chrisvoncsefalvay/vaers-outcomes huggingface dataset:
change in vision; significant knot in arm, real red; delayed hypersensitivity; excess white blood cells in aqueous fluid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISUAL IMPAIRMENT (change in vision), WHITE BLOOD CELL COUNT INCREASED (excess white blood cells in aqueous fluid), ERYTHEMA (significant knot in arm, real red) and HYPERSENSITIVITY (delayed hypersensitivity) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (excess white blood cells in aqueous fluid). On 23-Jan-2021, the patient experienced ERYTHEMA (significant knot in arm, real red) and HYPERSENSITIVITY (delayed hypersensitivity). On an unknown date, the patient experienced VISUAL IMPAIRMENT (change in vision). The patient was treated with PREDNISOLONE ACETATE (ophthalmic) ongoing since an unknown date for Eye inflammation, at a dose of 1 dosage form and CYCLOPENTOLATE (ophthalmic) ongoing since an unknown date for Eye inflammation, at a dose of 1 dosage form. At the time of the report, VISUAL IMPAIRMENT (change in vision), WHITE BLOOD CELL COUNT INCREASED (excess white blood cells in aqueous fluid), ERYTHEMA (significant knot in arm, real red) and HYPERSENSITIVITY (delayed hypersensitivity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
My arm got really stiff. At the injection site, it was red and sore for a day. Later that night, that is when the other side effects came (the adverse side effects). Severe fatigue; really bad headache; muscle pain that on a lot of days I was needing to take 6 Advil during the course of the day - really painful. Also, the Bell's palsy symptoms started up that night. It was like a really bad case of flu that wouldn't go away. A constant fever for about a week. I had chills. The nausea was full-blown for about 6 weeks. It also swelled up my joints so that in the morning or at night I couldn't move my hands or arms. I do get side effects with medications that I take. I took natural supplements and was bedridden for about the first week because the muscle pain and inflamed joints were so bad. I did acupuncture for Bell's palsy - that was onset after the vaccine. Bell's Palsy- usually my symptoms for chronic condition are nonexistent, but each time I had the COVID-19 vaccine, it made me have the worse Bell's palsy symptoms that I've had in my life. My eye that wouldn't close; my drooling from my mouth because I couldn't move it. Ringing in the ears, and metallic taste in my mouth. A week and a half after the side effects lessened, I got shingles - from June 18th and ended before my birthday on August 22nd. My doctors think I got it because of the vaccine. Shingles symptoms lasted about 8 weeks, and it was pretty painful. Growing across my head and over my eyes. They gave me an anti-viral and I also took olive leaf extract and I used EMU oil as well; with those, it stopped growing. Doctor said it was the vaccine that brought the symptoms. My body was under duress. I had a relapse of the shingles- the beginning of September. It was a minute about of it; they thought it was pseudo pain from the shingles which I may have re-occur for 6 months. October 1st, I had my flu shot. My prior flu shot was August 30, 2020.
Several hours post vax pt noticed swelling and redness at injection site. Two days later 2 in circular area noted with erythema.
Information has been received from a physician concerning a 63 year old female with no know allergies, Hyperlipidemia, and a history of Gastroesophageal reflux disease, and lung cancer treated with a left lower lung lobectomy, who on 10/7/02 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included influenza virus vaccine *aspirin (ASA), atorvastatin calcium (Lipitor), therapy (unspec'd) "premar", the start dates and doses were not indicated.* On the night of 10/7/02 the patient developed a local reaction, reported as swelling at the injection site. On approximately 10/8/02 when the patient was seen in the physician's office, the reporter stated the entire area, from front to back of upper arm, shoulder to elbow was red, and also reported the patient had an especially bad case of cellulitis. The patient was treated with a large dose of an unspecified antibiotic. On approximately 10/10/02 the patient's arm worsened and she was hospitalized for the cellulitis for a total of 2 days and was treated with unspecified intravenous antibiotics. It was noted she has recovered from the event. *F/UP report on 11/15/02: F/UP info received from a health professional included medical records which note the PT had received (no date provided) an unspec'd dose of oral cephalexin (Keflex) for the Tx of her increased left upper extremity pain, left upper arm inject site redness, and heat and tenderness at the inject site, subsequently there was no improvement. It was noted that on 10/10/02 the PT received "intravenous antibiotics" and methylprednisolone sodium succinate (Solumedrol). On 10/11/02 an MD indicated the arm looked "much" better, and she should continue the same medication. On 10/25/02 the reporter indicatd "her arm has improved but is still red". * Additional information has been requested. In additional info the reporter indicated the pt was seen in the office "today" (date not reported) and the pt stated, she still does not feel quite right. It was noted she felt fatigued. Follow-up info indicated illness at the time of vaccination as "redness of arm." In addition, it was noted by the reporter that the pt stated "now she is doing fine" (date not reported).
