chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested after exposure with multiple negative tests. Reports continued cough and some chest congestion along with a new rash on her chest.
developed headache; chills; 102°F fever; vomiting; left arm pain; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 at 11:00 (at the age of 36 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021 the patient experienced headache, chills, 102°F fever, vomiting, and left arm pain. The patient received treatment for the events with ibuprofen. The patient underwent lab tests and procedures which included body temperature 102°F on 17Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Information has been received from a nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot # K021936, expiration date 10-NOV-2016, dose and route unknown). No adverse symptoms were reported. Additional information has been requested.
Sunday: tightness in chest Monday : short of breath with walking Tuesday: extreme shortness of breath Wednesday: continued worsening SOB- sent for labs/ chest xray Thursday:  D-dimer back -4.53- sent to hospital CAT scan showed multiple pulmonary embolisms without cor pulmonale / ultrasound- multiple DVTs, hospitalized 01-21 to 01-23/ heparin drip, transitioned to apixiban Discharged  home
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 38-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Initial and follow-up information has been received from a physician concerning a female who in approximately April 2007, was vaccinated IM with the first dose of Gardasil. The day after vaccination, the patient experienced swelling of her lips and a member of the patient's family thought that her face was a little puffy too. The patient's outcome was not reported. Medical attention was sought. The patient was instructed to got to the emergency room. The patient has not followed-up with the office nor returned my telephone messages. The office is unaware if the patient went to the emergency room. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submittedon 7/16/2007. Additional information is not expected.
Serum-sickness type reaction, occurring 12 days after vaccine administration. Symptoms included: fever, arthralgias, fatigue, diffuse urticarial rash.
I was tired that evening and around 8PM began having mild muscle aches and felt cold (no fever). At the time I found out I was pregnant 2 weeks before receiving the shot. My doctor advised to get it. I am due September 26, 2021.
pt recv vax NOV95 & 17APR96 pt exp chicken pox w/8 spots that looked like red papules;pt recovered;MD also reported two additional children devel varicella following vax;
Anaphylaxis  While driving home: difficulty breathing, tightness in chest, swelling of tongue and lips, difficulty swallowing, tingling in left arm
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 52-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm, in 2022 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Apr2020 as dose 1, single (Batch/Lot number: unknown), in left arm and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (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 Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received paxlovid treatment from 13Sep2022 to 17Sep2022 for treatment of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT DEVELOPED SKIN RASH AND ITCHINESS INVOLVING ARMS AND LEGS FOLLOWING DAY OF THE VACCINE. STARTED IN ANTIHISTAMINES FOR RASH AND ITCHINESS.
1st dose - 25 Jan 2021, 2nd dose - 04 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25 Jan 2021, 2nd dose - 04 Mar 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency, Leukemia and Blood pressure high. Concomitant products included VALSARTAN, AMLODIPINE and HYDRALAZINE HCL for Blood pressure high.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25 Jan 2021, 2nd dose - 04 Mar 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25 Jan 2021, 2nd dose - 04 Mar 2021) outcome was unknown.            Patient height was reported as 5 feet and 9 inches.  Patient does not had any allergies and not had any Covid-19 diagnosis prior to or after getting the vaccine. . No treatment medications were provided.   This case was linked to MOD-2022-529246 (Patient Link).
Received the first dose on 8mar21 by accident; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose on 8mar21 by accident) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose on 8mar21 by accident). On 08-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose on 8mar21 by accident) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter.  The patient was denied the second dose because she was under 18 years of age.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received- the follow up report states that when patient when to receive the second dose of vaccination, the patient's mother got to know that her daughter received wrong vaccine(moderna)  instead of Pfizer vaccine. Reporter called Moderna and they suggested her to contact the Pfizer but danaid and  the locality of patient contains only the moderna vaccine which they could not give.
"Moderna arm":  large red, swollen area around injection site that itches and stings; mildly painful.  It developed 8 days after the injection.  Don't know how long it will last.
Almost 12 hours after receiving vaccine I had numbness and tingling on inside of mouth/cheek on the right side, numbness of right side of face, swollen right eye and slight dropping of right bottom lip
Patient had vaccine 11/15/2018. No reaction that day and no reaction ever at injection site. On 11/17/2018, patient began to experience swelling on the left side of his neck only. No pain or redness, and no throat swelling. No fever of rash. He said swelling has not resolved as of 11/19/2018. I encouraged him to discuss this with his physician.
