chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Minor bottom lip swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Minor bottom lip swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had never tested positive or diagnosed with COVID-19.  The patient's past medical history included Scar (old injury has resolved) and Dermal filler injection.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 26-Nov-2021, the patient experienced LIP SWELLING (Minor bottom lip swelling). At the time of the report, LIP SWELLING (Minor bottom lip swelling) had resolved.            No concomitant medication information was provided.  The patient had the similar event Minor bottom lip swelling with first dose as well.  No treatment medication information was given.   This case was linked to MOD-2022-558775, MOD-2021-079367 (Patient Link).   Reporter did not allow further contact
my blood pressure kept raising despite taking bp meds; Fatigue; Chills; Fever; body aches; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 12Apr2021 16:45 (Batch/Lot Number: EWO158, expiration date not reported) as single dose (at age of 45-years old) for covid-19 immunization. The patient medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included labetalol; paracetamol (TYLENOL); ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/Batch# ER8730, expiration date not reported), via unknown route in Left arm on 22Mar2021 as single dose (at age of 45-years old) for covid-19 immunization. The patient was allergy to Hydrocodone, oxytocin and similar meds, bacterium. Patient did not receive other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. The patient experienced blood pressure kept raising despite taking BP meds, fatigue, chills, fever, and body aches on 13Apr2021 at 16:00. The patient ended up in the Emergency room/department or urgent care because of it. The patient underwent lab tests and procedures which included blood pressure measurement kept raising on 13Apr2021, electrocardiogram and laboratory test: unknown result on unknown date. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering at the time of report.   No follow up attempts are possible. No further information is expected.
Patient complained of having itching, then redness and induration one day later. According to exam note from 07/23/2009 there was a 9X7cm edematous plaque with 2X3cm indurated portion surrounding injection site. No discharge, no callour. Mild TSP.
Vaccine administering nurse observed 5-15 second loss of consciousness along with mild tremors all over body. Did not collapse on floor from chair; did not bite tongue or urinate.
Pt with large amount of redness and swelling at and distal to injection site. Muscle spasm and pain in entire body prompting ER visit. Jaw pain, mouth sores.
The evening after vaccine administered he developed bright red cheeks and a diffuse red maculopapular rash over trunk and extremeities. He was seen the next day and Bactrim was discontinued and he was treated with Atarax. The night of the 18th he developed fever to 103. Today his temperature is 100.7 and the rash is still prominent but fading. He is to continue the Atarax.
Information has been received from a licensed visiting nurse concerning a female who was vaccinated with Gardasil.  Subsequently the patient fainted after being vaccinated with Gardasil.  Subsequently the patient recovered.  Additional information has been requested.
Severe h/a steady & pounding seen by MD 14OCT91; slight temp adm to hosp 16OCT91 when rt eye drooped; seen by neurologist while admitted;
struck periods for long duration(15) and gap between monthly periods have reduced from 25 days to 10days; struck periods for long duration(15) and gap between monthly periods have reduced from 25 days to 10days; This is a spontaneous report from a contactable consumer (patient) . This non-pregnant 39-year-old female patient received a dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EN6206) via an unspecified route of administration on 04May2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient reported that she had "struck periods" for long duration "(15)" and gap between monthly periods had reduced from 25 days to 10 days. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of "struck periods" for long duration "(15)" and gap between monthly periods had reduced from 25 days to 10 days were unknown. It was also reported that the patient had not been tested for COVID since vaccination.
This spontaneous report was received from a physician refers to a patient of unknown age who on 22-AUG-2007 and 12-JAN-2008 was vaccinated with GARDASIL (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient did not get the third dose yet. No adverse effect reported. The adverse event was not related to GARDASIL. Additional information has been requested.
I got out of bed on 11/6 with severe room spinning, almost fell.  This has continued and seems to be whenever I move my head to other than vertical; I also got a severe leg cramp that lasted 3 days and some heart palpitations.  By 11/9 I was sometimes not walking straight and I was getting confused and made an appointment to see my doctor;  Doctors visit on 11/12 and my doctor sent me to the ER.  ER Diagnoses:  Vertigo with nystagmus - started 11/6/2021 and continues (now day 9) - Horizontal nystagmus when my eyes move from right to left   Acute kidney injury   - diagnosed at Emergency Room after testing on 11/12/2021   - Creatinine 1.7   - eGFR 33   - BUN 28
swelling of the face and throat; extremely dizzy; weakness; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling of the face and throat), DIZZINESS (extremely dizzy), ASTHENIA (weakness) and CHILLS (chills) 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 16-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 SWELLING FACE (swelling of the face and throat), DIZZINESS (extremely dizzy), ASTHENIA (weakness) and CHILLS (chills). At the time of the report, SWELLING FACE (swelling of the face and throat), DIZZINESS (extremely dizzy), ASTHENIA (weakness) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Information has been received from a registered nurse concerning a 6 year old female with allergies who on 01/20/1996 was vaccinated with varicella vaccine IM in the left arm. This does not comply with the recommended route of administration. On 04/02/2001, the pt called the physician's office. On 04/03/2001, the pt was seen in the physician's office with greater than 50 lesions. In follow-up, the nurse reported the pt had "scattered papules, red-few vesicles at different stages, approximately 50 spots, and was diagnosed with atypical chicken pox." The pt recovered from the chicken pox. No further info is expected.
