chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe heart palpitations and diarrhea for about 2 weeks back in January, then recovered. I felt severe heart pain, now I just feel heart palpitations come at random and hard. I got an EKG. The doctor said it was fine but I still haven't shaken the heart palpitations.
Vaccine expired on 23FEB2023,  it was initially 13MAR2023 and administered on same date.; No adverse event; Pharmacist is calling to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Vaccine expired on 23FEB2023, it was initially 13MAR2023 and administered on same date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 052B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 23FEB2023,  it was initially 13MAR2023 and administered on same date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Vaccine expired on 23FEB2023,  it was initially 13MAR2023 and administered on same date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 23FEB2023,  it was initially 13MAR2023 and administered on same date.).    No concomitant medications were reported. Pharmacist was called to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine from 2 different vials on 2 different dates Individual vials Vial size was reported as 5.5 ml. On 13MAR2023, the vial was initially stored in the refrigerator  The vial did not undergo any temperature excursions. No treatment medications were reported. This case contains information for the 2nd patient out of 2 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717201 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717201:Patient No 01 (Master case)
Limited range of motion of left arm.  Unable to sleep on left side.  Red welt - 6" x 2" about 2" below injection site for 3 days.  Moderate joint pain, even in toes and fingers. Took Aleve to relieve pain and iced red area.  10/14/2015 redness was gone and pain in arm and joints finally subsided.
muscle cramping legs; sore arm; vomiting; diarrhea; weakness; headache; Profusely sweating; Other vaccine same date vaccine date 24Nov2021; Other vaccine same date vaccine date 24Nov2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Nov2021 12:30 (Lot number: FF2587) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 24Nov2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; DULOXETINE HCL. Past drug history included: Liquid codeine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (dose number=2, lot number=EN6202, lot unknown=False,, administrator route=Intramuscular, vaccine location=Left arm, administration time=14:00), administration date: 11Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (dose number=1, lot number= EN6201, lot unknown=False,, administrator route=Intramuscular, vaccine location=Left arm, administration time=14:00), administration date: 12Feb2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 24Nov2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 24Nov2021"; MUSCLE SPASMS (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "muscle cramping legs"; PAIN IN EXTREMITY (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "sore arm"; VOMITING (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "vomiting"; DIARRHOEA (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "diarrhea"; ASTHENIA (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "weakness"; HEADACHE (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "headache"; HYPERHIDROSIS (non-serious) with onset 25Nov2021, outcome "recovering", described as "Profusely sweating". Therapeutic measures were not taken as a result of muscle spasms, pain in extremity, vomiting, diarrhoea, asthenia, headache.  Follow-up attempts are completed. No further information is expected.
Could not lift her arm; Tiredness/ Staying in the bed; Arm hurting so badly; Nauseas; Chills; Head hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FATIGUE (Tiredness/ Staying in the bed), VACCINATION SITE PAIN (Arm hurting so badly), NAUSEA (Nauseas) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034f21a, 013m20a and 030a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (MONTELUKAST [MONTELUKAST SODIUM]), NIFEDIPINE (PROCARDIA [NIFEDIPINE]), COLECALCIFEROL (VITAMINS D3), ASPIRIN [ACETYLSALICYLIC ACID], FUROSEMIDE, IBUPROFEN (ADVIL [IBUPROFEN]) and PHENYTOIN (DILANTIN [PHENYTOIN]) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FATIGUE (Tiredness/ Staying in the bed), VACCINATION SITE PAIN (Arm hurting so badly), NAUSEA (Nauseas), CHILLS (Chills) and HEADACHE (Head hurting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain in arm, at a dose of 325 milligram. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FATIGUE (Tiredness/ Staying in the bed), VACCINATION SITE PAIN (Arm hurting so badly), NAUSEA (Nauseas), CHILLS (Chills) and HEADACHE (Head hurting) outcome was unknown.            Concomitant medication includes pulmonary hypertension medication  Following vaccination with the booster patient experienced the following: tiredness, could not lift her arm, arm hurting so badly, nauseas, chills, head hurting and staying in the bed.
Sore arms for two days after. Days 2-4 extreme fatigue. Day 5 started a rash and troubles breathing. Rash is on face and neck/chest area.
Information has been received from a physician concerning a 41 year old female with hypertension, gastroesophageal reflux disease and a penicillin allergy and a history of hepatitis B, who on 08-DEC-2005 had a varicella titer done it showed no immunity, therefore, on 26-JAN-2006 was vaccinated in the arm with a dose of varicella virus vaccine live. Concomitant therapy included omeprazole. On 08-FEB-2006 the patient developed a rash, first on her vaccinated arm (unspecified), then on her back and chest. She called he physician on 11-FEB-2006 and was seen. The patient was unable to work from the onset of the rash on 08-FEB-2006 until 14-FEB-2006. At the time of this report the patient was recovering. It was also noted that on 14-FEB-2006 she was started on acyclovir (ZOVIRAX) 500 mg, PO for 5 days. Additional information has been requested.
