chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At approximately 0300 09/20/2022 I woke up with a unusual painful sore throat and had difficulty swallowing my saliva. I went back to sleep, only to be awakened with pressure in my sinus, blistering headache, sweating profusely and chills. My wife who is a nursing student in her final semester of school directed me to take 500mg of acetaminophen and Halls to sougth my sore throat. I went back to bed and things only got worse, wheezing, and coughing and slight tightness in my chest. Following day I had a ringing sensation in both airs, severe sinusitis, bleeding nose with blood clots, difficulty swallowing, super painful sore throat, chills, racing heart, fatigue, pressure behind my eyes and practically lost my voice due to hoarseness, my headache got worst leaving me with dizziness upon standing. This lasted throughout the week, using the 500mg acetaminophen to control the fever and pain, Halls for the sore throat. Today 10/01/2022 I woke up with headache but not as bad as previous days, still passing bloody mucus clots from my nostrils. My hoarseness still persists, the ringing in the ears are gone but I still have difficulty hearing, the pressure behind my eyes still persist but not as bad as before. Throat pain has reduced considerably, and I am able to swallow with out pain and difficulty, slight dizziness still persist and I am unable to start my new job 10/03/2022. Have Md appointment 10/01/22.
On about 11/18/2022, I developed fatigue that lasted maybe two or three days. I was so fatigued that I went to bed at about 5:00 PM. I had the chills, so I covered up with every blanket in the house. At around 8:00 PM, I awakened, and I was extremely hot. I attempted to take a step to go to the bathroom, but I was unable to walk. I then called 911, and I was transported to the ER. At the ER, I underwent a COVID-19 test. They also did bloodwork and a urinalysis. A few white cells were detected in the urine, but not enough to cause alarm. The COVID-19 test yielded a positive result. I underwent a chest X-ray, which was normal. I was given fluids, which helped. The results of my bloodwork were also normal. I stayed at the ER for about five hours before I was discharged. I notified my rheumatologist, who prescribed me PAXLOVID. The main symptoms I experienced with COVID-19 were fatigue and hoarseness. I took a home antigen test about 18 days after being treated at the ER, and the result was positive. My rheumatologist then advised me to self-isolate for another week and then test myself again. Seven days after he told me that, I took another home antigen test, and the result was negative. The worst part of my illness was the isolation. I recuperated upstairs, while my family stayed downstairs. I really missed and needed the human contact.
Shortness of breath and accelarated heart rate. These two things happen only when I'm in bed and I'm about to fall asleep.   It started at the end of July 2021, every night, until the end of October 2021. Then It stopped for a while, but now it happens less often. It could be 1 or 2 nights in a row, every 3 weeks more or less. Last time this happens was the 3rd week of June 2022, and I had it for 3 nights in a row.
Patient developed a painful itchy lump about the size of a golf ball the day of the injection at the injection site that has persisted for 7 days post-vaccination despite used of HC cream and ibuprofen.   On exam, it is slightly erythematous and TTP, approx 2.5 cm in diameter.
Patient experienced heaviness on chest and elevated of BP (147/107) 19 minutes after receiving dose.  16 minutes after episode started BP decreased to 130/62 and patient felt better. Patient a reported a similar incident after receiving his 1st dose.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB 5 micrograms/0.5 mL (dose, frequency and route were not reported) lot # L010595 with an expiry of 12-NOV-2016. No concomitant medications were reported. No adverse effects were reported. This healthcare worker also inquired about the stability of M-M-R II, however, M-M-R II did not undergo a temperature excursion and is not included in this adverse event (AE). There was no product quality complaint involved. This is one of the several reports received from same reporter. Additional information has been requested.
Pt EXP Right Arm and Right Leg tingling/numbness at 1200 on 22APR2021. Pt rested then woke up with a penny size nodule superior of right clavicle. Pt went to urgent care at 930Pm on 22APR2021.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the Health Department recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working with the Health Department on a compliance improvement plan and has been reinstated vaccination privileges.
arm was sore; felt fatigued / wanting to stay in bed; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 1st dose of Shingrix. On 30th November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fatigue and feeling unwell. On 1st December 2020, the outcome of the pain in arm, fatigue and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The patient felt fatigued and his arm was sore, he described it as just not feeling well and wanting to stay in bed. The symptoms lasted approximately one day. The reporter consented to follow-up.
fever; Mouth sore; Difficulty swallowing; This case was reported by a consumer via other and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) for ulcerative colitis.   On an unknown date, the patient received the 1st dose of Shingrix. In August 2018, the patient started Xeljanz (oral) 10 mg twice daily (20 mg daily). On an unknown date, the dose was changed to 10 mg twice daily (20 mg daily). In October 2018, less than a year after receiving Shingrix, the patient experienced fever, oral pain and swallowing difficult. The action taken with Xeljanz was unknown (Dechallenge was unknown). Rechallenge with Xeljanz was unknown. On an unknown date, the outcome of the fever, oral pain and swallowing difficult were recovered/resolved.   It was unknown if the reporter considered the fever, oral pain and swallowing difficult to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient experienced fever, mouth sore and difficulty in swallowing last year in October 2018 ,after 1st dose of Shingrix. In October 2018, the patient missed few doses, The patient was off medication for few days, no symptoms reported during missed doses. Stools formed twice a day prior to start of therapy was feeling sad and resolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "known allergies: PCN (Penicillin)" (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 Aug2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: Rebound COVID/ SARS after negative test and resolved symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Aug2023 to 03Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-202300298495 Same patient, different drug/AE.;
46 y/o male c/o dizziness following Janseen vaccine. Pt was diaphoretic. No PMHx, No allergies, No meds. Vitals: BP=104/65, HR = 78, RR = 22, Sp02 = 97%. BBG = 114. Pt placed on medic stretcher and monitored for 45 minutes. Pt fully recovered and cleared by medical provider to go home with family. Last vitals: BP= 122/75, HR= 65, RR= 20, Sp02 = 98% RA. Cardiac monitor revealed NSR. Pt denied any symptoms when released.
Non-serious case received 09 October 2009 from a health care professional. A six-year-old female patient had received an intramuscular injection of FLUZONE (lot not reported) on 29 September 2009, even though she was diagnosed with an upper respiratory infection on that date. There was no adverse events immediately following the FLUZONE injection. On 08 October 2009, the patient was inadvertently given FLUMIST at school. The following day, the patient developed a fever and was evaluated by a nurse practitioner. The patient was diagnosed with bronchitis, and treatment with ZITHROMAX was initiated. At the time of the report, the patient had not recovered. No further information was provided. Follow-up information received on 09 November 2009 from a health care professional. The patient received FLUZONE (lot number U3174EA) in the left deltoid. The patient was seen on 28 October 2009 and had made a full recovery from the bronchitis. No additional information was reported. Documents held by sender: None.
Patient was given VIS sheet prior to administration of Vaccination,patient reviewed in front of RN but denied any issues with information on VIS. Vaccine was administered due to a negative Varicella titer drawn on 3-11-19. Patient started to break out in a rash to her body 3 weeks after Vaccination also with localized irritation, erythema to site of injection.
Fever 101 degree Fahrenheit, decreased appetite, vomiting, and diarrhea x 12 hours. Treatment is tylenol for fever, zofran for vomiting, and pedialyte for rehydration. Patient encouraged to go to ER if symptoms worsen or patient unable to hold down liquids with decreased output.
Headache, Myalgia, Arthralgia, Fever, Chills, fatique Narrative:
Lighthead, gave fig bar and water, observation  Note from MD: Complained of lightheaded after injection, now improved. No other complaints. States improved with oral intake. Exam: unremarkable. Plan: home. Unlikely to be serious allergic reaction.
Almost a week after I received the second dose of the Moderna Covid vaccine, I started experiencing some chest tightness/pressure, and extreme fatigue, which continued for another 6 weeks after May 3rd, during which I felt extreme fatigue, chest tightness, shortness of breath and heart palpitations (mostly at night, when lying down). I visited Urgent Care on May 3rd and had to go to the ER again on May 9th, for the same reason.
This spontaneous report has been received from an office manager, referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L027733 and expiration date 13-SEP-2017) (lot # L039660 and expiration date 04-FEB-2018) doses, anatomical location and administration route were not reported. The reporter stated that she was not aware of any adverse effects and no product quality complaint was involved. Temperature: 19.9 Fahrenheit degrees. 4 cycles below 24F. Time Frame: unspecified at the time of his reporting. Temperature excursion (cumulative time): 255 hours. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Patient became very warm, with tingling and nausea.  Pt vomited approximately 30 minutes after vaccine and face and neck became flushed.  Taken to ER for continued monitoring and treatment
Nodular palpable edema RRS.  No history of allergy!  Non-blanching.  Both limps and right elbow.  Painfull right distal quadriceps lateral head.
polymylactic rhumotosis,treated with Predisone for 8 months.  Methotrexate for 4 months
Caller confirmed that no symptomatic side effects were reported; Nurse calling to report administration of PROQUAD to an adult patient.; This spontaneous report has been received from a nurse, concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 08-MAY-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection at a dose of 0.5 milliliters (ml) as prophylaxis (product administered to patient of inappropriate age) (strength, route of administration, anatomical location, lot number, and expiration date were not provided). No symptomatic side effects were reported. No additional adverse events were reported
It was a pretty strong spasm and was completely uncontrollable/it was my right arm that started doing spasms; Muscles in my arm started twitching; episodes of muscle twitches; It was feeling like fire inside my arm; My fingers started tingling; Contraction of the muscle; This is a spontaneous report from a contactable consumer reported for herself. A 50-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jul2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 22Jul2021, the patient experienced muscles in her arm started twitching almost immediately, well not quite immediately, while later it started having these episodes of muscle twitches and during the evening last night, the muscles were spasming and then it was spasming and it was feeling like fire inside her arm and that lasted till about 12 o'clock then the spasming stopped and it was a pretty strong spasm and was completely uncontrollable and then it stopped, then her fingers started tingling and then didn't had any spasms for a little while and now it's just back to being little twitches again. The muscle spasming, it is not a spasm that causes pain. It's a contraction of the muscle. Consumer stated, "I would also like to know if the 2nd shot is advisable." Due date of 2nd shot: Consumer stated, "I am not sure the exact date but its 15Aug I think." The patient did not receive any treatment and just tried to apply pressure or massage it out and just try to do physically something to help it. The patient underwent lab tests and procedures which included weight: around 180 lbs. Outcome of the event muscle spasm was recovered; while others events was unknown. Information about batch/lot number has been requested.
Slept most of the day; Had little to no desire to eat; Ache; Fever; Very tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept most of the day), DECREASED APPETITE (Had little to no desire to eat), MYALGIA (Ache), PYREXIA (Fever) and FATIGUE (Very tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002L21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Food allergy and Food allergy. Concomitant products included LEVOTHYROXINE, OLMESARTAN MEDOXOMIL and ESTRADIOL, PROGESTERONE (BIJUVA) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced SOMNOLENCE (Slept most of the day), DECREASED APPETITE (Had little to no desire to eat), MYALGIA (Ache), PYREXIA (Fever), FATIGUE (Very tired) and CHILLS (Chills). On 24-Apr-2021, SOMNOLENCE (Slept most of the day), DECREASED APPETITE (Had little to no desire to eat), MYALGIA (Ache), PYREXIA (Fever), FATIGUE (Very tired) and CHILLS (Chills) had resolved.            Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-073793 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073793:First dose case
Mild case of covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Mild case of covid) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (Mild case of covid). At the time of the report, COVID-19 (Mild case of covid) outcome was unknown. Not Provided          No concomitant medication and treatment information was reported. Reporter stated that he and his wife both were vaccinated against COVID-19 in January and February 2021 and during Thanksgiving they both got a mild case of COVID, very mild case. He stated that he received Pfizer for his vaccinations ad his wife has got Moderna COVID-19 vaccine. He does not have her vaccination card and wanted to know how soon can they take the booster dose.  Company comment: This case concerns a 79-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unknown date after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient had a very mild case of Covid as well as her husband. The patient's age may have increased her risk of getting Covid.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 79-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unknown date after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient had a very mild case of Covid as well as her husband. The patient's age may have increased her risk of getting Covid.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Joint pain in shoulders, elbows and hands / not resolved; Muscle pain in shoulders, elbows, hands and triceps / not resolved; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2020, immediately after receiving Shingrix, the patient experienced joint pain and muscle pain. On 22nd December 2020, the outcome of the joint pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the joint pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shingrix, the patient started to experience joint pain in his shoulders, elbows and hands.   He was also having muscle pain in his shoulders, elbows, hands and triceps.   These side effects occurred almost immediately after receiving the vaccine.  The patient stated, at the time of reporting, it had been 2 months and the joint and muscle pain had not resolved.  The reporter asked how long these effects would last.   The reporter did not consent to follow up.
I woke up with my face swollen on right side. Lip was also swollen. Numbness on right side of face. Similar to Bells Palsy symptoms but no problem with eye closure. Next day the swelling went down but continued to have numbness and some nerve pain on face for about 10 more days.
administering only the adjuvant of MENVEO; administering only the adjuvant of MENVEO; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number IMAA687A, expiry date unknown), (batch number AMVI6H7A, expiry date unknown) and (batch number AMVA687A, expiry date 31st January 2022) for prophylaxis.   On 14th March 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 14th March 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   GSK Receipt Date: 24-MAR-2022, 24-MAR-2022 Reporter's Comments: The patient received a partial dose of Menveo as the nurse only administered the liquid CYW-135 component. The reporter consented to follow up. Additional supportive information: The patient received only liquid component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case US2022053912 is identified as duplicate of case US2022053914. All future correspondence would be added in case US2022053912, which stands as case of record for this patient and the case US2022053914 would be deleted. This case has been linked to US2022053914, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022053917:same reporter/patient - FU1 deleted US-GLAXOSMITHKLINE-US2022053914:same reporter
Moderate headache, moderate tiredness, dizziness, increased frequency of urination lasting 2-3 days.
HAD A MILD HEADACHE + LOW 98.8 TEMP + EXHAUSTED (HAD TO SLEEP) BEGAN EARLY 4/14 - WORKED UNTIL NOON, TOOK NAP IN OFFICE, THEN LEFT FO THE DAY. COULD NOT CONCENTRATE. HOME & SLEPT TILL 5 PM, BROKE OUT IN COLD SWEAT.  FELT OK FOR SHORT PERIOD, THEN MILD HEADACHE + TEMP RETURNED, CREATING FEELING OF EXHAUSTION. SLEPT MORE. IN BED BY 930. WAS WOKEN AT 330 AM BY COLD SWEAT. FEVER BROKE AGAIN. FELL BACK TO SLEEP, SELPT TILL 330. COULD NOT WORK. TODAY SOME WHAT TIRED BUT FEELING BETTER
p/vax pt devel inj site rxn of large lumps; redness; tenderness & warmth; resolved w/using compresses
Rash and tender at location of varicella shot. Pt also had temp up to 103.8.
At the injection spot I had a red spot about 3 inch wide.  Then there was 1 inch gap, then there was a circle about 1/2 inch wide.   As of now feb 28 at 3:15 the 1/2 circle is gone and the red spot is fading and disappearing