chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was seen in office on 10/5 after husband called stating that pt was a bit off mentally that morning and just not making much sense. She wasn't sure whether she had taken her medications or not and was unsteady on her feet. She had been up until about 3 am watching movies which is not atypical for her and did not use her CPAP so he thought it might be related to that. He had her use her CPAP for an hour or so but it did not improve things. In office pt was somewhat disoriented and confabulating. She was pale appearing and noted to be tachycardic and significantly hypotensive with bp in the 80's/40-50's. Initial 02 sat 88% but improved to 97%. Pt was taken to medical center for urgent eval in the ER. CT chest suggested interstitial infiltrates but negative CT of the abdomen and pelvis, markedly elevated WBC at 27.5, mild AKI with creatinine of 1.36, elevated liver enzymes as well as persistent hypotension and tachycardia with 02 sats in the 93-95% range. Final blood cultures showed no growth. Pt was treated for sepsis syndrome and atypical pneumonia with Ceftriaxone and Azithromycin and clinically responded very well.
chills; moderate fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; PYREXIA (non-serious), outcome "unknown", described as "moderate fever".  Additional Information: Events took place after the product use.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 12/25/2021 I started developing Covid symptoms & on 12/26/2021 I tested positive for covid.  Just had a video chat with doctor and he recommended a covid test.
Patient came into pharmacy one week after receiving high dose flu shot. Visible large bruise on left arm. Patient complained of swelling at injection site, soreness of left arm and shoulder, and inability to move her left arm. States symptoms have persisted for one week. Called patient's primary care physician to have them follow up with her for treatment if necessary.
Information has been received from a physician concerning a 16 year old female with no medical history or allergies, who on 11-JUN-2007 was vaccinated with a 0.5mL first dose of Gardasil. There was no concomitant medication. After receiving the vaccination the patient passed out for about five minutes and when she "came to", she began to vomit. The patient did go to the emergency room. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Tuesday: developed hive-like blanchable rash that was edematous which began on the back of my head and spread to my upper eye lids.  Wednesday: same rash spread to inner thighs, groin, armpits. Thursday: rash became less edematous but much more wide spread. Still blanchable but appears to develop in areas where the skin endures trauma (scratching, rubbing against something rough, warm/hot water). Friday: rash remains the same as Thursday  Tuesday and Wednesday I used Benadryl 50mg three times a day and switched to Zyrtec 10mg twice a day beginning Thursday and continue to use Zyrtec
numerous fluid filled vesicles c/w chicken pox developed, along with fever (low grade) and irritability
about 1 hr p/vax pt screaming episode w/elevated temp; rt leg started swelling turning black, high pitched cry rt leg doubled in size;
Acute motor and sensory axonal neuropathy, which progressed over 10 weeks and led to tetraplegia and respiratory weakness/failure
STARTED MINOCYCLINE THEN STARTED VIVOTIF; This spontaneous case report (PVX2019-2841) was received from a nurse on 18-Nov-2019. It described a 21-year-old adult female consumer who "started minocycline then started Vivotif" (PT: Labelled drug-drug interaction medication error). She was receiving Vivotif for an unknown indication and Minocycline for acne.  Case report: The consumer received Vivotif in July 2019 but did not start her vaccine yet. It was reported that she started taking minocycline for acne on an unknown date and then she started taking Vivotif on 17-Nov-2019.  Action taken with Vivotif and Minocycline with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient who was on minocycline for acne took a dose of Vivotif (Labelled drug-drug interaction medication error). Antibiotics (Minocycline) has a potential to inhibit the growth of the vaccine strain and may result in attenuation of the immune response. The event is labelled as per Agency. Considering the case information and the nature of the event, the causality of the event Labelled drug-drug interaction medication error is assessed as not related to minocycline. ; Sender's Comments: A patient who was on minocycline for acne took a dose of Vivotif (Labelled drug-drug interaction medication error). Antibiotics (Minocycline) has a potential to inhibit the growth of the vaccine strain and may result in attenuation of the immune response. The event is labelled as per Agency. Considering the case information and the nature of the event, the causality of the event  Labelled drug-drug interaction medication error is assessed as not related to minocycline.
