chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID; COVID; Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4434749-00.  An 81-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID"; PNEUMONIA (medically significant), outcome "not recovered". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid" and "pneumonia" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event (s) of COVID and Pneumonia with Humira (Adalimumab) was no reasonable possibility/ Not Related. The reporter's causality for the event (s) of COVID and Pneumonia with Pfizer BioNTech COVID-19 Vaccine was possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the limited information available, a possible contributory role of the Comirnaty vaccine cannot be completely excluded for the reported events.
Pt recv vax on 3/16/99; on same day pt exp hoarseness; 3/17/99 pt exp swollen glands; 3/18 fever (104.2), red/edematous throat, vomiting, lethargy, neck & cheeks swollen; tx=Amoxicillin
PT CALLED 1/11/21 STATING THAT SHE RECEIVED HER 1ST SHOT HERE ON 12/30/20. PT STATES THAT HER RIGHT ARM WAS BRIGHT RED FROM THE SHOULDER TO HER ELBOW. SHE SAID IT WAS HARD WHERE HER SHOT WAS GIVEN, BUT NOT HOT TO THE TOUCH. SHE STATED THAT SHE DID NOT HAVE A SMART PHONE OR COMPUTER SO SHE WAS UNABLE TO CONTACT ANYONE. I TOLD HER I WOULD DO THIS REPORT AND ATTEMPTED ON 1/11/21 BUT IT DIDN'T GO THROUGH.  I ADVISED HER TO SEE HER PCP. SHE CALLED TO MAKE AN APPOINTMENT AND THEY TOLD HER TO CONTACT THE HEALTH DEPT.
Patient reported feeling jittery after the vaccine; however, it resolved in 15 minutes.  Patient cleared by EMS.  .  Instructed patient to call his family physician, 911, or go to the nearest emergency room for any further issues.
No adverse event; Caller reported VARIVAX was administered to a 4 month old.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report as received from a certified medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 20-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # W031813, expiration date 05-OCT-2024, dose of 0.5 milliliter, subcutaneously in the right thigh, for prophylaxis.No additional adverse events were reported.
I originally got the J&J, and got the Pfizer booster. The J&J was in March of 2021. I had vey little side effects from it.  When I got the Pfizer booster on 11/9/202 which is what I reporting on here,  I got immediate and terrible reactions. First, fever and fatigue, then in the evening of the first night a dry cough and sore throat. By the next day I was sneezing and wheezing, having difficulty breathing as my chest was tight and had a terrible head cold.  2 days after the vaccine my left eye filled with blood and hurt. Then on the 4th day,  I got a   terrible mouth infection, oral thrush. Went to see my primary  doctor. She gave me cough medicine, an inhaler and a nystatin suspension for the fungal infection in my mouth. It took almost 2 weeks for me to feel better., and I'm still suffering from the fungal infection.
Body aches, Headaches, Vomiting, Diarrhea, Hypotension and lightheadedness.
TINGLING TONGUE, DRY MOUTH, "BRAIN FOG" - HAD PATIENT STAY WITH US LONGER, STARTED FEELING A BIT BETTER AFTER 17 MINUTES
pt recv vax; T of 103; unable to control w/ Motrin; coughing; watery eyes; not playful; acting as if out of it;
20NOV98 pain, swelling @ site;23NOV98 burning mouth, swollen lips/gums;24NOV98 to ER tx steroids, DPH;27NOV98 rash on lower extremities inflamed @ inj  site;30NOV98 seen by PMD & diffuse raised rash;
Presents with body aches, headache, chills, fever, fatigue and back ache with onset same day as second dose of COVD vaccine. She was given IV dexamethasone then discharged on oral prednisone x5 days.
Reaction onset 6-7 months after 7/1/2014 Hep A vac (lt. thigh) and 11 months after 3/6/2014 Hib and DTaP (left thigh) vaccines. 2/2/2015 Mom reports lump to left thigh x 1 month, noticed while applying lotion to skin, site itchy but lotion helps. Exam: dimple to right chest, "small less than pea size" nodule on left anterior thigh, no erythema or tenderness exam. 9/1/2015 Peds Surg f/u: 1 yr Hx intermittent swelling/itching over left ant thigh, child c/o sore thigh and itchy last night. HCP documented a normal exam no mass palpable. Referred to peds/allergy as may be chronic fluctuating response from a prior vaccination. 2017 reaction resolved and being monitored, has café au lait spots to area w/diagnosis of dermatographic urticaria by dermatologist. Mom's concerns about possible "glass in vaccine" as the reason for her daughters persistent itching and scratching with nodule at the vaccine site. Mom advised lots of specialty visits and symptoms have resolved as of 2017 (waxed and waned for 2 years). She questions "glass" in vaccine based on reporters article.
