chrisvoncsefalvay/vaers-outcomes huggingface dataset:
close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken and it was 166/86 (my normal BP is usually 100/60).; This is a spontaneous report from a contactable Physician (the patient).  A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, second dose, on 15Jan2021 14:30 at SINGLE DOSE for covid-19 immunisation.  Medical history included hypothyroidism and gastrooesophageal reflux disease, both from an unknown date and unknown if ongoing.  Concomitant medication included levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), estradiol, norethisterone acetate (AMABELZ), estradiol, levonorgestrel (CLIMARA PRO).   Patient previously received the first dose of BNT162B2 in left arm, on 24Dec2020 08:15 AM. No other vaccine in four weeks. Vaccination Facility type: Hospital. No COVID prior vaccination. COVID was not tested post vaccination.  No Known allergies. On 15Jan2021 about 5 minutes after the vaccination the patient experienced close to passing out, felt "heat waves" throughout my body, tingling, palpitations, blood pressure (BP) was taken and it was 166/86 (her normal BP is usually 100/60). No treatment was given. The symptoms slowly resolved over the next 45 minutes, with BP returning back to normal.  Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "close to passing out". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report was received from a registered nurse referring to an 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Participated in skilled therapy, continued visits w/oncologist, vaccine requested and administered, continued skilled therapy w/decrease  in strength as what brought resident to SNF w/RLE cellulits w/MRSA, Vaccine series completed, continued skilled therapy, WBCs chronically elevated per oncologist as expected may occur w/cancer tx med for active leukemia. Continued decline overall w/decline in intake of food and fluids, hospice care initiated. Over the course of months, resident declined to bedrest w/expiration 5/24/21.
Patient is scheduled to receive 2nd dose past 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is scheduled to receive 2nd dose past 42 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is scheduled to receive 2nd dose past 42 days). On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is scheduled to receive 2nd dose past 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medications.  No treatment medications were reported.
pt recv vax & several wk later, noticed a lump @ inj site; pt's MD had an x-ray performed & referred to an orthopedic surgeon; pt stated that the surgeon told her that has a mass in muscle; probably due to flu vax;
Information has been received from a registered nurse concerning a female patient who was exposed to her grandmother who on 08-FEB-2008 was vaccinated SQ in the right arm with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). Medical attention was sought on 24-MAR-2008 in the clinic. The patient had shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient was treated with acyclovir 400mg. The patient's outcome was not reported. Additional information is not expected. This is one of several reports from the same source.
Parasthesias, followed by Severe Dry Eye issues.  Eyes no longer producing oils or tears. Lesions on the cornea are leading to vision loss over the past 7 months. New palpitations and shortness of breath.
Post shot developed the following within hours:  head congestion, dizziness, nausea, brain fogginess, phlegm in my heart, headache, inability to fully concentrate to typical ability, major soreness in arm receiving shot, soreness developed in arm that didn't receive the shot with intermittent shooting pain at opposite arm shot sight as if being stabbed with a knife.  Overnight and into the morning:  significant joint soreness across body, diarrhea, brain fogginess worsened, nausea continued, phlegm continued, headache continued, noticeable fatigue (tired walking up stairs or even just standing - I'm in VERY good shape for my age and regularly exercise on my own.) These symptoms have continued over the several days post shot.  I'm day five post shot and I'm having difficulty staying focused, I'm saying things inaccurately like names, I'm still get tired standing and doing any activity for more than a few minutes, my headache persists.  My arm soreness has diminished and my joints pain has lessoned.  I'm an extremely health conscious individual, food and water intake, exercise 6-7 times a week at a relatively intense level, rarely take over the counter medications and don't get sick often.  These events are a major abnormal in my life and in how I typically feel on a daily basis. I was required to receive this vaccination even thought I did not want it at this time, (due to lack of full FDA approval, it's EUA status, and little long term data).  I respectfully request any help as "I don't feel right or like I normally do."  Thank you.
got a positive covid result; got a positive covid result; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported on the 17th or 18th she was sick and got a positive covid result on Jan2021. The patient underwent lab tests and procedures which included covid: positive on Jan2021. The event outcome was unknown.  Information about lot/batch number has been requested.
After the mandatory 15 minute waiting period in the vaccine waiting area at Hospital, I felt okay and did not feel the need to remain in the waiting area.   After I returned home between an hour and an hour and a half after receiving the first dose of the Moderna Vaccine,  I felt the onset of an anaphylaxis reaction in which my mouth felt dry and my throat began to feel swollen. I used my Epipen and took Benadryl to help the allergic symptoms subside. After this treatment, the symptoms subsided and I did not seek further medical attention as it was unnecessary.  I was in the care of my father who is a physician.
