chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy rash to his nose and eye lids/ has the symptoms on his cheeks and it comes and goes; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Itchy rash to his nose and eye lids/ has the symptoms on his cheeks and it comes and goes) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Nasal polyps.    No Medical History information was reported.   In August 2020, the patient started DUPILUMAB (DUPIXENT) (unknown route) 300 milligram. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced RASH PRURITIC (Itchy rash to his nose and eye lids/ has the symptoms on his cheeks and it comes and goes). At the time of the report, RASH PRURITIC (Itchy rash to his nose and eye lids/ has the symptoms on his cheeks and it comes and goes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient experienced small itchy rash to his nose and eye lids, and has symptoms on his cheeks and it comes and goes.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Admitted to emergency room with extreme pain in muscles around spine and unable to support weight on lega.
Serum sickness reaction versus erythema multiforme  Nurse follow up on 06/21/04 states: "Fussiness."
pt recv vax 19APR & 6 hr later pain devel @ site of inj lt deltoid; acute pain relieved following day, but then aching set in w/activity; pain has come & gone x 2 wk; aches in joint only w/movement;
Patient is 27 months male who had Typhoid and Hepatitis A vaccination 48 hours ago.  Mother reports after vaccination he became cranky about 5 hours after the vaccine and then at 0200 he woke up with fever.  His temperature measured by mother at that time was 104 degrees.  He was given Tylenol with resolution of the fever.  He subsequent had an episode of vomiting at 1000 that next morning and again at 1100.  He was subsequently given Tylenol again and given crackers and Pedialyte with another episode of vomiting.  This episode was 1600.  Mother was concerned that patient had a reaction to the vaccine and he was taken to ER.  No focal findings on exam but temperature was reportedly 104 degrees.  No blood collected.  He was given Tylenol and he went to sleep until Midnight.  Mother reports he awoke vomiting at 0500 with vomiting and temperature was again elevated.  His mother reports that patient is acting cranky and wants to be held a lot.  Appetite is decreased.  Sick contacts- well baby check on Monday.  Mother reports he was not sick prior to the injections.  He was eating and acting okay at the time. Treatment has been Tylenol and Motrin. Exam is unremarkable with absolutely no swelling or redness at sites of injection today.  No known sick contacts.
Severe Headaches, Cold Sweats, Blurred Vision in right eye, Aches and Pains over entire body, Severe Stomach Pain and Gastrointestinal Issues, Chest Pressure and Pain, Urinary Tract Infection symptoms, Skin and Tattoo distortion around site of injections, bloody noses, extreme spikes in Blood Pressure, Body slowed making blood platelets, Kidney injury and beginnings of failure, Triggered extreme flare up of Psoriasis and deactivated Humaira, Blood pooling and appearance of bruising in legs at knees down to feet, erratic EKG's.
ON A VENTILATOR; This spontaneous report received from a consumer via a company representative in social media  concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received 2 doses of non-company suspect vaccine included Covid-19 vaccine (unspecified manufacturer), (dose number in series: 1) (Form, route of administration, batch number, dose were not reported, expiry: unknown) for prophylactic vaccination. No adverse events were reported following vaccination with Covid-19 vaccine (dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin was not reported, batch number: unknown), 1 total was administered, start therapy date was not reported, for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. On an unspecified date, the patient was on a vent (coded to on a ventilator) for over a month and nearly died (dose number in series: 2). As per the report "well chances are you wouldn't have died anyway. My brother in laws dad had both shots and a booster on a vent for over a month nearly died. A friends mom 67 and healthy within 3 days of second shot in the ground blood clots in legs and lungs and brain things that make you go hmmmm". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of on a ventilator was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20220230577.; Sender's Comments: V0: 20220230407- covid-19 vaccine ad26.cov2.s on a ventilator. 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). Therefore, this event(s) is considered unassessable.
Narrative: PT REPORTS CHILLS, JOINT PAIN/STIFFNESS AND NO APPETITE
Information has been received from a physician concerning a 5 year old white male student with no prior medical history or known allergies who on 08/06/1998, at the age of 15 months, was vaccinated subcutaneously in the right thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 627842/0798M).  Concomitant vaccination on 08/06/1998 included a fourth dose of Haemophilus B conjugate vaccine (ACTHIB)(Lot # 0949110) intramuscularly in the left thigh.  There was no illness at the time of vaccination.  On 06/06/2002 the patient had a negative mumps titer of 0.56.  Titers were drawn because the patient's mother did not want the second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  It was noted that the patient's titers for measles and rubella indicated that he was immune.  Subsequently, the patient was vaccinated in the Spring of 2002 with a 0.5ml dose of mumps virus vaccine live.  Unspecified medical attention was sought.  Additional information is not expected.
