chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain and soreness in arm; very hard to raise arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain and soreness in arm) and HYPOKINESIA (very hard to raise arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain and soreness in arm) and HYPOKINESIA (very hard to raise arm). On 17-Jan-2021, VACCINATION SITE PAIN (pain and soreness in arm) outcome was unknown and HYPOKINESIA (very hard to raise arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes ibuprofen and arm exercises. No concomitant medications were provided by reporter.   This case was linked to MOD-2021-013686 (Patient Link).
Tinnitus.  Kept me up all night and had to cancel plans the next day.  Obviously, I don't know if it is connected to the vaccine.  Just that this is the worst tinnitus I have ever had.
started with a change in mood then severe headache. then progressed into pain in the deltoid much worse than it seemed it should be - and worse than previous flu shot. i had not eaten all day and the thought of food was disgusting. started shivering and chattering teeth, worse than the worst flu i have had. covered with many blankets, fever rose above 101 started to feel extremely nausea, fainted for one second then sat up quickly to vomit. vomitted everything in me and then back to blankets and chattering, fell asleep woke up very very hot, did not take temp but it was high, laid uncovered to try to bring temp down. woke up at 5am still unwell, dizzy, pain in all joints and muscles fell back asleep until 8, now, feel better but still weak, headache, some muscle joint pain, eyes feel hot, still mild fever under 101.
Aches; temperature 100 degrees F/Fever; Chills; Mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old 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 on 02Apr2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Apr2021 (reported as next day), approximately 18 hours after the second dose, the patient had temperature 100 degrees Fahrenheit, aches, chills and mild headache. Fever broke 12 hours later and the patient felt great the next day (on 04Apr2021). The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events aches, chills, temperature 100 degrees Fahrenheit/fever and mild headache. The clinical outcome of the events aches, chills and mild headache were resolved on 04Apr2021 while that of temperature 100 degrees Fahrenheit/fever was resolved on 03Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chills; cold feeling; Shaking; This is a spontaneous report received from a contactable reporter(s) (Physician).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; FEELING COLD (non-serious), outcome "unknown", described as "cold feeling"; TREMOR (non-serious), outcome "unknown", described as "Shaking".  Additional information: Patient had shaking and chills that she had never had in her life. Reporter says he doesn't know enough about the relative, she was just one of his relatives and she had the cold feeling and shaking. Reporter seriousness was unspecified.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Facial angioedema, bronchospasm w/in 4 hrs, lasting until morning.
Had varicella on 01/31/07 MMR was given 01/17/07 so invalid dose.
Initial unsolicited pregnancy report received from a nurse on 10 March 2016. This case is linked to 2016SA051134 (same reporter and same vaccine). This case involves female patient (age not reported) who was vaccinated with first dose of ADACEL (batch number- U5298AA, expiry date- 27 March 2018, site of administration not reported) intramuscularly on an unspecified date. Pregnancy information included last menstrual period, estimated delivery date, pregnancy trimester was not provided. The patient's medical history and concomitant medications were not reported. Illness at the time of vaccination was reported as none. On an unspecified date, same day following the vaccination, the patient had developed redness, swelling, warmth and fever. Relevant laboratory test was reported as none. The patient's corrective treatment included compresses and over the counter medications. The pregnancy outcome was not reported. Documents held by sender: none.
Sweats, aches, dehydration, diziness, light headed, rapid heart beat all starting the night of 3/17/2021, Covid test taken the morning of 3/20/2021 that came back negative, left for spring break with family. Still felt bad on Monday, 3/22/2020- checked into the ER. I was then admitted to the hospital for 2.5 days with white blood cell count extremely low and dehydrated. $20,000 worth of a stay and tests later to find the result all due to the vaccine
Per: MA. She had explained the procedure to patient and his legal Guardians and they were advised to sit in clinic x 15 min after vaccine administration to view for any adverse reactions. Once vaccine was administered patient stated he felt nauseous. MA advised patient to please lie down while she stepped outside the room to get an emesis bag and his pcp. While she was retrieving the emesis bag and provider; The MA'S heard screaming and found the patient on the floor. Patient had not layed down as advised by MA and fainted while she was retrieving the emesis and Provider. Pt was not unconscious for long, However, patient did have a minor cut on his forehead due to the fall; which was taken care of in office by the nurse and pcp. Vitals were also taken by the Nurse and MA.
Chest pain, rapid heart rate (126+ BPM) at rest, heart skipping a beat/heart palpitations , extreme fatigue, numbness in extremities, fever, chills
Typical mild effects (chills, fatigue) experienced a few hours after the shot (3/12), but strangely again a week later on 3/19 additonally slight headaches, soreness and itchiness at injection site. Chills went away the following day, headaches prolong a bit longer. Arm is still sore.
Like a flu, headache, body ache, no energy, fever, slept all day.
not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st received more than 6 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2023 A pharmacist called to ask for information about patient who received the first dose of Shingrix more than 6 months ago. The Healthcare professional asked if the patient need to restart the series. The reporter did not provide information about the patient. The reporter consented to follow up. This case was one of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR127219:same reporter, patient 3 of 3 US-GSK-US2023124590:Same reporter, patient 1of 3
Sore, swollen, red, hurts to move arm and shoulder. Motrin.  Vaccine given in rotator Cuff.
Started to feel tingling on right side of torso, two days latter had a visible outbreak of shingles on right side of torso with severe pain. Went on 1 week course of valACYclovir (1 g) while also taking Advil for pain. Pain has subsided and outbreak is clearing.
Narrative:  71yo M died on 7/20/21 on at community hospital after presenting to community hospital ER with Chief complaint: Shortness of Breath. Pt with a h/o Bladder cancer. No Death/DC Summary available. Pt had received covid vaccinations on 2/14/21 & 3/13/21. Appears death is not related to vaccinations.
This spontaneous report was received from a pharmacist, concerning a 45 year old male patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 14-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On 25-JUL-2017, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, an unspecified physician wrote a prescription for the patient, it couldn't be determined if a third dose was necessary. No adverse effects were reported.
HYDROCEPHALUS PRESSURE INCREASED; HIGH BLOOD PRESSURE; This spontaneous report received from a patient via social media concerned a 61 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hydrocephalus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced hydrocephalus pressure increased, and high blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hydrocephalus pressure increased and high blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516875-covid-19 vaccine ad26.cov2.s -Hydrocephalus pressure increased. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
heart started quivering/ shaking; jiggling/fluttering/shaking; heart would pound; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 06Mar2021 13:00 (lot number: EN6205), dose 2 on 27Mar2021 13:00 (Lot Number: ER8730), both via an unspecified route of administration, administered in right arm at the age of 79 years old as single dose for covid-19 immunisation. Medical history included environmental allergies. The patient's concomitant medication received prior vaccinations within 4 weeks included allergy shots. Vaccine was not Administered at Military Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Caller had a side effect from the Pfizer COVID shot. Her cardiologist suggested she call. She had the first shot 06Mar2021, and two days later on 08Apr2021, her heart started quivering/ shaking only at night. It would wake her up, or would wake her up in the morning when it was time to get up. It never happened during the day. The doctor said it could have just been because she was busy during the day, and didn't notice it.  She only noticed it at night. This went on for 2 weeks. After the first week, it was still doing it so she went to her cardiologist. The doctor gave her a heart monitor (Mar2021). She wore the heart monitor for 2 weeks. She just got it off a week this Tuesday, but didn't have results yet. She got the second vaccine. The heart issue got better. It was doing it anymore before the second one. Her heart would pound sometimes too (Mar2021), but not for a long time. It would be less than a minute, and it wouldn't happen every time she had the heart shaking. She could hear it. The jiggling/fluttering/shaking got better before she went for her second shot (Mar2021). She got the second shot on 27Mar2021, and it started up again two days later. For three days now she hasn't been awakened by it. Her heart hasn't been pounding. Her doctor thought she should let Pfizer know. She had never felt better now. She would take her heart rate and blood pressure after each episode, and her blood pressure nor her heart rate ever went up (Mar2021). She never felt bad the whole time.  It was just alarming to her when it would happen. She didn't know if it was gone for sure, but it had improved. She noticed it on a Monday the 08Mar2021 two days after the vaccine she got on 06Mar2021. She noticed it both times two days later. The events did not require a visit Emergency Room, but required Physician Office, didn't go first week was doing it regularly went to cardiologist made appt and went. The outcome of the event Heart pounding was recovered on an unspecified date, of the other events was recovering.