Analgesic; Injection site flared up with a nasty rash; neck and jaw felt numb; A little bit of pain/ a reaction around the injection site, it was hurting again; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (neck and jaw felt numb), HYPOAESTHESIA ORAL (neck and jaw felt numb), INJECTION SITE PAIN (A little bit of pain/ a reaction around the injection site, it was hurting again) and INJECTION SITE RASH (Injection site flared up with a nasty rash) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced INJECTION SITE PAIN (A little bit of pain/ a reaction around the injection site, it was hurting again). On 08-Jan-2021, the patient experienced HYPOAESTHESIA (neck and jaw felt numb), HYPOAESTHESIA ORAL (neck and jaw felt numb) and INJECTION SITE RASH (Injection site flared up with a nasty rash). On 10-Jan-2021, HYPOAESTHESIA (neck and jaw felt numb) outcome was unknown, HYPOAESTHESIA ORAL (neck and jaw felt numb) and INJECTION SITE RASH (Injection site flared up with a nasty rash) had resolved. At the time of the report, INJECTION SITE PAIN (A little bit of pain/ a reaction around the injection site, it was hurting again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included birth control pill and seartic. Treatment included anesthetic and Benadryl.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax & 18OCT95 exp severe ache for 3 to 6 days;there was a reddened area @ the inj site about the size of a quarter;
fever, red area 3-4 cm in diameter in area of inject; 2 days p/inject h/a;
Got sick with mild symptoms; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020.  This case involves two patients (kids) of unknown demographics who got sick with mild symptoms (Illness), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.   On an unknown date, the patient stated that he/she got sick with mild symptoms (Illness), with the INFLUENZA VACCINE afterward.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
After receiving COVID vaccine, patient reported Shortness of Breath, dizziness, loss of appetite, headache and chest pain. On 05/19/2021, patient exhibited right sided extremity weakness. Upon ED evaluation, was found to have suffered a TIA.
Initial report received on 29 July 2009 from a health care professional. A cluster of two five year old patients with a history of speech delay and autism received DAPTACEL (lot number C3141AA) intramuscularly in the left thigh on 27 July 2009 in the morning. By that evening the children had significant knee swelling of the left leg which extended to the upper thigh. The children were unable to walk that night. The next morning they were both walking with a limp. They were seen by a physician who diagnosed them with Arthus Reaction Type 3, severe local inflammatory reaction. Recovery status was unknown. List of Documents held by Sender: none. The reporter of this case is the same as case number 2009-03235.
On Tuesday 2-17-21 at a1am in the morning I started getting muscular pains in my body. I was able to breathe easily but when I  inhaled I felt the pain more dramatically. I started 2-16-21  feeling a bit achy but I went for a bicycle ride.  When I retuned home  i was still feeling achy but it was more pronounced in my neck and chest. I called my niece who is a PA and explained my symptoms and she told me to go to the ER to rule out that I was not having a heart attack. Went to Hospital. They took and EKG, Chest X-ray and blood work  and everything came back negative. I went back home and the pain in my chest and neck became progressively worse. Most of the pain was on the right side of my body. I was in a great deal of pain at this point.  I texted my Dr and he suggested I take 600 to 800 milligrams of Ibuprofen which  I did. (600) I was lying down at this point but no matter which way I moved  I was in uncomfortable pain. Approximately  20 minutes after taking the ibuprofen the pain subsided.   2-18-21 I feel better today but still have some slight pain in my neck . I am just relaxing today.
Case number PHEH2014US023845, is an initial spontaneous report from a consumer received on 25 Nov 2014. This report refers to a 64-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413301) intramuscularly on 29 Sep 2014. On 09 Oct 2014, ten days after vaccination, she experienced flu like symptoms included fever, body aches and stomach ache. Two weeks later she developed a rash. Outcome of the events was reported as not resolved. Seriousness and causality of the events was not reported.
Bell's palsy; Facial paralysis; Contusion; Chills; Fatigue; This case was received via FDA VAERS (Reference number: 1108212) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) and FACIAL PARALYSIS (Facial paralysis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), FACIAL PARALYSIS (Facial paralysis) (seriousness criterion medically significant), CONTUSION (Contusion), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with VALACICLOVIR at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's palsy), FACIAL PARALYSIS (Facial paralysis), CONTUSION (Contusion), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient mild chills and fatigue the following day after vaccination. The morning of the 17-MAR-2021, patient woke up and felt like the right side of my face was bruised, just under the apple of cheek. Looking in the mirror, patient saw right side of mouth had a droop. Patient notified the  Health Department where she had received the vaccine and then called PCP.  PCP did a telehealth visit with patient and confirmed Bell's Palsy characteristics. Patient had no other issues so no further testing was deemed needed and PCP prescribed a short course of steroids and vancyclovir. Patient have an in person visit with PCP next day.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Narrative:  Patient developed a fever, lethargy, rigors, and sweats the morning after receiving the Pfizer booster. However, upon admission to the hospital, it was revealed the patient had community acquired pneumonia. While the vaccine may have caused the symptoms, it is difficult to determine if the symptoms were solely caused by pneumonia.
PATIENT WAS EXPERIENCING PAIN/SWELLING AND REDNESS.  THESE SYMPTOMS STARTED DAY AFTER VACCINATION AND PROGRESSED UNTIL PATIENT SOUGHT MEDICAL TREATMENT ON 8/4/22.
