chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like the flu; Achy; Persistent low grade fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN (Achy) and PYREXIA (Persistent low grade fever after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain. Concomitant products included FENTANYL CITRATE (NARCO) for Back pain.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN (Achy) and PYREXIA (Persistent low grade fever after second dose). On 30-Apr-2021, INFLUENZA LIKE ILLNESS (Felt like the flu) and PAIN (Achy) had resolved. At the time of the report, PYREXIA (Persistent low grade fever after second dose) had not resolved.            No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-117924 (Patient Link).
muscle fatigue; arms began hurting; arm getting to the point they don't want to work and at this point he can't even drive; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MUSCLE FATIGUE (muscle fatigue), PAIN IN EXTREMITY (arms began hurting) and MUSCULAR WEAKNESS (arm getting to the point they don't want to work and at this point he can't even drive) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Myasthenia gravis since an unknown date, Diabetes since an unknown date and Arthritis since an unknown date. Concomitant products included AZATHIOPRINE and WARFARIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced CHILLS (chills). On 29-Mar-2021, the patient experienced MUSCLE FATIGUE (muscle fatigue), PAIN IN EXTREMITY (arms began hurting) and MUSCULAR WEAKNESS (arm getting to the point they don't want to work and at this point he can't even drive). On 12-Mar-2021, CHILLS (chills) outcome was unknown. At the time of the report, MUSCLE FATIGUE (muscle fatigue), PAIN IN EXTREMITY (arms began hurting) and MUSCULAR WEAKNESS (arm getting to the point they don't want to work and at this point he can't even drive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effect noted;
Pain, Numbness and heaviness running down Right arm.  Next morning patient reports, right hand swollen, unable to remove ring and unable to make a fist.  Symptoms completely resolved 72 hours post injection with no treatment and no MD visit and no ER visit.
This case was reported by a consumer via other manufacturer and described the occurrence of enlargement of lymph nodes in a female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown. It was unknown if the reporter considered the enlargement of lymph nodes to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that last year she was vaccinated with flu vaccine (manufacturer unspecified) and her lymph nodes swelled up like a golf ball. No other adverse event information was reported. Most information fields were marked as refused to answer as the caller declined to provide any additional information.
Breakthrough case. On 7/30/2022 I started coughing and sneezing and having post nasal drip. On the 7/31/2022 my symptoms became much worse, my cough was so intense that it felt like I was breaking my ribs with each cough, then I started vomiting. I took a rapid home test and it was negative. I was feeling so bad that I went to urgent care. They gave me guaifenesin codeine cough syrup and told me to test again the next day. I went home and tried to sleep. The symptoms kept getting worse though. I had a really bad headache with extreme body aches and was really fatigued. I took another rapid home test and it was positive. I called the PA at the local urgent care clinic and asked for PAXLOVID. They were hesitant to prescribe it, but I pressed and they finally game me the prescription. I started taking it that night. To try and get a good nights rest, with it I also took the guaifenesin codeine cough syrup along with NYQUIL so I could finally sleep. The next morning I was in so much pain I could barely get out of bed, I felt like I was run over by a train. I used a Pulse Oximeter to monitor the oxygen in my blood and it was averaging 88-89. As I took PAXLOVID I started to slowly get better. I took another rapid home test on 7/7/2022 and I tested negative. I took another home test on 7/8/2022 and it was negative as well. Then on 7/10/2022 I started to feel bad again. I tested again with the rapid home test and I tested positive again, but felt worse than before. Along with the other symptoms, my brain fog was so severe that I could barely focus enough to watch TV. I went back to urgent care and they gave me a chest x-ray and tested my blood and everything came.
Pt complain of pain at site of injection.  RN noted posterior deltoid reddened, swollen and warm to touch.
