chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a patient who, when she was younger, was vaccinated with COMVAX and meningococcal vaccine (manufacturer unknown). Subsequently, the patient had a reaction that resulted in lethargic symptoms and confined to bed for several days. As of 20-FEB-2007, it was unknown if the patient sought medical attention. The patient's outcome was not reported. Additional information has been requested. Information has been received from a nurse practitioner concerning a patient who, "when she was younger," was vaccinated with HEPATITIS B virus vaccine (manufacturer unknown) and meningococcal polysaccharide vaccine (manufacturer unknown). Subsequently, the patient had a reaction that resulted in lethargic symproms and she was confined to bed for several days. It  was unknown if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Information has been received from a nurse practitioner concerning a patient who, "when she was younger", was vaccinated with HEPATITIS B virus vaccine (manufacturer unknown). Subsequently, the patient had a reaction that resulted in lethargic symptoms and she was confined to bed for several days. It was unknown if medical attention was sought. The patient's outcome was not reported. There was no product complaint involved. No further information was provided. Additional information has been requested.
Had feverish response for 24 hours, then 36 hours later woke up with eyes and lips swollen. Is allergic to ibuprofen but did not take any nor any other medications to alleviate pain symptoms
This spontaneous report was received from a pharmacist referring to a male patient of unknown age with no allergies or drug reactions who was vaccinated on 2012 with the first dose of PNEUMOVAX 23, 0.5 ml, intramuscular (lot # H010515, expiration date, 13-FEB-2014). On 05-SEP-2013, was vaccinated with a 2nd dose of PNEUMOVAX 23, 0.5 ml, intramuscular. Pharmacist reported that the patient received his second dose of PNEUMOVAX 23 on 05-SEP-2013, a year after his first dose in 2012, and on 06-SEP-2013, a day after his second dose, the patient passed out and felt sluggish and weak. The outcome of passed out, felt sluggish and weak was reported as recovering/resolving. Patient spoke to pharmacist. The patient did not receive any treatment for the event and there were no laboratories performed. Upon internal review passed out was considered a medically significant event. Additional information is not expected.
experienced tenderness around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced tenderness around the site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination.     NO medical history information was reported.  The patient's past medical history included Hypertension since an unknown date and Diabetes since an unknown date.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (experienced tenderness around the site). At the time of the report, VACCINATION SITE PAIN (experienced tenderness around the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        Concomitant medications reported were Blood Pressure Medications, and Diabetes Medications.  No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced tenderness around the site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination.     NO medical history information was reported.  The patient's past medical history included Hypertension since an unknown date and Diabetes since an unknown date.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (experienced tenderness around the site). At the time of the report, VACCINATION SITE PAIN (experienced tenderness around the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        Concomitant medications reported were Blood Pressure Medications, and Diabetes Medications.  No Treatment information for the event was provided.
Injection site reaction: slight redness (24 hours), swelling (48 hours), tenderness (72 hours), and some joint pain in the shoulder with movement (24 hours) General side effects: within hour of receiving vaccine I experienced nausea that lasted for 48 hours; along with chills and headache.
PROQUAD given to patient that is 18 years old in error; PROQUAD given to patient that is 18 years old in error; Customer reports titers done on patient resulted immune to rubella and mumps and not immune to varicella and measles.; Customer reports titers done on patient resulted immune to rubella and mumps and not immune to varicella and measles.; This spontaneous report was received from a nurse, and refers to a 18 years old patient of unknown gender.  The patient's concurrent conditions, medical history, and drug reaction or allergies were not reported.   On 26-AUG-2020, the patient was vaccinated in error (product administered to patient of inappropriate age) with Measles, Mumps, Rubella and Varicella Virus Vaccine Live (PROQUAD) (lot # T010288 and expiration date 20-SEP-2021) with its sterile diluent (lot # S038151 and expiration date 02-AUG-2022), (dose and route of administration not provided) as prophylaxis. It was reported that the titers done on the patient resulted immune to rubella and mumps, but not immune to varicella and measles. The nurse wanted to know if the patient needed to be revaccinated with age appropriate vaccines. The outcome of Varicella virus test negative and Measles antibody negative was not provided.   The causal relationship of Varicella virus test negative and Measles antibody negative to Measles, Mumps, Rubella and Varicella Virus Vaccine Live (PROQUAD) was not reported.
Act-hib component with sterile diluent; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional and consumer non health care professional via Medical Information number: 00784569.  This case involves an unknown age female patient who was received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ422AA and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to Inappropriate reconstitution technique (latency: same day).  It was reported that nurse who states she doesn't have any information other than what was provided in initial contact. Caller isn't sure what diluent the medical assistant mixed the Act-HIB powder with. Caller states it "like what comes with Varicella" and informed her that is not our product.  At the time of reporting, no adverse event was 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 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.