Feeling Faint; Lightheadedness/dizziness; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EP7533, via an unspecified route of administration, administered in left arm on 07Apr2021 13:00 as single dose for Covid-19 immunisation. Medical history included Crohn's disease, penicillin allergy. The patient was not pregnant at the time of vaccination. On 09Apr2021, the patient experienced feeling faint and lightheadedness/dizziness. No treatment information was provided. The outcome of the event was not recovered.
Patient came to clinic to receive second dose of Pfizer. First dose of Pfizer was given on 4/26, second dose given 5/11. 16 days between doses. Pt contacted concerning dose being given early and educated about no extra doses needed to be given.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient's issues are resolved. I told her I would document the reddness she had on most of her right arm. Patient did take antibotics to treat it.
Dizziness, Myalgia, Fever, Lightheadedness Narrative:
Beginning a few days after my first injection, I began feeling joint and muscle pain in my lower body only:  hips, glutes, quads, calves, inner thighs, pelvis (not knees). Sore as though I had undergone a heavy exercise workout the day before.  This continues today, though seems to be easing somewhat (I am 4 weeks post second vaccination). It has not inhibited my energy level or mobility.  Taking an Advil/Aleve relieves the symptoms.  This may NOT be related to the vaccine at all; however, I do have degeneration in my hips, and it seems as though the vaccine has targeted inflamed areas in my body.
Breastfeeding and milk supply dropped by more than half by the morning after the vaccine and over a month later has not returned.
Reactive Arthritis. Extreme pain to knees, can barely walk and have two rounds of steroids
Patient received first dose on 09/07/2022 and received a second dose on 09/13/2022.
This is a spontaneous report from a contactable nurse practitioner. A 9-month-old male patient received a dose of PREVENAR on an unknown date. Relevant medical history and concomitant medications were not reported. The patient reportedly experienced lost all motor skills immediately after PREVNAR was administered. The patient was taken to the hospital and treatment was administered. The outcome was unknown. No further information was provided. No further information expected. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR.
Manufacturer Moderna  040AZIA (pt unsure if 040A2IA due to legibility on the card)  Day that symptoms started: 3/17/21 Arm sore, Malaise. Cough started 3/18/21 per patient. No fevers. Doctors appointment on 3/25/21.
This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (Sinuses started to swell up), COUGH (Coughing), OROPHARYNGEAL DISCOMFORT (So much flowing down the back of her throat), DIZZINESS (Dizzy) and RASH (Rash across her chest) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Astra Zeneca (Dose Number: 1 (participant in study), Lot no: A03326-105174, Left arm) on 08-Dec-2020, Astra Zeneca (Dose Number: 2, Lot no: A03468-112807, Left arm) on 05-Jan-2021, Pfizer (Dose Number: 1st booster, Lot no: 30145BA and Left arm) on 28-Sep-2021. Past adverse reactions to the above products included No adverse event with Astra Zeneca, Astra Zeneca and Pfizer. Concurrent medical conditions included Controlled hypertension (Recent change in status: controlled on medication) since 2004 and Allergy NOS (Allergies a lot). On 11-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Aug-2022, the patient experienced DIZZINESS (Dizzy). In August 2022, the patient experienced SINUSITIS (Sinuses started to swell up), COUGH (Coughing), OROPHARYNGEAL DISCOMFORT (So much flowing down the back of her throat) and RASH (Rash across her chest). At the time of the report, SINUSITIS (Sinuses started to swell up), COUGH (Coughing), OROPHARYNGEAL DISCOMFORT (So much flowing down the back of her throat), DIZZINESS (Dizzy) and RASH (Rash across her chest) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative and (Negative) Negative. No concomitant product use was provided. The patient didn't have any side effects from any of the previous vaccines. The patient didn't experienced a similar event in the past. The patient doesn't had COVID positive test or diagnosis. The patient states she went home after getting the Moderna booster on 11-Aug-2022. She immediately started feeling dizzy. She had a rash across her chest. Her sinuses started to swell up. Pretty soon there was so much flowing down the back of her throat that she started coughing. She's been coughing for a week. She states it's not the active ingredients in the product. She states Moderna vaccine has PEG, which has known allergenic effects including anaphylactic shock. She had it previously for a colonoscopy that she got so sick, she couldn't have the procedure. It never occurred to her that Moderna would put this horrible PEG in the vaccine, it's the relative to car anti-freeze. The patient already had a sensitivity. The AE cause patient to seek medical care for doctor call 2 days ago. The symptoms were improving gradually. No treatment medication was provided.
