chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt given 1 (HEP A) vaccine/left office - went to wait for bus/reported by doctor that child suddenly turned pale (lasted few sec) taken back to office/child crying - calmed down.
My symptoms started with scratchy throat and cough which became worse. Within the next 2 days, I had a runny nose. I had a bronchitis type of cough and nasal drainage. I went to the doctor and had a positive COVID-19 test. Nasal drainage resided within 3 days and my cough went away after a week.
Chills, tremors, dizzyness skin cold/pink/dry Vaccine given at 1600 and symptoms started at 1605 Diphenhydramine was given orally to patient at 1617.  Patient states that the symptoms are getting better 1628. Doctor gave patient Tylenol at 1643
A week after the vaccination I had an enlarged lymph node in my neck. It was visible and it was painful. It was on the left side on the same side as the vaccine. It slowly reduced in size but it is still a little enlarged after ten weeks. It was about the size of a small marble.
Presented with lower back pain that radiated to abdomen; dx w/COVID-19 pna; tx w/abx, steroids, zinc, O2. Weaned to RA, dc'd home.
Had flu shot 10-4-10; c/o swollen gland (resolved), and pain in (L) upper arm; pain when moving arm up laterally & often travels from neck to fingers. Seen by Ortho doctor in December 2010; states she has a "frozen shoulder" set off by flu vaccine.
Moderate, continuous, bilateral tinnitus which began 2 hours after vaccination, and has continued to present (15 days later)
pt was given pediarix and should have received infanrix, pt did not have any side effects after 30 minutes of receiving vaccine as pt was in office being monitored, pt mom was informed and instructed to continue to monitor pt and present to ER if needed
Weakness on the first day (couldn't really move). After 3 days, my leg muscles started paining me. If I moved my left leg, I felt a bad pain. Now I don't move it (sometimes to avoid that).
Patient began getting dizzy and passing out, initially was believed related to the heat or dehydration. Diet and fluids were changed, episodes continued June and July. In August, began having seizures after fainting episodes. No history of fainting or seizures in the family. Patient was a healthy active 17 year old. We have had numerous tests and now admitted to the hospital 9/7/21 and still no reasons for why this is happening.
Initial unsolicited report received from a physician in via other company (Pfizer) (Manufacturer Report Number: 2016291804) on 01-Aug-2016. This case involves a patient (sex, onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date following vaccination, the patient experienced fever, hives and swelling. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (Lot number J014129 and expiration date 07-NOV-2014) (dose and route were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Severe exhaustion.  After 3 weeks I got a B12 shot at recommendation of doctor.  Benefit has worn off and I need to get another B12 shot.   I went from running for an hour after work every day to having to take an hour nap after work if I want to make it through dinner.
Pt stated 3-4 days p/recvd shot noted pain, redness, swelling & sl itchiness area lt arm 7 was warm to the touch; approx grapefruit size area; pt was told to use DPH ice to area PRN;
I experience a small amount of painless vaginal bleeding on10/09/2021.  Then today, 10/13/2021, a larger amount of painless vaginal bleeding was present.  My gynecologist office opens at 9am I will be making an appointment.
Vaccine rec'd a series of 3 Engerix-B vax according to 0, 1, 5 mo schedule. About 2mo p/3rd dose given (lt deltoid) serology done 3JUL90 & testing indicated vaccinee failed to develop antibody titers;
Patient received Pfizer COVID vaccination (10/23)- 2 days prior starting symptoms of leg pain. On 11/6 Diagnosed with DVT and pulmonary embolism.
Hypertension/HTN; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 17Aug2021 at 17:00 as dose 3 (booster), single (Lot number: FC3181) at the age of 68 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 1990 (ongoing), notes: Lung Disease (Asthma: requiring more frequent albuterol); "GERD", start date: 2014 (ongoing); "Insomnia", start date: 02Jul2002 (ongoing); "Former smoker" (unspecified if ongoing), notes: Social smoker for 10 Year, Quit: 1983; "Daytime somnolence" (ongoing); "NASH" (unspecified if ongoing), notes: Liver disease; "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT taken for asthma (ongoing); LOSARTAN/HCTZ oral taken for hypertension (ongoing); PANTOPRAZOLE oral taken for gastrooesophageal reflux disease (ongoing); ZOLPIDEM oral taken for insomnia (ongoing); ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma. Vaccination history included: BNT162b2 (Dose Number: 1st, Date: 06Jan2021, Site of injection: Left Deltoid, Route: IM, COVID-19 Vaccine Name: Pfizer , Batch/Lot number: EM9899), administration date: 06Jan2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2nd, Date: 27Jan2021, Site of injection: Left Deltoid, Route: IM, COVID-19 Vaccine Name: Pfizer , Batch/Lot number: EL1283), administration date: 27Jan2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: HYPERTENSION (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Hypertension/HTN".  Additional information: The patient received booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Vaccination Facility Type was reported as Pharmacy or Drug Store.  They did not considered the Pfizer product had a causal effect to the adverse event hypertension.
