chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt here for second Twinrix - stated a reaction after 1st visit - states had large inflamed node under left arm over weekend after vaccination. States about size of baseball or larger. Felt lethargic and listless. Better by following Monday (5-28). Instructed to be aware of reaction when having next tetanus and let provider know beforehand.
Around Noon the day following my 1st vaccination dose, I started to feel hot at work but, I wasn't sweating. My eyelids burned, my cheeks were flushed. I started to have pain in every joint in my body shortly after that. Aching, throbbing pain. I was moving slowly, sluggishly, felt exhausted. I took an Aleve to help with symptoms. By 3pm, I was in bed trying to sleep through it. My temp was 100.8. Anytime I left my bed, I got chills and the joint pain did not stop until morning. The following day, I developed a swollen lymph node in my left arm pit that is tender still. My joint pain and fever were gone by the morning of the 20th. I still have tenderness in the lymph node under my left armpit. Injection site is still tender to the touch but, not noticeable otherwise.
itchy red inflammation / lumps on elbows and knees; itchy red inflammation / lumps on elbows and knees; itchy red inflammation / lumps on elbows and knees. The inflammation spread slightly to forearms and there was a small amount on one of ankles.; This is a spontaneous report from a contactable healthcare professional, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the upper left arm on 06May2021 at 11:15 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any known allergies. Concomitant medications included METRONIDAZOLE for an unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07May2021 at 00:00, the patient experienced itchy red inflammation/lumps on elbows and knees. The inflammation spread slightly to forearms and there was a small amount on one of ankles. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy, red inflammation, lumps on elbows, and knees, the inflammation spread slightly to forearms and there was a small amount on one of ankles was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Initial report was received from a consumer on 04 April 2012. A male patient (age and date of birth not reported) with a three year history of atrial fibrillation and atrial flutter, had received an injection of DTaP (manufacturer, lot number, route and site unknown) on 21 February 2012. Twenty four hours later, the patient experienced atrial flutter. One week after the vaccination, the patient needed cardioversion to regular heart rate and three weeks following that had another episode of atrial flutter. One year ago, the patient was treated by ablation and had only one episode of atrial flutter in the previous year. It was unknown if the patient had any other vaccinations within four weeks, took any concomitant medications, had any illness at the time of vaccination or had an additional past medical history. The patient's outcome was not recovered. Documents held by sender: None.
Has not yet received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose of Twinrix adult received intramuscularly on 2nd September 2021, Dose:1ml, Batch number:a955s, Expiry date:22nd May 2022).   On an unknown date, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of Twinrix adult till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Left bottom side of arm, red, hot, painful to touch since Monday 10/30/06
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 13-MAY-2013, the patient was vaccinated with the second dose of VARIVAX lot#: 0610AE which was stored improperly. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax & devel irritability;screaming high pitched;rxn to DTP per mom ;
Lt leg large red knot area swollen and red - warm to touch. Rt leg - Very large area red, swollen, and hot to touch. Area is baseball sized. Pt was seen by APRN and given an RX for Cephalexin. Has F/U appt on 5/22/17.
A dose of Menveo / administered / 30 hours after reconstitution; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA432A, expiry date 31st October 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reported reported that the dose of Menveo was adminstered to the pateint 30 hours after the reconstitution, which led to wrong technique in drug usage process. The information regarding consent to follow up was not reported.
LEFT DELTOID/INJECTION SITE "VERY PAINFUL, SWOLLEN, RED AND HOT".
Pt. reported dizziness and nausea approx. 5 minutes after administration. Pt. denied eating sufficiently today. BP: 141/87. HR: 70. pt. didnt know baseline BP. Pt. reported symptom improvement after 15 mins of observation. pt. was given water, food, a damp wet cloth for neck. pt. left 30 minutes after observation reported she felt better.
Immediate complete syncope: unresponsive; fleeting seizure-type activity, i.e. tremors; pale; sweaty.  Responded to voice spontaneously in less than 2 min.  Initial BP 70/30, P-80, gradually increased to 120/80 and P-84 over 20 min at which time she was up walking and stated she felt normal.
9 year old developed acute onset croup and respiratory distress 2 days after FLUMIST. He received oral steroids, antibiotics and albuterol / ATROVENT in ER. No history of asthma. It had been years since previous croup.
pt recv vax 23MAY97 & 24MAY97 pt devel erythema multiforme;tx w/meds;
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # K021484, expiration 03-NOV-2016; dose, frequency were not reported), which had been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient. A 50-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DIPHENHYDRAMINE; FAMOTIDINE, start date: 01Mar2022; SENNA-S [DOCUSATE SODIUM;SENNA ALEXANDRINA]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown reusult. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: From 16Jul2022 to 20Jul2022 the patient was treated with Paxlovid for covid-19. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information the reported events  vaccination failure and Covid-19 are assessed as related to suspect drug Comirnaty.
Developed redness & swelling within 10min of vaccine administration. Gave 6.25ml of Benadryl & had him  wait for another 10 min w/ no further reactions.
on the opposite arm she had a knot on her right wrist/in between the forearm and underarm the skin was also knots; the knots on her arm might be a reflex of swollen lymph nodes; Arthritis; on the bottom of her thumb got swollen and another know developed; she had severe pain; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced had severe pain on 02Aug2021 (2 hours after vaccine administration) with outcome of unknown, on the opposite arm she had a knot on her right wrist/in between the forearm and underarm the skin was also knots on 03Aug2021 with outcome of unknown, the knots on her arm might be a reflex of swollen lymph nodes on 03Aug2021 with outcome of unknown, arthritis on 03Aug2021 with outcome of unknown, and on the bottom of her thumb got swollen and another 'know' developed on 03Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included  ultrasound of her veins, then her doctor told her she had two things going on: Arthritis and the knots on her arm might be a reflex of swollen lymph nodes on 04Aug2021. The events involved emergency room visit.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Narrative: Patient has a history of tinnitus for several years. Reports that tinnitus worsene after admin of 2nd covid vaccine.
pt recvd vax & exp a local react manifested by redness, swelling, heat & soreness; pt recovered; No further details were provided;
This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced WHEEZING (Wheezing). At the time of the report, WHEEZING (Wheezing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.
At 9:20 AM, MMR vaccine administered. A 9:25 AM two large vesicles (1cm and 1 1/2cm) were noted below the injection site of the MMR vaccine on left arm on an erythematous base approximately 4cm in diameter. Phone consult at 9:40 AM epinephrine 0.15 ml administered in right arm at 9:55 AM the vesicles and redness cleared.
This 31-year old female was vaccinated with Vivotif (Batch no.: unknown) on 04-Apr.2006. She also received yellow fever and tetanus-diphtheria vaccine on the same day. She had developed ADENOPTAHY IN THE NECK AND AXILLAE. Her doctor is planning to biopsy one of her nodes. Further information is expected. The case was reported to be non-serious.
Had fever chills head ache a dizziness start evening after shot. Fever chills only lasted 2 days. Dizziness nausea pain behind left eye continues to get worse. Still seeing doctors and going through testing
I had a fatty liver, I also had a CT scan on 11NOV2022 which was for the liver. I also, had a blood test on 10OCT2022.
This spontaneous report as received from a Licensed Practical Nurse refers to a female patient of unknown age. On 18-FEB-2013 the patient was vaccinated with a dose of CERVARIX instead of the second dose of GARDASIL (dose, route, lot number reported). Date of first dose GARDASIL was unspecified. No product confusion discovered, just medication error. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
Patient for 2 weeks complained of numbness and weakness in lower extremities. Upon admission to ER he had pulseless lower extremities and had left flank pain.
Dizziness, memory loss, confusion, not sure if it lasted for part of one day or if it began the evening before.
Left thigh 10 cm x 8 cm.  No pain with palpation but child states it hurts a little.  Treatment given to the child included Tlenol and Benadryl.
At 1035 patient complained of feeling light headed and weak immediately following the injection of the vaccine. Lead RN and EMTs made contact with client who stated she felt very weak, dizzy  and light headed. Client began to slide out of her chair while fully conscious. EMTs helped client sit up in chair and a first set of vitals were taken while seated at 1035: BP 110/58, HR: 66, RR: 12 skins cool, dry and pale for ethnicity. Client was A&Ox4. Client stated she had the same feeling when having blood drawn. Client was assisted to a wheelchair and to the zero gravity chair without incidence. Client stated she was feeling "incredibly nervous" about getting the shot and explained she was scared to get "myocarditis". Lead RN provided education on the different vaccines and potential side effects and client stated that made her feel better. Client denied any pertinent medical history, denied allergies to any medications/foods/environment. Client stated she had depression and she takes a weekly anti-depressant which she couldn't remember the name of,  last dose was Saturday August 17th. Client denied any other medication use. Client stated last oral intake was a pastry just before arrival to the vaccination site. Client was given a bottle of water which she sipped and a granola bar which she ate slowly. At 1040 a second set of vitals taken while seated: BP 100/56, HR: 58, RR 12, skins warm, dry and normal for ethnicity. . Client instructed to rest and relax in the chair for an additional 30 minutes for monitoring. Client stated symptoms of dizziness, weakness and lightheadedness resolved. At 1055 RN took another BP reading: BP 98/60. At 1110 client stood up and walked around the observation area stating she felt much better. At 1125 a third set of vitals taken while seated: BP 98/60, HR: 66, RR 12. At 1128 EMT took another BP reading with the automatic BP reader while client was seated: BP 96/61, HR: 68. Client stated dizziness, weakness and lightheaded feeling had resolved.  At 1145 a final set of vitals taken while seated with automatic cuff: BP 101/67, HR: 68 RR 12. Lead RN educated client on ER precautions. Client stated she felt much better and left the observation site on her own accord with a normal gait.
