chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tiny dizzy; low fever; headache; litte chills; mild sore arm; fever 99.8F; very tired; feverish (above 100F); cold symptoms; stuffy nose; sneeze; sore arm; headache; tired; low fever; body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), DIZZINESS (tiny dizzy), NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (stuffy nose) and SNEEZING (sneeze) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0 or D 26L20A and 0381C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  Concomitant products included METOPROLOL for Blood pressure high, ATORVASTATIN for Cholesterol, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for product   for unknown  indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN (body aches), MYALGIA (sore arm), the first episode of HEADACHE (headache), FATIGUE (tired) and the first episode of PYREXIA (low fever). On 24-Jan-2021, the patient experienced NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (stuffy nose), SNEEZING (sneeze) and PYREXIA (feverish (above 100F)). On 17-Feb-2021, the patient experienced FATIGUE (very tired). On 18-Feb-2021, the patient experienced the second episode of PYREXIA (low fever), the second episode of HEADACHE (headache), CHILLS (litte chills), MYALGIA (mild sore arm) and PYREXIA (fever 99.8F). On 20-Feb-2021, the patient experienced DIZZINESS (tiny dizzy). At the time of the report, PAIN (body aches), NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (stuffy nose), SNEEZING (sneeze), MYALGIA (sore arm), FATIGUE (tired), PYREXIA (feverish (above 100F)), the last episode of PYREXIA (low fever), the last episode of HEADACHE (headache), CHILLS (litte chills), MYALGIA (mild sore arm) and PYREXIA (fever 99.8F) had resolved and DIZZINESS (tiny dizzy) and FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol for headache. Action taken for mRNA-1273 was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: No specific follow-up information recorded.
THE PATIENT WAS ADMITTED TO HOSPITAL WITH FLUID AROUND SOME OF HIS MAJOR ORGANS ABOUT 3 WEEKS AFTER THE FIRST DOSE OF MODERNA
On 10/16/11 pt seen in ER with intussusception. Transferred.
Vasculitis. 4-5 days after injection red, blood filled, blister-like (burst capillaries and dead tissue)  swollen areas started to appear on face, ears, mouth and hands followed by significant swelling, pain and stiffness in a number of joints including knees, elbows, hands, fingers and feet. Biopsy pathology came back as vasculitis. Severe symptoms last 2 weeks and lesser symptoms continue following prescribed course of anti-inflammatories. Doctor suggested symptoms may persist until vaccine dissipates in symptoms (approx. 30 days from injection date).
TIA; Lost vision on the left side; lump in left leg; vasculitis in the  varicose vein; Chills; Feels tired; This spontaneous case was reported by a health care professional and describes the occurrence of VASCULITIS (vasculitis in the  varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA) and BLINDNESS (Lost vision on the left side) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Feels tired). On 05-Mar-2021, the patient experienced VASCULITIS (vasculitis in the  varicose vein) (seriousness criteria medically significant and intervention required). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant), BLINDNESS (Lost vision on the left side) (seriousness criterion medically significant) and LIMB MASS (lump in left leg). At the time of the report, VASCULITIS (vasculitis in the  varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA), BLINDNESS (Lost vision on the left side), LIMB MASS (lump in left leg), CHILLS (Chills) and FATIGUE (Feels tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  Patient required on full anticoagulation due to events experienced.  Lab details were not provided.  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.; 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.
reports 4 year old was given Fluzone HD with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse on 12-Nov-2020.  This case involves a 4 years old female patient was given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event (Product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 11-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ479AA and expiration date: 30-Jun-2021) 0.7 ml once via intramuscular route in right deltoid for prophylactic vaccination.  It was potential medication error case due to product administered to patient of inappropriate age.    Action taken and event outcome were not applicable for both events.  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 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.  No further relevant information was reported.
pt recvd vax & several hrs p/vax devel swelling in rt axilla & down into rt lat chest wall, pain; no redness or pruritus; By time of exam 18AUg onl sl prominance remains over rt latissimus dorsi compared to lt;
Pt states that that evening following the flu vaccine she developed a high fever, reports that thermometer said 107 but thinks that it is broken.  During the night she did not sleep well due to chills and shaking.  The next day when she went to take a shower she states that at some point she passed out hitting her back and chin.  She is unsure if she had any dizziness or felt lightheaded prior to passing out.  She reports that after the incident in the shower she then passed out three more times and states that they were in close succession to each other.  Pt states that later in the day she did feel a little lightheaded and thought she may pass out again but did not.  She did not seek any medical treatment. Today she states that at home her temp was 107 again thus making her think that her thermometer is broken because her temp here at work was normal.   She does states that she feels much better today but feels like she was "hit by a truck" due to the soreness from passing out.
she is feeling lightheaded; diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 20Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer BioNTech COVID-19 vaccine on 20Mar2021. The patient reported that on the second day, she had diarrhea and vomiting on 21Mar2021. Should we like to know if this is a normal side effect with the vaccine. She also mentions that today she was feeling lightheaded in Apr2021. Spoke from the full emergency use authorization (EUA) prescribing information PFIZER-BIONTECH COVID-19 VACCINE prescribing information tables 1-4 to let caller know that vomiting and diarrhea were commonly reported side effects in the clinical trial. The patient reported that today she was feeling lightheaded and would like to know if she was okay to take Tylenol since her second dose of the Pfizer BioNTech COVID-19 vaccine was coming up this Saturday. After giving the patient the available information, she stated "You've been very helpful." The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Client reported stinging at injection site at time of injection. Followed later that PM with tenderness and swelling - slight warm to touch. Tenderness till today with induration. No fever. Advised to continue with warm compress, and anti-inflammatory and ibuprofen.
Abscess at vaccine injection site. 3 given - same thigh. About 2 x 2 cm erythematous area. Rx with antibiotics and warm soaks to area.
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Swelling and tenderness noted to left posterior cervical lymph nodes-Medium, Systemic: Lymph Node Swelling-Medium
Minor headache; Sore arm; This is a spontaneous report from a contactable Other-HCP.   A  43-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 08Jan2021 at 15:30 at single dose on left deltoid/arm  via an unspecified route of administration  for COVID-19 immunization. Patient was instructed by head of infectious DZ Dept hospital to premedicate with Tylenol and Benadryl. On an unspecified date she experienced  minor headache and sore arm, without other response to second dose. At the time of the reporting event outcome was unknown.  Information about lot/batch number has been requested.
she had a lot of side effects that lasted a long time after the 1st two Moderna vaccines.; swelling at the site of injection (Left Arm); nausea; fatigue that lasted for 4-weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she had a lot of side effects that lasted a long time after the 1st two Moderna vaccines.), VACCINATION SITE SWELLING (swelling at the site of injection (Left Arm)), NAUSEA (nausea) and FATIGUE (fatigue that lasted for 4-weeks) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-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 VACCINATION COMPLICATION (she had a lot of side effects that lasted a long time after the 1st two Moderna vaccines.), VACCINATION SITE SWELLING (swelling at the site of injection (Left Arm)), NAUSEA (nausea) and FATIGUE (fatigue that lasted for 4-weeks). At the time of the report, VACCINATION COMPLICATION (she had a lot of side effects that lasted a long time after the 1st two Moderna vaccines.) and FATIGUE (fatigue that lasted for 4-weeks) had resolved and VACCINATION SITE SWELLING (swelling at the site of injection (Left Arm)) and NAUSEA (nausea) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-417541 (Patient Link).
This spontaneous report as received from a consumer refers to a currently 78 year old female patient reporting on herself. No pertinent medical history, drug reactions or allergies reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported) lot # J014404, expiry date: 22-JAN-2015. Concomitant therapies included lisinopril (manufacturer unknown) (5mg, once daily). On an unknown date, the same day she received the vaccine, the patient experienced "severe adverse reactions" that included, pain and swelling in her arm that hurt so bad she could not move it. The patient stated that the pain and swelling increased the next day. No treatment was given for the adverse events. No lab studies were performed. The patient did not seek medical attention. On an unknown date, after the third day, the patient was recovered. Causality was not reported. Additional information has been requested.
Information has been received from a physician concerning a 38 month old white male with no known allergies and a history of cleft palate who on 8/28/02 at 11:15am was vaccinated SC in the right arm with a first dose 0.5ml of varcella virus vaccine live (lot #640070/0482M). Concomitant therapy on 8/28/02 at 11:10am included a first dose IM in the right lower arm of tuberculin purified protein derivative (TUBERSOL) (lot C1115AB). There was no illness at the time of vaccination and no adverse events following prior vaccinations. Subsequently at 11:25am, within five to ten minutes after receiving varicella virus vaccine live the patient exhibited an allergic reaction: sneezing, coughing, SOB, and swollen eyes. The patient was also reported to be crying and the cough became more frequent and tight/wheezing was observed. The patient was treated in the physician's office with an albuterol nebulizer treatment and the respiratory distress improved. Periorbital swelling began and increased during treatment; therefore, diphenhydramine hydrochloride (BENADRYL) was administered orally and all symptoms improved or resolved within 60-75 minutes of the event (also reported as about 25 minutes). The patient was reported as recovered on 8/28/02. Upon internal review, hypersensitivity reaction and respiratory distress were considered to be other important medical events.
Patient reported being dizzy, nauseous and couldn't feel his fingers a couple minutes after receiving the vaccine. He described his fingers as tingly and unable to bend them into a fist. We offered him Benadryl to help with the reaction. Patient declined. Brought him a cold cloth and ice pack, which he used on his head. His friend got him Gatorade and a snack, which he ate. Monitored patient for 30 minutes. During that time he improved and got feeling back in his hands. The nausea subsided. Offered to get further medical treatment. Patient declined. He stated he had a similar reaction after shot number one of this series but got better within 15 minutes.
Heart palpitations, soreness, b/p 170/100, pulse 100-117
arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore). On 15-Feb-2021, PAIN IN EXTREMITY (arm sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     This case was linked to MOD-2021-051603 (Patient Link).
Pt received a higher dose than intended due to no dilution. Pt had no side effects and Dad is ok with that. Planning on getting 2nd dose
No other adverse effects were reported in the patient.; a patient received one dose each of PROQUAD and MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 05-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, vaccine dosage detail and route of administration were not reported; lot# S022914, expiration date 19-JAN-2021); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, vaccine dosage detail and route of administration were not reported; lot # S007813, expiration date 14-MAR-2021), both for prophylaxis (inappropriate schedule of product administration). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT). No other adverse effects were reported in the patient. The outcome of inappropriate schedule of product administration was unknown.
Patient called 7-6-09 c/o (L) arm stiffness from ADACEL. Advised to use ice and ibuprofen. Saw PCP on 7-7-09 advised to continue ibuprofen - Note states "Injection site high in deltoid" called doctor 7-14-09 to report continued severe pain and limitation of movement. Reports PCP, has been scheduled for MRI on shoulder for 7-16-09.
Ever since I had the Moderna booster I have been randomly experiencing occasional chest pain, chills and body aches, lower jaw(tooth) pain, fatigue and irritability.
PREVNAR and FLUZONE administered into medial left deltoid, FLUZONE anteriorly and PREVNAR posteriorly. The following day patient developed swelling and erythema below the vaccination sites and central to the medial deltoid. The affected area is about 2 inches in diameter. VSS. No H/A. Patient reports no tenderness to left deltoid.
Ringing in ears or tinnitus, ongoing problem being treated by an Ear Nose and Throat (ENT) specialist. Lose of hearing in both ears shown in hearing test when compared to a prior test..
This spontaneous report was received from a currently 80 years old female patient via Pfizer (#2019126612). The patient's medical history, concurrent condition, concomitant medications were not reported. On an unknown date in March 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (lot# and expiry date was not reported) for prophylaxis. On an unknown date, the patient experienced cold and cough that was not gone away. The outcome of nasopharyngitis and cough was reported as not recovered. The causality for the events nasopharyngitis and cough were unknown.
Less than a week after getting my 3rd (booster) vaccination my hands and sometimes my whole body became shaky and it hasn't subsided. The shaking never happened with the first 2 doses.
CLIENT'S DATE OF BIRTH REPORTED, MAKING HIM 13 YEARS OLD. HE RECEIVED A PFIZER PEDIATRIC LOT # AND DOSE INSTEAD OF THE ADULT LOT# AND DOSE.
Patient started feeling warm and dizzy around the last few minutes of waiting for the vaccine 15 minute window. About 13 minutes after the vaccine was administered. We provided the patient with water and informed him to sit and wait a few more minutes.
Administered 0.5 mls from single dose vial to left deltoid IM instead of 0.25 mls. Single dose vial was overfilled. Mother called and notified of error, explained how error occurred, educated on potential side effects and stated supervisor will follow up on child's well being.
I received the vaccine on the 19Th and on the 28th night had sever chest pain and had to go to ER. On the same day I started developing skin rashes. I was prescribed Hydrocodone ( Which I have had previously with no allergy) for pain and omeprazole for possible heart burn.  The next day, I went back to the ER with severe drug allergy with swollen lips, eyes and rashes and hives all over my body and had to be given epinephrine. My chest pain continued and upon endoscopy , I was diagnosed with allergic esophagitis , with high eosinophil count in my esophagus. My skin rashes and hives continue to persist even after a month and is very random.   I believe that, given no change in food habits or external stimuli, this could be a delayed onset allergy to the moderna covid vaccine.
currently patient has NOT suffered any reaction.  The above mentioned vaccine was given before time frame had lapsed for MMR (given on 12/30/19)
Just redness, warmth, swelling, and soreness at the site of injection for 2 days and minimally on day 3.
APAP given 1030AM pt recvd vax 1040AM; APAP given 330PM-530PM recvd children Motrin crying for 1hr then 750PM APAP then 11PM woke up w/t102.8 tympanic
BLOOD CLOT IN ONE EYE; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAR-2021, the patient experienced blood clot in one eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in one eye on MAR-2021. This report was non-serious.
Booster; they are doing testing for lupus she is border line right now; she got two Moderna vaccine; booster was Pfizer; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (Lot number: FG3527) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL taken for arthritis. Vaccination history included: Moderna covid-19 vaccine (Dose: 1. Lo t# 030B21A), for COVID-19 immunisation; Moderna covid-19 vaccine (Dose 2 Lot #  008505), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 06Dec2021, INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Dec2021 16:00 and all described as "she got two Moderna vaccine; booster was Pfizer"; IMMUNISATION (medically significant), described as "Booster"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset 06Dec2021 16:00, described as "they are doing testing for lupus she is border line right now".  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a pharmacist and refers to multiple patients of unknown age an gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received incorrectly stored doses of PNEUMOVAX23 (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. The temperature excursion was detected by a 'Digital Data Logger'. The specific temperature and time frames were not reported. There were no previous temperature excursions. The product quality complaint was not involved. Additional information has been requested.