Sudden vertigo, severe sweating, and muscle weakness, fatigue after an episode. Vertigo lasts about 1-2 mins and other symptoms last 1-3 hours
1/9/2022-Preentated via EMS complaint of weakness and SOB, tested positive for Covid 12/29. Po2 of 89 requiring 8L via NRB to maintain sats in low 90's. Ferritin 437 and D-dimer 455. Chest x ray-extensive bilateral interstitial infiltrates.  Admit acute hypoxic respiratory failure with sepsis Covid -19 pneumonia. Started IV Decadron, rocephin, doxycycline, Remdesivir and baricitinib.  1/11/2022- O2 12L via NC spo2 96%. Afebrile. 1/12/2022- Down to 10L via NC spo2 94%. 1/15/2022- Improving, afebrile and maintaining o2 sat. 1/19/2022- Spo2 high 90's on 7L o2 via NC. 1/22/2022-Patient oxygen desatting when ambulating.  Currently at 4L o2 via NC. 1/23/2022- Afebrile. Spo2 92-97% on 4L o2 via NC. Symptoms improved, discharged home with Hospital at Home service.
All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.
My left shoulder frozen . It  became extremely painful to life.  I continue to have pain in my shoulder joint. It is stiff and I am unable to raise it more than 6 inches from my side since a few days after the injection. A day prior to the injection I was doing 50 sit ups a day in addition to jump roping. I can no longer do any arm exercises that include my left arm.    I have tried physical therapy. It has not helped.
headache; itching; hives on my lower back and shoulders; swelling of my face especially around eyes and lips; swelling of my face especially around eyes and lips; swelling of my face especially around eyes and lips; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer reported for herself. A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0182), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:00 (at the age of 62-years-old) as a single dose for covid-19 immunization. Medical history included dermal filler injection from Aug2020 to an unknown date. Concomitant medication(s) in two weeks included phyllanthus emblica, terminalia bellirica, terminalia chebula (TRIPHALA); vitamin d3; curcuma longa (TURMERIC [CURCUMA LONGA]); magnesium; ammonium chloride, betaine hydrochloride, pancreas extract, pancreatin, pepsin, spleen, stearic acid (ZYPAN). The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26May2021 06:00, the patient awoke on Day 21 with headache and itching. Realized she had hives on her lower back and shoulders. When she looked in mirror, noticed swelling of face especially around eyes and lips. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. Outcome of the event was recovered on an unspecified date in 2021, at the time of this report. Follow-up attempts are completed. No further information is expected.
MMR, V, PREVNAR, Hep A administered each thigh. Band Aids applied. Within 5 minutes erythematous blanching reaction approx 4 cm. Improved when Band Aids removed, 6.25mg diphen.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Pt has history of fainting from needles that was not reported prior to vaccine administration. Pt began feeling dizzy/nauseous/blurry vision immediately after administration, no difficulty breathing or signs of swelling, epipen not administered. pt was laid down on back and feet were propped up, began to feel better. She was evaluated by EMT, all vital signs stable and she had recovered by the time of their arrival, did not go to hospital. Symptoms likely from needle anxiety, not vaccine itself
chills; fever; painful headache; neck ache; muscle and joint pain; nausea; extremely tired; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot unknown: Not available), via an unspecified route in the left arm on 17Feb2021 at 09:30 (age at vaccination: 67-year-old), as a single dose for covid-19 immunization. Medical history included A-fib. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), telmisartan, apixaban (ELIQUIS) and tamsulosin, al. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot unknown: unknown), via an unspecified route in the left arm in Jan2021 at 09:30, as a single dose for covid-19 immunization. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 18Feb2021 at 01:00, tired about 16 hrs after the shot patient experienced chills, fever, a painful headache, neck ache, muscle and joint pain, nausea and extremely tired. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered.  Follow-up attempts completed. No further information expected.
Pt recv vax on 11/16/98; 15 min post vax pt exp sore Rt Arm, pain of right hip to knee, stuffy nose, headache & nausea; pt imp 24 hr
Serum sickness reaction, including painful, multi-joint swelling (hands, wrists, elbows, knees, jaw, neck, hips, etc), erythematous rash, fever, fatigue, diarrhea, insomnia.  Required steroids for treatment (Prednisone 40mg x 3d, 20mg x 3d, 10 mg x3d.) Slow resolution.  Much better but not yet fully normal today (7/19/20).. (Note: Dr. consultation on the phone x2)
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 28-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 14-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after vaccination. The reporter assessed the case as non-serious. This case 201804107 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 09Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "Heart Rhythm" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "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 which included Paxlovid from 04Aug2022 to 08Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
palisaded granulomatous dermatitis; rubella virus granulomatosis disease; Literature Report:  This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 55-year-old female patient. The patient's concurrent conditions included hypertension and hyperlimidia.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as thirteen years after vaccination), the patient experienced papules and nodules that coalesce into larger plaque with focal pustules localized to the left arm which was diagnosed initially as granulomatous dermatitis and was treated with surgical excision, intralesional triamcinolone and hydroxychloroquine. After ten years from the onset of the event, an skin biopsy was collected and histopathology results showed palisaded granulomatous dermatitis concerning for rheumatoid nodule or infection, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 462 mg/dL (low), blood immunoglobulin A: 36 mg/dL (low), Blood immunoglobulin M: 32 mg/dL (low), CD3 T cells count: 957 mm3, CD3 CD4 T cells count: 883 mm3, CD3 CD8 T cells count: 71 mm3 (low), CD19 B cells count: 255 mm3, CD56 CD16 NK cells count: 230 mm3, Rubella IgG titer: 1623 IU/ml, Rubella neutralization titer: 10240 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease (Granulomatous dermatitis and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Red spot; Swollen; Tenderness; Warm; Soreness in her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Red spot), SWELLING (Swollen), TENDERNESS (Tenderness), INJECTION SITE WARMTH (Warm) and PAIN IN EXTREMITY (Soreness in her arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M201A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Bacitracin, Neosporin). Concomitant products included METRONIDAZOLE for Rosacea, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) and OMEPRAZOLE for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 21-Feb-2021, the patient experienced ERYTHEMA (Red spot), SWELLING (Swollen), TENDERNESS (Tenderness), INJECTION SITE WARMTH (Warm) and PAIN IN EXTREMITY (Soreness in her arm). On 27-Feb-2021, ERYTHEMA (Red spot), SWELLING (Swollen), TENDERNESS (Tenderness), INJECTION SITE WARMTH (Warm) and PAIN IN EXTREMITY (Soreness in her arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Reporter information was updated. Product Dose details was updated. Patient details are updated (height, weight, pregnancy status). Added relevant history like allergic to Bacitracin, Neosporin.Events are recovered.
syncopal episode; 3 seconds after injecting vaccine, the patient (who was sitting on the exam table) was awake but momomentarily not responsive, body was rigid, "fell asleep" snored, kicked once; then woke up rigid; the MA then put him recumbent, he was sweating; he regained full consciousness; he was unaware of all the events;he said that he was dreaming, and woke up from a dream. He was not in any distress or discomfort.
T105R 7 1/2hrs p/receiving vax; Vomited x 1 the morning p/receiving the vax; Remained fussy but consolable for 72hrs; @ 48hrs awoke screaming twice during the night, & cried for 5min; Seen the next day & had normal exam;
Vomited 5 minutes, and ten minutes after vaccines were administered. Immediately went to sleep, and woke up 20 minutes later screaming, which lasted 4 hours. Body, especially arms and legs, also extremely stiff, and his fever was 100.2. We gave him children's Tylenol 1 hour after vaccine was given, and children's ibuprofen 2 hours after vaccine, because there was no improvement after Tylenol. By about 1:20, he suddenly fell asleep for 4 hours, and again woke up in a sudden scream which lasted another 3 hours. Fever at this point was 100.3. A half dose of Tylenol and half dose of ibuprofen was given about 15 minutes after he woke up. This pattern continued for four full days. He ate very little during this frightening and diffucult time, and we had to give him Pedialite to prevent dehydration. He has since almost completely stopped 'cooing and babbling', which he had been regularly doing prior to the vaccine. He also has very little eye contact with us now. His screaming has subsided, and he is eating a little better, however he seems to have very little energy, and is often very limp. Doctor says he should be fine soon.
Headache for over 12 days, fever, chills, muscle aches, shortness of breath, fatigue, diarrhea.
Right upper leg, red and swollen around site of dtap injection.  Vaccine given on 1/19/07, pt returned to ofice on 1/22/07. induration reddish patch RAT SK6 cm, with central bluish discoloration and diffuse margins, warm to touch, no fluctuation, no drainage.
24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-reminded if She gets worse-GO the ER-or have someone drive her there-for instance-SOB 25th Jan 2021-Monday-legs, to mid calves-swollen  26th Jan Tuesday-still coughing a lot 27th Jan like the 24th of Jan 2021-hurts to breathe, HA, body slows, hoarse when speaking, Cough a lot. 28th Jan 2021-Thursday-her Back hurt.  Her waist & shoulder blades painful 29th Jan 2021-today-she said COVID-19 reaction-that's why she called
Immediately upon given td vaccine - patient's left arm started to swell.  No redness, just swelling at localized injection site.
bumpy rash(size of coin); flu like symptoms; fever of 101; Achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever of 101), PAIN (Achy) and RASH (bumpy rash(size of coin)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever of 101) and PAIN (Achy). On 30-Jan-2021, the patient experienced RASH (bumpy rash(size of coin)). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever of 101) and PAIN (Achy) had resolved and RASH (bumpy rash(size of coin)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.