Off balance starting the day after receiving the H1N1 vaccine. Symptoms persisting x 2 wks as of this report.
Meningitis vaccine ordered. Shingrix was mistakenly administered by the Medical Assistant. Error was immediately recognized. Pt and mother of child were informed and opt to hold off on the Meningitis vaccine today. Reviewed signs/sx of adverse reaction - will monitor for these effects. Pt discharged without signs of immunization reaction.
Extreme pain, muscle weakness in right arm so severe that I could not move my arm, extreme vertigo, tremors throughout body and in hands, fingertip numbness both hands, fever, chills, fatigue, high blood pressure. The walk in clinic doctor thought I was having a stroke (I wasn't).
12/03/2002 - "Darkened reddened raised area, warm to touch from knee to groin area." - Per phone call from grandmother
Child described as cranky after vax. At 4 pm parent noted skin hot to touch. At 8 pm child had a seizure. Rectal temp was 103. Child was diagnosed with bilateral OM. Treated with rocephin.
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation.  Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath.   Noted to have uvular swelling and wheezing on examination.  Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM.  within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk.  Noted to be pale, HR in 140?s.  Given second dose of epi IM and symptoms improved.  Was transferred to Obs Unit., within 2 hours (approx  6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing.  Again noted to have swelling of uvula, wheezing on exam.   Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer.  Was transferred to ICU, all meds held except Pepcid.  Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting.  Again noted to have uvular swelling and wheezing.  Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb.   Solumedrol started q12hour dosing.  Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms.   Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing.   Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer.   Solumedrol changed to q8 dosing.  Approx 4 hrs  later nurse noted rash worse on face, associated with itching, throat tightness.  Given additional Benadryl, Racemic Epi neb with improvement.   Rash continued that night with throat tightness,  got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine).  Transferred to telemetry floor.  Day#3 post vaccine rash improved, but still present to chest and face.  Throat fullness present, especially after drinking.  Am still hospitalized while writing this report
Patient was given two immunizations in the same arm 1-2 inches apart. Patient was given PNEUMOVAX 23 and FLUZONE HD. The patient presented to the pharmacy the next day with redness, swelling, tenderness to the area, and reported 'dry heaves'. Patient self admitted to ER for observation the evening of 9/12/16.
DTAP given 9/11/08 left thigh; 9/16/08 patient presented with urticaria type rash, conc at injection site of DTAP left thigh, trunk and face areas itchy.  Benadryl 12.5 q 6.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare  consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the Dept of Public Health and Environment on a compliance improvement plan and has been reinstated vaccination privileges.
VACCINE ADMINISTERED 6 HOURS POST PUNCTURING; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced vaccine administered 6 hours post puncturing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered 6 hours post puncturing was not reported. This report was non-serious.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 04-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Severe Joint inflammation  feet, hands especially.  Hips amd knees as well. Cannot barely walk
Writer called pts father and informed him of incident.  Pts father denies pt having signs or symptoms of side effects.
got shot, got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, 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 Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had shingles, then the patient received the two Shingles shots that was supposed to be better and got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Swollen eye lids, swollen lips, red itchy hives on neck, face, lips, arms, butt, vaginal area. Treated with Benadryl 50 mg every 8 hours, did not get better, more swelling and hives persisted, forced to seek help 10/11/2015 at urgent care center, received a cortisone shot and week worth of steroids. Continue with Benadryl 50mg every 8 hours.
