chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seen in ER 6-10-13 and treated with KEFLEX for cellulitis at immunization site; redness started day before. Today 6-21-13 seen with red-purplish spot at site. Not raised; 4cm circular purpuric lesion (L) thigh; not acutely infected, no warmth, no erythema, no induration.
CHILD RECEIVED TdaP, MENACTRA, INFLUENZA VACCINE. GOT UP, HAD SIGNIFICANT ABDOMINAL DISCOMFORT, VOMITED FORCEABLY, DEVELOPED SWELLING IN CHEEKS, LIPS, EYES. GIVEN ORAL BENADRYL WITH SOME RESOLUTION. SENT TO ED FOR FURTHER CARE
8-16-11 18 yr old female client seen in Immunization clinic around 11:30am and given a Tdap vaccine. At 7pm client had hives and itching all over body and felt dizzy. Client took Benadryl at home with no relief. At 11pm client went to hospital where client was given treatment and discharged with diagnosis of generalized vaccine reaction.  Client was told by Hospital to continue Benadryl for relief of symptoms.   8-17-11 Father called into IZ clinic at 2pm to advise clinic of clients vaccine reaction. Nurse advised father to call MD or take into hospital if Childs symptoms are not improving or get worse at any point.  Nurse also advised father of client that whenever client receives subsequent vaccines they should notify provider of this past vaccine reaction after Tdap vaccine. VAERS report done.
Hospitalized for COVID pneumonia 12-16-22 and died 12-25-22
Face swelling; Lips swelling; Eyes itchy and red like allergies; Neck itchy and red; Neck itchy and red; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swelling), LIP SWELLING (Lips swelling), EYE ALLERGY (Eyes itchy and red like allergies), ERYTHEMA (Neck itchy and red) and PRURITUS (Neck itchy and red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SWELLING FACE (Face swelling), LIP SWELLING (Lips swelling), EYE ALLERGY (Eyes itchy and red like allergies), ERYTHEMA (Neck itchy and red) and PRURITUS (Neck itchy and red). At the time of the report, SWELLING FACE (Face swelling), LIP SWELLING (Lips swelling), EYE ALLERGY (Eyes itchy and red like allergies), ERYTHEMA (Neck itchy and red) and PRURITUS (Neck itchy and red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
received the vaccine too high on her shoulder; Experienced a lot of pain; A spontaneous report ( was received from a physician concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced received the vaccine too high on her shoulder (incorrect route of product administration) and a lot of pain.  The patient's medical history was not provided by the reporter. Concomitant medications were not reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   It was reported that the patient, who was a healthcare worker, received her vaccination too high on her shoulder.  Additionally, she experienced a lot of pain.  Treatment for the events was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, received the vaccine too high on her shoulder, was considered recovered/resolved.  The outcome of the event, a lot of pain, was considered unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected event of Incorrect route of product administration for mRNA-1273 (lot # unknown) with associated unexpected adverse event of pain.  Adverse event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
at hour 12 post-administration (0200am), woke up with fever, chills, headache.  Shortly after began to vomit repeatedly, was unable to stop vomiting.  ER visit at 1600 (afebrile by that point- only had fever for 12hrs).  Potassium 3.4, given 3 L fluids, meds to stop vomiting.  Sent home at 2300.  Continued to vomit at home until about 0200 on 1/22/2021.  Headache persisted on a daily basis through 1/28/21.  PCP virtual followup for headache on 1/27/21.
Chest pain , nausea, sweating,  back pain, light headed , high blood presser. 159/108 .
Incredibly debilitating headache, increased level of fatigue similar to an exacerbation with MS
Fever x 4 days, Body aches, joint pain, nausea vomiting first night, Shingles developed on roof of mouth 2 days after vaccine
Mom reports that pt had a fever up to 102 degrees F and fatigue on night of vaccination, 02/17/2012, but then sx resolved. Today, pt was at school, and right before lunch she started developing "itchy bumps" on both arms. Rash shows red raised bumps on upper arms, more on Lt arm than Rt. Some on forearms and some on both hands. Bumps on hands appear to have a pinpoint head, but upper arms appear more like hives. Mom denies fever today, but reports that pt complained of sore throat and chest congestion last night. Pt appears very nasally congested today with watery eyes. Discussed possible hives vs possible varicella-like rash reaction from vaccine vs other. Discussed that some children, about 3% can develop a mild varicella like rash. Pt denies any rash or itching anywhere else on body. Pt denies any new foods, soaps, lotions, etc... used today. Instructed mom to keep pt home from school, visitors, activities,etc... and highly encouraged her to be seen by PMD. Pt given numbers for two local clinics and mom states she will call Clinic today to be seen. Discussed possible Benadryl to help with itching, but encouraged mom to check with clinic first. I will call mom tomorrow to follow up. Mom has my number to call if she needs. Discussed transmission of chickenpox and prevention briefly.
Noteworthy:  hands become ice cold before feeling hungry and this symptom remains Odd: lump under rib cage? blockage? congested area? on left side of heart seems to have disappeared and/or no longer feel like it is there
More than 36 days have passed since first dose; mild body aches; mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose), MYALGIA (mild body aches) and PYREXIA (mild fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose), MYALGIA (mild body aches) and PYREXIA (mild fever). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose), MYALGIA (mild body aches) and PYREXIA (mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No Treatment Medications were reported.
Patient was just diagnosed with polycythemia vera, which was a blood cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of POLYCYTHAEMIA VERA (Patient was just diagnosed with polycythemia vera, which was a blood cancer) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in November 2020.    On 19-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYCYTHAEMIA VERA (Patient was just diagnosed with polycythemia vera, which was a blood cancer) (seriousness criterion medically significant). At the time of the report, POLYCYTHAEMIA VERA (Patient was just diagnosed with polycythemia vera, which was a blood cancer) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient was trying to find out if there was a correlation, or if anybody reported, between that hematologic problem and the Moderna vaccine. The reporter explained that her husband did not have a genetic marker. Reporter found that polycythemia can occured in 60 and older. Patient had his first two treatments where they take a pint of blood once a month to get the hematocrit to come down. Company comment This spontaneous case concerns a 72-year-old male patient with no medical history reported, who experienced the serious, medically significant, unexpected event of Polycythemia Vera. The patient received the fifth dose of mRNA-1273.222 (BA.4/BA.5). The event onset date was not provided, thus, exact latency between vaccination and onset of the event could not be assessed. It was reported that he was just diagnosed with Polycythemia Vera and received treatment with blood withdrawals which decreased his hematocrit. It was reported that he did not have a genetic marker. No further clinical information was provided for medical review. The patient's age could be a contributory risk factor for the event. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) is not affected by this report.   This case was linked to MOD-2023-729263 (Patient Link).
ARM DISCOMFORT; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced arm discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm discomfort on 19-APR-2021. This report was non-serious.
they reacted to the vaccine; Painful lump under armpit; Painful lump under armpit; cold sweats at night; dizziness; chest pain; sore throat; losing voice; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (sore throat), APHONIA (losing voice), AXILLARY PAIN (Painful lump under armpit) and COLD SWEAT (cold sweats at night) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (sore throat), APHONIA (losing voice), DIZZINESS (dizziness) and HEADACHE (bad headache). On 08-May-2021, the patient experienced AXILLARY PAIN (Painful lump under armpit), COLD SWEAT (cold sweats at night) and MASS (Painful lump under armpit). On an unknown date, the patient experienced VACCINATION COMPLICATION (they reacted to the vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (sore throat), APHONIA (losing voice), AXILLARY PAIN (Painful lump under armpit), COLD SWEAT (cold sweats at night), DIZZINESS (dizziness), MASS (Painful lump under armpit), VACCINATION COMPLICATION (they reacted to the vaccine) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up information received : new event info updated.
Possible Myesthenia crisis after 2nd dose of Pfizer vaccine. Currently in ICU receiving mechanical ventilation
Patient called on 5/5/23 stating she has an aching pain in her chest, especially at the end of an exhale.  Described and discomfort and ache in her chest.
Every joint had deep aching. Slight fever of 99.8 degrees. Head ache (different than my migraines). Low energy. Lethargic. Exhaustion. No appetite. Lasted about 3 days.
Concern for vaccine reaction - 10/15/19 received both PPSV23 (PMHx asthma) in L deltoid, Tdap given in R deltoid. Later that day at pharmacy was given flu shot in L arm. - Started feeling bad the next day at work, woke up that morning with bad headache, sweaty. Made it through work day, had to leave a little early. That early oral temp, as high as 101, then down to 98 and would feel OK, then back up. Body sweats, needed to change clothes. Headaches that can't go away - History of migraines: on propranolol 20 TWICE DAILY, Mobic 15mg daily. Is on PRN rizatriptan which she uses after aura of smell, sensation in eyes. Has not been taking rizatriptan over the past 2d because this is a different headache than her migraines. Next appt is 11/18 with neuro Dr. - Taking ibuprofen 400mg q4hrs regularly for headache  - Headache in the back of L eye, pounds, pressure feels like head is going to burst. Different than migraines which usually start with smell, visual tunneling, trouble forming sentences - headache wraps around then starts vomiting. - Arm looks red, hot swollen. Feels like someone punched her a lot in the arm. Has not been sick before this in a long time. - Last took ibuprofen around 9am.    Assessment/plan:  Vaccine reaction: 2 days following PPSV23 and flu shot in left deltoid, Tdap and right deltoid, has been experiencing symptoms consistent with vaccine reaction left arm along with systemic manifestations confirmed on physical exam.  Patient's information will be submitted to VAERS system with patient's consent.  Will treat the acute phase of vaccine reaction with Benadryl 50 mg every 8 hours, Tylenol 1000 mg 3 times daily as needed for fever and discomfort.  Advised to stop Mobic while taking ibuprofen, continue ibuprofen as she has been taking.  No signs or symptoms of anaphylaxis, airway clear, counseled on indications to seek emergent management  Headache: Pain around left eye, relieved with massage to left periorbital musculature, similar massage to temporalis and masseter on the left side.  Possible muscular strain related to eyeglasses prescription?patient was advised to return to optometrist whom she saw a few months ago to ensure that prescription does not need to be adjusted.  Otherwise continue with ibuprofen and Tylenol as above.  Seasonal allergies: Boggy nasal mucosa, likely contributing to discomfort.  Reportedly with history of seasonal allergies, less likely in the context of URI?we will trial Flonase for continued symptom medic improvement  Return in about 3 days (around 10/21/2019), or if symptoms worsen or fail to improve.
Hours after the vaccine developed cough, tiredness, neck aches, chills, headache, orbital pain, nausea. By that evening had fever 100.6 in addition to other symptoms. Next morning same symptoms. That afternoon, extreme tiredness along with prior symptoms. That evening fever 102.8. Next morning, exteremely dizzy, head foggy, orbital pain, minor cough. By Thursday no better so got covid test.
Information has been received from a physician concerning a 12 year old female patient was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Several months post vaccination, the pt developed full blown chickenpox. Unspecified medical attention was sought, but no treatment was required. Subsequently the pt recovered. A product quality complaint was not involved. The reporter also mentioned a second pt that developed chickenpox post vaccination with varicella virus vaccine live. Additional information has been requested.
I got red spots in different parts on my body. Some of them are more itchy than other. They start showing while I am sleeping. Earlier I thought they are bed bugs till I checked with my brother and another two friends. They got exactly the same. Also this comes and agoes
within 5-6 hours..extreme reaction..chills..aches all over body..Migraine headache..nausea..loss of appetite Lasted approx 30 hrs..arm still sore on day 4
Caller reported an Improperly stored administered PROQUAD; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 14-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD); lot # T013540, expiration date 17-OCT-2021 (strength, dose and route were not reported) for prophylaxis (product storage error).   The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (11.7 Fahrenheit degrees) for a time frame of 25 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved.
Patient reported (following her 2nd dose of her vaccine):   a fast heartbeat, dizziness / weakness, numbness and tingling.   She also reported chills, nausea and diarrhea - along with "cloudy vision".  These were reported to have started within 4 hours of receiving the vaccine.   She reported at a PCP visit on 10.26.21:  "She reports her eyes are "gloomy/foggy" since receiving both COVID shots in September. She believes that this has worsened with her recent illness."
PATIENT HAD PFIZER VACCINE ON Dose 1 date: 12/18/2020,  Dose 2 date:  01/8/2021, AND TESTED POSITIVE TO COVID ON 9/2/21.
Pt recvd DTP/OPV/HIB on 22NOV91 & devel prolonged crying & screaming x 10 hrs; these occurred 2-3 hrs p/immun;
1h after the vaccination, I had the usual arm pain which lasted for a few days and then completely cleared away (next day I also had fever 37.5-38 C, fatigue, and muscle pain).  However, 8 days after the vaccination, on Friday 30th of April 2021, I woke up in pain: my arm was hurting again and this time I could not find a position on how to keep my arm and not feel pain. I eventually fell asleep but the arm pain at injection site persisted for days. Today (5th of May), five days after the second I still feel some discomfort in the shot area which sometimes goes above the pain threshold.   I did read about people having delayed arm pain, especially with the Moderna vaccine, which is a some kind of delayed antibody reaction. But I did not read about people having both just-after-shot pain and delayed pain and I do not know if I should take the second dose while my arm still hurts from the first does (I have my second shot in 2 weeks). Should I wait for no pain? Should I do it in the other arm? Could you please advise?  Probably nothing, but just to mention everything I know: one contributing factor could be that I went to the gym the previous day of receiving the vaccine and worked my shoulders - I was already a bit sore when I got the vaccine.
Allowed 4 patients to be vaccinated with the vaccines that experienced a temperature excursion; A spontaneous report  was received from a physician regarding product storage error.   On 05 FEB 2021, a physician contacted the safety team regarding five (5) vials of Moderna's COVID-19 vaccine (mRNA-1273) that had a temperature excursion of less than 12 hours at maximum of 50 degrees Fahrenheit. It was moved to a refrigerator that was within the acceptable range immediately.  She stated that she exercised clinical judgement and allowed 4 patients to be vaccinated with those vials.; Reporter's Comments: This report refers to a case of product storage error regarding five (5) vials of Moderna's COVID-19 vaccine (mRNA-1273) (Lot # unknown) with no reported adverse events. No further information is expected.
Patient developed Acute ITP or Immune Thrombocytopenic Purpura within 1.5 weeks of the vaccination with MMRV.  Presented with bleeding gums, nasal bleeding. Seen in ER 6/29/2020 and admitted to Hospital on 6/31/2020 - 7/2/2020. Received IVIG. Recovering.
This spontaneous report was received from a pharmacy technician concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 19-DEC-2016, the patient was vaccinated with a dose of M-M-R II (rHA) lot # L043703, expiration date: 03-NOV-2017, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 61.7 Fahrenheit degrees for 1 hour. A previous temperature excursion was reported of 47.4 Fahrenheit degrees for 30 minutes. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Additional information is not expected as there was no consent to contact the reporter.
Fell down; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer reported for a male patient (Husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Patient fell down 3 weeks after the 1st or 2nd Pfizer vaccine dose, reporter could not remember which one. The outcome of the event was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
Hives started on stomach and spread to chest, back and into arm pits. He has been using cortizone cream and benedryl daily
No adverse effect; patient received a vaccine following a temperature excursion; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On 25-OCT-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #, expiration date and dose were not provided) orally for prophylaxis, following the vaccine temperature excursion. The vaccine underwent the excursion with the lowest temperature below 36 Fahrenheit degrees/ 2 Celsius degrees (35F) in a time frame of 430 minutes. There was no previous excursion and data logger was not involved. No adverse effects were reported.
Erythema, induration, pain, and warmth over injection site. 4 X 4 1/2 cm right deltoid at 48 hours.