Anaphylactic shock; sick; This case was reported by a consumer via interactive digital media and described the occurrence of anaphylactic shock in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's 2 older sisters had shingles and were in pain and discomfort for weeks).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anaphylactic shock (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the anaphylactic shock and sickness were unknown.   The reporter considered the anaphylactic shock to be possibly related to Shingrix. It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient reported that he/she had anaphylactic shock from the Shingrix vaccine and recommend people to get a blood test first to see what their immunity levels were. The patient reported that he/she had natural immunity and by getting the shot made sick. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Soreness at injection site 2 area's of induration one 2cm by 2cm one 4cm by 4cm, pain with pressure, 2-3/10. Pain with arm use overhead. No warmth,no lymphadenopathy, no drainage.
This case was reported by a healthcare professional via a sales representative and described the occurrence of inconsolable crying in a subject aged between two months and  fifteen months of age unspecified gender who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On unspecified dates, at two months of age, four months  of age, six months of age and 15 months of age, the subject received the first, second, third and fourth doses of Infanrix (.5 mL, unknown). At an unspecified time after vaccination with Infanrix, the subject experienced inconsolable crying lasting four to five hours, and a fever of 104 degrees Fahrenheit. It was not reported whether the events occurred following each Infanrix vaccination, or if the events occurred following only one Infanrix vaccination. At the time of reporting the events were resolved.
Itching, hives on arms, neck, torso. Facial flushing, white of eyes red, throat clearing, coughing. Red, puffy face. Wheezing.
Date and time adverse event started: right after vaccine started she napped now can not feel fingers   Did the adverse event start after the first or second vaccination?  second pins and needles in fingers, pale and cold fingers advised to go to an ED , She will go to hospital 3/30-Return call received from patient, no improvement in symptoms, still has numbness/tingling in left arm and no feeling in fingertips. Seen at ER yesterday, advised by staff to take ibuprofen and follow up in one week. No radiology exams done. No other complaints. Does not have PCP, advised to f/u as directed and/or return to ER if symptoms get worse.
3 pm 10/30/08 Sister phoned stating Pt does not feel good at all. States pt's face is very flushed, P-100, R-44 and feeling very anxious. Pt vomited. Denied SOB, wheezing, hives, paleness or dizziness. Pt advised per Dr to use TYLENOL and rest. May also take BENADRYL.
Breakthrough COVID-19 case with symptom onset 8/23/2021: Runny Nose/Congestion, Shortness of breath/difficulty breathing, Loss of smell or taste, Fatigue or tiredness, Chills, Cough. UI believes they were exposed during their trip from 8/19-8/23. Patient started to experience symptoms the night they returned from their trip. Patient reported symptom onset began with coughing spasms, congestion, fatigue and shortness of breath. Patient then developed severe diarrhea which led them to the ER. Patient was admitted to the hospital for dehydration, pneumonia and renal function observation. Patient was discharged after one week and reported symptoms have completely resolved. Hospitalized 8/29/2021-9/5/2021
Pain and numbness radiating down the left are and a knot at the injection site - reported it to doctor on 12/24/2013, in March 2014, July 2014 and September 2014. Was referred to a neurologist and am no receiving physical therapy.
