chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of rash in a patient who received Flu trivalent vaccine for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. About 10 to 15 years ago, 1 to 2 patients experienced rash after receiving flu vaccine. The healthcare professional (HCP) reported that they used to pre-treat patients with BENADRYL who had reactions (rash) to flu vaccines (unknown brand). They would give 1 dose of BENADRYL an hour beforehand and ask patients to take one more dose 4 hours later, they usually do fine and they did not have any reaction again with the same sort of rash thing. Currently they have flu vaccine with no egg protein and no preservatives so they no longer have to do this. No details regarding patients or flu vaccine brand were provided.
Vaccine administered Thursday - Friday became very fussy and Saturday morning mother removed pajamas and noticed leg swollen from knee to groin and unable to bend leg - parents out of town and called clinic.  Sxs resolved by Monday.
Hives developed evening of 7/25/11, spread overnight, diffuse urticaria 7/26/11, no other symptoms.  Treated 7/26/11 with zyrtec, atarax, triamcinolone topically.
Nose bleeding, chest pain, wheezing, scaled tongue, high fever 41*. These were the same symptoms when received the second dose of Moderna. Not reported previously. Severe joint pain since the first dose a year ago
Patient is a 56 y.o. female patient with history of CAD, hypothyroidism, HLD, HTN, anxiety, type 1 DM, obesity, who presented to Hospital with SOB.   Acute hypoxemic respiratory failure due COVID PNA: Viral sepsis: Viral PNA: Fever, improved CTPA with no evidence of pulmonary embolism. Date of onset of symptoms: 1/28/2023 Symptoms present on admission: fever, chills, SOB, cough Date of covid positive test: 01/29/23 Vaccination status: vaccinated Imaging: CT with LLL PNA Oxygen requirements on admission: 2 Lpm by NC Current oxygen requirements:room air Medical therapy: steroids Consultants following: ID Anticipated special isolation end date: 2/7/2023 Legionella and strep pneumonia antigens negative.  Influenza negative. Follow-up blood cultures and urine culture.  No growth to date Patient was started on IV ceftriaxone for secondary bacterial pneumonia we will switch to p.o. Keflex for 5 more days on discharge   Chest pain, noncardiac 1/30/2023, the patient developed chest pain.  Midsternal.  Tender to touch.  Gets worse with deep breathing.  Not related to exertion.  Not relieved by rest.  EKG with no new changes from baseline EKG.  Troponin negative. Tylenol as needed   CKD stage III Creatinine 1.35 on presentation.  Around baseline.  Continue to monitor   Elevated lactate, clinically undetermined Lactate 3.2 on presentation with no acidosis on BMP.  No intervention needed at this time   Type 1 DM: Insulin dose adjusted Continue Lantus  Lispro AC/HS   GERD: Continue pantoprazole   HTN: Continue Lopressor   CAD: Continue current SA, Plavix, Lopressor  Hypothyroidism: Continue levothyroxine   Morbid obesity, BMI 40.29: Encourage diet modification, active lifestyle, and weight reduction   Anxiety and depression -Continue doxepin and Ativan -Continue Ambien at night to help with sleep -Evaluated by inpatient psych who recommend outpatient follow-up
blood would not clot; Debilitating joint pain/weak joints were extremely sore; Back really itched; uncomfortable; felt achy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Back really itched), COAGULOPATHY (blood would not clot), DISCOMFORT (uncomfortable), MYALGIA (felt achy) and ARTHRALGIA (Debilitating joint pain/weak joints were extremely sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma. Concurrent medical conditions included Arthritis NOS. Concomitant products included GABAPENTIN for Arthritis, ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE/ATROPINE), VITAMIN B NOS, LOPERAMIDE, NAPROXEN, PARACETAMOL (TYLENOL) and VITAMIN D NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (Back really itched), DISCOMFORT (uncomfortable) and MYALGIA (felt achy). On 30-Jan-2021, the patient experienced ARTHRALGIA (Debilitating joint pain/weak joints were extremely sore). On 04-Feb-2021, the patient experienced COAGULOPATHY (blood would not clot). At the time of the report, PRURITUS (Back really itched), COAGULOPATHY (blood would not clot), DISCOMFORT (uncomfortable), MYALGIA (felt achy) and ARTHRALGIA (Debilitating joint pain/weak joints were extremely sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood test: abnormal (abnormal) pre-operation bloodwork done and result showed her blood would not clot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Due to bloodwork result ,Patient scheduled lung surgery on 05-Feb-2021 which had canceled.  A few lymph nodes were removed robotically and lung nodule removed robotically on 19-Feb-2021.  No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received: New events added and event outcome updated, concomitant medications added.
Severe  and persistent Headache, lasting 5+ hours, 6/10 pain scale
Moderna COVID-19 Vaccine EUA I received vaccine on 4/12 without any reactions.  On the morning of 4/22  we noticed both my cheeks were red. As day progressed they seemed bit warm to touch and started to harden/swell.  I took 1 Claritin and called dr's office.  I had Restalyne Lyft injections on March 1st, 2021.  I spoke with injector, who instructed to take a second Claritin.   On 4/23 both cheeks felt "hard" and slight swelling under right eye.  I applied cool cloth, more took Claritin.   On morning of 4/24, still "hard" but not as full feeling.  Still red in cheeks but not as warm to touch. Under eye swelling not as prominent.
@ 8pm the same day as I received the vaccine I started to violently jerk all over my body.  Jerking was severe for 25 minutes then went to moderate for another 30 minutes.  Felt like my back was going to break.  Around 2am the next morning I experienced mild nausea for about 10 minutes, had a bad headache for 6 hours and temperature for @ 4hours.  All symptoms resolved @ 5 a.m. of the next morning.
Onset 4 days post vax, fever 101 and fussy.  10 days post vax, temp of 104.  No firm dx made. Possible benign neutropenia of childhood. No treatment needed.
No additional AE reported; An expired dose of PROQUAD was administered to a 5 years old patient; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient with unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-MAR-2022, the patient was vaccinated with an expired dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (lot #T030943 with an expiration date on 09-MAR-2022) administered for prophylaxis (strength, anatomical location and route of administration were not provided) (expired product administered).   No additional adverse events were reported.
Severe Headache, muscle aches and cramping, muscle stiffness, assistance needed to walk because of muscles weakness and soreness. Unable to move arm where vaccine was administered.  Swelling, bruising at vaccine injection site. One week later still having pain in left arm and mobility issues. Muscle weakness and inability to have full range of motion in arm where vaccine was administered. Also experiencing pain that is radiating down left arm into hand. Awakening at night because of severity of pain in arm where vaccine was given.  General pain throughout the day.
Client complained of dizziness, diaphoretic post vaccination 1 minute after. Client had an episode of syncope which lasted for few seconds. Client was then place on the cot with the legs elevated. Three sets of  vital signs were taken , had varying unstable vitals, further complained of abdominal discomfort and numbness of upper and lower extremities. Cool packs and fluid offered for hydration.  Patient with non-resolving symptoms. EMS was activated at 6:43 PM. EMS came and monitor at the clinic and transferred to Medical Center for further monitoring.
by Sunday afternoon my left shoulder was in agony. On a scale of 1 to 10 probably a 9. This lasted until the middle of the night Tuesday/Wednesday when the pain went almost entirely away.
Information has been received from a physician concerning a 12 year old (also reported as 11 year old) female patient who on 11-MAY-1998 and 01-AUG-2001 was vaccinated with the first and second doses of MMR II respectively.  On 14-JAN-2010 the patient experienced mumps.  On 17-JAN-2010, the patient was diagnosed.  The patient had right parotitis.  On 17-JAN-2010, the first blood work was performed (no result provided).  At the time of the report, the outcome was unknown.  No further information is available.
Pain at injection site, body weakness, malaise, sleeping for five days, extreme muscle pain on day four and five, legs very weak on day three four and five.
Pt states that she  developed a hard crusty lump in her left arm after getting shingles vaccine. However, our records state she received the shot in her right arm.
