chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness; swelling; itching really bad; arm was sore to touch; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore to touch), PRURITUS (itching really bad), ERYTHEMA (redness), SWELLING (swelling) and VACCINATION SITE ERYTHEMA (red at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore to touch) and VACCINATION SITE ERYTHEMA (red at the injection site). On 15-Mar-2021, the patient experienced PRURITUS (itching really bad). On 16-Mar-2021, the patient experienced ERYTHEMA (redness) and SWELLING (swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm was sore to touch) and PRURITUS (itching really bad) had resolved, ERYTHEMA (redness) and SWELLING (swelling) had not resolved and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported. Patient was prescribed Benadryl cream, The report is not clear about the specific indication or start/stop date.   This case was linked to MOD-2021-253021 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non-significant follow up
Was seen Monday 11/6/17 for 18 mo WCC and given flu, Hep B, and a PPD. Monday night was given a dose of tylenol for low grade fever. Tuesday night got another dose of tylenol ~7:45 pm for low grade fever. ~Midnight he woke up from sleep, eyes rolled back in his head, entire body was shaking, and arms and legs got completely stiff. The convulsing and eyes rolling back in head lasted for about 2 minutes. He was unable to move his arms and legs for ~30 minutes. EMS was called. When they got there his temp was 101 and they gave ibuprofen. By the time he got to NS, his temp was 104. He was given a dose of tylenol. He was discharged around 4 am.
pt recv vax & awoke w/a bloodshot eye, sneezing & flushing of the face;pt felt tired & overall washed-out;sx lasted for 36hr & the pt recovered;
Patient presented to hospital 4/6/21 with rectal bleeding and subacute dysnpea on exertion/fatigue over the preceding several weeks and was found to have immune thrombocytopenic purpura (ITP) w/ platelet count of 1000.  Anticoagulation was reversed (on warfarin at home for history of PE). Platelet count  responded to steroids and TPO-agonists per typical ITP treatment. Incidentally, the patient was found to have H. pylori stool antigen + and commenced with quadruple therapy for this. Platelet counts continue to improve slowly w/ treatment.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A, 029L20A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Abdominal pain (right upper quadrant), Pharyngitis, Sprain of lateral collateral ligament of knee (collateral ligament instability, right knee), Prostate cancer, Skin cancer, Lung cancer and Colon cancer. Concurrent medical conditions included Peripheral neuropathy (arm, left arm/elbow post vaccine injection), Groin pain (right), Vitamin D deficiency, Gout (right great toe), Meniscus tear of knee (right knee), Glucose intolerance, Unspecified disorder of autonomic nervous system, Seasonal allergy and Atrial fibrillation. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, COLCHICINE (COLCRYS) for Gout, ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder, BERBERINE CHLORIDE, COLECALCIFEROL, MENAQUINONE-7 (VITAMIN K2 + D3 [COLECALCIFEROL;MENAQUINONE-7]), ACETYLSALICYLIC ACID (ASPIRIN LOW), TART CHERRY and METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  Patient has routine physical exam, lab exam and observation and evaluation for suspected exposure to other biological agent.
NDC 19515-912-52.  Patient started suffering from flu symptoms including fever, stuffy nose, headache, post nasal drip, achy bones, and cough.
Woke up at 11:30pm on 11/1 with severely heavy menstrual bleeding, cramping, and blood clots. Golf ball size blood clots. Bled through super plus tampons per hour. Had to change clothing every hour b/c I was bleeding through everything.  Continued all night and into next day, 11/2. Unable to report to work in the office.  Extremely heavy bleeding and cramps continued. Sent a message to my ob/gyn on 11/2 because I'm on continuous birth control pills and do not normally get a period. This was extremely unusual and concerning.  Bleeding continued all week. Spoke with triage nurse on 11/4. Said their are studies for menstrual side effects related to covid vaccine. Prescribed me medroxyprogesterone 10mg to help with heavy bleeding. However bleeding stopped Friday, 11/3 so I did not take medicine. Bleeding began again 11/3 in the evening.  Cramping and bleeding continued. Not heavy bleeding at this point, more like a typical menstrual period. As of 11/12 the bleeding and cramps continue. An appointment with Doctor on 11/23/2021
02/13/2021 evening started to feel cold and tired, slightly sore arm. 02/14/2021 woke up with fever, chills, achy, lethargic, slight sore throat, decreased appetite. These symptoms continued the entire day. Slept most of the day and night. Took ibuprofen for symptoms. (Did not take prophylactically as had seen could reduce effectiveness of vaccine). 02/15/2021 symptoms improved, still achy and lethargic. Was awake most of day. 02/16/2021 woke up feeling well. Knew immediately that the symptoms were gone.
