chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12:35 parent states pt not feeling well. Nurse provided water and had him lie down, 60 BPM pulse, pt diaphoretic, c/o feeling "weird". BP 104/60 after lying down. After 10 min. pt sat up, drank juice, pulse 64. Pt states feeling better. Left with parent. Advised to f/u as needed in ER or Ped. office. Addendum 7-28-11 - TC placed to pt's Father. He states pt is fine, without sequelae from yesterday's event.
Pt. came back on 10/17/2011, complained that after receiving the flu shot, she got home threw up, then took a nap, then threw up again. This cycle continued for about 4 hours.
patient stated she felt warm and flushed after receiving the vaccine. Doctor instructed patient to lay down in medical station for at least 15 minutes. Vital signs were taken and everything within normal ranges. No signs of discomfort/distress. After laying down, Patient verbalized she is feeling fine and would rather go home. Patient was called 2 hours laters and states she is doing very well and feels fine.
Information has been received from a currently 42 year old female patient with no pertinent medical history and allergy to sulfa and morphine who on an unspecified date was vaccinated with a dose of MMR II (Lot # not provided), 0.5 mL, "when she was a kid". Concomitant therapy included albuterol. On approximately 18-May-2010 (two weeks ago) the patient had a titer test done and was negative for measles. At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the patient who reported that although she may received a dose of MMR II (Lot # not provided) as a child, she had a negative measles titer on 10-MAY-2010 (result: 0.60). The patient received a dose of MMR II on 02-JUN-2010 (Lot # not provided) 0.5 mL, SC. A second titer was drawn on 02-AUG-2010, and the result of that titer was also negative (result: 0.53). The patient stated that she was trying to become pregnant. Follow up information has been received. It was reported that the patient received a dose of MMR II Lot # 663767/1773X, on 06-JUN-2010 at morning. The patient waited two months to repeat the titer. It came back negative for measles. It actually came back lower. The hospital ran the test twice. The patient did not seek medical attention. Follow up information has been received from the patient who reported that her third measles titer read on 18-OCT-2010 was 1.04. This is one of several reports received from the same source. No further information is available.
Pt appeared with moderate facial drooping; pt remained A&O x4 with slurred speech; pt informed nurse of seizures with vaccine administration (this being her third seizure with three vaccinations); vs taken, pt informed of severity of bp elevation, pt tolerated education; pt informed of concern and possible hospital admission to monitor bp elevation, pt declined education, stated "I'll be fine once the medication kicks in." pt reassessed 5mins after initial assessment and vs, pt A&O x4, clear speech, and no facial drooping; pt informed nurse of willingness to go home after gaining back full consciousness and no hospital admission was needed; pt ambulatory with front wheel walker independently, left the unit @1200  Vitals:  10/06/21 1147 10/06/21 1155 BP: (!) 194/77 (!) 177/56 BP Patient Position: SITTING SITTING BP Location: RL-RIGHT LEG RA-RIGHT ARM Pulse: 73 75 Resp: 20 18 SpO2: 99% 99%
(R) upper arm (Tdap site) with 5 x 8 cm dry itchy papular red tender reaction. (L) upper arm (MENACTRA site) with 14 x 14 cm dry red itchy tender papular reaction. Both sites better after BENADRYL 50 mg.
A report was received from a health care professional on 12 November 2003, concerning a 23-month-old female vaccine who inadvertently received Fluvirin on 12 November 2003.  On 12 November 2003, the vaccine inadvertently received Fluvirin intramuscularly.  The vaccine did not experience any adverse symptoms at the time of reporting.  There was insufficient information to determine the reporter's causality assessment.  Follow-up pending.
Red, itchy both left and right deltoids. Benadryl or Claritin prescribed. Right deltoid 80mm erythema, Left deltoid 60mm erythema.
Todays date, 1/31/2020  I still have a faded bruise on my left arm!  Had an achy muscles in the same area.  Now my stomach not feeling well for a week.  Slight head ache off and on....not sleeping well.
Headache, Myalgia, Arthralgia, Fever, Diarrhea,  MUSCLE PAIN/FATIGUE (HX LONG-STANDING 45 YEARS  AUTOIMMUNE MUSCLE DISEASE - IMMUNE COMPROMISED),  INJECTION SITE PAIN  Narrative:   Other Relevant History:
Pt is a member on Mobilization Orders. He received his 1st Anthrax Vaccine on 15 Mar 2009 in his left Deltoid Region. He reported to facility complaining of severe pain and tenderness at the injection site. The Chief Medical Officer assessed the injection site and determined a Moderate Vaccine reaction. Pt was ordered Motrin for swelling and discomfort, instructed to monitor the site and return to the clinic within 7 days if the symptoms worsen.
pt recv vax; swollen at site w/ pain since vax time; fever 3 days ago;draining pus lasting 3 days;given keflex x 10 days;
Sore arm; sweaty; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HYPERHIDROSIS (sweaty) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) on 19-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included METFORMIN and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HYPERHIDROSIS (sweaty). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HYPERHIDROSIS (sweaty) outcome was unknown.            Concomitant medications include Heart medication. No treatment details were reported.
Large area of swelling and erythema with slight edema at site of DPaT injection. No significant fever. Rx: Motrin, Benadryl, cool compresses.
From telephone contact with reporting physician, it was stated that 66 year old female patient received a Fluzone SV '00 - '01 vaccination on 12/08/00. On 12/20/00, the patient developed redness around the eyes that progressed into a bilateral asymmetrical rash/papular eruption of the extremities, hairline, neckline and scalp. The doctor, who considers the condition as chronic, performed a biopsy.
nausea and fatigue the next day pelvic pressure 4 days later I don't know if it's brain fog, but my brain isn't working quite right. I get adequate sleep, so that's not a contributing factor. Some examples are: I almost ran a red light not realizing it was red, walking into work one morning and walking right past my building without realizing it, driving to a different restaurant than where I had planned to go. These symptoms were noticeable 3 & 4 days after vaccine.
Initial unsolicited report received from a non-healthcare professional on 23 December 2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of ADACEL (lot number was reported as unknown, expiration date, dose, dose in series, route and site of administration was not reported) on 09 December 2015. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Any other vaccination within four weeks of vaccinations was reported as unknown. On 18 December 2015, nine days after the vaccination, (reported as approximately 10 days after vaccination) the patient experienced sharp, shooting pain from injection site to wrist which had not subsided and deep knot at injection site, pharmacist was unable to palpate knot. No redness, erythema or numbness to arm. Lab data and corrective treatments were not reported. The patient was not recovered from sharp, shooting pain from injection site to wrist. Outcome of deep knot at injection site was reported as unknown. List of documents held by sender: none.
Right side face pain and swelling began on 03/04/03.  Saw MD who is designated as the adverse event physician on 03/06/03.  Prescription given for Famvir 500mg to be taken for 7 days.  Was hospitalized from 03/07/03 through 03/10/03 for IV antibiotic treatment, oral antiviral treatment and pain control.
The patient received VARIVAX and PROQUAD (unknown lot and expiry); No addtional adverse event; Extra dose administered; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 17-OCT-2016, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneous injection, then on unknown date, also, the patient received one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, plus an sterile diluent, solution for injection/infusion(accidental overdose)(strengths, doses, routes of administration, anatomical sites of injection, lot numbers and expiration dates were not reported). On 20-MAY-2021, the patient received extra dose (extra dose administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, plus an sterile diluent, solution for injection/infusion due to human error(lot number t037957 which has been verified to be valid, expiration date reported and validated as 09-MAY-2022) (strength, route of administration, and anatomical site of injection were not reported) All of the vaccines were administered as prophylaxis.   No additional adverse events were reported.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Injection site red and hard. Streaking up arm with swelling, warm to touch, blurry vision, shoulder pain, drooling. Joint pain in wrists, fingers and bilateral shoulders, eye droop. Treating w/Prednisone and methotrexate.
Had fever, hives 8/24. Still has rash, no blisters but red bumps on about every inch of my body. Ha head and back pain, skin hurt everywhere. Saw Dr on the 28th and 29th, Started in Prednisone 28th and feel better already. Dr gave me a dose pack. Recommended no more MMR. Continue Hep A and B vaccines. Trip in Nov Abroad. Wait until rash clears before beginning oral Typhoid. VAERS completed.
Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & light headed, her BP went up to 163/90 and she had tingling in her feet "as if I were wearing tight compression socks". Medical record indicates that she called 911 the day after her vaccine & reported dizziness & slurred speech. She was told to go to the ER, but did not go. She reported to her PCP's office that she had arm itching, she was anxious & fatigued as well. She also reported that she "felt funny in the back of her throat" & seemed to be coughing more. Headache also reported.
Pt complained of tightness, fever, headache, nausea and chills 6 1/2 hours, post vax. Taken to ER via EMS with a fever of 103F. The pt states he felt "fine" prior to the vaccine and 6 hours after. At ER, the pt received IV of 0.9 NS, 1 liter at 150cc/hr. Tests and physical exam were WNL. Vaccine site was without erythema or induration per DC/exam ER papers. Discharge dx listed as Viral syndrome vs febrile response to HBV. Discharge instructions listed: increased fluids, Motrin for body aches and fever.
30 minutes post vaccine injection I stood up and felt lightheaded, paramedic on site took my blood pressure was 167/85, minutes later was 163/82.  Ekg normal, blood sugar by finger stick 109, oxygen 98%.  After 15 minutes BP improved to 137/73.  While driving home I felt weak again unable to finish conversation.  Walking from car mildly lightheaded, rested in bed.  At 2:33 pm BP  105/58 heart rate 78, tired.
Patient tested positive for Covid on 01/17/2022.  Admitted to hospital on 01/25/2022 with symptoms: runny nose, sore throat, cough, shortness of breath.  Patient develop pneumonia and was in acute respiratory distress.  Patient did have an abnormal chest xray.  Patient has multiple underlying health conditions.
Don't have interest in eating or drinking; TMJ; Groggy; I can't balance; Face is pouring sweating; Maybe I'm dehydrated; Pain when my cheek hit the floor; Dislocated my finger; Head full fog; Vertigo; Bad joint pain; Fatigue; Faint; Neck spasms; Shaking; Jaw clenching; Spasms / Neck spasms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced TREMOR (Shaking), BRUXISM (Jaw clenching), MUSCLE SPASMS (Spasms / Neck spasms) and CHILLS (Chills). On an unknown date, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), DECREASED APPETITE (Don't have interest in eating or drinking), TEMPOROMANDIBULAR JOINT SYNDROME (TMJ), SOMNOLENCE (Groggy), BALANCE DISORDER (I can't balance), HYPERHIDROSIS (Face is pouring sweating), DEHYDRATION (Maybe I'm dehydrated), FACIAL PAIN (Pain when my cheek hit the floor), JOINT DISLOCATION (Dislocated my finger), FEELING ABNORMAL (Head full fog), VERTIGO (Vertigo), ARTHRALGIA (Bad joint pain), FATIGUE (Fatigue) and MUSCLE SPASMS (Neck spasms). At the time of the report, SYNCOPE (Faint) had resolved and TREMOR (Shaking), BRUXISM (Jaw clenching), MUSCLE SPASMS (Spasms / Neck spasms), DECREASED APPETITE (Don't have interest in eating or drinking), TEMPOROMANDIBULAR JOINT SYNDROME (TMJ), SOMNOLENCE (Groggy), BALANCE DISORDER (I can't balance), HYPERHIDROSIS (Face is pouring sweating), DEHYDRATION (Maybe I'm dehydrated), FACIAL PAIN (Pain when my cheek hit the floor), JOINT DISLOCATION (Dislocated my finger), FEELING ABNORMAL (Head full fog), VERTIGO (Vertigo), ARTHRALGIA (Bad joint pain), FATIGUE (Fatigue), CHILLS (Chills) and MUSCLE SPASMS (Neck spasms) outcome was unknown.            Treatment information was not reported.   This case was linked to MOD-2021-056711 (Patient Link).   Reporter did not allow further contact; Sender'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
Information has been received from a nurse via a company representative referring to a patient of unknown age and gender. Patient's concurrent conditions, concomitant medication and medical history were not provided. The patient received four doses of GARDASIL (injection, lot#, dose and route were not provided) on the following dates: first dose on 28-JAN-2009, second dose on 28-MAR-2009, third dose on 11-AUG-2009, and fourth dose on 26-FEB-2015. No adverse effect was reported. Additional information has been requested.
Body aches; Chills; Headache; Tiredness; Muscle pain all over body; Flu Like Symptoms; torso not comfortable; Torso not comfortable; sore arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGLES VACCINE with an associated reaction of herpes zoster (received in 2007 and experienced Shingles and neuralgia outbreaks).   On 14th May 2019 13:00, the patient received the 1st dose of Shingrix (intramuscular). On 14th May 2019, 2 hrs after receiving Shingrix, the patient experienced pain in arm. On 14th May 2019 23:00, the patient experienced general body pain, chills, headache, tiredness, generalized muscle aches, influenza-like symptoms, chest discomfort and abdominal discomfort. On an unknown date, the outcome of the general body pain, chills, headache, tiredness, generalized muscle aches, influenza-like symptoms, chest discomfort, abdominal discomfort and pain in arm were recovering/resolving.   It was unknown if the reporter considered the general body pain, chills, headache, tiredness, generalized muscle aches, influenza-like symptoms, chest discomfort, abdominal discomfort and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 14th May 2019 at 1 PM pacific time, the patient received Shingrix vaccine in left deltoid. About 10 hours later at 11 PM at night he started experiencing body aches, chills, headache, flu like symptoms, tiredness, muscle pain all over the body and mostly his torso was not comfortable. About 2 to 3 hours post vaccination he experienced a sore arm.  All the side effects had subsided a little bit. This case has been linked with case US2019AMR088872, US2019AMR088911 and US2019AMR088873 reported by the same reporter
Got the vaccine, on the first day within the first hour she started feeling itchy, tingling sensation above her eyebrow over the left eye.  Didn't stay long, but sensation of itching left her.  Then noticed a pin dot of a little red spot on the left side of the eye, temple area, itchy and then it went away.  That night the soreness started in the arm.  The next day the whole arm was sore, but she kept exercising it and moving it.  On the third day the arm was clearing up like she didn't get a shot.  Then, the left thigh had some achiness.  The right ankle was achy as well, didn't stay long.  She is still waking up with a rapid heart beat.  She has a FU APT for labs and revisit with her PCP in a month.    On Saturday, 3/20/17 and woke up with heart palpitations, which they continued until she went to the ER around 4:00 AM.  They checked her, did an EKG, ran labs and VS.  The labs came back and told her that her potassium was depleted, and gave her something to calm her down.  She went to the store on Sunday and got some potassium citrate to maintain herself until she could get to the Doctor on Monday.  They did give her potassium while she was in the ER.  She went to the doctor on Monday, and he started her on a prescription for potassium.  She also made an appointment with her nephrologist to make sure she was okay before she gets the 2nd vaccine since she only has one kidney.  She also has had a lot of bruising from the blood draws in the hospital.
Patient's arm is swollen and shows redness and discoloration.  Patient reports no fever, and the area feels warm.  Not itchy, slight pain when pushed down
Shot was given too high up on left shoulder resulting in a dark bruise.  About a week later when bruise finally went away, began noticing pain and loss of strength in left shoulder.  Today, 11/23 I am having extreme pain and loss of strength.
Severe shoulder pain, low-grade fever, chills, decreased range of motion secondary to pain, edema, erythema, elevated WBC/ANC.
irregular heart rate,  Digenoused 6/3/2012 with pvc. Additional exams scheduled week of 6/14 thru 6/17
A patient received both IPOL and PENTACEL and they were both expired doses, no adverse event; Initial information received on 22-Jun-2021 regarding an unsolicited valid  non-serious case from a consumer/non-health care professional and physician via Information (under reference 00651487).  This case involves a 3 years old male patient who was vaccinated with an expired dose of both 0.5 ml IPV (VERO) [IPOL] (lot number and expiration date not reported) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (total, lot UJ228AA (HIB)/ UJ315AA and expiration date: 04-Apr-2021) via intramuscular route in an unknown administration site for prophylactic vaccination on 21-Jun-2021 (expired product administered).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included a dose of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (lot number and expiration date not reported) via unknown route and site of administration for prophylactic vaccination on 21-Jun-2021.  It was a case of an actual medication error due to expired vaccine used (same day latency).  Reported that the caller was with a question on whether dose needs repeating and on adverse effects to expect due to patient receiving IPOL as well as PENTACEL.   At time of reporting, the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for IPOL.
Patient stated that she has an itchy, irritated rash on the arm where she got the injection.
light headed- unsure if related to vaccine since he stated he had that before because of sciatica pain which he currently had as well
Significant local reaction to injection of flu vaccine, localized  pain, redness, swelling, raised like a "hive"  approximately size of entire palm to injection site lasting 1-2 days so far.
DTaP GIVEN IN LEFT ARM 06/28/04.  TELEPHONE CALL FROM MOTHER STATING PATIENTS LEFT ARM RED AND SWOLLEN TODAY, 06/30/04.  NO OTHER SYMPTOMS REPORTED, ADVISED MOTHER TO GIVE BENEDRYL AND/OR TYLENOL, CALL IF ANY OTHER SYMPTOMS DEVELOP.
COVID the next day, double pneumonia, fatigue, weakness, heart arrhythmia and palpitations, blood clots x2
I had pain in my right rib cage. It was in my lower ribs at first. The pain spread towards my diaphragm. The pain got bad, and I decided to go to the doctor after dealing with it for 6 or 7 weeks. They did a blood panel and an x-ray, and it came back normal. They told me to take 400mg of Advil twice a day. They also told me to take MiraLAX every other day for a week. I am feeling better now.