chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/07/2022: Event occurred after 2nd vaccine. Patient is coming with right leg pain and swelling apparently been going on since she left the hospital a month ago. She was discharged from here on the 29th she did have a PE on that admission as well as residual DVT in the popliteal region.   Also complain of shortness of breath was also tested positive for COVID couple days ago has been symptomatic for about a week.  Does have mostly URI symptoms no nausea and vomiting
She said she had redness, swelling and itching. Site of injection spread to half dollar size.
Arm is red - potentially infected, wants to be careful, a little swollen, painful, feels like someone punched in the arm.
Staff member went in to vaccinate patients. Once vaccine was administered staff went ahead and helped mother fill out forms and while filling out the forms patient out of nowhere collapsed and fell onto the floor face front. He convulsed about .2 seconds and that is when mother stepped out the room  and called out for help. Provider then went in and assessed patient. Patient was observed and discharged home.
This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age. ON an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported) and a dose of FLUZONE (dose, route and lot # not reported). The pharmacist reported that on an unknown date, the patient experienced flu like symptoms for one day. The patient did not receive treatment for the adverse event. The patient did not seek medical attention. The outcome of flu like symptoms was reported as recovered. Additional information has been requested.
Pt recv 1st & 2nd dose vax 15July83 & 07April94 respectively.11Feb98 pt devel mumps. Pt MTR & sister also devel mumps.
Pt was give the incorrect dose - Pt was given 0.5ml of Moderna instead of the recommended booster dose of 0.25ml
9-13-12. Pt received flu vaccine (lt) arm & afterwards received 5 cm across/4 cm down red, indurated area that's tender to touch. Red area goes out & circulates area where injection given which is below deltoid area. 9-17-12. Pt notified to check on area same size: red, less swelling. Pt will call on Wed with update.
Sore arm - Days 2 to 4  Tired and felt like fighting flu symptoms or coming down with something - Days 2-4 Woke up with itchy rash and redness larger than a baseball at the injection site. Had pharmacist who injected the vaccine look at it and she recommended Benadryl or Hydrocortisone cream. I chose the cream as Benadryl bothers me. It took the itching away on Day 9 and 10. Thereafter, off and on, I was having a sore arm and itching at the injection site. My 2nd dose is due 4/9/21. I just have a little soreness in my left arm. Plan to have next dose in my right arm as recommended for Covid Arm reaction.
Within first week of vaccine, developed tinnitus and muffled hearing. This has persisted for the past year. Was referred to ENT and audiologist. Diagnosed with cochlear hydrops and some permanent hearing loss in left ear.
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 6 years old female patient who was vaccinated with FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s),family history and concomitant medications were not provided. On 19-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1807, expiry date: 27-Jun-2019) via intramuscular route in unknown administration site. This was a case of actual medication error due to inappropriate age at vaccine administration because safety and effectiveness of Flublok Quadrivalent have not been established in children 3 years to less than 18 years of age. If administered to person less than 18 years of age, they should be re-vaccinated with age appropriate influenza vaccine. It was not reported if any adverse event 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 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. Documents held by sender: none.
ANKLES AND KNEES JOINTS ACHES AND SWOLLEN, MUSCLE PAIN, NERVOUSNESS, HEAD ACHES, DIFFICULTY SLEEPING, HAIR LOSS.  08/06/2007 MR received for multiple OVs between 3/2/2004 and 7/23/2007, including multiple psych evals for Depression and OCD. Primary care visit 9/9/2004 with c/o hip pain, myalgias, arthralgias, and chronic insomnia. PE WNL except (+) joint pain/swelling, myagias, and depression.  LE pulses 3+. Assessment:  Myalgias, Arthralgias, Hyperlipidemia. Next Primary Care visit for c/o persistant ankle pain with hx of gout w/ normal uric acid values (4.5).  Assessment:  Tendonitis vs Arthritis. Addendum- Spoke with pt.  Language barrier caused misunderstanding of "Life Threatening". Pt. feels condition threatens his life, however there was no event where he was at risk of death.