I did not have an adverse reaction to the vaccine. I began not feeling well on 02/19/2023 with nasal congestion. I tested positive for COVID-19 on 02/20/2023. I did not go to the doctor, and I isolated.  I used all natural products to help with my symptoms and Tylenol for the headache and fever. I did see my ENT after recovering from COVID-19 to check my vocal cords. As of today, I have a lot of congestion due to the pollen.
Erythema-redness and warmth at injection site upper left outside arm.  Reports pain at site.  Approx 1.5inches wide and 2.5 inches long.
Pt got the vaccine on 12/28 and he said within a week he started having seizures. The second time he had seizures again was on 1/12 and was hospitalized.  He said the seizures this time is more severe as he had dislocated his shoulders and broke his foot.  Pt described these seizures as abnormal. Pt do have a hx of seizures and is on seizure med.
After about three hours, my arm started hurting.  That progressed to an unimaginable throbbing pain.  I also was nauseous and shivering.  My arm was useless.  Today, the pain is better.  The throbbing has ceased but I am still having trouble using my arm.
Large red, firm warm local reaction at site of immunization with some itching. No pain. Keflex 125 tid x 10 days and oral Benedryl with ice pain.
Information has been received from a physician (also the patient's mother) via an employee from Pfizer concerning a 3 year old male patient. The patient was constantly sick with chronic sinusitis. On an unknown date when the patient was 12 month old, he received PREVNAR 13 and finished the four doses on time. On 29-DEC-2016, the patient had titer level test and the result showed he had no response to PREVNAR 13. On 12-JAN-2017, the patient was vaccinated with one dose of PNEUMOVAX23 (dose, route, lot# and expiration date were unknown) for prophylaxis. On 22-FEB-2017, the patient did a Titer level test. The result showed that the patient did respond to a few of the stereotypes in PNEUOMOVAX but there were still a lot of stereotypes which the patient did not respond to. The reporter considered PNEUMOVAX23 was not successful. The outcome of the event and the causality between the event and PNEUMOVAX23 were unknown.       Additional information has been requested.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (Apr2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of Covid-19. Antiviral treatment details: start date: 26Apr2022, stop date=29Apr2022, lot number=FX2741 used for the treatment of COVID-19. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Presented to ED for worsening SOB, COVID+ x 2 wks; admitted for COVID-19 pna and acute resp failure; tx w/O2, abx, steroids, zinc, Vit-C; pt developed hypoxic ischemic brain injury; he maintained his saturations off ventilatory support with no improvement in his mental status and was discharged to hospice
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from an-other health professional. This case is linked to cases 2018SA271976, 2018SA271982, 2018SA271981 and 2018SA271983 (Same reporter). This case involves a 16-years old patient (gender not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ011AG and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on 25-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccines were in transit to long. It was unknown if any adverse event was occurred or not following the vaccination. 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.
Sore arm; Afluria Quad aministered to pregnant woman; This spontaneous case, initially received from other non-health professional (together processed with follow-up received on 27-Sep-2018) on 26-Sep-2018, concerns a 31-year-old, adult pregnant patient.  The patient had no relevant maternal and paternal medical history. The patient did not use any contraceptives. The patient had no birth defects and congenital anomalies were occurred in previous pregnancies.   The patient's husband did not take any medications prior to conception. The concomitant medications included Prenatal vitamins (ascorbic acid, biotin, minerals nos, nicotinic acid, retinol, tocopherol, vitamin b nos, vitamin d nos), Claritin (clarithromycin) and ranitidine for unknown indications. This was the patient's first pregnancy.  The patients last menstrual period (LMP) date was 09-Jun-2018.  On 25-Sep-2018, the pregnant patient (15-week gestation period) was administered Afluria (TIV) (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical site: deltoid, batch number: YT38207B and expiry date: 30-Jun-2019) (coded as vaccine exposure during pregnancy) as active immunization against influenza disease [explicitly reported as Afluria Quadrivalent]. The reported batch number (YT38207B), does not match Afluria Quadrivalent batch numbers, however, the batch number was mapped to Afluria (TIV). Hence, the suspect vaccine was coded as Afluria (TIV).  On the same day after vaccination, the patient experienced a sore arm.  There was no evidence of defect or adverse finding from a prenatal test.  The patient's estimated date of delivery was on 16-Mar-2019.  At the time of this report, the outcome of the event was not reported.  The reporter assessed the case as non-serious.  Non-significant follow up received from the reporter on 08-Jan-2019: It was reported that, the patient was not enrolled in the pregnancy registry. The reporter also confirmed that, the attempts to reach the patient had exhausted and no further follow up would be conducted. Hence, this case was considered as lost to follow up.  Non-significant follow up received from the reporter on 19-Feb-2019: It was reported that the patient was tried to reach on 19-Nov-2018, 20-Nov-2018 and 03-Dec-2018 but no information was obtained. Reference number (Med info number:SEQ18-06663) was updated in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 31-year-old, pregnant patient experienced a sore arm on the same day after the administration of Afluria TIV (coded as vaccine exposure during pregnancy). The company assessed the causality as related for the event pain in arm' due to plausible temporal relationship between the event and the suspect vaccine. The causality of event vaccine exposure during pregnancy' was assessed as not related considering it as a special situation.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022; No adverse event; patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022).    Concomitant medications were not reported.   Patient received half dose.They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions.  Treatment medications were not reported.