I had continuous fever and its fluctuate it doesn't drop; in the morning it was 102 and spikes in night goes up to 103; Chills; Joint pain; It burns to urinary; The second dose did not work for me; I am having trouble with pain relief medicine not doing their job; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no: not reported/Lot number- ER8727) via an unspecified route of administration in arm left (reported as left) on 21Mar2021 (at the age of vaccination of 69-years-old) as dose 2, single for COVID-19 immunization. Patient also received ibuprofen (oral suspension) via an unspecified route of administration on an unspecified date. Patient's relevant medical history included with blood pressure, cholesterol, gout, kidney stones and enlarged prostate. Concomitant medications included ongoing amlodipine for the Indication of Blood pressure, ongoing Atorvastatin for the Indication of Cholesterol, ongoing allopurinol for the Indication of Gout, ongoing potassium citrate for the Indication of Kidney stones and ongoing tamsulosin for the Indication of Enlarged prostate, all were from unknown start date. On 22Mar2021, patient had continuous fever and it was fluctuated it does not drop; in the morning it was 102 and spikes in night goes up to 103, chills, joint pain, it burns to urinary, and he had trouble with pain relief medicine not doing their job. Patient reported as he had Covid-19 Vaccine on 21Mar2021, and the nurse told me that he could expect the side effects and they would last for 24-36 hours. On 22Mar2021, patient started experiencing side effects however this was his 4th day which he had continuous fever and it was fluctuate it does not drop, in the morning it was 102 and spikes in night goes up to 103 that's pretty much the fever for 4 days that kind he had and he taken Ibuprofen as Treatment for which it worked for the first dose and for the second dose did not work. Patient had trouble with pain relief medicine not doing their job and asked for any better option for this, hence Ibuprofen coded as Conservatively captured as co-suspect. Also, he had chills, joint pain and have been treated for enlarge prostate, drinking lot of water like he supposed to but it burns to urinary some and it does not a big urgency, so he had some effects with prostate. Investigation Assessment was reported as No. Treatment was received with Ibuprofen for the events. Outcome of the events was not recovered.   No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained. No further information is expected.
Mom noted this morning while taking shorts off a large "baseball size" erythematous lesion on R lateral thigh. Pruritic with some pain.
pt to ED via EMS with SOB, productive cough, weakness, diarrhea; 82% O2 sat on RA; placed on supplemental O2 via NC;  admitted to hospital; dyspnea with exertion; positive test result for COVID; AFR due to COVID pneumonia; poor renal function; gave steroids, Vitamins C, D, and zinc; pt's condition worsened requiring intubation; developed septic shock, placed on vasopressors; condition deteriorated and pt died in the hospital
Dose administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  Reporter states that, vial was initially stored in the refrigerator on the date 4Jan2022 and was first punctured on 5Jan2022 at 8:30am.
The main symptom I had a head to toe rash.  The rash was profusely on my stomach, I though I was going to have scars from the rash.  It was extremely itchy.  I also got tingly fingers, which I still have as of today.  I made 3 trips to the walk-in clinic and got cortisone shots and cortisone pills 3 different times.   I also gained 15 pounds over that time period.  I also went to a allergist and he advised I was probably allergic to something in the shot.  He advised not to take the second shot.   All the other healthcare providers advised me not to take the second shot as well.   I have not had the second shot due to the symptoms I had.   With the "tingly" fingers there was also joint pain in the wrist and hands.
Sore throat; Tired; Sick/ Fell bad; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), ILLNESS (Sick/ Fell bad) and OROPHARYNGEAL PAIN (Sore throat) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced FATIGUE (Tired) and ILLNESS (Sick/ Fell bad). On 25-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, FATIGUE (Tired), ILLNESS (Sick/ Fell bad) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
mom reported pt woke up 330AM c/o feeling sick-T101.5, labored breathing, diff walking to bathroom;mom did not give anything for fever;mom advised to call MD;no one else in house is sick;did not have these sx p/prev vax;dx juvenile diabetes
pt recv vax 5MAR97 & 23JUN97 pt devel chickenpox from which recovered;
After receiving the initial inoculation, later on the night I started feeling sharp pain to my heart. Almost like heart burn with throbbing  pain at times. The pain slowly went away after a few days. I also felt dizzy, low energy, forgetting recent events and lethargic. Most of the symptoms went away after a couple of weeks. I also noticed my skin turned blotchy white where the inoculation was administered to my upper left arm. 03/10/21 Same symptoms for the second dosage. More blotchy white marks around the second inoculation. 03/31/21
BODY SORENESS; FEELING BAD WHOLE SECOND DAY; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body soreness, feeling bad whole second day, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body soreness, feeling bad whole second day, fever, and headache on 12-MAR-2021. This report was non-serious.
