chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red at both injection sites; puffy at both injection sites; tight at both injection sites; sore at injection site; sleepless night for a week; hot to the touch (little bit of a temperature) at both injection sites; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleepless night for a week), VACCINATION SITE WARMTH (hot to the touch (little bit of a temperature) at both injection sites), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE ERYTHEMA (red at both injection sites) and VACCINATION SITE SWELLING (puffy at both injection sites) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm hurt). On an unknown date, the patient experienced INSOMNIA (sleepless night for a week), VACCINATION SITE WARMTH (hot to the touch (little bit of a temperature) at both injection sites), VACCINATION SITE ERYTHEMA (red at both injection sites), VACCINATION SITE SWELLING (puffy at both injection sites), VACCINATION SITE INDURATION (tight at both injection sites) and VACCINATION SITE PAIN (sore at injection site). On 07-Apr-2021, VACCINATION SITE PAIN (arm hurt) had resolved. At the time of the report, INSOMNIA (sleepless night for a week), VACCINATION SITE WARMTH (hot to the touch (little bit of a temperature) at both injection sites), VACCINATION SITE ERYTHEMA (red at both injection sites), VACCINATION SITE SWELLING (puffy at both injection sites), VACCINATION SITE INDURATION (tight at both injection sites) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown.            No Concomitant medications were provided  No treatment medications were provided.   This case was linked to MOD-2021-259330, MOD-2021-259330 (Patient Link).
Experienced a shingles outbreak down my left leg. It has currently been approximately one week. I did report prior to my injection that I am on immunosuppressants, methotrexate for Lupus. It was cleared by my rheumatologist, neurologist  and other specialists to get the injection as I am a RN. I have been running a low grade fever and have extremely painful blisters all down my left leg following my nerves.
I had a delayed allergic reaction in my ear. It was red, swollen, and stiff. These lasted for about a week. I went to the doctor about this. They told me that the Covid-19 vaccine can bring out new allergies. They did a full blood work and a Covid-19 test there.
This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeed after vaccination) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeed after vaccination). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeed after vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. No treatment medications were reported.
Information has been received from a physician concerning a 24 year old female who on 22-JAN-2009 was vaccinated with a 0.5 mL third dose of GARDASIL (lot # 661046/0381X). On 22-JAN-2009 the patient experienced pancreatitis and was hospitalized. Additional information has been requested.  2/13/09 MR received for DOS 1/23 with D/C DX:  Psuedointestinal Obstruction, S/P stomach, intestine, pancreas and liver transplantation on Immunosupression.  GERD.  Mild Pancreatitis probably 2' to Gardasil Administration, although the cause effect of this intervention is not proven. Pt presented with intestinal abdominal pain, achiness and generalized malaise.  PE (+) for abdominal tenderness. No sign of obstruction found. D/C and transferred to higher level of care.  MR received for DOS 1/24-30/2009 with D/C DX:  S/P Multivessel transplant. R Femoral vein DVT.  Abdominal pain r/t dilated Fallopian Tube. Pt presented 1/24/09 with c/o abdominal pain. Some nausea. Pain is in lower abd and crampy. Tx: IVF and D/C to f/u with gyn.   2/23/09 PCP records received including some hospital records. Seen 10/23/08 for migraine with light sensitivity. Worst H/A ever had. Seen again 1/19/09 for migraine x 1 week with phono/photophobia and visual changes.  3/3/09 GYN records received for f/u visit 2/18/09 for salpingitis, now resolved. Of note: pt received 2nd HPV in 8/2008. Thrombic events in upper extremity noted.
Following the shot, I went to a movie theater and during the movie began having severe symptoms which are most like flicker vertigo, causing severe dizziness.  Fortunately my wife was driving, this could have been catastrophically dangerous.  I went home and watched TV, with some symptoms in the car.  Again at home, watching TV, the severe symptoms returned.  I discussed this with my older brother, who had the same symptoms with the same vaccine (he is Dr.  I also had a discussion with my team and had another employee (federal) who experienced dizziness after the shot.   Note, that I am a huge advocate of vaccination, but folks need to be aware of this possible side effect.