Information has been received from a physician concerning a 49 year old male pt with a chronic white coated tongue who in May 2000, was vaccinated with hep b vaccine recombinant. In July 2000, the pt was vaccinated with a second dose of hep b vaccine recombinant. There was no concomitant medication. The physician reported that in July 2000, the pt complained of achiness in his arms and sometimes in his legs. In September 2000 the pt experienced an obnoxious taste in his mouth and his tongue was white-coated which the physician stated was a chronic condition. Unspecified medical attention was sought. He also noted that the symptoms were present everyday and the pt has had no relief. The pt had no difficulty swallowing and no heartburn present on a regular basis. In November 2000, the pt was vaccinated with a third dose of hep b vaccine recombinant. Additional info is not expected.
MMR vaccine diluent was added to the mix and administered to a patient.; MMR vaccine diluent was added to the mix and administered to a patient.; Wrong solution used in drug reconstitution; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 1st December 2020, the patient received Menveo. On 1st December 2020, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, incorrect dose administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate preparation of medication, incorrect dose administered and wrong solution used in drug reconstitution were unknown.  Additional information received as follows: The age at vaccination was not reported.  Menveo vaccine was reconstituted using the powder and the approved diluent and then an MMR vaccine diluent was added to the mix and administered to a patient. Addition of another diluent to the Menveo vaccine. This led to inappropriate preparation of medication, incorrect dose administered and wrong solution used in drug reconstitution. The reporter did not consent to follow-up.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PT was 95 Years of age, with a PMH significant for t2dm, htn, hyperlipidemia. Patient deceased 4/29/2021 however no notation regarding death or recent illness noted.
Over the course of 6 days developed 5 areas of shingles like-symptoms: all on torso, look like shingles pictures I see on internet, but did not develop blisters.  All groups of spots were red, itchy, but tender too. No other apparent reason for these spots.
None known. Client received H1N1 nasal mist. No reaction. No adverde event. Misadministration of vaccine; vaccine not licensed for this age.
I experienced mild shortness of breath; fatigue; headache; This is a spontaneous report from a non-contactable consumer or other non-HCP (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 08Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021 the patient experienced mild shortness of breath, fatigue, headache. It was reported that caller stated "she received the first dose of the Pfizer vaccine 24 hours ago. She experienced mild shortness of breath, fatigue and headache. She works on a boat she checked her 02 level it was between 99 to 100 % Sometimes it's her cycle. It could be she had mild shortness of breath due to her mensuration." The patient underwent lab tests and procedures on an unspecified date which included oxygenation index: it was between 99 to 100 %. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Immediately after receiving the injection, patient verbalized chest tightness and epigastric tightness. Patient developed a hive on the legs bilaterally. Patient verbalized being very fatigued. Patient was medicated with 50mg Dimenhydrinate orally. Vital signs stable with oxygen saturation dipping to as low as 90%. 911 was called where patient was then transferred out of clinic via ambulance to hospital.
Information has been received from a consumer concerning her approximately 15 month old son who has no known allergies or pertinent medical history, who 7 1/2 years ago, in approximately March 1999, was vaccinated SC with a 0.5 ml first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no concomitant medication.  Subsequently, "around the same time" the vaccine was given, the patient started "showing signs" of autism. Medical attention was sought, a hearing test was performed and the patient's brain stem was "tested", results were not reported. At the time of the report the patient had not recovered. No further information was available. There was no product quality complaint involved. The patient's brother (WAES0609USA03020) also had an adverse experience after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested.
Pt recv vax on 10/29/97; 5 min post vax pt exp faint feeling, dry &thick tongue, heart racing, dry mouth, hypertension; tx=Benadryl
Patient experiencing tachycardia with rates in the 150's, shortness of breath and hyperventilation.
Significant pain at site of injection; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. On first shot the patient had significant pain at site of injection.  The patient used heating pad that night to sleep.  No further information, but patient stated she did subsequently get the 2nd dose shot. The reporter denied permission to follow up.
Right after injection had slight tingling in my arm all the way down to my fingers in the right arm, the arm they gave injection in.  My arm was sore that day, but nothing too severe.  The next morning I woke up and felt like someone had hit me multiple times with a baseball bat in my right arm.  It was very sore and hurt to move.  I also noticed that my legs seemed very stiff and my walking was more difficult.  I have multiple sclerosis and do have mobility issues.  I have been doing physical therapy for the past 6 months and getting stronger and my walking was getting better.  Ever since my first vaccine, I have noticed greater difficulty with my gait and increased spasticity in my legs, and heightened lack of energy.  My physical therapist has also noticed the changes and the direct correlation between my decline and the date of Moderna vaccination.  I have chosen not to get the second one because the symptoms were so severe and lasting.  MS is a disease that affects the immune system.  It is like my immune system mounted a response to the vaccine and has never calmed down since then.  My walking is definitely worse than prior to the vaccine!!