chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 at 15:45 as dose 1, single (Lot number: EL9264), in left arm, on 15Mar2021 at 09:30 as dose 2, single (Lot number: EN6203), in left arm, on 29Sep2021 at 15:00 as dose 3 (booster), single (Lot number: PC3184), in right arm and on 31Mar2022 at 13:30 as dose 4 (booster), single (Lot number: FK9395), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney disease" (unspecified if ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM], start date: 01Jan2022; AMLODIPINE, start date: 01Jan2022, also reported as other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  Clinical information: Patient had known allergies included NKDA. Patient received COVID-19 Treatment with Paxlovid from 28Dec2022 to 03Jan2023. Patient began to experience symptoms on 04Jan2023 at 09:00 included headache, sore throat, sinus congestion. No treatment received for symptoms and not recovered from symptoms.
temperature excursion due to Adacel vaccine was exposed to 27F for more than 3 hours/No AE; Initial information was received on 01-Jul-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174941, 2020SA174906, 2020SA174940, 2020SA174932, 2020SA173110 and 2020SA174911. (same reporter)  This case involves a 17 years old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed it (product storage error).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On 15-May-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6621BA, expiry date: 21-Mar-2022] via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt c/o redness, warmth, and itching (R) arm, (R) side of body and (R) leg. Lasted x 48 hours. Took Benadryl and helped.
Hospitalized for right upper lung  pulmonary cavitary abscess with dyspnea and cough on 1/30/22 with dyspnea and cough. Symptoms have not changed since admit but  found to be COVID 19 positive on 2/9/2022.  Treated with 3 day course of Remdesivir.
Medical assistant gave PT DTAP-IPV component of PENTACEL by it self Lot: U6584BA. Medical assistant gave PT Haemophilub B conjugate vaccine (Tetanux Toxoid Conjugate) Lot: UJ157AA with sterile diluent Lot:N029157 medical assistant also gave a sterile diluent by it self lot:N029157
Swelling and redness around 13 inches in diameter at the injection site in the lower part of the arm. Painful, itchy and hot. Pt. had some ringing in his ears for 30 seconds. Treatm: BENADRYL, Prednisone and cool compress.
periods of inconsolable crying began 12hr p/vax;lasted 48hr;gradually improving;sl fever per mom not documented w/home thermometer;afeb in office 3AUG(6;no tx required;
Patient received vaccine on 6/4/21 at 2:30 pm. Patient woke up early (before 6 am on 6/5) and complained of headache and feeling tired. Patient had fever that reached as high as 101F at 2 pm. Patient felt chills and sweats while he had fever. Patient felt better by 9:00 pm with fever down to 99F. Fever was resolved by morning of 6/6/21. Patient also had moderate pain at injection site and swollen lymph nodes in left armpit (injection side). Patient slept during the day on 6/5 and drank extra water and fluids during the day. No other treatment was provided.
Patient experienced severe syncope and nausea almost vomited and couldn't stand up for almost 15 minutes. I applied ice to the back of neck and gave her orange juice. She left with her dad about 20 minutes later.
Information has been received from a physician concerning a 64 year old female with hypertension, hyperlipidemia, and hypothyroidism and with no known drug allergies who on 03/04/04 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N).  Concomitant therapy included amlodipine besylate (Norvasc)(2.5mg qd), simvastatin (20mg qd) and levothyroxine NA (Synthroid)(0.05mg qd). The pt presented to the physician on 03/04/04 with complaints of recurrent warts on her nose, and wanted the dermatologist to remove. At this visit, the pt was vaccinated. On approximately 03/07/04, "one or two days following vaccination" (also reported as "about 3 to 4 days after vaccine"), the pt began to experience cold symptoms. The symptoms worsened and the pt returned to the clinic on 03/18/04. At that time, the pt stated that a day or two after receiving pneumococcal 23v polysaccharide vaccine, she started with cold symptoms, coughing, wheezing, mild shortness of breath ("improved now"), mild increased temperature, but no real fever/chills. The pt's lungs had scattered rhonchi with an occasional inspiratory wheeze. She was noted to have good air movement but sounded very congested. The pt was prescribed Zithromax, an albuterol inhaler (2 puffs every 4 hours as needed), codeine phosphate (+) guaifenesin and loratadine (Claritin)(10mg qd). The pt was diagnosed with acute bronchitis. The pt returned to the clinic on 03/29/04 with a productive cough with yellow, blood-tinged mucus and a low grade fever. Her lungs were clear to auscultation. She was treated with Tequin. The pt was diagnosed with sinusitis. Unspecified medical attention was sought. There was no product quality complaint. There were no adverse events following prior vaccinations. Lab data is listed below.  Additional information has been requested.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2015149558) on 18-Jan-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS TOXOID) (batch number, expiry date, dose and dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient had developed allergy. Laboratory investigations and corrective treatments were not reported.  The outcome of the event was unknown. List of documents held by sender: none.
Information has been received from a 55 year old male pharmacist with diabetes and no allergies who on 16-APR-2007 was vaccinated IM with a first 1.0 ml dose Recombivax HB (Lot # 654436/1106F) and on 20-MAY-2007 was vaccinated IM with a second 1.0 ml dose of Recombivax HB. Concomitant therapy included insulin glargine (LANTUS) and insulin lispro (HUMALOG). It was reported that after vaccination, on 01-JUN-2007 the patient experienced pain and stiffness in his wrists and shoulders. The patient began to experience pain and stiffness in the wrists and shoulders of both arms but the symptoms were more severe in the left arm. The patient also stated that the pain had become progressively worse and pain often caused him to wake up at 3:00 in the morning. A diagnostic laboratory test of blood work was done (results not provided). Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. The patient's experiences were considered to be disabling. Additional information has been requested.
severe muscle aches including back, headache and extremely fatigue for two and half days. eight days later, dizziness and extreme fatigue with low blood pressure was experienced for 1 and half.
mom states pt started crying MD office, & did not stop for 3 hrs; mom gave APAP; t103 R; no redness or swelling @ site of inject;
Trouble walking, dizziness, headache started about 2 hours after vaccines and still on next day. Had red face and trouble breathing for about half an hour.
Anaphylactic Shock; trismus; angioneurotic edema; tingling of the facial nerve from ear to neck; airway obstruction. Symptoms repeated three more times in following weeks.
Patient received the shot on 2/20/19 and he said he had pain in his right shoulder starting that day. He came into the pharmacy a couple weeks after saying he could not lift his arm. He said there was never any bruising or redness, just pain.
Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-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 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Changed my whole attitude, making me mean; Sore left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MOOD ALTERED (Changed my whole attitude, making me mean) and MYALGIA (Sore left arm at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concurrent medical conditions included Sleeplessness (inability to sleep on her left side because of dizziness after shingles diagnosis) and Osteopenia. Concomitant products included APOAEQUORIN (PREVAGEN [APOAEQUORIN]) and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Sore left arm at injection site). On an unknown date, the patient experienced MOOD ALTERED (Changed my whole attitude, making me mean). At the time of the report, MOOD ALTERED (Changed my whole attitude, making me mean) and MYALGIA (Sore left arm at injection site) outcome was unknown.        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.   Treatment information was not provided.   This case was linked to MOD-2021-312939.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received on 08-sep-2021.  includes new event as vaccine series ulter whole attitude, Patient age, Medical history.
Immediately after vaccination when waiting in the 15 min wait area, my wife experienced blurred vision while looking at her mobile phone. We have assumed it to be due to the bright sunlight. However it got worse over a period of time. Over the period of next few days every morning when she woke up she felt the vision for further detoriated. We have consulted opthomologist but they have mentioned the eye looks good, it might be temporary and suggested to use glasses. It?s worrying that the vision got worsened in a weeks time. Prior to this there was no problem with vision. Currently my wife is nursing a 6 month baby.
Patient was instructed to wait 15 minutes in the room sitting in chair provided. After 3 minutes felt lightheaded and laid her head against Dad's shoulder and proceeded to pass out. Dad picked up patient and laid her on the floor and called for help. With Dad, doctor, and medical assistant present, patient quickly came to on her own, but was very green in color and feeling very weak. After letting her lay for 5 minutes, she was helped to a sitting position against the wall with pillow behind her back and given water and some saltines. After 1 hour and evaluation patient was able to ambulate from the clinic with her father and felt fine. Father was given instructions to keep her hydrated and healthy foods tonight. If she is still feeling poorly tomorrow, to call and have her come in for appointment.
Completed VSafe daily check-ins each day they were sent via text message; attempted to report this via that program, but the links available stated the check-ins were already complete and nothing new could be added.  Day 9 after vaccine, large, red welt reappeared at injection site. The red welt is hot to the touch and extremely itchy. Pain which had subsided returned to the injection site as well.  Symptoms are not debilitating and are managed by topical Benadryl and Tylenol, but this seemed like important information to have since data collection is on going.
