chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported; the patient was inadcertently administered a dose of MMR II, that was expired; Information was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 10-APR-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-RVAXPRO) (rHA) (dose and route were not reported, lot# N02469, expiration date 07-APR-2019) for prophylaxis, that was expired. No adverse effect reported.
From initial information received on 29Nov04 from a health care professional regarding an adverse event occurring, it was reported that a seven month old male pt received his second dose of Fluzone SV 2004-2005 vaccination at 1:15PM on 29Nov04. The pt had no illnesses at the time of vaccination, no known allergies and was not taking any concomitant medications. Approx 2:30PM that same day, the pt developed intermittent body twitching. He was seen in the doctor's office and now has twitching of both arms. The pt's recovery status is reported as unk. Follow up information received on 18Jul05. Based upon new medical information, this case is being upgraded to serious. The pt was seen at a physician's office on 29Nov04. The parents reported that the pt had short jerking episodes. The episodes would occur every 45 seconds to one minute.  The pt was awake during the episodes and would otherwise appear normal. The pt was admitted to the hospital that same day, where it was noted that he had myoclonic jerks that looked a lot like startle reflex. The occurrence of the episodes gradually wore off until they were intermittent and then once every six to eight hours. An electroencephalogram was normal for age and there were no focal spikes. An MRI of the brain showed an incidental finding of Arnold Chiari type 1 malformation with a downward displacement of the cerebral tonsil into the upper cervical canal. The physician reported that this was an incidental finding and was unrelated to the current problem. It was felt that there was no need for any anti seizure medications, just clinical observation. The pt was to be seen for follow up in a neurology clinic in one month. The subject was discharged from the hospital on 30Nov04 and has recovered from these events.
1830 Caller states on march 1 got 2nd shot.  had a little lump under the skin that went away.  today at around 1800 was taking a shower rubbed area where shot was given  left deltoid .  Lump was back ,  looked in mirror and area is bruised today .  No other symptoms.   advised any other symptoms or if bruising increases or occurs on other parts of the body seed medical attention without delay.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccines on 4/02/2021, 5/1/2021 and 12/22/2021. Presented to ED on 6/7 with SOB. Recently had hip sx and was admitted to outside nursing facility for rehab following hip hardware replacement in Jan. c/b sepsis. EMS arrived on site and found pt tachypnic in 30s - 40s w/O2 sat 70%, placed on BiPAP w/improvement in O2 sat. Previously tested COVID+ in facility and w/UR sxs. During current stay, she was tachypneic, HR 124, temp 95.8°. Creatinine of 1.18, w/anion gap acidosis cont. Lactic acid was 3.4. Troponins 0.13.  ProBNP elevated, leukocytosis 12.6. ABG showed a pH of 7.34, pCO2 was 29, bicarb 16.  CXR - multifocal PNA. Tx'd w/decadron, vancomycin, zosyn, and remdesivir. Transitioned to comfort care and DNR with no intubation/CPR on 6/11/22. Pt expired on 6/12/22.
Got really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Got really sick) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced ILLNESS (Got really sick). At the time of the report, ILLNESS (Got really sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-568296, MOD-2022-568298, MOD-2021-571297, MOD-2021-024069 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Patient demographic details were updated.
Patient is being admitted for COVID-19, symptom onset approximately 1 week PTA. Patient also with Bacteremia. Patient is receiving meropenem and dexamethasone.
Dizziness, Headache, Nausea, NauseaVomiting, swelling pain at injection site
Headache, Myalgia, Fever & NauseaVomiting Narrative:  Missed one-day work following first dose of Moderna vaccine due to flu-like symptoms. Tmax 101.4
Patient is a 36-year-old female with significant past medical history of alcohol abuse (4-6 years) and hypertension (untreated) who presented to the emergency department with a chief complaint of chest pain.  Patient states associated nausea and vomiting.  Patient admits to heavy alcohol use over the past 4-6 years following her divorce, she reports that she drinks every day (vodka and red wine), last alcohol intake was yesterday evening.  Degree at onset was moderate degree of present is moderate.  She denies any alleviating or exacerbating factors.  Patient was seen examined in the emergency department, she appears somewhat uncomfortable with upper extremity tremors and tachycardia noted.  Lab work revealed mild leukocytosis with white count 11.8, D-dimer was elevated at 1.83 however CT scan of the chest was negative for pulmonary embolism however did suggest ground-glass opacities and therefore COVID-19 has been ordered, LFTs were elevated as well as elevated lipase at 324.
The following report was received from another manufacturer.  This case was reported by a physician and described the occurrence of an unspecified reaction in a 50-year-old subject of unspecified gender who was vaccinated with influenza virus vaccine 9Flu vaccine, manufacturer unspecified for prophylaxis.  On an unspecified date the subject received an unspecified dose of Flu vaccine.  At an unspecified after vaccination with Flu vaccine, the subject experienced an unspecified reaction.  The type of reaction to the flu vaccine was unknown.  The flu vaccine was not given by the reporter.  At the time of reporting the outcome of the event was unspecified.  No further information was available.
