chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events were reported; Inappropriate route of vaccination; This spontaneous case report has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug and/or allergy reactions were provided.  On 28-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); lot # T001214 has been verified as valid and expiration date established as 12-JAN-2022 and varicella virus vaccine live (oka/merck)(VARIVAX); lot # T010309 has been verified as valid lot number and expiration date reported as established as 24-MAR-2022) (strengths, doses, vaccination schemes, anatomical location of administration were not reported) both for prophylaxis.     Nurse reported the patient was inadvertently administered Both vaccines intramuscularly instead of the approved route of administration; subcutaneously. No more information was provided.
This spontaneous report was received from a physician via a company representative concerning five patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (lot number, expiry date, dose and route unspecified). On an unknown date, after the vaccination, the patients developed shingles. The patients sought medical attention (spoke to the physician). It was unspecified if any treatment was given or if any lab tests were performed. On an unknown date, the patients were recovered form shingles. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Information has been received from a woman at a physicians office, concerning a 13 year old male with no pre existing allergies or medical conditions, who on 4/14/2005 was vaccianted SC in the left arm with a second dose of varicella virus vaccine live (649275/0897P). The patient was no ill at the time of vaccination. The reporter mentioned, that as per the parent, in the PM on 4/14/2005 the patient developed a bruise and hive at the injection site. The patient recovered. It was noted that one month later, the patients varicella IgM was positive. The patient did not have any adverse events following prior vaccination. Additional information has been requested.
Painful, swollen(right deltoid area) site noted next AM. Temp as high as 102 degrees F on the 18th + 100 to 100.8 19th. The 20th (3rd day post injection) temp still about 99-100, Right arm very painful as well as site swollen, red and painful to touch. Dr was notified.
Immediately upon receiving the vax pt held her breath, did take a breath, stiffened, eyes rolled back became non responsive lasted approx 60 sec did come around was glassey eyed, lethargic;
The right deltoid (injection site) was painful and tender for two days. Today, 8 days after receiving injection, the right deltoid began itching and there is a small area of urticaria at the injection site. No other symptoms today.
soreness at the injection site; itchiness at the injection site; scabbing at the injection site; Aching of left arm; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown,) via an unspecified route of administration, in the left arm on 31Mar2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diastolic heart failure.  The patient previously received PERCODAN, morphine (MANUFRATURER UNKNOWN) and GEODAN on unknown date and for unspecified indication. Concomitant medications included pramipexole (MANUFRATURER UNKNOWN), carvedilol (MANUFRATURER UNKNOWN), topiramate (TOPAMAX) and erenumab (AIMOVIG) all from unknown date and for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the right arm on 03Mar2021 at 15:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Apr2021, the patient experienced soreness, itchiness, and scabbing at the injection site, aching of left arm which was persisting over a month. The clinical outcome of the events soreness, itchiness, and scabbing at the injection site, aching of left arm were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Individual experienced pain in right muscle and arm 45 minutes after receiving influenza immunization, Took Ibuprofen and exercise and applied cold compresses after calling Health Dept. later that day. Later still experiencing muscle pain and some weakness in right arm, Symptoms are off and on, NO redness swelling or bruising observed, Presently mild tenderness over injection site with pressure. Pain with movement and positioning of arm.
SEVERE FLU SYMPTOMS; HEADACHE, DIZZY, HIP/MUSCLE PAIN , NAUSEA, AND MALAISE X 2.5 WKS. DID CONTACT PCP AND WAS TOLD SHE WOULD HAVE TO 'RIDE IT OUT'.  HAS MEDS FOR PAIN, DIZZYNESS AND NAUSEA. STATES SHE DOES FEEL A LITTLE BETTER NOW.
itchy, red, hardened area about 2 inches in diameter at the injection site 8 days after injection
Runny nose, burning ears, reddened eyes, mattery eyes, throbbing lips, hives, angioedema.
Broke out in hives, post vax. No breathing problems. Recommended OTC Benadryl and call office if any other problems. This was vaccine #3.
Severe body aches and pain, chills, headache, 102 degree fever, fatigue. Severe symptoms lasted about 16 hours, mild symptoms after 24 hours. Feeling almost back to normal after 48 hours except for a maintained arm soreness where injection was taken.
I had the booster  on 10-11-21 at 11::00 am  I waited for the 15 minutes, with no adverse reaction. Around 3:00pm I experience fatigue ? around 10:00pm  started to feel bad, shills, back pain, headache, sinus type pain and general body aches , upset stomach . For the 1st two shots I didn?t have any symptoms. I took some Alive around 6:00am the next day but, didn?t help the pain ?  at 2:00pm took two tablets of Tylenol  it help to ease the pain ? it?s 8:00pm I took two more tablets  ?  on the third day felt a lot better ?
Extreme fatigue, body aches to the point of not wanting to get out of bed, headaches (I rarely get headaches), nausea, diarrhea, it progressively is getting worse rather than better, at first I only had a day of pain, now it?s up to 5 days in a row. I had a negative Covid test yesterday - it?s not Covid.
Rash noted on back and around waist.  Patient reports rash and itching started the day after injection.  Also had fever for 3 days after injection.  Patient treated with Kenalog 40mg Intramuscular, right glut.max; patient treated with OTC hydrocortizone cream.
Mom returned to clinic approx 10 mins p/pt recvd MMR; pt was sneezing & cough & c/o hard time breathing; pt eye were red & eye lids swelling; pt given Adrenalin;
Mother states child has had episodic fevers since vaccine administration. Unable to recall elevations left leg had gotten swollen at site of injection, has became red and mother states there appears to be an infection beginning. Referred to MD for evaluation.
Fever over 102 - 2:30PM. Weakness - 6:00PM. Behavior changes - fussiness - 5:30PM. Vomitting - 11:45PM. Paleness - two days after symptoms began. Loss of appetite and didn't want to drink fluids - 6:00PM. Fast Heartbeat - 7:30PM. Headache - on and off days one and two after symptoms began. Drowsiness - all three days following when symptoms began. Inflamed throat tissue - 8:00PM.
Shortness of breath, dizzy/lightheadedness, chest heaviness.    Occurred nearing the end of 15 minutes waiting period following vaccine administration.  Pt began feeling short of breath, dizzy upon standing, chest heaviness and heart racing.  Breathing slowed and eased, chest heaviness resolved and Pt reported feeling back to normal within 40 minutes following initial event.
64 yo female with history of anxiety reports having a egg sized lump adjacent to her injection site on her left shoulder. She used HC cream with minimal improvement.
Dizziness, Diarrhea, TIGHTNESS TO INJECTION SITE AND ARM, NECK Narrative:  Other Relevant History:
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Feeling ill for over 30days, Nightly fever over 100, fatigue and joint pain.
patient seen in emergency room 10 days after vaccine administration for febrile seizure.  not completely known if connection with MMR but it had to be reported.  no hospitalization required and patient is doing well now (11-4-02) and is afebrile.
pt recv vax & exp flu-like sx;MD had no desire to vaccinate the pt further;
Vertigo; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient (at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, in arm left on 30Dec2020 at 12:00 (lot number was EL1284 and expiration date was not reported) as 1st dose single and the dose 2 via an unspecified route of administration, administered in arm left on 20Jan2021 at 12:00 (lot number was EL 8982 and expiration date was not reported) as 2nd dose, single for COVID-19 immunisation. Medical history included mitral valve prolapse (MVP) from an unknown date and unknown if ongoing, atrial fibrillation (Afib) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 at 12:00, the patient experienced vertigo. It was reported that vertigo was more prominent when laying on left side in bed. It also happened if the patient got up too fast. It was gradually subsiding. It was more prominent after first dose however it was still happening occasionally. The patient did not receive treatment for the event. The seriousness of the event was reported as non-serious. The outcome of the event was recovering.   Follow-up attempts are completed. No further information is expected.
Client  11 year of age receive vaccine recommended for age 12 years and above.                              Weighted 130 lbs., Monitored for 30 minutes, No signs symptoms of distress.                                                       Left from clinic with mother to home at 11:00am
no sense of taste; no sense of smell; felt like a head cold; throat felt like it was swollen; hard to breath; dry cough; throat felt like it was tingly; throat felt as if something was in it; pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), NASOPHARYNGITIS (felt like a head cold), PHARYNGEAL SWELLING (throat felt like it was swollen) and DYSPNOEA (hard to breath) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes mellitus (from past 49 years) since an unknown date.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), NASOPHARYNGITIS (felt like a head cold), PHARYNGEAL SWELLING (throat felt like it was swollen), DYSPNOEA (hard to breath), COUGH (dry cough), THROAT IRRITATION (throat felt like it was tingly), OROPHARYNGEAL DISCOMFORT (throat felt as if something was in it) and HEADACHE (pounding headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), NASOPHARYNGITIS (felt like a head cold), PHARYNGEAL SWELLING (throat felt like it was swollen), DYSPNOEA (hard to breath), COUGH (dry cough), OROPHARYNGEAL DISCOMFORT (throat felt as if something was in it) and HEADACHE (pounding headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.
Both legs became reddened and blotchy from ankles to hips, not raised. No temp, swelling or difficulty breathing. Advised to pediatrician.
