chrisvoncsefalvay/vaers-outcomes huggingface dataset:
440, Pt arrives in observation, approx 5 min after receiving vaccine, observed sitting in chair comfortably, no apparent distress, no cough observed at this time, skin appears dry, appropriate skin color, no s/s increased respiratory effort, Smiling playing games on phone, denies any discomfort at this time.  500- Observed pt with intermittent dry cough Pt describes as "just a little tickle", lips pink (mask removed temporaily), talking without difficulty. Denies distress, Offered water, no obvious increased respiratory effort. Pt agrees to continued observation, Offered water, appears to be swallowing without difficulty. 5:05 pt reports "harder to talk without cough" observed increase in frequency of dry cough, pt reports that she wants to continue to be observed, does not want benadryl at this time. Pt agrees to plan that includes, if she feels worse, she will be offered benadryl, she agrees, that if she does receive benadry, she will not attempt to drive herself home.She reports that benadryl "makes me drowsy"She agrees to call family to have them come pick her up. Lead RN at pt;s side. 510- increased frequency in coughing, pt reports that "it's harder to talk without coughing, itchiness in throat increasing" she denies shortness of breath, but reports that she is concerned that she will become short of breath, therefore agrees to 50mg benadryl IM (r deltoid), still awaiting family arrival. Pt reports, "feel hot" No observed increase in respiratory Moved to bench couch(prior to recivng benadryl, , EMT present , vitals taken, bp 148/92,pulse=83, pulse ox 96-98%, pt reports that this BP reading is "higher than usual for me", denies pain except for pain at vaccine injection site,  5:20. No obvious change of status noted, skin remains pink, +cap refill, lungs cta no wheeze herd per EMT.  5:24- pt reports that she is "getting a little drowsy, but feeling better". Cough appears to be less frequent.Pt appears more relaxed, talking without effort, respirations appear to be without effort, relaxed.Conitues to agree not to drive herself home, awaiting her daughter to come get her and drive her home, Encouraged pt to have daughter come up to floor, did discuss with pt, although she is feeling better at this time, if she feels worse, once she is driven home by daughter, she will seek emergent care immediately. Pulse ox 98%, appears to be in no distress. Only occasional cough noted.  5:28, pt reports that she sees her daughter on floor and walks (with normal gait),towards a couple, went to offer to escort pt to car, but she walked away from couple, and left floor without coming back to observation.  5:30, pt observed (from 3rd floor window), talking to another adult woman presumptively her daughter, 5:35, pt observed (from 3rd floor window getting into a different car, by herself, sitting in drivers seat and drives off by herself, driving the car.
Vaccine gave me shingles/Suspected Vaccination Failure; Gave shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Vaccine gave me shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Gave shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-MAR-2023 The case  was received from the patient via interactive digital media. The patient reported that the Shingles vaccine gave him/her shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
bels palsy; patient had a reaction; Initial information received on 24-Feb-2021 regarding an unsolicited valid serious case received from a pharmacist via call-center.  This case involves female patient (age not reported) who experienced bels palsy (facial paralysis) and had a reaction (unevaluable event), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  In 2009, the patient developed a non-serious reaction (unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a serious bels palsy (facial paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Caller states they do not know which vaccine the consumer received and not sure if she got the bells palsy from the vaccine but trying to make her more comfortable. they have no patient information but she thinks it was a Sanofi vaccine.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for unevaluable event.  At the time of this report, outcome of the facial paralysis was not recovered (now has bells palsy).  Batch number has been requested for suspect product for this case.; Sender's Comments: A female patient who presented with facial paralysis and an unevaluable "reaction" following the vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
This case was reported by a physician via sales rep and described the occurrence of adverse reaction in a 15-month-old male patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to DTaP vaccine. Additional details were provided as follows: This case was reported by the patient's father, who was also a physician. The age at vaccination was not reported. The patient experienced unknown reaction after vaccination with DTaP vaccine (unknown manufacturer). Limited details were available. This case has been linked with case US2016148523, reported by the same reporter.
itchy on my arm; Hives from head to toe; Rash; Low fever; palms started getting itchy; Achy; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PRURITUS (itchy on my arm), URTICARIA (Hives from head to toe), PAIN IN EXTREMITY (Arm pain) and PRURITUS (palms started getting itchy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Achy) and PAIN IN EXTREMITY (Arm pain). On 15-Apr-2021, the patient experienced PRURITUS (palms started getting itchy). On an unknown date, the patient experienced PRURITUS (itchy on my arm), URTICARIA (Hives from head to toe), RASH (Rash) and PYREXIA (Low fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 10-Apr-2021, PAIN (Achy) and PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, PRURITUS (itchy on my arm) had resolved, URTICARIA (Hives from head to toe), PRURITUS (palms started getting itchy) and PYREXIA (Low fever) outcome was unknown and RASH (Rash) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
One week after vaccinations, patient had very severe headache, stiff neck, and low grade fever (less than 100F).
PT recvd vax on 6AUG92 & exp h/a & vertigo;
HIVES ON UPPER THIGHS THAT ARE ITCHY; HEADACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was not reported and height was 165.1 centimeters. The patient's past medical history included pulmonary embolism, and concurrent conditions included marijuana abuse, alcohol use, non smoker, and penicillin allergy.  The patient was previously treated with rivaroxaban for pulmonary embolism. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced headache. On 25-MAY-2021, the subject experienced hives on upper thighs that are itchy. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 25-MAY-2021, and had not recovered from hives on upper thighs that are itchy. This report was non-serious.
was dizzy; missed her appointment; soreness of arm; nauseous; threw up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (was dizzy), PRODUCT DOSE OMISSION ISSUE (missed her appointment), PAIN IN EXTREMITY (soreness of arm), NAUSEA (nauseous) and VOMITING (threw up) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN 70/30), CARVEDILOL, METOLAZONE, TORSEMIDE, PRAVASTATIN and POTASSIUM CHLORIDE for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (was dizzy), PRODUCT DOSE OMISSION ISSUE (missed her appointment), PAIN IN EXTREMITY (soreness of arm), NAUSEA (nauseous) and VOMITING (threw up). On 18-Mar-2021, PRODUCT DOSE OMISSION ISSUE (missed her appointment) had resolved. At the time of the report, DIZZINESS (was dizzy), PAIN IN EXTREMITY (soreness of arm), NAUSEA (nauseous) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details reported.
Patient did not need the Hep B that was included in the combo vaccine. Patient needed HiB. No adverse reactions noted.
Flu-like symptoms; Skin Sensitivity; Emesis; Nausea; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RF5J, expiry date 25th April 2022) and (batch number 57EE5, expiry date 25th April 2022) for prophylaxis.   On 31st July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th August 2020, 9 days after receiving Shingrix, the patient experienced influenza-like symptoms, sensitive skin, vomiting, nausea and headache. On an unknown date, the outcome of the influenza-like symptoms, sensitive skin, vomiting, nausea and headache were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, sensitive skin, vomiting, nausea and headache to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on left arm and experienced flu-like symptoms: headache, nausea, vomiting and skin sensitivity approximately 10 days after. The reporter did state the patient was starting to feel better but not fully recovered. The reporter consented for follow up.
Patient felt sweaty, dizzy and had some nausea. This lasted most of the afternoon.
PFIZER COVID VACCINE #3 GIVEN 8/17/21, LOT # FD8448; pt had a positive COVID test on 6/13/22; pt passed away at home; COD:  refractory combined encephalopathy, respiratory failure, COVID - 19 pneumonia; PCP not known; no other medical records
Severe abdominal pain, cough, sore throat, watery eyes, wheezing, vomiting, chills, increased heart rate.
Low grade fever, rash on abdomen at 12 hours after immunization mild cough, c/o SOB 18 hours after immunization grandmother took child to ER - dischg'd with prednisone and BENADRYL. SAO2 done 100% no other tests.
All three reactions were the same. I woke up feeling like my throat had a flap that was not allowing me to inhale. I had been snoring and work up abruptly because I couldn't breathe at that moment.  If I inhaled sharply or sniffed hard to try and clear my throat, my airway blocked. I had a fever and also swollen glands in my neck and under my jaw. Once I got out of bed, I drank a glass of cold water and walked outside in the cold. I felt like it was an allergic reaction; so I took a Benadryl and I tried to go back to bed, but when I laid down it seemed worse, so I spent the night in my recliner. The first reaction was the worst in severity and happened about two weeks after my first injection. The second reaction was less than two weeks later,  the last one happened 4 days after my second injection. All three incidents lasted about 12 hours, but I still feel like my glands are a bit swollen, and I have a hesitation when I swallow. I talked to my doctor today 3/1, he ordered a COVID test and ordered me to quarantine until I get the results.
received only the liquid portion of menveo; received only the liquid portion of menveo; This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA673, expiry date March 2023) for prophylaxis.   On 18th July 2022, the patient received the 1st dose of Menveo (intramuscular) .5 ml. On 18th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: The registered nurse reported that the medical assistant vaccinated patient with only the Menveo diluent. The reporter was unaware of the second vial that required reconstitution to provide patient with an effective vaccine dose. On 29th July 2022, the patient was re-vaccinated with properly reconstituted dose of Menveo and tolerated well.   No adverse reaction reported. Additional Supportive Information: The patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with case US2022108245 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022108245:Same reporter
PATIENT REPORTED ITCHING BEHIND KNEE ABOUT 20 MINUTES POST INJECTION, AND NOT 5 MINUTES LATER SAID HE WAS CHEWING HIS TONGUE AND HAVING DIFFICULTY SPEAKING. I GAVE 0.3MG EPIPEN AT THAT TIME 6:50PM. 1 MINUTE LATER EMS ARRIVED AND EVALUATED. THEY TOOK PATIENT TO THE HOSPITAL AT 7.02 PM.
Day of administration around 2100 I started feeling a little off, got a little bit of a headache and felt warm. While sleeping I could feel that I had chills and felt very warm. Woke up at about 0200 to take my temperature. Felt dizzy when I got up, still had a headache and a fever of 101.0 (taken orally). Contacted a nurse triage line to ensure I can take t=Tylenol to bring the fever down and get rid of the headache. She said yes, which is when I took 500mg Extra Strength Tylenol rapid release. Continued to feel not so well, and broke my fever around 0630 timeframe. Once I woke up around 0900 (day after administration) still felt a little warm  (99.5)  and a mild headache. Will keep an eye on any other adverse reactions.
ACHES AND PAINS; CHILLS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced aches and pains. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 100.3-100.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches and pains and low grade fever was not reported. This report was non-serious.
This spontaneous report was received from a State Immunization Official and refers to multiple patients (exact number unspecified) of unknown age and gender. The patients' concurrent conditions, drug reactions or allergies, concomitant therapies and medical histories were not provided. On multiple unspecified dates, the patients might have been vaccinated with improperly stored doses of VARIVAX injection, lot# M014908 and expiration date 25-MAR-2018, lot# M028553 and expiration date 07-JUN-2018, lot # M033907 and expiration date 20-JUL-2018 (doses and routes of administration were not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 11.0 degrees Fahrenheit (F) for 12 hours 2 minutes, 9.7 F for 6 hours 38 minutes, 8.1 F for 6 hours 5 minutes, 7.2 F for 6 hours 57 minutes and 7.7 F for 2 hours 51 minutes. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA009918: US-009507513-1612USA014168: US-009507513-1612USA014169:
Around 12:00 a.m. on Monday, March 15, 2021 (which was 12 hours after receiving the vaccination) I started to experience cold chills so severe I thought I was having a seizure.  My husband stacked 10+ blankets on top of me trying to get me to warm up.  I was running a fever of 103, and my heart rate was at 104 all night long.  My fever didn't break until shortly before 8:00 a.m. on Monday, March 15, 2021 but my heart rate stayed between 95 - 102 most of the day.  The body aches weren't too terrible, but I did have those.  I have bruising, puffiness, and swelling at the injection site.
it was rpt fro RN concerning pt who was vax & exp a local react, erythema & swelling @ inject site
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-395985 (Patient Link).
Information has been received from a registered nurse concerning an approximately 23 year old female who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she had another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm she the needle withdrawn".  The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning an approximately 23 year old female (patient 1 of 4) with no known drug allergies, who on 27-OCT-2006 was vaccinated IM into the deltoid area with a dose of GARDASIL (lot# 653938/0954F). The registered nurse reported that she and another nurse had given "numerous" GARDASIL vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The bleeding only lasted a few seconds. The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Pressure was applied and a bandaid. Bleeding resolved and the patient was sent home. Additional information is not expected.
6/24/10 had a partial seizure.  Went to ER and was sent home that day. 6/28/10 Fever and rash. 6/30/10 Fussy and rash. 7/4/10 Running fever, 45 minute long seizure that ended in respiratory failure.  He was intubated, which caused him to aspirate and that led to pneumonia.  He was in PICU/PEDS for 14 days and had 7 more seizures.  When he was extubated we noticed that he had lost all of his motor skills and speech.  Now that he is out of the hospital he has PT/OT and speech several times a week.  Patient is also having follow up care with his pediatrician and the neurologist that saw him in the hospital.  He is also scheduled to see a physical rehab doctor.
Vaccine was given more than 12 hours (after 15 hours) past puncture.