chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received an expired DAPTACEL with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received an expired daptacel with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength, dose, route, administration site and lot number not) for immunization.  On an unknown date, the patient received an expired daptacel with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
Hypoxia with COPD, syncope and probable vasovagal response.   O2 titrated and BP meds adjusted. Isosorbide is decreased to 5 mg twice per day.  Magnesium should be 250 mg twice per day. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a licensed nurse practitioner concerning an adult female patient, with unknown medical history and unknown drug reactions/allergies, who on 24-OCT-2005 was vaccinated in the left deltoid intramuscularly with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P).  The patient called the office the same day complaining of vomiting, body aches, redness and heat in the deltoid about 10 centimeters in diameter.  She was seen in the office, given promethazine hydrochloride (PHENERGAN) intramuscularly for vomiting, and an ice pack was applied to the arm.  Subsequently, it was reported that as of 27-oct-2005 the patient was doing "well".  No further information is available.
This spontaneous report as received from a healthcare worker refers to a 82 years old male patient with pertinent medical history of hypertension, kidney damage, diabetes, sleep apnea and stroke and with no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (Lot# reported as H014366, exp date: 06-NOV-2013, subcutaneously, dose unspecified) on 12-OCT-2012. Concomitant medications included potassium, hydralazine, metformin, PROCARDIA, MICARDIS, LASIX, PROSCAR, FLORASTOR, QUESTRAN and UROXATRAL. On 13-OCT-2012 the patient developed the shingles. The patient had sought unspecified medical attention. No lab diagnostics studies were performed. Treatment of acyclovir and DOMEBORO solution were given for the event. The outcome of shingles was reported as not recovered/not resolved. VZVID packet faxed. Additional information has been requested.
105.6 rectal fever, irritability, refusal to eat/drink, diarrhea.
Breakthrough case admission after 2 vaccines Janssen 3/30/21 Lot# 1808609;  Moderna 1/28/22 Lot# 022J21A
Metallic taste in mouth after receiving vaccination, in the corner of the eye the skin in crease began to become irritated, eye became pinkish, fatigue, lump on neck on the left side (golf ball size), injection site is tense, warmth feeling in vaginal area, heaviness in chest area.
A consumer reported that her 6-month-old son received a dose of Prevnar, DTaP (manufacturer unknown), and IPV vaccines on 17-DEC-2001. Approximately 1-2 hours later, the child began "rolling his head side to side and had a goofy look in his eyes" The child was cranky and screaming all evening and had developed an injection site reaction described as "hot to touch", swollen, and "very" tender. By the following day, the child had stopped screaming and was no longer cranky. No additional information was available at the date of this report. a copy of this report has been forwarded to the manufacturer of the IPV vaccine
Patient is a 51 y White or Caucasian male admitted 1/22/2022 initially presenting with c/o SOB, TBI and is a quadriplegic s/p MVA. Patient arrived hypoxic, not on home O2, placed on supplmental O2.  CXR noting B/L lung atelectasis.  Patient admitted with consult to ID. Patient was started on IV Unasyn. Patient was weaned to room air, he can be downgraded from moderate care.  Aspiration pneumonia likely- ordered Unasyn. Patient went home on PO abx augmentin and another 5 days of steroids
Extreme Pain in arm, swelling.  Pain goes from arm to shoulder.  Fingers on left hand tingle and numb.
Pt c/o tongue numbness, throat itching, throat tightening, difficulty breathing, difficulty swallowing, lightheadedness. Epi IM 0.3 mg right lateral thigh X1 given at 1628. V/S taken 134/72, 102, 20, 100% O2 Sat. Called 911 per protocol. Ambulance arrived arrived at 1645.
