chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre Syndrome; Bell's palsy,bilateral facial nerve palsy; This is a spontaneous literature report.  A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on Mar2021, as dose 1, single, for COVID-19 immunisation. Medical history included mild asthma. The patient's concomitant medications were not reported. In the first few hours, he noticed muscle soreness, leg heaviness, and fatigue. Three days later, he developed a right facial droop. He presented to the emergency department on postvaccination day 7, where he was diagnosed with Bell's palsy and given oral steroids. Several hours later, he noticed a new left facial droop with paresthesias in his bilateral hands and feet. He was admitted to the hospital where his SARS-Cov-2 PCR testing was negative. His neurologic examination demonstrated bilateral severe facial nerve palsy and lower extremity areflexia with intact limb strength and sensation. MRI of the brain was unremarkable. Cerebrospinal fluid analysis demonstrated elevated protein of 116 mg/dL and no white blood cells, consistent with a diagnosis of Guillain Barre Syndrome. Electromyography (EMG) demonstrated bilateral facial nerve palsies with both demyelinating and axonal features, with normal nerve conduction velocities. He was treated with a five-day course of intravenous immunoglobulin (IVIG) resulting in mild improvement of his facial weakness. Conclusion(s): This variant of GBS occurring within one week of Pfizer- BioNTech vaccination suggests that this may be a rare complication of the vaccine. IVIG was the treatment of choice. Further observational studies were needed to better understand the association between vaccination and the GBS variant. Nevertheless, the benefits of the vaccine far outweigh its potential risks. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relation, the association between the events of Guillain Barre syndrome and Bell's palsy and the suspect product of BNT162B2 cannot be completely ruled 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.
Child is 15 months not able to walk as of bedtime. Her right leg is bruised under the markings of the shots. Also the child is not able to put pressure on right leg. She is avoiding to stand on right leg. She is in a lot of pain regarding her right leg predominently.
PATIENTS WIFE CAME TO PHARMACY ON 10/22/19 AND SPOKE TO RPH REGARDING ADVERSE REACTION THAT OCCURRED AFTER RECEVING VACCINES ON 10/17/19. PATIENT REPORTED SWELLING ON RIGHT ARM WHERE 2 VACCINES WERE GIVEN AND REPORTED TO HOSPITAL WITH SHORTNESS OF BREATH. CELLULITIS WAS SUSPECTED AND PATIENT WAS ADMITTED TO ICU FOR 2 DAYS, THOUGH SAFELY DISCHARGED.  IT APPEARED FROM A PHOTO THAT VACCINES WERE CORRECTLY SPACED >1" APART,
(R) arm swelling S/P KINRIX (DTAP/IPV) vaccination. Diffuse swelling of (R) arm, greatest at the wrist and forearm, entire arm warm to touch. No cellulitis - no redness or tenderness.
Approx. 4 hrs after vaccination pt threw-up, turned pale, lips blue, stopped breathing. Called EMS child taken to Hospital.
In April 2021, I got my first COVID shot (Pfizer ER8732) on 4/3/21. In May I got my 2nd COVID shot (see details above) at the same pharmacy and again the Pfizer vaccine. About a month after my 2nd dose, I developed a one sided sore throat out of the blue with no explanation. My immune system became incredibly run down, and during this time tested negative for COVID. With no prior history of issues with infections or my esophagus, I developed some sort of infection that doctors are still trying to find (have low T lyphocytes so immunologist and ID specialist looking for it). I had absolutely no history of swallowing troubles. I have been corresponding with several other people who experienced dysmotility the day after they got the vaccine. Whether or not this is a coincidence I am not sure, but it is quite odd I had no problems before this and then just a month later I have issues and other people have described the same thing. I am reporting this in case there are others who have reported something similar for data collection to see if their is a correlation. My immune system is quite damaged and my treatment continues. There were points when I could barely swallow water last year and this year but I have a good treatment place in plan with the gastroenterologist, immunologist, and infectious disease specialist. I have since relocated and received my eosinophilic esophagitis diagnosis here, but am still awaiting some results from immunology and finding the infection that I have. It's a journey though. I am wondering if the vaccine effected my immune system somehow and targeted the nerves/muscles. It could also be a coincidence.
APPROXIMATELY 4-5 HRS. AFTER FLU VACCINE GIVEN DEVELOPED A RASH ON NECK, BOTH ARMS,AND UPPER TRUNK. DESCRIBED AS DIFFUSE AND LIKE MOSQUITO BITES.  ITCHING TREATED WITH BENADRYL 50 MG P.O. X ONE DOSE, AND ITCHING RESOLVED  PER PHYSICIAN ADVISE TAKING CLARITIN 10 MG EVERY 12 HRS TO RELIEVE RASH.  RASH RESOLVED AFTER 3 DAYS TREATMENT WITH CLARITIN.
Headache for 10 days. It started 2 days after the shot. Self-treated with paracetamol.
ON 1/11/21 DEVELOPED DIZZINESS, CHILLS, AND WEAKNESS. WAS SEEN IN URGENT CARE ON 1/12/21
This non serious case was received on 01 April 2009 from a health care professional. A 40 year old female patient received ADACEL (lot number UF457DA) intramuscularly in the right deltoid on 24 March 2009 at 10:00 AM. Concomitant therapy included Sudafed. On 28 March 2009 at 4:00 PM the patient  developed swelling, redness, and warmth at the right axilla near the right side of the breast. The patient developed a blister on the right wrist which was 1 cm round. The patient was reported as recovered. List of Documents held by Sender: none.
needle hub was loose, when provider went to inject, the dose spilled out  onto individual. Individual was not able to stay for 2nd redose. Individual returned the following day for a full booster dose with no issues.
Right arm swollen and hot to the touch, my temperature got up to 103 and lasted two days.
Severe nausea (no vomiting), fatigue, flu-like symptoms for 3 days post vaccine administration. Redness and swelling in arm.
W/in 8 hrs p/immun, 1yo child experienced a fever of 103.5, lethargy, & irritability; Seen in office; PE w/in normal limits; Fever less than 102 tx w/APAP;
NO REPORTED ADVERSE EFFECTS.  IMMUNIZATION CONSENT FORM, WHICH WAS FILLED OUT BY PATIENT OR SOMEONE IN FAMILY ON-LINE,  ERRONEOUSLY HAD THE INCORRECT BIRTHDATE.  PRODUCT TO BE GIVEN SELECTED ON-LINE WAS MODERNA.  I SPOKE TO Patient's MOTHER THIS EVENING. SHE SAID SHE WAS CONTACTED BY SOMEONE ELSE THIS WEEK, AND WAS TOLD PER CDC RECOMMENDATION, IF THE INCORRECT PRODUCT WAS ADMINISTERED, THE SECOND SHOT SHOULD BE THE SAME PRODUCT.  WE PLAN TO GIVE A SECOND DOSE OF MODERNA THIS WEEK.
pt recv vax & devel swelling, redness & warmth @ the site of Acel-immune administration;pt was seen by MD 2 days post vax w/prophylactic ATB;this is 1 of 4 pt from this site to devel an inj site rxn p/vax;
Muscle aches entire body for approx 24 hours. Fever for approx 8 hours. Fatigue for approx 48 hours. 1 extra strength Tylenol, 2 doses over first 24 hours.
No adverse events.  Was given a covid vaccinebefore it was mixed with the dilution.
The pt experienced hives on abdomen and back 24 hours post vax. Atarax was prescribed for itching. No SOB, cyanosis or other symptoms reported.
Significant (7-10cm) local reaction with edema, slight induration, mild tenderness. I?'s given near (not in) a hemangioma at left upper arm.
LT THIGH SWOLLEN, RED, WARM TO THE TOUCH, HARD LUMP
report an Adverse Event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report an Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report an Adverse Event). At the time of the report, VACCINATION COMPLICATION (report an Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was provided NoTreatment medication was provided
One week after recieving smallpox vaccine to right arm, patient noted numbness of left tricep area. Over the next few days he experienced pruritis of the left should blade area. One week after symptoms began "bumps" began forming near the left axilla. Bumps spread over the next few days in a dermatomal pattern over the back. These were initially painless.
Urticaria rash on the body. Temp 99.7. (Back, trunk, abd wall, all ext) No resp. distress.
Fall asleep; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Fall asleep) and FATIGUE (Tired) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced SOMNOLENCE (Fall asleep) and FATIGUE (Tired). At the time of the report, SOMNOLENCE (Fall asleep) and FATIGUE (Tired) outcome was unknown.            Treatment drugs were not reported concomitant drugs
This spontaneous report as received from a nurse refers to a patients (unspecified number) of unknown age, who were vaccinated with a dose of live (Merck) VARIVAX (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient could have received doses of live (Merck) VARIVAX that were improperly stored. The nurse reported that her practice had "dormitory-style" freezer and when new thermometer was placed in, temperature reading was around 10-15 F. The nurse reported that could not tell how long live (Merck) VARIVAX might had been exposed to 10- 15 F. No adverse effects reported. Additional information has been requested.
Information has been received from a physician as part of a market research focus group concerning a 17 year old female patient who on an unknown date was vaccinated with a first dose of GARDASIL (lot number, route and site not reported). In May 2008, the patient developed swelling, redness and nausea. Therapy with GARDASIL was discontinued. Subsequently, the patient recovered from swelling, redness and nausea on an unknown date. Additional information has been requested.
stabbing pain in right ear/ intermittent ear pain; loud ringing in right ear; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, 7 hours after receiving the vaccine the patient woke up from a deep sleep with a stabbing pain in right ear and loud ringing in right ear and six weeks later, the patient still have ringing in ears, pain in ear was slowly going away and had intermittent ear pain. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with an unspecified medication. The clinical outcome of the events a stabbing pain in right ear/ intermittent ear pain and loud ringing in right ear was recovered with sequelae on an unknown date.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & 5 to 6 days later pt exp flu-like sx including fever, nausea, vomiting & gen malaise;4 patients were reported (WAES 96081699 through 96081702);
On May 29th, I had bright lights in my eye, like a lighting blot. I had cloudy in some of my eye vision. I contacted my eye doctor, I was advised that it was not an emergency. When I seen them they just over looked it. I experience color light in my left eye. On June 21st, I seen another eye doctor because I had lost vision in my left eye completely. I had complete Rhegmatogenous detachments. I had to have an emergency eye surgery to fix this. On August 31st, my retina started to tear again. On Sept 2nd I had another emergency eye surgery for the retina tear. I still have blurry vision.
2/1/2023 I have a history of PVC's. The PVC's increased in frequency. I also have had issues with my blood pressure going up and down since I had COVID and was off my blood pressure medications, temporarily. I am now back on those. I called my cardiologist and had tests done. All the results are not in yet. I have an appointment on 5/16/23 to go over the tests.
pt recvd vax; 1 wk p/ 2 dose, exp facial numbness & tingling, and slurred speech; subsided
Numbness and tingling in both hands, down right leg.  Patient observed for 30 minutes.  No worsening of condition and patient declined further medical care.
aches; chills; High fever (103+) for two consecutive days; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (aches), CHILLS (chills) and PYREXIA (High fever (103+) for two consecutive days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), CHILLS (chills) and PYREXIA (High fever (103+) for two consecutive days). At the time of the report, PAIN (aches) and CHILLS (chills) outcome was unknown and PYREXIA (High fever (103+) for two consecutive days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103+ (High) High fever (103+).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-441955 (Patient Link).
Information has been received from a 63 year old female consumer reporting on herself with drug reactions or allergies to clindamycin, penicillin and codeine and no pertinent medical history who on 29-JUN-2009, was vaccinated with a dose of ZOSTAVAX (Merck) administered into the back of her left arm (dose, route, lot number not reported). Concomitant therapy included hydrocodone and valacyclovir HCl. On approximately 04-MAY-2012, about three weeks ago, the patient was diagnosed as having shingles. The patient noticed the red spots up under her arm, across the breast and center back. It went from center front to center back. She felt like she had nerve damage. The patient thought if she had have been better informed, she would had gone to the physician sooner. Since the patient had the vaccine, she did not think she would get the shingles. If the patient did not start the medicine within 72 hours, she could get nerve damage. After the first week is scabbed up and dried over and then it felt like nerve damage. It still hurt a lot and the patient felt numbness down her whole arm and into her foot. As a treatment for shingles, the physician gave to the patient an antiviral and something for pain which caused her to vomit. At the time of the report the patient's outcome was recovering. No laboratory tests were performed. The patient sought medical attention. There was no PQC. Follow-up information has been received from physician who stated that the patient reported that she had shingles vaccine 3 years ago and developed shingles in May of 2012. The relatedness for the patient's shingles was not reported for ZOSTAVAX (Merck). Additional information is not expected.
Wife reports patient was fevering. Temperature would spike to 102 degrees. Soak through t-shirts at night. He would be fine for a moment and then the same thing would happen again. This happened for about five days. Tried to get into the doctor but couldn't, they recommended they go to the ER. ER gave him a cream and was advised to see his PCP. Hands developed a rash and swelling up to his arms. March 5th they see his PCP. Had mild congestion, abdominal pain and diarrhea Topical creams (Triamcinolone) used the first time and then a stronger cortisone cream (Valisone) was suggested and that helped. PCP stated it could be Sweet syndrome Erythema Multiforme.
