chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing; Tired; massive swelling of mouth/side of mouth looks like swollen  lips were like big and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 05Jun2023, outcome "unknown", described as "Coughing"; FATIGUE (non-serious) with onset 05Jun2023, outcome "unknown", described as "Tired"; LIP SWELLING (non-serious) with onset 05Jun2023, outcome "not recovered", described as "lips were like big and swollen"; MOUTH SWELLING (non-serious) with onset 05Jun2023, outcome "not recovered", described as "massive swelling of mouth/side of mouth looks like swollen . Additional information: Patient stated she had possible side effect. She called health care professional and was informed to call to see if any data on side effect she was experiencing. Friday afternoon (unspecified date), she had the shot; she had standard reaction and outcome. She was feeling like she was finally over it "last night". This morning (05Jun2023), she woke up to take blood pressure medication. She was coughing a little. She went back to bed because she was tired. She later got up and had massive swelling of mouth. Her lips were like big and swollen. The side of mouth looks like swollen . There was no pain or dental issues that she was aware. Has not reduced. Patient asked how long this would take as she was waiting for call from her doctor as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient states that post immunization, he experienced flu like symptoms, but no fever. Then two days later he said his right arm became sore from the shoulder blade down to his tricep. He said by the third day, it felt like his whole arm was paralyzed and he could not move it up and down. There is swelling at the tricep and a red rash. Patient went to an urgent care where they prescribed Prednisone 20mg 5 days of therapy and Clindamycin 300mg  with 10 days of therapy.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included open heart surgery. Concurrent medical conditions included angina pectoris and post-traumatic stress disorder (PTSD). Concomitant products included amlodipine, Aspirin, Atorvastatin, Bupropion, Buspirone Hcl, fenofibrate, Losartan, Magnesium, Meclizine, Montelukast, omeprazole, ranitidine hydrochloride, ZYRTEC, Calcium+D3, clonidine, Fluticasone Nasal Spray, hydrochlorothiazide, Insulin, KLOR CON, melatonin, metoprolol, NITRO-PATCH, primidone, TRESIBA and TYLENOL. On 19th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 19th July 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, memory loss, skin discoloration, chest discomfort, anxiety and pain in arm. On an unknown date, the outcome of the fatigue, memory loss, skin discoloration, chest discomfort, anxiety and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the fatigue, memory loss, skin discoloration, chest discomfort, anxiety and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient planned to follow-up with her physician on an unknown date. The patient has given consent to contact their physician.
At 9 pm the day that the vaccine was given(8/27/2020), patient had an episode of abnormal movements of extremities followed by stiffening of the extremities, not responsive and spacing out. lasted about 1-2 minutes. 911 was called and patient was examined by paramedics. Had returned to baseline soon after incident. Seen in the office 9/1/2020, normal exam.
0.5ml H1N1 administered to child less than 36 mos instead of 0.25ml
Moderna COVID-19 Vaccine EUA Bursitis type feeling in shoulder of arm where vaccine was received.  Came on about 2 days after injection and lasted 3 more days.  Took Ibuprofen to alleviate pain.
Information has been received from a consumer concerning a 12 year old male with penicillin allergy and a history of chickenpox who on 11-MAR-2008 was vaccinated with VARIVAX. Concomitant therapy included MENACTRA and DTAP (+) Tetanus toxiod. The patient was previously vaccinated on 06-Mar-1997 with VARIVAX. On 24-MAR-2008, the patient did "not feel well", and on 26-MAR-2008, the patient developed white oblong shape very itchy hives that went away with Benadryl. At the time of this report, the patient was recovering from hives. The consumer talked with the physician. Additional information has been requested.
10 inches x 6 inches area of erythema. Hot, tender and raised 2 inches. Began 3 hr after injection
This spontaneous report as received from a nurse refers to an 8 months 4 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
At about 1800 had sudden onset of coughing felt scratchy throat and itchy chest. Proceed to go to get a drink of water and saw hives on my lips. Notified my charge nurse and doctor then started feeling lightheaded, dizziness, palpitations, itchy and had nausea with one bout of emesis.  They started IV, was on cardiac monitor, was tachycardic prior to meds and received epi, Benadryl, Solumedrol, and lorazepam IV.