Covid19 breakthrough.  1st vaccine received on 08/04/2021.  48 y/o with PMHx of Multiple Sclerosis treated with monthly IV Solumedrol and Ocrevus every 6 months presents to ED with c/o progressive SOB, congestion, fevers that have worsened since diagnosed with Covid19 2 weeks ago.  Pt also c/o intermittent blood clots from nose.  CXR-multifocal PNA, Pt febrile, Room air sat 95%.  Started on IV Abx, steroids and Remdesivir.
Fever, numbness, body aches, chills, shortness of breath, vomiting, dizziness, headache, rapid breathing
Event occurred after 2nd dose. Presents with fatigue, burning sensation in anterior chest  Aspirin, multivitamin, Tylenol Discharged
3 weeks after first shot had first case of tachycardia, then two weeks after second shot started having shortness of breath with exertion more frequently.  Tachycardia episodes then became more frequent with exertion.  May 27th ended up admitted to the hospital, with any exertion heart rate was over 140-150.  Chest pain, dizziness, SOB, extreme exhaustion. Diagnosed with myocarditis at urgent care.  Echo shows LV hypertrophy, trace leaking of all four heart valves, possible SVT.
I do not know how to answer Q17 Dose Number because I originally had the one dose J&J vaccine and did experience similar yet not as intense symptoms. This dose was a Boster by Moderna. Normal injection site soreness on left arm but my lymph glands on left collar bone and neck were very swollen and painful. The gland on neck above collar bone was very red. Most painful on day 2-4 after shot and swelling and sensitivity lasted through day 5. It seems to be getting better daily.
arm was blown up; sore; lumpy; swollen; hot; looked a little red; A spontaneous report was received from a Nurse concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lumpy, swollen, hot and red reaction at injection site, arm was blown up and sore in arm.  The patient's medical history was not provided. Concomitant medications reported were Calcium, Vitamin D, Vitamin B12, Zinc, Vitamin C, Metoprolol, Boniva for drug use for unknown indication.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced lumpy (vaccination site mass), swollen (vaccination site swelling), hot (vaccination site warmth) and it looked a little red (vaccination site erythema). On 16 Feb 2021, the arm was blown up (swelling arm) and was sore (pain).  Treatment details included Ice pack.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Moderna COVID-19 Vaccine EUA; Experienced Malaise, Fatigue, Aches, Fever, Chills days 6 through 8 after vaccination; fatigue still exists.
Mother took child to the car post vaccinations and noted child having a seizure. Brought back into office and child continued to seize. Subsequently given Diastat rectally x's 2. Child continued to have seizure activity during the visit. Transported to ED by ambulance. Eventually intubated at ED.
Approx. 5 min after vaccination, child fell against wall and hit head on floor. Eyes were fluttering, did not respond to conversation or commands, diaphoretic, and became incontinent. Wet towel applied to forehead, legs elevated on chair. Responds to mothers voice after about 5 seconds, able to open eyes and spoke to mother. Administrative clerk called for Emergency Response Team and second nurse called 911 EMS. Vital signs and verbal instructions with appropriate responses obtained, Emergency Response Team on site within 1 minute of incident. 911 arrived at approx 5:12 and transported by ambulance at 520. Informed supervisor and program manager of incident.
CHILD CAME IN FOR WELL VISIT, BUT WAS ALSO HAVING SNEEZING, RUNNY NOSE AND WATERY EYES. NO FEVER OR LOW GRADE ONLY. TREATMENT PRESCRIBED WAS AN ANTIHISTAMINE DONATUSSSIN, HOWEVER PATIENT DID NOT GET PRESCRIPTION FILLED AND USED OTC MEDS INSTEAD, PER REPORT. CHILD HAD SOME VOMITING AND DIARRHEA THE NEXT EVENING AND AM OF DEATH. Received Autopsy Report which revealed COD as acetominophen poisoning.  Manner of death: accidental (inadvertent overmedication).
administered with expired dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired dose of vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022 at 9:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. It was reported that vial was initially stored in the refrigerator on 07 Apr 2022 at 1:00 pm and the vial did not undergo any temperature excursions. No adverse event had been noted on the patient so far. No treatment medications were provided.
Body aches, joint pain, chills, headache, injection site pain; Body aches, joint pain, chills, headache, injection site pain; Body aches, joint pain, chills, headache, injection site pain; Body aches, joint pain, chills, headache, injection site pain; Body aches, joint pain, chills, headache, injection site pain; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received bnt162b2 (BNT162B2) lot number and expiration date were not reported, intramuscular (arm right) first dose on 16Dec2020 13:45 at a single dose for immunization.  Medical history included migraine with aura, ovarian cyst and paragard IUD. Concomitant medication included fluconazole (DIFLUCAN), probiotics and famotidine. The patient previously took codeine and experienced drug hypersensitivity. The patient reported adverse events of body aches, joint pain, chills, headache, and injection site pain on 09Dec2020 at 03:45 PM (pending clarification). The patient had not taken any other vaccine in 4 weeks. The events were considered non-serious. The patient recovered from the events body aches, joint pain, chills, headache, and injection site pain on an unspecified date. There was no treatment given due to the events. The patient was not diagnosed with COVID-19 prior to vaccine nor was she tested positive for COVID-19 since vaccination.   No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.