Developed migratory angioedema. Swelling started approx 5 days after Moderna COVID booster.  Developed painful lymph node in armpit (near injection site) for 5 days, then developed swelling in feet. Could not walk for 24 hours d/t pain.  The swelling migrated around body approx every 48 to 72 hours. Starts as a "tingling" sensation  To date the following areas of body involved: feet, knees, hands, tongue, cheeks, lips, genitals, left side of my face Seen by allergist.  Now on 3 Allegra daily at 180 mg each. Takes lasix and prednisone 10-20mg prn for swelling Seen by cardiologist and medical conceirge physician.
Patiet came for 2nd dose of Jynneos Vaccine. Wheal did not form.Patient  successfully revaccinated with appropriate dose intadermally per policy.
11:30 ? vaccine administration 11:41 ? scratchy throat that progresses into laryngeal and tongue swelling. Increased heart rate (tachycardia) and decreased blood pressure. 11:55 ? laryngeal and tongue swelling worse, now accompanied by chest heaviness and shortness of breath. Also light-headed. Used albuterol inhaler x2. 12:15 ? symptoms gradually decreasing. 12:30 ? took 25mg Benadryl 13:15 ? still some swelling and chest heaviness, took additional 25mg Benadryl.
Secure message to MD 07/20/2018 @ 2:17 p.m. : Pt has some significant redness around the vaccine that was placed in his muscle. He doesn't have a fever and he is acting normally, but the redness has grown over the last few hours to about 3 inches. Call center RN advise notes 07/20/2018 @ 2:57p.m: Call Notes: KEY SYMPTOMS: site of IM immunization now redness with 3 inches in diameter warm to touch, itching, denies pain. ONSET/DURATION/INTENSITY: last night, getting worse. PERTINENT HISTORY: vaccines yesterday, mom allergic to adhesive tapes. TRIED (BETTER/WORSE): none.
The patient was inadvertently given a second flu vaccination this season. He had already had 2 doses last season. The patient had no adverse event happen by administering this extra dose.
**17 weeks pregnant, Due date 8/11/21, 1st pregnancy** I got the shot at 3am and was feeling fine. When I woke up my arm sore and felt really cold, my temp was 100, I called and they advised me to take Tylenol and rest. I did that and it lasted for about 24 hours.
Ischemic patches with ulcers on transverse colon with unknown etiology. Severe pain.  Hospitalization 5 days.   Currently after 3.3/4 months healing.  No meds at this point.
This spontaneous report was received from a health care professional refers to a female patient of unknown age. On 16-NOV-2014 (also reported as 16-NOV-2015) the patient was vaccinated with VARIVAX (Merck) (dose, route, lot # unspecified). No concomitant medications were reported. The patient became pregnant. The LMP and EDD was not known. It was reported that the patient was now pregnant, about 2.5 weeks after was vaccinated with VARIVAX (Merck) on 16-NOV-2014 (vaccine exposure during pregnancy). The reporter stated that the patient has not experienced any adverse effects. No further information provided. The pregnancy outcome was pending. Additional information has been requested.
Pt vaccinated with Recombivax in 1987 or 88 in Oct90 was hospitalized with headache. Cerebral arteriography revealed diffuse cerebral vasculitis. At the time of the report the pt headache had resolved.
pt recv vax & then left clinic;mom returned 2hr later c/o pt being difficult to arouse & color funny;pt was able to arouse @ that point but pt saw MD again & was found to have elevated temp of 102;APAP given APAP;
Mom tc 1MAY91 to ask if sx pt experiencing "normal" reports 2 hrs post vax began to hold rt arm; later that night noted "patchy" rash on top of rt arm & swelling under arm area of armpit; c/o pain shoulder area & won't move rt arm at all;
I received my Covid booster (3rd shot) on 2/28/22 and the next day I had a huge red welt on my arm which lasted for 5 days. After the redness went away, the welt turned into a black and blue (bruise-like) color and that lasted another 2 days. Since then, I have had a bump in the same spot that I received my shot. My muscle occasionally twitches in that spot and causes spasms that hurt for at least an hour long for each episode. I had no reaction to the first 2 doses. The RN who administered my vaccine did a great job and I didn't feel it. However, since then I have been in pain in the same spot I got my vaccine.
