chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 64 year old female who on 23-MAR-2007 was vaccinated IM with a dose of Zostavax (Merck). Subsequently the patient experienced injection site redness which persists as of 20-APR-2007. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Follow up information indicated that the patient had no adverse event (previously reported that the patient experienced injection site redness). Nofurther information was provided. Additional information is not expected.
PULMONARY EMBOLISM , CHEST PAIN IN JAN-MARCH AND IN  JUNE HAVING SHORTNESS OF BREATH , SYNCOPE ON 8/1/22 AND DIAGNOSE WITH PULMONARY EMBOLISM
Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On 25-SEP-2016, the patient was vaccinated with improperly stored  VARIVAX subcutaneous injection (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-SEP-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provided contact details to contact other registered nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA009079: US-009507513-1610USA001984: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA009083: US-009507513-1610USA009084: US-009507513-1610USA009078: US-009507513-1610USA009081:, MERCK 1610USA009080:Mfr number.
Severe Headache, nausea, fatigue, lightheadedness, muscle weakness in left arm and arm pain in left arm, chills Fatigue started in the morning and other symptoms started to emerge after a few hours. Severe headache started midday. Symptoms made it hard to focus and get work or anything else done. Took ibuprofen which helped headache, but it did not go away completely and lasted in to the next day
5:13pm- Patient complained of burning, itchy, scratchy throat.  NO breathing issues stated or observed; 05:15 pm- B/P 176/102, HR 101 pulse ox 98% on RA, RR-22; 05:18 pm- 25 mg Benadryl given PO; 05:42 pm-B/P 142/86, HR 79, 98% on RA, RR 22, patient stated choking sensation starting in upper throat. 05:43 pm- patient states less burning, itchy, scratchy throat, but throat "tightness"; 05:34- 25 mg Benadryl given PO; 05:42 pm- B/P 142/86, HR 79, pulse ox 98% on RA, RR 22; 05:56 pm- patient reports decreased amount of burning sensation, itchiness, scratchy throat symptoms, but denies completed relief of those symptoms, still throat "tightness"? 18:02 pm- B/P 152/92, HR 91,  98% on RA, RR 22; After showing signs of some relief from Benadryl, instructed patient to be seen by a doctor since patient?s reaction could possibly continue. Patient and husband agreed to head to urgent care. Husband verbalized understanding of signs and symptoms of increasing reaction and stated that he would pull over to side of road and call 911 if airway compromise became present. Patient report called to Urgent Care.
swelling under his armpit; very weak; like a dead man; shivering; cold; sweaty; fever; body hurt/ body ache; This is a spontaneous report from a contactable consumer. This consumer reported for male patient (brother). A 29-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 06Apr2021 at 08:30 (at the age of 29-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. He was healthy, eats well and works out. On 06Apr2021, by the end of the day, he was sweaty, cold, had fever and his body hurt. The next day on 07Apr2021, he came into work and looked like a dead man, he was very weak, was shivering, had fever and body aches. On 08Apr2021 he was feeling better but noticed a swelling under his armpit in the arm where he got the shot, but he was feeling much better on 09Apr2021.  The reported asked if this was side effect because his other brother, who doesn't go to the gym or watch what he eats, had no side effects at all. The outcome of all the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
out of breath; This is a spontaneous report from a non-contactable consumer from a Pfizer Sponsored Program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date was not reported), via an unspecified route of administration on an unspecified date Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient was a little out of breath, said he was exercising on an unspecified date Mar2021, had 2nd dose of covid vaccine about 2 weeks ago and still having light symptoms from vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Fever, Warmth, Redness, Rash from injection site down to 2 inches above elbow.
pt recvd vax in MAR1988; 2 wks later pt exp a grand mal sx; No further details were provided;
ER visit on 5-9-03 with fever of 102F and vomitting. Treatment: Tylenol and Motrin every three hours and fluids.
Had Moderna vaccine. On 11th day after the vaccine, my left arm I got my vaccine in, broke out red and swelled up. It was hot to the touch. From top to right above elbow. Throbbed a little. Lasted for about 3 days. My feet have been itchy and swollen at night a few times since I got the shot.
Patient complained of burning sensation of the feet and some intermittent sob not worse with exercise. burning sensation of the feet happened on the 17ths and sob of breath comes and goes starting the 17th and on. Patient also endorsed worsening migraines.
