chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm for a few days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     No Medical History was Provided by Reporter.  Concomitant products included HYDROXYZINE, METOPROLOL, SIMVASTATIN, HYDROXYCHLOROQUINE, PREDNISONE, ALPRAZOLAM (XANAX), HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm for a few days). At the time of the report, VACCINATION SITE PAIN (sore arm for a few days) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.
Patient became dizzy, flushed and 'not right' 15 minutes post vaccination, BP and HR elevated, as time passed pt also developed nausea , MD evaluated and suggested to be transferred to ED for further monitoring
at day 18 or 19, post first covid vaccine shot, I began to have many symptoms and did not feel well. These were chills, slight fever, no appetite, nausea, muscle aches, fatigue
nausea, dizziness, emesis. patient went home early to rest as she did not have any other major adverse effects
Beginning the night of 4/6: heavy sweating, nausea, congestion in left nostril, and lethargy.  Day of 4/7: heavy congestion, lethargy, nausea and the beginning of flu symptoms.  Night of 4/7: body aches, chills, temperature fluctuation, nausea, headache, heavy congestion and sinus pressure. All day 4/8: heavy flu symptoms (same as night of 4/7). Biggest symptoms were nausea, heavy congestion/sinus pressure, lethargy, and body aches. Day of 4/9: Continuation of heavy flu symptoms. Convinced I contracted either a flu or Covid and went to local urgent care for Covid 19 rapid test. Test was negative.  Night of 4/9: Flu symptoms became slightly more mild. Day of 4/10: Mild flu symptoms. Less body aches and temperature control issues and more congestion, nausea, and lethargy. 4/11: Return to somewhat normal and in recovery from body's battle with vaccine. Returned to complete normal by 4/13.
Patient is 75 years old male with no significant past medical history except from varicose vein.  Patient also reported that he received 2nd dose of by the COVID-19 vaccine in February 2021 presented to ED with chief complaint of exertional shortness of breath and dizziness and cough for 10 days.  Patient denies any long travel or prolonged immobilization.  No known history of cancer.  No recent surgery.  Patient stated that he walked 5 mi every day and recently still able to walk but a little winded and need to work slowly due to shortness of breath. CTA chest showed Small caliber pulmonary embolus in the right lower lobe subsegmental pulmonary artery.  No evidence of right heart strain.  He also had bilateral below knee deep venous thrombosis involving the right posterior tibial vein and left peroneal vein. Patient was started on Eliquis and tolerated Eliquis. He had continuous persistent cough, and he was not found to have pneumonia. His cough improved with antitussives. He saturated well on walk test and was cleared for discharge home to follow up with Heme/onc for the remainder of the work up for hypercoagulable state.
Patient flew from city to city through another city on Tuesday 3/16/21.  He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane.  He could not go to work and was required to get Covid tested on 3/18.  Still coughing and having trouble sleeping (laying down).  Rapid Covid test negative on 3/18.  PCR test results negative on 3/21 from hospital.  He continued to grow weak and cough from 3/16-3/21.  At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing.  Taken to hospital via ambulance.  When transfered to ER bed, Dr said that he lost pulse.  They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest.  Dr said that they could not maintain a heart beat.  He asked me if the patient had a history of blood clots?  No he did not ever has a blood clot that I know of.  He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.
Arm became sore after receiving flu immunization to the point unable to sleep on it and if reaching (full extension) needs to support arm to carry out task.  Denies redness, fever swelling, rash.
Cold chills, Fever chills. Actual Fever over 102. Headache. Aperiodic sweating. Malaise. Day 2-3 Cough, Runny nose, Upper respiratory cold.  Common cold symptoms turned to ear/sinus infection. More anatomical- patient related. Con't cold chills for several months. Feet could not stay warm.  Persistent cold last over 2 months.  Prolonged time off work. Inability to be out in the cold. Full body chills for months after.
