chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the red area is the size of a golf ball; non stop headaches; chills; nausea; injection site is red; injection site is swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (the red area is the size of a golf ball), HEADACHE (non stop headaches), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE ERYTHEMA (injection site is red) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced VACCINATION SITE MASS (the red area is the size of a golf ball), HEADACHE (non stop headaches), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen). At the time of the report, VACCINATION SITE MASS (the red area is the size of a golf ball), HEADACHE (non stop headaches), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Body temperature: 99 (High) 99 degree Farenheight temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Information has been received from an M.S. concerning a 5 year old white male with asthma who on 24 JUN 1997 was vaccinated with one dose of varicella virus vaccine live (lot #622969/0423E). On 08 NOV 2000 the patient experienced varicella. On 16 NOV 2000 the patient recovered from varicella. Other patients were reeported with similar symptoms following varicella virus vaccine live (WAES01072609-01072613; 01072415-01072617; 01030289; 01072717; 01072719). No further information is available.
Several hours after vaccines, had sudden onset head jerking and extreme irritability. Irritability x 2-3 hours. Admitted for observation. Head jerking resolved spontaneously.
Information has been received from a patient via of a letter who was vaccinated with a dose of ZOSTAVAX (Merck) on an unspecified date.  On 15-FEB-2009 the patient had awakened in the night with pain in the left outer thigh.  It felt like as though the patient had bumped into something and the patient could not determine the reason.  The patient thought a bruise would be seen.  No.  On 16-FEB-2009 at the same time, same thing, same time frame, the patient was stilled puzzled as to the cause.  On 17-FEB-2009, the same thing repeated.  The patient noticed a red eruption on the left inner thigh.  On 18-FEB-2009 the patient visited the doctor who readily verified that it was shingles.  The patient reported that she took 5 pills (not further specified) a day for one week and continued to have off and on pain in her left outer thigh and leg as well as discomfort in the inner thigh region.  On 04-MAR-2009, inner thigh rash was nearly gone.  However, some remains even as of 19-MAR-2009.  The pain persisted periodically in the outer hip, thigh and leg.  The patient considered ZOSTAVAX (Merck) did not work.  The patient thought there was unnecessary pain which the patient still experienced.  Additional information has been requested.
Right upper quadrant discomfort duller mild 3/10 constant to intermittent, more notable after eating.  At times discomfort to middle upper abdomen, left upper quadrant sharp to dull 3/10.  Very notable because I never have abdominal discomfort or GI issues. Resolved  one to two days after initial symptoms (which started a day and half after vaccine dose given).  No further issues at this time.  Have not yet followed up at doctor.  Will address with provider at next annual scheduled in March.
Client came back to flu clinic at approx. 12:30pm complaining of "not feeling right".  Received her flu vaccination at approx.10:30am.  Stated she began with asthma symptoms within 1 hour of receiving her flu vaccination.  Describes symptoms of tightness in chest, with some difficulty breathing.  She administered 2 puffs of her Albuterol Inhaler with minimal relief at approx. 11:30am.  She also complained of tingling in her L arm at the site of flu injection.  Minimal reddness/swelling noted.  BP at 12:30pm was 130/82  HR-76 reg and Respir.20 easy and non-labored.  Dr was notified at this time.  Information re: clients medical history/medications and visit assessment given to Dr.  Dr. felt this not to be an acute event and no further tx was warrented at this time. He did ask that client be informed to see her Primary Care Physician if symptoms became more severe and writer did inform client of Dr's recommendations.  Writer did call client back at 3:00pm for  follow-up and client stated her symptoms had improved.
The same day as vax, on 5/19/99, the pt became dizzy and developed a fever, nausea, and headache. He recovered within 24 hours without treatment, The pt received his second injection of Lymerix on 6/17/99 he had no adverse experience following this injection. The pt received his third injection on 5/11/00. The next day on 5/12/00 the pt became tired and experienced pain at the injection site. The injection site pain resolved. The pt was still tired as of 1/30/01.
Fever of 102F first night; painful swelling  (6-8 cm x 2-3 cm) in left armpit  within 36 hours, later diagnosed as reactive lymphadenopathy following an ultrasound at the emergency room. Emergency room visit was based on referral from my primary care physician, whom I saw first. Suggested treatment was warm compresses and waiting to see if condition resolved within 4-5 days.
