chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inc temp to 103.4R, rash, limpness, paleness, high pitched screaming for 1.5hrs; Fever unrelieved by APAP; Rec'd pediaprophene & DPH in ER:
This spontaneous report was received from a Licensed Practical Nurse and refers to a 86-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date on 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308:
SLUGGISHNESS; GENERAL PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On an unspecified date, the patient experienced sluggishness, general pain, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggishness, general pain, headache, and nausea. This report was non-serious.
This spontaneous report was received from a registered nurse and refers to a 12 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 27-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 78 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Resident was given Afluria 0.5ml Im at 11am on 10/22/08.  At 9:05PM on 10/22/08, resident was observed with grand mal seizure activity. Resident was transferred to Saint Luke's Hospital in Bethlehem, Pa where she was admitted with a diagnosis of seizures.  The resident did not have a history or diagnosis of seizures prior to this event.  12/5/08 Reviewed hospital medical records of 10/22-10/31/2008. FINAL DX: status epilipticus w/prolonged encephalopathy. Records reveal nursing home patient experienced seizures x 2 with the last one lasting approx 40 min.  Lethargic, unresponsive & respiratory distress.  Intubated overnight & loaded w/antiseizure meds.  Neuro consult done.  D/C back to nursing home on pureed diet w/assist.  Coumadin d/c due to falls risk & tx w/ASA.
Telephone call from clinic. Pt is 6 weeks pregnant by ultrasound. Pt had hep B #1, MMR #1, and varicella #1 on 11/6/02. Had denied pregnancy at that time.
Adverse effects; Greater difficulty physically performing things that he also did last year; Feels degraded from how I felt before the vaccine; Muscle pain that has been getting worse/ muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse effects), IMPAIRED WORK ABILITY (Greater difficulty physically performing things that he also did last year), MALAISE (Feels degraded from how I felt before the vaccine) and MYALGIA (Muscle pain that has been getting worse/ muscle soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced MYALGIA (Muscle pain that has been getting worse/ muscle soreness). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse effects), IMPAIRED WORK ABILITY (Greater difficulty physically performing things that he also did last year) and MALAISE (Feels degraded from how I felt before the vaccine). At the time of the report, VACCINATION COMPLICATION (Adverse effects), IMPAIRED WORK ABILITY (Greater difficulty physically performing things that he also did last year) and MALAISE (Feels degraded from how I felt before the vaccine) outcome was unknown and MYALGIA (Muscle pain that has been getting worse/ muscle soreness) had not resolved.            No concomitant medications were reported. No treatment information was reported.
Patient received Moderna COVID vaccine on 4/3/21 (lot # 026B21A), 5/1/21 (lot # 021C21A), and Pfizer COVID vaccine on 12/7/21 (lot # 33030BD). On 2/9/23, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID-19 pneumonia, leukocytosis and emphysematous cystitis related to her Crohn's disease, and AKI on CKD. Patient discharged home on 2/13/23.
Heart rate up to 122; Still have Heart palpitations; A spontaneous report was received from a 30 year old, female nurse who developed heart palpitations (palpitations) and resting heart rate up to 122 (tachycardia),    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot# 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient began to experience heart palpitations and her resting heart rate was up to 122.   On 31 Dec 2020, her heart rate was back to normal but was still having heart palpitations. On follow up call 06 Jan 2021, patient stated her heart palpitations have not ended.    Treatment for the event included urgent care visit, Holter monitor in place and cardiologist visit scheduled 19 Jan 2021.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, heart palpitations (palpitations) was not recovered. The outcome of the event, resting heart rate up to 122 (tachycardia), was resolved on 31 Dec 2020.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Constant Headache, ringing in ear, Body Aches, and Pain in abdomen and lower back.
Red spot at injection site, hot, itching, sore, raised area at injection site,  occurring 11 days after first shot of Moderna,  red spot about 3in long by 2 in wide
Pt complained of pain in the upper arm immediately following an influenza vaccine. Pain did not improve until Nov 19, and she continues to have mild pain in upper arm area near acromion several inches above where vaccine was given when she sleeps on that arm. Pt did lift heavy suitcases x one week while on vacation starting Oct 21, 2016. She has FROM of the extremity without visible evidence or area induration. No further follow up needed at this time.
2 bloody noses; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (2 bloody noses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (2 bloody noses). At the time of the report, EPISTAXIS (2 bloody noses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
This spontaneous case was initially received on 12-Apr-2016. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 11-Apr-2016 - unknown stop date, Batch no: U58808, Route of administration: Subcutaneous, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 12-Apr-2016, 1 day after starting / treatment with AFLURIA the patient's arm is very red (non serious, outcome: Unknown). For relevant test results see appropriate report section. Reporter's assessment: Seriousness criterion/criteria: Non serious. Case correction (05-Jul-2016): AE as reported term 'received one subcutaneous dose of AFLURIA 'recoded to LLT' inappropriate route of vaccination'. Listedness for the AE as reported term 'arm is very red' corrected to unlisted.
Initial report received from consumer (patient) on 22 June 2013. A female patient whose concomitant medications were not reported, had received a second dose of IMOVAX (batch number: H1091 route and anatomical site of administration were not reported) on 21 June 2013. On 18 June 2013, the patient had received RIG and rabies vaccine of unknown manufacturer. The patient was allergic to TORADOL which causes itching, breathing difficulty. The patient had no other medical concerns and the patient had no illness at the time of vaccination. On an unspecified date, after receiving IMOVAX, the patient had experienced heart racing, face numbness, eye twitching, and cramps in legs. jittery feeling and vomiting. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none,
temperature excursion; This spontaneous report was received from an office manager referring to a 2-year-old male patient. The patient's concurrent condition, medical history and allergic histories were not reported.  On 06-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # was T003706 with an expiration date of 30-JAN-2022, dose and route were not reported) for prophylaxis.On the same date, the patient was also vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # was S029454 with an expiration date of 19-SEP-2021, dose and route were not reported) for prophylaxis.      On 30-SEP-2020, the above vaccines underwent temperature excursion of -14.27 degrees Celsius for 20 minutes. There was no previous temperature excursion. The digital data logger was involved in recording excursion details.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA002670:
pt  came to report on 1/10/23  side effect that she has bruises and dizziness.   However, the bruises were not from the site of the injection.  She said she is getting better
Medical assistant administered just the liquid from the menveo without it being mixed with the powder. After consulting with my superiors and doing research of the menveo website, it was decided to give another dosage for full coverage.  The patient was given the MenquadFi 20 mins later to give full coverage. No symptoms to report at this time.
Headache, severe muscle and joint pain, weakness, nausea, malaise/fatigue.
Sore throat, congestion, cough, fever, severe bilateral otitis media with perforation.
48 hrs p/flu vax pt was note to have a BP of 80/22, c/o feeling sick, was pale; pt recovered;
Roughly 2 days after my booster vaccine, I was at work at and suddenly had a very loud ringing in my ears. Within a few hours, I had complete hearing loss on my left and 75% on my right ear. I sought care from an ENT specialist. I was given 3 injections in my eardrum which has not helped. In addition I have Tinnitus in my left ear which is keeping me from sleeping, There is a 30% chance of recovery of my hearing. However the condition has remained the same and in fact has worsened within the past few months.
Raised area of erythema, 5 cm diameter slight tender to palpitation, itchy.
Patient reported episode of increased heart rate, felt like "heart was racing", for about 1 minute following dose of vaccination.  This resolved, patient noticed she started to have dry mouth, and increased saliva.  This was brought to the attention of the nurse during observation period, and patient brought into examination room. Name and DOB confirmed, vitals obtained and within normal limits.  Patient given water, declined juice or snacks.  Symptoms resolved after about 20-minute observation period, patient requested to leave at this time.  She denies any current chest pain, headache, dizziness, extremity weakness, or loss of consciousness.
I woke up the next morning with a headache, nausea and very sore arm, jaws painful when chewing breakfast.  Not feeling well and very tired (napped a bit during day) for the next two days.  The next day (Sat) woke up feeling a little better but by 9AM after a light breakfast (still a bit nauseous) while still sitting at table. The room started to shift about me.  I felt very weak and nauseous and needed to lye down but couldn't stand called 911 and by 2-3 min my neck started jerking and by 3-4 more min. I was jerking uncontrollable over my whole body. I went to hosp. by ambulance to emergency.  By noon most of the jerking was gone.  I never lost consciousness.  Still tire easily some nausea but headache gone.
Chills, tired,  body aches, loss of smell, fever, rash on hands and thighs, stomach aches, no appetite, on day 10 and still not feeling 100%.
The patient had received a first dose of Moderna COVID 19 vaccine 28 days prior to receiving a dose of Pfizer COVID 19 vaccine. I did not notice that the patient had marked his screening form or record card as Moderna until after I had delivered the dose. The patient was scheduled and arrived on a date when only Pfizer vaccine were being given.
PT VACCINATED WITH RECOMBIVAX HB GIVEN 2 DOSES LATER EXPERIENCED SEVERE STOMACH CRAMPS. LAB EVALUATION REVEALED ABNROMAL LIVER ENZYMES. PT LIVER ENZYMES REMAINED ELEVATED. ADDITIONAL DETAILS ARE BEING REQUESTED.
Fever of 102.5 and chills for over 24 hrs.  Headache and body aches for 4 days High blood pressure for 3 days Dizziness for 6 days
Flu shot given 10-2-18 330PM - reaction of large Red, hot area on my arm.
Hyperemia of the arm and upper trunk. immununization feeling of heat: symptoms occurred after one and a half hours, after vaccination WH LPV and Hep B. Trance instructed to lay down on a bed. Benadryl 7wal im, Hydrocorizine sodium succimate 100 mg after 1 hour skim normal. Feel normal.
This case was reported by a physician via call center representative and described the occurrence of fever in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional information was received as follows: The reporting physician stated that three patients experienced expected side effects of SHINGRIX. The reporting physician stated that he and his wife are two of three patients who experienced expected side effects of SHINGRIX. The patient in this report is the third patient. The patient experienced a fever after vaccination. The age at vaccination was not reported. This case was one of three cases, reported by same reporter.
Patient reported that her left arm "bubbled up" at area around the injection site. On 11/7/11, she told me that the bubble became a "small knot" and that it continued to go up her arm so that on 11/13/11 she had a "big soft painful knot" at the base of her left side on neck - she went to the ER, was treated with antibiotics, pain med and PHENERGAN. Reported had "infected lymph node" the site appears fine at this time, client denies any problem with arm currently.
Information has been received from a medical assistant concerning a 26 month old male with no medical history or drug reaction/allergies, who on 27-SEP-2010 was vaccinated with the first 0.5 ml dose of MMR II (lot # 666844/0036Z) subcutaneously. Other suspect therapy included VARIVAX (MSD). Concomitant therapy included PENTACEL and PREVNAR. On 05-OCT-2010 the patient experienced rash and fever after receiving his first dose of MMR II. No lab/diagnostics studies were performed. At the time of reporting, the outcome of rash and fever was unknown. On an unspecified date the patient sought medical attention via office visit. The reporter requested a lot check for MMR II (lot # 666844/0036Z). A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from the medical assistant concerning a 26 month old male with otitis media and no medical history or drug reaction/allergies, who at around 2:30 p.m. on 27-SEP-2010 was vaccinated with the first 0.5 ml dose of MMR II (lot # 666844/0036Z) subcutaneously into his right arm. Other suspect therapy included VARIVAX (MSD, lot# 666862/0605Z) subcutaneously into his right arm at around 2:30 p.m. on 27-SEP-2010. On 05-OCT-2010, about 8 days after vaccination, rash started. The patient came to office on 09-OCT-2010 and returned on 10-OCT-2010 due to worsening of rash which was all over entire body, excluding palms and soles. The patient had been treated with CLARITIN and BENADRYL for itch. At the time of the reporting, the patient had recovered from the events. This is one of several reports received from the same source. Additional information is not expected.
Progress Notes MD (Physician) ? ? Endocrinology      Date:  12/22/2020                                                                                    Subjective Patient is a 21 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination.    He denied any history of previous adverse reactions to vaccines.   He was given the Pfizer vaccination in the right deltoid muscle.  Vitals:   12/22/20 1838 12/22/20 1839 BP:   129/81 Pulse:   90 Temp: 97.4 °F (36.3 °C) 97.4 °F (36.3 °C)   Vitals are normal   Checked his blood sugars- normal at 96 98% o2 sat     During his 15 minute waiting period after the injection, the patient began to experience dizziness.  He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, abdominal pain, hypotension, dysrhythmia, chest pain and collapse.          Objective     Physical Exam Constitutional:      Appearance: Normal appearance. He is normal weight.  HENT:     Head: Normocephalic and atraumatic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are dry.     Pharynx: Oropharynx is clear.  Eyes:     Extraocular Movements: Extraocular movements intact.     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat. Bowel sounds are normal.     Palpations: Abdomen is soft.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: He is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: water, rest. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.           MD Electronically Signed 12/22/2020 6:39 PM
Pateint had Moderna booster, (6:12pm) and about 10 minutes ,(6:20pm)later pasted out. He was unconscience for approximately 20  seconds while wife was at his side. EMT  arrived at approx  6:25pm.  EMT did diagnosis and transported pateint to hospital. Wife stated that her husband felt nauseated and wife wanted him taken in for diagnosis.
Patient presented to ED and admitted for hypotension/AKI/dehydration. Treated with IV fluids. Found to also be anemic. no blood products administered.
Within 4 hours I developed severe fatigue and debilitating brain fog. I could not concentrate or even remember what I just thought. Also, body aches, chest pressure, headaches, and just an extreme unwell feeling. My arms also felt numb off and on.
itchy; tenderness; swelling; rash at the injection site; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling ), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (redness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and CANNABIDIOL (CBD OIL) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling ), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling ), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.            Treatment information not reported.
Initial report received on 15 February 2010 from a physician. A female patient had received a dose of TDAP vaccine on 04 September 2009. The trade name, manufacturer name, lot number, route and site of administration was unknown at the time of this report. Approximately two and a half months post-vaccination, around 25 November 2009, the patient developed "small nerve fiber peripheral neuropathy" with symptom of burning sensation in her feet. No other symptoms were noted prior to this time. It was not reported whether the patient required medical evaluation, or if diagnostic tests or treatments were performed/received. Recovery status was not reported. Documents held by sender: None.