This spontaneous report as received from a registered nurse. On an unknown date, at least two patients was vaccinated with the second dose of GARDASIL (lot#, dose, frequency, unspecified) about a year after the first dose of GARDASIL. No demographics or dates available at the time of the report. No adverse event reported. Additional information is not expected.
This spontaneous case reported by an other healthcare professional, describes the occurrence of back pain, vaccination complication (drug side effect) and chills in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Co-suspect product included adalimumab injection for psoriatic arthritis. No medical history reported. On an unknown date, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form and adalimumab (unknown route) 1 dosage form. On an unknown date, patient experienced back pain, vaccination complication (drug side effect) and chills. At the time of the report, back pain and vaccination complication (drug side effect): not resolved and chills outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided. Most recent follow-up information incorporated above includes: On May 3, 2021: No new information provided.
Pharmacist called to request for information regarding administration of GARDASIL 9 after interruption in 3-dose schedule for 21 year old patient who received first dose in 2020 and is now requesting to complete series.; No additional AEs; This spontaneous report was received from a pharmacist and refers to a 21-year-old female patient. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.  On an unknown date in 2020, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, dose of 0.5 milliliter, once (strength, route and site of administration, lot # and expiration date were not provided) for prophylaxis. The patient was now requesting to complete vaccination series (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).
PATIENT STATED SHE FELT LIGHT HEADED ALMOST IMMEDIATELY AFTER THE IMMUNIZATION. SHE DIDN'T REPORT THAT TO ANYONE AT THE TIME AND SHE SAID IT GOT BETTER BEFORE SHE LEFT THE IMMUNZATION AREA. SHE SAID THE NEXT EVENING (3/3/21) AROUND 6PM SHE STARTED TO EXPERIENCE SHORTNESS OF BREATH AND LOOKED AT HER THROAT AND SAID IT SEEMED SWOLLEN, SHE TOOK BENADRYL  AND STATED THE SHORTNESS OF BREATH DIDN'T GET WORSE AND RESOLVED WITHIN ABOUT 2 HOURS. SHE ALSO STATED SHE FELT ACHY AND FLULIKE WITH CHILLS AND FEELING FEVERISH BUT WITH NO FEVER. SHE FELT PRETTY ACHY AND TIRED FOR A COUPLE OF DAYS AND THEN EVERY THING RESOLVED.
I started having dizziness. It feels like I am on a ship, it comes and goes. It feels like I am going to pass out. These are new symptoms. I went to the doctor about this on November 29th. She was unsure what is causing it. If it gets worse then they are going to do more tests.
NAUSEA; HIGH FEVER; VOMITING; DEHYDRATED; This spontaneous report received from a physician concerned a 43-year-old White Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic back pain. The patient experienced drug allergy when treated with cefaclor and prochlorperazine. On 2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: unknown) dose was not reported, administered on 16-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced vomiting and in the afternoon she was dehydrated. On the same day at 23:00, the patient experienced nausea and high fever. Physician stated that she was taken care in the clinic for almost a day and ended up in hospital the day after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, vomiting, high fever, and dehydrated on 18-MAR-2021. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint (PQC) number 90000178598. The suspected product quality complaint has been confirmed to be voided as adverse events were reported but there is no claim of a product quality issue with Janssen covid-19 vaccine. Voided no PQC was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.; Sender's Comments: V0 20210509100 -COVID-19 VACCINE AD26.COV2.S- Vomiting, Dehydration. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210509100-COVID-19 VACCINE AD26.COV2.S- Nausea, High Fever. This event(s) is labeled per RSI and is therefore considered potentially related.