6/13 95-year-old female with history of paroxysmal A. fib, hypertension, hyperlipidemia, CHF, remote history of malignant melanoma presents to the emergency room on 6/13 as a transfer from ER with complaints of weakness.
This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
tiny knot in the are of the injection; extreme soreness at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (tiny knot in the area of the injection) and VACCINATION SITE PAIN (extreme soreness at the site of the injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (extreme soreness at the site of the injection). On an unknown date, the patient experienced INJECTION SITE MASS (tiny knot in the area of the injection). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 06-Mar-2021, VACCINATION SITE PAIN (extreme soreness at the site of the injection) had resolved. At the time of the report, INJECTION SITE MASS (tiny knot in the are of the injection) 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.   No relevant concomitant medications were reported. Treatment include Advil
Fatigue: 3/27, 3:30 pm - 3/29 Chills: 3/27, 4:30 pm - 3/29 Nausea (off and on): 3/27, 4:30-10:00 pm Soreness at injection site: 3/28, 8:00 am - present
Patient developed chest tightness and pain after exercising for the first time in a while on 6/7/2021. This worsened over the next several days and he presented to the hospital with these symptoms on 6/13/2021. Lab work revealed elevated troponins, EKG showed elevated ST segment elevation and he was diagnosed with an acute perimyocarditis.
No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report has been received from a medical assistant, regarding a 4-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-JAN-2023, a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) underwent a temperature excursion between 6- and 14-degrees Fahrenheit (F) for one hour, this as a result of data logger. On 02-FEB-2023, the patient was vaccinated with the improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, intramuscularly in the right thigh as prophylaxis (lot number: W019627, which was determined to be valid, with an expiration date on 19-DEC-2023) (strength, dose and scheme were not reported). There was not any report on previous temperature excursion.   This case is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007837: US-009507513-2304USA007843: US-009507513-2304USA007869:
56 yo female with a history of follicular lymphoma (diagnosed in May 2021 s/p bendamustine and rituximab, complicated by left ureteral obstruction), HTN, and HLD. In December 2021, she presented to an OSH with abdominal pain, nausea, and vomiting. Imaging revealed a retroperitoneal tumor. She underwent biliary and ureteral stent placement on 12/22/21. In addition, she was diagnosed with Bells Palsy due to left ptosis without facial nerve involvement and orbital mass on imaging. She was discharged home on 12/24/21. On 12/30, she presented to ED with complaints of nausea and vomiting and was diagnosed with COVID 19 on admission. On 1/3 patient developed acute hypoxia requiring supplemental oxygen. She was started on dexamethasone and remdesivir on 1/5, diuresed, and received one dose of tocilizumab. Her course has been complicated by worsening hypoxia with increased requirements of oxygen prompting multiple RRTS. On 1/9 the patient was transferred to the ICU for application of Optiflow for additional oxygen support. The patients respiratory status continued to worsen requiring several days of BiPap before eventual intubation on 1/19. Abx were started following fever. She remained on the ventilator with high requirements. She passed 1/22/22 at 1514.