injection site was itchy; she scratched off the scab from the site in her sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 06Mar2021, outcome "unknown", described as "injection site was itchy"; VACCINATION SITE SCAB (non-serious) with onset 06Mar2021, outcome "unknown", described as "she scratched off the scab from the site in her sleep".  Additional Information: The patient was asking if she can receive the second dose of Pfizer-Biontech Covid19 vaccine in the same arm as she received the first.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very swollen left arm in the site of injection; Very sore left arm in the site of injection; Big lump in the left armpit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Very swollen left arm in the site of injection), VACCINATION SITE PAIN (Very sore left arm in the site of injection) and AXILLARY MASS (Big lump in the left armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059D21A and 088D21A) for COVID-19 vaccination.     The patient had no allergies. The patient had no medical history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Very swollen left arm in the site of injection), VACCINATION SITE PAIN (Very sore left arm in the site of injection) and AXILLARY MASS (Big lump in the left armpit). On 17-Oct-2021, VACCINATION SITE SWELLING (Very swollen left arm in the site of injection), VACCINATION SITE PAIN (Very sore left arm in the site of injection) and AXILLARY MASS (Big lump in the left armpit) had resolved.            No concomitant medications were reported. No other vaccines were taken within 1 month prior to Moderna COVID-19 vaccine. The patient was never tested positive for COVID-19. The patient did not experience any similar event in the past.  The patient did not seek any medical care or took treatment.     This case was linked to MOD-2022-541694 (Patient Link).
Noted entire Left and Right buttocks red, swollen and warm to touch. Mom stated checked by PMD on 04/06/2005 and was instructed to apply cold compresses.
3 in red, swollen, hot at injection site. Noticed day one, currently bigger on day 5. Also starting to itch. Stiff neck.
The next morning after the vaccine I developed a knot at the injection site it was swollen, severely itchy and painful. A fever developed, but I am not sure if it was from the vaccine or because I was still dealing with issues related to my positive COVID-19 infection status I received between both doses, and all symptoms lingered on up until today, when I was able to finally get a little relief and begin to feel a little like my normal self. I had a bilateral lung x-ray to see if pneumonia is present in my right lung, and additional blood work has been done but no results yet.
I felt fine initially but started feeling sick later in day. I was diagnosed with Covid Jan. 29; was very ill. Our school district offered the J&J vaccination which I had March 15. I became sicker than when I had COVID. Hives all over body, extreme exhaustion (both physical & mental); fever, chills, mental blankness, loss of appetite, nausea  vomiting; inability to concentrate or physically complete routine tasks; achy legs with weird lumps and visible veins. I was active, fit, and healthy. Now I feel like I'm 150 years old, had & had a lobotomy, Have no short term memory or energy.
Angioedema of the upper lip started about 50 minutes after receiving her second dose of the vaccine. She was seen in the ED and discharged home. Also on lisinopril for many years with no adverse events to it. Unclear which of these agents caused her swelling. No prior history of dermal fillers or any aesthetic procedures to her face.
Mother phoned with report of local reaction to site where varicella vaccine was given.  Patient was seen by physician at urgent care.
my arm got very swollen and was extremely painful; my arm got very swollen and was extremely painful; I had a lot of severe pain and I could not drive; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm on 25Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced my arm got very swollen and was extremely painful, i had a lot of severe pain and i could not drive on 03May2021. It was reported that as per patient, she received her 1st dose on 25Apr2021 and 8 days later her arm got very swollen and was extremely painful. She went to urgent care and they gave her pain pills but it did not work. It was only in Jul2021 that the pain stopped completely. She was told she had no scar tissue. Patient want to ask if it would be ok to get the second dose now. She received the first dose on 25Apr (clarified as 25Apr2021) and experienced swelling on arm after taking the first dose. She missed the second dose and she was asking when should she taking it again. Patient also reported that well it was not just the swelling. She had a lot of severe pain and she could not drive. So, that was the reason she could not have the second one. she only had that arm and if she got the injection on the other arm and that one swells with pain and then she would not have any arm to drive. So, then she went to the doctor and the doctor checked her arm for any scarred tissues, she did not see any scar tissues. She said it was not an allergic reaction but it was more of a rare reaction and she did not seem to know when she said when do she take the next one. She said when do she take or if she should take it. When asked for permission for further probing, patient stated that well, she does have some people here and she does not feel well to leave her information. The patient underwent lab tests and procedures which included laboratory test: had no scar tissue on 2021. Therapeutic measures were taken as a result of events with pain pills. The outcome of the events was recovered on unspecified date of 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After getting MMR, patient stated he didn't feel well. He lowered his head and fainted. Placed on floor. Stated "I can't see help me. Had seizure lasting 5-10 seconds.