chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got his first dose gave him the shot/his arm might get sore and it did/it little puffed up/redness and circle around the injection site/throbbing pain in circle around injection site; got his first dose gave him the shot/his arm might get sore and it did/it little puffed up/redness and circle around the injection site/throbbing pain in circle around injection site; got his first dose gave him the shot/his arm might get sore and it did/it little puffed up/redness and circle around the injection site/throbbing pain in circle around injection site; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6203) via an unspecified route of administration, administered in right arm on 20Feb2021 09:15 as dose 1, single (age at vaccination 79-year-old) for covid-19 immunisation. Medical history included ongoing blood pressure high (diagnosed at 40 years old) it was controlled and ongoing diabetes from 2000 (controlled). The patient's concomitant medications were not reported. The patient reported that he got his Pfizer Covid 19 first dose 20Feb2021 and was told by the nurse that his arm might get sore and swollen. The following day there was redness and circle around the injection site that was 1-2 inches and also experienced throbbing pain. Asking if that was one of the reported side effects. The patient reported that the lady that gave him the shot said that his arm might get sore, and it did and it puffed up. He reported that it was just sore and a little puffed up, then the day before it started aching every once in a while, and then there was a red circle around it about 1.5 inches. He was not in deep pain, but it throbs. Throbbing pain in circle around injection site was reported as worsened. He wanted to know whether that was a side effect and should he have worried about it. The patient did not remember when his arm started getting sore and puffed up, it was either Saturday night or Sunday morning. The throbbing pain started the day before and even woke him up last night. The redness around the injection site was about the same as when he noticed it the previous day, but he did not know when it started. He was scheduled to get his 2nd dose on 10Mar2021. Outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A volunteer at a mass vaccination site inadvertently administered this vaccine to a 16-year-old
PATIENT IS POSITIVE FOR COVID-19 AFTER BEING FULLY VACCINATED, UNKNOWN LOT # AT THIS TIME, THIS PATIENT BELONGSTO MILITARY AND THERE IS NO DOCUMENTATION OF LOT/EXPIRE DATE IN MEDICAL RECORD AT THE TESTING FACILITY, ONLY INFORMATION IS THAT THE MODERNA SERIES IS COMPLETED AS OF 9 FEB 2021.
1 day p/vax  c/o pain lt axilla;no urticaria, SOB, facial swelling;inj site w/o erythema or swelling;tender lt axilla axillary node;
COVID; COVID; 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-163-4463628-00.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID". The action taken for adalimumab was unknown. The elderly female patient experienced an event of non-serious COVID with Humira (Adalimumab). On an unknown date, the patient experienced COVID. Pfizer-BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter considered "covid" related to BNT162b2.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was no reasonable possibility.  Causality for event COVID-19 (COVID-19) as per reporter with Humira was reported as not related. Causality for event COVID-19 (COVID-19) as per reporter with Pfizer-BioNTech Covid-19 Vaccine was reported as 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 information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid19.
Employee states became sick 2 days after 1 vaccine.  Employee had fever of 101, coughing, sneezing, body aches and chills.  Employee reported symptoms began 48 hrs after vaccine and lasted until  10/10/2021.  Employee took OTC cough medicine.
Believe it triggered slurred speech/stuttering and confusion. Sleep walking event, but was wide awake before the vaccine. Spent 2 days in the hospital. Developed a mild sinus infection.
SORE ARM; NASAL CONGESTION/RUNNY NOSE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM) and NASAL CONGESTION (NASAL CONGESTION/RUNNY NOSE) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 16-Mar-2021. Concurrent medical conditions included Iodine contrast media allergy (IVP dye), Penicillin allergy and Allergy to antibiotic (Amoxicillin).   On 12-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021 at 9:30 AM, 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 PAIN IN EXTREMITY (SORE ARM) and NASAL CONGESTION (NASAL CONGESTION/RUNNY NOSE). At the time of the report, PAIN IN EXTREMITY (SORE ARM) and NASAL CONGESTION (NASAL CONGESTION/RUNNY NOSE) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product details was not reported.  Treatment details was not reported .
Information has been received from a nurse concerning a 7-year-old patient (gender unknown), who on 19-JUL-2007 was vaccinated with Zostavax. The patient was vaccinated due to human error. It was reported that the patient had no symptoms. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Follow-up information received from the registered nurse (R.N.) indicates that the patient is a healthy male with no pre-existing allergies, birth defects or medical conditions who was vaccinated in the right arm with a first subcutaneous dose of Zostavax (lot# 656607/0163U) instead of a dose of Varivax at 11:47 AM. (It was previously reported that he was to receive a dose of Gardasil, which was reported in error). There was no illness at the time of vaccination. There were no concomitant medications given. On 20-Jul-2007, the doctor notified the mother of the error in immunization. The mother reported that the child had no fever or rash. On 26-Jul-2007, the patient came in for a follow-up clinic visit and it was noted that there was no reaction to the Zostavax. There were no laboratory or diagnostic tests performed. It is reported that the patient has never had an adverse event following prior vaccinations. Additional information is not expected.
She said right upper arm is painful & swollen. She has a red rash with chills & shakes to the PNEUMOVAX vaccine.
Pt presented with angina, inital troponin normal, then rose to 5.2. Ck-MB and MB index also rose and fell consistent with MI.  D-dimer was normal. EKG without clear evidence of ishcemia or pericarditis.  Coronary angiogram with no culprit lesion identified (either spontaneous coronary artery dissection or thrombus).  Echo did not show wall motion abnormalities or pericardial effusion.  Differential for this hospitalization with NSTEMI includes myocarditis, coronary spasm, or subclinical dissection.
Patient returned to pharmacy shortly after receiving vaccine to report she was experiencing numbness/tingling in her arm. I assessed the location of vaccination to determine if it was too high and could be bursitis but that did not seem to be the case as she was indicating no discomfort in her shoulder, only below the injection site. I told her to keep an eye on it and if it worsened to contact me or doctor, otherwise just to monitor until it goes away. I asked her to move the arm to help blood flow to see if that would help relieve the feeling. Will follow-up with her tonight and tomorrow.
2:30 AM - Started to get a bad headache 2:45 AM - Headache continued to worsen 3:00 AM - Intense pain in upper left arm / shoulder, dizzy and disoriented 3:05 AM - Lost consciousness, broke two upper front teeth on counter during fall. Regained consciousness and called for help then fainted again. 3:30 AM - Emergency room visit - given fluids and diagnosed with syncope of unspecified type
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number H4922, expiry date 9th October 2022) for prophylaxis.   On 17th October 2022, the patient received Shingrix. On 17th October 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 17-Oct-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used.
Gave the monovalent pediatric under 5. Gave to 2 patients, on 12/19/2022 and 12/20/2022. No adverse events reported.
Rash on anterior Bicep. First noticed Sunday morning. Patient complained of it itching and it being warm. Recommended OTC anti-itch products.
Hives; This case was reported by a physician via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On 30th August 2019, the patient received Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced hives. In September 2019, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was seen in August 2019 was administered the Shingrix vaccination and patient complained of reaction within 24 hours of administration. The patient had of raised Hives, was symptomatic for 3 days. The reporter consented for follow up. This case was linked with US2020026081, reported by same reporter.
Information has been received from a physician concerning a 4-year-old child who on 26-DEC-2002 was vaccinated with a dose of Varivax (Lot # 641783/0262M). Subsequently, on 20-NOV-2006, the patient experienced chickenpox. The outcome was not recovered. No other information was provided. Additional information has been requested.
Client called nurse to report that her tongue felt numb and she had slight sob/wheezing.  Client took two puffs of her Albuterol that she had in her car.  Client complained afterwards of light headedness.  Given ammonia to sniff.  Client instructed to lean back in seat and lower her had.  Client stated that she was feeling worse despite sniffing on ammonia.  Client refused for 911 to be called, stating she wanted to go home and rest as she lived around the street. Manager came to observation site.  Client said she wanted to go home.  Client left with her 3 children one of whom had received the vaccine today.
On day 11 post vaccine, palms of hands and scalp became extremely itchy.  No lesions or rash on hands, found none on my scalp. The next morning I woke up with my back extremely itchy and discovered red itchy rash/hives. Since then I have had hives break out all over my body including hands and soles of feet, elbows, groin, thighs tops of feet, stomah and wrists.  Some disappear relatively quickly but new hives continue to pop up in various places. Still have intermittent very itchy scalp and palms.
Information has been received from a health professional concerning a patient (9 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F). It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day. Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the agency and was released. Additional information has been requested.
PROGRESSIVE ASCENDING BILATERAL LOWER EXTREMITY NUBMNESS/TINGLING AND WEAKNESS
I have a rash; hives; itchy; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 02 patients (Husband and wife). This is 2nd of 02 reports. This consumer (Patient's wife) reported for a male patient (Husband). A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, would call it hives, very itchy. Consumer further stated, her husband and she had got the same thing. they got shot and stuff together. And he had got the same, he got them two weeks ago. He had still got them, they are lessening. The outcome of events was recovering.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021218620 same drug/same event, different patient.
Large, red, itchy circle on right arm at injection site. Swollen lymph node in right armpit.
Nausea, chest tightness, difficulty swallowing, fatigue, chills, generalized not feeling well within 30 minutes of vaccine.
Localized induration, redness and warmth, 6 cm in diameter at site.
Pt report fever the next morning of 99.9, then later 98 then later 100.0.  Instructed pt to continue to monitor and f/u with primary care
extensive deep vein thrombosis with embolization and massive pulmonary embolism ; patient presented with shortness of breath and severe bilateral leg and back pain unable to move with extensive thrombosis noted.  patient had cardiopulmonary arrest  was on ecmo  now decannulated and extubated , awake, alert oriented in recovery phase
Discharge Provider: DO Primary Care Provider: DO Admission Date: 10/14/2022 Discharge Date: 10/16/2022  HOSPITAL COURSE 74-year-old presented to ER with four days of not acting right.  She was more hypoxic than at baseline.  See H&P for full details.  Chest x-ray showed emphysema.  COVID was positive.  Clinically she had a COPD exacerbation 2° COVID.  Admitted and treated with Solu-Medrol, Symbicort, Spiriva, albuterol MDI.  Given three days Remdesivir.  She did very well during the hospitalization.  On the 2nd day of hospitalization she was stable on her home 2 L and did not desaturate with ambulation.  We felt she would benefit from three days of Remdesivir and she agreed; this was completed.  Today she is able to maintain saturations while ambulating up to 90 ft.  She feels well and would like to go home.  She is stable for this.  DISCHARGE DIAGNOSES 1. COVID positive 2. Acute exacerbation of end-stage oxygen-dependent chronic obstructive pulmonary disease 3. Acute hypoxic respiratory failure on chronic hypoxic/hypercarbic respiratory failure 2° #1 and #2  4. Chronic diastolic CHF 5. HTN 6. SSS s/p pacemaker 7. History of PE and RLL arterial thrombosis 2° mass 8. RLS 9. HLD 10. History of genital HSV 11. Chronic pain syndrome 12. History of recurrent SCC lung 13. Left DCIS 14. Chronic thrombocytopenia/lymphopenia 2° bone marrow suppression from chemotherapy
No adverse effects were reported.; the patient was administered the first dose in the GARDASIL 9 series "on an unknown date 3 years ago." / patient was administered the second dose in the GARDASIL 9 series 2 years later; This spontaneous report was received from a medical assistant regarding a 22-year-old patient of unknown gender. There was no information reported about the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On an unspecified date in 2016 (reported as: "on an unknown date 3 years ago"), the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (route, anatomical site, lot number and expiration date not provided) for prophylaxis. Then, on 18-JUL-2018 (conflicting information, also reported as: "2 years later") the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number N021571, expiration date 29-APR-2020) intramuscularly in right deltoid for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
anaphylactic reaction; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004150.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown"; SWELLING FACE (non-serious), LIP SWELLING (non-serious), PHARYNGEAL SWELLING (non-serious), SWOLLEN TONGUE (non-serious), outcome "unknown" and all described as "face, lips, throat and tongue swelled up". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Incorrect birthday noted: system has wrong DOB, also, vaccinator documented the adult code (230425) instead of the 12 and up code (233599): On 5/10/2021, Pfizer was authorized for age 12 and up
Patient called reporting he was seen by opthamologist on 1/14/20 with dx of herpes related eye infection. He reports his symptoms started approx. 7 days after the injection of the second dose of the Shingrix. He reports being placed on Valtrex 500mg po bid and pred forte every 4 hours. At baseline, he is on atenolol and brimonidine twice a day for eye related issues followed by their office. He reports the infection has caused corneal edema of the right eye and elevated IOP and iritis of that eye. He was seen again on 1/20/20 for recheck and will follow up with them in 1 week from that date.
missed dose; he still had not gotten the third dose of GARDASIL 9; No adverse event information was provided; This spontaneous report has been received from a 45-year-old male dentist (also reported as physician (conflicting information) reporting about himself.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was administered the first two doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.  It was reported that on an unspecified date (reported as on schedule at 6th month), when the patient went to get his third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the insurance denied coverage of the third dose at the time, which resulted in a missed dose. It was reported that it was now 8 and a half month since the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and he still had not gotten the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of vaccine administered. No adverse event information was provided.
Sore arm day 1 and 2, day 8  on 1/14, injection site  itched, has swelling and was warm to touch, cleared up after a couple days then on 1/20/2021,  which was 2 weeks post injection, I had swelling, redness and warm rash bigger than the delayed response on 1/14.
Patient complains of pain immediately after technician administered vaccine and several hours after vaccine. Trouble moving arm. Complains vaccine was given to high in the arm near shoulder.
nose congestion; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nose congestion) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot # 007M208) for COVID-19 vaccination.     No medication history was provided.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced NASAL CONGESTION (nose congestion) and HEADACHE (headache). At the time of the report, NASAL CONGESTION (nose congestion) and HEADACHE (headache) outcome was unknown.        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.
Breakthrough COVID-19 case with symptom onset 9/15/2021: Runny Nose/Congestion, Loss of smell or taste. Hospitalized with diarrhea 9/15/2021, admitted for at least 6 days.
Chills, no energy, very tired, gets cold and hot flashes having hard time keeping eyes open.