Pt reported a blotchy rash on her chest area and left arm that started about a week after her 1st Shingrix, which was given on 10/18/19. She said it took about a month to go away. Patient said that she did go out of town and she said she wonders if it could have been just her being in the sun or the new sunscreen that she used but with the proximity of the symptoms being so close to the time that the Shingrix was given she is thinking it is from Shingrix.
3RD DOSE PFIZER COVID VACCINE GIVEN 3/3/22, #FJ1620; pt admitted to hospital on 8/26/22 with vague abdominal sx, hypotension, FTT; found to be positive for COVID; respiratory status stable on RA; dysgeusia, given zinc; Decadron; holding Remdesivir due to kidney function; pt requested comfort care and hospice; DNR; pt dc'd on 9/4/22 to Hospice Facility where she passed away
This spontaneous report as received from healthcare worker refers to a patient of unspecified demographics. On 25-MAR-2014, the patient received an expired dose of PNEUMOVAX 23 injection, dose unspecified, (lot # H01661, expiry date 02-FEB-2014), intramuscularly. Concomitant therapy was unspecified. The healthcare worker stated that the patient would probably be revaccinated. No adverse effects reported. No product quality complaint was involved. The outcome of patient received an expired dose of PNEUMOVAX was unknown. No further information was provided. Additional information has been requested.
patient came in the evening on august 5th to obtain her last moderna vaccine. she stated later on that night her arm starting hurting more than it normally does after a vaccine. she took some Ibuprofen and went to sleep but through out the night and through the next morning it was getting progressively worse. Patient states that she can't move or lift her arm anymore. Currently recommended she contact her primary care physician.
started crying around 8PM 17FEB93 unable to get comfortable, inc fever 102.4 @ 3AM mom stated pt started screaming & cont to 6AM called answering service of pvt MD & was referred to ER; pt refused to eat for 2 days;
10-29-2013 itiching and hives took Benadryl no relief. 10-30-2013 spoke to doctor started Zantac.  Hives all over body now. 11-1-2013 called into clinic to report symtpoms and question allergy to flu shot.  She reported increased hives and throat irritation and was advised to go to clinic to be seen.  Noted that patient received flu vaccine containing latex.  Patient had previously noted on consent that she had latex allergy.
Day after  vaccine I was having extreme muscle pain for 2 days Then on the 6th day I had a Red swelling on the injection site and developed VERY Chapped skin around my mouth. The red swelling went away within 5 days but I still have acute chapped lips around my mouth which has not cleared up. I spoke to the pharmacy today  They said I should not get the 2nde shot
Major migraine, hot/cold sweat at the same time, body aches, arm sore, fever, uncontrollable shakes, skin all over body felt like it was on fire
10/01/12 red, swollen, inflamed knot, itching, 1 1/2 inches apply BENADRYL cream.
depression - very dark thoughts (which were not her at all); anxiety; vivid dreams; Sore arm; She wasn't feeling good; constant scratchy throat; "ache-y" joints; days with deep fatigue (up to this day); headache; fever; body aches; lip or mouth is on fire; feeling flushed; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (lip or mouth is on fire), FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety) and ABNORMAL DREAMS (vivid dreams) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] and MAGNESIUM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (lip or mouth is on fire), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever). an unknown date, the patient experienced FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety), ABNORMAL DREAMS (vivid dreams), PAIN IN EXTREMITY (Sore arm), MALAISE (She wasn't feeling good), THROAT IRRITATION (constant scratchy throat), ARTHRALGIA ("ache-y" joints) and FATIGUE (days with deep fatigue (up to this day)). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (lip or mouth is on fire), FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety), ABNORMAL DREAMS (vivid dreams), THROAT IRRITATION (constant scratchy throat), MYALGIA (body aches), ARTHRALGIA ("ache-y" joints), HEADACHE (headache) and PYREXIA (fever) had resolved and PAIN IN EXTREMITY (Sore arm), MALAISE (She wasn't feeling good) and FATIGUE (days with deep fatigue (up to this day)) outcome was unknown.            It was reported that the laboratory results of the patent indicated no sickness. She reported that her doctor ruled that the side effects were due to the vaccination   This case was linked to MOD-2021-268142 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow-up information included no new information.
Swelling in the left bottom eyelid and surrounding 3 inches for the past week.
Started with Flu like symptoms - fever, weakness, earache, tingling of tongue - then 2 days later - eye twitching - then HA; neck pain and eye twitching  - left sided facial weakness-paralysis. Progress recovering.  12/9/09PCP records rec'd for DOS 9/29/09 with dx:  Bell's Palsy.  Pt presented with 5 day hx of L-sided facial numbness/weakness. Also c/o L-sided earache, neck pain and frontal h/a.  Dizziness 2' to eyepatching. PE (+) for L facial droop with decreased sensation, otherwise neuro exam WNL with normal strength in upper and lower extremities. Tx: Pred and Acyclovir.