stated throat felt "funny" and scratchy, difficult to swallow. Paramedics were called, client was examined. No swelling of tongue or lips they advised to take 1/2 a BENADRYL tab. Patient took the tablet, stated she felt better a few hours after.
Patient self-reported that she received her injection subq vs. IM/deltoid as intended.  She developed a very large lump at the injection site requiring an ED visit and antibiotics.  She also missed one day of work.
Nearly fainted after the injection. I was very close to passing out, though I soon regained consciousness. My heart rate dropped to 40bpm with the blood pressure being 71/40. After 10 minutes of laying down in front of the pharmacy I felt better with my feet elevated, though I was tired for the rest of the day with an acute headache.
The swelling is associated with decreased mobility, fever and warmth. The patient denies any appetite change, bleeding, blistering, bruising, chest pain, diaphoresis, dyspnea, fatigue, generalized weakness, headache, joint pain, lymph.
second dose in error; fatigued / tired; sore throat; fever; was very sick; played very low all weekend; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 28-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Concomitant products included HBV (Engerix B adult).   On 4th June 2020, the patient received the 2nd dose of Engerix B adult. On 4th June 2020, the dose was an unknown dose. On 4th June 2020, unknown after receiving Engerix B adult and an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too short. In June 2020, the patient experienced fatigue, sore throat, fever, sickness and weakness. On an unknown date, the outcome of the fatigue was not recovered/not resolved and the outcome of the sore throat, fever, sickness, weakness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fatigue, sore throat, fever, sickness and weakness to be related to Engerix B adult.  Additional details were provided as follows: The reporter stated that, after vaccination, the patient was very sick over the weekend with a fever, sore throat, very fatigued. The patient played very low all weekend. The patient received 1st dose on 1st June 2020 and 2nd dose on 4th June 2020, which led to shortening of vaccination schedule. The reporter consented to follow up.
syringe leaked at hub of syringe when plunger was pushed / no AE; syringe leaked at hub of syringe when plunger was pushed down. Vaccine ran down the patient's arm during injection / no AE; syringe leaked at hub of syringe when plunger was pushed down. Vaccine ran down the patient's arm during injection / no AE; syringe leaked at hub of syringe when plunger was pushed / no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old female patient who was vaccinated with 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6695LA (Expiry date 02-Jun-2020) via intramuscular route in the left deltoid on 25-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to vaccine underdose and Accidental exposure while administering drug .  It was also a case of syringe leak and Exposure via skin contact.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
tested + for covid initally on  2-9-22 and on same date + at Med Center 2-9-22 and 2-17-22.  Deceased 2-22-22.
This is a spontaneous report from a contactable consumer or other non-health care professional (patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: unknown; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient experienced contracted COVID-19 on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test positive on an unspecified date. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Redness, warmth, swelling right thigh concerning for possible cellulitis. Seen in Urgent Care and started on Clindamycin. Follow-up with PCP on 8/22 showed significant improvement ? strong site reaction to KINRIX vs. cellulitis.
I don't get headaches -- day after mild headache --  2 days after 8-10 ocular migraines and a good headache.   3 days after things started to clear.     Chronic ache in injection right arm for over a day ..  Started several hours after injection.
Patient received first dose of Pfizer vaccine today. Approximately 5-10 min post-vaccination patient reported dizziness/lightheadedness and clammy skin. He states that he has had this reaction to shots in the past. Patient was given bottle of water and brought to urgent care by wheelchair.
Flulaval administered 9/7/2023. 9/11/2023 patient experienced a severe migraine upon waking with arm weakness and tremors. Patient also experienced nausea from 9/11/23 to 9/13/23. Patient has not had to return for further evaluation since.
14-16 hours after the shot with severe chills, jackets on, and heated blanket. The shakes, headache, vomiting, and it didn't hit until the 14-15th hour. I saw a doctor and I wanted to make sure if it was part of the COVID-19 shot. I was in bed for the first shot for 2 weeks. I was really sick and nauseous. Symptoms lasted about two weeks. This time it was a few days less. There are still some symptoms that are popping up. I recently had surgery 11/2/2021 and have another surgery coming up on 11/5/2021 from the coma. COVID-19 positive in April 2020, Coma for 5 months from 4/26/2020 - 08/2020. Coded 3 times during coma and was in hospice 3 times.
Patient felt extremely achy all over body with hot and cold flashes and was up all night going to the bathroom.
Patient presented to emergency department on 10/22/2021 with cough and shortness of breath for 12 days. He was found to be COVID-19 positive and admitted for further management. He was treated with treated with dexamethasone, remdesivir, and supplemental oxygen. Patient was discharged home on 10/30/2021. Patient presented to emergency department again on 11/9/2021 with shortness of breath. He was discharged with home oxygen on 11/13/2021.
