chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning her 36-48 month old daughter who, "when she was 15 months old", in approximately 2002, was vaccinated once with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). In December 2004, the patient experienced a mild case of breakthrough varicella with less than 30 lesions. It was reported that she had no fever but the lesions were itchy. The patient was given an oatmeal bath. Subsequently, the patent recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient presented back to clinic from lab complaining of nausea and sweating following OV today. Patient had received 3 vaccines at end of OV, Prevnar 20, flu shot, and tdap. RN brought patient back to a private clinic room and performed vitals, blood pressure was 156/97, heart rate 86, respirations 20. Patient was visibly diaphoretic. Patient denied shortness of breath, chest pain, throat tightness, itching/rash.  Patient stated he hadn't had anything to eat or drink since dinner yesterday. Apple juice and cookies provided to patient. Patient ate cookies and drank juice, however he complained of feeling very warm, sweaty, and nauseated. Patient was laid down, cold cloth applied to forehead. Writer reviewed with Dr who ordered POC blood glucose and Zofran 8 mg oral disintegrating tablet now. While RN was getting Zofran, patient vomited. Blood glucose was checked, which was 99. Oral Zofran given per orders. After about 15 minutes blood pressure rechecked - 127/85, heart rate 65. Patient stated he was feeling better. Patient stated he no longer felt nauseated and his diaphoresis stopped. Patient was sat up and he walked with a steady gait over to a chair. Patient denied lightheadedness or nausea. Patient stated his only complaint is mild headache which was improving the longer he sat up. Dr assessed patient, noted reaction was likely from Prevnar vaccine. Patient stated he felt fine and that he was okay to drive. Emergency ER plan reviewed. Last blood pressure check 136/85. Patient was released from clinic and advised to call office with any further concerns. Patient agreed with plan. Allergy list updated.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There were no other medication in 2weeks. Vaccine lot unknown reason was misplaced/discarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was an influenza vaccine - I am not sure of the specific type given. It has been 10+ days since the vaccine and he still has a large rash the size of his palm around the injection site (high upper left thigh).  He is otherwise fine and it is not bothering him.
Patient was observed being unsteady ambulating with her cane. She was helped to a chair and assessed, alert times 4, slightly elevated blood pressure and respirations, and pulse of 60.  Brief history was taken and she stated she was diabetic. Patient stated that she had taken her morning diabetic medication but had not eaten anything yet today. Patient was given a bottle of water, small bag of cookies, and a package of graham crackers. She was monitored continuously for 20 additional minutes at which time the client stated she felt fine and wanted to leave. She was walked to her vehicle and secured in her seat.
Pain in lungs, side of lungs to back of lungs; Symptoms started right after the first shot, within a couple hours started in stomach region, mid abdominal area, left side/Felt really sick on first shot, pain settled on left side; Hard to breathe, started after getting the vaccine; Felt really sick on first shot, pain settled on left side; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Pain in lungs, side of lungs to back of lungs), ABDOMINAL PAIN UPPER (Symptoms started right after the first shot, within a couple hours started in stomach region, mid abdominal area, left side/Felt really sick on first shot, pain settled on left side), DYSPNOEA (Hard to breathe, started after getting the vaccine) and ILLNESS (Felt really sick on first shot, pain settled on left side) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (Pain in lungs, side of lungs to back of lungs), ABDOMINAL PAIN UPPER (Symptoms started right after the first shot, within a couple hours started in stomach region, mid abdominal area, left side/Felt really sick on first shot, pain settled on left side), DYSPNOEA (Hard to breathe, started after getting the vaccine) and ILLNESS (Felt really sick on first shot, pain settled on left side). At the time of the report, PULMONARY PAIN (Pain in lungs, side of lungs to back of lungs), ABDOMINAL PAIN UPPER (Symptoms started right after the first shot, within a couple hours started in stomach region, mid abdominal area, left side/Felt really sick on first shot, pain settled on left side), DYSPNOEA (Hard to breathe, started after getting the vaccine) and ILLNESS (Felt really sick on first shot, pain settled on left side) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. No treatment information was provided. Patient has not received medical care due to lack of insurance and was concern about not being able to pay. The patient's mother inquired if there was any medicine available that the patient could take for pain.   This case was linked to MOD-2021-278329 (Patient Link).
Some blood noted in diarrhea with 100.5 fever(x1) on 1/7/2020. Baby is better now and improving. Unknown cause of the bloody diarrhea now better. Since event happen approximate 30 days off the vaccine I wanted to report it.
Fainted, seizure 30 seconds after shot. Hit head on floor.  He laid down for 20 mins. after.
severe headache, BLE weakness - 16 hours after shot  slight SOB, itchy throat, dry cough. Lower back neural pain(sensitivity) - 19 hours after shot  light-headedness - 25 hrs after shot  no treatment taken lower back neural sensitivity worse when in contact with heat (car seat exposed to sunlight), and diffuse to gluteus major
10 min. after receiving vaccine, pt. was at home when he became very pale and limp.  He was placed on the floor.  He vomited x1.  His breathing was slow and shallow and lips appeared to be blue.  EMS was called. He was awake, and alert and "appeared fine" when they arrived.  They transported him to Hospital.  He was admitted into ICU for observation.  Mother states final diagnosis was vasovagal reaction to injection.  He is fully recovered. 12/03/09 ED  and Hospital records received for DOS 11/11-11/12/09. Pt. presented with history of eyes rolling back in head, shallow breathing, vomiting at home 30 minutes after receiving vaccine.  Pallor, cyanosis noted while in ER. Admitted to pediatric ICU. Cardiology, Neurology consults obtained. DX: Possible vasovagal reaction
None from initial vaccination.  I received another vaccination about two weeks later, and have received (to date) two boosters, the last of which was in April 2022.  In March 2023, I had R lower leg redness, pain, and swelling.  ER visit indicated deep vein thrombosis.  I am currently on Xarelto blood thinner for this condition.  It is unknown what the source of the clots might be.
slightly tingly down arm to pinky finger, slight dizziness, slight headache that day. 5 days later I began having diarhea after drinking or eating anything. Severe headache, exhaustion, loss of appetite and taste or smell, wanted to sleep in bed. hard to concentrate, I had severe somach ache and diarhea for 18 days. body and joint aches. Felt thumping on my heart with mile activity and when lying down. sore throat and neck and ear. I had a pretty severe headache and it was difficult to thing through, follow through. I felt too ill to want to follow through to visit the Dr. I did take a Covid test 15 days after reaction started and test was negative.
I started to feel pain/itchiness in my urethra area. I haven?t seen a doctor as it?s not become worrisome yet. This occurred about 36-48 hours after the booster vaccine of the same brand.
Eye swelling; Itching in throat; Adverse drug reaction; Rare allergic reaction; Nausea; Coughing; Severe chest pain; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), CHEST PAIN (Severe chest pain), EYE SWELLING (Eye swelling), THROAT IRRITATION (Itching in throat) and ADVERSE DRUG REACTION (Adverse drug reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Mid December; Patient had lingering effects from it including chest pain which happened randomly. Patient took cold and flu medications for 6 days.) in December 2020.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced COUGH (Coughing), CHEST PAIN (Severe chest pain), HYPERSENSITIVITY (Rare allergic reaction) and NAUSEA (Nausea). On an unknown date, the patient experienced EYE SWELLING (Eye swelling), THROAT IRRITATION (Itching in throat) and ADVERSE DRUG REACTION (Adverse drug reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Coughing) was resolving, CHEST PAIN (Severe chest pain), ADVERSE DRUG REACTION (Adverse drug reaction), HYPERSENSITIVITY (Rare allergic reaction) and NAUSEA (Nausea) outcome was unknown and EYE SWELLING (Eye swelling) and THROAT IRRITATION (Itching in throat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications also included steroid.  Patient was presented to emergency room and they put in the notes that the cause of her symptoms was an adverse drug reaction.  She had an ECG,CXR, CT scans, and an Echo which was all normal prior to receiving the vaccine and also undergone a stress test before having vaccine. Patient stated that her valves looked perfect.  Mother passed away at 60 from a heart attack.   This case was linked to MOD-2021-339242 (Patient Link).