Found fallen in exam room, decreased consciousness, jerky movements of right forearm and had urinary incontinence, vital signs stable, water found, came quickly to alertness; Sent to ER.
expired DAPTACEL was given with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old male patient to whom expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]was given with no reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 25-Jan-2022, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (strength, lot number was unknown and expiry date: 23-May-2021) via intramuscular route in the right thigh for Prophylactic vaccination.   On 25-JAN-2022 the patient developed a non-serious event " expired daptacel was given with no reported adverse event"(expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported"18 month old patient who received an expired DAPTACEL. NP (Nurse practioner) is requesting to know what the recommendation is regarding repeating the vaccine or what other options they have. EXP: 05/23/2021."  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired DAPTACEL was given with no reported adverse event).  At time of reporting, the outcome was Unknown for the event expired daptacel was given with no reported adverse event.; Sender's Comments:  00950423:
Hospital admission for abdominal aortic Aneurysm. Patient transferred to hospice. Hospital admission within 6 weeks of receiving the COVIDD vaccine.
a patient receives 0.3mL on their first administration of the moderna vaccine for covid; A spontaneous report was received from a healthcare professional concerning a patient, of unknown gender and age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and administered 0.3mL of the mRNA-1273 vaccine, an underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection. The patient was administered 0.3mL of the mRNA-1273 vaccine, an underdose.   No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, vaccine underdose, was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection and administered 0.3mL of the mRNA-1273 vaccine, an underdose. There were no reported adverse events in this case of underdose.
Patient developed red rash around injection site. She claims the area is tender, burning and inflamed.
10-15min p/immun started having dyspnea, wheezing, & itchy, fine rash all over body;
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (injected left arm is sore) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016B21A) for COVID-19 immunization. No medical history reported. On Mar 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 29, 2021, patient had vaccination site pain (injected left arm is sore). At the time of the report, vaccination site pain (injected left arm is sore) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. This case linked to MOD-2021-097930 (patient link).
Screaming. Hid in corner. Couldnt breathe later that evening. Rushed to ER.
Seen at hospital 12/03/08 for swelling of right upper arm, treated with Bactrim, seen again 12/4/08 for flu area slightly bigger, sent to hospital
Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient presents for regular dialysis session with diarrhea and cough. Dialysis session not completed, patient transferred to emergency room, found to be hypoxic with rhinovirus, pulmonary edema, and fluid overload. Patient received oxygen, underwent emergent dialysis with symptom improvement, and was discharged to home medically stable.
Patient c/o generalize weakness.  Pt verbalized that she had the same reaction with first dose.  Pt. seen and assessed by EMT and assessments are as follows: BP 113/79, HR 79, O2 100%, BS 109.  17 minutes into observation client voiced that she had felt better and was cleared to go home by EMT..  Client advised to seek medical attentions if symptoms worsen.
patient called and said she started having sore and swollen arm after receiving shingirx on 04/14/23. Informed patient these are listed as side effects and suggested to the patient to take some antihistamine (benadryl, zyrtec, claritin) to help with the inflammation. (Patient received Boostrix on the same day in the same arm as well)
Pt recvd 3 doses of Engerix-B & did not seroconvert; booster dose was administered;
Red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red) and PRURITUS (itchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ERYTHEMA (Red) and PRURITUS (itchy). At the time of the report, ERYTHEMA (Red) and PRURITUS (itchy) outcome was unknown. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reported. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Patient reported soreness, warmth, and minor inflammation first day, and subsided. But two days later, the symptoms returned in the right arm. Instructed patient to continue to massage and move the arm, take some tylenol, and continue to ice as needed.  Patient is uncertain which vaccine was given in that arm (heplisav-b or prevnar 20).  Patient reported the incident.
Noticed a lump on right breast 48 hours after the vaccine that wasn't there before. Got mammogram and biopsy immediately.
I'm a 55 yo who had their flu vaccine at health dept on 10.20.15 secondary to volunteer position as a Physician Asst there. About 48 hrs. later vertigo episodes began and mostly occurred with positional change (eg. from sitting to standing) but sometimes spontaneously. I was afraid to walk because of my imbalance and certainly wouldn't have driven a vehicle. I had moderate nausea as well except it was severe during episodes. My symptoms lasted for 4 days. I had no fever, vomiting or diarrhea. I have no known drug allergies. I am not allergic to eggs. My current meds include 100mg lamotrigine QD (have been on this x 3 yrs), fish oil capsules, and Vit D.
After the child received her vaccines the child became "scared" due to the pain and began breathing really fast and then her eyes rolled back and her arms clenched and shook and she made a vocalizing moaning sound.  She did lose urine but not consciousness or stool.  It lasted about 30 seconds.  She became sleepy afterwards.
Vaccines administered approximately 1:15-1:30 with no immediate adverse reactions noted in clinic. Child returned to clinic 1 hour later with red rash to face, scalp, ears, neck, torso and back. Client scratching at rash. No breathing problems noted. Went to doctor and benadyl given at 3:00. Rash cleared up by 6:00.