Severely sore arm; unable to use arm; Began hurting several hrs p/inject; Instructed by MD since arm still very painful -Tylenol/warm compresses - appt to be seen.
915 am had flu mist, 930 am complaints of "croupy cough." Parent with child states has diagnosis of "croupy cough" when ill. Color fair, mom states child does not have asthma but does have albuterol inhaler for "croupy cough." Child taken home at 940 am for albuterol inhaler and follow-up call to PMD.
Hospitalized with altered mental status, chills, fever, COVID detected  treat dexamethasone 10 days and Remdesivir  5 days.
Huge bruises on breasts, stomach, legs and fist sized bruising in both groin areas.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, solution for injection), on 03Feb2022 at 11:00 as dose 1, single (Lot number: EL9261), on 24Feb2021 at 13:45 as dose 2, single (Lot number: EN6201), in left arm, on 29Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8762) and on 05Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Hypothyroidism" (unspecified if ongoing); "Chronic Lyme" (unspecified if ongoing); "Chronic Epstein Barr" (unspecified if ongoing); "Babesia" (unspecified if ongoing); "Known Allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; T3; ESTRIOL; TESTOSTERONE; PROGESTERONE; NALTREXONE. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin"; Serevent, reaction(s): "Known allergies: Serevent"; Ibuprofen, reaction(s): "Known allergies: Ibuprofen"; Bactrim ds, reaction(s): "Known allergies: Bactrim DS". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 13 days 10 hrs after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2021) Positive; (21Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events Drug ineffective, COVID-19 cannot be completely excluded based on temporal association.
heart rate while laying in bed has been at 115 beats per second; was diagnosed with the flu; flu; breathing issues; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 31st January 2020, between 2 and 3 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and difficulty breathing. On an unknown date, the patient experienced heart rate increased. The patient was treated with fluticasone furoate, vilanterol trifenatate (Breo Ellipta). On an unknown date, the outcome of the vaccination failure, difficulty breathing and heart rate increased were unknown and the outcome of the influenza was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, influenza, difficulty breathing and heart rate increased to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional information was received as follows: The patient received flu vaccine on left arm. The Patient received a flu shot from an unknown manufacturer in mid-November 2019. On 31st January 2020, she was diagnosed with the flu which was still unresolved. The patient had breathing issues which get bad at night since having the flu. The patient mentioned that her heart was working hard to get her lungs to work, her heart rate while lying in bed has been at 115 beats per second. The patient would now wear a heart monitor at night. The patient was prescribed Breo Ellipta for her breathing issues, however, she is unable to afford the medication.  The report consented to follow up.
Pt was given IPV, DTaP, HBV, Prevnar and Flu vaccine on 2/27/03. That night she was taken to ER for 102 temp. She also experienced a seizure witnessed by mother. She has history of seizure disorder and is on Tegretol.
This case was reported by a nurse via sales rep and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills and fatigue. On an unknown date, the outcome of the chills and fatigue were unknown. The reporter considered the chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: Nurse reported to sales account manager that, she received SHINGRIX in the last couple of days and that evening of the vaccination she experienced chills that occurred again the following night. The patient also had fatigue. No further information available (all questions asked). This case has been linked with case US2018102548, reported by the same reporter.
Information has been received from a physician concerning a 11 year old female who on 26-FEB-1999 was vaccinated with the first dose of MMR II, and second dose (HSA) on 02-JUL-2002. On 13-DEC-2009 the patient developed mumps. She was diagnosed with mumps on 30-DEC-2009. The patient had parotitis, she did not have a fever. Blood works were performed on 30-DEC-2009. The serum immunoglobulin M test result was< 1:10. The serum immunoglobulin G was 6.93 and the serum amylase was 149. At the time of the report, the patient's outcome was unknown. Follow-up information has been received concerning the female patient who on 04-DEC-2009 experienced onset of symptoms. On 07-DEC-2009, the patient was diagnosed with mumps. The patient had a fever of 101 F degree and had right parotitis. On 07-DEC-2009, blood work was done and revealed that IgM was <1:10, IgG was 5.36 and serum amylase was 143. It was noted that the patient had exposure to others with mumps. At the time of the report, the patient's outcome was unknown. The AE onset date and blood work results have been updated. No further information is available.
DEMAND ISCHEMIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 12/9/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Ocular migraines started end of April. Had never experienced them before. To date, I have -4 per month. They are of 15-20 min duration. During this same time period, I started noticing irregular heart beats, skipped beats and runs of tachycardia which persist to date and have resulted in seeing a cardiologist, having an echocardiogram, wearing a monitor for a week,  being prescribed a heart medication.