Received a Meningococcal Vaccine on June 21st at 6:00 pm.About 24 hours after the shot developed a sudden high fever, a headache, was felt very sick to his stomach, was dizzy and his heart was racing. I brought him to hospital. I was told him more than likely had a reaction to the shot. They ran blood test and urine test which came back okay. I was told to give him Advil and Tylenol alternating, each one three hours apart. I was also told to watch him closely and also that I needed to bring him back the next day,which is June 23rd, to make sure he is doing better.
This spontaneous report was received from an office manager, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administered doses of improperly stored ROTATEQ (lot # L037574, expiration date 01-JUL-2017). It was reported that the vaccine was exposed for 22 hours at 30.9 F degrees. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Brief exacerbation of baseline asthma (had to resort rescue inhaler) Low grade T(99) 2-3 cm sore spots at injection site left arm.
Approx, 1 hour after having vaccines - dad called and said patient was having tightness in her chest and it hurt to breathe - advised to go to ER after a delay dad brought her to ER for eval.
So the skin rash occurred gradually since Sept of 2021 and it ended up making my hand completely dry and I went to the Dr. and got the cream to get the reaction down I have used cream for some time but it did not conclude the rash and I received the cortisone shot and it went away for 3 weeks and in February I started having problems sleeping and problems breathing and I did not have the flu and tested negative for Covid. I still have the rash and it doesn't appear to be going away any time, it is only on my four fingers, and hand and in-between my fingers but it is not on my thumb. My hand also bleeds from it. The breathing and sleeping problems have resolved. I feel short but I have to take airplanes when I fly and after when I fly.
I went to the Dr 4 days after the dr prescribed Keflex in case I needed it ( I did not), it went from 3x3 cm redness out to like 8 cm circumference with swelling and redness and it itched, I was told to take Benadryl orally  and apply Benadryl cream and cortisone cream for the site. It took about 1.5 weeks total
Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with GARDASIL (lot # not reported), 0.5 mL, IM administration. The nurse stated that the patient was feeling uncomfortable after getting the GARDASIL, and she came back to the physician's office. The patient laid down and she later felt fine. Additional information has been requested.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown dates, the patient was vaccinated with an improperly stored dose of one of the following vaccines: ROTATEQ, GARDASIL, GARDASIL 9, PNEUMOVAX 23 or PEDVAXHIB. All of the mentioned vaccines were improperly stored, but the reporter disconnected before indicating which one received the patient. No adverse effects were reported. Additional information has been requested.
chills; sever body aches; fever; nausea; This is a spontaneous report from a non-contactable consumer. This female consumer reported for herself.  A (non-pregnant) female patient with unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: unknown), via unknown route, administered in left arm on 03Mar2021 08:15 as dose 2, single for COVID-19 immunization. patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EH9800, Expiration date: unknown), via unspecified route, administered on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Hashimoto's disease from an unspecified date to unknown ongoing and concomitant medications includes Levothyroxine Sodium (SYNTHROID) and Gabapentin. Past drug event includes Zithromax induced Drug hypersensitivity. On 03Mar2021 06:00 PM, after the vaccination, the patient experienced chills, sever body aches, fever and nausea. No other vaccines were administered in four weeks, Patient was not diagnosed with covid prior vaccination and covid was not tested post vaccination. The outcome of the events was recovered.  No follow-up attempts possible. No further information expected.
Soreness in arm that calmed down and radiated to heart and chest area causing tightness. No pain and so not seeking medical attention but wanted to report the chest tightness, especially on the left side near the injection site, to share symptoms from the vaccine. The tightness in the chest doesn't bother me except for the fact its on the left side (near the injection site) around my heart. It's been constant for 10 hours now but I think it will go away in a couple days with the soreness in arm.
Itch at injection site began 1-28-21, redness at injection site began 1-29-21. Itch continues on 1-29-21. It feels maybe like a bee sting. It doesn't hurt and the itch/redness doesn't stop me from going about my daily business. It is mildly annoying.
She got her vaccine, after she went to sleep that night around 11:00 PM her arm started hurting ,she could not lay on the arm and when she felt of it it was warm and swollen.  The next morning when it looked at it in the mirror it was red and swollen from her shoulder to her elbow almost completely around the arm.  Later in the day it developed a hard knot larger than her fist from top to bottom.  You could tell by looking at the arm that it was swollen and warm, which lasted about a week.  She did not call her doctor, but did call the pharmacy to see if there was anything recommended to do for it, and she was advised to put cool compresses on it, which she did not do.  She then called us and left a VM.  She did take some Tylenol a couple of times, and gradually started going down about Wednesday and by Friday it was gone.  it also had a sort of rashy look to it, but nothing really raised, but felt like rough, dry skin.