Systemic: PT COMPLAINT FEELING SICK AND CANNOT CLEARY EXPLAIN WHAT-Medium, Systemic: Hypotension-Medium, Additional Details: IMMEDIATELY AFTER SHOT PT COMPLAINS FEELING WEIRD AND FEELING SICK;PATIENT LIED DOWN STILL FOR FEW MINUTES.STILL TALKING.NO RASH OR ITCHING.BP CHECKED AND WAS LOW WHILE SITTING.PT LAID DOWN AND BP WAS FOUND RETURNING TO 108/68. PT STAYED FOR ALMOST 30 MINUTES.DRANK WATER.PARENTS WERE WITH HIM AND WAS FEELING OK AND LEFT WALKING.DID NOT REPORT ANY DIFFICULTY BREATHING OR DISORIENTATION.OFFERED TO CALL 911.REPORTED WAS SICK LAST TIME GOT THE VACCINE.CALLED AFTER 1HR MOM SAID HE FEELING BETTER.
About two days after receiving my fifth dose of the Pfizer Bivalent vaccine, I started to feel fatigued. I was experiencing shortness of breath and just really tired. It was hard for me to catch my breath when I went outside of my house. I knew something was going wrong because my throat was staying dry. When I went to my doctor, she told me that I have a fungus in the back of my throat. She gave me the mouthwash to help with that. I also noticed that I had a red rash show up on my leg, but as of yesterday it was no longer present.
This spontaneous report has been received from a Medical Assistant refers to unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # K009181 exp. date on 24-APR-2016 and Lot # K017573 exp. date on 11-JUN-2015), oral (strength and dose were not provided). There was no concomitant medication reported. No adverse experiences reported. Product quality complaint was not involved. A phone call was made on 28-SEP-2015 to the reporting Medical Assistant who was no longer with the company. A detailed message was left for the supervisor to return the call. This is one of several reports received from the same reporter. Additional information has been requested.
Night of vaccine- soreness and tenderness in arm Morning (9 hours post vaccine)- Vision issues (inability to focus, blurred vision); total body muscle stiffness/rigidity; dull headache; fatigue and weakness; extreme muscle soreness and tenderness in arm.  Side effects improved over 12-24 hours.
I all of a sudden have now broke into whole body hives, face, lips, eye swelling. I now carry an epi pen
104 temp, aches, fever on 11/4/19. Woke up on 11/5/19 with puffy face and lips, puffy and sore down right side from jaw bone to hips. Went to ER and was given IV Benadryl per patient report. called pharmacy with this info on 11/6/19
Patient was in clinic on 10-29-07 and received Gardasil, Tdap and Dep-Provera around 3:00 - 3:15 pm. Mother reported around 6:00 pm the patient broke out in hives on the right side of her neck, right/left sides of chest/back. Waited in ER and left. Called hospital. They told her to give Benadryl and Tylenol still itching 10-30-07. No rash.
p/vax pt exp fever & serum sickness; tx w/ofloxacin s (levofloxacin) & unspecified ATB initiated followed by dec white blood cells; PE was nl;
Pt had a grand mal sz 3 days p/vax;pt w/CP VP shunt;seen by MD
Resident passed away at 8:15 am on 1/28/21-found to be without pulse/respirations/DNR order in place.
Approximately 12 hours after I received my first Moderna shot, I had the typical soreness in my arm, along with fatigue and headache. The issue with my right inner ear began shortly thereafter. The pressure and faint ringing is constant, and is aggravated when I speak or am exposed to elevated sounds, which results in an almost quivering sensation accompanied by faint crackling/static sound that's extremely unpleasant but not painful. I have taken Tylenol and have been drinking plenty of water, but that hasn't alleviated the symptoms. My sinuses are clear and I'm not dizzy or lightheaded. I'm now on day three post-vaccination, and my hearing is diminished in my right ear. I cannot hear lower-pitched sound, especially anything that has heavy bass, but can hear higher pitched sounds, albeit they sound distant and muffled.
No additional AE; Caller reported that PROQUAD that underwent a temperature excursion was administered.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 22-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # W010061, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [rHA] [PROQUAD], expiration date reported and upon internal validation established as 20-SEP-2023) (dose, anatomical location and route of administration were not reported). The vaccine was administered for prophylaxis after a temperature excursion (temperature of -14 Celsius degrees [°C] up to -10°C [-14.18C] for 0 hours 15 minutes and 0 seconds) (Product storage error). The vaccine did not have previous temperature excursions.  No adverse event was reported.  This is one of three cases reported by the same reporter.
Proquad given outside of age range. Contacted Health Authority. advised to not administer again. Patient  had no adverse reaction.
A few minutes after the patient received the Janssen covid vaccine, he passed out and wet himself. The paramedics were called and they suspected it may have been a seizure. The patient passed out or had another seizure and the paramedics took him to the hospital.
Patient received second dose too early. Patient received second dose of vaccine only 13 days after first dose.
High pitched ringing in ears lasted 20 minutes.  Less high pitch ringing in ears after.wards; continuous.