Has rash after each COVID (Pfizer) vaccine.  He does not remember how long after the 1st shot on 3/11/21 he developed a rash at the injection site.  Resolved relatively quickly on its own.  Had rash again after the 2nd shot; around the injection site and on his bilateral lower back.  It took several weeks for the rash to resolve on its own.  However, after the booster on 10/1/21, developed a more diffuse rash that has not resolved on its own, unlike the others.  R>L antecubital fossa, back of neck, above the beltline, R upper back, and some on the inner thigh (L>R).  No systemic symptoms.   Currently, 3.5 months from the booster, he has a 4 in x 2 in lesion on his R thigh, lesions on his neck, at the injection site, and on his back (upper L and R and lower L and R).
TDAP vaccine inadvertently administered, had intented to administer Hepatitis B vaccine.
Muscle pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Feb2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to the vaccination, the patient was diagnosed with COVID-19). The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unknown indication from an unknown date and unknown if ongoing. On 23Feb2021, the patient experienced muscle pain in lower right arm from elbow on down which started 2.5 weeks after the vaccination. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. On an unknown date in Feb2021, the patient underwent COVID-19 virus test and the result was unknown. The clinical outcome of the event muscle pain was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 18JUN96 & w/in 24hr pt exp cellulitis @ inj site which was described as a reddened, sore area, 4-5inches in diameter;pt exp a  lump @ inj site on 28JUN96 which MD dx as sterile abscess;
No adverse event; Pediatric Booster dose was administered instead of Booster Bivalent.; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Oct-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent.).    No concomitant medication were reported.  It was reported that pediatric booster dose was administered to the patient instead of the bivalent booster dose.   Unfortunately, the Moderna Pediatric vaccine vial was mixed with the Bivalent Booster vials. The goal was to administer the Booster Bivalent dose, but instead the Pediatric vial was administered. The AE did not cause patient to seek medical care. The patient did not experienced a similar event in the past no information on Primary Doses.  No treatment information was provided by the reporter.
Pt came to ER c/o cough, fever, body aches, diarrhea, received vaccine for Covid day last night.
Redness very slowly swelling until I went to the doctor in November. He gave me antibiotics but the site began oozing massive amounts of pus. I continued with the medication. It's closed now but red and still feels like something is in my arm.
Hospitalization: 1/10/2023 - 1/13/2023 (3 days) Presentation to the ED: shortness of breath.  COVID + date: 1/10/2023 Treatment: Remdesivir and steroids.  Discharge to: Home.   029A21A 3/5/2021 006B21A 4/2/2021
Experienced tingling (feeling like pins and needles) from fingers on left hand to left forearm. started shortly after administration of vaccine- was still having sensation two hours after vaccine. patient was following up with primary care doctor the following day and would address with physician then.
Pt reports rash prior to bed that evening. Pt self treated with BENADRYL 12/10/09 without improvement. 12/11/09-Prescribed ALLEGRA, ATARAX, ZANTAC and prednisone.
Chills, nausea, fever, headache, body aches: resolved in 24 hours  Arm rash in vaccinated arm, not resolved as of today
eyes twitching mainly the right eye sporadically; soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (eyes twitching mainly the right eye sporadically) and PAIN IN EXTREMITY (soreness in the left arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PROGESTERONE for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced BLEPHAROSPASM (eyes twitching mainly the right eye sporadically) and PAIN IN EXTREMITY (soreness in the left arm). On 10-May-2021, PAIN IN EXTREMITY (soreness in the left arm) had resolved. At the time of the report, BLEPHAROSPASM (eyes twitching mainly the right eye sporadically) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
BRUISING AT INJECTION SITE; DARKER DISCOLORATION ON OUTSIDE AND A LIGHTER COLOR ON INSIDE OF BANDAGE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included arthritis, and smoker, and concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no other bruises recently or petechia, chest pain, leg or abdominal pain, difficulty breathing, headache or blurred vision and no allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23/JUN/2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for arthritis. On 27-APR-2021, the subject experienced pain at injection site. On 29-APR-2021, the subject experienced bruising at injection site. On 29-APR-2021, the subject experienced darker discoloration on outside and a lighter color on inside of bandage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruising at injection site, had not recovered from pain at injection site, and the outcome of darker discoloration on outside and a lighter color on inside of bandage was not reported. This report was non-serious.
p/immun pt kept sleeping drowsy for 6 hrs then started w/fever around 7PM; began APAP temp not taken until 11PM; t105 R; Called ER told to give bath; to ER;
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 28-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N023828 (expiration date 25-JUN-2020). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661: