chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sweating Profusely; lump on the right side of neck; swelling on the right side of face; pressure in ears; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (lump on the right side of neck), SWELLING FACE (swelling on the right side of face), EAR DISCOMFORT (pressure in ears) and HYPERHIDROSIS (sweating Profusely) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced NECK MASS (lump on the right side of neck) (seriousness criterion medically significant), SWELLING FACE (swelling on the right side of face) (seriousness criterion medically significant) and EAR DISCOMFORT (pressure in ears) (seriousness criterion medically significant). In August 2021, the patient experienced HYPERHIDROSIS (sweating Profusely) (seriousness criterion medically significant). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency; CEFALEXIN (CEPHALEXINE) for Adverse event, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Ear discomfort, at an unspecified dose and frequency. At the time of the report, NECK MASS (lump on the right side of neck), SWELLING FACE (swelling on the right side of face), EAR DISCOMFORT (pressure in ears) and HYPERHIDROSIS (sweating Profusely) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood test: positive (Positive) Antibodies for the Epstein Barre virus.         Relevant concomitant product usage were not reported by the reporter. On an unknown date, patient underwent CT Scan to rule out Cancer. Results were not received. Biopsy of the lymph nodes was also planned.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  No further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  No further information is expected.
Patient called stating that she started experiencing muscle weakness in her arms, legs, and back about 3 days after getting her first COVID vaccine. She reports that she has had difficulty walking and it became so bad that she went to the emergency room. She also reports she had the normal side effects of vomiting, diarrhea, and body aches.
Both MMR and Varicella given intramuscular instead of correctly subcutaneously. Error noted following charting the immunizations. No immediate local reaction noted on either arm.  Completed internal incident report, VAERS report, and spoke with supervisor.  Per current guidance, revaccination of MMR and Varicella not necessary and doses given IM count. No other follow up completed at this time.
the vaccine was administered after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 29-APR-2022, the patient was vaccinated with an improperly stored dose (administered after temperature excursion) of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U026207 with expiration date of 24-AUG-2023 or lot # U029496 with expiration date of 21-SEP-2023, for prophylaxis (dose, route of administration and frequency were not reported).         Temperature excursion -9 C; Time frame 1 hour 45 minutes; no previous temperature excursion.   No further information provide.         ?
body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Red, itchy, splotchy about 2 inches in size with knot; itching has subsided but redness remains.
listlissness; run down feeling; joint pain; pain at the site of the injection; soreness in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of LISTLESS (listlissness), FEELING ABNORMAL (run down feeling), PAIN IN EXTREMITY (soreness in his left arm), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the site of the injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029o20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his left arm) and VACCINATION SITE PAIN (pain at the site of the injection). On 13-Feb-2021, the patient experienced LISTLESS (listlissness), FEELING ABNORMAL (run down feeling) and ARTHRALGIA (joint pain). At the time of the report, LISTLESS (listlissness), FEELING ABNORMAL (run down feeling), PAIN IN EXTREMITY (soreness in his left arm), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the site of the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-465694, MOD-2022-465795, MOD-2022-465812 (Patient Link).
Pfizer Dose 1 6/23/21 (EW0181) Pfizer Dose 2 7/18/21 (EW0198) COVID Positive 1/5/22  1/5/22: Patient is a 51 year old male with past history of alcohol abuse, tobacco abuse, and severe COPD who was admitted with melena and hematochezia and also was found to be COVID-19 positive.  History is obtained from chart review as well as discussion with the patient and the ED provider.  Patient has a long history of alcohol abuse and drinks at least 6 beers per day.  Does have chronic lower extremity swelling for which he is on Lasix 40 mg b.i.d..  He was seen by Pulmonary last year and started on inhalers for severe COPD.  Patient had some dark red diarrhea last night and then black diarrhea today.  He also had vomiting of black material.  He does admit to taking ibuprofen most recently yesterday.  He does not have a known history of cirrhosis although there has been discussions with his PCP about obtaining testing.  He is not having any chest pain and denies any shortness of breath other than his baseline COPD.  Currently does not have any nausea.  He denies any fevers or chills.  He does have a wound to his left shin after he fell a couple weeks ago.  He states he has received his COVID-19 vaccinations but not a booster.  1/8/22: 51-year-old male with a history of chronic alcohol abuse, COPD and chronic smoker presented with melena/hematochezia.  He was also found be with 19 positive.  CT scan of the abdomen revealed severely fatty liver.  He was diagnosed with likely upper GI bleed due to chronic liver disease and portal hypertension.  He was commenced on pantoprazole and octreotide infusion.  Had an upper GI endoscopy which revealed the above findings. Patient required no blood transfusion. Patient has minimal respiratory symptoms with O2 saturation of 96% on room air.  On re-evaluation this morning he has no new complaint.  Hemoglobin remains stable.  He will be discharged home on oral pantoprazole 40 mg p.o. b.i.d. and continue with pre-admission medications.  He will follow-up with the PCP in 1-2 weeks.  Patient was advised to continue with respiratory isolation for at least 5 days despite he is asymptomatic as per the new CDC recommendation.  He is fully vaccinated.    More importantly patient was advised to quit drinking and smoking.
