chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness at injection site; swelling at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site) 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 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I HAVE ISSUES AND TRYING TO SEE IF ITS RELATED TO GBS SYNDROME; This spontaneous report received from a female patient of an unspecified age. Local reference number EZR20210103586.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Race and ethnicity not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. The patient called to get information regarding the warning on news that was released. The patient mentioned that she received JANSSEN vaccine and has some 'issues' and trying to know if it's related to the GBS syndrome.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of (I have issues and trying to know if it's related to GBS syndrome) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Patient experienced shaking of hands, sweating, and lightheadedness approximately 3 to 5 minutes after administration. Patient started to feel "pins and needles" feeling in hands and fingers 1 minute after. No swelling of the throat or mouth or blockage of airway was observed.  911 was dialed after symptoms of numbness and tingling of hands and fingers, sweating and heavy breathing  were persisting after 2 minutes. Stayed with patient until emergency services arrived. While waiting, patient's symptoms of heavy breathing begin to subside
Very lethargic, motor skills slow to respond, listless, unable to focus, tiredness, stopped verbal noises and cooing as previously done, lasted approx. 2 weeks, gradually improved.
11/22 nauseated  11/23  dime sized red area lower bicep left arm  11/24  50 cent size red area lower bicep left arm "warm to touch" , normal ROJM  r/t PCP for f/u   11/25  PCP  dx cellulitis  rx antibiotics  not over vaccination site did not feel it was related    12/05  PCP permission for Health Department to revaccinate for Shingrix and Twinrix
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL dose 2, intramuscularly. Dose and lot number were not reported. The nurse reported that the second dose of GARDASIL was administered later than recommended. No adverse effects were reported. The outcome of dose was administered later than recommended was unknown. Reporter causality assessment was not reported. Additional information has been requested.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Unable to Sleep-Medium
Pfizer-BioNTech COVID-19 Vaccine EUA  Vertigo, low grade fever, fatigue started in afternoon 26 Jan 2021 Vertigo all day, slight tightness in chest 27 Jan 21
BRUISING ON ANKLES; RED SPOTS ON LEGS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced bruising on ankles. On 29-MAY-2021, the subject experienced red spots on legs.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red spots on legs, and bruising on ankles. This report was non-serious.
Lips swelled, body turned red & was itchy everywhere about 30 min. after administration patient on her own took CLARITIN & felt better in an hour. Symptoms resolved after 3 hours & was back to normal.
Extra dose administered; Chills; Joint pain; Tightness in the chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in the chest), EXTRA DOSE ADMINISTERED (Extra dose administered), CHILLS (Chills) and ARTHRALGIA (Joint pain) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 028A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced CHEST DISCOMFORT (Tightness in the chest), CHILLS (Chills) and ARTHRALGIA (Joint pain). On 23-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 23-Oct-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, CHEST DISCOMFORT (Tightness in the chest) and CHILLS (Chills) was resolving and ARTHRALGIA (Joint pain) had not resolved.            No Concomitant medication was reported.   This case was linked to MOD-2021-362076 (Patient Link).
Patient sent message to team in September 2021 with concens that they have had prolonged ringing in their ears (tinnitus) after receiving the Pfizer COVID-19 vaccinations. Pt states that tinnitus symptoms started about 5 days after each injection. Pt has Hx of tinnitus, but states symptoms felt "different" or "worse" than normal. Pt states complaints that tinnitus has not fully improved from baseline since that time.