This spontaneous report was received from a medical assistant referring to a 53 year old male patient. The patient's medical historyallergy to trazodone (manufacturer unknown)with reactions of throat swelling, shortness of breath and rash (captured in MARRS case # 1702USA002231); allergy to lisinopril (manufacturer unknown) with anaphylaxis and angioedema (captured in MARRS case # 1702USA002230); history of rash with oxycodone and latex anaphylaxis. Concomitant therapies included nortriptyline hydrochloride (PAMELOR), omeprazole (PRILOSEC), pregabalin (LYRICA), morniflumate (FLOMAX ), warfarin sodium(COUMADIN), acetaminophen (TYLENOL), amlodipine besylate (NORVASC), dapagliflozin, diazepam (VALIUM), docusate sodium (COLACE), famotidine (PEPCID), insulin aspart (NOVOLOG), lovastatin (MEVACOR TABLET), magnesium, metformin hydrochloride (GLUCOPHAGE) and metoprolol succinate (TOPROL). On 27-JAN-2017 the patient was vaccinated with a dose of PNEUMOVAX23 intramuscular, lot # M036728 and expiration date: 20-MAY-2018 (strength, dose and anatomical location were not reported) for prophylaxis. On 28-JAN-2017, the patient experienced rash, feeling of heat (feeling hot), skin discolouration (pink and purple) and swelling that went from the injection site to the armpit. The patient received an unspecified treatment for the events; but no laboratory diagnosis were performed. At the time of reporting, the patient had not recovered from the events. The relationship between the aforementioned events and PNEUMOVAX23 was not established or mentioned by the reporter.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002230: US-009507513-1702USA002231: US-009507513-1702USA000334:
Initial report received on 18 July 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a three-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL; lot number C3176AA received on 17 October 2008, lot number C3200AA received on 22 December 2008 and lot number C3228AA received on 23 February 2009; and one dose of DAPTACEL; lot number C3139AA received on 08 December 2009 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 01 June 2012, approximately two years and six months after the last dose. On 04 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive apnea. Laboratory testing included positive PCR on 12 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 13 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
administered 2 doses from vials that were stored for more than 30 days at the fridge; administered 2 doses from vials that were stored for more than 30 days at the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 doses from vials that were stored for more than 30 days at the fridge) and PRODUCT STORAGE ERROR (administered 2 doses from vials that were stored for more than 30 days at the fridge) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Norvasc).    On 06-Dec-2021 at 2:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 doses from vials that were stored for more than 30 days at the fridge) and PRODUCT STORAGE ERROR (administered 2 doses from vials that were stored for more than 30 days at the fridge). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered 2 doses from vials that were stored for more than 30 days at the fridge) and PRODUCT STORAGE ERROR (administered 2 doses from vials that were stored for more than 30 days at the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.  Dose was stored in the fridge on 3 Nov 2021. Patient had no adverse event.   This case was linked to MOD-2021-406580 (Patient Link).
Had a bad reaction; Missed 2nd dose; Injection site became pinkish red and itchy; Injection site became pinkish red and itchy; Left arm was swollen; Bad chills; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a bad reaction), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose), VACCINATION SITE PRURITUS (Injection site became pinkish red and itchy), VACCINATION SITE SWELLING (Left arm was swollen) and CHILLS (Bad chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information history was provided.  Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Mar-2021, the patient experienced CHILLS (Bad chills) and NAUSEA (Nauseated). On 16-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Left arm was swollen). On 18-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site became pinkish red and itchy) and VACCINATION SITE ERYTHEMA (Injection site became pinkish red and itchy). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a bad reaction) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). On 15-Mar-2021, CHILLS (Bad chills) had resolved. At the time of the report, VACCINATION COMPLICATION (Had a bad reaction), VACCINATION SITE PRURITUS (Injection site became pinkish red and itchy), VACCINATION SITE SWELLING (Left arm was swollen), NAUSEA (Nauseated) and VACCINATION SITE ERYTHEMA (Injection site became pinkish red and itchy) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication.  Treatment details included cold compress.  Patient did not want to take 2nd dose after having serious side effects of 1st dose in march.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Narrative updated On 09-Aug-2021: Follow up received included new event was added.
patient developed hoarse voice + swallowing Difficulty after Pfizer vaccine - got vaccine around 1430, came to ED 1648 - Pepcid, solumedrol, Loratadine + Benadryl for Tx
This spontaneous report was received from a registered nurse concerning a female patient of unknown age. On 08-FEB-2013, the patient was vaccinated with an expired dose of ZOSTAVAX lot # 671609/1165AA, exp. date 19-OCT-2012, 0.65 ml, subcutaneous. No adverse effect was reported. The outcome of the event was unknown. The reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
Patient fainted after 4th injection for 5 sec. then patient was alert and awake. Patient then stated that she has history of family with any needle injections.
Pt developed significant case of varicella, around 100 lesions, with fever. It is a breakthrough infectio, not mild. Better but not well yet.
Received dose from a vial that had been punctured more than 12 hours/ probably a total of 18 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that had been punctured more than 12 hours/ probably a total of 18 hours) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 014M20A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that had been punctured more than 12 hours/ probably a total of 18 hours). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that had been punctured more than 12 hours/ probably a total of 18 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient received booster dose from the vial in the fridge that was punctured on 14 Dec 2021 at 10 AM.   No concomitant medication details was provided. No treatment medication details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Non Significant follow up appended snapshot document appended.
Patient stated he received vaccine on 1/29/21 at 10:30 AM and started to feel lethargic by 2:00PM. He states that he woke up at 12:00AM 1/30/21 with a fever 104.7, chills, trembling, sweating and body aches. He states that this continued for four days with development of diarrhea. He states his  fever continued to  decrease to 103, then 102, then 100.4.   He had visit with provider about his symptoms today 2/2/21
pt recvd flu vax & the next day pt reported soreness in the rt arm; 11 days p/inj pt exp weakness in the upper rt arm;
10/17/2011. ZOSTAVAX injection. Patient had Bells Palsy 12/1/2011. Patient convinced his immune system is not working as well as before ZOSTAVAX. ZOSTAVAX received via Pharmacy.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a sore arm that lasted for days.