Arm is red but only where he get the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm is red but only where he get the shot) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm is red but only where he get the shot). At the time of the report, VACCINATION SITE ERYTHEMA (Arm is red but only where he get the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant and treatment details reported.
Bruising, swelling, pain and red rash at injection site. Pain and swelling make it difficult to lift left arm overhead
11/23/16, pt experienced nausea, dizziness, headache, and hives. Nausea, and hives. Nausea, dizziness and headache have lessened, with hives spreading. Pt advised to take CLARITIN, monitor and to ER if worsening.
A report was received from a 32 year old female consumer who developed soreness of the left arm after receiving a dose of Flu Shield on an unspecified date in December 2002. The pt developed an injection site reaction characterized by soreness of the left arm. The reporter indicated that she could not sleep for days and had trouble putting on her clothes. After a few days, the soreness resolved without treatment. No additional info was available at the time of this report.
guillain barre syndrome; Initial information received on 17-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who experienced guillain barre syndrome while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine (formulation, strength: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient developed guillain barre syndrome (guillain-barre syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (guillain barre syndrome).  At time of reporting, the outcome was Unknown for the event guillain barre syndrome.; Sender's Comments: Sanofi Company Comment dated 24-Jan-2022. This case involves an unknown age female patient who experienced guillain barre syndrome while receiving vaccine Influenza Vaccine. Based upon the reported information, the role of a vaccine cannot be assessed  Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.
Immediately after vaccine felt flushed with high heart rate and lightheaded. An hour after, developed chronic mild headache, chronic mild lightheadedness, and chronic moderate fatigue which are expected symptoms with the immune response. HOWEVER, symptoms did not improve in 3 days and actually very slowly worsened until I couldn?t function for work about 2.5 weeks after the vaccine. At this point, the lightheadedness and fatigue were severe and headaches varied between moderate to severe, resulting in me being out of work for 9 consecutive  work days. Had multiple MD visits with tons of tests. During the time I was out, I developed severe lower abdominal pain for two days and severe lightheadedness/nausea/mild vomitting due to being nauseated with chronic headaches. OTC meds did not help much for the headaches nor other symptoms. I have never dealt with symptoms like these before and am very healthy.  At the 4.5 week mark post vaccine, these symptoms finally started to very slowly improve, VERY slowly. Tests at MD were inconclusive. I?m still dealing with chronic mild headaches, lightheadedness, and this past Friday now unusual chest pains that move location and severity.
07/20/2022-mom stated patient had a fever but didn't check the degree 07/21/2022-vaccinations give that morning-that evening temp 104, lethargic, not eating and no ambulation 07/22/2022-monotone mood, 103 temp, still ambulation altering Ibuprofen and Tylenol 07/23/2022-playing, no walking till that evening, no fever 07/24/20022-fever free 07/25/2022- fever free, acts normal per mom
Pain at injection site. Numbness in left arm. (Note, Not sure of manufacturer!!).
My vision has been affected. Starting  4 days after the shot, I had discomfort while driving. I was wearing contacts and had my prescription renewed 2 days before my vaccination so I don't think my contacts are the issue. I  The discomfort feels like my eyes are having trouble focusing even though I can see fine. It's as if my eye muscles are strained. It also feels like I've been trying to look at something very close to my eyes for a long time even though I haven't. I'm not certain, but I think the discomfort is on top or behind my eyeballs. My optometrist told me to stop wearing contacts for 2 weeks and that's helped but I still have slight discomfort still, especially when driving or having to focus on near and far objects.
Pt complained post vaccine of joint pain, fever, swelling in calves and fingers and mild rash all over body.
Presents to the ED c/o generalized weakness fatigue for 1 week. Diagnosed w/COVID-19 pna; tx w/abx, steroids, zinc, O2.
Narrative:  COVID infection following COVID vaccine series 02/09, Pfizer, dose #1 03/010, Pfizer, dose #2 08/9 pt cc: Cough, Fatigue, Fever, Headache, Loss of taste or smell, Myalgias, Rhinorrhea, Sore throat exposure: unknown 08/12 COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE B.1.617.2 08/12 SARS-COV-2 CLADE 21A DELTA