Narrative: On 9/23/2021, patient reported to PCP had rash and swelling of throat after 2nd dose of COVID vaccine. No other information available regarding vaccine or administration.
Heart Arrhythmia (pounding heart), motoprolol succinate 25mg 1xday  Small improvement
Information has been received from a legal firm concerning an 18 month old male who on 10/22/99 was vaccinated with a dose of haemophilus b conjugate vaccine (lot 627558/0725H). The child is alleged to have suffered "devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via an IM injection of mercury". It was reported that the child has been in the care and custody of his parents since birth. He was born "perfectly normal" and healthy, with an Apgar score "well within the normal range". Developmentally, neurologically and socially, the child was reported to have achieved every developmental milestone anticipated of all normally developing children. These milestones included: by 3 months of age, he was alert, cooing, responding to sounds, responding to others and beginning to recognize and interact with his parents; at 6 months of age, he made speech sounds that form parts of words and was behavior responsive to his environment, his parents, other children and toys; at 18 months of age, he used 3 words strung together in a sentence-type form and had a vocabulary of approx. 25 words. It was reported that at approx. 18 months of age, he was "neurologically devastated by the accumulation of Mercury in his body, having been exposed via IM vaccinations and suddenly regressed developmentally, losing milestones of neurological development previously achieved". It was reported that the pt became withdrawn, unable to speak and unresponsive to his environment. He had a loss of language skills, motor skills and affect. It was also reported that the child received the following vaccinations, along with haemophilus b conjugate vaccine, "that contained the Mercury preservative Thimerosal": on 6/26/97 (lot 441103), 8/26/97 (lot 440-746) and 10/27/97 (lot 440-745), a dose (each date) of Engerix-B; on 8/19/98 (lot 362A2), a dose of Infanrix. The child was vaccinated "in compliance with the then prevailing vaccine schedule". It was alleged that the concomitant and aggregated injections of these vaccines has exposed him to mercury "in excess of all known Federal safe limits" and that the total exposure rate, at the time of report, was 187.5mcg. Upon internal review, mercury toxicity of 187.5mcg, developmental regression/loss of milestones, "unable to speak"/loss of language skills and loss of motor skills were determined to be "Other Important Medical Events". No further information is available.
Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Patient stated that they were 4 weeks from last vaccine, however they were only 3 weeks - vaccine administered 1 week early. No adverse reaction reported.
Sore throat, runny nose, extreme fatigue.  Started around 12 hours after shot.  Lasted all through the following day and night.  Felt much better 48 hours after shot.  Mild soreness in left arm.
Patient complained of redness at the site, vomiting, dizziness. The site of injection is swollen and hot. She went to urgent care and was prescribed an antibiotic.
info has been received from a physician concerning a 15 month old white female with no known medical history or allergies and was born full term, who on 11/3/05 was vaccinated, SC, with a 0.5 mL dose of varicella virus vaccine live. Sixteen days later, on 11/19/2005, the pt developed a mild case of chickenpox. Unspecified medical attention was sought. No lab diagnostic tests were performed. Subsequently, the pt recovered. There was no illness at the time of vaccination. The pt did not experience any adverse events following prior vaccinations. There was no product quality complaint involved. Additional info is not expected.
Very sore arm for two days after injection.  7 days after injection a red rash appeared at the injection site (Covid arm)
Patient complained of Left arm pain starting at time of injection but did not seek care until 4/22/2021 in my office. She was diagnosed with DVT brachial vein in Left arm at elbow.
pt recv vax 13OCT97 & reports rash initially on rt leg & spread to both arms;posterior thorax & presently on face w/swollen lips;instructed to notify primary care MD;
Side effects when began including muscle and body aches especially to lower back, both legs, hips, right arm and shoulder, hands and wrists achy and stiff/is being treated currently with prednisone/was diagnosed with PMR on 10-26-2020.
Small red bumps on stomach, back and bottom. PRELONE 4 ml PO, BENADRYL 5 ml PO in office-afternoon.
Abscess/infection on arm.  Fever.  Fever presented same day as vaccines administered.
Witnessed seizure at 7:30 pm EDT on May 2, 2021.  No prior medical problems.  Serum sodium dropped to 117.  Potassium on arrival 3.3.  Continued seizure activity (second seizure after arriving in ER.)  Acute respiratory failure after aspirating in ER, placed on ventilator for 5 days.  Acute hyponatremia; likely SIADH component related to seizure as causative factor.  Prior history of low sodium November 2018.  New onset hyponatremia versus any other causes.  CT head with negative findings.  Hypokalemia.  Diarrhea reported by nursing staff.  Developed pneumonia.  My mother was hospitalized with low sodium 2 weeks after receiving the second dose of the Pfizer vaccine due to low sodium of 125.  My seizure took place 12 days after the second dose of the Pfizer vaccine.
Mom called on 12-21-07 and stated child received the Tdap, Varicella #2, and Menactra on 12-19-07 at our health department.  About 2 hours after shot, he became lethargic and passed out.  He was taken to emergency room.  He also had a rash on both cheeks.  The doctor in emergency room felt it might be a reaction to one of the shots.  He was given fluids and EKG was done since blood pressure and pulse were elevated.  He also experienced a headache and some nausea.  He was sent home.  Was sluggish yesterday but doing fine today.  Mom stated child was very anxious about getting shots.  No temperature.
Patient presented with ?5/10? abdominal pain in left lower quadrant approximately one hour after vaccination.  Pain was characterized as inguinal and no constitutional symptoms were present.  EMS staff as well as pharmacy staff concluded that implication of vaccine was highly unlikely but patient contacted friend to take him to the ER for further evaluation.
Burning tight pain in right calf, toes, and feet. Numbness in feet and legs. Caledonia in her wrists and trunk. Off balance when walking.
Pt has had both VARIVAX and was diagnosed on 8-19-10 with chicken pox.
On 22 MAY 04, headache, fatigue, and generalized aches and pains started 2 days after vaccination.  On 26 MAY 04, pt developed joint aches, fatigue, and fever.  Fever peaked at 103 degrees on 28 MAY 04 at same time as developed erythematous papules, which eventually coalesced into large papules around injection sites on both arms.  Shots #1 and #3 on L deltoid, shot #2 on R deltoid.  Pt reported on 1 JUN 04 that symptoms were decreasing but not resolved.  Pt was taking Tylenol 3000-4000mg/day at that time.  Exam of injection sites on 1 JUN 04 showed R deltoid having very few, small erythematous papules within 3 cm of site and small, firm nodule at site, and no increased warmth.  L deltoid had few small erythematous papules within 4-5 cm of sites and approx. 4 cm nodule at sites, with increased warmth, and very slight erythema.  Pt saw PMD on 27 & 29 MAY 04.  Rash went away 31 MAY 04, fever gone 1 JUN 04.
This spontaneous report as received from a registered nurse refers to a identifiable adult patient.  The patient's medical history, concurrent condition and concomitant medications were not reported. On 15-DEC-2017, the patient was vaccinated with first pediatric dose of VAQTA lot # N017094 expiry date 31-AUG-2018 by intramuscular route for prophylaxis (drug administered to patient of inappropriate age). On 17-FEB-2018, the patient was vaccinated with second pediatric dose of VAQTA lot # N017094 expiry date 02-SEP-2018 by intramuscular route for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1802USA011849: US-009507513-1802USA012041.
