chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 26-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M004883, expiration date on 02-OCT-2017), oral, which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Child had vasovagal response after administration of GARDASIL vaccine - fell and struck parietal area of skull and right wrist. CT of skull showed right posterior parietal scalp hematoma 15 mm in thickness with transverse diameter of 6.5 mm. X-ray arm negative. Also developed vomiting.
Saw Dr in Oct for vaccine. Called clinic talk to nurse, Nov or Dec. Saw Dr Feb '15. Immediately - not feeling well; stayed awake during night, due to flu vaccine; had flu vaccine, late day 10/28/14. Next morning, had pneumonia vaccination: my concern; too much for my body due to flu shot?? Answer "No" not too much; days and weeks to follow: I became stumbly (like running into door facings); feeling faint at most times; very faint HR and heartbeat. Would soak in tub of hot water to revive. Unable to drive or go places. Extremely weak. This went on into Feb '15/March 15. Chelation to remove until adverse reaction to chelation also.
The patient stated that by the evening on 02/12/2018, that her upper arm was sore, a little itchy, and red. At bedtime, the patient noticed from her shoulder down to her elbow was swollen. Patient said that pain, itch, and the redness intensified throughout the overnight. Upon rising on 02/13/208, the patient said she decided to go to urgent care/after hours care. At that time, her inner upper arm had developed a blue/purple "bruise" like and the swelling continued down her arm and into her wrist. The patient was prescribed Keflex 500mg 1qid x10 days from the urgent care.
Dizziness. It was very slight when I waited for 15 minutes so I thought maybe I was getting a headache. I was fine for a while then around 8 pm, I started feeling very dizzy when I went to a store. After eating again, I felt better but just exhausted
Patient presented to ED with complaints of severe fatigue and generalized weakness. He complains of chills as well. WBC found to be elevated. No electrolyte abnormalities found. Patient is suspected to have a urinary tract infection. Patient received ceftriaxone for UTI. Patient was admitted to the hospital.
My son started having breathing problems, his chest would go up and down rapidly and you could see his ribs while inhaling and exhaling, he started making heavy breathing noises and required medical attention where they had to put him under the nebulizer, he required 2 doses of their albuterol. My son never had any respiratory issues, nor symptoms of such sort prior to vaccination. The exact date I listed of when he started to show respiratory issues isn't exact but I know it was fairly after receiving his vaccination, and I made sure to come back to his doctor to voice my concerns. He was completely unconcerned and recommended steroids for his condition when it didn't improve and the albuterol stopped working.
UritcariaPruritus Narrative:  itching developed within 15 minutes of the injection; responded to antihistamines
This spontaneous report was received from a healthcare worker referring to 3 patients of unknown ages and genders. On an unknown date, the patients were placed on therapy with TICE (dose, frequency and indication not reported). Healthcare worker reporting that the pharmacy is possibly using one single vial of TICE to treat 3 patients at a time. Healthcare worker did not know what dose the patients were receiving. He stated he was not aware of any PQC issue. Healthcare worker was not certain if the pharmacy was actually using the vials of TICE in this manner or if he misunderstood the pharmacist. No symptoms reported. Additional information has been requested.
I got it in my arm I started getting dizzy I have history of vertigo, so I thought that's what was going on. I sat down and the back of my neck started to feel tight, I had turned beat red and the staff asked if I wanted an ambulance and I felt weird not like myself at all. Then my husband made me walk to the car and took me home and my husband helped put ice all over my body (head, neck, and arms) then I started having a migraine and my joints hurt. I asked some of my nursing friends about TYLENOLs and was told not to and after some time I took some anyways. I also used BIOFREEZE and the pain went away after a few days. I also noticed some swelling in my legs that I still currently have. They got the size of grapefruit, and no doctor has been able to pinpoint why I lost my balance. I was given anti-vertigo and anti-nausea medication that I didn't take. I just elevated which did help some.