SOB, confusion, lethargy; COVID Pneumonia; hypoxia, lt side pneumothorax with chest tube placement; inpt hospice; treatment - fluids, abx, O2, dexamethasone, 1 dose tocilizumab. not a canadite for remdisivir; high flow O2 + NRB
Patient states approximately 1 week after the shot he developed pain in his left arm and armpit.  He states it bothers him mostly when he is laying down trying to sleep.  It seems to be better when he is moving it around. Recommended seeing a doctor for this pain.
Moderna 0.5 ml administer to indivdual under age 18. The individual was accompained by his mother and another adult.
SEVERE RIGORS, FEVER TO 100.8 AND MUSCLE ACHING LASTING 12-14 HRS. RESPONDED TO TYLENOL AND WARMING.
This spontaneous report as received from a health care professional and refers to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 23-FEB-2015 the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # J005071 expiration date 19-ENE-2015, (strength, route, dose and frequency were not provided). There was no concomitant medication described. No adverse effect was reported. Additional information has been requested.
12-24-22 was having migraine that got worse of the past 2 days with headache in right occipital region.  Had a stroke early morning 1-2-23. In ED at 0817 with left-sided weakness, left face droop.  Noncontrast CT of head - SAH blood on CT.  Primary diagnosis of stroke.  Facial palsy, subacute right MCA infart secondary to right carotid thrombus with extension to R M1.  Hospitalized from 1-2-23 to 1-18-23.  Discharged to acute rehab, then skilled nursing, then assisted living.  No evidence of atrial arrhythmia during hospitalization.   Hospitalized at a local Clinic Hospital.
This spontaneous report was received from a healthcare worker refers to 3 patients of unknown demography. On an unknown date, the 3 patients were vaccinated with PNEUMOVAX 23 lot # J006921 (Expiry: 09-AUG-2014), 0.5 ml, intramuscular. It was reported that the three patients have received PNEUMOVAX 23 for the first time. On an unknown date after 2 to 3 hours after vaccination with PNEUMOVAX 23, the three patients experienced severe redness and swelling of their arms at the injection site. The three patients sought medical attention. The outcome of the events severe redness and swelling of their arms at the injection site was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to case 1403USA001356 (same reporter link). Additional information has been requested.
Redness/hardness at injection site. Red rash expanded to an oval shape that was about 6-7 inches long and 4 inches wide. Warm to the touch but only painful at the actual site of injection.
soreness; has missed her  second  dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has missed her  second  dose.) and MYALGIA (soreness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (has missed her  second  dose.). On an unknown date, the patient experienced MYALGIA (soreness). On 06-Jan-2021, PRODUCT DOSE OMISSION ISSUE (has missed her  second  dose.) had resolved. At the time of the report, MYALGIA (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicine  were not provided. Treatment medicine were not provided.
PT ALMOST PASSED OUT WITHIN 5 MINUTES OF RECEIVING MODERNA COVID-19 VACCINE. PER EMS SHE WAS HYPERVENTILATED  DUE TO PANIC/ANXIETY ATTACKS. PT WAS FINE AFTER 15 TO 20 MINUTES. PT HAS LEFT THE FACILITY.
The shot was given on Friday around 1 pm.  Blurry Vision immediately after vaccination, then felt fine until 7 pm.  At 7 pm she fainted at Lacrosse practice.  The following day, Saturday,  she fainted at work and was sent home.  Sunday, she slept most of the day.  Monday, she fainted at school and was sent home.  Symptoms have been feeling of her heart racing,  blurry vision, fainting, weakness, and major fatigue.  No fever.
Patient stated she felt her "throat closing". Vital signs stable, 100% oxygen saturation. Denies shortness of breath, denies tongue, lip, face swelling. Patient transferred to the office of the doctor on call, they administered 10 mg of Zyrtec sublingual. Symptoms resolved and patient was discharged.
Patient said felt throat staring to close and we administered epi-pen 0.3 mg. Patient was transported to hospital, checked out and released later same day.
No additional AE/ PQC reported at this time; MMR II (stored in freezer) and VARlVAX, temperature excursion; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. The patient's pertinent medical history, concomitant medication, drug reactions/ allergies were not reported.     On 17-MAR-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 ml,  strength and route were not reported, lot # T025945 has been verified as valid, expiration date 30-JUL-2022) for prophylaxis and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA (0.5 (unit not provided), strength and route were not reported, lot # S039319 has been verified as valid, expiration date 04-DEC-2021) (stored in freezer) for prophylaxis.  The varicella virus vaccine live (Oka/Merck) (VARIVAX) administered experienced a temperature excursion of -10 degree Celsius to 8 degree Celsius (-1.6 C), for a time frame of 1 hour 36 minutes 0 seconds.  The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered experienced a temperature excursion of -50 degree Celsius to 8 degree Celsius (-1.6 C), for a time frame of 1 hour 36 minutes 0 seconds. There was no previous temperature excursion. Digital data logger was involved. No additional adverse event reported at the reporting time. The outcome of the event was unknown.