Woke up with black eye that began in corner of left eye and progressed down to middle of lower lid,  later that day I had sudden onset of throbbing pain on left side of upper gum and cheek area.   The pain in mouth would come and go and responded to heat pack and extra strength Tylenol.   I also had a headache on the left side of my head.   The black eye went away in about three days.  The mouth pain went on off and on for about 7 days gradually subsiding in intensity over that time frame.  The headache only lasted for a few days.  I also felt some pressure behind my left eye.
Delayed reaction to both shots.  11-12 days after, low grade fever ( continues) Lower leg pain, mild chills each evening.. last shot 2/11
Nausea; chills; This is a spontaneous report from a contactable Pharmacist (patient) reported for herself. A 62-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9269), via an unspecified route of administration, administered in left arm on 24Feb2021 10:00 AM as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took erythromycin and experienced (Known allergies: erythromycin/Allergies to medications, food, or other products and full body rash). Historical vaccine included BNT162B2, first dose (Lot number: EL9261, Administration time:10:15 AM on Left arm) on 03Feb2021 for covid-19 immunisation. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Patient experienced nausea (dry heaves) and chills, starting approximately 16 hours after the injection 25Feb2021 04:00 AM and lasting approximately 8 hours for the nausea and the chills are still occurring 12 hours (now). Patient did not receive treatment for adverse events. The outcome of the events was recovering.
Pt developed rash/hives to neck/chest/back/ head & scalp/ Left arm & Left hand.  L arm/hand swelled up & open, draining wounds developed. OPen areas to neck/back developed.  UNresolved with Rx & OTC TX
Red area below injection. Itchy, soreness, raised bump. Slight stomach cramping, loose stool, slight body ache.
on 2/16/21 began to have chills in late afternoon  persisting into evening.    oral Temperature at bedtime  averaged 99.6 persisted with decreasing chills by 2/28/21  Please note that received 2nd dose of pfizer on 3/1 and symptoms of chills, inc temperature returned along with nausea thru most of the day  on 3/3/21
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4471699-00.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single, on 02Feb2021 as dose 2, single and on 04Oct2021 as dose 3 (booster), single at the age of 66 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENBREL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
8 hours after receiving the vaccine I was doing maintenance my fish tank and began to feel physically fatigued as if I had just worked an 8 hour shift of manual labor, although I hadn't. By 6:30 PM I was feeling shaky and weak so I laid down. At 6:45 PM I was feeling feverish (chills even though my body was radiating heat). I woke repeatedly due to muscle soreness and chills. At 10:30 I checked my temperature and got a reading of 103.2 F. I had a mild headache as well. I drank some green fruit/vegetable juice and went back to tossing and turning on the couch. I took an Ibuprofen at 5AM with water and was able to get a couple of hours of sleep. !) AM I checked my temp again and got a reading of about 98 F. I was still feeling a bit sluggish and slightly dizzy at times throughout the day.
Patient developed itchy throat 10 minutes after receiving 1st moderna vaccine.  Patient was given Benadryl 50mg po and within 10 minutes stated that the symptoms had resolved.
Chills and fever, severe headache.  Took Tylenol and better next day.
/21/2022, 1730 Approximately 2 minutes after covid vaccine (Booster) administration. patient fainted while seated in a chair in waiting in room. BP 88/60, P 54R 15 O2 sat 99%.pt patient was unconscious, skin pale and clammy. Within 30 seconds patient gained consciousness, alert and oriented x 4, speech clear. Patient reported that he feels like being in a dream, no c/o dizziness, pain or any discomfort. BP 98/64, P 64, RR 20 ,02 SAT 99%, drank cup of apple juice and water. Then later the patient stated that he feels much better and left office with his wife. The patient' s mother reported that pt has HX of passing out after injection.
Pt. recv'd flu vax around 4p.Chest tightness occurred approx 7p; lasting 3-4 hrs.
period was late by more than a week; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 24Apr2021 at 11:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none and was perfectly healthy. Patient did not receive any other medications within 2 weeks of vaccination. Patient did not take any medications in the past. The patient had no known allergies to food, medications or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in May2021, the patient experienced period that was late by more than a week. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event period that was late by more than a week was recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
has bruising on the area especially on pneumonia shot; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (051529).  A 62-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAVIX. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 2022, outcome "unknown", described as "has bruising on the area especially on pneumonia shot".  Additional information: Patient reports that she recently received pneumonia, influenza and COVID-19 booster and has bruising on the area especially on pneumonia shot. Also gets bruising on insulin injection sites. Takes Plavix and doctors are aware.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previous information: Product was recoded to reflect appropriate drug device combination license.
Patient fainted while waiting 15 minutes after the vaccination.  BP was ok at 130/82 and pulse 61 ambulance was called to make sure she was ok.
Approx 5 min after receiving vaccines c/o "I don't feel well". Was sitting in chair - put head between knees - sat up and then went limp in dad's arms who was standing at side of chair. Placed on exam table - was unresponsive for approx 2 1/2 - 3 minutes when placed on table remained unresponsive. Then started with clonic/tonic type movement to arms- were curled up besides body- no incontinence or rolling of eyes but appeared to be seizure. Apparent seizure lasted approx. 2 minutes 911 was called at onset of going limp- Dr called to examining room and witnessed seizure. Transported to Medical Center for evaluation per Fire Dept.
I fainted, which has never happened to me before. I totally blacked out, but it was about a week and a half after the vaccine. I really don't know if it was related, but I don't have  any other reason. It was the middle of the night and I got up to use the bathroom and fell totally passed out in the bathroom. My husband yelled about what was happening and I woke up. I've been fine since. However, 2 of my other friends also had this happen so I thought I would report it.
red streaks extending form HIB vaccination site occuring 10 hrs. after vaccination. Follow up: Cellulitis involved the left leg at the sit of the Hib immunization.
After 2 doses of the pfizer vaccine, I noticed that my nails were deteriorating. I never had any thing likes this before. I went to the dermatologist and he said I had nail psoriasis. I also noticed, other skin issue flare ups that never occurred before. Overall, I received 3 pfizer vaccines from Dec 2020, to Dec 2021. The symptoms started after my second dose, and continued to worsen.
Client received H1N1 intranasal - client states she crossed out pregnancy on medical screening questionnaire and checked no pertaining to question about pregnancy.
Received first dose Aug 31st and started having some pain in left ear.  Received second dose Sept 21st and ears started filling up with fluid.  Seen five doctors in a week, had drainage coming from both ears, swollen and inflamed ears.  Put in 5 different antibiotics, had a myringotomy, tubes put in ears, didn?t get better.  Got referred to IU and was directly admitted to IU for 2 weeks.  Put on 3 IV antibiotics and had numerous tests.
Starting evening 9/22/16 stiff neck (and range of motion backward) continuing through 10-3-16 (date of report). No fever, no other SXS. Tried naproxen, little relief, tried heat and cold, short term relief. Advised physician visit to patient.
1 of 4 pts vaxed from the same lot# (total of 90 pts vaxed from this lot) during MAY95 who exp fever & inj site rxn w/in 24-48hrs following vax;recovered;unk if treatment was initiated or it pt required MD visit
This 17-year-old patient inadvertently received 0.25 mL of Moderna which is approved for 18+. Patient was observed for 15 minutes with no adverse reactions.  This was the third dose for the patient; the first 2 doses were the Pfizer (purple cap) for 12+.
Initial report received on 16 May 2008 from a nurse in the United States. Five female patients (ages and dates of birth not reported) had received an intramuscular injection of ADACEL (Lot # C2899AA) on 14 May 2008. The routes and sites of administration were not provided. At an unspecified amount of time later, on the same day, the patients experienced nausea, runny noses, stuffy ears, temperature of 100.0 to 101.0 degrees Fahrenheit, and sore arms. The patients did not receive medical attention and no treatment was provided. No diagnostic tests, or laboratory data were performed. At the time of this report, it was "unknown" if the patients had recovered.
Pt recv vax on 3/4/99; 3 hr post vax pt exp general urticaria, stomach ache, chest pain; tx=Benadryl
On the 3rd day 9/20/2018 my arm was red, hot and hard to my elbow. Went to doctor on 21st and they said cellulitis and put me in KEFLEX. Within 2 weeks I was diagnosed with Clostridium Difficile from the KEFLEX. My arm is scarred and I've been sick since. The doctor has apologized and reprimanded the MA for giving me the wrong vaccine in the wrong location. I was only supposed to get an MMR but she administered MMR w/ varicella and she put it under my left arm.