Increased HR 108 x min Pt reports feeling fine at exit.  Pt stated he was using Albuterol for asthma.  Last dose 1 hour prior to vaccine.  Pt was monitored for 40 min.  HR: 98 x min at exit.
Patient called and said her arm started hurting within an hour of receiving her vaccine. Two days later, she still cannot lift her arm without severe discomfort. She said she feels it all over around her rotator cuff.
Patient appeared for second Moderna COVID-19 dose. Due to paperwork and communication error, patient received Janssen COVID-19 dose instead. Patient was informed of the administration error. Documentation was corrected. Patient experienced no adverse outcomes from the vaccine as of 36 hours after vaccination.
had diarrhea, uncontrollable diarrhea; next morning I woke and I could not get out of bed, could not lift my head off the pillow; got up and I had a pain in my stomach; was very tired all day; was okay that day but then other then my arm hurt a little bit; Initial information received on 25-Oct-2023 regarding an unsolicited valid non-serious Courtesy case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who had diarrhea, uncontrollable diarrhea, next morning i woke and i could not get out of bed, could not lift my head off the pillow, got up and i had a pain in my stomach, was very tired all day and was okay that day but then other then my arm hurt a little bit after receiving vaccines Influenza USP Trival A-B Subviron No Preservative Vaccine [Fluzone] and vacuna pfizer-biontech covid-19.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2023 at 10 in the morning, the patient received a dose of suspect  Influenza USP Trival A-B Subviron No Preservative Vaccine Suspension for injection (lot number, strength, dose ,expiry date not reported) via unknown route in the left arm as prophylactic vaccination and on the same day and time the patient received vacuna pfizer-biontech covid-19 not produced by Sanofi Pasteur (lot number: HG4633, strength, dose, form unknown) via unknown route in the right arm as prophylactic vaccination.  On an unknown date, the patient reported that the next, I was okay that day but then other then my arm hurt a little bit (pain in extremity), next morning I woke and I could not get out of bed. I could not lift my head off the pillow (hypokinesia) and I finally did and I was very tired all day (fatigue) and I did nothing all day. Then next morning, the 4 o'clock in the morning, I got up and I had a pain in my stomach (abdominal pain upper) and I wanted to go to the bathroom I never made it to the bathroom, I had diarrhea, uncontrollable diarrhea (diarrhoea) (Unknown latency) following the intake of Influenza USP Trival A-B Subviron No Preservative Vaccine and vacuna pfizer-biontech covid-19.  It was reported "Well, a couple of days ago I had a flu shot and I also had a Covid booster and I had a very bad reaction. I had, first time I ever took 2 vaccines at a same time because I saw a lot of advertisements and for that you could get both the vaccines at the same time. I went to have them both. I wanted to report this because I don't know if it has anything to do, I have a feeling that it has do something to do with the flu shot. Because I do get that for. When Paraphrased the concern: Consumer stated, "Yes and I just have the feeling that because this is the powerful flu shot that this may have done it. I never had a reaction to a vaccine before."   Action taken: not applicable.  The patient was treated with PARACETAMOL (TYLENOL).  At time of reporting, the outcome was Unknown for the events.
Swollen eyelids; Sore arm; A spontaneous report was received from a consumer, concerning herself, a 80-year-old female patient, who received Moderna's COVID-19 vaccine and developed swollen eye lids and a sore arm.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09-Jan-2021, the patient woke up with swollen eye lids and a sore arm. The patient did not take any treatment medication; however, her symptoms were improving.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events, swollen eye lids and a sore arm were considered resolving at the time of this report.; Reporter's Comments: This case concerns an 80 year old, female patient, who experienced a non-serious unexpected event of swelling of eyelid, and non-serious expected event of pain in extremity. The events occurred 2 days after first dose of mRNA-1273, lot # 025L20A. No treatment was administered, and the event appeared to be improving. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Additional information has been requested.
Fatigue, dizziness, headache, fever, nausea, severe pain around injection site and arm of injection site, chills, aches
Day 1 - bilateral groin pain. Left groin pain subsided on Day 4. Right groin pain persisted ( more than 1 month, now). Intermittent moderate to severe pain,3 to 5 times a day, not precipitated by stress or movement, worsened with movement, occurs more when at rest, no inflammation, no swelling, no erythema, no palpable mass, no fever.
Information has been received from an RN concerning a 65 year old patient who in November of December 2007 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine, lot #657626/1084U. The patient commented that the injection was painful and 1-2 days later developed warmth and localized hives at the injection site. The patient also reported pain from the shoulder to the breast area. Medical attention was sought. The patient was recovering. The nurse indicated that 2 additional patients had identical adverse experiences from pneumococcal 23v polysaccharide vaccine, lot #1084U, and requested a lot check to ensure the product was safe to use. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Client received 0.2ml of Pfizer COVID vaccine (orange cap) instead of 0.3ml Pfizer COVID vaccine (purple cap). No adverse effects noted. Guardian made aware.
She got her vaccine, a little diarrhea, a slight headache, foggy brain, overwhelming fatigue, slight nausea for a few days and then it stopped.  She is having these symptoms again, and is having this for the third time which started a few days ago with the same reactoin, plus muscle weakness, just feeling sick like, crappy feeling.
4 ;04 PM: client felt lightheaded, loss of hearing, was lay down flat with legs elevated, PoD director, EMS, and dr present, V/S: 101/75,pls at 91/min, SAT at 98%.    client said that she did not have lunch and has history of fainting.    At 04:13 PM: 104/65, pls at 101/min and SAT at 99%.   At 04:23 PM: 107/67, pls at 101/min, SAT at 99%.  Client seat upwright and eat snack, hearing is back.   04:33 PM: 118/79,pls at100/min and SAT 97%.. at 04:43 PM: 114/72, pls 107/min, SAT at 98%.  04:49PM:  seat in chair, 123/79, pls 109/min and SAT 96%.  04:56 PM, client stand up, 107/74, pls at 93/min , client feel good and discharge by dr.
A few weeks after my vaccination I began hearing ringing or background noise in my ears, never had it before.
vaccine given at 7:45am, 7:50am developed rash/redness upper torso and head, itching. No issues with breathing. BP 165/107. P 86. R 20 Benadryl 50mg IM given at 7:52am , brought to Emergency room.
Started with itching on back and arms on Wednesday 2-10-21.  By Friday evening I had a rash all over my back and hives on my back and right arm.  Some hive are also apparent on my left hand and wrist.  I contacted my doctor Sunday 2-14-21 as the rash and itching were not being controlled by benadryl and hydroctorisone cream.  My doctor gave me Prednisone to take 60mg daily for 5 days.  I am now on day 2 of therapy and the rash on my back has gone down some, the rash on my right wrist and hand are still severe.
Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.; Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A and 032F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included GERD since 20-Aug-2020, Hyperlipidemia since 15-Jul-2020, Migraine since 08-Dec-2018, Hypertension since 08-Dec-2018 and Vitamin D deficiency since 15-Jul-2020. Concomitant products included FAMOTIDINE from 22-Jul-2020 to an unknown date for GERD, PRAVASTATIN from 06-Jul-2022 to an unknown date for Hyperlipidemia, HYDROCHLOROTHIAZIDE from 21-Mar-2019 to an unknown date for Hypertension, PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]) from 08-Nov-2019 to an unknown date for Migraine and Hypertension, CHOLECALCIFEROL from 15-Jul-2020 to an unknown date for Vitamin D deficiency.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Nov-2021 at 9:19 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Jul-2022 at 1:56 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Jul-2022 at 1:56 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 02-JUN-2022 The vial did not undergo any temperature excursions. No adverse events had occurred. Treatment information was not provided.   This case was linked to MOD-2022-607867 (Patient Link).
Mother reported temperature of 104.8 the morning of 7/1/09.  Low grade temperature the evening of the immunization.  Treated with Motrin every 6 hours.  No other symptoms or findings on medical examination.  Child was seen by physician 07/01/2009.  Physician felt temperature due to immunizations.
This spontaneous report was received from a physician and refers to a female patient in her 20's. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, reported as "within the last year", the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported). On an unknown date, within approximately one day after receiving the PNEUMOVAX 23, the patient experienced injection site reaction, injection site reaction of severe swelling, pain and inflammation. It was reported that the patient had recovered. The causality between injection site reaction, injection site swelling, injection site pain and injection site inflammation was not reported. This one of two reports from the same reporter. Sender's Comments: US-009507513-11710USA013810.
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 54-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetes" (unspecified if ongoing). No known allergies. There were no concomitant medications received in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment start date: 23May2022 and stop date- 28May2022. The patient was joyous, happy mood, energetic, lack of fever, euphoria, friendliness and talkative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse concerning a 22 year old female with a history of sulfonamide allergy with no pertinent medical history, who on 02-MAR-2009 was vaccinated IM with 0.5 ml first dose of GARDASIL (lot number: 0981Y). There was no concomitant medication. The nurse stated that the patient received the first dose of GARDASIL and immediately stated she was dizzy. The patient called to the physician's office and she stated that she was nauseated, light headed, shaky and had a dry mouth and she did not experienced fever on 03-MAR-2010. No laboratory test was performed. At the time of the report the outcome of the patient was not recovered. The patient sought unspecified medical attention. Follow up information has been received from the nurse concerning the 22 year old female patient who on 02-MAR-2009, at 13:00, was vaccinated IM with 0.5ml first dose of GARDASIL (lot number: 0981Y). On 03-MAR-2010 the patient developed nausea, shaky and light-headed. The patient had no fever. At the time of this report, the patient had recovered. Additional information is not expected.
I received the Shingles shot at 3:00 Pm at the doctor's office went home, in about 2 hours after receiving it my upper arm was feeling sore, as the night progressed on my upper right arm felt like someone punched me in the arm. Went to bed at 10:30Pm  woke up at 3:00 Am  Shivering,some muscle ache, upper right arm still sore. I took a tylenol when the tylenol kicked in it helped a bit with the soreness in my upper right arm fell back asleep 40 mins after woke up at 10:30 am No shivering but, feel tired arm still sore to the touch