Rash all over body. Getting worse by the day. Now 6 weeks after second shot
102 fever that began at 0300 the night after vaccine administration as well as redness and swelling of left arm
AFTER RECIEVING THE SECOND DOSE OF PFIZER PEDIATRIC VACCINE, THE PATIENT DEVELOPED A SMALL RASH (DIME SIZED) ON THE RIGHT SIDE OF HER FACE NEAR HER MOUTH., CHIN.  THE FATHER SAID IT STARTED DEVELOPING THE NIGHT AFTER THE PATIENT RECEIVED THE VACCINE.  HER MOM ADMINISTERED BENZADRYL THINKING THAT IT WAS  AN ALLERGIC REACTION. IT DID NOT CLEAR.
This case was reported by a healthcare professional and described the occurrence of arms itching in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2012 the subject received unspecified dose of FLUARIX (unknown). On 11 October 2012, within hours of vaccination with FLUARIX, the subject experienced arms itching and mottled skin. The healthcare professional reported that the subject experienced itchiness on her arms and her arms were mottled. The subject did not have any symptoms in her throat, just her arms. The healthcare professional recommended BENADRYL and for the subject to keep an eye on the symptoms. No other details were provided because the healthcare professional was in the middle of a flu clinic. At the time of reporting the outcome of the arms itching and mottled skin was unspecified.
This serious initial spontaneous case, was received from a pharmacist on 13-Nov-2017, concerning a 36-year-old, female patient. The patient's medical history was not reported. The patient was allergic to soy. The patient's concomitant medication included imipramine for unknown indication. On 09-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195239, expiry date: May-2018). On the same day, after 30 minutes of vaccination, the patient experienced swelling in tongue, itching and redness at the site of injection and throughout her arm. The patient had an allergy to vaccine. The patient went to the emergency room (ER) in fear of anaphylactic reaction as she was allergic to soy and thought that soy could be in vaccine. It was confirmed that the patient had an anaphylactic reaction. The patient was treated with steroids, BENADRYL at ER and MEDROL dose pack, hydroxyzine once at home. The outcome of the events was reported as recovered on 09-Nov-2017. Follow up received on 29-Nov-2017: It was reported that patient had an anaphylactic reaction. The narrative was amended accordingly.
Unable to sleep well/ can't get a full nights sleep/ just lay there wide awake/ Woke up at 4 am Friday. Didn't go to bed until 2 am Saturday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 25Mar2021 15:45 (Lot number: ER8727) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing), notes: Levocetirizine for allergies. Concomitant medication(s) included: LEVOCETIRIZIN taken for hypersensitivity; [ASCORBIC ACID; CYANOCOBALAMIN;ERGOCALCIFEROL; NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE MONONITRATE]. The following information was reported: INSOMNIA (non-serious) with onset 26Mar2021 04:00, outcome "not recovered", described as "Unable to sleep well/ can't get a full nights sleep/ just lay there wide awake/ Woke up at 4 am Friday. Didn't go to bed until 2 am Saturday". Therapeutic measures were not taken as a result of insomnia. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355281 same report/drug/AE, different patient; US-PFIZER INC-2021355282 same report/drug/AE, different patient
arm pain, achy, tired, foggy head, just really exhausted, slight chills.
about 2 hrs p/inject, arm became swollen & warm @ inject site; began coughing, shakey & throat tight; arms became stiff & hands clenched; treated w/Epi, monitor, IV d5W, Decadron IV, Volium
Patient recieved a COVID-19 vaccine and about 5-10 minutes later she said she felt like her throat was closing up.   911 was called immediately.  She was not short of breath but felt like the swelling was coming in waves and could not swallow.  Patient was monitored until EMT showed up, and patient left with EMT for follow up at the hospital.
Nurse was vaccinating at flu clinic at a school.  The only flu vaccine we had available to send was Afluria which is dosed differently for ages under 3.  She gave the full dose of 0.5 to a this child who is under 3 (she was about 11 months).  Mom was called and informed of error and was very understanding and was going to call her PCP.  No adverse affects noted.
This spontaneous report was received from a nurse concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB with lot # M014925 Expiration date: 16-FEB-2019 (dose and anatomical location of administration were not reported). No concomitant therapy was provided. The temperature reported was 50.9F with a time frame of 8 hours. It was unknown if it was detected by a digital data logger. Some previous temperature excursions were reported; 49.6F for 14 hours and 34.9F for 24 hours. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Within 6 minutes of receiving the vaccine, I got a slow moving pain down my thoracic spine and started to continuously belch. I also have what feels like "goose bumps" from cheek to cheek and on my upper lip. The pain has subsided but the belching and goose bumps have not and I am now about 50 minutes post vaccine. The same thing happened with my first dose but I did not think that it was the vaccine. Tonight confirmed that it was. My first dose was given on 3/19/21 and the lot number was 047A21P. I did not have symptoms with the second dose.
