chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US000524 is an initial spontaneous report received from a nurse on 03 JAN 2014. This report refers to an 11-years-old male patient. His medical history and concomitant medications were not reported. It was reported that he was only administered MenCYW-135 liquid component of MENVEO (batch number: M13012, expiry date: Sep 2014) at a dose of 0.5 ml intramuscularly and did not receive MenA lyophilized conjugate on 05 DEC 2013. No adverse reactions were reported following the maladministration.
Pt. received her vaccine without any issues - while vaccinating her siblings, she felt dizzy and began to perspire. I had her sit for 15 minutes and checked her BP 110/58. She felt better after 15 minutes, stood up for a minute and her dad walked her out.
2 y/o patient received Bexsero; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 22-month-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 19th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 22 months old patient received dose of Bexsero, which led to inappropriate age at vaccine administration. No additional details available about adverse event. The parent and CDC were notified.  The patient was doing fine. The reporter consented to follow-up.
INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 94 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic kidney disease, anemia, high cholesterol, hypertension, latex allergy, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-OCT-2021, the patient experienced incorrect product storage. On 07-OCT-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
Pt here for 2nd COVID vaccine. + hx of Code Blue after 1st COVID vaccine 2/4/21 Few minutes after shot, pt again noticed palpitation, shaking, flushing, SOB from tachycardia, dizziness and mild HA, similar as last time. MA immediately started vital signs monitor, pt was transferred to exam table. Provider and nurse notified and onsite right away. Pt's HR up to 140-150 bpm, BP up to 160-170/90-100, mild tremor and sig flushing but no wheezing, no throat closing, no hives. Symptoms lasted for about 5 minutes and HR started to go down gradually. BP eventually down to 140/80 and HR 105 bpm when pt felt back to baseline except some mild mid chest pain. EKG performed at bedside, showed sinus at 100bpm with nonspecific ST-T changes and Q in III and aVF, no acute changes.  Pt has cardiology appt next wk Pt was then discharge to home with the accompany of her husband.
Case number PHEH2014US024334, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 22 Jan 2015. This report refers to a 73-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 22 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
patient received her moderna covid vaccination first dose  in the consultation room (she had stated that she was nervous and wanted her husband to come in with her  and I assured her it would be fine -she -  was fine at first but a few minutes later she stated she was feeling nervous so I had her go and sit in the waiting area with her husband in case the consultation room was claustrophobic. a few minutes later the technician called me stating that she had passed out. I asked her to cAll 911 whilst I checked her breathing. she came around shortly thereafter and the paramedics arrived and attended to her - she had come Around by the time the pAramedics arrived, and wanted to go home They however advised her to go the ER, to get checked and she and her husband left with them
RASH SIMILAR TO DARK PURPLE/RED ITCHY AND BURNING SPOTS ALL OVER THE BODY; PAINFUL RASH; This spontaneous report received from a consumer 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, and batch number were not reported) 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 patient experienced rash similar to dark purple/red itchy and burning spots all over the body, and painful rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash similar to dark purple/red itchy and burning spots all over the body and painful rash was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049049.
3 episodes of abrupt and transient hypertension (max measured 218/113) with fever (38.1 C), marked headache and dyspnea on March 3, 4 and 7, requiring visits at Emergency Department (ED) on March 4 and 7. Episode on March 3 and 4 lasted few hours and self-resolved (2 liters iv saline on 3/4 at ED). Episode on March 7 required use of iv Atenolol at ED and oral Atenolol for the next 5 days. Starting March 5, flashes and floaters (?oily? spot in the right eye). All symptoms disappeared after March 12, except for the floaters in the right eye.
Pneumonia; Hypoxic; Tested positive for COVID; Became sick; A spontaneous report was received from a physician concerning a male patient of an unknown age patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced became sick/ illness, tested positive for COVID/ SARS-CoV-2 test positive, pneumonia and hypoxic.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 05 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly (injection site not provided) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient became sick and he tested positive for COVID and experienced a medically significant events of pneumonia on x ray and hypoxic.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the events became sick, pneumonia, hypoxic and tested positive for COVID was not reported.