First dose: on second day had extreme exhaustion lasting two days. Second dose:  began a very heavy menstrual cycle with clotting and 5x more bleeding than usual.  This was just 5 days after ending regular cycle-approx 25 days earlier than normal.  I am not or have not had any other changes that could possibly have affected my cycle aside from vaccine.  I thoroughly researched and went over my medical/health/stress/activity and finally googled if it was possible or any others were known.
Flu like symptoms, aches, chills, headache, muscle pain all over , especially at injection. lasted 24 hours, fine the next day.
01/29/2021: Presents to clinic with chilling/shivering to the point of being in pain, loose stool, sweating. Placed in treatment room. Had taken advil and tylenol at home. Warmed fluids IV gen. Valium 2.5 mg IV given. Has muscle relaxants at home to use. Told no work for the weekend.
Patient was combative and pulled away before IM injection was complete.  Resulted in only 0.4 ml of vaccine being administered
Information has been received from a female for GARDASIL, a Pregnancy Registry product, concerning herself with a history of intra-uterine contraceptive device insertion and no drug allergy who on 02-JUL-2009 was vaccinated with the third dose of GARDASIL. Concomitant therapy included vitamins (unspecified). Subsequently, she discovered that she was pregnant when the patient was looking for a new clinic to place a new IUD (intrauterine device). At this new clinic, she was tested for pregnancy when she reported having nausea. At the time of the report, the patient was 11 weeks pregnant. Her LMP was about 19-MAY-2009. Expected date of delivery was 23-FEB-2010. She is not having any symptoms, exception for some nausea associated with the pregnancy. Also, she was told that the pregnancy is healthy. Additional information has been requested.
A day after shot got in arms (deltoids) erythema and tender. Fore arm and thigh area tender and erythematous. Oral Benadryl given, DTaP
Heavy, painful menstrual cycle lasting 3 days longer than normal; Breakthrough spotting and cramping 9 days before next expected cycle; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: FA7485) at the age of 24 years as dose 1, single and administration date 21Aug2021 (Lot number: FC3181) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSMENORRHOEA (non-serious), outcome "not recovered", described as "Heavy, painful menstrual cycle lasting 3 days longer than normal"; DYSMENORRHOEA (non-serious), outcome "not recovered", described as "Breakthrough spotting and cramping 9 days before next expected cycle".  No follow-up attempts are possible. No further information is expected.
Woke with silver dollar size area around imm. site that was red and hot to touch by 6:30pm. Leg swollen down to and around knee rash that looks like hives on leg. Reaction increased to 16cm x 12cm oval lesion in 24 hrs (2/12/03).
This non-serious spontaneous case, was initially received from a physician on 14-Aug-2017, concerning a 12-year-old female patient. Physician reported 10 patients who were vaccinated after multiple temperature excursions. This report was 2nd of 10 reports. On 09-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 185686 (reporter as 185586 and 186686), expiry date: 31-May-2017, dose, route of administration and anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), on 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and on 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) which was considered as incorrect product storage. The patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. The outcome of the events was not reported. The reporter did not provide the seriousness assessment. Non-significant case correction received 14-Aug-2017: Batch no. (185686) was captured in the case form and narrative was amended accordingly.
Pt recv vax on 2/2/99; on 2/3/99 pt exp hives, shortness of breath, cough; tx=Benadryl, Zantac, Solumedrol Follow-up: Still going through checkups with respiratory care. Anthrax vaccinations were administered at the pt's unit, not in the clinic. No other vaccines were administered on the same date as Anthrax vaccines. Vaccines were procured from the clinic by the unit staff. Records were maintained in database but these are deleted when a patient retires and that is the case with this patient.
24 Hours after injection, left arm has large red, itchy knot on it.  It is now 11/14/2021 and the adverse event continues.  Or three days later.
Patient missed 2nd dose and scheduled to receive 2nd dose on day 42 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose and scheduled to receive 2nd dose on day 42 after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose and scheduled to receive 2nd dose on day 42 after 1st dose). On 13-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose and scheduled to receive 2nd dose on day 42 after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Moderna COVID-19 Vaccine EUA Approximately 10 days after the 1st injection, red bumps appeared with redness about the diameter of two inches, and were itching. The following day, my left arm was swollen and felt tight, and was much more red, with an increased diameter to approximately 3.5 inches. I took Zyrtec and Pepsid and the swelling and redness reduced in a couple of hours.