that night I felt exhausted and nauseous. Next day in the the morning I felt tired for a few hours but able to go to work. Around noon, the side effects really hit me and I had to take the rest of the day off. I felt extreme fatigue and nausea, I had a migraine (which I am prone to having), felt hot and cold, but no real fever. My temp stayed between 97.9- 98.6. This lasted for the next 24- 36 hours. I also got a red circular rash on the arm I received the shot on but about a few inches under the injection site. About 4-5 day after the vaccine, I got swollen in my right arm pit and then the day after I got swollen in my left arm pit. (I get this reaction usually in the arm of the injection site when I get the flu vaccine). About 5-6 days later, the red rash came back on my left arm and was itchy, not sure if I got bit by a mosquito or if this was a side effect from the vaccine.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 07-DEC-2015, the patient was vaccinated with (Oka/Merck) VARIVAX (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
p/recv vax pt exp allergic blotching on forehead, swollen eyes, photo sensitive vision
After receiving booster shot on Friday November 19th, one day later started to have pain in left side of neck from ear  down to collar bone, and some fullness in left cheek. Pain has been increasing. It is more than a swollen node. Left side is swollen, and sore to the touch, difficulty with full range of motion of neck. Saw doctor, said it was an adverse reaction interfering with day to day activities. Prescribed anti-inflammatories.  It's more than just a swollen lymph node.
Lightheaded,  Metallic taste in mouth,  and tingling in my throat for the first 15 min after vaccine given. Then after that just localized injection pain to site
Patients Inadvertently received an additional dose of Menactra.  No adverse reaction.
Patient began itching on 12/26/07.  Itching is localized to either the back, chest, stomach and head. Patient reports that the itching will last 1-2 days in one spot, will vanish for 1 day, and then will reapear in another area.  As of todays date, 3/5/08, the patient is still itching.  She takes diphenhydramine 25mg by mouth when the itching is severe.
Small area of erythema no induration 2.5 in x 1.5 in non tender.
Severe fatigue.  Cough, congestion, and sinus infection after 11 days of symptoms.
03/10/21 injection site got sorer as the day went. Felt a little tired  03/11/21 injection site very sore but also felt kinda fatigued and sweating on and off.  03/12/21 woke up at 7:00 a.m with my throat red and tonsils red and lymph node on right side of neck was a-little swollen. Ear hurt on right side. I sounded muffled sounding when talked. I called in sick to work took some Tylenol and went back to bed. I slept all day till 8 p.m got up and ate something and went back to bed.  03/13/21. Throat still sore and red but a little better took Tylenol. Ear hurt on right side as well.  03/14/21 Throat a little better but still felt sore took Tylenol felt energetic all morning and about 5:30 or so felt fatigued.  03/15/21 ear still sore some throat better than before  went to work. Had a temp Of 99.1 03/16/21 Sweating on and off today
This case was reported by a healthcare professional and described the occurrence of arm swollen in a 11-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  Concurrent vaccination included VARIVAX (Merck) given in the left arm on 18 August 2009.  There were no concurrent medications.  On 18 August 2009 at 08:00 the subject received 1st dose of BOOSTRIX at 0.5 ml in the right arm.  On approximately 19 August 2009, 1 day after vaccination with BOOSTRIX, the subject experienced arm swelling (to the size of a baseball), hot arm, arm redness and nausea.  The healthcare professional considered the events were disabling.  The subject was treated with ice.  At the time of reporting the events unresolved.  The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Vaccines given on 3/31/17. Fever began the following day and lasted 4 days. Tmax = 105 degrees. No other symptoms.
Within hours of injection, patient experienced dizziness, nausea and fatigue. Within 48 hours of injection, symptoms increased. 72 hours of injection, patient experienced blurred vision. 96 hours after injection, patient experienced slurred speech. Patient went to ER and was released the same night (11/23/2009). Patient saw neurologist on 11/25/2009. On 11/28/2009, symptoms increased. Called neurologist. On 11/30/2009, symptoms worsened. Called neurologist & Primary Physician, went to ER (11/30). Saw staff neurologist on 12/01/2009 and was released. Symptoms continue.
pt recv vax & devel swelling on the site of inj & feeling ill in general;
Received flu vaccine 11/11/16. Since injection L arm painful. Worse with movement No swelling or redness Full ROM ALEVE for pain.
Night of vaccination approx. 4 hours after began feeling flushed, dizziness, arm soreness, severe body aches, nausea. Continued through night worsening on/off with chills. Had episode for 4 hours where had numbness in hands bilat. Still feels fatigue, achiness today. Attempted to work today but kept getting flushed and dizzy so was sent home.