Sore and swelling at injection site started on the second day. The sore and swelling became more sever on the third day, the effected arm became heavy to pick up, swelling down to elbow, and red blotch on the skin. Family doctor prescribed oral BENADRYL and Ice pack to the site. The symptoms improved in a day after the treatment.
Within 7 days started with generally feeling unwell, swollen gland, escalated blood pressure, and joint pain.  By day 12, I started have "flutters" of my heart and feeling like my heart was jumping in my chest several times a day.  This made me highly anxious and feeling even more unwell.  I noticed shortness of breath and weakness.  I normally walk 2 miles each morning and was unable to walk without feeling dizzy.  On May 31st was a work and pressure in chest, dizziness, chest pain escalated and I was having difficulty thinking straight, and slurring my speech talking to my husband, so I went to the emergency room.  Diagnosed with TIA in ER.
Bad headache, low fever, chills, body aches, nausea, diarrhea, progressing from onset then improving just shy of 2 days. Redness 12 cm x 6cm (L) arm. 2 days of symptoms.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 or 01-MAY-2015, the patient was vaccinated with either improperly stored (Merck) VARIVAX (strength, dosage, frequency and route unspecified) (Lot: reported as K015375 expiration date: 18-SEP02016, Lot: reported as K018990 expiration date: 15-OCT-2016, Lot: reported as K011317 expiration date: 13-AUG-2016, Lot: reported as K016153 expiration date: 24-SEP-2016)or improperly stored MMR II (strength, dosage, frequency and route unspecified) (Lot: reported as K021930 expiration date: 10-NOV-2016, Lot: reported as K021487 expiration date: 03-NOV-2016, Lot: reported as L001329 expiration date: 13-JAN-2017) incorrect product storage). It was unspecified exactly which lot # of the vaccine the patient was given. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I woke in the night with the urge to evacuate my bowels. It was diarreha (twice during the night; I also vomited once during the night.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: ER8732) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FENOFIBRATE. Vaccination history included: Bnt162b2 (Batch/lot number: ER8732, Date of start of drug  31Mar2021, Anatomical Location :Arm Right), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "recovered", described as "I woke in the night with the urge to evacuate my bowels. It was diarreha (twice during the night"; VOMITING (non-serious), outcome "recovered", described as "I also vomited once during the night.".  Additional information: Within 16 hours of receiving second dose, i woke in the night with the urge to evacuate my bowels. It was diarreha (twice during night, once early morning). I also vomited once during the night. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Pneumonia vaccine (Both varieties)/ Neither vaccine prevented my contracting the disease; Pneumonia vaccine (Both varieties)/ Neither vaccine prevented my contracting the disease; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received pneumonia vaccines (both varieties) and neither vaccine prevented her from contracting the disease on an unspecified date. The outcome of the event was unknown. The reporter stated that the event might have been related to the drug.  Information on the batch number has been requested.
Patient received dose 1 of Moderna Vaccine on 1/14/21 administered by pharmacy. Patient was hospitalized on 1/31/21 due to shortness of breath and diminished O2 sats down to 88%. Patient was in atrial fibrillation. Patient discharged from hospital on 2/25/21 to home. Patient received dose 2 of Moderna Vaccine on 2/25/21 prior to discharge from hospital. Last hospital note stated that patient was pleasant and cooperative with good motivation. Patient passed away after discharge from the hospital on 2/26/21. Patient's son called the hospital to report his passing.
Redness swelling and induration anterior Right thigh at typical location of immunization -- MMR and DTaP adm on right side x 2-3 days. Afebrile. Treated with warm compress and rx'd Children's Motrin.
Numbness and tong lines in right hand. Pain at site of injection. Muscle aches, migraine, 101 fever. Swollen lymph node in armpit closest to  injection site.
This spontaneous report as received from a licensed practical nurse refers to an elderly female patient of unknown age. There was no information about the patient's concurrent conditions, medical history, concomitant medications or any known allergies or reactions. On 30-MAR-2017, the patient was vaccinated inadvertently with a dose of VARIVAX (lot # M023380, expiration date: 11-MAY-2018), for prophylaxis (dose and route of administration were not reported), reconstituted with sterile diluent (lot # M042852, expiration date: 30-MAY-2019; dose not provided), instead of a dose of ZOSTAVAX. No symptoms reported. The reporter did not provide additional details. No further information provided. No product quality complaint was involved. Additional information has been requested.
Patient had pain immediately upon injection (however, did not report right away.) After the pain in her shoulder did not subside after several days, she sought treatment from an orthopedist. They said she had a vaccine injury from shot placement being too high on the shoulder. (She called in "frozen shoulder.") She is in ongoing treatment.
the patient started to experience weakness in her arm; severe shoulder pain; muscle pain in the arm and it is difficult to move; muscle pain in the arm; patient began to have difficulty breathing; This spontaneous report was received from a physician assistant referring to a 66-year-old female patient. The patient was allergic to some unspecified medications. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 04-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscular, in an unspecified arm (dosage schedule, lot number and expiration date were not reported), for prophylaxis.   On the same day 3 hours after the vaccination, the patient experienced weakness in her arm (muscular weakness), severe shoulder pain (musculoskeletal pain), muscle pain in the arm (myalgia) and difficulty to move the arm (injected limb mobility decreased). The patient sought medical attention by calling her physician assistant and she went to an unspecified emergency room. After calling the office, the patient began to have difficulty breathing (dyspnoea), which was handled with unspecified treatments and then she was discharged on the same day. While in the emergency room, comprehensive metabolic panel (CMP) and complete blood count (CBC) showed normal results. Additionally on 09-NOV-2019, the patient was given prednisone and referred to physical therapy. The outcome of muscular weakness, myalgia, injected limb mobility decreased, dyspnoea and musculoskeletal pain was reported as not recovered.  The causality assessment between the adverse event and the suspect therapy was not provided.
Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates, the patients were administered with improperly stored ROTATEQ (lot # L013206 with expiration date of 29-JAN-2017, lot # L035510 with expiration date of 13-MAY-2017, dose unknown, oral). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Presents due to swelling of his legs bilateral and erythema and found to be covid positive and placed on 5L oxygen NC .TX Steroids, lovenox, oxygen, inflammatory markers. Disposition: home.
It was reported that a 56 year old female pt received a dose of Fluzone SV '2003-'2004, lot #U1135EA, administered IM in the left deltoid on 10/15/03. Two days later, the pt developed rash on her back, arms and torso for which she took Benadryl and steroids. On 10/19/03, the pt was admitted to the ER due to generalized rash, for which she was given Zyrtec, Prednisone, and Rantidine and then discharged. The following day, the pt reported bilateral leg swelling and was hospitalized the next day due to persistent symptoms and remains hospitalized. Reportedly, the pt is vaccinated with the flu shot every year. Due to previous cellulitis of the legs 10/2/03, cause dby insect bites, the pt was recently treated with 500mg of Duricef.  Follow up on 11/17/2003: "From additional information received through a telephone call on 11/10/2003 from the primary reporter, the patient's primary physician's information was reported.  The reporter indicated that all the information available has been provided.  A call was made to patient's primary physician, who was out of the office that day.  The secretary provided the patient's full name and correct physician information, as well as the fax number for the office.  No additional information was given at this time." From additional information received on 17/Jan/2004 from a physician, it was reported that the case was reviewed and there is no additional information at this time. Further information is not anticipated, this case is considered closed. Follow up 01/06/05: Medical assessment: There were no investigations reported. The amount of availabe data is not sufficient to readly assess the case. In the absence of another etiology, the hypothesis that skin eruption and leg swelling correspond to clinical manifestations of a serum sickness like reaction after administration of cefadroxil or due to insect venom could be evoked.