Neck and armpit warm to the touch; Swelling like a lump on neck and left armpit; Left armpit hurts; bones pain; Full body pain; joints pain; Fever; A lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones pain), VACCINATION SITE WARMTH (Neck and armpit warm to the touch), PAIN (Full body pain), ARTHRALGIA (joints pain) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced BONE PAIN (bones pain), PAIN (Full body pain), ARTHRALGIA (joints pain), PYREXIA (Fever) and FATIGUE (A lot of fatigue). On 09-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Neck and armpit warm to the touch), VACCINATION SITE SWELLING (Swelling like a lump on neck and left armpit) and VACCINATION SITE PAIN (Left armpit hurts). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 08-Apr-2021, BONE PAIN (bones pain), PAIN (Full body pain), ARTHRALGIA (joints pain), PYREXIA (Fever) and FATIGUE (A lot of fatigue) had resolved. At the time of the report, VACCINATION SITE WARMTH (Neck and armpit warm to the touch), VACCINATION SITE SWELLING (Swelling like a lump on neck and left armpit) and VACCINATION SITE PAIN (Left armpit hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included high blood pressure medication. Treatment information included tylenol for fever.
I had a significant reaction to shot 2. Fever type feelings, aches, pains, nausea, etc. I was in bed for many hours.  One of those symptoms on day 2 seemed to be a throbbing pain in my right knee and right foot. it seemed quite strange at the time.  By Tuesday morning - about 40 hours after the shot - when I felt well enough to move around I noticed that I had numbness in my right leg starting at the knee and working up the leg about 9-10 inches.  The numbness is only on the front of my leg and only in a strip about 3-4 inches wide starting about half way on the kneecap and working up the leg again about 9-10".  This numbness almost feels like the sensation after a dentists numbs the mouth for a procedure, like local anesthesia.  I just assumed it was temporary and would completely heal. It has not. I informed my primary care doctor and sent a follow up that it is continuing to manifest itself.   My leg is functioning normally and I have no other symptoms or issues - only the numbness in the leg in that one area.  Because this has gone on for so long I felt I should report it.
High fever, shaking chills, shortness of breath, dizziness.  Passed out onto bedroom floor.  Woke up 4 hours later drenched in sweat. Heart palpitations.  Palpitations lasted on and off for several days
Mother stated patients eyes began to "roll back in head", had stiff neck and stiff right arm after immunizations that resolved in 1 to 2 hours after immunizations.
This spontaneous report was received from a 75 year old female patient and refers to herself. The patient's medical history included having unspecified lab work done from previous years but they didn't say anything that caused allergies. The patient's concomitant medications and past drug history were not reported. In an approximately October 2010 (also reported as 4 years ago) the patient started ZOSTAVAX (route, dose, frequency and lot # not reported) symptoms described as little pimples, redness and hurting. It was reported that in an approximately October 2010 (also reported as 4 years ago) her doctor prescribed her ZOSTAVAX and she was administered the vaccine from a nurse at the pharmacy. On 20-OCT-2014 (also reported as a week ago) the patient got shingles again which included symptoms on her face, swelling, redness, pain, itchy and bloody. The patient stated that ZOSTAVAX injection did not really help with the shingles (on 20-OCT-2014) but it stopped the virus. It was reported that on 24-OCT-2014 the patient went to urgent care and they gave her treatment for the shingles symptoms, which included doxycycline and valacyclovir to take for a week. The doctor at the urgent care advised her to follow up with her primary care physician and optometrist because they want to make sure that nothing would complicate her eyes because it was on her face. There was no relevant laboratory data. It was reported that as of the time of the report (25-OCT-2014) the patient reported that everything was down including swelling being better, symptoms around her face, pain, redness and bleeding. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Pt admitted to hospital on 1/4 with epigastric abd pain and tested positive for COVID. Discharged to recover at home on 1/6. Presented to different hospital 1/12 with progressive SOB. Remains admitted, being treated for Acute on chronic respiratory failure with hypoxia due to COVID-19 pneumonia.
swelling at the injection site (1st dose); slight temperature (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)) in a 63-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2022-525568 (Patient Link).