0811 patient came to RN and indicated patient felt like she was going to pass out. Pt in waiting room sitting in chair. Pale and c/o feeling nauseated. Denies breathing difficulty. No facial swelling and no difficulty breathing. Said she felt funny and was going to pass out. Diaphoretic. Assisted to wheel chair and brought to treatment room. Two person lift from W/C to treatment table. C/O fingers and hands tingly and "I'm scared". 0813 BP 84/52 HR 74. Resp 28 supine position. 0816 Lips pink and verbalizes feeling little better. Denies having this occur after any other vaccine. Verbalizes did not eat today. Explained a vaso vagal response to her and instructed for all future vaccines to remind us this occurred and vaccine can be administered lying down. Verbalizes understanding.  0827 BP 92/64. Assisted to slowly sit. c/o mild dizziness when moving into sitting position. Skin remains pink and is warm and dry. Eating lollipop due to not eating anything today.  0828 Denies dizziness.  0834 BP 98/72 Accompanied to waiting room and instructed to sit for 15 min until released by staff. Notify staff if feels funny again. Verbalizes understanding 0850 Denies further dizziness. Skin pink. Warm and dry. Allowed to go home.
3 inch x 2 inch oval shape area of redness, moderate swelling, firmness, and warmth to touch in location of flu vaccine. Advised monitor for increase in size, swelling and pain. Area outlined. Apply ice for comfort, if site itchy can apply otc hydrocortisone cream locally. If not improving  in next 24 hours, or worsening come back in to be evaluated again.
1st Vaccine given approx. 1900 hrs. At approx 2130the pt began c/o severely swollen labia. (-) difficulty breathing, hives or flushing. Benadryl 50mg PO given. 02/12/2010 Initial and follow up information has been received from a nurse concerning her 20 year old daugher with no medical history and no known drug reaction or allergies on 01-MAR-2009 was vaccinated IM in the left deltoid with the first 0.5 ml dose of GARDASIL. There was no concomitant medication. On 03-MAR-2008 the patient experienced swelling of the vagina and labia. The patient begun to experience the swelling two hours after receiving the vaccination. The swelling was reduced with the administration at 50 mg Benadryl. Swelling persisted for 24 hours. Patient did not seek medical attention. Patient outcome was recovered on 05-MAR-2008. Additional information has been requested.
Onset of very noticeable arm weakness from the deltoid down, with some mild paresthesia most pronounced in the ulnar nerve distribution.  Symptoms began somewhat suddenly around 11am and lasted an hour or so, then waxed/waned, with another strong flare of it around 8pm also lasting around an hour.   Now 24 hours later, seems mostly resolved, not quite 100%.  Prior to this, there was only mild injection site tenderness, less than other IM vaccines.
3/12/21- pt with h/o dairy allergy non-anaphylactic but states her nose feels "full" when exposed. No other allergy history. Vaccinated without incident at 9:25am. Pt. placed in 30 minute monitoring area. Approximately 20 minutes into monitor, pt. developed hives, complaints of feeling dizzy and nauseated. Pt. placed in prone position per her request. Tachycardic and hypertensive. Was not administered any epinephrine at initial assessment. Called EMS for assessment and transportation to hospital. After 10 minutes hives disappeared and heart rate and BP lowered, although still elevated. EMS assessment completed and pt. placed into seated position. Upon sitting, hives returned, became diaphoretic, tachycardic and hypertensive again. Pt. placed on stretcher and transferred to hospital for further care. Husband notified by patient. Advised to pt. to check with physicians regarding feasibility of receiving second dose.
This case was reported by a nurse via sales rep and described the occurrence of nausea in a female patient who received BOOSTRIX for prophylaxis. On 16th November 2018, the patient received BOOSTRIX. In November 2018, less than a week after receiving BOOSTRIX, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were unknown. It was unknown if the reporter considered the nausea and vomiting to be related to BOOSTRIX. Additional details were received as follows: The age at vaccination was not reported. The patient had nausea and vomited twice after vaccination with SHINGRIX. The reporter agreed to follow up from GlaxoSmithKline.
The second dose was administered @ 1307 in the left deltoid. The employee initially experienced nausea. However, this symptom quickly recovered and she felt fine. Then the employee waited 15 minutes with no additional symptoms. At 1327 the employee became warm, shaky, nauseated and then began vomiting. She was provided with rest, ice packs, crackers and sports drink.  She continued to vomit and feel unwell. Therefore a call was placed @1452. We spoke with RN who recommended the employee apply self care at this.
Patient had a syncope episode and  failed sitting. While trying to stand patient had another episode and was slided down on the floor by  the nurses. Paramedic  came and attended to patient. Patient recovered after few minutes and family member pick patient to home.
Low grade fever, nausea, and tingling in right fingers and right toes. Low grade temp is still going on at 99 today (11-3-09- tingling in fingers and toes have stopped).  Have had today 11-03-09 low grade temp (99), fatigue, diarrhea, nausea. Called doctors office, could not get someone to answer my question if this was a side effect of the H1N1 shot. Was too fatigued to drive 40 miles to doctors office. Treatment staying home from work until symptoms subside. If it gets worse I will go to ER since I am an insulin dependent diabetic.