Moderna 2/13/21, 3/13/21, 10/12/21. Positive on 6/12/22
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. From 05-SEP-2017, through 20-SEP-2017, the patients were vaccinated with improperly stored M-M-R II lot # M035389 with expiration date on 02-AUG-2018 and lot # M045394 with expiration date on 14-NOV-2018, (dose and route of administration were not reported) for prophylaxis. The doses of M-M-R II were exposed to a temperature excursion of 10.4 degrees Celsius (°C) during a time frame of 50 minutes which was detected by the data logger. Previous temperature excursion was reported as 13.9°C for 173 minutes. There was no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1709USA010570:US-009507513-1709USA010723:
4 family members got shingles. 8 got shingrex vaccine/ Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. Eight family members of patient received Shingrix vaccine. After receiving Shingrix vaccine, the patient experienced shingles.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case was 1 of the 4 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063309:Same reporter US-GLAXOSMITHKLINE-US2021AMR063310:Same reporter US-GLAXOSMITHKLINE-US2021AMR063311:Same reporter
Started runny nose the following evening after receiving vaccniation also felt a little stuffy. Next few days felt fine during the day but had a runny nose in the evening. Wednesday (day 4) felt front head stuiffiness and fogginess similar to a head cold. Want to know if this is a side effect I didn't see listed or the possiblility of coincidentally acquiring the virus. I had no symptoms prior to the injection.
Pfizer-BioNTech COVID-19 Vaccine EUA: one day after immunization patient hospitalized for worsening diverticulitis. Managed with antibiotics and supportive care. Patient discharged to home medically stable.
I got my flu shot and here I am day 5 of the flu; Initial information received on 03-Jan-2023 regarding an unsolicited valid Social media non-serious case from a consumer/non-health care professional.  This case involves an unknown age and gender patient who got his flu shot and here his day 5 of the flu after receiving Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for influenza immunisation.  On an unknown date the patient had got my flu shot and here i am day 5 of the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for event.
Pt reports that he had pna vaccine morning of 08/26. In the afternoon, arm was sore and tender to touch. No swelling or redness. No warmth or sxs of infection.  Took Advil qhs with relief of sxs.
Syncopal event at home, resulted in falling and splitting open bridge of my nose. Visit to ER to get stitches on nose, doctor ordered Holter monitor, blood panel
I developed DVT and PE blood clot issues. No family history. Non smoker, non drinker. Physically active daily.
Adverse effect of other vaccines and biological substances, initial encounter on 2021-12-14, Bulky stools on 2021-12-15.
Swelling at injection site, raised, reddened area measuring 70mm X 70mm at injection site of left deltoid. Pt experienced some malaise and fatigue. Seen by our MD. Treated with ibuprofen prn.
I called patient about an upcoming appointment and she reported that she had been up all night with vomiting and diarrhea. Denied a fever. Had a round reddened area on left deltoid where injection was given. She slept until 11 am and stayed home from work. Did not report and vomiting or diarrhea for today.
This is a spontaneous report from a contactable consumer (mother). A female patient of an unspecified age received the first dose of TRUMENBA, via an unspecified route of administration on 08Aug2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain on the site of injection on 09Aug2018. The mother wanted to know how long it will last. The outcome of the event was unknown. Information on the batch number has been requested.
Fullness and fluid in ears that has led to tinnitus and hearing problems; have taken antibiotics for 9 days and nothing has changed. Still having humming, whirring, and buzzing sounds in left ear
red at injection site, swelling, intense itching, hot to touch, redness spread from small circle around injection site to near full arm (from elbow to shoulder).    on the day of injection I had only mild pain, was a bit fatigued and arm was sore to move.  for the next few  days arm continued to be sore to lift but otherwise OK.  7 days after injection I woke up to a very swollen arm (at injection site) that continued for 3 days to increase in pain, redness and swelling.  relief in symptoms began on day 11.
excessive fatigue yesterday; today feeling better, though still slightly 'crummy'; no fever since last night - Denies dyspnea, no painful respirations, no loss of taste or smell
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose# 12/18/2020pfizer Lot#EK5730 2nd dose:.01/05/2021pfizerLot#EL3246 Diagnosed covid positive: 01/22/2021 Exposure:HoemExposure Symptoms:Fatigue
An expired dose of TENIVAC was inadvertently administered, with no reported adverse event; Initial information received on 07-Mar-2022 regarding an unsolicited valid non-serious case received from the health care professional.  This case involves a 57 years old female patient who was inadvertently administered with an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids (Tenivac), with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. No other vaccines administered.    On 07-Mar-2022, the patient was inadvertently administered with an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids (dosage: 0.5 ml once; strength and formulation: not provided) (lot number: U6603AA, expiration date: 05-March-2022) via intramuscular route in the left deltoid for immunization (expired product administered) (latency: same day). The reporter asked whether dose needed repeating. No adverse event was reported.   Action taken with diphtheria-2/tetanus-5 adsorbed toxoids was not applicable.  At time of reporting, the outcome was Unknown for the 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.
This spontaneous case was initially received on 08-OCT-2015. The case report was received from a(n) Health Professional and concern(s) a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and concomitant medications and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): the patient received AFLURIA on 06-OCT-2015 - 06-OCT-2015, Batch no: T57505, Route of administration: intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 06-OCT-2015, the patient inadvertently administered expired AFLURIA PFS. Reporter Comment(s): the reporter stated that she heard no complaints from any of the 10 patients. She also continued that no patients were pregnant. Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.  Reporter's assessment: Not provided.