after vaccination, pt left pharmacy fine with no immediate AE, but on 1/28/21 she reported that at on 1/26th midnight she experienced body ache,  swelling of face and puffy eyes, but not lips, or tongue. Pt stated she had mild difficulty breathing but she is smoker and had breathing problem before.   Pt did not receive any medical treatment, and stated that after 15 hrs (next day) she felt normal and much better.
Information has been received from a pharmacist concerning a 71 year old female who in 2006 was vaccinated with ZOSTAVAX (Merck), 0.65 ml and had a case of shingles just recently in November 2008.  Follow-up information was received from a pharmacist which reported that the patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Merck vaccine VZV strain.  The date of vaccination was on 17-APR-2007, dose 0.5ml, in the right upper arm (lot# 656394/0162U).  Concomitant therapy included ATENOL, Calcium (unspecified), TYLENOL, CADUET, COMBIVENT and vitamins (unspecified).  The patient did not develop a rash at injection site or elsewhere within 42 days of the vaccination.  The patient did not develop a rash at injection site or elsewhere within 42 days of the vaccination.  The patient had multiple lesions in her head, right arm including shoulder.  There was pain in the lesions.  There was no recent exposure to chickenpox or shingles.  At time of reporting, the patient was recovered.  Additional information is not expected.
C/O bones aching next day pain, progressing to worse, severe headache, shivering, had bones aching and temp 10/7. Bones aching this a.m.
Shortly after getting vaccinated, my arms and legs felt as if they weighed a ton. I could move, but with difficulty. This lasted for approximately 2 hours.  I have a severe phobia of needles and usually feel weak, but the heaviness has not happened before.
Pt received her 2nd dose of the Moderna COVID19 vaccine. Pt reported after her first dose within three hours she felt like the arm which she received an injection in became swollen. Pt reported no other symptoms. Pt stated while sitting in observation today she felt like within minutes her arm was beginning to swell near the injection site. EMS on site and evaluated pt. Pt signed refusal for transport to the hospital. Pt was given ED precautions. Pt verbalized understanding.
throwing blood clots within a few weeks of final vaccine.; This is a spontaneous report from a contactable consumer (patient's daughter) via a Pfizer-sales representative. A male patient of an unspecified age received the second dose (reported as final dose - pending clarification) of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. Medical history included history of blood clots and transient ischemic attacks (TIAs). The patient's concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On an unspecified date, the patient experienced throwing blood clots within a few weeks of final vaccine. The patient and the daughter are concerned about the vaccine having this effect. The outcome of the event was unknown.  Information about the batch/lot number has been requested.
SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
My heart was like killing me; heart still hurts and I never had problem with my heart; Flu like symptoms; Severe muscle ache; Joint ache; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: ER8734) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported.The patient previously received first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: EN6202) via unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. It was reported the patient was little freaked out, received second dose Pfizer (Covid) vaccine and 12 hours after started having flu like symptoms, severe muscle ache, joint ache and muscle ache and like heart was killing him like. Patient did not know whether need to go to Emergency room or not. Patient was healthy individual, and only go to the Doctor once a year and if it was just a side effect and he will be ok but, heart still hurts. Do patient need to go see a cardiologist. The patient never had problem with his/her heart. The patient was not recovered from heart was like killing me; heart still hurts and unknown for the flu like symptoms, severe muscle ache, joint ache.   Follow-up attempt are not possible. No expected further information.
Severe Spasms in all muscles from feet all the way up through back, lasting for up to 10 seconds and occuring every 10 to 15 minutes. I felt as if my entire body was frozen during the spasms. Had a very hard time breathing. Called 911, no fever, taken to emergency room. Was given an injection of ativan and it relieved the spasms. I slept the rest of that night and woke up very sore in all muscles for 5 days after.