Pt. seen 3/11/14 for 5 yr WCE. Per mom's request, both required imm. were given in (Rt) arm (pt. is lt-handed). Developed s/s: (Rt) arm with erythema 3 x 5.5 cm to upper arm with mild warmth; non-tender. TX with ibuprofen and ice packs PRN.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 07-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On unspecified dates, the vaccine had two temperature excursions; one for 168 hours in which the lowest recorded temperature was 33 degrees Fahrenheit (0.555555556 degrees Celsius) and another one for 192 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
R ear hurt,is not listening, it is as if covered; L ear plugged; cough/ alot of phlegm; nose is stuffed with mucus; L ear hurt for 2 days, then right ear hurt, today left ear plugged and it hurts; arm pain for 3 days; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (R ear hurt,is not listening, it is as if covered) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain for 3 days) and PYREXIA (fever). On 15-May-2021, the patient experienced PRODUCTIVE COUGH (cough/ alot of phlegm), RHINORRHOEA (nose is stuffed with mucus) and EAR PAIN (L ear hurt for 2 days, then right ear hurt, today left ear plugged and it hurts). On 17-May-2021, the patient experienced DEAFNESS UNILATERAL (R ear hurt,is not listening, it is as if covered) (seriousness criterion medically significant) and EAR CONGESTION (L ear plugged). The patient was treated with IBUPROFEN at an unspecified dose and frequency; BENZATHINE BENZYLPENICILLIN (MEGACILLIN [BENZATHINE BENZYLPENICILLIN]) 15-May-2021 at a dose of 1 UNK; BENZATHINE BENZYLPENICILLIN (MEGACILLIN [BENZATHINE BENZYLPENICILLIN]) 24-May-2021 at a dose of 1 dosage form; AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AUGMENTIN S) at a dose of 875 mg and FLUCONAZOLE at a dose of 1 dosage form. On 13-May-2021, PAIN IN EXTREMITY (arm pain for 3 days) and PYREXIA (fever) had resolved. At the time of the report, DEAFNESS UNILATERAL (R ear hurt,is not listening, it is as if covered), PRODUCTIVE COUGH (cough/ alot of phlegm), RHINORRHOEA (nose is stuffed with mucus), EAR PAIN (L ear hurt for 2 days, then right ear hurt, today left ear plugged and it hurts) and EAR CONGESTION (L ear plugged) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were 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.; 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.
Client received his first dose at County Public Health on 3/16/2021 (lot #046A21A). He used our link to schedule his second dose at  County Public Health on 3/25/2021. He stated, "I knew there was a 28 day interval between the two doses but thought the system wouldn't have allowed me to schedule any earlier but it did, so I continued with my scheduled appointment." The client completed the screening questionnaire the day of his appointment, and reported receiving his first dose less than 10 days apart. He was not questioned or stopped at any point during clinic. He received his second dose of Moderna at County Public Health on 3/25/2021 (lot # 016B21A), this is less than 10 days after receiving his first dose.
I experience sharp pain in my chest when trying to breathe. I then went to the ER. I was diagnosed with Pleurisy.
52-year-old with calcifications in left breast; core biopsy showed ductal carcinoma in situ (DCIS), intermediate to high nuclear grade
J96.00 ACUTE RESPIRATORY FAILURE 6/11/2021 CONFUSION J96.00 ACUTE RESPIRATORY FAILURE 6/11/2021 PALLIATIVE CARE
6 hours after adm mom noticed "twitching" and sl occ involuntary movement of extremities, fussiness. Admitted to Hosp. 4/1/14 for "convulsions" per mom.
Extremely red face and face broke out with several markers that resembled chicken pox.  The face was the only place this occurred.  25 minutes after vaccine.  Disappeared approximately 90 minutes after injection without treatment. Day 2 small rash on left chest near shoulder blade,  fading today.
Itchy rash on left lower leg, both forearms and back of neck.  Very small red raised area.  Pt didn't feel very uncomfortable except for itching in back of neck.
Woke up at 7 am on NOV 20 2013 w/ tingling, numbness in arms, legs, hands and feet. Also had a tightness around my midsection, as if a belt was being tightened. Numerous tests were given by doctors.
Body aches, soreness in the injection site, headache, elevated resting heart rate for 2 days, pins and needles in hands and legs for 4-5 days
Patient was given vaccine and less than 5 minutes later patient fell limp into chair, unconscious for less than 10 seconds with his eyes rolled back in his head. While attempting to lay patient on the floor he woke up extremely confused and tried to run away. When he came to, we sat him down and placed him into a seated position with his head down. Temperature was normal however patient appeared very pale and proceeded to vomit. Patient was able to answer his full name, age, and knew where he was. Patient asked us to call emergency services who came promptly. Patient did not leave with emergency services and proceeded to leave the pharmacy, stating that he felt better.
A few days after the first vaccination experienced painful and frequent urination; A few days after the first vaccination experienced painful and frequent urination; Vaginal itching; Abdominal pain; Feeling like bladder wass full but wasn't; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration on 19Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, few days after the first vaccination the patient experienced painful urination, frequent urination, vaginal itching, abdominal pain and "feeling like bladder was full but it wasn't". The patient had experienced the same events a few days after the second vaccination also. On an unknown date, the patient underwent lab test which included urine test for UTI and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful urination, frequent urination, vaginal itching, abdominal pain and " feeling like bladder was full but it wasn't" was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Right shoulder deltoid area became red and uncomfortable. Redness was 6" in greatest dimension.
Fever, body aches, hot/cold, headache, fatigue, redness/swelling/lump at site of injection.
An extreme migraine feels like my frontal lobe of my brain is on fire. Feeling extremely sore all over my body ears ringing
HIB, PCV-13 AND VARICELLA ADMINISTERED IN LEFT THIGH. CHILD HAS KNOT FOR 1 MONTH, MOTHER OF PATIENT IS UNSURE OF FEVERS DUE TO TEETHING. NO ERYTHMA NOTED. MILD BRUISING.
Guillian-Barre Syndrome with loss of sensation in hands/feet and proximal muscle weakness onset on 12/08/08. No improvement as of yet 4 days of IVIG beginning 1/15/09 (Hospitalized).  5/8/09 Received Neuro medical records of 1/12-4/20/2009 which included hospital d/c summary & H&P of 2/16-2/28/09 admit. FINAL DX: acute inflammatory demyelinating polyneuropathy Records reveal patient seen for eval on 1/12/09.  Exam revealed decreased sensation in hands/feet, decreased reflexes.  Seen by second Neuro on 1/15 & 1/28/09 for eval & repeat EMG/NCS which remained abnormal & c/w acute/subacute sensory-motor demyelinating peripheral neuropathy w/significant radicular component.  RTC 3/17/09 improved, started on steroid taper & referred for PT/OT.  RTC 4/15/09 & continued to slowly improve w/excessive tiredness, fatigue, paresthesias of hands/feet & difficulty walking uphill.  Continued PT/OT.  3/18/09 Received hospital medical records of 1/15-1/18/2009. FINAL DX: atypical Guillain-Barre syndrome  Records reveal patient experienced progressive numbness, tingling, pain & weakness of extremities esp hands/feet, difficulty walking, grip strength & dexterity were decreased starting 2 weeks s/p flu shot.  LP done.  Reflexes present but decreased.  Tx w/IVIG & made slight improvement.  Sent to inpatient rehab.  Patient was readmitted for relapse from 2/16/09-2/28/09 FINAL DX: acute GBS s/p vaccination   Patient developed increased difficulty walking, increased muscle weakness, SOB, loss of balance.  Had repeat EMG/NCS done as outpatient which were c/w sensory motor, peripheral neuropathy w/demyelinating features.  Exam revealed near normal muscle strength but DTRs were diminished throughout, sensation was slightly decreased & gait was quite abnormal.  Tx w/plasmapheresis x 7 & steroids. Follow-up: Residual generalized weakness (muscle strength), fatigue, neuropathic pain, and continued paresthesia/numbness feet.
patient used the expired formula  (2019-2020) which was expired on 29 May 2020 /no AE; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (unspecified age and gender) who were vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number not reported and expiry date: 29 May 2020) via unknown route in unknown administration site in 2019-2020 for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided  This was an actual medication error case due to expired vaccine used (latency was same day).  Patient used the 2019-2020 formula which was expired on 29 May 2020 of Fluzone Quadrivalent prefilled syringe.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sore arm; 1st dose Pfizer- 2nd dose Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer- 2nd dose Moderna) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    Concurrent medical conditions included Autism.   On 28-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer- 2nd dose Moderna). On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm). On 25-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer- 2nd dose Moderna) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        No concomitant medications reported. No treatment information was provided.