Presented to the emergency department on 9/8/21  with complaints of fatigue and abnormal labs.  Patient was tested positive for COVID in ER.  She has no COVID symptoms.  Saturating well on room air.  Labs unremarkable except for troponin which was minimally elevated 0.074, downtrending.  CT chest showed no acute PE.  Evidence of ground-glass opacities consistent with changes of COVID pneumonia. Admitted on 9/8/21. Will discharge on cefdinir and azithromycin.  Her potassium was 2.8 which was replaced and repeat BMP within normal limits.  Will continue 10 mEq potassium at home at discharge since she is also on Lasix.  Hemodynamically stable for discharge.  Follow-up with primary care. Discharged 9/9/21
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced petechiae all over body, and blood vessels popping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the petechiae all over body and blood vessels popping was not reported. This report was non-serious.
24 hours after vaccination had severe orthostatic hypotension, body aches and joint aches, low grade fever, chills, shortness of breath, and increased lethargy for 24 hours
Next day pt felt achy, chest, back, felt dizzy, sharp chest pain, weak, mild nausea, felt like face was drooping, no fever at time, felt very weak, had bad headache, stomach ache, mostly upper epigastric area, no emesis, no rash, had diarrhea, to ED (had fever that night, and next am, none since) 8-6 - admitted x 2 days- normal CT brain, normal CSF, ultrasound kidneys normal, CXR normal, positive rapid strep but had no sore throat, no adenopathy, no rash - released on KEFLEX, TYLENOL, omeprazole, had normal urine culture - after release presents today still some achiness, no weakness in gait, normal exam, but for upper chest wall costochondritis features.
patient observed in office 1 hour post injection, diphenhydramine  12.5mg x 1 dose administered without escalation of symptoms
Pericarditis - diagnosed by a physician. I am taking medication for this until 02/2022
pt recv vax 5DEC96 & pt immed devel erythema, swelling, blistering @ the inj site;
Reporter recvd call from another hosp pt arrived DOA 15DEC92; reporter does not know of specific cause of death or any recent sx pt may have demonstrated; <7 days since DTP;
2nd pfizer dose administered too soon (15 days between doses) 1st dose administered 4/26/21
She received H1N1 shot RA-IM injection at 11am 11/18/09 face immediately itched mom did not tell us, took her home called office around 12:20-c/o bumps on tongue, fatigue itchy-hives started, hacking then cough-asthma flare, less alert felt miserable-911 called- Neb given-the epipen -IV started ambulance-keep 23hr holding room -ER- was given. IV ZANTAC, PREDNISONE (SOLUMEDROL), BENADRYL-D/c home 11/19/2009 with Rx PREDNISONE, ZANTAC, FLOVENT, BENADRYL, ALBUTEROL NEBS. 11/20/09:  Discharge summary and Hospital record received for dates of service 11/18/09 to 11/19/09.  Final Dx:  Severe allergic reaction, likely to influenza vaccine.   Assessment:  Presents with c/o severe allergic reaction.  Discharged on albuterol, steroids, benadryl and zantac.  To f/u with PCP.  Condition at discharge good and improved.    ICD 9 code 995.3R.
Lef arm swollen & painful. Couldn't lay on my left side for 3-4 days. There was a rash below the shot 2 to 3 inches wide. Still a little tender & flushed looking.
Started 12/19/02 (time unknown) with rash. Seen by my coleague 12/20/02-"multiple erythematous lesions with central duskiness, some confluent, concentrated on LE, buttock, some on arms and face, slightly palpable." Given ovepud 15mg/5ml 3/4 tsp po qd x 5d (2mg/day).
6 dose vial was diluted with 0.8mL of NS instead of 1.8mL. Patient was given a 0.3 mL dose of under diluted vaccine before the error was discovered. The patient was notified of the error and instructed to watch for any unexpected side effect or adverse events. He had no ill effects or addition treatment given to him at the time of notification (approximately 2 hours after the event)
Patient received 0.5ml for 3rd doses instead of .025ml  Patient did not experience any problems.
I had several episodes of Meniere's Disease with severe vertigo.  I had not had any such episodes since 2013