Approximately 6-7 days after the first dose of COVID vaccine (Pfizer) patient had low grade fever (100.8) malaise, and not feeling well. Progressed to chest pain and slight SOB. Continued low grade fever controlled with Tylenol and Motrin. Was seen in urgent care and tested for COVID. COVID PCR negative. EKG done (abnormal). Suggested covid 19 pneumonia and follow up with PCP. Was seen in ER that evening for increasing chest pain, SOB. Chest xray done. EKG not done. No labs sent. COVID PCR done. Negative.  Improved at home with rest, Tylenol, Motrin. Sunday afternoon, was taken to ER for chest pain, increased SOB, and not feeling well. BP elevated, CXR done, EKG done, and bloodwork done. Troponin negative, D Dimer negative, labs WNL. No acute MI. Suggested pericarditis based on EKG results. Follow up suggested with cardiologist. Echo and EKG done on Tuesday May 4. Improving pericarditis/myocarditis. Final EKG done on Friday 5/7.
Patient developed approximately 100 lesions across his body, including legs, hands, mouth, and genitals. Most were small, but a few were 1/2 inch in diameter. He also had a low-grade Fever that lasted for 4 days.
Post vaccination at approximately 10:30 am client reported feeling numbness and tingling in hands, developing a cough and a subsequently developing a felling of throat "closure" or tightness.  Client was evaluated by Emergency response team and relocated to the Emergency response tents.  At 10:45 am client was noted to become hoarse and requiring neck extension to swallow water.  Client at this point was reported to be unable to speak in full sentences.  Epinephrine was administered by Emergency Response physician at 10:50 AM.  EMS was on site, oxygen was administered and transport to a nearby hospital emergency room was initiated and completed. Note: In retrospect client stated that he had similar symptoms after his first intramuscular vaccine dose (Pfizer, three weeks prior) for three days and had self medicated with Benadryl but had subsequently felt better.
Pt reports she experienced immediate pain in left deltoid after receiving vaccine. Continues to experience soreness when she raises her left arm since vaccination. Pain is steady getting worse. Decreased ROM in left arm. Scheduled physical therapy appointment.
Information has been received from a healthcare student concerning a 50 year old female patient with Crohn's disease and no drug reactions/allergies, who in late January 2010 and on 27-MAY-2010 was vaccinated with a first and a second dose of PNEUMOVAX 23 (Lot # not provided) respectively. Concomitant therapy included LEXAPRO, LIPITOR, omeprazole (MSD), cyanocobalamin, TRICOR, nitroglycerin, albuterol and QUESTRAN. The healthcare student also reported that on 28-MAY-2010 the patient experienced mild soreness at the injection site. At the time of this report, the patient was in the process of recovery. The patient sought unspecified medical attention. There were no labs/diagnostic studies performed. Additional information has been requested.
Patient noted red, hot swollen right upper arm with significant discomfort Saturday evening when bathing. Used ice and topical Benadryl. About size of hardball.
No additional AE; Medical assistant reported expired dose of VARIVAX administered to patient.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications or medical history was not provided.  On 30-MAR-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose of 0.5 mL once, lot number: t010311 was confirmed to be valid, expiration date: 24-MAR-2022 (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (dose, route of administration, lot number and expiration date were not provided). No additional adverse event (AE) (no adverse event). No product quality complaint (PQC). No additional information.
This spontaneous report as received from a healthcare workers refers to a 3 month old patient. The patient's medical history and concurrent conditions were not reported. On 16-APR-2015, the patient was vaccinated with VAQTA (strength: 25/0.5 (units not provided), lot # K012457, expiration date: 04-JUN-2017, route of administration, dose and frequency was unknown) inadvertently. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Tested positive for COVID after receiving the first dose of the vaccine; Tested positive for COVID after receiving the first dose of the vaccine; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ-685, expiration date: Mar2021), via an unspecified route of administration in the right arm on 21Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient tested positive for COVID on 26Dec2020. Now, she is wanting to know if she should still get the second dose. Outcome of the events was unknown.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and COVID-19 test positive on 26Dec2020.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
never got the second, early days of the Covid lockdown; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got 1st dose before Covid pandemic, was not sure about date but late 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient stated, got the first dose of Shingrix before Covid and never got the second as it was schedule in early days of the Covid lockdown. The patient asked, did he/she need to start over.
Dyspnea one week after receiving second COVID vaccine dose on 4/23/21. Pulmonary embolism diagnosed on 5/19/21, started on Eliquis.
6 days after MMR, Varivax, Hib and Prevnar had temp of 104.8 and 8 days after these vaccines had a fine red rash on trunk and vesicular rash over body. No Tx needed and everything resolves without any difficulty. Gave only fever reducers. No apparent complications.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "acid reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment medication for Covid-19 from 28Dec2022 and stopped on 02Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DVT in R Leg from Ankle through Pelvis, Eliquis 10MG/day 6 months, rescan after 3 months no change.  Changing dose to 20MG/day for 3 months