chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site swelling. Injection site pain. Injection site erythema. Incorrect route of drug administration. This case was reported by a healthcare professional and described the occurrence of swelling injection site in approximately 13 subjects of unspecified ages, and gender who were vaccinated with influenza vaccine trivalent (FLULAVAL, GlaxoSmithKline) for prophylaxis. On unspecified date the subjects received a dose of FLLAVAL (0.5ml, subcutaneous, unknown) and experienced inappropriate route of vaccination. One hour after vaccinations with FLULAVAL, the subjects experienced swelling injection site, injection site pain, and injection site redness. The reporter stat that there were approximately 13 subject who received FLULAVAL via subcutaneous route rather than deep intramuscular administration. The reporter did not know specifics for each subject. She reported that these subject experienced erythema, swelling and pain at the injection sites, which began approximately one hour after administration. At the time of reporting the outcome of the experienced swelling injection site, injection site pain, injection site redness and inappropriate route of vaccination were unspecified.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for Atrial fibrillation, chronic failure syndrome, hypertension. Patient deceased at 88 years of age at outside entity hospital. No documentation regarding hospital stay or cause of death available.
I received my 2nd Maderna COVID shot on 21 Aporil 2021 and I have had an ache in my left arm since then (seems to have got worse over time and cannot find any relief.)   This ache in my upper deltoid left arm down into my triceps muscles group and keeps me up at night and during the day interferes with my use of it.
Pt is 17 years old and received Moderna, guardian was not present.  Staff spoke with mother on 8/25/21.  Mother was aware that her son received a COVID vaccine and that it was Moderna.  She said he had no side effects.  Mother willing to be present and give written consent for future 2nd dose in series.
the area that was still inflamed on my hands; enlarged blood vessels, hands, feet, lips and genitals; This is a spontaneous report from a contactable consumer (patient). A 63-year old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: en6205), via an unspecified route of administration in left arm on 04Mar2021 at 13:30 (at the age of 62 years old) as dose 1, single for covid-19 immunisation. Medical history included asthmatic taking montelukast sod 10mg. The patient had known allergies to eggs, nuts, eggplant, some seafood. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) 25 mg; emtricitabine, tenofovir disoproxil fumarate (EMTRICITABIN TENOFOVIR) 300mg. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 07Mar2021 at 12:00 patient experienced enlarged blood vessels, hands, feet, lips and genitals most went back to normal except two vessel on both hands, the second vaccination the same thing happened, but the area that was still inflamed on her hands doubled that has still not reduce but double in size with the second dose. The patient received second dose of BNT162B2 (Lot number: en6205) on 25Mar2021 via an unspecified route of administration in left arm for covid-19 immunisation. The event enlarged blood vessels, hands, feet, lips and genitals resulted in doctor or other healthcare professional office/clinic visit. The patient did not received treatment due to the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from an unspecified reporter referring to a 4 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Headache, Myalgia, Fever & NauseaVomiting day 1 and 2 dose 2: Headache, Nausea, Chills, Body Ache, Fatigue, pain at inj site
sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 53-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received first dose of Shingles and had no issues except a sore arm for a few days. For tolerance refer case US2021AMR214985, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR214985:same reporter, second dose
Ring-shaped rash around injection site in day 12. Looked like ring worm rash
Patient received Janssen COVID vaccine on 4/6/21 (lot #202A21A) and Pfizer COVID vaccine on 1/11/22 (lot #FJ5683). On 8/10/22, patient tested positive for COVID and admitted to our inpatient facility (med/surg unit) with generalized weakness and acute metabolic encephalopathy in the setting of COVID infection and dementia. As of today (8/18/22), patient is still admitted in the med/surg unit.
Approximately 30 hours after vaccines administered, she developed a hard, erythematous "knot" in her right thigh where the Prevnar was admnistered.  From there, erythematous papules spread from that area.  However 3 days after the vaccine, the papular rash to spread to the other leg (also concentrated around vaccine site), chest, arms, legs, palms and face.  No mucosal lesions.  Not itchy or painful.  Some diarrhea (possibly from Amoxicilin), but acting normally, no fever, eating and drinking well.
13 days of vaginal bleeding, clots present. Rash and irritation on the face.
headache, chills, vomiting, extreme exhaustion, body aches, lack of appetite, brown urine, chills, hot flashes Symptoms lasted 5 days, on and off throughout each day.
Tachycardia even with Metoprolol. Baseline heart rate is 60 BPM.  Now 90 BPM
pt recv vax; devel measles like rash following exposure to his cousin who had devel similar rash following vax;
This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On 29-SEP-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ 1 dose orally, lot number lot M043836 and expiration date 17-JUN-2018 (strength and frequency were not reported) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 degree Farenheth to 77 degree Farenheith, time frame of 12 hours and no previous temperature excursion. Digital Data logger was involved.; Sender's Comments: US-009507513-1710USA001900: US-009507513-1710USA001901:
Presented with confusion, fever 102, chills, HA, body aches, sore throat, cough, SOB, Nausea, vomiting, diarrhea, hypoxia even on O2, tachypnea (resp rate 38).  Respiratory status worsened, options for ICU transfer and intubation with mechanical ventilation or comfort care measures discussed with family. Comfort care measures initiated 12/14//2021 and patient died at 2300 on 12/14/2021. If further medical record information is needed please contact the admitting hospital.
Rash on forearm. Recommended to give BENADRYL and called us back in the morning & report swelling of the arm. Told pt to contacting Dr. & they did contact.
Pt presented to ED 8 days after second covid injection due to pain for 5 days and diagnosed with PE
4 hours after injection - some stiffness in left upper arm with pain on any movement of the left arm.  Pain increasing during the night. By 6 hours (midnight) after I had chills, sweating, and fever. Any movement or touch was extremely painful. Took 3 Ibuprofen with minimal relief. By 6 AM I had headache and back ache. 15 minutes after getting up I nearly passed out -pale, clammy and faint. By 9 AM I was somewhat better. Now, 19 hour after injection, I still feel achy, injection site is painful to touch, and it is painful to raise my arm but overall I feel much better than this morning.
weakness, nausea, dry heaving, abdominal cramping and headache for a 2 day duration. Abdominal CT showed 5 cm left adrenal mass consistent with acute adrenal hemorrhage. Platelets were 32,000 on admission. On the evening, the patient had a change in mental status; head CT revealed acute subarachnoid hemorrhage and small intraparenchymal hemorrhage.
same day - headache, extremities tingly, chills. Next day - headache, mental fogginess
I had a fever of 101.0 fever that lasted for two days, shivering, body aches and fatigue.
Severe chills, fever, muscular spasm in back, inability to move, sever heart palpitations - 48 hour reaction
A few hours after receiving an injection of Diphtheria, Tetanus, Acellular Pertussis Vaccine (DtaP, Infanrix), the patient experienced an episode where she was screaming and frightened for about 3 minutes and became very red in the face. She let out a long yell, then suddenly stopped screaming and her body went totally limp. She could be aroused by verbal and physical intervention. After a few seconds, she would go back to being limp, then aroused. This cycle happened 3-5 times over a 10-30 second time span, screaming intermittently while awake. After the episodes concluded, the patient appeared to be spaced out for approximately 1 hour. The mother stated that the patient appeared pale at the time of the event and did not appear to stop breathing. The episode was diagnosed as either a breath-holding spell or a hypotensive hyporesponsive episode (HHE) secondary to pertussis vaccine.  10/02/2007 MR received for DOS 7/10-11/2007 with DX:  Breath-holding spell vs hypotonic-hyporesponsive episode.  Infant was admitted with cheif complaint of ALTE.  On the day of vax child went limp following a screaming fit. Child appeared pale.   Arousable with stimulation, but went limp 3-5 times with screaming in between.  Mom states child appeared to be "spaced out" afterwards.  PE significant for hypotonia and absent reflexes bilaterally.  Erythematous lesion R cheek.  No further episodes of cyanosis, limpness or pallor.  D/C home.
This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (sore arm) and fatigue (tired), with outcome of unknown. The batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101206787 same reporter/drug/event, different patient.
Pressure on head internally. Stiff neck particularly on left side. Tingling numbing down left side all the way down to leg. Unable to sleep due to pressure inside head. Pain in left arm. Coldness on left side.  Nauseous. Face puffing and pressure on eyes. Stuffed left nose. Body aches inhaling.