Information has been received from a health professional concerning a 5 year old, who's infant sibling was vaccinated with a dose of ROTATEQ vaccine (lot 652964/0145F) on 7/28/06. There was no concomitant medication. It was reported that the pt developed diarrhea. Follow up information from a health professional indicated that the vaccainted child was perfectly fine and had no symptoms of diarrhea. The reporter thought that it would be strange for the pt to have developed diarrhea in such a short period of time of 24  hours after the infant receiving the vaccine and that most adults would be immune to ROTATEQ vaccine. the reporter noted that no family member were immunocompromised. The reporter also noted that the diarrhea could have been due to a viral illness that the family had acquired just coincidentally at the time that the child was vaccinated with ROTATEQ vaccine. the pts brother experienced diarrhea following vaccination of his infant sibling with ROTATEQ vaccine (WAES0610USA05118). Additional information has been requested.
AT 25 MINUTE POST VACCINATION, PATIENT APPROACHED ME AND ASKED IF WAS ABLE TO LEAVE. WHEN ASKING HER HOW SHE FELT, SHE STATED "HOT, FLUSHED, REDNESS TO FACE, AND A LITTLE BIT OF CHEST TIGHTNESS" PATIENT DID TAKE BENADRYL 50MG PRIOR TO 2ND DOSE OF VACCINATION.  STATES SHE WAS ALSO ITCHY AT UPPER EXTREMITIES.
Information has been received from a registered nurse concerning a 78 year old male who on 21-MAR-2007 was vaccinated with ZOSTER (Oka/Merck), one dose, subcutaneously.  On 23-JUN-2008, the patient experienced a severe case of shingles.  The patient also had pain.  The patient's present status is not recovered.  The patient sought medical attention at the office.  Additional information has been requested.
Initial misuse report received from a healthcare professional on 02 January 2014. This is invalid case as the individual patient identifiers missing. Patient received ACTHIB which was reconstituted with sterile water. It a production reconstitution issue. No adverse event was reported. List of documents held by sender: none.
On the 15th, I had a runny nose and I have allergies. I did not think anything of it because I have allergies, by the third day I developed a cough and I tested and was positive for COVID. I took Mucinex. I did have a bit of a weird feeling in my chest, I went to a walk in clinic and they did an EKG, it was normal.
Moderna COVID-19 Vaccine EUA  Pain at injection site and headache 12 hours later
patient got Pfizer first dose, Moderna second; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient got Pfizer first dose, Moderna second) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient got Pfizer first dose, Moderna second). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient got Pfizer first dose, Moderna second) outcome was unknown. Not Provided    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.   No relevant concomitant medications reported.  Treatment: Unknown.
While they were administering it, some of the vaccine came out and dribbled down her arm; Small drop leaked out of recipient's arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEVICE CONNECTION ISSUE and UNDERDOSE in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 30A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE and UNDERDOSE. On 05-Apr-2021, DEVICE CONNECTION ISSUE had resolved. At the time of the report, UNDERDOSE had resolved.   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 product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above On 08-Apr-2021 Batch number of vaccine updated, location of vaccination, additional reporter details, additional event of 'Underdose' added.