Moderna Dose 1 2/3/21 (012M20A) Moderna Dose 2 3/3/21 (022M20A) COVID Positive 1/14/22  1/14/22: 44-year-old female with rheumatoid arthritis and dermatomyositis on DMARDs, seizure disorder, migraine, tobacco abuse presented with cough and shortness of breath. Patient reports symptoms started about 1 month ago with cough productive of whitish sputum associated with fever and upper respiratory symptoms.  Since that time she has completed 3 courses of antibiotics with Keflex, doxycycline and azithromycin with some improvement of her symptoms when she takes antibiotics , symptoms return within a couple days of completing the antibiotics course.  Most recently started levofloxacin which made her feel worse with numbness and tingling, worsening shortness of breath and dizziness.  Continued to have cough productive of whitish sputum, diaphoresis and  fever.  Tested negative for COVID-19.  Denies chest pain, orthopnea PND or leg swelling.  No recent travel, works as  maintenance security supervisor in a large facility.  In the emergency room patient had a T-max of 101.7°, blood pressure was 82/55 she is requiring 2 L of oxygen.  Chest CT showed no pulmonary embolism noted extensive bilateral pneumonia concerning for COVID-19 with reactive hilar lymph nodes,  2 centimetre right hepatic lobe nodule.  Patient received Zosyn and vancomycin, IV fluids in the emergency room.  Hypotension improved after IV fluid and Solu-Cortef.  1/16/22: 44-year-old female with a history of rheumatoid arthritis and amount to myositis on DMARDs, seizure disorder, tobacco use presented with cough and SOB of over a month duration but has been prescribed for different antibiotics at various times with resolution of symptoms but there was recurrence of symptoms few days before presenting to the ER.  CT scan the chest contrast revealed extensive bilateral infiltrates concerning for viral pneumonitis.  She was admitted for bilateral pneumonia and commenced on IV antibiotics Zosyn and vancomycin.  The following morning COVID-19 PCR came back positive.  However Sao2 remains perfectly normal at 96-97% on room air, no complaint of SOB though she is still have cough productive of scanty sputum.  On re-evaluation this morning she voiced no new complaint and actually feels much better.  She will be discharged home on her pre-admission medications and in addition I will give a prescription of Ceftin for additional 5 days.  She will follow up with PCP in a week.
20mm x 20mm hard red ara where vaccination was injected SQ (on 3-19-15) area warm, itchy and sore given TYLENOL 650mg po 3/19/15 PM and 3/20/15 AM. On 3-20-15 AM area still slightly.
4 month old child received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 4-month-old female patient who received an expired dose of act-hib with no reported adverse event while receiving vaccine Hib (Prp/T) Vaccine [Act-Hib].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (Hepatitis B Vaccine) for Prophylactic vaccination (immunization).  On 15-Jun-2022, the patient received a 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE (3rd dose without the pentacle) lot number, formulation, strength not reported, expiry date: 14-May-2022 frequency: once via intramuscular (IM) route in the thigh nos (IM/R vastus lateralis) for prophylactic vaccination (immunization).  On 15-Jun-2022, the patient developed a non-serious event 4 month old child received an expired dose of act-hib with no reported adverse event (expired product administered) (latency same day) following the administration of HIB (PRP/T) VACCINE.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product 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 guidelines. 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.
left elbow pain, left upper arm pain, numbness and tingling in left hand / fingers, subjective weakness left arm and left hand grip
After first vaccine, developed fever, fatigue, and sweating lasting 4 days. She also had a loss of taste and smell for one day.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JAN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # K023622, expiration date: 20-FEB-2016 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 70 days (reported as 70 days +) since 22-SEP-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Temp max of 103.5, remained elevated from 12 hours post vaccine until 36 hours post vaccine. Remained 100.5; headache; muscle aches; skin tenderness; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on the left arm on 13Jan2021 07:00 at a single dose COVID-19 immunization. Medical history included none. The patient is not pregnant. The patient's concomitant medication includes an unspecified birth control pill. On 13Jan2021 19:00, the patient experienced a temp max of 103.5, remained elevated from 12 hours post vaccine until 36 hours post vaccine. Remained 100.5 with ibuprofen 800 mg and Tylenol 1000mg. The patient also experienced headache, muscle aches and skin tenderness x 48 hours. The patient was given treatment for the events. The outcome of the events was recovered on an unspecified date.
chest pain that progressively got worse. stabbing pain in the heart (middle of the chest). started around 12-14 hours after vaccination and progressively got worse -> felt like jabbing/stabbing into the heart.   went to ER about 28-30 hrs after vaccination. (not a heart attack)   felt better ~72 hours after vaccination date.
Dizziness, Headache, Myalgia, HYPERtension, flushing, chills