RECEIVED PFIZER-BIONTECH MONOVALENT (NDC 59267-1025-04) INSTEAD OF INTENDED BIVALENT (NDC 59267-0304-02)
Vaccine overdose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (Vaccine overdose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OVERDOSE (Vaccine overdose). At the time of the report, OVERDOSE (Vaccine overdose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
pt recv vax & exp flu sx & had a positive viral cult;pt tx w/rimantadine;reporter indicated pt had been vaccinated w/one of the recalled lots, but was unable to ID specific lot#;
pt had headache, fatigue, and severe neck pain one day after receiving 2nd covid vaccine. Was seen in ER on 05/06/21 . was seen in peds office 05/10/21 for follow up.
fever, body aches, runny nose, cough, sore throat, chills that lasted about 4 days.  Symptoms subsided substantially after 2 days, but I did not feel completely well for nearly a week.
None , Patient was at off site clinic patient got booster dose and she is 12 years but got her 2 nd dose 6months ago in June 2021. I call patient  and hung up the phone on me when I told about their and daughter and this pharmacy . I also tried to call after numerous time but it was unsuccessful and left a voice mail to call us back .
Lip swelling; throat swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number er8723 /expiration date: not provided), via an unspecified route of administration, on 27Mar2021 at 17:30 (at the age of 29 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included asthma, Triaminic allergy and requip allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included trazodone and alprazolam.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Apr2021, one week after vaccine was given, the patient experienced lip swelling and throat swelling which required a physician's office visit. The patient received treatment for the events lip swelling and throat swelling which included prednisolone injection. The outcome of the events lip swelling and throat swelling was recovering. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : same patient, different vaccine dose/event
Pt had syncopal episode after flu vaccine. Pt was monitored for 30 mins. Both Mom and pt felt ok to leave. Pt will be called tomorrow to inquire how they're feeling.
24 hours post vaccines began to feel unwell. Fever chills, body aches -> Put on TAMIFLU with minimal improvement (by primary) Nov.2 - put on Doxycycline and chest XRay revealed pneumonia (by primary).
Had signifficant soreness at left arm entry site 1 day after 3rd {Booster} shot that continues today, approximately 3 months later.  More importantly, during that same time period, also continuing today, I experience severe pain in both shoulders and in both arms every morning at 5:30 a.m., 1/2 hour before I get up for the day at 6:00 a.m.  This pain subsides, for the most part, approximately 1 hour after I am up and about for the day.  In hopes that these events would go away in time, I have not seen my PCP for any possible treatments.  I have not made any changes to my current medications list during the past year.    Just want this info to be noted in your files for future reference.  My list of medications is on
red, raised rash at and around the injection site. It doesn't itch too much. formed within 30 minutes of getting the vaccine and is still present 24+ hours later. Has not spread. It isn't too bad, but I did want to report it in case there was a concern with getting the second dose and because it is so new.
Shortness of breath; Dizziness; A fast heartbeat; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9269) on 05Feb2021 18:15 at left arm at single dose for COVID-19 immunization. Medical history included known allergies was Dust, mold, cat. Patient is not pregnant. Concomitant medication was not reported. Patient experienced shortness of breath, dizziness and a fast heartbeat, all on 05Feb2021 10:30 PM. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Patient was recovered from the events in Feb2021.  Follow-up attempts are completed. No further information is expected.
states arm was extremely painful x 2 wk post inj; 3cm erythema noted w/no induration on 11JUL95; c/o nausea, fatigue, dizziness beginning 2 wk p/vax & lasting 2 wk until present;
didn't want anything to eat; cold chill; feel tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (cold chill), FATIGUE (feel tired) and DECREASED APPETITE (didn't want anything to eat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 Vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced CHILLS (cold chill) and FATIGUE (feel tired). On an unknown date, the patient experienced DECREASED APPETITE (didn't want anything to eat). At the time of the report, CHILLS (cold chill), FATIGUE (feel tired) and DECREASED APPETITE (didn't want anything to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events were unknown.   This case was linked to MOD-2021-023940 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: No specific follow-up information recorded.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Itch at site of injection; Sore arm; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch at site of injection), MYALGIA (Sore arm) and VACCINATION SITE SWELLING (Swelling at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itch at site of injection), MYALGIA (Sore arm) and VACCINATION SITE SWELLING (Swelling at injection site). On 08-Mar-2021, VACCINATION SITE PRURITUS (Itch at site of injection), MYALGIA (Sore arm) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Started to get hives in October. Brought my daughter to ER. Administered Benadryl pills but got worse. Next, they infused her with dexamethosone, famotidine, diphenhydramine. It calmed the hives down. ER sent us home with Prednisone and famotidine. Next day, she got hives again. Went to the ER again, but hive started going away while waiting so we left. That night hives returned but only at her feet. She slept through it. Woke up the next day with hives again. Met with her Immunologist that day and told to take Zyrtec. Hives went away within a day. Continued on Zyrtec AM and PM and famotidine for a week. Following week, Zyrtec AM and PM only. Following week, Zyrtec AM only. Following week, no medicine. 3 days following her last dose of Zyrtec, she broke out into hives again + bad eczema flare up. Put her back on Zyrtec to calm it down. She did lab work today ordered by her immunologist - 8 vials of blood. Will get her results in a week.