Patient was documented to have received influenza vaccine at nursing home and admitted to hospital with symptoms of ascending weakness approximately 5 weeks later. Symptoms further progressed to respiratory failure, requiring intubation. Patient received x5 sessions of plasma exchange, was extubated but transferred to long term acute care facility for rehabilitation.
vomiting; diarrhea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2022 at 16:00 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "no side effects". The following information was reported: DIARRHOEA (non-serious) with onset 15Dec2022, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 15Dec2022, outcome "unknown"; VOMITING (non-serious) with onset 15Dec2022, outcome "unknown". The events "vomiting", "diarrhea" and "headache" required emergency room visit. Therapeutic measures were taken as a result of vomiting, diarrhoea, headache.  Additional information: Caller mentioned it took more than a month for them to get the second dose because everybody only got the booster shot. Her son did not have a problem to the first shot. He received the second dose of the vaccine yesterday at 4 o'clock and had a reaction at about 12 o'clock got the diarrhea and headache. She also mentioned giving medication to her child for the side effects. Doctors are closed so she will be reaching out to a pharmacy or bring him to the ER. Caller mentioned towards the end of the call that she won not let her son get the booster anymore. Patient  reported other Conditions also. Investigations was not Provided. Caller states the patient has Asthma and he received his first Pfizer shot with no side effects. Caller stated her son was murdered before his son could get the second one, so she made sure his son got the second dose  yesterday at about 4:00 p.m. Caller reported the patient has diarrhea, he has vomited once and he has a headache. Caller asking, what should she do? Caller stated she has given him Tylenol for his headache and crackers and rice to deter the diarrhea. States if the patient was not feeling better, she was going to go to the ER. Caller states she has full custody of the patient, since his father, her son, was    The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Case previously recorded as MA2009-4313. Initial case report received from a health care professional via MedCom on 16 NOV 2009. A 54 year-old female patient was vaccinated with S-OIV FLUVIRIN (batch no. 101716P1A) i.m. on 10 NOV 2009. The patient experienced tingling that began in feet and traveled to arms on 11 NOV 2009. The patient felt worse on 14 and 15 NOV 2009. On 16 NOV 2009, patient exam showed motor function to be normal, normal speech and grip strength, and normal respiration. No treatment was given. The patient did not recover at time of this report. MedCom reference no.: NA09-008292.
Patient seen thru ER for chest pain/pressure and shortness of breath; suspected pericarditis. Referred to cardiologist and was given NAPROSYN Rx also had Echo and Doppler results neg. ER visit 8/28/13.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient felt tongue swell and face felt itchy and numb. Patient was conscious, talking and able to swallow water. Gave her 25 mg of benadryl. Called 911, medics transported to hospital.  Patient called and said hospital  gave her more benadryl and steroids.
arm of the injection site was red; arm of the injection site was warm; sinus infection symptoms; feeling bad; A spontaneous report was received from a healthcare professional concerning a 52 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sinus infection symptoms, feeling bad, redness at the site of injection in the arm and warmth at the site of infection in the arm.  The patient's medical history was not provided.  The concomitant medications reported were unknown blood pressure medication, unknown cholesterol medication, 2 unknown anti-depressants and estrogen replacement (unknown).  On 20 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) in the arm for prophylaxis of COVID-19 infection. The patient route of administration was unknown.  On 25 JAN 2021, the patient experienced sinus infection symptoms and was feeling bad. On 31 JAN 2021, the patient experienced redness at the site of injection in the arm and warmth at the site of infection in the arm.   Treatment included Aleve.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date, the outcome of the events sinus infection symptoms and feeling bad  was resolved. At the time of this report, the outcome of the events redness at the site of injection in the arm and warmth at the site of infection in the arm was unknown.  The consent to be contacted was received from the patient.
I'd say between 12 and 36 hours, fatigue, lightheadedness, nausea, pain at the injection site, diarrhea, cold sweats, and chills. I did go in late to work that day, as a health care professional. I did not contact my DR as I work in a health care facility. I did have an ECHO in February that came back normal for me, it was negative for any new findings. I was prescribed an antidepressant for anxiety and the symptoms have subsided.
This spontaneous report was received from a nurse, referring to 40 unspecified patients of unknown gender and age. No information regarding the patients' concomitant medications, pertinent medical histories and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot# N005274, expiration date: 03-APR-2018 and lot# N008823 and expiration date: 26-MAY-2018 (dose and route of administration were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature of 12.2 Celsius degrees for a time frame of 37 minutes. The temperature excursion was recorded by a digital data logger and the previous excursion was reported as 9.3 Celsius degrees for 16 minutes for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007367: US-009507513-1708USA008138: US-009507513-1708USA008139: US-009507513-1708USA008140.