This was a vaccine error - booster dose given to patient under 18.  The patient did not have an adverse event.
Within 1-2 minutes, felt like an infusion or flush with a chemical/metallic smell, taste. Extreme weakness, dizziness. Had to sit down for a long time, couldn't really open my eyes. Bad head feeling. Eyes hurt, but were not swollen. No swelling, just that constant metallic overwhelming. Dizzy. Stayed at pharmacy for about 40 minutes. On drive home, hot face, metallic infusion, very warm. Fever at home,  achy all over, 99.8, very dizzy, brain fog, very weak, arm sore. Next morning, no better. Took a Nexium and immediately big hive popped up on my chest. Disappeared about an hour later. Took 3 days to feel like myself. Still concerned about allergic reaction. I'm a little itchy, tingly. I'm now terrified of getting that second shot.
About 30 min after injection my left arm started feeling tingly and hot, my fingers went numb, and my head started feeling like I was going to get a migraine.  About 45-60minutes after injection I started having trouble swallowing and then started having labored breathing/ wheezing because my throat felt tight.  I took Benedryl and about 2 hours after my injection (1 hour after Benedryl) I felt fine.
Systemic: Diarrhea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Admitted to ER on 3/15/21 released on 3/16/21. Experienced extreme vertigo, vomiting, and diarrhea.  Still a little weak today (3-18-21).
Sore arm headache,left arm couldn't lift ,chest pains,Nausea
Pt had swelling of arm and hand. Referred pt to MD office. Advised to ice it down. RPh called on pt 3 days later & Pt was fine.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Non-alcoholic fatty liver disease" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Mar2021; OMEGA-3-ACID ETHYL ESTER, start date: Mar2021. Past drug history included: Bnt162b2, start date: 07Oct2021, stop date: 07Oct2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 3 (BOOSTER), SINGLE; Lot Number: 30145819; Bnt162b2, start date: 19Mar2021, stop date: 19Mar2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 2, SINGLE; Lot Number: EN6208; Bnt162b2, start date: 26Feb2021, stop date: 26Feb2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 1, SINGLE; Lot Number: EN6203; Bnt162b2, start date: 07Oct2021, stop date: 07Oct2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 3 (BOOSTER), SINGLE; Lot Number: 30145819; Bnt162b2, start date: 19Mar2021, stop date: 19Mar2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 2, SINGLE; Lot Number: EN6208; Bnt162b2, start date: 26Feb2021, stop date: 26Feb2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 1, SINGLE; Lot Number: EN6203. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Mar2022, outcome "unknown", described as "sore arm when vaccinated". Additional information: The patient had no known allergies.
About 6-7 weeks after second shot, I had severe pain where my gall bladder used to me, although I don't have one.  It was bad enough that after consulting with my primary care physician, I went to the ER. They did a CT scan and said that I had an enlarged lymph node in that area.  A few days later, I noticed that I also had an enlarged lymph node in my neck on the left, just below my head.  About one day later it all disappeared.
After patient received vaccine and waited 15 minutes she asked if she could wait longer because she didn't feel well. Paramedic was called and took patient to the EMS tent - per EMS pt was diaphoretic with hypotension and near syncope -after laying down BP normalized and pt resumed normal status. Pt requested to go to the ED. Pt is currently being treated with chemotherapy and had her last dose 5 days prior.  She was brought in by EMS after appearing cool, diaphoretic, nauseous, and unwell after vaccine administration.  Patient states that she was feeling nauseous, dizzy, and weak 1 hour after administration.  She likely had a vasovagal-like response to vaccine administration.  Did not lose consciousness.
PATIENT WAS ADMINISTERD A MODERNA BIVALENT BOOSTER VACCINATION ON 10/18/22 BUT ONLY RECEIVED 0.3ML.  PATIENT WAS REVACCINATED ON 10/21/22 WITH MODERNA BIVLAENT BOOSTER 0.5ML (LOT 059F22A) PER CDC INTERIM CLINICAL CONSIDERATION APPENDIX D  LOWER-THAN-AUTHORIZED DOSE ADMINISTERED.