Muscle fatigue; 4 days later in the evening felt nauseous; Woken up daily since feeling like ants crawling under skin; Exhaustion (couldn't stay awake) after four hours; Heavy arm within one hour; Chills within 5 minutes; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 29Apr2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 12:45, within 5 minutes of vaccination, the patient experienced chills. On 29Apr2021 at 13:45, within one hour of vaccination, the patient experienced heavy arm. On 29Apr2021 at 16:45, four hours after vaccination, the patient experienced exhaustion (couldn't stay awake). Since 30Apr2021 at 04:00, the patient woke up daily at 04:00 feeling like ants crawling under skin which went away within 2 minutes. On 02May2021, 4 days after vaccination, in the evening, the patient felt nauseous and on 03May2021, on day 5 after vaccination, the patient experienced muscle fatigue. The clinical outcome of the events exhaustion, woken up daily since feeling like ants crawling under skin, heavy arm, chills, felt nauseous and muscle fatigue was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and 3 days after received vaccine experienced shingles. Follow-up would not possible as no contact details were available.
I felt fine until I went to bed around 11:10 pm. First I had a mild headache, followed by upset stomach. Then muscle aches, fatigue and shivering so much that my body shook and my teeth chattered. I finally fell asleep at maybe 1am, after completely covering myself with pajamas and thick socks. Then awoke at 2:20 am. The cold and shivering had subsided, but other symptoms remained. I woke up off and on all night. I was achy and unable to get comfortable. By the way, I have never had more than a sore arm and fatigue after a vaccination, so this was very unusual for me.
Pt verbalized she has become lightheaded with previous vaccinations. Pt received three separate injections at time of visit. After final vaccine, pt fainted but roused approximately 5 seconds later. Pt was seated in chair and did not fall. No injuries noted. Pt advised to lay down on treatment table and elevate feet. After several minutes, pt stated she felt better. Pt assisted to seated position. Pt escorted to waiting room after no report of dizziness and advised to remain for additional 15-20 minutes.
FEELING BAD; BODY WAS HURTING; LOSS OF ENERGY; HEADACHE; GETTING A COLD; DRY MOUTH; DIARRHEA; This spontaneous report received from a patient concerned a 51 year old female. 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: 1805018 and  expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dry mouth. On 2021, the subject experienced diarrhea. On 2021, the subject experienced body was hurting. On 2021, the subject experienced loss of energy. On 2021, the subject experienced headache. On 2021, the subject experienced getting a cold. On 10-APR-2021, the subject experienced feeling bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry mouth, and feeling bad, and the outcome of diarrhea, body was hurting, headache, loss of energy and getting a cold was not reported. This report was non-serious.
AT THE END OF THE 15 WAIT TIME, THE PT COMPLAINED HE DID NOT FEEL WELL AND WAS DIAPHORETIC.  HE STOOD UP TO MOVE TO A WHEEL CHAIR AND COLLASPED TO THE FLOOR.  HE WAS UNCONSCIOUS FOR 5-6 SECONDS. HE WAS EASED TO THE FLOOR AND CODE BLUE WAS CALLED. WHEN HE REGAINED CONSCIOUSNESS, HE STATED HE WAS TRYING TO FIGHT PASSING OUT.
Pregnant and vaccinated; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and vaccinated) in a 30-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRAK) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 28-Oct-2020 and the estimated date of delivery was 28-Jul-2021. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and vaccinated). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant and vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
angioedema p/first anthrax inj, w/in hr of second inj and three angioedema episodes since then;none prev, no hives, no meds;
10days after receiving vaccine developed an anaphylactic allergy after eating shellfish which I was never allergic to. I developed a red itchy rash over the entire body with throat tightening. Went to ER where I was treated with H1 H2 blockers steroids. After being treated and observed for a few hours I re developed the rash and symptoms again requiring further treatment and observation.
Information has been received from a registered nurse concerning an adult patient who on approximately 18-OCT-2010 ("this week") was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z). On approximately 18-OCT-2010 the patient developed adverse reactions. Injection site reactions included swelling, erythema, and pain. The nurse requested a lot check. At the time of the report the outcome of the patient was unknown. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Mild erythema, induration 2-3 cm x 5-6 cm oval shaped right deltoid
allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Bexsero.  Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not reported. The reporter reported that, the patient had allergic reactions to dose of Bexsero. The reporter was scared.
Patient arrived and reported no previous vaccination.  Requested J&J which was administered. Upon entry in System it was noted that patient received one dose of Moderna on 02/16/2021.