chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels worse than when she had Covid"; she woke up with a fever 102.9.; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels worse than when she had Covid"), CHILLS (chills) and PYREXIA (she woke up with a fever 102.9.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (chills). On 05-Mar-2021, the patient experienced FEELING ABNORMAL (Feels worse than when she had Covid") and PYREXIA (she woke up with a fever 102.9.). At the time of the report, FEELING ABNORMAL (Feels worse than when she had Covid"), CHILLS (chills) and PYREXIA (she woke up with a fever 102.9.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that the Shingles shot hurts almost as bad as the shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.
Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out. Felt better minutes later. Reports rash to body 2 weeks after 1st injection.
Reports headaches in the daily in the afternoon. Reports oral pain relief medication helps the headache, but it comes back again the next day. Has had the headaches since he received the vaccine all except for "maybe 1 day". Reports headache pain 8/10 on a 0-10 scale. Notified PCP.
Night of vaccination, patient's arm was sore and she had trouble sleeping because of it. In the morning, on 9/14/17, she went back to bed for 3 hours. She took TYLENOL throughout the day for the soreness. A fever had developed the morning of 9/14/17 also, but the fever was gone by 9/15/17. The morning of 9/15, she noticed and felt an itchy rash starting on her upper left arm that spread down to her elbow. As of 7pm on 9/15/17 when she reported the event to the pharmacy, the rash was still present.
Patient specifically state that she experienced painful tardive dyskinesia for 6 to 7 hours that started in the evening day of vaccination. She also experienced a slight headache which was not as concerning to her.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of birth year was provided as 1949 No concomitant medications were provided. No treatment information was provided by the reporter.
This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included traumatic brain injury (reported as mtbi). The patient was allergic to animals. The patient previously had gluten and experienced gluten sensitivity (gluten allergy). The patient did not take any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient experienced sporadic blurry vision for 4-5 days and was seeing stars when getting up 2-3 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events.  The clinical outcome of the events sporadic blurry vision for 4-5 days and seeing stars when getting up 2-3 days was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Severe pain with feverishness & swelling from elbow to shoulder. Pain is so bad that it is hard to move the arm. NOTE: I am a regular blood donor & have a high pain tolerance - so this is very unusual. I have never had this reaction to any other vaccinations.
He got his vaccine, he started having severe headaches, throbbing/stabbing type.  A lot of dizziness and head pressure, brain fog.  He also had heart palpitations, sometimes ringing in the ears, lots of fatigue, lots of pain all over his body.  He had a lot of shortness of breath, nausea and sometimes stomach discomfort.   He had a TIA on 12/3/2021 which his doctor does not feel it was related to the vaccine.  His Cardiologist couldn't say whether he felt it was or not either.   His symptoms are progressively getting worse.  He saw an interview by Dr regarding this and realized that he had this condition.    He got his first vaccine and had some headaches at times, lots of heart palpitations and shortness of breath.  He saw his cardiologist who did an Echocardiogram, and some blood work and he didn't think that it was related to his heart.  He wasn't sure until he had the 3rd one.    His saw his PCP since the TIA and also his cardiologist who did a sonogram of his carotid arteries.  He is scheduled to see a neurologist on 4/27/22.     He is still having all of these symptoms since having the vaccine.  He has been wanting to go to the hospital for the dizziness and the shortness of breath and is avoiding that due to fear of dying from COVID he may catch in the ER.    When he had the 2nd vaccine the headaches got worse, not as much dizziness, but the brain fog started about that time, the fatigue, head pressure, shortness of breath continued, nausea continued and heart palpitations.
No additional AEs or PQC reported; Caller reported PROQUAD administered to a 6 month old and is also documented as being administered IM.; Caller reported PROQUAD administered to a 6 month old and is also documented as being administered IM.; This spontaneous report was received from  a nurse prescriber and refers to a 6-month-old patient of unknown gender.The patient's medical history and concurrent conditions were not reported.   On 07-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter, lot #W024968, expiration date: 05-FEB-2024, administered intramuscularly(IM) for prophylaxis (strength was not provided) (product administered to patient of inappropriate age, incorrect route of product administration; the reporter was unsure if injection was truly given IM or if the documentation was incorrect). On the same date and visit, the patient also received the first doses of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided; no information was provided but since patient received first dose at 6 months of age,  the use was outside of prescribing information (PI)); and  hepatitis a vaccine inact (HAVRIX), administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided). No additional adverse events were reported.