Arthralgia in shoulder, wrist, and back of neck started 1 week after receiving flu shots. Headaches x 2 days in frontal lobe. Patient started taking Aleve and symptoms are getting better. Symptoms lasted approximately 2 weeks. Patient denied any injuries or increased activities.
Diffuse itchy red, rash that started on arms and legs, spread to trunk and neck over several days.
Fever of 102, chills, aches, minor heart racing, injection site pain, headache
anaphylaxis.  SOB, dizziness, double vision, tongue swelling, wheezing
Severe vertigo, vision complications, pressure in the head, ringing/chirping in the ears and vomiting.
Received PPS V23 and TIV on 12-8-09, PT noticed a lot of pain and weakness in L arm 1-2 hours after receiving vaccines, both in L deltoid. Pt then started noticing redness and warmth and swelling to L upper arm, which progressively worsened. Also had nausea, stomach upset, HA, myalgias and fatigue since. No vomiting or fever, but had chills. RTC 12-10-09 more or less 80% of L upper arm erythematous with some streaking noted, hot to touch and tender to palpate. Treated for cellulitis with ROCEPHIN 1000mg IM and Rx for BACTRIM DST BID x 10 days and Diphenhydramine PO 50mg q 6 hours PRN.
Started with involuntary jerking of his right arm; m Friday night started involuntary muscle spasms of the right leg more like a jerking motion; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (m Friday night started involuntary muscle spasms of the right leg more like a jerking motion) and DYSKINESIA (Started with involuntary jerking of his right arm) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced MUSCLE SPASMS (m Friday night started involuntary muscle spasms of the right leg more like a jerking motion). On 08-Feb-2021, the patient experienced DYSKINESIA (Started with involuntary jerking of his right arm). At the time of the report, MUSCLE SPASMS (m Friday night started involuntary muscle spasms of the right leg more like a jerking motion) and DYSKINESIA (Started with involuntary jerking of his right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Treatment of COVID-19; COVID-19 Infection after immunization; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN 6202), in right arm, on 21Mar2021 as dose 2, single (Lot number: ER 8727), in right arm, on 09Oct2021 as dose 3 (booster), single (Lot number: FF 8841), in right arm and on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "afib" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "Treatment of COVID-19"; COVID-19 (medically significant), outcome "not recovered", described as "COVID-19 Infection after immunization". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At approximately 9 a.m. on Feb. 20 -- some 21 hours after receiving vaccine, started to feel as though I had contracted a mild cold or flu -- felt achy, feverish (even though temp was 97.2 at that time), spacey, tired, "brain fog"... symptoms lasted all day and into the evening. Slept 8.75 hours straight (unheard of for me) and feeling better today.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer or other non-HCP. A 34-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 34-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history and concomitant was not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient received no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02Aug2021, the patient had signs of illness came on quickly. Started with a tickle in her throat in the afternoon, then woke up very ill in the middle of the night and tested positive the following morning. The patient informed tested positive for COVID on 03Aug2021 via rapid test (nasal swab). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The treatment medication included cough syrup thus far, only 1.5 days into illness. The outcome of the event COVID-19 was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the Fluzone HD shot on 10/23/2020. A few days later, pt was complaining that her arm was hurting. Her son took her to the doctor's office on 12/04/2020 since she wasn't getting any better. Dr's office called the pharmacy on 12/04/2020 saying the pt had a reaction to the Flu shot.  Dr gave the patient Lidocaine patches and arm pain cream.  They did an x-ray and are awaiting the results as of today when we spoke to the dr's office.
Severe rash over torso and left arm around injection site. Red blotchy and puffy patches. Took regular antihistamine and allergy med first with no results (Allertec and Allegra both). Then 8 hours later took Benadryl and that helped.  Prior to Benadryl had spotty  prickly pain on back and itchy skin. Now it's been several days and looks like rash is mostly gone but still have prickly pain and itching on back. Stopped taking Benadryl after 3rd day. Not taking anything but it's annoying and hard to sleep.
large local rxn w/erythema & induration causing a 2" inc in diameter of arm from elbow to shoulder;occurred 30hrs p/inj;treated w/DPH;dx cellulitis-adm to hosp 3 days for tx w/IV ATB;
Fullness, hardness and redness of his left thigh injection site with pain and bruising.
STORAGE IN REFRIGERATOR (2C-8C) UP TO 30 DAYS. (VACCINE USED AFTER 10-16-2021).
EMPLOYEE STATES BEGAN FEELING NAUSEA LIGHT HEADED AND INCREASED ANXIETY. DONOR THEN REPORTED TO MANAGEMENT THAT SHE JUST TOOK AND ANTIBIOTIC (NOT PREVEOUSLY REPORTED).