chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 18-NOV-2015 at time- 23:03, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.3 and 2.2 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
I am a 34 year old female in generally good health.  I take no medications, and have no chronic conditions other than Celiac disease.  I am petite, and have a BMI of 19.7 My first shot caused significant pain at the injection sight, but was otherwise well tolerated. My second shot caused multiple adverse reactions as detailed below. 12-36 Hours after the shot: Nausea and Extreme Fatigue 48 Hours after the shot: supraclavicular and axillary lymphadenitis on the side vaccine was given 72 -168 Hours after the shot: lymphadenopathy continues reducing in the axillary area and becoming severe across head and neck area.  Shooting submandibular, tonsillar, and preauricular lymph node pain.  Swelling, stiffness, and pain around cervical and occipital lymph nodes.  Intermittent headaches were also present during this time. Hour 200: Extreme headache, triggered by exertion? 168 Hours to 260: Intermittent but extreme pressure in both ears.
muscle soreness in the medial head of the shoulder blade; slight loss of taste; I experienced redness and skin itching on my neck and hip; I experienced redness and skin itching on my neck and hip; My BP was 141/111; I experienced a watering sensation in my mouth similarly to when you vomit.; mild headache; redness at the injection site area; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 15Apr2021 11:00 (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation. Medical history was none. The patient allergies were none. Concomitant medications included ibuprofen, received medication in two weeks, taken for an unspecified indication, start and stop date were not reported. Th patient was not received other vaccine in four weeks. The patient was not received covid prior vaccination. On 15Apr2021 at 11:30, the patient experienced redness and skin itching on my neck and hip, his BP was 141/111. The patient experienced a watering sensation in his mouth similarly to when you vomit. The patient had mild headache from the front area of his skull. Moreover, he got redness at the injection site area. Five hours later, the patient still had skin redness and itching. At the time of reporting on 16Apr2021, the patient had muscle soreness in the medial head of the shoulder blade. Lastly, he had noticed a slight loss of taste. No treatment was received for the reporting events. The patient underwent lab tests and procedures which included Nasal Swab Covid test on 01Feb2021 and result was Negative. The outcome of the events was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given Kinrix and Proquad in Left arm on 4/26/21 patient came to clinic on 4/28/21 Left arm is warm to touch and hard and redness is radiating down left arm. Instructed per provider to put ice on arm and give benadryl at this time if not better by tomorrow bring back tomorrow.
Full body reaction of Dermatographia, started very severe just about 1 week after booster.   Managed with Zyrtec 10mg BID and Benadryl and Pepcid
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (a little shortness of breath) and PAIN IN EXTREMITY (pain on the right arm and hand) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included Menacycline for Acne. On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, the patient experienced DYSPNOEA (a little shortness of breath) and PAIN IN EXTREMITY (pain on the right arm and hand). At the time of the report, DYSPNOEA (a little shortness of breath) and PAIN IN EXTREMITY (pain on the right arm and hand) outcome was unknown. Patient had no concomitant medications and allergies. Treatment information was not provided. This case was linked to MOD-2021-400083 (Patient Link).
On Tuesday night she had a seizure while sleeping. On Wed. afternoon she had another one. Wed. evening at about 8:15pm, she was sleeping next to me. She had a seizure loosing control of arms. 2nd one at 10-15 min later loosing control of head and arms.
c/o headache; temp 102.8, lethargic and sleeping most of day.  Sunday lethargic, no temp, started coughing and runny nose.  Returned to school on Monday.
Swollen on the Injection Site; Feels Heavy Entire Left Arm and Hand; Numb Entire Left Arm; Pain in Chest to neck and to waist Moving to the legs; Hot Injection Site; Shooting pain; Big Red Blotch 3" Injection Site; Tender Left Arm Injection Site; Every muscle in her body hurts; Headache; Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), PAIN (Pain in Chest to neck and to waist Moving to the legs), VACCINATION SITE WARMTH (Hot Injection Site) and LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2016, the patient experienced FATIGUE (Exhausted). On 16-Feb-2021, the patient experienced PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), VACCINATION SITE WARMTH (Hot Injection Site), VACCINATION SITE PAIN (Tender Left Arm Injection Site), MYALGIA (Every muscle in her body hurts), HEADACHE (Headache) and ARTHRALGIA (Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body). On 21-Feb-2021, the patient experienced PAIN (Pain in Chest to neck and to waist Moving to the legs). On 22-Feb-2021, the patient experienced LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand) and HYPOAESTHESIA (Numb Entire Left Arm). On 16-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen on the Injection Site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), PAIN (Pain in Chest to neck and to waist Moving to the legs), VACCINATION SITE WARMTH (Hot Injection Site), LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand), HYPOAESTHESIA (Numb Entire Left Arm), VACCINATION SITE PAIN (Tender Left Arm Injection Site), VACCINATION SITE SWELLING (Swollen on the Injection Site), MYALGIA (Every muscle in her body hurts), FATIGUE (Exhausted), HEADACHE (Headache) and ARTHRALGIA (Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab data included all tests were normal.  No concomitant medications are reported.  Treatment medications included Ice.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information.
Within 20 minutes of injection my right arm became tingly; my torso, back, both arms and neck were red, itchy with a raised rash.; my torso, back, both arms and neck were red, itchy with a raised rash.; my torso, back, both arms and neck were red, itchy with a raised rash.; extremely tired; nauseous; This is a spontaneous report from a contactable Consumer. A 53-years-old (Adult 18-64Years) non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in right arm on 05Mar2021 (at the age of 53-years-old) as a single dose for covid-19 immunization. The patient medical history included asthma, allergies, cardiomyopathy, history of anaphylaxis. The patient concomitant medications were not reported. The patient had allergies with latex, penicillin, shellfish. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in right arm on 12Feb2021 at 13:15 (at the age of 53-years-old) as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 13:45, it was reported, "within 20 minutes of injection my right arm became tingly then within 2 hours my torso, back, both arms and neck were red, itchy with a raised rash. That evening I became extremely tired that lasted for 4 entire days. I was also nauseous for 4 days. On the fourth day the nausea was gone, the fatigue was somewhat better, but the rash is still as bad as when it began. I have been taking Benadryl with little relief". Therapeutic measures were taken as a result of pruritus and rash popular. The patient did not receive any other treatment. Outcome of the event was recovering, at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient left, ten minutes later returned and said he was light headed. Took his blood pressure it was 60/40 for 3 times.  Called 911 and took his blood pressure and it was 80/nothing. Emergency techs took him to the hospital.
About 5-10 minutes (11:10 to 11:15) after patient was given these two vaccinations, patient started to have what appeared severe painful back spasms/pain. This went on for about 5-10 minutes and it seemed to have slightly subsided, but pt appeared to be in alot of pain. Ambulance was called for patient (around 11:15 am) but patient refused to wait citing concerns of cost of treatment. Encouraged patient to stay to be evaluated by paramedics but patient left store against our advice.
I got shingles twice after my first shingles shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got shingles twice after my first shingles shot). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient via interactive digital media. The patient would not return for the 2nd shot.   The follow-up could not be possible as no contact details were available.
inadvertently administered an expired Adacel to a patient/no AE; Initial information received on 20-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 37 years old female patient who was inadvertently administered with vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 18-Jan-2020, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5829AB, expiry date: 24-Sep-2019 via intramuscular route in the right deltoid.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  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 EC and Module VI of the 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.
Fatigue; Headache; Chills; Mild fever; A spontaneous report was received from 83 years old female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, headache, chills and mild fever.  Medical history was not reported.  Concomitant medication was not reported.  On an unknown date, prior to the onset of the events fatigue, headache, chills and mild fever, the patient received their first of two planned doses of mRNA-1273 (lot/batch: O11L01A) via unknown route in unknown anatomical location for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced events fatigue, headache, chills and mild fever.  Laboratory details was not provided.  Treatment medication included acetaminophen and aspirin at an unknown dose and frequency via an unknown route for fever.  Action taken with mRNA-1273 in response to the events fatigue, headache, chills and mild fever was not provided.  The outcome of the events fatigue, headache, chills and mild fever was not provided and the outcome of the event mild fever was recovered on an unknown date.  The reporter did not provide the assessment of the events fatigue, headache, chills and mild fever to study drug.
CHILLS, SHAKES, VOMITING...PAGED HER PCP OFFICE AND HAD HER SENT TO ER.