Caller has had pain in his left shoulder since receiving the 2nd vaccine dose. It has been over 2 months now.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had pain in his left shoulder since receiving the 2nd vaccine dose. It has been over 2 months now it hurts when he lifts up his arm; like taking off his shirt and putting on deodorant. The outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
hives; swollen lip; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives) and LIP SWELLING (swollen lip) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) and LIP SWELLING (swollen lip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) outcome was unknown and LIP SWELLING (swollen lip) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Reported tingling in left hand shortly after vaccine administered.  No other symptoms.  Declined Benadryl.  After 10 minutes, right hand also began to tingle.  Patient declined any further care and left after 15 minutes, stating he was fine.
flu shot given 23OCT92 during 7-3shift; 4Pm t99.4; 930PM temp 102; pt died 945 PM;
temp 101, pain @ inj site x 3 days;whole rt shoulder sore;body aches all over;
pt fell to floor a few min p/recv vax, became pale, clammy. improved w/juice & rest. MD in to evaluate pt
pregnant female accidentally received a dose of FLUZONE QIV NP from a prefilled syringe in the office on 22SEP2021 that had expired on 30JUN2021 (with no reported adverse event); accidentally received a dose of FLUZONE QIV NP from a prefilled syringe in the office on 22SEP2021 that had expired on 30JUN2021 (with no reported adverse event); Initial information received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/ Non-Healthcare Professional.  This case involves a 25 years old female patient who received expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], while she was 36 weeks pregnant (during third pregnancy trimester).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was reported as 14-Jan-2021.  The estimated due date is 10-Nov-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 22-Sep-2021, the patient received (first dose in 2021) a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7041NA, expiry date- 30-06-2021 via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired product administered (latency same day).  It was also the case of vaccine exposure during pregnancy.  It was reported "Caller states that a patient accidentally received a dose of FLUZONE QIV from a prefilled syringe in the office. Caller asked if there was anything additionally that needed to be done on her end. Caller states that she is aware of a 28 day waiting period to re-administer live vaccines and asked what the guidelines were for this situation."  At time of reporting, no adverse event was reported.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.   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.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 78-year-old female patient who received SHINGRIX. Concomitant products included PREMARIN. On 28th February 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th February 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 2nd March 2018, the patient experienced injection site rash. On 7th March 2018, the outcome of the injection site rash was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site rash and injection site pain to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient's daughter. The reporter was a floater and the facility address was where she was working on the day of reporting. The patient never had chicken pox but her physician advised her to get the vaccine anyway. On 2nd March 2018 at 2:00 hours, the patient received SHINGRIX on left deltoid. Forty eight hours after receiving SHINGRIX, the patient developed a circle shaped rash presenting an inch below the injection site approximately 5 inches in length stopping at her elbow. The patient also mentioned slight pain at the injection site when injected. The reporter provided her home address for further follow up.
On 7/17/2021, case was hospitalized due to COVID. Symptoms: Fever, muscle aches, fatigue
Red swelling around the injection site. Dr. marked around the swelling the swelling was more than the area marked next day. Dr. prescribed her BACTRIM. Area is hot.
Patient started to have issues wth the skin; Itch; Rash; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SKIN DISORDER (Patient started to have issues wth the skin), PRURITUS (Itch) and RASH (Rash) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (Patient started to have issues wth the skin), PRURITUS (Itch) and RASH (Rash). At the time of the report, SKIN DISORDER (Patient started to have issues wth the skin), PRURITUS (Itch) and RASH (Rash) had not resolved.            No concomitant medications were reported. The patient's wife reported that both she and patient received original doses of the Moderna vaccine and three boosters. About two months after patient received second initial vaccine and started to have issues with his skin. They have seen dermatologists, allergists, their regular primary physician, his gastroenterologist and now a rheumatologist. Patient had relief from time to time, but the rash and itch has never gone away completely. Currently the patient skin was in terrible condition, according to the inquirer. The reporter stated that they do not believe that patient ever had Covid.  No treatment medications were reported.
Red welps up and down neck area upper hands and left knees red bumps on left leg and hands and inner thighs, all spots itching so much I took Benadryl.. all sights still itich and red 5 days later.
Information has been received from a physician concerning a female patient with a history of asthma and no known drug allergies, who on Nov 22, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. There was no concomitant medication. On Nov 22, 2002 one hour after the administration of pneumococcal vaccine 23 polyvalent the patient experienced an anaphylactic reaction, described as "hives and her throat started to close". It was noted the patient was taken to the emergency room and she was treated with diphenhydramine hydrochloride (Benadryl) epinephrine, and methylprednisolone sodium succinate (Solu-Medrol). No further data was provided. Anaphylactic reaction was considered to be immediately life threatening. Additional information has been requested.
4 x 4 cm of warmth, induration, intense pruritis, erythema with tenderness to the touch at site of vaccine administration - rapidly progressive. No red streaking.