I had vaccination on 09/07/2022. On 03/19/2023 I started to have a scratchy throat feverish and fatigue. I tested COVID-19 positive on 03/20/2023. I previously had COVID-19 on 05/2020 and I had had long haulers. I called my doctor right away and was prescribed an anti-viral. I feel like I have recovered on 04/19/2023 except for an infection on my wrist. I am unsure if related to COVID-19 as I did have COVID toes etc.
Patient stated that she woke up on the night of 8/28/18 with a fever, chills, and body rash. This continued for 1 full day. When she reported this on 8/31/18, the symptoms had subsided.
Complains of pain & swelling of left upper arm (over past 2 days). Injection site left upper lateral 1/3 of deltoid upper arm erythematous, swelling involving left middle 1/3 of left upper arm plus warm complains of some pain on elevating left upper arm. No fever, plus warmth in left middle 1/3 upper arm. Patient applied ice, cold compress only.
Patient was seen in Covid vaccine clinic, December 13, 2021. She is 7 years old. Patient received a Pfizer (adult) vaccine dose (0.3ml/30meq). She should have received Pfizer (pediatric) vaccine dose (0.2ml/10meq).  At the time of departure, Patient did not have any sign/symptoms.
Patient received Tdap 8/25/2010 (historical in MCIR). Patient inadvertently received another dose 8/24/2016 6 yrs after 1st dose. Td/Tdap not needed at this time.
5/28/2023 - 6/13/2023 (16 days) treated with IV remdesivir/Decadron off oxygen left lower abdominal pain  030B21A 4/14/2021 003C21A 5/12/2021 032H21A 12/7/2021 016A22A 6/29/2022
rt thigh swollen & large reddened area;6 in diameter w/a few small blisters;the size of a pinpoint;no discomfort;area warm to touch;
Redness, itching and rash at injection site at distal left forearm. No pain, no fever, no streaks and no swelling. Seen ED 12/16/15 and treated with Benadryl.
Information has been received from a physician concerning a 48 year old female who in 2/00 was vaccinated with pneumococcal vaccine 23 polyvalent. In 2/00, the pt developed urticaria at the site of the injection (injection site wheal). It was noted at the time of the report in 10/00, that "for the past 8 months", the pt had experienced episodes of urticaria on her trunk and extremities which "comes and goes". The pt developed chronic sinusitis, was seen by ENT (otolaryngology) and was treated with Allegra and Flonase. The pt sought unspecified medical attention. Addition information has been requested.
Received MMR at 0730 am. 8 am covered in hives, ankles swollen, pupils dilated. Took 50 mg BENADRYL by mouth. MMR ingredients include hydrolyzed gelatin! (Beef and pork connective tissue) 4 hour reaction.
Systemic: Chest Tightness/Heaviness/Pain-Medium, Systemic: Hypertension-Medium, Additional Details: Patient got a booster of Moderna. His first 2 doses were Pfizer. After the booster was administered he experienced chest tightness, which he described as feeling like having anxiety but he was not anxious. His blood pressure was 146/97. He said his baseline is high but was not sure of the level. He experienced this for about 2.5 hours and is now completely back to normal everyday activities.
Dizziness, difficulty sleeping, headache, irritable skin, muscle pain, joint pain, disorientation,  difficulty breathing, uncontrollable shaking, nausea; most just lasted from evening day of to next morning, muscle aches and sensitive skin lasted for a few days
Diarrhea; Nausea; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset 2022, outcome "unknown"; VOMITING (non-serious) with onset 2022, outcome "unknown".  Additional information: Diarrhea and nausea the evening after receiving the COVID bivalent booster and vomiting the next day. The patient was 10, M, 52 lb, >4'. Name of Product: COVID 19 bivalent booster, kid's dose. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had "tingling" on his throat. Bilateral rash on arms. Elevated B/P 170's. Nausea and vomiting Pt was given 25mg Benadryl. Pts b/p lowered. Nausea and vomiting resolved.