started to experience ache; started to experience/ feverish; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 23rd November 2020, the patient received Shingrix and PNEUMONIA VACCINE. In November 2020, less than a day after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on unknown arm and pneumonia vaccine on unknown opposite arm and 24 hours later she started to experience ache and feverish and she still had the symptoms.  It was unknown if the reporter considered the pain and fever to be related to pneumonia vaccine. The reporter did not consent to follow up
left jaw stiffness and swelling; tongue tingling; mild difficulty swallowing   mild soft tissue swelling over left TMJ/parotid/angle of mandible/ submandibular area; mild fullness some radicular area, no mass or lymph node palpated. mildy tender there  treatment:  adminster H2 blocker, H1 blocker, solu-medrol, and IV fluids; Diphenhydramine hcl, methyprendenisolone na succ, prednisone (5 days)
Pt recvd 3 doses of Engerix-B 12SEP90; 29OCT90 & 14MAR91 & recvd Attenuvax 14MAY91; Pt was supposed to recvd a 2nd dose of Attenuvax but was mistakenly given a 4th dose of Engerix-B 16JUL91; 17JUL91 pt exp nausea, vomited & muscle aches;
Redness surround area including upper arm and down to elbow, including underneath arm. General body stiffness, dolor of location as well as patient experiencing chills. Urgent care told her it was reaction to a shot and had patient come here. Clinic told patient to take BENADRYL, ibuprofen and apply heat. Patient has not utilized treatments yet.
Presented with N/V x 4 days; Covid + in ED; admit to facility with Covid 19 infection; CXR consistent with Covid PNA; tx with Vit C, singulair, zinc; no supplemental needed.
On all four injection sites I had knots underneath my skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 20Aug2021 at 10:00 as dose 3 (booster), single (Lot number: EW0186) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Retinal vein occulusion", start date: 01Aug2018 (ongoing), notes: Pertinent details: eye lea injection every 4 to 6 weeks; "High blood pressure" (ongoing), notes: Onset date: 10 years ago, Pertinent details: metoprolol succinate 100 mg 1x a day; "Thyroid" (ongoing), notes: Onset date: 10 years ago, Pertinent details: Levothyroxine sodium 25 mcg. The patient's family history included: "Stroke" (unspecified if ongoing); "Alzheimers" (unspecified if ongoing); "Arthiritis (RA)" (unspecified if ongoing); "Eye Dieases" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Both are decreased. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose:01,Time: 10:00, Anatomical site of injection: Right upper arm, Route of administration: Intramuscular, Lot number: EL0142), administration date: 04Jan2021, for Covid-19 immunization, reaction(s): "On all four injection sites I had knots underneath my skin", "Pain that radiates down, my arm to my right thumb.", "Pain that radiates down, my arm to my right thumb."; BNT162b2 (Dose:02, Time: 14:00, Anatomical site of injection: Right upper arm, Route of administration: Intramuscular, Lot number: EL8a82), administration date: 26Jan2021, for Covid-19 immunization, reaction(s): "On all four injection sites I had knots underneath my skin". The following information was reported: VACCINATION SITE NODULE (non-serious), outcome "unknown", described as "On all four injection sites I had knots underneath my skin". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not received any prior vaccination within 4 weeks of suspect vaccine. Patient had 2 vaccines for COVID that were Pfizer on dates 04Jan2021 & 26Jan2021. Then two Pfizer boosters on 20Aug2021 & 01Oct2022. Her right upper arm where two of the injections were given stay sore along with pain on occasion traveling down her arm into her right thumb. This had been ongoing for quite awhile and she thought it was her side sleeping but bought a spinal alignment pillow and it still persists. The pain was not severe but was there.
I had fever, chills, coughing. I used a home COVID-19 test that came back negative. I made an appointment to see my physician. I was retested in his office, I was test for COVID-19, Strep, Influenza A and B, the COVID-19 test was the only test that came back positive. I was prescribed benzonatate to help with the coughing, and advised on which over the counter medications may best help me. Within in a week I was feeling better.
INFLAMMATION IN THE ABDOMINAL AREA; TIRED/FATIGUE; MUSCLE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031,expiry: not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced muscle pain. On an unspecified date, the subject experienced inflammation in the abdominal area, and tired/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, and the outcome of tired/fatigue and inflammation in the abdominal area was not reported. This report was non-serious.
Information has been received from a 90 year old female consumer referring to herself. No pertinent medical history was reported. On 17-JUN-2015, around 11:00, the patient was vaccinated with a dose of 0.65ml ZOSTAVAX (lot # K016325, expiration date 24-DEC-2015), subcutaneously. No concomitant medication included. On the same day, the patient experienced burning and stinging in both leg after administration. In that evening, her legs felt like "they were on fire" and were "marked with red dots". On that day, the patient developed red patches and blisters on both legs. The patient contacted her unspecified physician via telephone and she advised her to take BENADRYL. No lab diagnostics studies were performed. The outcome of blister was unknown. The patient stated she was recovering from other AEs and she was presently still taking BENADRYL. Additional information has been requested.
face turned red/eyes swelled shut about a day and a half after she received her second dose of shingrix
A female patient, with a history of ulcerative Proctitis diagnosed at age 52, received a subcutaneous injection of Influenza vaccine (manufacturer and lot number not reported). She was taking Sulfasalazine, Mercaptopurine, and intermittent steroids concomitantly, and her ulcerative Proctitis has been in remission for approximately nine months. Within hours of vaccination, the patient developed bloody diarrhoea and abdominal pain. She had very active ulcerative colitis with ulceration, friability and exudate, and recurrent bilateral uveitis. She was hospitalized, and treated with corticotrophin and tapering PREDNISONE. Symptoms improved, but did not resolve. Mercaptopurine and steroid doses were increased. One year after diagnosis, the patient underwent a total colectomy with ileoanal pouch anastamosis. She experienced intermittent pouchitis for one year before her pouch and ileum appeared normal. The patient noted that she had experienced a milder exacerbation of ulcerative colitis in the past following receipt of Influenza vaccine.
Had vax 11DEC91 onset hardness, itching & hot @ site of inject; 13DEC91 w/red whelps on neck last few hrs relieved by DPH;
Achy body; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy body), PYREXIA (Fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MYALGIA (Achy body), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, MYALGIA (Achy body), PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up information received on 16-Apr-2021 contains non-significant information.
Became sick; Sick with overnight cold lots of mucus and chills; Chills; Coughing; Headache; Body pain; Shallow breathing; No energy; Lots of mucus; Sinus ran on; Felt like I was sweating but when I touched the skin it was dry.; Slept for long periods if time.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 13Jun2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, neuropathy and acute migraine. The patient had known allergies to Xray dye. Concomitant medications included metformin (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BAYER ASPIRIN); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 23May2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. 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 14Jun2021 at 08:00, the patient experienced sick with overnight cold, lots of mucus and chills, coughing, headache for 4 days then some of mucus cleared up but headache and sinus ran on, body pain, shallow breathing, felt like she was sweating but when touched the skin it was dry, no energy, slept for long periods of time. 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. The clinical outcome of the events sick with overnight cold, lots of mucus, chills, coughing, headache, sinus ran on, body pain, shallow breathing, no energy and slept for long periods of time were resolving at the time of this report.    The batch/lot number for BNT162b2 was not provided and will be requested during follow up.
Patient given IM injection to R deltoid.  Within 3 minutes patient developed significant itching at the injection site and upper arm of same extremity.  Minutes later patient developed itching to L upper arm followed by the development of itching to upper back.  No respiratory distresss occured.
Tested positive for Covid-19; Tested positive for Covid-19; Dose received:3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Dec2021 (Lot number: 330258D) at the age of 44 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 24Mar2021 (Lot number: EK5730) as dose 2, single and intramuscular, administered in arm right, administration date 03Mar2021 (Lot number: EJ1685) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 22Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021, outcome "unknown", described as "Dose received:3"; VACCINATION FAILURE (medically significant) with onset 12Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 12Jan2022, outcome "recovering" and all described as "Tested positive for Covid-19". The event "tested positive for covid-19" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course: covid prior vaccination was reported as no.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ, and PEDVAX were improperly stored (event captured in MARRS#1405USA012894, 1406USA000955, 1406USA000957, and 1406USA000958 respectively). No adverse effects were reported.   Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as 20-MAR-2014 to 07-MAY-2014). The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department.   Follow-up information has been received from the Registered Nurse on 27-JUN-2014. The reporter stated that on an unknown date one patient received PNEUMOVAX lot # J009723 and exp date 30-JAN-2015 which were stored improperly (highest temperature: 9C, number of hours prior to administration: 7 hours: 4 patients; highest temperature: 9.5C and number of hours prior to administration: 13 hours: 1 patient) for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). This is one of several reports from the same reporter.  Additional information is not expected, as correspondence was returned by post office.
arrythmia, syncope, chest pain, fatigue, shortness of breath, bundle block, disorientation,