Initial case was retrieved from the scientific literature on 30 September 2010.  "A 36-year-old woman presented to Medical Center with a 1-week history of progressive leg weakness, numbness below the chest, and urinary retention.  The symptoms began 4 weeks after a routine influenza vaccination (0.5 ml, inactivated, trivalent, split antigen).  No antecedent illnesses were identified; the vaccination had been otherwise well tolerated.  Neurological examination revealed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level, and a decrease in rectal tone.  Conventional spin-echo MRI of the cervical and rostral thoracic spine (General Electric 1.5-T Signa scanner) at admission revealed mild diffuse fusiform enlargement of the spinal cord extending from C-3 to the visualized upper thoracic levels, best appreciated on T1-weighted images (Fig 1).  These same areas showed confluent intramedullary lesions containing increased T2 signal (Fig 2).  After administration of intravenous contrast (gadopentetate dimeglumine), no abnormal enhancement was noted (not shown).  In addition, MRI of the brain, both with and without contrast material, was unremarkable (not shown).  The cerebrospinal fluid contained 84 white blood cells (90% lymphocytes and 10% monocytes), 3 erythrocytes, a total protein concentration of 96 mg/dl, and a normal glucose level; myelin basic protein was elevated (6 ng/ml; normal, <2).  An extensive laboratory evaluation for an alternative underlying cause was unrevealing (Table).  Intravenous methylprednisolone therapy (1 gm/day for 5 days) led to a marked recovery by 2 weeks.  At a routine outpatient visit 6 months later, she reported only minimal bowel incontinence and occasional exercise-induced leg paresthesias.  Results of a neurological examination were normal except for trace weakness in the left quadriceps and pin-induced paresthesias of the lower extremities.  One year later, she demonstrated a complete recovery with no incontinence or paresthesias; the neurological examination was completely normal.  A repeat MRI examination was not performed."  Documents held by sender: None.
This spontaneous report as received from a pharmacist refers to a 70-year-old female patient with Crohn's disease. The patient's medical history included palpitations after SUDAFED. Concomitant therapies included PENTASA. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX. On 03-SEP-2016, the patient was vaccinated with the second dose of ZOSTAVAX subcutaneously (dose and lot number not reported). On 03-SEP-2016, the patient had itching and warmth to the are of injection. No rash was present. There were no lab diagnostics studies performed. The patient sought unspecified medical attention and was given treatment for the adverse events. The outcome of itching and warmth to the area of injection was unknown. The relationship between vaccination with ZOSTAVAX and the events was not provided. Additional information has been requested.
Pt came to appt on 5/3/23 & showed nurse the redness & swelling that has improved in her R delt.
tested positive for Covid; terribly ill/so very sick; couldn't function; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (terribly ill/so very sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't function) and SARS-COV-2 TEST POSITIVE (tested positive for Covid) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006A21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Relevant medical history not reported.).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ILLNESS (terribly ill/so very sick) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't function). On 10-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid). At the time of the report, ILLNESS (terribly ill/so very sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't function) and SARS-COV-2 TEST POSITIVE (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, COVID-19: Positive.         Concomitant medication use was not reported.  Treatment information was not reported.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
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 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced sweating. On 30-MAR-2021, the subject experienced leg weakness. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced fever. On 30-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, leg weakness, chills, fever, and muscle pain on 31-MAR-2021. This report was non-serious.
Mom reports shortly after getting injection she had a near syncopal episode pale, dizzy but did not pass out/lose consciousness. The next day she was very fatigued, her arm was sore. About 4 days later she experienced tingling "like her arm fell asleep" and numbness below injection site and into fingers. Mom reports her skin was normal colored in arm, pulse was "good" and had no problems with circulation. Mom called Pediatrics with information 11/27/17.
Pt contacted provider via pt email. Pt received vaccine at approximately 1030 am. reaction came on suddenly at 1130 pm. Sx included severe headache, weakness, chattering of teeth, rapid heart beat and "felt like temp of 105."
Patient had seizure 10 minutes after injection.  No history of seizures, but brain tumor resection about a year ago. 911 was called; EMS evaluated and had patient transported to hospital
After receiving the vaccine, upon sitting in the recovery area. Pt c/o nausea and dizziness and was sent to the EMS area. Pt was assessed. Pt has eaten today but denies having to drink and thinks that she was probably dehydrated. SBP was in the 80's. Gait was still steady.  Pt was rechecked after drinking water. BP was 100's/60's. Pt felt better and decided to go home. Pt felt better.