10/10/2022- I noticed a lump in my right breast. I made telephone calls to get in as quickly as possible I had to get a referral to see my oncologist. I previous had a mammogram on 8/2021 and the results were clear. I went to get another mammogram on 12/14/2022 and they found a lump. The doctor did a biopsy on the spot of the mammogram. He called in the information on 12/16/2022 to my primary care doctor. 1/13/2023, I had my partial mastectomy on my right breast. I had 2 lymph nodes and a tumor removed.  I was sent home to heal and was back at work in 10 days.  The results of the biopsy showed the margins of my biopsy were clear. The doctors suggested chemotherapy and radiation, but I do not want to go down that path.  I was fully vaccinated, and I contracted COVID-19 infected on 02/09/2023 and it took me out for 10 days. I did not have any treatments.
Pt lost consciousness for a few seconds, then was groggy for a few seconds, then recovered.
Started wheezing; localized in right lower lobe; went in on the 9th and was given an inhaler with a spacer - Benzatete 200 mg 3x day as needed -  Tesslon Pearls; Codeine cough syrup. 11th still wheezing and coughing - went back in and got a round of steroids' - Prednisone -20 mg BID for 5 days and an Albuterol Inhaler Q4 hrs. 11th , I had a Chest x-ray - negative; CBC and CMP bloodwork and those were normal .Finished that round of steriods and was starting to cough more on 18th/19th it was productive - another chest x-ray and it was negative for anything. Drugs given: Z-pac for 5 day course.  40 mg QD of Prednisone for five more days. Cefdinir - 300 mg twice a day for 7 days. Was also given Codeine/Phenergan cough syrup to take three times a day as needed which has been needed. Still fighting it - cough is less and less productive. I feel like I have a couple of broken ribs on right that is making it challenging. Getting slightly better but affecting overall function. Have seen a provider four times.
medication error due to a patient being administered only the DTAP-IPV liquid component of the PENTACEL vaccine, with no reported adverse event; Initial information on 19-May-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 2 months old male patient who had medication error due to a patient being administered only the dtap-ipv liquid component of the pentacel vaccine, with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (Hepatitis B Vaccine); Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar); And Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) all for prophylactic vaccination.  On 06-May-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine, frequency: once, dose number 1st (route, strength, formulation: unknown) lot uj531aaa, expiry date: 22-Jul-2022 via intramuscular route in the thigh nos for prophylactic vaccination.  On 06-MAY-2022 the patient developed a non-serious event medication error due to a patient being administered only the dtap-ipv liquid component of the pentacel vaccine, with no reported adverse event (Incorrect product formulation administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with was not applicable.  It was not reported if the patient received a corrective treatment for the event (Incorrect product formulation administered).  At time of reporting, the outcome was Unknown for the event Incorrect product formulation administered.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Body Aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient, based on the information received by Pfizer from RA (Reference ID.   A 56 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Body Aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Low-grade fever of 99.9, normally it is 97.6,4 days of fevers; somewhat nauseous; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Low-grade fever of 99.9, normally it is 97.6,4 days of fevers) and NAUSEA (somewhat nauseous) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 08-Oct-2022, the patient experienced PYREXIA (Low-grade fever of 99.9, normally it is 97.6,4 days of fevers) and NAUSEA (somewhat nauseous). At the time of the report, PYREXIA (Low-grade fever of 99.9, normally it is 97.6,4 days of fevers) and NAUSEA (somewhat nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2022, Body temperature: 99.9. On an unknown date, Body temperature: 97.6.         No concomitant medication details was reported. No treatment medication details was reported. It was reported that all of her 5 doses were Moderna vaccines.  Patient experienced fever going on for more than 1-3 days.   Reporter did not allow further contact
His mom came to the pharmacy 8 days after his vaccine to report that he still is experiencing violent shaking/chills and sweating.  His fever has gotten up to 103.5.  He had swollen lymph nodes, headache and sore throat also.  His mom took him to an urgent care because he doesn't have a PCP.  She is giving him electrolytes, vitamins and keeping him hydrated.
By 5:30pm I became febrile at 101.4 and had severe pain on the left side of my face.  When I woke up in the morning, I couldn't open my mouth (trismus).  Fever continued throughout Saturday with continued severe facial pain (along the facial nerve and axillary n. pathways).   By Sunday, fever had resolved but facial pain and trismus continued.   Was seen by primary care doctor on Monday who started me on a prednisone taper.  Facial pain has improved but but still significant.  I can open my mouth but if pushed I get shooting pains down along my jaw and up along the L side of my face extending caudally past my hairline onto my head.