Heart failure (myopathy). Began with fluid accumulation in lungs, eventually led to hospitalization within weeks. Ejection fraction was at 18%. Treated with hospitalization, medication, cardiac rehabilitation therapy, defibrillator vest.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-JUN-2017, the patient was subcutaneously vaccinated with an expired dose of ZOSTAVAX lot # L046295, expiration date 17-FEB-2017 (dose was not reported). No adverse effect was reported. No product quality complaint (PQC) was not involved. Additional information has been requested.
pt recv vax 13JUN95 & 10DEC97 pt devel pustule type lesions over torso legs w/a fever of 102;
severe itching all over body in ears and eyes,  all over rash red sunburn type ,  hot skin head to toe,  massive headache , nausea, all over body ache,   Doctor prescribed a Medrol dose pack ( prednisone)  and Benadryl on March 4th  most symptoms continue today ( still experiencing headache, all over body itch, head congestion, body aches and stomach upset  )    Dr currently told me to use over the counter Benadryl for itch,  Motrin for headache, and Sudafed  and Flonase for congestion and see what happens for a few days.   as the prednisone is wearing off the itch is becoming more severe.
pt had flare up of copd, fever. he was not too sure if it was related to vaccine or not
Patient had the Influenza Flu Vaccine ( inactivated or recombinant) is what her form says.  (I may have selected wrong vaccine named up above her form doesnt state anything else)  Patient had the vaccine at 12p  during her physical appointment.   By 9 pm 8/28, she started to feel sick and complain her arm hurt alot. She Started to feel nauseous.  At 3am 8/20, she spiked 102 temperature. Began to get chills and feeling hot and cold. She then felt like she was going to puke. Her whole body began to ache alot as well.   It is now 12p on 8/29 her temp is down but is very weak and tired feeling.
Itchy blister spots; Itchy blister spots; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy blister spots) and BLISTER (Itchy blister spots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 16-Feb-2021, the patient experienced PRURITUS (Itchy blister spots) and BLISTER (Itchy blister spots). At the time of the report, PRURITUS (Itchy blister spots) and BLISTER (Itchy blister spots) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Half dollar size  of Petechia rash  just below injection site. And two small patches on left arm.
Received vaccination approximately 2 PM. Arrived home 6P. Local edema at site noted. Laying on cough watching TV fell asleep "passed out" awoke 3 H later diaphoretic and muscle aches, fatigue and lethargic.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 9:43 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided.  Reporter stated that the vaccine facility members placed the vaccines into the freezer the same day they were delivered. They only removed a vial from the freezer and put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.  Vaccine facility members did not have a vial stay in the refrigerator for more than a week, since all unused vials were utilized for the patients. Then only removed enough vials to provide vaccines for those scheduled for that day and provided scheduled vaccines, no walk-ins.   This case was linked to MOD-2021-405575 (Patient Link).
Tinnitus began 1-3 weeks after injection. Tinnitus has persisted for at least one month. Sought medical advise and physician asked that I file a report with CDC.
A week and two days after receiving the vaccine, I had a seizure while walking my dog.  I was taken to the hospital and a Cat scan, MRI and EEG were all administered.  No specific cause can be attributed to the cause of my seizure and the only factor that was different was that I was given the vaccine on 4/22/21.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned multiple patients. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20210743638. This report was associated with product quality complaint: 90000186715.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
ill; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced ill after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had developed ill (illness) after receiving an unknown dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization with unknown form, strength, frequency, route, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (ill).  Outcome: Unknown.
24 hours after developed elevated BP 130/90 and pulse 102. Resolved on it own after 8 hours.
Swelling, redness, itching at the injection site on right upper arm. Father reports fever but did not report temperature. Symptoms began the evening of 2/15/2017.  He presented to the clinic today 2/24/2017 with redness around the injection site, approximately 1-2 inches in diameter along with firm swelling.
"Too many lesions to count." Lesions in various stages-widespread. Dx: varicella, Tx: Acyclovir.