Patient received moderna vaccine on 5/16/21, 6/13/21 and 1/24/22. Presented to ER on 5/17/22 and found to be COVID 19 positive. presented to the emergency department secondary to refractory vomiting.    Was also positive for COVID-19.  Electrolytes and kidney injury corrected over the course of his 1st 24 hours of admission with IV fluids and p.o. was advanced as nausea and vomiting had resolved. Pain issues were addressed with Tylenol and lidocaine patch.  Was monitored for hypoxia and was oxygenating normally throughout his hospital stay.  Daily alcohol drinker and he was monitored closely for signs of withdrawal but did not show any.  Cessation of alcohol and also nicotine encouraged sun his hospital stay. By 05/18/2022 was tolerating p.o. without difficulty and as there was an absence of COVID-19 symptoms was discharged home with advisement to quarantine for 5 more days and also with discussion as to signs and symptoms that would be of more urgent concern. Discharged on 5/18/22
Patient states she cannot move arm and has severe pain. Saw a doctor initially who saw no problems. Had a massage which helped short term. Had ultrasound and X-ray at hospital which showed nothing. Saw Dr. who recommended PT (physical therapy).
Arm Rash - Red, Ichy, Swollen, Painful, Warm
Itching/Uncontrollably itching; Red skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching/Uncontrollably itching), ERYTHEMA (Red skin) and HYPERSENSITIVITY (Allergic reactions) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034f21a, 025b21a and 002A21A) for COVID-19 vaccination.     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 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRURITUS (Itching/Uncontrollably itching) and ERYTHEMA (Red skin). In December 2021, the patient experienced HYPERSENSITIVITY (Allergic reactions). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching/Uncontrollably itching), ERYTHEMA (Red skin) and HYPERSENSITIVITY (Allergic reactions) had not resolved.            Patient's MD and dermatologist mentioned it could be an allergic reactions 2 weeks after vaccination.  No concomitant medication was reported by reporter.  1 week and a half after receiving the booster dose patient started to experience the symptoms.
0800 11/06/07 Shortly after receiving flu vaccination in left deltoid. Pt described swelling in left hand unable to make a fist. No nausea, dizzness, difficulty breathing, tightness in chest or throat. Only Sx experienced was swelling in left hand. Pt. states went to personal physician who told him it was a reaction to the flu shot and gave him an "anti-inflammatory medication", P.O.. Pt. states swelling subsided by approx 2330 on the  6th and has had no other effect from the flu shot. States that he is back to normal again.
Light head, nausea, "hot flash", flushes, chills, numb tongue, chest pain, shortness of breath, headache, hematoma to injection site, difficulty extending left arm. Took Benadryl and is currently in the emergency department.
Heart palpitations while lying down, going to bed.  I felt very light-headed like I was going to pass out.  This happened for several weeks.
Left deltoid injection site paid, headache, general body aches. Administered Tylenol
Had burning sensation in fingers,lft hand, immed. after HBV #2.This subsided until 7:30pm, a rash began at inject. site & spread to opposite arm, back & chest. Rash was raised,scattered all over,dull & red in color, felt like sand-paper.
18 to 20 hours after the shot patient had 102 fever and redness on injection arm. Arm was red and itchy and swelling went from shoulder to elbow.  On 10/9 patient went to patient first and was diagnosed with cellulitis.  Abx was started 10/9 for a 5 day therapy.
Patient got  Covid 19 vaccine(janssen) by miscommunication on 06/17/21.  She already got 1st shot of Covid 19 vaccine (Pfizer) on 06/16/21 at different store. After she got Covid 19 vaccine(janssen) on 06/17/21 about a few hours she said through email that she is fine except  very small chest pain.  Rph. told her that she needs to go to Emergecy Room if she gets worst.  And also told her not to take 2nd dose of Pfizer (based on CDC guidance).
JOINTS GOT ALL SWOLLEN HARD TO WALK ANKLES HURT SO BACK FELT SICK TO MY STOMACH MIGRAINE
"A nurse reported that an 11 month old male received Rota Shield and Tripedia on 5/11/99 and subsequently developed a poor appetite. He was seen by the physician. The infant's appetite returned within 10 days. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Rota Shield. The infant received a 2nd dose of Rota Shield on 6/15/99 without any adverse reaction. From additional information received on 9/29/99, additional pt information was provided. From mailed follow-up correspondence received on 06/13/01, it was reported that the patient recovered from this experience. No further information is anticipated for this report. Case is closed
Within 10hrs of receiving the vaccine she woke up with ringing in her ears and the worse head. It has been 19days
spike antibody test, cov2 AB Ig G was a 1.8. (considered not good); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jul-2021 and was forwarded to Moderna on 23-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD IMMUNOGLOBULIN G DECREASED (spike antibody test, cov2 AB Ig G was a 1.8. (considered not good)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (A touch of high blood pressure) and Blood cholesterol abnormal (statin for cholesterol).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD IMMUNOGLOBULIN G DECREASED (spike antibody test, cov2 AB Ig G was a 1.8. (considered not good)). At the time of the report, BLOOD IMMUNOGLOBULIN G DECREASED (spike antibody test, cov2 AB Ig G was a 1.8. (considered not good)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 1.8 (Low) Considered not good.         Concomitant medication iinclude statin for cholesterol.  No treatment information were provided.  Patient received both Moderna vaccines and after receiving the vaccines, went to MD and had spike antibody test, Cov2 AB Ig G and the score was a 1.8. (considered not good) hence wanted to know if there was any data available on these tests and would booster be recommended for lower numbers on antibody tests (to spike numbers up).
4 months between first and second dose; feeling sick; Have a rash again; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose), MALAISE (feeling sick) and RASH (Have a rash again) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose) and MALAISE (feeling sick). 23-May-2021, the patient experienced RASH (Have a rash again). On 23-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose) had resolved. At the time of the report, MALAISE (feeling sick) and RASH (Have a rash again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported. Patient visited allergist and was recommended to take second dose late .   This case was linked to MOD-2021-163604 (Patient Link).
Shot given subq in back if right arm instead of IM.  Hive and itching started just past 2 hours after shot. Redness itching swelling has continued for 2nd day after shot.  Started on steroids, antihistamines, topical cortisone and keflex as redness is moving into elbow joint.
Swelling of thigh with extension to knee with effusion clinically not red or tender, very slightly warm.
disoriented; ran a red light when driving; don't feel right; Anxiety; Euphoria; Nausea; pain around site; Muscle pain; chills; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 09Aug2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included diabetic and bone on bone. Concomitant medications included cortisone acetate (CORTISONE) taken for bone on bone and unspecified heart medications (as reported: and stuff). The patient experienced disoriented, ran a red light when driving, don't feel right, anxiety, euphoria, nausea, pain around site, muscle pain, and chills on 10Aug2021. The clinical course was reported as follows: She had to leave work on 10Aug2021 because of anxiety, euphoria, nausea, and pain around site. She had to finish most of her job. She was just trying to report the muscle pain and soreness at site. She wanted to go into work on 11Aug2021, but she was not one hundred percent. She works night shift. She went to have a cortisone injection put in the knee and that was the main reason she went in. While she was there, she got the BNT162B2 vaccine. That evening she had to stay home and iced it. She took ibuprofen (MANUFACTURER UNKNOWN) that night and iced her knee. She works shift work from 14:30 to 23:00. On 10Aug2021, she had to leave at 20:30 which was two and a half hours early because she was so disoriented in a way. She shouldn't have been driving. She made it to the house. She still didn't feel right. The patient clarified her symptoms started about 18:00. It started coming on and she pushed through and finished the job. She had to sit down because she was disoriented. It was so bad that she ran a red light when driving. Everyone was sitting at the red light. She wasn't just taking off and going through it. They were just sitting there and a person did a U-turn and she just went ahead and went. That was about nine something at night. She is not going to get on the road. She also iced her arm. The patient stated she knows that it was not the cortisone injection as she has had them before. She had one 8 months prior to this one in the right knee as both of her knees have bone on bone. Therapeutic measures were taken as a result of pain around site, muscle pain, and chills as aforementioned. The clinical outcome of disoriented, ran a red light when driving, don't feel right, anxiety, euphoria, nausea, pain around site, muscle pain, and chills was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.