She was administered 0.5 ml of Moderna Covid 19 Vaccine which is currently not approved for patients less than 18 years of age. The event was realized three days later. The patient's father was contacted and the patient is not having any problems. We plan on administering the second dose in 4 weeks and using the Moderna vaccine again according to CDC guidelines.
Patient experienced large hive like reaction below the site of injection. The hive was about 8 inches long and covered the width of her biceps. She has had the Pneumovax before with out incident. Rt arm became too sore to sleep on. Following morning arm was swollen, Red, sore, became worse by the next day and was moving to the elbow also, went 25 mi to closest Emergency room - saw by doctor who prescribed CEPHALEXIN 500 mg for 10 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 at 09:00 as dose 5 (booster), single (Lot number: G36665) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 at 13:00 as dose 1, single (Lot number: EN6207), in left arm, on 09Apr2021 at 09:00 as dose 2, single (Lot number: EW0153), in right arm, on 11Oct2021 at 09:00 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 14May2022 at 09:00 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Mar2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Mar2023) positive; (14Mar2023) Negative; (15Mar2023) Negative; (16Mar2023) Negative; (17Mar2023) Negative; (18Mar2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient had no known allergies. Patient tested positive 07Mar2023. Paxlovid treatment started on 08Mar2023 to 12Mar2023 as COVID 19 Treatment. Patient tested negative 14Mar2023 to 17Mar2023. Symptoms returned and tested positive on 18Mar2023.   No follow-up attempts are possible. No further information is expected.
Patient developed a reddened area on her left upper thigh area.  Mom attached a picture to the patient's portal to communicate.  Mom stated that it was itchy as first but has used hydrocortisone cream and it helped with the itchiness.  Mom states that it is still red and swollen but has not increased in size.  Provider was aware on 5/18/2020 and made the mom aware that this could last 4-6 weeks and if the patient develops a fever to call us back.  I checked on the patient today and no increase in swelling at this time.  Made aware again that if the child develops a fever to call us.
One day after vaccine, patient developed chest pain and headache. Three days after vaccination, presented to PCP then ED with chest pain. Found to have elevated troponin. Transferred to PICU with persistent chest pain. Chest pain dissipated after NSAIDs.
After the second dose on Tuesday morning (1/19/21) patient had severe arm pain that got worse as the day progressed. The next morning patient woke up with a fever of 100.8, chills, headache, nausea, severe arm pain (hard to even use it), and extreme fatigue.  1/22/2021, patient is feeling much better but still not 100% in terms of arm pain and fatigue.
Flu like side effects every 4 days interval; Headache; Nausea; feel like vomit if she didn't lie down; Didn't take second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like side effects every 4 days interval), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (feel like vomit if she didn't lie down) and PRODUCT DOSE OMISSION ISSUE (Didn't take second dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like side effects every 4 days interval), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (feel like vomit if she didn't lie down) and PRODUCT DOSE OMISSION ISSUE (Didn't take second dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like side effects every 4 days interval), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (feel like vomit if she didn't lie down) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Didn't take second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was scheduled for her second dose on 31-MAR-2021 but at vaccination site they postponed her dose schedule to 12-APR-2021 or 13-APR-2021. No concomitant medications were provided. No treatment drugs were reported.
On 12/28/2022, in the afternoon, I began to feel feverish, sick to my stomach, and I was coughing and sneezing. I took an at home COVID-19 test and it was negative. I made a doctor's appointment the next day where I tested positive for COVID-19 and Flu. She prescribed a ZPAK and PAXLOVID. She also prescribed something for my aches and pains. The next day, they advised that I quit taking my daily medications and to only take the prescribed medications along with prescription levels of zinc and vitamin C. I had a really slow recovery. I was wheezing for days, and my rib cage became sore from all of the coughing and sneezing. Finally, around 5 days in, I began to feel somewhat better. However, right now I have swollen glands and I still have a cough with some occasional sneezing.
pt recvd vax & approx 7-14 days later exp generalized muscle twitches;
Shingrix vaccine both doses 2 years ago and still got Shingles/ suspected vaccination failure; shingles; Rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix and experienced shingles. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter did not consent to follow up.