Pt recvd vax & began to exp serum sickness type react consisting of joint pain, weakness &/or diarrhea; workup included numerous tests for collagen vascular disease, & been non-diagnostic;
/1/8/21 developed sore throat cough, little congestion after vaccine given 1/7/21 did covid test which was negative at that time.
A few weeks after taking the 2nd dose of the Pfizer vaccine in June 2021, my speech became slow. I also developed brain fog and would faint every time I would get in a steam bath or go near the waterfall where there would be steam. After some time, I started to have back pain and severe shoulder pain. I took Advil for pain relief thinking this would be a minor muscle pain. Last October, I started to experience loss of sensation in my right pinky and ring fingers followed by pain in my right arm. This went on for about 2 months and I thought that one of my nerves may have been pinched, so I visited a neurologist. The neurologist performed an EMG test on my right arm and the results were normal. The neurologist prescribed 1 Gabapentin 300mg/day for one week and recommended to take 600mg after that. I took Gabapentin for about 1 ½ months and noticed that the loss of sensation has spread to the rest of my limbs. I couldn't walk for a very long distance due to stiffness and numbness in my legs, dizziness, tiredness and feeling fatigue. My fingers would lock in the morning after waking up and would take a few hours to unlock after stretching and putting my hands under hot water. With the neurologist's supervision, I withdrew from Gabapentin. The neurologist prescribed Cymbalta, but I didn't agree to taking it. The results of my MRI for cervical spine and brain with/without contrast were showing white matter but the neurologist said it was insignificant and ruled out any neurological diseases. The neurologist also performed a Lyme disease test, blood tests, and lumbar puncture. My lumbar puncture results were showing 2 oligoclonal bands. Again, the same neurologist ruled out any neurological diseases. My blood test returned lower Vitamin D level (17 ng/ml). During this time, I went to the ER 3 times because of severe back and neck pain, feeling weakness in my body, heart palpitation, and experiencing head spins. I visited rheumatologist, endocrinologist, gastrologist, cardiologist in the meantime trying to get to the bottom of my health issue. The rheumatologist wrote a few blood tests, and the results were normal. I am yet to follow up with my endocrinologist, gastrologist, and cardiologist. My endocrinologist prescribed Vitamin D2 50000 IU/week and the urgent care doctor prescribed Vitamin B12 injection/week. To accelerate the recovery process, I started taking supplements such as Magnesium, Zinc, Omega3, Glutathione, Turmeric, NAC, and Quercetin. I also have been going to physical therapy, acupuncture, and cupping. I went to three other neurologists. The last neurologist I visited, diagnosed me with GBS and recommended IVIG. On my second visit, the doctor voided the request for the IVIG without any known reasons. The loss of sensation is still there, and my fingers still lock in the morning after waking up. Lately, I have noticed that drinking coffee and consuming some other foods make me nauseous, dizzy, cause developing of mucus in throat, and fast/irregular heartbeat. The above adverse events started after taking the second dose of the COVID vaccine.
Nausea that lasted a month.  Rash started under left armpit.  Rash eventually spread over chest, neck, breasts, under both armpits, on both arms. Left arm pain. Rash under armpit and left arm pain still continue.
Red splotches/ hives on arms, belly, and legs. Some are slightly raised. There is no pain, itchiness, or discomfort. This happens on occasion. It is similar to the reaction I have to penicillin. It happens sometimes when I?m ill with a flu or cold, but I?m not sure if the reaction is due to the illness or OTC or prescription medication. I?m not concerned for my health. I just wanted to report the reaction.
A non-serious spontaneous report of gave expired FLUMIST was received from a nurse concerning a 12-year old male. On 03-Feb-2010, the patient received FLUMIST that expired on 2-Feb-2010. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. No late occurring adverse events were reported. Additional information was received on 11-May-2010 and incorporated into the narrative: information on late occurring adverse events.
20 min after receiving vaccines, fainted while standing, hit back of head on floor. Remained unconscious for 2 min.