My arm became red and swollen and the injection site.  The next day I got the chills and was very cold.  The swelling and redness on the injection site is growing.  It feels like there is a hard mass underneath the skin.  The mass feels like it is growing too.  My arm is very sore and hurts to raise it.  I also have had a headache since 08/17/2021.  My entire body aches, as though I have the flu, but without the nasal congestion or sore throat.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 70 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Sore arm after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after the injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm after the injection). On 17-Jan-2021, VACCINATION SITE PAIN (Sore arm after the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Patient presented and was admitted through ED for tachycardia.  Patient was noticed to be fatigued and weak during stress test at outside cardiology clinic and he was noticed to be in A. fib RVR tachycardia. Patient has medical history significant for hypertension, diabetes mellitus type 2, aortic stenosis, coronary artery disease, chronic atrial fibrillation, history of Hodgkin's lymphoma.  Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.
Started 2 days after immunized: Fever 100.4, severe stomach cramps, headaches and poor appetite.
R09.02 HYPOXIA 4/29/2023 ATRIAL FIBRILLATION, PAROXYSMAL R09.02 HYPOXIA 4/29/2023 RIGHT FEMUR FX INIT R09.02 HYPOXIA 4/29/2023 RENAL CALCULUS R09.02 HYPOXIA 4/29/2023 RIGHT SUBTROCHANTERIC FEMUR FX, DISPL INIT R09.02 HYPOXIA 4/29/2023 CONSTIPATION
Patient states that she vomited, aches, chills, and fever. She also has red skin reaction where both shots were given in her left arm due to breast cancer.
In the evening of 3/22/00, pt developed a fever of 105-106. He was lethargic, cranky, fussy and would not walk. During the night of 3/23/00, pt again had a fever of 105-106. On 3/25/00, pt developed rash and vomiting. There was no treatment given that mother remembers. Mother had not reported events to Health Dept previously, but she was called while tracking was being done. These were pt's first immunizations.
Pt developed fever, abd pain, N/V/D, mild cellulitis at site. Seen in Urgent Care/ER 7/18/20 Started doxy BID - Neg test. Return to ER 7/22/20 for continued abd pain + diarrhea. pt currently in ER/UC
Pt received  dose of Pfizer Covid vaccine on 4/9/21 Received  dose of Moderna Covid vaccine on 5/7/21
Co-injection of TDAP, MMR (left arm) and flu vaccine (right arm) was followed by my husband following on the ground and being like paralyzed with only his eyes moving This episode lasted a few seconds and was followed by an epileptic crisis (this was the first crisis of his life). These events occurred right after the injections of the vaccines. My husband is 38 yo and never had any health problems.
Information has been received from a certified medical assistant referring to unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were provided. On an unknown date these patients were vaccinated with GARDASIL (lot # K007264, expiration date 02-MAR-2017; dose, frequency and route not reported) which were improperly stored at 32.9F for 22 days. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse referring to two patients of unknown age and genders. Patients' medical history and concurrent conditions were not reported. On 01-OCT-2015 and on 02-OCT-2015, the patients were vaccinated with an improperly stored doses of VARIVAX (Merck) (lot #s L015046, expiry date 29-APR-2017 and L016125, expiry date 06-MAY-2017). No adverse effects were reported for any of these two additional unspecified patients. This is one of three reports from the same reporter source (MARRS linked cases 1510USA002521 and 1510USA002651). Additional information has been requested.
I tested positive for Covid-19, contacted my primary care physician who prescribed Paxlovid as a precaution. I did not take Paxlovid due to symptoms that were never more than mild. I had a runny nose and an occasional cough. This was as mild a ?cold? that I ever had. I attribute the mild symptoms due to being vaccinated and boosted. I had no significant issues from the actual vaccines. I reported previously mild and managable  reactions.
Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff). This case involves a 11 years old male patient who received a standard dose 0.5 ml vaccine DAPTACEL (lot number: C5190AA, expiry date: 24-apr-2019) via unknown route in the left arm  instead of ADACEL on an unknown date. The Health Care Professional picked up the wrong vial & there were no other factors. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunisation; and GARDASIL for Immunisation. It was a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. Corrective action: They will correct the medical record to show DAPTACEL was given and per standard the dose should be counted as the adolescent Tdap (ADACEL) booster. 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. Documents held by sender: none.
REDNESS PAIN SWELLING AT INJECTION SITE TREATMENT:  BENADRYL, ICE
Dose #2 of Moderna COVID-19 vaccine given one day too early on 2/2/21 (day 23). Patient received 1st dose on 1/10/21. There is no adverse event that occurred. This is reported merely due to timing issue for the 2nd dose.
