chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed severe itching on arms and legs; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix one and half year ago from reporting date and developed severe itching on arms and legs for 3 months.  The patient visited doctor for several times to get medicine to stop the itching. No other information was reported. This case has been linked with US2020AMR040809, reported by same reporter.
Information has been received from a healthcare worker concerning a 53 year old female patient with no pertinent medical history and no drug reactions or allergies who on 15-APR-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 668008/1157Z, expire date 08-MAR-2012), 0.5 ml, intramuscularly. There was no concomitant medication. The healthcare worker stated that on 16-APR-2011, the patient reported that her skin was tight from her shoulder to the area just above her elbow. The area was hot to the touch, very red and there was a hard bump at the injection. On an unspecified date, the patient went to the office and was evaluated by the physician. The physician noted that the "bump" was the size of a quarter and hard to the touch. The physician recommended cold compress, TYLENOL as needed and the physician prescribed ZYRTEC for the patient. There were no laboratory diagnostics tests performed. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 5 years old male patient who was inadvertently vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6315SA and expiry date: 30-Jun-2019) via intramuscular route in left vastus lateralis on 11-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported. It was a case of actual medication error due to vaccine underdose because the patient was vaccinated with 0.25 ml instead of 0.5 ml. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by the sender: none.
6/2/2022 I woke up and was on a cruise ship abroad and just didn't feel right. Felt like mild cold symptoms and I was tested myself with a COVID-19 home kit on the ship and it came back negative.  Later in the day I tested on ship and tested negative for COVID-19 and my wife had also tested and she was positive for COIVD-19 and they came to the room and tested me again and I was positive for COVID-19. I lost my taste and smell for about 6 days and missed a week of my cruise. On the second week I flew home from vacation and when I returned I had stiff neck and sought medical treatment and my C reactive proteins elevated and then I developed front line scalp irritation and after a week those went away.  I was prescribed Tizanidine which I can't take anymore due to hallucinations.
Breakthrough case admission after 2 vaccines Moderna 3/9/21 lot# 030A21A; Moderna 4/6/21 lot# 007B21A;
First dose of Pfizer vaccine administered @ 1348. ~1355 patient stated she did not feel well. Unable to hold head up, experienced tingling sensation to both arms. c/o nausea, vomiting and shaking. VS monitored. B/P 180/79, HR 116.  Pt responsive to commands. Hx shellfish and olive oil allergy. Husband reports, patient carries an Epi Pen. Con't to vomit and c/o of numbness in all limbs.  EMT response team arrived @ 1415 started IV to Left Hand. Administered oral Ondansetron 4 mg @ 1428. Benadryl 50 mg IV given @ 1429. O2 sat 97% on room air. B/P 142/87. Transport to ED via ambulance.
Patient experienced mild numbness traveling from injection site up and down arm that subsided over 20 minutes.
T-101 day after imms. give TYLENOL, monitor, call if worse or sx change.
Headache and sore arm; Headache and sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: unknown), via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunization. The patient's medical history included Hypertension, Osteopenia and Prediabetes. Concomitant medication was not reported. Patient has not tested positive for COVID-19 since having the vaccine (03Feb2021). On 04Feb2021, the patient experienced Headache and sore arm, for which Tylenol was given as treatment. The outcome of the event Headache and sore arm was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 1 hour after receiving  vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change.  I kept trying unblock by swallowing etc.  That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year.  That lasted 40-50 minutes.  Approximately 32 hours after feel like I have to keep swallowing to unblock my ears.  That altitude flucuation again feeling but not as bad as the first encounter.  This was related to the vaccine.  No doubt in my mine.  Never had anything like this before unless on an airplane.  Sand paper sound, never.   I let my physician know tonight via email.  In addition I felt dizzy within 5 minutes of receiving the injection.  Subsided within 15 -20 minutes.  Felt aloof the remainder of the day.  Also arm hurt so bad the next day I had to cancel golf.   Low grade fever plus headache
This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 26-MAR-2018, the patient was concomitantly vaccinated with PROQUAD (lot # N021728, expiry date: 06-FEB-2019) and VARIVAX (lot # M035142, expiry date: 03-AUG-2018) (dose and frequency were not reported) subcutaneously for prophylaxis. No adverse effects reported. No product quality complaint involved. Albumin status for PROQUAD is recombinant human albumin (rHA). This is one of several reports received from the same reporter.
First 24 hours after injection: severe headache, general lethargy. Second 24 hours: moderate headache, motion sickness. Third, fourth, fifth, and sixth 24 hours: moderate headache motion sickness. Symptoms were treated with over the counter medication with negative results to treatment.
SEVERE REDNESS OF THE EYES, DARK FLAT PATCH ON THE NECK WHICH WAS ITCHING FOR AT LEAST 2 WEEKS, AS WELL AS BURNING NERVE PAIN ON HER BACK STARTING 1 WEEK AFTER THE IMMUNIZATION.