Unexplained sudden and severe hair loss resulting in many visits to dermatologists over the last year and a half.  This has resulted in meds prescribed by two dermatologists without significant results.  Our daughter has also experienced several episodes of mono-like symptoms resulting in visits to the campus doctor and local doctor with negative test results.  She continues to be extremely fatigued even when well-rested and has unexplainable headaches. 4/8/09 PCP notes received. Pt seen 3/23/07 for OV with c/o planter's wart on foot, anxiety r/t school work and difficulty focusing, keratosis on arms and allergy sx.  PE (+) for allergic facies, boggy nares with some throat drainage.  Sent for derm consult and allergy meds prescribed.  1st HPV vax given. Seen again 7/6/07 with c/o URI with ear pain, cough and sore throat. Assess:  Nasal Pharyngitis.   Per TC with MD-not aware of any AE from vax. Has not been seen since 7/6/07 visit. 4/14/09 Derm consults received.  Pt presented 6/19/08 with c/o warts: thumb and plantar, and 8 month hx of hair loss.  Generalized hair thinning noted.   Warts removed and shampoo rx. Returned 7/10/08 for wart and mole check. F/U 3/19/09 for warts, acne and hair loss from the scalp.  PE (+) for circular patches of hair loss with moderate flaking and minimal erythema of the scalp.
Vaccine administered at 16:00. At 16:35 c/o dizziness, nausea, then loss of consciousness. Increased BP R 197/131, (L) 170/30 (+) tachycardia, slurred speech, confusion. Confirmed increased BP. 911 called and patient transported to local ED. Given ATIVAN and IV fluids. to f/u with neurology. 9/17 (+) erythema. warmth, numbness to (L) arm. (+) pain to (L) arm.
This spontaneous report as received from a nurse refers to 3 unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On 06-SEP-2015, one unspecified patient was vaccinated with a dose of improperly stored MMR II lot # L001336, expiry date 13-JAN-2017 (route and site of administration, dose were not reported). On 11-SEP-2015, two unspecified patients were vaccinated with doses of improperly stored MMR II lot # L001336, expiry date 13-JAN-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
tinnitus; soreness of the neck; lymph nodes in the back of her neck achy,lymph nodes in the shoulders achy; soreness of the shoulders; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), NECK PAIN (soreness of the neck), LYMPH NODE PAIN (lymph nodes in the back of her neck achy,lymph nodes in the shoulders achy) and ARTHRALGIA (soreness of the shoulders) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus), NECK PAIN (soreness of the neck), LYMPH NODE PAIN (lymph nodes in the back of her neck achy,lymph nodes in the shoulders achy) and ARTHRALGIA (soreness of the shoulders). At the time of the report, TINNITUS (tinnitus), NECK PAIN (soreness of the neck), LYMPH NODE PAIN (lymph nodes in the back of her neck achy,lymph nodes in the shoulders achy) and ARTHRALGIA (soreness of the shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included inhaler for Asthma.  No treatment medication provided.
A non-serious, spontaneous report of pain in leg, stomach pain, fever and nausea was received from a nurse, concerning an 11 year-old female subsequent to FLUMIST. There was no relevant medical history reported for the patient. Concomitant therapy include GARDASIL vaccination given on 04-Nov-2008. The patient received FLUMIST, nasal, on 04-Nov-2008 for Flu vaccination. Six hours after administration the child had symptoms of stomach pain. On the morning of 05-Nov-2008 the patient still had stomach pains along with a fever of 101F, some nausea and hurting in the legs. The health department nurse referred the child to a local medical doctor for evaluation and the patient was seen by the physician on 05-Nov-2008 for the reported symptoms. By the time the patient was seen by the physician the symptoms had gone away and per the patients mother, the daughter "was all better". The treating physician informed the patient's mother events were likely related to stomach gas.
Heart rate over 180, tingling in hands/face/tongue/legs, dizziness, feeling shaky.
Fever or Chills  Cough  Muscle or body aches  Congestion or running nose
A large hot swollen area down her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (A large hot swollen area down her left arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE SWELLING (A large hot swollen area down her left arm). At the time of the report, VACCINATION SITE SWELLING (A large hot swollen area down her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.