chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweating; hoarse voice; second day was the worst and he spend it mostly in bed; Drowsiness; arm is red and hot six inches around the injection site.; fever/intermittent fevers; Chills (couldn't get warm enough); Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness), MALAISE (second day was the worst and he spend it mostly in bed), HYPERHIDROSIS (Sweating), DYSPHONIA (hoarse voice) and ERYTHEMA (arm is red and hot six inches around the injection site.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MELOXICAM (MOBIC) for Arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SOMNOLENCE (Drowsiness), ERYTHEMA (arm is red and hot six inches around the injection site.), PYREXIA (fever/intermittent fevers), CHILLS (Chills (couldn't get warm enough)) and HEADACHE (Headache). On 27-Apr-2021, the patient experienced MALAISE (second day was the worst and he spend it mostly in bed). On 28-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating) and DYSPHONIA (hoarse voice). On 29-Apr-2021, HEADACHE (Headache) had resolved. At the time of the report, SOMNOLENCE (Drowsiness), MALAISE (second day was the worst and he spend it mostly in bed), HYPERHIDROSIS (Sweating), DYSPHONIA (hoarse voice), ERYTHEMA (arm is red and hot six inches around the injection site.), PYREXIA (fever/intermittent fevers) and CHILLS (Chills (couldn't get warm enough)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Within an hour of vaccine administration, the patient started to experience fever, drowsiness, chills (couldn't get warm enough) and a headache. On the second day the symptoms were worse and he spent most of the day in bed. On the third day he experienced intermittent fever, chills, sweating and a hoarse voice and arm is red and hot six inches around the injection site. Treatment included concomitant medication meloxicam acetaminophen to help with fever.
Mother called on 4-6-09 stating that patient had a fever of 103.6 for 48 hours.  No other symptoms noted.
No additional AE reported; MMR II and VARIVAX that had undergone temperature excursion were administered; This spontaneous report was received from a nurse referring to a currently 13-month-old male patient. The patient's current condition, pertinent medical history and concomitant therapy were not reported.  On 14-JAN-2022, date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (Lot # T031436 and expiration date upon internal validation was 15-SEP-2022) and varicella virus vaccine live (oka/merck)(VARIVAX) (Lot # U015845 and expiration date reported as 19-MAY-2023) that had undergone temperature excursion for prophylaxis (Product storage error). No additional AE reported. No PQC reported.
Information has been received from an unspecified reporter referring to a 15 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 13-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
tiredness; headache; muscle pain; chills; fever; nausea; feeling unwell; All the flu symptoms  tiredness, headache, musclepain, chills, fever, nausea, feelingunwell; injection site pain; This is a spontaneous report received from a non-contactable consumer, the patient. A 27-years-old male patient of received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 08:00 AM (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications was 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 was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021, at 02:00 AM, It was reported that the patient experienced all the flu symptoms, injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received ibuprofen (MANUFACTURER UNKNOWN) and icepack/heated pack as a treatment measure for the reported events. The clinical outcome of flu symptoms and vaccination site pain, tiredness, headache, muscle pain, chills, fever, nausea and feeling unwell was recovering at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt visited PCP on 1/14/22 complaining of sore throat, difficulty swallowing, dry cough and itchy rash on the chest and neck started yesterday, she received a booster vaccine the day before, has been using prednisone and albuterol. Pt instructed to continue prednisone and albuterol, start Zyrtec and Benadryl at night, symptomatic treatment and follow-up with problems
Patient had onset of cough 3 days prior to admission, patient had nausea and vomiting and went to bed early, the next morning her children found her poorly responsive in bed. In the ER, blood was noted in her mouth with gaze deviation, brain imaging supportive of PRES. Pt admitted for hypertensive emergency, acute respiratory failure, encephalopathy, concern for seizure at home, tested positive for Covid. Patient treated with Remdesivir, Solu-Medrol, IV abx. Patient also suffered a CVA. Patient discharged home.
A little bit of pain at the arm and fatigue. Approximately one week later on 4/22, I noticed 2 pea-sized swollen supraclavicular lymph nodes and have extreme collar bone and a/c joint/shoulder pain. I read case studies about other vaccine recipients who had a lymphadenopathy in similar areas, so I will wait to see if it clears up before seeing a doctor.
Reported by the employee, "Received flu shot at around 1130 on Wednesday, 09/12/12. Woke up around 2330 with generalized severe urticaria. Called and spoke with Pharmacist and Dr who both offered to either see me in the ED as a patient or to call in scripts for allergic reaction. I chose to have scripts called in. I took the prescrbied meds and the itching subsequently resolved over the next couple days."
Vaccine error  I stuck the needle in his deltoid muscle and as I was pushing the plunger the syringe came apart and the vaccine spilled on his arm. I cleaned his arm with an alcohol swab. I explained to the patient that I wasn't sure how many mLs actually went in but from what he felt, and I saw, we believe anywhere from 0.1 to 0.2 mL was actually injected.
Dizziness, blacked out - fainted (out for 1 min.), nausea, paleness, sweating, weakness, tired, weak, dizzy and headache for several hours after (still has symptoms 24 hours later)
bilateral persistent leg/calf pain the day following immunization, tachycardia, pain improved with tylneol and ibuprofen but required monitoring in the emergency room given severity of pain.
Experienced under both arm pits a rash that is described as a rug burn that is painful.  Doesn't think there is swelling of the lymph nodes?
2 wk p/vax uncontrollably crying, sporadic for almost 1mo 1-2hr;sl fever;
Pt up fr nap crying & cont x 10 min then stopped breathing, turned blue & stiffened x 10 sec; resumed breathing; EMT's transported to hosp & eval w/t105 & dx UTI; pt sent home w/ATB & seen by MD next AM; MD felt had febrile sz due to UTI;
Patient received 2nd dose on 3/31 and immediately reported feeling pain and itchiness in her throat and ears. Patient also reported headache, dry throat, and blurry vision.  Clinic MD assessed patient and observed patient for extended observation. Per client, client vision became better after 15 minutes passed- patient reported eye pain on movement and continued dry throat. Patient was told to see HCP if further issues.
Swelling of bottom lip, increased swelling on the left side. I woke up to the swelling 2 days after the vaccine. It could have possibly been swollen through the night while sleeping. Benadryl alleviated the swelling.
Tinnitus within 5 hours of receiving vaccine. Saw two Ear, nose, and throat specialist. Received steroids to help with inflammation.
Patient is a 82 y.o. female who presented with covid 19. Symptoms started 3 days prior to arrival, and consisted of SOB, N/V/D. She was progressively weakening, so her family brought her in. She was found to have profound hyponatremia with sodium 112. Nephrology was consulted, she received initially some hypertonic saline and then NS, with which she had. GI and respiratory symptoms resolved. She tolerated diet. She was cleared by nephrology, and discharged home in stable condition with instructions for outpatient follow up.
Case number PHEH2012US019924 is an initial spontaneous report received from a nurse on 28 Sep 2012. This case refers to a patient of unspecified age and gender. The patient was vaccinated with FLUVIRIN (batch number: 12262P) on an unspecified date. On an unknown date after vaccination the patient was hospitalized with cellulitis of the arm for two days. The outcome and causality of the event was not reported. A quality investigation was requested for this batch of FLUVIRIN with reference number 186103. No other information was available.
1wk p/vax on 3MAR97 pt began devel hives beginning over the site of the inj;hives & joint swelling cont for @ least 10 days;
Episode of atrial fibrillation/atrial tachycardia- responded to propranolol-had blood work which showed elevated d-dimer-had a neg cta-had an echocardiogram which showed elevated right sided heart pressures-follow-up right heart cath showed elevated pulmonary artery pressures with exercise- 2 points away from being dx with exercise induced pulmonary htn-6 min walk test oxygen dropped to 93 and heart rate was elevated-awaiting PFTs  Since early april have been have significant SOB with mild acitivity along with episodes of tachycardia and bradycardia-also days with significant fatigue
No additional adverse effects reported; one patient was inadvertently administered an expired dose of properly stored PROQUAD which was reconstituted with properly stored but expired STERILE DILUENT; one patient was inadvertently administered an expired dose of properly stored PROQUAD which was reconstituted with properly stored but expired STERILE DILUENT; This spontaneous report was received from a medical assistant, referring to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not reported.  On 11-MAY-2020, the patient was inadvertently vaccinated with an expired dose of properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHa) (vaccination scheme, anatomical location of injection and route of administration were not reported; and lot number R026722, which has been verified to be valid, expiration date reported and validated as 17-MAR-2020) as prophylaxis (expired product administered), which was reconstituted with properly stored but expired sterile diluent (MERCK STERILE DILUENT) (concentration, dose, frequency, indication, and route of administration were not reported; and lot number N029636 which has been verified to be valid, expiration date reported and validated as 29-MAR-2020) (expired product administered). No additional adverse effects reported.