Client had Hep A vaccine in Left deltoid. I then gave her HPV vaccine in her right deltoid.  Her mother, who was sitting in the room, noticed that the client was becoming pale and suggested she needed some "sugar" because she had not eaten in the last few hours. Client then fainted in the chair.  With the assistance of another nurse, I was able to lower the client to the floor and elevate her feet without any injury.   Her pulse was weak, and she was pale and diaphoretic.  Blood Pressure was 118/68. Ammonia inhalant was used and client was responsive within seconds.  Client had shown some anxiety over vaccinations but denied any previous reactions. Mother recalled that client had also had a fainting episode after a dental procedure in the past when the dentist was injecting novocaine.
Sick for 4 Days with fever, chills, body ache, severe headache.  After that developed rash on torso.  Looked like chicken pox.  Still  have marks on torso.  Also noticed that my eyesight seems altered.  Nothing is clear and crisp as it was before.  Wear bifocal lenses, and both near and distant affected.
Swollen eyes Swollen face Eyes swollen shut Red spots on face and neck Severe dehydration Hours of vomiting Extreme stomach pain Extreme chills
Right arm pain near injection site as well as weakness  when trying to lift items or reach for things. Lasting one month to date. Pain is mild and not worsening. Taking pain medication on occasion.
4/5/11 per pt a few hrs after immuz given noted - pain (L) upper arm & neck - later after midnight began to have fever. On 4-5-11 also began to note swelling of (L) upper arm from inj site to elbow. Pt contacted MD office 4-6-11 with sx refused Urgent Care visit seen by MD 4-7-11.
Woke up this morning with a red spot about 3 inches in diameter about 2 inches below injection site.
PT REPORTED TO SITE WITH C/O A RASH COVERING TORSO AND FACE AND A MILD TEMP, WITH THE RASH BEGINNING TO SPREAD TO UPPER LEGS. PT WAS PREVIOUSLY SEEN IN THE ER AND AT CLINIC BY PCM. PT STATED THAT HE BEGAN USING CORTISONE CREAM FOR THE ITCHING.
She developed a pulmonary embolism after having 3 rounds of vaccine GARDASIL.  She was a healthy, active teenager. 2/23/09-autopsy report received immediate cause:Massive pulmonary embolism. Mild cardiomegaly. Last several days C/O cough and congestion. 3/9/09-ED records received for DOS 10/26/08-presented in full cardiac arrest after suffering a full and prolonged cardiac arrest, aystole. Expired.
Anaphylaxis. 2 EpiPens, 50 mg Benadryl PO. Was with patient for 2 hours before ambulance arrived. Tingling and numbness to lips, tongue and mouth. Swelling of lips. Pruritis of throat. Dry unproductive cough. "Feel like I'm being strangled". Grogginess (may have been due to Benadryl). Disorientation. Increase in blood pressure. Increased respiratory rate and labored breathing. Left chest discomfort (non-radiating). Hoarseness. Appeared syncopal and weak.
Itching, redness at injection site starting to appear 10 days after vaccination. 1 day later still itching, redness, and some swelling, hard to touch. 2 days later (2 days after initiation of symptoms), significant swelling around injection site, hard to touch, redness, still itching.
Janssen COVID-19 Vaccine EUA  Patient was found on the ground in home and admitted for observation on 6/24/21, reported frequent fals. Patient was provided J&J COVID Vaccine on 6/25/2021. On 6/26/2021 at 8:14 pm patient was noted to have left sided facial droop. Pt alert, confused. Can lift arms and legs for full 10 seconds. No weakness noted. Pt unable to tell when touching her left arm with her eyes closed x 3 attempts. Denies tingling/numbness in this arm. Not present in face/left cheek or left leg. 14 MRI brain showed small right MCA infarction on the background of considerable chronic microvascular changes.  MRA head and neck showed diffuse intracranial and atherosclerosis without significant. stenoses or occlusion.
Had erythema, swelling and pain into (R) chest that started night of administration. The progressively developed severe myalgias and arthralgias that prevented her from sleeping. Saw her on 9/25 stating it had not resolved and not getting better.
48 hrs hx of fever 102-104.8 beginning 2 hrs p/inject p/fever broke, diffuse macular rash noted; 1OCT93 still fussy, dec appetite, rash present x 24 hrs;
Headache, Myalgia, Fever NauseaVomiting, Clammy/sweaty, soreness injection site radiating to lower back , trouble sleeping Narrative: