chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt achy, arm sore at injection site.  11/12 had loose bowel movement and and subjective fever (Tm 99.8).  11/13 started coughing (wet, productive). 11/16 received seasonal flu and TdaP.  11/17 had wheezing and felt poorly.  Referred to PMD or emergency room.
very much in pain/ pain in arm / patient is very much in pain; lot of pain in her belly; lot of pain in her stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very much in pain/ pain in arm / patient is very much in pain), ABDOMINAL PAIN (lot of pain in her belly) and ABDOMINAL PAIN UPPER (lot of pain in her stomach) 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 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (very much in pain/ pain in arm / patient is very much in pain), ABDOMINAL PAIN (lot of pain in her belly) and ABDOMINAL PAIN UPPER (lot of pain in her stomach). At the time of the report, PAIN IN EXTREMITY (very much in pain/ pain in arm / patient is very much in pain), ABDOMINAL PAIN (lot of pain in her belly) and ABDOMINAL PAIN UPPER (lot of pain in her stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: significant followup has been appended
local rxn rash; pain swelling, inc warmth, induration or lump w/o abscess; adenopathy, allerg event hives;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 17Feb2021 as dose 2, single (Lot number: Em9310), in right arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 320308D), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication received in two weeks. Patient received treatment for covid-19 with Paxlovid. Patient started paxlovid on 08Oct2022 and stopped on 12Oct2022. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Hives/Rash on head and trunk.  Pruritus moderatly relieved by Benadryl.
Information has been received from a pharmacist concerning an "older" female patient who was vaccinated with a dose of Pneumovax 23. Subsequently the patient developed a round band of inflammation below the injection site. The area was warm to the touch. The vaccination was administered at the pharmacy. The pharmacist indicated she had never seen anything like it before. The patient's outcome was unknown. Additional information has been requested.
Patient reports rash on opposite arm and chest the day after she received vaccine. She called doctor and doctor told her to call back in a week if still there
slightly raised, red, well demarcated rash around the injection side. The edges were more red than the center. Bruising at the injection site. The rash extended about 2.5 inches above and below the injection site and one inch on either side of the injection site.
3 inch round, erythematous, edematous, warm and tender area around injection site. Faint, lacy rash down whole arm. Pain w/movement of upper arm. Tx: NSAIDS, diphenhydramine, ice.
radiating to shoulder blade and up the left side; shoulder joint pain; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an  unspecified route of administration in the left arm on 01May2021 at 13:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation and patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0182) via  an unspecified route of administration in the left arm on 24May2021 at 14:00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, GBS, IGA deficient and  atrial fibrillation. Concomitant medication included Nexium (MANUFACTURER UNKNOWN), Losartan (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date. 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 didn't  received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 02May2021 at 5:30, patient experienced shoulder joint pain. On an unknown date, patient had radiating pain. Its reported that the next day, resulted in shoulder joint pain after the first shot. Almost 8 weeks after the first dose and pain had not gone away. In fact the joint pain had gotten worse in the left shoulder and radiating to shoulder blade and up the left side of the neck. The clinical outcome  of the event of  shoulder joint pain was not recovered while outcome of radiating pain was unknown. No follow-up attempts are needed. No further information is expected.
My COVID-19 symptoms started on 12/12/2022 in afternoon around 04:30PM. I had body aches, headaches, congestions, brain fog, and chills. On 12/13/2022 I had cough along with other symptoms. I also did a COVID-19 home test which was positive. On day 4 all the symptoms got worse. On 12/15/2022 I called my doctor's office and they prescribed me with PAXLOVID for 5 days.
Developed flashing light in his eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHOTOPSIA (Developed flashing light in his eyes) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PHOTOPSIA (Developed flashing light in his eyes). At the time of the report, PHOTOPSIA (Developed flashing light in his eyes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he did not receive treatment for his symptoms. He visited opthalmologist.
This client apparently went to another clinic previously and received a Pfizer vaccine. He then came our clinic site at his place of employment and got a Moderna  Vaccine on 4/13. His second dose of Pfizer was then given on 4/14 at another clinic.
Client describes a tingling in her legs, feet and arms that started about 6-8 hours after receiving the shot. She also felt her face getting red and feeling hot and took Tylenol after going to bed. The next day, she had a rash on her forehead, scalp, neck, arms (elbows to hands) and ankles - red and a little itchy. She used soap and alcohol which had helped previously with other sensitive skin issues. This did not help for this and she starting using hydrocortisone cream, which helped some, but the rash returns. The rash which appears on her forehead has blisters.
Swollen red and painful at injection site two weeks following the shot.  November 23rd -Chest pain, shortness of breath, tire easily. Diagnosed with myocarditis
Left arm pain starting on 4/26/21 and then redness at the site of injection started that spread outward from there. Was raised, warm, and red. On 5/4/21 slightly pink in color but still mildly warm to the touch and mildly swollen. Still painful on the left deltoid when lifting arm because of the mild site swelling that remains. Swollen lymph node in the left armpit on 4/24 and 4/25 but then resolved.
Sharp pain around area where pelvis meets left leg/femur.  Day 1 had limp with mild pain when walked and put pressure.  Day 2 and 3 pain worsened to point could not walk without severe pain.  Stopped walking except essential.   Started home treatment with 2 ibuprofen per day, 3 applications/day of local pain reliever (icy hot, massaging of area and ice packs on Day 2).  Day 4 pain subsided to less than Day 1.  Day 5 99% back to normal.
Approximately 5:09 pm on 11/5/21, 44 year old male client arrived to vaccination site to receive Pfizer booster of COVID-19 vaccine.  After review of client's vaccination record, it appears that client was 1 day shy of the 6-month eligibility criteria as outlined by CDC Guidelines. Elevated this inquiry to Clinical Supervisor, who received approval from medical provider to provide Pfizer booster dose to client at this time.  Pfizer booster dose administered to client by Nurse on 11/5/21.  No adverse reactions noted during 15 minute post-observation period.  VAERS and VERP also completed.
Fever 102 F, 103 F, severe confusion with mental status changes, chills/rigors, hypotension, redness and raised skin surrounding injection site.
Chills; Low grade fever; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were not recovered/not resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11 NOV 2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient reported that received the 2nd dose of vaccine. The patient stated still having chills and low grade fever.
Patient received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and indicated that this lot  maintained  activity necessary to protect against covid 19. Patient did not call in   to  report any adverse events.  This is administrative error without adverse event.
Pt recvd vax & 4 hrs p/vax exp nausea, vomiting, chills, fever & diarrhea x 4-6 hrs, h/a & mild nausea x 24 hrs; exp UTI sx then began to exp arthritic sx (pain & swelling of various joints including knees) assoc w/fatigue;
metal/odd taste in mouth; headache; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient received bnt162b2 (Solution for injection,Lot number was not reported), via an unspecified route of administration on 05Feb2021 to 05Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced metal/odd taste in mouth and headache on 05Feb2021. The patient neither have Covid prior vaccination nor tested Covid post vaccination. The outcome of events was unknown.  Information on the lot/batch number has been requested.
The night of my injection i started having heart palpitations and pain in my joints and nerve pain in my legs. For days I was unable to stay awake and was having constant pain. A week later I went to the emergency room, because my hands, feet, chest, neck and face were going numb. They sent me away saying it would go away after a few days of rest. It?s now been 3 months and I am still having nerve pain in my legs, joint pain in my fingers, feet, and elbows and chest pains.  There has been no treatment given.
Tenderness, swelling, severe cellulitis like reaction from vaccination site to elbow, nausea, loss of appetite, fever 101 - urgent care diagnosed cellulitis - BACTRIM prescribed. Seen 3 times.
On 6/17/14 I observed my daughter not being able to no longer walk and stopped speaking. I took her to the ER on 6/18/14 and she was diagnosed with cerebellar ataxia. She then developed a speech delay and still requires speech and language services.
Constant, chronic bilateral Tinnitus, Hyperacusis, Hypoacusis  starting on January 7, 2021, ongoing and persisting through the date of this report May 3, 2021. Intermittent vertigo starting on January 7, 2021, ongoing  and persisting through the date of this report May 3, 2021. Intermittent feeling of fullness in both ears, starting on January 7, 2021, ongoing and persisting through the date of this report May 3, 2021. Burning mouth sensation, Jan 7-Feb 6, 2021 Minor loss of hearing  from Jan 7, 2021
delayed onset 1hr p/vax flushing, burning sensation, itching, hives;given Epi;no resp diff;
Three days later, she called complaining of ankle swelling without pain, shortness of breath, chest pain. Was advised to limit salt intake and return if without improvement. 11/1/02, she had 2++ pedal and ankle edema; no other abnormalities. Cardiovascular exam normal; BP was normal. She has developed rapid change of her renal function with edema and increased creatinine.  Medical record received on 4/14/2004 states anemia, hypertenstion, and acute kidney failure. Follow up received on 6/1/04: Severe nephrotic syndrome secondary to minimal change nephropathy. Acute renal failure. 6/6/03 Started to into remission the nephropathy. As of 12/8/03 she relapsed of her minimal change glomerulonephritis. As of 4/5/04 she is in remission.
Initial side effects subsided at 1 week after receiving the injection. Today, nine days after receiving the vaccine, I noticed a rash on my left arm at the injection site and surrounding area. I am also experiencing itchiness and a sensation of heat around the rash area. The area is noticeably swollen as well. Around this same time the rash appeared, I also experienced feeling weak upon standing a couple of times, although I am not sure if this is related.
Prolonged chills, nausea, diarrhea, fatigue.  Still present after 5 days.  I had covid 8 weeks ago.
Information has been received from a 21 year old female who in approximately November 2007, was vaccinated with the first dose of GARDASIL (route and site not reported). Subsequently on an unknown date, the patient was diagnosed with human papilloma virus (HPV). The patient stated she had been unable to get second and third dose of GARDASIL. At the time of report, the patient's outcome was unknown. No further information available.
Patient reported that she has "cluster like headache" 2 days post Pfizer vaccination on 4/6/2021. Vision wnl. She then developed rash around her  left eye.   She was evaluated by an ophthalmologist on 4/14/2021 and was dx'd with "Ophthalmic Zoster". She was treated with Acyclovir x 7d. Completed Acyclovir on 4/22/2021. All the lesions resolved.   Skin - clear with minimal dry, scaly lesions on the left scalp.
Arm went numb from injection site to elbow; Numbness in some parts of her hand; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (Arm went numb from injection site to elbow) and HYPOAESTHESIA (Numbness in some parts of her hand) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021 at 11:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021 at 11:30 AM, the patient experienced VACCINATION SITE HYPOAESTHESIA (Arm went numb from injection site to elbow) and HYPOAESTHESIA (Numbness in some parts of her hand). At the time of the report, VACCINATION SITE HYPOAESTHESIA (Arm went numb from injection site to elbow) and HYPOAESTHESIA (Numbness in some parts of her hand) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  Patient reported that her arm was no longer numb but had the sensation of numbness.But when she touched her arm, she could feel the sensation.  The treatment information was  not provided.
Extremely painful arm starting in the afternoon of the day of the shot; feverish in the afternoon; took Tylenol; deep mucousy racking cough and fever overnight; less sore arm the next day; sore throat, chills, took Tylenol, chest congestion continues.
My arm has been weak ever since I got the injection, My vision gradually became blurry in my left eye over the course of two weeks. I saw a rheumatologist that diagnosed macular edema.
itching and scratching on stomach, both underarms has raw rash, groin, ear, face nothing working
Experienced persistant h/a (morning p/Im adm) & "bad taste" p/receiving rabies vax; h/a required immobility to tolerate;
A 66 year old female reported that she received an injection of Pnu-Immune 23 on 10/25/00. Within 3 hours of the vaccine administration, the patient was not feeling well. The following day, she developed an injection site reaction in her left arm characterized by swelling, redness, and pain which extended through her left shoulder, mid-back, and neck. She was seen by the physician and diagnosed with necrotizing cellulitis. The patient was hospitalized on 10/26/00. An MRI was performed; however, the results were not available. The reporter stated that the physician felt she was "going into shock" and central venous line was inserted. She was treated with IV fluids, Unasyn (Ampicillin / Sulbactam) and Morphine. The patient was discharged on 10/27/00 with an unspecified antibiotic. Reporter also states that the physician felt she was "allergic to the Pneumonia vaccine". Follow up information received from the physician on 03/07/2001 indicated the patient was diagnosed with angioedema and injection site edema rather than fasciitis/shock. The patient's symptoms resolved rapidily and she recovered.
diarrhea, cramping, nausea, severe sweating, low temperature (95F), dizziness, weakness - unable to get off the bathroom floor at work duration of symptoms: 24 hours
Epi and Benadryl, soar throat difficulty breathing, swollen eyes, lips, and throat area, itching, headache, tachycardia
intermittent ringing of the ears; mild arm soreness; Tiredness; headache; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE JOINT SWELLING (mild arm soreness), TINNITUS (intermittent ringing of the ears), FATIGUE (Tiredness) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k202a and 007m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, LEVOTHYROXINE, BUPROPION, MULTIVITAMIN & MINERAL, CALCIUM and VITAMIN D3 for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE JOINT SWELLING (mild arm soreness), TINNITUS (intermittent ringing of the ears), FATIGUE (Tiredness) and HEADACHE (headache). At the time of the report, INJECTION SITE JOINT SWELLING (mild arm soreness), TINNITUS (intermittent ringing of the ears), FATIGUE (Tiredness) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment information includes Z-park
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 25-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was reported.
VACCINE WAS GIVEN TO PATIENT ON 10/12/2022, VACCINE GOT RECALLED BY PHARMACY ON 10/13/2022 FOR EXPIRATION DATE. VACCINE WAS SET TO BE EXPIRE 1 YEAR AFTER MANUFACTURE DATE WHICH WAS 09/30/2022. HOWEVER, ONCE WE RECEIVED VACCINE WE USE BUD DATE 10 WEEKS AFTER RECEIVED VACCINE WHICH WILL BE 10/30/2022. MANUFACTURE DATA INDICATED THAT VACCINE'STABILITY AND EFFICACY ARE STILL GOOD AND STABLE. REVACCINATION IS NOT INDICATED AND CONTACT PATIENT IS NOT REQUIRED.
Patient is a 33 year old AAM with no prior medical history who presented to the Emergency Room at Hospital on 8/9/2021 with headache, seizure and thrombocytopenia with a platelet count of 75. Imaging showed cerebral venous sinus thrombosis, as well as Left Lower Lobe sub-segmental  Pulmonary Embolism and Portal Vein Thrombosis. He was initially treated with Lovenox but transitioned to Argatroban after HIT ELISA was positive on 8/13/21 (OD 3.75). Subsequent SRA was negative. Repeat HIT ELISA was positive on 8/19/21  (OD 2.36) SRA negative. He was discharged on Eliquis. Concern for possible Vaccine Induced Immune Thrombocytopenia and Thrombosis (VITT) vs Spontaneous HIT syndrome
Hives, severe crying and localized Redness to the left thigh. Reaction lasted several hours. Pt was given Zyrtec and Decadron IM.