Sunday  1/16/2022: fever and shivers  Monday 1/17/2022:  swollen underarm lump
Information has been received from a registered nurse and a dialysis technician concerning a 55 year old male dialysis patient with nephrosclerosis who on 6/17/03 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (lot #644219/1079M). There was no illness at the time of vaccination. Concomitant therapy included paroxetine HCl, Ca acetate, ascorbic acid (+) folic acid (+) vitamin B complex and Rena gel. On the night of 6/18/03, the patient started to experience severe chest pain and had a bad cough. On 6/19/03, at his dialysis appointment, the patient still complained of the chest pain and continued to have a bad cough. The patient received dialysis treatment and was sent to the ER. Later that same day, the patient was hospitalized as a diagnosis of pneumonia was made. While hospitalized, the patient was treated with levofloxacin and a electrocardiogram was abnormal. In June 2003, the patient was discharged from the hospital as his pneumonia resolved. The dialysis technician requested that a lot check be performed. The dialysis technician also considered the pneumonia to be disabling. The dialysis technician also reported that another patient developed pneumonia after being vaccinated with penumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Severe asthma attacks, increasing asthma and eczema on 1/15/00. eczema breaking out prior to severe asthma attack.  Started on Prednisone, Benadryl (childrens), albuterol nebulizer and oxygen as needed.
Headache, malaise, low grade fever 100.5, muscle aches, abdominal cramps, mild cough.
Tinnitus worse since vaccine; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on an unknown date Apr2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included High BP (blood pressure high). Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), rosuvastatin (ROSUVASTATINE) and multivitamin (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 22Mar2021 at 12:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, the patient experienced tinnitus worse since vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of tinnitus was not recovered.  No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist and described the occurrence of drug dose administration too long in a unk patient who received ENGERIX B. Concomitant products included HBV. On an unknown date, the patient experienced the 2nd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced drug dose administration too long. On an unknown date, the outcome of the drug dose administration too long was unknown. It was unknown if the reporter considered the drug dose administration too long to be related to ENGERIX B. Additional information: 1st dose of ENGERIX B was given on 22 May 2014 and the patient has not received the second dose in series that led to drug dose administration too long. No details on patient and lot numbers were available. No symptoms were reported.
In less than 24 hours I experienced flu like symptoms, chills, severe back pain sufficient I needed to lay down. I had to leave work. 4 hours later even having taken 1000mg of Tylenol and 800mg of Ibuprofen.  Little to no relief. Dizziness and severe body aches. As bad or worse than when I was diagnosed with COVID-19, 4 weeks prior.  Back pain radiates up my back and into my neck.
Pt returned to office due to itching / hives / redness. No difficulty breathing / resp. distress. Pt O2 sat 88-91 with O2 3L blow by. Pt had large stool, loose. X2 RNs assisted father cleaning / changed pt. after pt had x1 large emesis. RN x2 assisted clean up. Pt O2 100% on room air. No diff breathing/distress. Pt dc'd home after monitoring. Gave BENADRYL 2 tsp PO upon return to office.
Large area (20 cm x 30 cm) of redness, warmth, swelling at area of vaccination. Also headache and chills w no fever. Several areas of pruritic macular rash on ankle and hip. Treated for cellulitis of (L) arm with Keflex.
arm very sore and hard to move; headache; restless-unable to sleep (not normal for me); sore eyes; stuffy nose that was non-existent the day of vaccine.
Febrile seizures x2 (GTC and brief)within 12 hours of immunization. Patient did have documented low grade fever and pharyngitis prior to immunization. He was evaluated in an ER and discharged home. Patient went on to develop clear URI symptoms, OM, and bronchiolitis over next seveal days.
Mild fever; Sluggish feeling; This is a spontaneous report from a contactable Health Care Professional through a Pfizer sales representative.   A 68-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose and influenza vaccine, both received on an unspecified date (at the same time in different sites), at the pharmacy, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient complained of a mild fever and sluggish feeling. Clinical outcome of the adverse events was unknown at time of this report.  The information on the lot number has been requested.
Rash on my arm where the vaccine was given; Slight tenderness, upper arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm). At the time of the report, VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient visited his local doctor. Patient was told to put some heat on it and take some Tylenol.   No Concomitant medication was reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm). At the time of the report, VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient visited his local doctor. Patient was told to put some heat on it and take some Tylenol.   No Concomitant medication was reported.
diarhea, foggy and dizzy, numbness on right side including hand and foot. Started about 4 hours after shot.