Gave tb skin test in L forearm, then administered varicella.  Pt. passed out after injection on her mom.  We laid her down <15 seconds later she woke up and sat up.  Pt. was pale and c/o nausea.  Waited approx 10 min, pt. color began to return immediately.  After 10 min pt. was perky, no longer c/o nausea.
Within 2 minutes, Severe allergic reaction, with diffuse erythematous rash, throat tightening, chest discomfort, nausea, and BP240/120. (Normal BP 124/74). Had premedicated with 50 po benedry. Required 50 mg IM benedryl, ambulance ride to the ER, 125 mg of IV solumedrol.
I received covid vaccine around 20 weeks pregnant 1st dose April 2021 no adverse reaction. 2nd dose in May, flu like symptoms. Shortly after second dose was received i began having heart palpitations, shortness of breath and increased heart rate. Delivery 10/13/2021. Palpitations subsided post partum; however shortness of breath and newly diagnosed HBP remain.
Hurt alot; Sore arm; Red lump with a 2 inch diameter; it was tender, sore and itchy; it was tender, sore and itchy; Red lump with a 2 inch diameter; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Red lump with a 2 inch diameter), VACCINATION SITE PRURITUS (it was tender, sore and itchy) and VACCINATION SITE PAIN (it was tender, sore and itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE, ATENOLOL and METFORMIN for an unknown indication.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Red lump with a 2 inch diameter), VACCINATION SITE PRURITUS (it was tender, sore and itchy), VACCINATION SITE PAIN (it was tender, sore and itchy) and VACCINATION SITE ERYTHEMA (Red lump with a 2 inch diameter). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 23-Feb-2021, PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (it was tender, sore and itchy) and VACCINATION SITE PAIN (it was tender, sore and itchy) had resolved. At the time of the report, VACCINATION SITE MASS (Red lump with a 2 inch diameter) and VACCINATION SITE ERYTHEMA (Red lump with a 2 inch diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Heart rate high; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a question about the COVID 19 vaccine. She wanted to know if it was possible for it to cause an extremely high heart rate. She got her first dose on Monday (in Dec2020) and had to go to the emergency room for a high heart rate. After 48 hours it went back to normal. She stated she didn't think she was going to get the second shot because of this. The patient is a healthcare worker, a nursing assistant and it was (Pharmacy name) gave her the vaccine. The outcome of the event was recovered in Dec2020.
10/12/98 pt came down w/slight fever & earache, 10/13/98 seen by m.d. & presented w/``definite 1-sided soft, non-tender swelling behind the angle of the jaw & over the top of jaw. pt dx w/vax induce mumps.
Red; Sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Sore). At the time of the report, VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medications were not provided.
horrific headache; tired; This spontaneous case was reported by a medical assistant and describes the occurrence of HEADACHE (horrific headache) and FATIGUE (tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Irritable bowel syndrome, Hypertension and Asthma. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST, LINACLOTIDE (LINZESS), OMEGA-3-ACID ETHYL ESTER (LOVAZA), ATORVASTATIN, TELMISARTAN, DIGOXIN, FAMOTIDINE (PEPCID [FAMOTIDINE]), ACYCLOVIR [ACICLOVIR], LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]), BUTALBITAL, CAFFEINE, PARACETAMOL (ESGIC) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced HEADACHE (horrific headache) and FATIGUE (tired). At the time of the report, HEADACHE (horrific headache) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the vaccine in her left arm shoulder deltoid muscle. She received her second Moderna Covid-19 vaccine on 05-Feb-2021 with lot number 026L20A.  No treatment information was reported.   This case was linked to MOD-2022-549009, MOD-2022-549089 (Patient Link).
devel gen urticaria, macular rash arms, chest w/in 10min of vax;VS remained stable-no drop in BP or pulse;
Was fine for 2 days-then deathly ill-violently projectile vomit-empty bowels-could not talk, move, stand-took nausea pill from previous incident 2 mos before-then hit me it had to be vaccine. Almost called ambulance again. I am totally convinced that if I had heart trouble or high BP-or was in delicate health-this could have killed me. My husband was scared to death. I was totally helpless both times. I didn't correlate being so sick with vaccine until the second (and last) vaccine.
Within 24 to 48 hours post vax, the pt developed a 50 cent piece sized area of redness at the injection site. The reporter indicated that 2 pts experienced this event, however, only 1 is presently identifiable. As additional report will be generated when identifying information is provided. The lot number was reported as 471-869; however, this is not a valid Lederle lot number.
sore left injection site arm after first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm after first vaccination) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (On 28-FEB-2020 Patient experienced chest pain at that time and  Treatment received with Dr) in February 2020.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm after first vaccination). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm after first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-331229 (Patient Link).