The day after the booster I had a headache and sore throat that lasted for several days. Did two COVID tests, both were negative.  Symptoms continued. PCR test and throat culture was done per my primary doctor. My lungs felt heavy and a sense of burning. After Christmas I did a telehealth visit and was prescribed Augmentin. I still wasn't better, called her back and went into the office to be seen. I was sent for a blood draw and chest x-ray...both came back normal. I still have a wifty feeling in my head, not dizzy all the time usually when I have some sort of physical activity.  I am very active, and I am just feeling light headed. I had to sit in the shower, which is unusual for me. I am not short of breath, and my heart is not racing. I got a referral to an Infectious Disease doctor. He ordered an antibody test and another Covid test. Doctor said it's possible I have long Covid, and also that this could also be from my injection. He also ordered a viral panel. He is treating me symptomatically. Some days I feel ok, and sometimes I don't, not a pattern I can discern.
Information has been received from a healthcare worker concerning a 75-year-old female with a history of "treatment back pain stenosis", an allergy to CARDIZEM and LOPRESSOR who on 29-NOV-2007 was vaccinated subcutaneous in the left arm with a 0.5 ml dose of Zostavax (lot # 658395/0966U). Concomitant therapy included hydrochlorothiazide (manufacturer unspecified), MONOPRIL, aspirin, VICODIN, ULTRACET, multi-vitamins (unspecified) and calcium (unspecified). On 11-DEC-2007 the patient called the "office" and reported that she had a headache since 09-DEC-2007. The headache was described as a 9 out of 10 and intolerable. The patient also reported that her blood pressure was elevated. The patient went to the emergency room and was released with a negative CAT scan on 11-DEC-2007. As of 17-DEC-2007 the patient still had a headache which has lessened but is still intolerable. At the time of the report the patient's status was recovering. A product quality complaint was not involved. The adverse events reported were considered to be disabling by the reporter. Additional information has been requested.
6th pregnancy, 3rd viable. Due 9/18/2021.  I was super tired and had diarrhea
As soon as I got the shot it felt like something was flowing through my body limb by limb. My chest starts to feel tight and my upper back my arms were tingling. My right calf and right lower abdomen began having a sharp pain. About 25 minutes later I began sweating and felt like my chest was going to rupture. My heart was racing. Broke out in hives. After about 8 hours I was bedridden Ill. I was puking, fevering, headache and could not move my body I was in so much pain. I was afraid to go to sleep cause I thought I was going to die.
11/07/2019 This morning, at 9:30, I had a flu shot at store.  3 to 4 minutes after, I had a strange reaction. Face flushed,  a quickening pulse or anxiety feeling,  slight lightheadedness, light pain but with serious weakness in both legs spreading across my lower back. Lucky I had a shopping cart to assist me. Great difficulty in walking. Struggled to my car nearby and drove to my doctors office, Dr. I was immediately seen by a nurse who checked me for chest pain. None. But there was no doctor to see me, so I was directed to a walk-in clinic. I was now feeling somewhat improved. I approached the clinic small waiting room. There sat about a dozen people, half of them wearing masks. I declined and came home. Flushed face was improving and I was a little steadier on my feet. Took my blood pressure. 140/64 pulse 61 Now 4 hours later I am approaching normal but guarded. I am 80 and reasonably fit.
Extreme lower back pain following flu shot.  After about 10 minutes pain went away as quickly as it started.  Called 911.  Patient was evaluated.  Patient drove herself home.
achy; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001270 (Novavax).  A 69-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "achy"; PYREXIA (non-serious), outcome "unknown", described as "fever".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300347497 Same patient, different AE/vaccine dose;
Headache, Myalgia, Fever, chills, fever 101.3F, bitter taste in mouth Narrative:
Mild chest pain after first vaccine.  After second vaccine, two days later moderate chest pain and tightness.  After three days severe chest pain and tightness.  Went to ER July 18.  Referred for stress test.  Stress test 07/21 and failed bc of a spasming vessel in the heart and severe chest pain.  Referred for echo and cardiac cath on 08/03.  Cardiac cath showed normal vessels that did not require stenting.  A portion of the heart muscle showed spasming around a vessel.  Still having palpitations and fluttering.  Was told no vigorous exercising.  follow up visit with Dr. on 08/24
sore right arm; 3 days after shot, tongue and lips burning for 24-36 hrs.; Headache; Fatigued for about a day, 24 hrs after second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MOTRIN [IBUPROFEN]; ZYTREC; WELLBUTRIN. Vaccination history included: Bnt162b2 (Dose number: 1, Lot unknown reason: Misplaced/discarded, Administration date: 25Mar2021, Administration time: 02:00 PM, Vaccine location: Left arm), administration date: 25Mar2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "sinus headache", "Sore left arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Apr2021 17:00, outcome "recovering", described as "sore right arm"; BURNING SENSATION (non-serious) with onset 17Apr2021 17:00, outcome "recovering", described as "3 days after shot, tongue and lips burning for 24-36 hrs."; HEADACHE (non-serious) with onset 17Apr2021 17:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 17Apr2021 17:00, outcome "recovering", described as "Fatigued for about a day, 24 hrs after second shot". Therapeutic measures were not taken as a result of pain in extremity, burning sensation, headache, fatigue.  Additional information: It was reported that the events might be from food but unsure so was listing because not normal. The patient did not have any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not tested COVID post vaccination. The patient did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain ache on both sides of the lower spine. Thursday, neck pain on both sides of the spine. Not a sharp pain. A constant pain.
This spontaneous report has been received from the mother of a 18 years old female consumer. The patient's medical history included low blood sugar, ovarian cysts, slow bowel syndrome, drug reaction/allergy to an unspecified laxative, and constipation. The patient was vaccinated with her first dose of GARDASIL on 13-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 13-SEP-2012, about a month after vaccination, the patient experienced joint pain. On an unknown date the patient experienced low blood sugar at 58, rheumatoid level of 20 and dizziness. No treatment information was reported. The outcome of rheumatoid level of 20, dizziness, joint pain and low blood sugar at 58 is unknown. The relatedness for joint pain, rheumatoid level of 20, dizziness and low blood sugar of 58 was not reported for GARDASIL. Additional information has been requested.
patient had 1st Shingrix in 10DEC2019 and received 2nd dose on 17JUL2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 49EL9, expiry date 07-FEB-2024) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose on 10th December 2019).   On 19-JUL-2023, the patient received the 2nd dose of Shingrix. On 19-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient had 1st Shingrix in 10DEC2019 and received 2nd dose on 17JUL2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 19-Jul-2023 The reporter consented to follow-up. The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
SOB/swelling of face, hands, feet, tongue lasting from 12/21/20 0200h to approx 1000h (resolved with diphenhydramine 50mg PO) Flu-like symptoms/malaise/chills lasting from 12/21/20 0200h to approx 12/21/20 1800h Headache from 12/21/20 0200h; continuing as of 12/22/2020 1130h
Headache, Myalgia, Arthralgia, Metallic taste in mouth, chills, fatigue Narrative:
Thursday the 8th around 1:30pm:Started feeling sick   By 5:00pm had chills, headache, very tired, body aches Friday April 9th- Monday April 12th: Chills, arms continues to switch from hot to cold, pins and needles feeling, difficult to hold something in had for a long period of time. The vaccine spot was very sore and red. By Sunday evening it started itching. Tuesday April 13th: Spot is still red however swelling has gone down. Arm still switches from hot too cold with pins and needles. Still cannot grip something in hand for a long period of time.
Fatigue around 7:00PM same day as the vaccine. Around 10PM several waves of chills. Fever from 10PM- 9AM. Woke up every two hours, usually I sleep all through the night. Body aches, and migraine. Took 600mg of ibuprofen. Migraine stopped, but fatigue continued. Laid on the couch all day, and slept from 2PM- 8:30PM, took a cold shower,and was back in bed at 10PM, fever returned. Day 3, slight headache, body aches, but fatigue has lessened. Back to general activites.
Time of injection much pain, next day more pain in arm. Pain and extreme fatigue continued to progress daily/weekly until by May(2 months later) pain and fatigue intolerable and unable to function in normal capacity. Now 3 months later only getting worse, intolerable and no one seems to know how to help. I cannot go on like this.
Memory loss and difficulty concentrating, light vaginal bleeding, Shortness of breath and the chills, Intense pain in both legs on the night, Insomnia 2 hours later after going to bed, Tiredness and sleepiness, Bruises on right leg.
Initial information was received from a registered nurse concerning a 6 years old female patient with an unspecified pertinent medical history or drug reactions/allergies who on 15-NOV-2012, the patient was vaccinated with intramuscularly with the first 0.5ml dose of GARDASIL (indication and lot were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse reactions were reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Preterm labor at 36 weeks (0 days), infant born at 5 lbs, 9 oz., otherwise healthy. Born 4/14/21, due date 5/12/21. 2-day hospital stay, no NICU. First pregnancy, mother healthy with no PMH. All labs normal, no jaundice. Breastfeeding and gaining weight appropriately.