Patient received incorrect vaccine on 10/7/22. They were scheduled to receive the COVID-19 bivalent dose and instead received the Pfizer vaccine without Omicron coverage. No ADRs have occurred.
Tooth infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Rheumatoid arthritis.    No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2022, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TOOTH INFECTION (Tooth infection). In 2022, TOOTH INFECTION (Tooth infection) had resolved.            The concomitant medication was not reported by reporter. In Feb 2022, the patient was off of Skyrizi for a little while because she had an infected tooth and was on antibiotic. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623737 (Patient Link).
pt recv vax 1MAY97 & on approx 8NOV97 pt devel shingles;
Erythema, warmth and induration of left thigh starting 1 day after vaccines. < 1 cm blister on left posterior thigh. Low grade fever.
11 days after 3rd Moderna shot I broke out in hives, that are ongoing despite famotidine and montelukast. Was supposed to take Allegra also, but has not picked it up.
pt devel fever to 104.4, irritability, high pitched screaming & rapid HR/RR-HR 218, RR 68; no other sign of infection; pts fever reduced, HR/RR improved, irritability cont but less so; lethargic;
Expiration Vaccine was administered Exp: 07-Jul-2023; Adult patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5 as first dose.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expiration Vaccine was administered Exp: 07-Jul-2023), WRONG PRODUCT ADMINISTERED (Adult patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5 as first dose.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: IMVANEX. Past adverse reactions to the above products included No adverse event with IMVANEX.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expiration Vaccine was administered Exp: 07-Jul-2023), WRONG PRODUCT ADMINISTERED (Adult patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5 as first dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expiration Vaccine was administered Exp: 07-Jul-2023), WRONG PRODUCT ADMINISTERED (Adult patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5 as first dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2023, Mycobacterium tuberculosis complex test: Inconclusive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expiration Vaccine was administered Exp: 07-Jul-2023) and WRONG PRODUCT ADMINISTERED (Adult patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5 as first dose.).    Concomitant product use was not provided by the reporter.  Expiry date of suspect vaccine was reported as 07-Jul-2023.  Treatment information was not provided.
Red rash on shoulder/arm/chest/back about 20 x 30cm, starting from injection site (TD).  None stated.
Started feeling a reaction immediately after the vaccine, felt blurred vision, dizziness, racing heartbeat, chest rash and face, itching all over, difficulty swallowing, tongue tingling and wheezing. Sent to ED. EPI and Benadryl.  1800 Went to see her in the ED, room 33. She has red rash to neck, shaky hands itching to neck and chest.  ED Dr to discharge, she stated husband to pick her up and she will follow up with OH tomorrow. --------------------------------------------------------------------------------------------------------------------RN   ED gave her Epinephrine 0.3 mg, Methylprednisolone 125mg, Diphenhydramine HCL 50 mg, Zofran 4mg, Lorazepam 1 mg, Hydroxyzine HCL 50 mg Sumatriptan 6mg ,  Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------------------- RN 12/29/2020 1715 called to check on patient. left voicemail for her to call OH. ???????..?  12/29/2020 1838 left voicemail for patient to call OH. ??????????????????????. 12/30/20 2030 spoke with her. Tuesday 12/29 3pm-4pm dizziness, confusion, sob. Wheezing. Ambulance called. Hospital   admitted. Intubated for less than 24 hours. Breathing treatments, epi drip. Now just on steroids and walking around and feeling better. Still admitted at hospital. Hoping discharged tomorrow. --------------------------------------------------------------------------RN
This case was reported by a healthcare professional and described the occurrence of hepatitis b antibody negative in a 39-year-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject completed the hepatitis B vaccine series.  When tested in 2007, the subject's titers came back showing non-protective levels for hepatitis B.  No additional details were provided.