*ADMINISTRATION ERROR*  34 y/o female patient presents to clinic for her second dose of Moderna Covid Vaccine. As stated by FDA, and CDC a primary dose is 0.5 mL, and any booster dose is 0.25 ml. Administration error was committed by the immunizer when he inadvertently administered a "booster dose" of 0.25 mL when the patient needed to complete her primary series.  Patient was called and informed that she must return to clinic to receive another 0.25 mL dose to complete her 0.5 mL of second dose.  Patient accepted and will return to clinic today.
EH9899 - Lot number wasn't indicated as different on the second dose. Few hives returned - had taken Benadryl  50mg - prophylactically . Subsided. Next evening (7th) - Hives returned and I took Zyrtec - 10 mg  and they went away. (24 hours also -  on the 7th)  Did feel feverish, chills and achy after 24 hours after and I took an ibuprofen for that. Bumpy night; fitful sleeping but when I woke I was symptom free. Feverish went away sometime in the night and hives by the morning.
About 21 hours after receiving the vaccine, she developed a temp of 101.8, fatigue, headache, muscle aches and pain, chills and nausea, did not vomit. Back to normal today.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of refrigeration was mentioned as 19-8-2021. No concomitant medications was reported. No treatment drug details was reported.
Severe neck pain between shoulder blades on right side of neck.; This is a spontaneous report from a contactable other hcp (nurse). A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 20Apr2021 08:30 as 1st Dose, single for COVID-19 immunization at facility. The patient's medical history included drug hypersensitivity, allergies: PCN; it was reported that the patient was diagnosed with COVID-19 prior to vaccination. The patient did not take any vaccinations prior to COVID-19 vaccination. Concomitant medications included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. On 22Apr2021 at 07:00, the patient experienced severe neck pain between shoulder blades on right side of neck. Deep tissue massage were taken as therapeutic measures as a result of the event. The outcome for the event was recovered with sequelae.  Information on the lot/batch number has been requested.
Pt presented with throbbing pain to left extremity with numbness and tingling about 2 hours after receiveing a Thyphoid vaccination. Pt complained of 8/10 pain throughout the arm with generalized weakness to the extremity. Pulses equal and no neurological impairment. Pt received 1ml of Benadryl IM in right arm.
A report was received from a health care professional on 10/28/2002, concerning a 40 year old female vaccinee who experienced an injection site reaction, and swelling of the clavicular and axillary lymph nodes after receiving the 0.1ml  of Fluvirin vaccine subcutaneously on 10/24/2002. On 10/25/2002, the vaccinee noticed a swelling at the site of administration as well as swelling of her axillary and clavicular lymph The local swelling resolved on 10/26/2002 and the swelling of the axillary lymph nodes resolved on 10/27/2002. The clavicular lymph node swelling has improved greatly but has not completely resolved. The reporter has assessed the relationship of the vaccine to the events as possible. Update1./ 01/02/2003: A report was received from a health care professional which indicated that the vaccinee experienced supraclavicular lymph node swelling on 10/26/2002. No action was taken for the swelling which resolved. The vaccinee recovered on 11/02/2002. The reporter has assessed the relationship of the vaccine to the supraclavicular lymph node swelling as probable.
Pt. rec'd 12 mo. immunizations in office on 7/13/17. Mom C/D office 7/14/17 to report localized redness and edema to (LT) at 0900 AM 7/14. Pt. seen by PCP on 7/14. 1 1/2 cm red, circular patch around injection site. Plus induration. No rash/fever. Slightly warm to touch. Tx with TYLENOL/ibuprofen PRN. Monitor site for increase.
Bell's Palsy - predniSONE 40 MG for 7 days valACYClovir Take 1 tablet (1,000 mg total) by mouth 3 times daily
unevaluable event; This case was received via United States FDA VAERS (Reference number: 0937243) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of UNEVALUABLE EVENT (unevaluable event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (unevaluable event). At the time of the report, UNEVALUABLE EVENT (unevaluable event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.
warm; upper arm is still red; itchy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (upper arm is still red) and VACCINATION SITE PRURITUS (itchy) in an 89-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (upper arm is still red) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (upper arm is still red) and VACCINATION SITE PRURITUS (itchy) had not resolved.            No concomitant medications were reported. no treatment details were reported.
(R) arm red, swollen, tender to the touch 70mm redness, 45mm induration.
fever; weakness; vomiting; nausea; headache; This non-serious case was reported by a physician via call center representative and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 25DB5, expiry date 31-JUL-2023) for prophylaxis.   On 25-MAY-2023, the patient received the 1st dose of Bexsero. On 25-MAY-2023, 24 hrs after receiving Bexsero, the patient experienced fever (Verbatim: fever), weakness (Verbatim: weakness), vomiting (Verbatim: vomiting), nausea (Verbatim: nausea) and headache (Verbatim: headache). The outcome of the fever, weakness, vomiting, nausea and headache were resolved (duration 72 hrs).   It was unknown if the reporter considered the fever, weakness, vomiting, nausea and headache to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, weakness, vomiting, nausea and headache to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 26-JUN-2023 A physician reported about a patient who received Bexsero on 25May2023 and within 24 hours the patient developed fever, headache, nausea, vomiting, and weakness, the reactions subsided after 72 hours.  The vaccine Administration facility was the same as Primary Reporter. The reporter was consented to follow up via postal.
Started with headache, early Sunday morning through Tuesday afternoon. Extreme fatigue all day Sunday, Monday and Tuesday. Chills/body aches off and on Sunday through Tuesday. Dizziness Monday and Tuesday. Shot arm (left) sore & red around injection site Saturday through Tuesday.
approx 8 days p/vax pt devel varicella zoster, patches of vesicles.
Petechial Rash and Fever.  Given Ceftriaxone for possible meningococemia. 8/27/07-records received for DOS 7/15-7/17/07-DC DX: Petechial rash possible secondary to MMR vaccination reaction.  presents with 5 day history of rash, fever, bilateral otitis media, diarrhea, lethargic on day of admission and temperature of 103.5. Patient had been chewing on hands more often.
Sudden blood Pressure rise, tachycardia, Anxiety disorders.  It happens randomly and sometimes wakes me up at night. These events have occurred around 6 to 7 times since the first episode.
Stroke-like symptoms  Other cerebral infarction due to occlusion or stenosis of small artery
This spontaneous report was received from a nurse and refers to a 4 year-old Hispanic patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions or allergies or concomitant therapies provided. On 23-JUN-2017 at 11:58, the patient was vaccinated with improperly stored VARIVAX, in the left thigh (lot # M047662 with the expiration date of 02-DEC-2018, second dose; exact dose and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse events were reported. The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of several reports received from the same reporter..; Sender's Comments: US-009507513-1706USA009938:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration 05-JUN-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 1008 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
t103 c/o severe h/a & pain in neck;mom called PMD they advised them to cont w/APAP & watch child;it becomes worse bring pt in;seemed to be better so didn't take pt in;temp & h/a gone by 16OCT96;
I am a well-nourished (doctor-speak for chunky), 65-year old female in fairly good health.  My main issue is severe rheumatoid arthritis, for which I take Humira (abdulimumab) by injection every two weeks.  I?ve been taking this medication for years and it has managed my condition well.  March 5 I received my (Janssen) vaccine and suffered no side effects, not even swelling or discomfort at the injection site.  Piece of cake!  March 11 I took my regular injection of Humira.  Pain started in my ankles, wrists, elbows and knees, increasing through the evening.  I developed a sore throat, but there were no other signs of allergic reaction.  Pain increased, waking me through the night.  March 12 Discomfort has increased severely.  Can?t put weight on my right leg and the slightest movement of any part of my body causes searing pain, especially in right leg from mid-thigh to below the knee.  I can?t lift the leg on its own; have to move it using my hands.  Pain is a constant 10, and I?m crying like a baby.  My left foot shows gout-like symptoms with heat, swelling and pain at the base of the toes.  The entire foot is very tender to the touch.  Taking Norco every six hours and using a cane.  I?m not a wimp.  I spent 10 years in the military, have had two total knee replacements, a reconstructed ankle and fought breast cancer twice.    March 13 Pain has diminished, but is still localized in the ankles, knees, wrists and elbows.  Taking ibuprofen instead of Norco, drinking a lot of liquids and icing swollen foot.  The most intense discomfort evolved during the 24 hours following the Humira injection.  I?m not a clinician, but it seems that the Humira didn?t react well to the introduction of the vaccine.  It?s as if it was saying ?Sorry, this spot is already taken,? and decided to duke it out.  I?m a bit concerned about the next dose of Humira, but the vaccine has supposedly done its work within two weeks.
PATIENT HAS A RED RASH ON HER UPPER LEFT ARM BUT NOT AROUND THE AREA WHERE THE VACCINE WAS GIVEN.
all COVID symptoms; shortness of breath; chest pain; taste very little; feeling of  light headedness upon bending; hardly can walk; body aches  all over; headache 24X7; extremely  tired; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (all COVID symptoms), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), AGEUSIA (taste very little) and DIZZINESS (feeling of  light headedness upon bending) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), AGEUSIA (taste very little), DIZZINESS (feeling of  light headedness upon bending), GAIT DISTURBANCE (hardly can walk), MYALGIA (body aches  all over), HEADACHE (headache 24X7) and FATIGUE (extremely  tired). On an unknown date, the patient experienced SUSPECTED COVID-19 (all COVID symptoms). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of once or twice  a week. At the time of the report, SUSPECTED COVID-19 (all COVID symptoms), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), AGEUSIA (taste very little), DIZZINESS (feeling of  light headedness upon bending), GAIT DISTURBANCE (hardly can walk), MYALGIA (body aches  all over), HEADACHE (headache 24X7) and FATIGUE (extremely  tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Colonoscopy: normal (normal) Normal. In 2021, Electrocardiogram: normal (normal) normal. In 2021, SARS-CoV-2 test: negative (Negative) negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included a cholesterol medicine and few other medications; names were not reported.  Treatment includes inhaler to be used every 8 hours for shortness of breath..   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non significant follow up. Source document (with no new information ) attached