Beginning June 21' in her own home Limbs became numb with frequent falls. Extreme Confusion/Brain Fog. Stabbing pains in upper thighs. Continued and increased until June 30th when fell AGAIN and was taken by Ambulance to ER. Brain bleed detected. Transferred to Trauma hospital. Went thru 2 more hospitals with diagnosis of Alzheimers/Parkinsons and unknown Nuero disorder. continued through rehab hospital which said permanent paralysis most likely. Hands are balled up and cannot be used. Legs do not work and  cannot stand. wheelchair bound and requires assistance for everything. Cannot feel hands or feet. Now Resides in Assisted Living.
After 5 minutes I felt hot, flushed, and my skin started burning, itching, and rashing. I felt nauseous, and light headed; "poisoned"! This remained throughout the rest of the day and evening.  The next day I had rushes of heat, nausea, and dizziness flow through through me that lasted several minutes and then passed. This continued for four days, slowly diminishing in severity.
pt recv vax 5FEB98 & 19FEB98 pt exp inj site redness, warm the & swelling;pt required a visit to MD office on 20FEB98;the reporter assumed that pt sx resolved, because the pt had not returned;
Pt devel hives w/in 24 hr period p/recvd DTP; MD said noDTP only Ped DT; (hives were on face & trunk-itching-1 dose of DPH relieved them stated mom;
About 11 hours after vaccine, I started to get the chills. I couldn't sleep and threw a bunch of blankets. I got a fever. Couldn't sleep and I didn't go to work the next day. I had a headache and random stomach, headache and joint pains The next day I was super fatigued for two days. After 24 hours of this - the symptoms were gone except catching up on the fatigue. Except I noticed I had the sniffles for about four days.
COVID-19 with symptoms; COVID-19 with symptoms; This is a spontaneous report from a non-contactable consumer (patient).  A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 at 03:30 PM, as a single dose for COVID-19 immunization. Medical history included Hashimoto's, Hyperlipidemia, Meniere's Disease and Sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL), celecoxib (CELEXA), hydrochlorothiazide/triamterene (DYAZIDE), atorvastatin (LIPITOR) and fusidate sodiume (ZETA). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was exposed to COVID on 07Mar2021 tested negative via SARS-CoV-2 test on 12Mar2021. The patient became symptomatic on 14Mar2021 and subsequently tested positive via SARS-CoV-2 test (via nasal swab) on 16Mar2021. The patient did receive any treatment for the events which included a steroid, inhaler, benzonatate (TESSALON). The clinical outcomes of the COVID was recovering.
TOOK LAST DOSE 24 HOURS LATE; This spontaneous case report (PVX2019-2492) was received from a nurse on 04-Oct-2019. It described a female consumer who "took last dose 24 hours late" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took Vivotif on days 1, 3, 5, and 8. The consumer took her last dose of Vivotif 24 hours late, on an unknown date (day 8).   Action taken with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took last dose 24 hours late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose 24 hours late" was considered as not applicable.
Right sided facial pressure, pain and numbness. Ear and Neck pain/pressure. Treatment- pain medications and consultation/follow up instructions.
Within 24 hrs of injection, I had extreme pain in my left shoulder that lasted a couple of days.  Over the last few months, the pain has traveled down my left arm, my fingers have tingled.  Currently, my arm aches constantly and the pain is mostly in my elbow.
Fever from 3:00 am to 6:40 pm (99.7 - 101.4) treated with extra strength acetaminophen. Temperature is now 99.5 Fatigue for 1/11 and 1/12 Intermittent muscle aches on arms and calves