Patient received vaccine in right deltoid. Approximately 90 seconds later he lost consciousness. Had seizure like activity for approximately 30 seconds, then regained consciousness. BP checked and 130/90. HR initially irregular to auscultation then became steady. Strong pulse to palpation. EMS was called. Patient was given juice and crackers.  Patient denies pruritis, difficulty swallowing, difficulty breathing, or facial swelling. Hx vasovagal response to vaccines in the past. No hx seizures.   EMS arrived within 5 minutes and evaluated patient. Patient declined transportation to ER. He and partner waited in observation area for 30 minutes with no additional adverse effects.
About 3 days after the vaccination, 02/19/2021, a red sunburn like rash on my neck, all down my torso, on my back.  I did not notice it so much on my legs. It was not itchy. I took Benadryl and Allegra around the clock. The rash lasted for about 4 or 5 days. On 02/20/2021 I spoke to a tele-doc, and showed him pictures of the rash.  I was concerned because it was not getting better and I didn't know how long it was going to last. He prescribed Prednisone, but I did not take it because I had read it could lessen the efficacy of the vaccine. In case it did get worse I would have taken it. I took Benadryl the whole time until it subsided within 4 or 5 days.
About 2 weeks after vaccines given developed fever and rash (which resolved in short period of time), but rash faded and actually persisted until seen on 9/3/08 for sick visit -> Diagnosed with croup & new BSOM -> AMUXIL + ALBUTEROL treatment. PRELONE never given by parents , rash was a faint scattered tiny macules, blanching in diaper area and arms, very faint on trunk.  Respiratory symptoms improved but rash continued and got worse, so reevaluated on 9/9/08, no fevers, no pruritis, rash this time was papular in nature, and on arms, legs, face and with various degrees of clustering and erythema, some? petechial appearance to rash, no pustules, no vessicles, no burrows, no rash on wrists, trunk, palm or soles or diaper area (parent said child was exposed to someone with scabies also) Child referred to dermatology, rash felt to be viral, and scabies testing negative.  9/16/08 well checkup, rash markedly improved, actually drying up, with some mild erythema, development at this visit age appropriate, and also age appropriate prior to this visit.  Patient was babbling, and saying MA MA, DA DA, saying upto a maximum of 5 words as per parenets history.  Vaccines given were DTAP, HIB, PNC 11/3/08 sick visit bom/sinusitis, treated with AMOXIL 11/10/08 sick visit/recheck, OM improved, finish AMOXIL, no rash today 12/15/08 18 month checkup and sick visit, BOM and sinusitis, AMOXIL restarted, failed mchat, loss of speech milestones, failure to interact with new sibling ENT evaluation 1/09 no middle ear fluid, ABR to be done neurology evaluation 1/09 speech delay expressive greater than receptive, PDD/autism evaluation in progress CBC/PB normal Patient also being evaluated by early intervention services.
Shortly after the shot I experienced extreme cold from the inside out. I was shaking, it was kind of a hyper feeling inside my body. Then I got body aches and joint aches. The entire night I wasn't able to sleep. The pain in the joints increased and I still couldn't get warm. The next day the symptoms persisted throughout the day. I developed Diarrhea. The body aches started to move into various parts of my body (knee, right hip, hands). On Sunday I started with a fever and chills and also extreme sweating, finally day the fever broke. I should have gone to the hospital then because at that point I couldn't close my hands or touch my thumb to my finger. My left ankle and hand started swelling on the left side, I couldn't bend my foot. It dragged as I tried to walk. The knuckles on the back of my hand started swelling as well. Both hands wrist, right elbow, right knee, left ankle, right hip. That is where the pain seemed to be located the most. When I went to the hospital, they gave me opioids even though I am very sensitive to it. They gave me a small dose of Morphine that I severely reacted to and ended up with esophageal reflex and they had to treat that. At that point they called the rheumatologist, without seeing me and he had a suspicion that I developed RMS. He suggested they try prednisone, and they gave me extra strength Tylenol. At that time, they made the decision to keep me in the hospital. They gave me more prednisone, but it didn't take effect. I wasn't able to sleep more than 5 hours over the course of the days from vaccination. Next day they wanted to give me more opioids, which I denied. They increased my 100 mg of gabapentin dosage to a 900 mg dosage of gabapentin. They prescribed me prednisone and melatonin to help me sleep and that worked. I was discharged that night. The pain isn't totally gone, and I am very aware that too much activity make cause more pain.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 20-JUN-2017, an adult patient was given pediatric dose of RECOMBIVAX HB lot # M010671, expiry date: 02-JUN-2018 (dosing details unknown) intramuscularly for prophylaxis. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
This case was reported a physician, via sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine, (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B vaccine, the subject experienced not responding to therapy. The physician reported that the subject received an unknown hepatitis B vaccine series and did not seroconvert. The subject still did not seroconvert after receiving a total of four or five dosed (one or two doses after the initial three dose series (vaccination error)). The series was administered years ago. At the time of reporting the outcome of the event was unspecified.
Patient was given Pfizer bivalent vaccine which had been expired/exceeded beyond use date/time since first puncture to vial on 5.2.2023. Vaccine was delivered to patient on 5.3.2023.
Erythema, inflammation, hard to touch, itching initially then began to look like a rash at area of injection at left deltoid area.
Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 24 year old female patient who on 13-MAR-2009 was vaccinated with the first dose of GARDASIL vaccine (Lot # 661846/1312X) with no incident. On 01-MAY-2009 the patient received the second dose of GARDASIL vaccine (Lot # 658271/0558X). There was no concomitant medication reported. It was reported that "26 days after receiving vaccine", on  27-MAY-2009, the patient developed a red bump at the injection site after receiving GARDASIL vaccine. On 27-MAY-2009 the patient called to the office to report that she has developed a "bump" under the skin at the injection site was painful to the touch. There were no laboratory diagnostic tests performed. The patient has not been seen by the physician for evaluation but was offered a physician's appointment and the patient stated that "she would call back to schedule and appointment to see the physician if the bump under skin at the injection site and the pain to touch persisted". It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Vaccine rxn x2d. Warm to touch swollen (R) leg  Dx: (R) thigh cellulitis give Benadryl & Motrin in 8 hrs. keep leg up,  Apply ice pack.
This spontaneous report was received from a registered nurse regarding a 16-months old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N013868, expiration date 04-MAY-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccine experienced a temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This was one of several reports received from the same reporter.
Tinnitus worsened considerably about a day after getting the the Covid-19 shot.
Presents for education of what vaccines he can/cannot take with thimerasol and neomycin allergies.  Has taken FluMist, IM Influenza w/o adverse events since allergies identified.  Received allergy testing 4/2002 following a one year history (onset Feb 2001) of chronic left TM rupture/OM partially responsive to treatment (neomycint gtt, po Augmentin, Sudafed, then cortisporin otic gtts, acetic acid gtts, cipro HC gtts and po).  ENT referrals began in July 2001. He later developed bilateral eczema dermatitis to external ear canals tx w/Valisone/Diprolene.  On December 7, 2001 he presented to ER w/bilat eye swelling, painful itching face with papules and scales c/w eczema.  He stated onset began w/Cipro use last October w/wo med use but s/s worse.  Used Hydrocortisone cream w/relief. Dx Eczematous blepharitis w/periorbital edema in "raccoon eye" distribution. F/u exams dx eczematous papular rash (ear) left neck and shoulder ?to debonide? Resolution of symptoms was documented 12/20/01 with dx hypertension and EKG changes after prednisone use.  Eczematous Plaque to lt jaw and pinpoint periorbital papules upper lids returned @ 2/11/02. By 4/2002 his dx centered towards airborne allergic contact vs adult eczema. Patch testing ordered - positive for thimerasol (3-4+), neomycin sulfate (0-1) and epoxy resin (0-1). Referral to allergy and immunology was conducted 12 Jan 06 following use of desomide about eyes in 2001-2.  Can he received flu shot and tetanus shot as no problems w/previous vaccines?  Has seafood allergy to lobster (tightness of throat/swallowing prob).
Patient experienced shortness of breath, sensation of throat swelling, fatigue, body aches, and sore throat about 1 hour after vaccine was administered at a hospital setting and was seen about 6 hours later a different medical office. These symptoms gradually became worse throughout the day. Patient was given Benadryl 25 mg oral syrup one time and emergency medical services were called to the clinic. Patient was transported to the emergency room by paramedics. Patient was called today by provider for a wellness check and notes shortness of breath and sensation of throat swelling resolved after being treated by paramedics and emergency room providers. Patient states she is overall feeling much better.
Fever 102.8, chills, fatigue, bone pain, groin pain, injection tenderness and develop covid arm
Heart palpitation; Flu like symptoms; She started having her period, which includes excessive bleeding and clotting; Severe abdominal pain; Muscle pain; Joint pain; Headache; Fever; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (Heart palpitation), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Severe abdominal pain) and MYALGIA (Muscle pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced ARRHYTHMIA (Heart palpitation), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Severe abdominal pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, ARRHYTHMIA (Heart palpitation), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Severe abdominal pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            No treatment information was reported.   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.   This case was linked to MOD-2021-187152 (Patient Link).   Reporter did not allow further contact; 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.
Within 5 min pain at inj. site radiating down (L) arm to fingers & overall feeling of warmth, progress to HA, dizziness, nausea, vomiting, chills, 100.4 temp, fasciculations, malaise, myalgias, photosensitivity, pressure (L) temporal area & behind (L) eye & jaw claudication over 3 days cont. with interm. fasciculations, nausea with occas. emesis, arm soreness & weakness, fatigue, HA & now increase eye pressures, night diaphoresis, nausea & tachycardia with occas. abd pain (gastric). Dx'd with cervical nerve root irritation from vaccine by neuro. F/U with neuro 2/21/13.