Felt faint after immunization, fell and hit right side of head, denies LOC. Reports history of vasovagal responses to vaccines. Initial BP 53/40, HR48, 17 minutes later recovered with BP 105/66, left in stable condition
6 hours after vaccination:  vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination:  Nausea, vomiting, headache, body aches, fever  (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination:  vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms.  It lessened them somewhat but I was still not able to function fully for several days.
dizziness/Light-headed feeling; confusion; posterior neck pain; tinnitus; made my day to day living very difficult; brain fog; fatigue; chronic headache/pulsing pain in head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/Light-headed feeling), CONFUSIONAL STATE (confusion), NECK PAIN (posterior neck pain), TINNITUS (tinnitus) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (made my day to day living very difficult) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-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 an unknown date, the patient experienced DIZZINESS (dizziness/Light-headed feeling), CONFUSIONAL STATE (confusion), NECK PAIN (posterior neck pain), TINNITUS (tinnitus), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (made my day to day living very difficult), FEELING ABNORMAL (brain fog), FATIGUE (fatigue) and HEADACHE (chronic headache/pulsing pain in head). At the time of the report, DIZZINESS (dizziness/Light-headed feeling), CONFUSIONAL STATE (confusion), NECK PAIN (posterior neck pain), TINNITUS (tinnitus), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (made my day to day living very difficult), FEELING ABNORMAL (brain fog), FATIGUE (fatigue) and HEADACHE (chronic headache/pulsing pain in head) outcome was unknown.            Treatment medication not provided. Concomitant medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received contains reporter's updated information.
9/5/13 Cellulitis rt upper extremity prescribed clindamycin 300 mg 4 times daily for 7 days.
Chills, malaise, headache, dizziness. Onset a few hours after shot, continue as of today 3/17. I have a scheduled appointment with Dr. on 3/19 and will discuss.
The pt was involved in a high risk occupational exposure to blood. He received post-exposure prophylaxis and began experiencing leg weakness, and in approximately 3 weeks was hospitalized with leg weakness.
Apparent vaccine administration error. According to  electronic vaccination registry, this patient received a complete 2 dose Pfizer series  on 1/13/2021 and 2/03/2021, respectively.  This was done at a different long term care facility by  Department of Health did verify that records indicate vaccine doses were administered. Current facility and patient's wife indicated to us that no previous covid doses given and he was in need of the series.  Error in the registry? Possible same name and date of birth but 2 different people?  Wife a poor health historian?   Regardless, another series was completed on 6/17/2021 and 07/16/2021. 4 DOSES. Patient experienced no known adverse effects.
This spontaneous report was received from a Certified Medical Assistant (C.M.A), regarding to multiple unspecified patients of unknown ages and gender. The patients' medical history or concurrent conditions were not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (therapy type: Digital Data Logger) (lot # L004649, expiration date 11-FEB-2017 and Lot # L044526, expiration date 09-NOV-2017) (dose, route of administration and anatomical location were not provided). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint was not filed. This is one of several reports from the same source (MARRS #1605USA012734, 1606USA005737, 1606USA005738, 1606USA005739, and 1606USA005741).
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with sulfa hypersensitivity who on 09-MAR-2015, was prescribed an unspecified dose of prednisone for an unspecified reason. Historical conditions were not reported. On 12-JUN-2015, the patient was vaccinated with one dose of ZOSTAVAX (lot # L008357, expiration date 11-JUN-2016), 0.65 ml, subcutaneous. It was confirmed that the patient was no longer taking Prednisone at the time of the ZOSTAVAX administration, the stopped date of Prednisone was unspecified by the primary reporter. 13-JUN-2015, the patient experienced injection site erythema reported as "redness", injection site pruritus "reported as itching" and injection site swelling. The patient sought medical attention calling to the pharmacy. The pharmacist stated that treatment was recommended in the form of ice application to the injection site, and an unspecified dose of BENADRYL. The outcome of injection site erythema, injection site pruritus and injection site swelling was reported as not recovered/not resolved. The reporter did not assess the relatedness of ZOSTAVAX to injection site erythema, injection site pruritis and injection site swelling. No cancer or overdose were related to this case. Lot # L008357 is valid lot number for ZOSTAVAX, expiration date 11-JUN-2016. Additional information has been requested.
Patient experienced fever sores around mouth and a blistering rash around eyes and neck appoximately three hours after receiving a Fluzone HD shot.
Mild arm soreness - about four hours later; about 5 1/2 hours later a mild headache. I did take Tylenol which helped the symptoms. I had mild nausea and in the middle of the night and I took a Zofran - which helped with my nausea. I still had a mild headache the next morning and I took another Tylenol - but the end of that day I was totally fine.
Information has been received from a health professional concerning an approximately 24 month old female who on 23-JAN-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot# 649817/0728R). Following vaccination, in January 2006, the patient experienced a fever of 103F that lasted 3-4 days. No rash was present and the child recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided.  Additional information has been requested.