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9, lot # N020353, expiry 28-APR-2020 (dose, frequency and route were not reported). It was reported that the sterile diluent (MERCK) used to reconstitute GARDASIL 9 was properly stored. The administered doses of the GARDASIL 9 experienced a temperature excursion of 10.9 degrees Celsius (°C) for 30 minutes, as recorded by a data logger. The vaccine had a previous temperature excursion of -3.5°C for 660 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA005930: Original Case: 1808USA005930; US-009507513-1811USA010211: Original Case: 1811USA010211; US-009507513 1811USA010213: Original Case: 1811USA010213; US-009507513-1811USA010215: Original Case: 1811USA010213.
Patient got JJ vaccine. Questionnaire stated no to any previous reaction. Upon talking to patient she stated she had itching in throat before with the flu shot. I asked if she had ever had an anaphylactic reaction or needed an EpiPen, patient stated no. She did mention she was a nurse, so in the past with the flu shot she would take Benadryl for the itching sensation in throat. I counseled patient to stay in area following vaccination so I could monitor her. Approximately, 10 minutes following vaccination she came up to the counter stating her throat was feeling itchy and that she needed Benadryl. I told her I cannot give her Benadryl, we are only able to give Epi and call 911 per our protocol. She stated she would take Epi but didn't want 911 called. At this point, it was not an anaphylactic reaction since patient was verbal. I did go and ask the urgent care in our store if they can give Benadryl and they said no, so the patient ended up buying her own Benadryl and taking it. I monitored the patient for 30 minutes and gave her some water. She stated she was feeling better after taking her Benadryl. After 30 minutes, patient stated she was fine, felt slightly dizzy, but overall good. She then left the store. I called the patient this afternoon to check on her and she said she was good.
Within 3 hours of injection, she developed periorbital edema without descending edema to rest of face; this resolved by 9 hours after injection.  She described it as significant swelling.  5 hours after injection developed a skin rash on entire arm which lasted until the next day.  The next day, she developed tightness in her neck and shoulders which lasted a couple of days.
pt. recvd. booster vax & developed sore throat,fever,& faint rash on chest.
tested positive for covid 3-4 days afterward; tested positive for covid 3-4 days afterward; This is a spontaneous report from a contactable consumer. This male consumer of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The consumer received first dose 20 days before in Jan2021 and tested positive for COVID 3-4 days afterward in Jan2021. He was tested himself after 15 days and it said he had zero antibodies in Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
June 30, 2020   Shingrix 1st dose at 11:33 am 1:00 pm - 10 pm: arm sore; grew fatigued; queasy 10 pm - 2 am: in bed:  extreme cold, shivering. wool socks, flannels, down comforter, heating pad  2 am: nauseous, legs could barely hold me up, staggered to bathroom, urinated. didn't throw up 2:15 am:  severe coldness gone; slept without down comforter.  July 1, 2020: 7:00 am: up to take medicine. Husband helped me but only could stand for a minute or so. sat: shivering,         dry heaves, profusely sweating, threw-up some liquid. didn't take medicine. 7:30 am: slept in blue chair until 10 am 7: 30 am - 1 pm slept in bed. 1 pm: took medicine. extreme thirst. not hungry; left arm so sore couldn't hold anything in hand. 1:15 pm - 9:30 pm: mostly sat in chair; drank liquids. eggs for dinner 9:30 pm: bed; no coldness. slept July 2, 2020: 6:36 am: woke up.  left arm still very sore, but could hold plastic cup in hand.   took medicine.  very very fatigued.  July 3, 2020, July 4, 2020:   6 am: woke up left arm sore. very very fatifue.   Stayed inside.. napped 2 hours. July 5, 2020 left arm sore. able to walk on treadmill 45 minutes.  July 6, 2020 woke up with sore throat, nausea. very fatigued. mainly sat all day. couldn't sleep-- freezing cold again. not as bad as June 30 coldness, but I had to wear flannels, wool sock and use down comforter. finally got up at 3 am.  very fatigued. July 7, 22020 mild sore throat. congested. I have to keep clearing my throat. Sinuses clogged.
RN alerted lead RN of a 14 year old male client received Pfizer (for 5 through 11 years of age, Lot # FK5127) at 10:50am. Client should have received Pfizer for 12 years of age and older. Lead RN informed mother of client that client will receive Pfizer for for 12 years of age and older for client's second dose per clinical lead RN, mother of client verbalized understanding.
Information has been received from a physician concerning a 25 year old female with a history of hair loss who in June 2009, was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On approximately 05-AUG-2009, 3 weeks ago the patient experienced "mild" hair loss. The patient had a past history of temporary hair loss after she had received a series of hepatitis B virus vaccine (unspecified) when she was in high school. At the reporting time the patient had not recovered. Additional information has been requested.
Patient presented to Ophthalmologist on September 4, 2014 for emergency appointment from atypical symptoms that had progressed since first noticed on Saturday, August 30 and had pain in left eye, little to no acuity upon exam. Ophthalmologist diagnosed Optic Neuritis and sent patient for a STAT MRI of Brain and Contrast of Orbits. Patient PCP was consulted and PCP sent patient directly to ER for immediate treatment and before MRI to be completed in which IV Steroids were administered (1000 mg, 1x per day 9/5, 9/6, 9/7) and admittance to Hospital for duration of treatment. MRI of Brain and with contrast of Orbits was completed on Friday September 5, 2014 and confirmed diagnosis of Optic Neuritis. Patient remained in hospital through 9/7 and was released on oral steroids, gradual diminishing dosages through 9/18.
Pt stated that they were feeling diaphoretic and "tingling" immediately after their first Pfizer vaccination in their left arm. Pt was laid on the ground in a Trendelenburg position and then felt better. After standing patient became dizzy. Last oral intake was at 08:30 hours. Pt was given water and pretzels. Last Vitals conducted 16:25 hrs HR: 97, R: 18, BP: 140/87, SPo2: 98%. Pt was lucid and aware of their surroundings with AxO-4.
Information was received on 02-NOV-2016 from a nurse regarding an unspecified number of patients. On unspecified dates, an unspecified number of patients may have received improperly stored M-M-R II, (lot # M004063, expiration 25-JAN-2018; lot # M010426, expiration 01-MAR-2018), PEDVAXHIB (lot # M020101, expiration 07-MAR-2019, lot # M025194, expiration 22-MAR-2019) and  RECOMIBVAX HB (lot # L045117, expiration 06-OCT-2018). Temperature: 9.3 degrees Celsius for 2 hours and 14 minutes. No adverse effects were reported. No previous temperature excursion was noted. No further information was provided. Additional information is not expected.
Information has been received from a physician concerning his daughter who "last week" was vaccinated with her second dose of Gardasil (lot # unspecified).  There was no concomitant medication.  Subsequently the physician reported that his daughter received the vaccination and fainted.  The shot was given by another physician at a pediatric office.  Subsequently, the patient recovered on the same day as the shot.  Additional information has been requested.
Vaccines given 5/28/02 mid-afternoon. Seen 5/30/02 at approximately 10:30. Left arm with swelling of proximal 1/3 with erythema about 85% circumferential. Small bruise in center at injection site of DTAP. Not tender or red. Painful and tender evening after injections. Swelling noted next day. On 5/10/02, sister had similar reaction but not as bad at DTAP site; same lot number.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 05-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. Combination product report: Yes; brand name: RECOMBIVAX HB SYRINGE (DEVICE); common device name: Hepatitis B Vaccine (Recombinant); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp.; device lot number: S022583; expiration date: 31-OCT-2021; device age and unit: 0; malfunction: Unknown; device usage: Initial; evaluated by mfr: Not returned to manufacturer; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp rep rationale: Case information does not meet the criteria for Reportability: Sender's Comments: US-009507513-2010USA001083.
The first weekend - flu-like aches and pains along with fatigue. (had lab work for an upcoming unrelated doctor's appointment and found out that numbers elevated indicating inflammation). The second weekend - Friday, August 27, became nauseous, throwing up around 7pm, reduced appetite the next 2 days, tender stomach, weak, fatigued, by Monday, August 30 - continued weak & fatigued, nausea mostly gone, appetite had returned.