The pt experienced hives ranging from the size of a quarter to a dinner plate all over my body, with general itching. The pt is taking Zyrtec which helped, but when discontinued the hives returned.  Follow UP: lot number is unknown."
4/4/22: Day of Vaccine  11:30am: 2.5 hours post vaccine administration: Fever, chills, soreness at injection site 8:00pm: High fever (102.5), worsening chills, body aches, soreness at injection site 4/5 to 4/7/22: Fever continued, sores inside left nostril and under nose, cellulitis left arm (injection site), all over joint pain (fingers, hands, wrists, feet, ankles, low back, neck, knees) and extreme tiredness needing to sleep 4/13/22: Pain in left breast, lumps noted Up to 4/19/22: All over joint pain and stiffness, burning in joints and fatigue. Pain in left breast continues (Pending GYN appt)
Chills beginning at 4:30 am., Fever/temp at 7 am 101.4. > 500 mg of Acetaminophen given. Fever at 10 am 100.4, Fever at 1:45 pm 101.7 > 500 mg Acetaminophen given. Called Hospital and told to call if climbs to 102.
Pt had nausea, vomiting, diarrhea, severe HA, body aches. She went to ED and given IVF and Ibuprofen. She has deferred 2nd COVID vaccine since then.
This spontaneous retrospective pregnancy report was received from a physician refers to a 22 years old female patient. On 25-APR-2012, the patient received the first 0.5 ml dose of GARDASIL (Lot# unspecified), intramuscularly, location unspecified. On 25-JUL-2012, the patient received the second 0.5ml dose of GARDASIL (Lot# unspecified), intramuscularly location unspecified. The patient became pregnant (LMP unknown), and was in office on 20-NOV-2013, for routine visit after delivering baby in October 2013. Patient wanted to receive the third 0.5ml dose of GARDASIL (Lot# unspecified), intramuscularly location unspecified on 20-NOV-2013. No adverse effect was reported. Additional information has been requested.
patients that received a vaccine past the 30 day storage on the refrigerator.; patients that received a vaccine past the 30 day storage on the refrigerator.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients that received a vaccine past the 30 day storage on the refrigerator.) and PRODUCT STORAGE ERROR (patients that received a vaccine past the 30 day storage on the refrigerator.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     It was reported that patient had no known drug allergies (NKDA).  Concomitant products included TRIAMCINOLONE and MELATONIN for an unknown indication.    On 20-Apr-2022 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients that received a vaccine past the 30 day storage on the refrigerator.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients that received a vaccine past the 30 day storage on the refrigerator.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients that received a vaccine past the 30 day storage on the refrigerator.) and PRODUCT STORAGE ERROR (patients that received a vaccine past the 30 day storage on the refrigerator.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 25-Feb-2022.The vial did not undergo any temperature excursions.HCP confirmed that the patients are not experiencing any side effects yet.  No treatment information was provided.   This case was linked to MOD-2022-545267 (Patient Link).
Patient received his first dose of Moderna covid-19 vaccine today. Patient stated that he felt fine immediately after receiving his vaccine. Patient forgot his imz card and went back to the drop off station to collect it when he fainted. Both of his parents were next to him to help guide his fall. A pharmacist was walking out to talk to him at the time he fell and also helped him as he was coming to the ground. Patient was instructed to say sitting on the the floor as he came to. I had a technician grab an orange juice that we gave to the patient. After a couple of minutes we moved him from the floor to a chair. Patient appeared very pale and sweaty but was in good spirits, he said he felt embarrassed that he fainted. After a few more minutes in the chair he appeared more pale and laid down on the cold floor while I elevated his feet. After a couple of minutes on the floor he returned to the chair and felt nauseous. Patient's mom went to pull their van up to the front of the store. Multiple times I asked the patient if he felt ok or if he was injured and he said that he would be ok and was not injured. I asked if he wanted me to have someone come exam him and he declined. I walked the patient out of the store with his dad at approximately 6:30. Patient was able to walk on his own and get into vehicle on his own.
Received the vaccine 1/19/21.  On 1/20/21, states hurt all over - generalized aches and pains, nausea, diarrhea. Did not get out of bed all day. Denies any chills. Subsided over the next 2 days and was gone by Friday.  All s/s gone by Saturday.  Also c/o arm soreness at injection site for the same time frame.
Patient was administered Pfizer Bivalent Vaccine instead of Pfizer Monovalent.