Irregular periods (4 with in a two month time frame) plus spotting in between; Irregular periods (4 with in a two month time frame) plus spotting in between; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the left arm on 04Jan2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jan2021, the patient experienced irregular periods (4 with in a two month time frame) plus spotting in between. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular periods (4 with in a two month time frame) plus spotting in between was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Vasovagal response. Several minutes after receiving this dose, the patient became very light headed and dizzy. He got warm, sweaty, and pale. He said his vision went black for a minute or two. Once he laid down and put his feet up, he began feeling better. His vision was back to normal and he was no longer dizzy. After laying on the floor for several minutes, the patient sat up for another few minutes before going home. Paramedics were called by management. They checked his vitals during this time, but did not provide any treatement.
+35 min post injection, Tightness/closing throat only, difficulty swallowing, tachycardia, runny nose, marked increase in paresthesia body wide (pin pricks), itching body wide, feeling of swollen tongue but not visualized.  Tx w/ diphenhydramine. 100mg liquid prn symptoms (2 doses 5 hrs apart).  Diphenhydramine reduced symptoms but tightness in throat sensation, paraesthesia,  and mild itching remained w/ sudden shorts bursts of increased symptoms.  No antihistamines administered after second dose and most symptoms subsided, except increased paresthesia and ?fuzzy? tongue/throat.  Appx 1530 on 01/17/21, sore throat arose that is uncomfortable but not serious, tongue tingling.
hives and blotches on my torso. blotches went away the next day. hives lasted just over 24 hours. took bendryl. had flu like symptoms next day and lasted just over a day. still have pain, slighlt swollen, and itchy on left shoulder where injection was given on day 3.
Pt recvd MMR vax on 14JAN92 & on 30JAN92 pt devel fever 103 & had 2 min grand mal sz w/postital; 31JAN92 seen by MD placed on therapy w/Amoxicillin; pt recovered;
5 mins after recieving vaccine patient felt warm and lightheaded He was instructed to lie on his back and elevate feet, he was given an ice pack since he felt warm At 10 mins he was not feeling better but not feeling worse and recieved 25mg diphenhydramine At 20 mins he felt much better and did not want to wait any longer left the pharmacy
Very Sore left arm, fatigue, strong headaches, diarrhea, nausea all started around 1 PM day of vaccine administration, headaches and diarrhea have progressed/worsened. Headache has lasted all day, feels like throbbing/pounding with severe noise and light sensitivity.
Uncontrollable crying for 6 hours. Now pt is autistic from the thimerosal he received in all the vaccinations.
Left  side of body where neuropathy is ,is the worse for me .  Site was sore after injection
Information has been received from an office manager concerning a patient who was vaccinated with a dose of Zostavax. Subsequently two weeks after vaccination, the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Following injection typical sore arm for a couple of days, and then pain increase, restricting range of motion. I have difficulty getting dressed, washing hair, etc.   I spoke with my primary care Doctor, he is hoping it will subside, it hasn't yet.  It certainly has caused me distress.   I am a senior fitness coach and it has hampered my ability to lead sessions.
-Digestive/Intestinal discomfort and pain -sharp upper abdominal pains  -inflamed kidneys (both left and right)
Throat edema; Arm soreness; Swelling in both hands and fingers; Aches; Fever; Fatigue; Right handed could not move; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL OEDEMA (Throat edema), PAIN IN EXTREMITY (Arm soreness), PERIPHERAL SWELLING (Swelling in both hands and fingers), PAIN (Aches) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE, PERPHENAZINE, PRAVASTATIN, LOSARTAN, MELOXICAM, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA), PREGABALIN and SULFASALAZINE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PHARYNGEAL OEDEMA (Throat edema), PAIN IN EXTREMITY (Arm soreness), PERIPHERAL SWELLING (Swelling in both hands and fingers), PAIN (Aches), PYREXIA (Fever), FATIGUE (Fatigue) and MOBILITY DECREASED (Right handed could not move). The patient was treated with SULFASALAZINE at an unspecified dose and frequency. At the time of the report, PHARYNGEAL OEDEMA (Throat edema), PAIN IN EXTREMITY (Arm soreness), PERIPHERAL SWELLING (Swelling in both hands and fingers), PAIN (Aches), PYREXIA (Fever), FATIGUE (Fatigue) and MOBILITY DECREASED (Right handed could not move) was resolving.
Pt. states arm very sore all the way down the forearm. Also circle around area where shot was given.