Nerves are irritated and raw; Shingles without rash or blisters or redness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included shingles (Approximately 1 year ago, the patient developed shingles on his left side without blisters). Previously administered products included Zostavax (The patient received vaccine about ten years ago).   On 25th September 2021, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2021-2022 season. In September 2021, 2 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced shingles. On an unknown date, the patient experienced neuralgia. The patient was treated with gabapentin. On an unknown date, the outcome of the shingles was unknown and the outcome of the neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the shingles and neuralgia to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: This case was reported by the patient. The patient received the first dose of Shingrix and at the same time he received the Flu vaccine (high dose).  The patient could not recall which arm (deltoid) he received the Shingrix.  He stated that 2 days after receiving the Shingrix vaccine, he developed shingles on his right side - from right axilla to chest . He said there was no rash, redness, or blisters.  He stated that the nerves were irritated and raw. He was currently taking Gabapentin for treatment.   The patient asked if it was safe to get the second dose of the shingles vaccine.  The reporter consented to follow up.
Fever 101.4F, Chills, nausea, dry heaving, achy joints, Low back pain, headache Treated with Tylenol
Patient received the shot on 10/27/18 from the charge nurse. Two weeks after the shot she noticed she was still having pain at the injection site. Pain started to get better and waited to see if it would resolve on its own. Pain began to increase again and she was not able to lift her left arm above her chest, no range of motion, unable to put on or take off shirt without extreme amount of pain. On 11/28/18 she contact health coordinator to discuss her symptoms. She was going to look into this and get back to her.
I was tired after the shot. I slept for 11 hours. I developed something like a cough, but it feels like I am losing my breath at times. It can be painful. It's like I struggling for air. It does not last long, but it seems to be happening a little more often. I have also experienced a little more film that I have to spit out. The shot triggered my hot flashes again as well.
I had a friend come over who helped me do some home renovations that was symptomatic a couple days later and then tested positive. I also started showing systems and feeling bad for two or three days and went to take a PCR test that came back positive. I started taking Paxlovid on 08/15/2022 and on 08/25/2022 I tested positive for DVT in my left leg. I was put on Eliquis to help keep my blood thinned.  Doctors have determined that the blood clot is gone.
nose bled; 6 weeks did not get her period; This spontaneous case was reported by an other health care professional and describes the occurrence of EPISTAXIS (nose bled) and MENSTRUATION DELAYED (6 weeks did not get her period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (nose bled) and MENSTRUATION DELAYED (6 weeks did not get her period). At the time of the report, EPISTAXIS (nose bled) and MENSTRUATION DELAYED (6 weeks did not get her period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
got COVID about 2 weeks later; got COVID about 2 weeks later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2, single and administration date Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID about 2 weeks later". Clinical course: reporter asked is it crazy to think that someone could get cancer or something serious happen to them a year or two after receiving the (Pfizer COVID) vaccine, it usually happens within a few weeks if something serious is going to happen, right. Caller states, "I have some concerns. I wound up getting the (Pfizer COVID) vaccine, first one was in Aug2021, second one was in Dec2021 and got COVID about 2 weeks later. I did a ton of research, back and forth. I instantly regretted it after getting the vaccine. I've been reading a lot of articles about recalls with medications and I'm getting nervous. This thing about CEO not divulging information, it feels like he is not being honest, my aunt saw a video where he (the CEO) is caught on tape saying there are more toxins in the vaccine than anticipated but is still putting it through. I don't know there is just something about him that I don't trust. Wouldn't you think it would be weird if the CEO of Pfizer didn't get a Pfizer COVID vaccine but got Moderna or J&J instead. Doesn't that mean he doesn't think it is safe. Why isn't it public knowledge about how many Pfizer employees have received the Pfizer COVID vaccine. Wouldn't Pfizer want the public to know that information to help prove that it is safe. Reporter asked, "could the ingredients in the vaccine still be in the body even after someone's antibodies are gone after they've received the vaccine, for example like a year later. Reporter stated, "I listened to a podcast from a conspiracy theorist about how everyone who received this (Pfizer COVID) vaccine are all going to die within 2-3 years, could that be possible. Reporter asked, "typically when they do trials like for other vaccines, they do it over 5 years, but this one they were able to do quicker is that because they had more people available to run the trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.
pt rpt sore/swollen @ rt arm since vax, seen @clinic w/bruising, slight swelling @ rt arm, full rom rt shoulder/arm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 03:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "cancer survivor" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: day 9 with persistent positive tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the reported events Drug ineffective and Covid-19 cannot be excluded for the suspect drug (BNT162B2, BNT162B2 OMI BA.4-5).
received shot at ll:45 am was fine went home. about 4:00 started to get cold.  developed flu like symptoms, headache, fatigue little bit of fever, pain up back of neck and to my ears. was in bed all night on 3/12/21, stayed in bed all day 3/13/21.  Had some oatmeal, gatorade, juice.  Could not taste anything back to bed.  Sunday got up thought I was good.  But dizzy and lightheaded, little itching on my legs and a little nausea.  Had tuna sandwich could not taste it, thought it was awful.  Back to bed all day.  Monday I am up but still dizzy when standing trying to stay up but just sitting.  Taste has come back.