chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 48-year-old female patient received an initial dose of Menactra, lot number U2154CA, administered in the left deltoid on 18/Sep/2006. The route of administration was not reported. Within eight hours, the patient developed a low grade fever of 99.2  degrees Fahrenheit, chills,  body aches and pain at the injection site. The patient also complained of fatigue. The following day, the patient developed increased fatigue and dark urine, which tested 3+ for blood. The patient also had left lower back pain, lower quadrant pain, a swollen lymph node in her right axilla which measured approximately 2 X 2 in size, and tenderness in both axillae. The patient self-medicated with Motrin. According to the reporter, a nurse practitioner will complete a urinalysis and will refer the patient to her primary care physician to rule out kidney stones. The patient's recovery status was not reported.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no drug reactions or allergies. The patient's other pertinent medical history and concomitant medications were not reported. On 08-APR-2016, the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX lot # L039096, expiration date 08-JAN-2017 for prevention of shingles. On the same day, within the first hour of getting the vaccine the patient experienced swelling at the injection site which progressed to "swelling in the armpit and shooting pain down the arm and into the site of her chest." The patient reported to the pharmacist that she was having "bad pain over the weekend". The reporter stated that the patient self-applied an ice pack to the arm. The patient did not have any laboratory diagnostic test performed. The patient sought medical attention by calling the pharmacist. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
patient  came on today 9/27/2022 6 days after vaccination stating that she has had swollen feet, the symptoms started 2 days after the vaccine, patient stated it started with pain on the bottom of the feet and then swelling began. Currently left foot is swollen/retaining fluids and right foot is only moderately swollen.  Patient was advised to elevate feet.  She states the symptoms have decreased over the last few days.
Initial health care professional report received on 08 Dec 2009: This 2 year old child inadvertently received 0.5 mL IM dose of FLUVIRIN (batch no: 102133P1) on 08 Dec 2009. No adverse event was reported. No more information was available.
My father began experiencing loss of motor function. Distal to proximal pattern.  Was taken to the ER. Was transferred to ICU and became vent depend.
The site of the shot seem little bit swollen and stiff; The site of the shot seem little bit swollen and stiff; I had difficulty sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset Sep2022, outcome "unknown", described as "I had difficulty sleeping"; VACCINATION SITE SWELLING (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset Sep2022, outcome "unknown" and all described as "The site of the shot seem little bit swollen and stiff".  Additional information: The patient stated that they had flu shot given at the same point; side effects could have been from anything. The patient reported that they got the new vaccine yesterday which was Bivalent booster shot (Suspect captured as per verbatim), she mention that they experienced some side effect and they want to know if they can take Advil or aspirin. When they got the first shot including the boosters, they were told not to take Advil or aspirin. The patient forgot for how many days afterwards. So they don't want to do anything to screw up the efficacy of the vaccine. The patient stated that there was nothing that would need to use the, take the Advil for. The site of the shot seem little bit swollen and stiff and patient had difficulty sleeping but none of that was critical, to and for patient those are reasonable side effect. The patient also have to add come to think of it. Patient had flu shot (Further clarification unknown, hence captured as Unspecified flu shot) given at the same point. So the side effects could have been from anything. It could be from either of those things. The patient stated that the question was very simple, just want to know whether can take Advil and if can't how were it and were Aspirin if can't how long that goes on to work it's simple. Patient got all the information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Emergency Department Course and Clinical Decision Making 53-year-old male presenting to the emergency room for cough for 1 week.  He has had some intermittent shortness of breath is associated with active coughing.  Denies any chest pain.  Patient's wife is known Covid positive.  He is fully vaccinated for Covid with Pfizer. Discussed with patient that he would be a candidate for potential antibody infusion.  He already has had a rapid test performed in triage.  In triage, noted to have an oxygen saturation around 90%. Given the patient's vague shortness of breath with coughing and duration of symptoms, will obtain blood work related to inflammatory process, CMP, and chest x-ray with EKG while waiting Covid swab results here in the ER and also reevaluated patient's oxygen saturation.  Patient emergency room at rest with oxygen saturation 88 to 90%.  Walking oxygen saturation as low as 83%. Patient was trialed on albuterol with some improvement subjectively and some improvement in the scant wheezing. He is placed on 2 L nasal cannula with immediate improvement in saturations. Covid test positive.  Review of labs reassuring  including D-dimer.  Slightly elevated inflammatory markers, consistent with Covid. Chest x-ray with very faint infiltrates noted bilaterally. EKG with a right bundle branch block.  No comparison available.  As the patient is not having any chest pain and has a D-dimer that is not elevated, I do not think that performing a CAT scan the chest is warranted today in the ER for evaluation of a pulmonary embolus. Patient given Decadron in the ER remdesivir for Covid pneumonia with hypoxia. Given hypoxia, requested admission to our hospital.   (patient is still hospitalized as of the date of submission of this report; has not recovered yet)
ok I can?t say 100% what happen to me was the 3rd vaccine dose but it seems possible I got a TIA a Stroke where I could not talk and lasted for serveral hours
Received injection on 02/11/2021. "normal" side effects fever, chills, sore arm.  02/12/2021- body aches, short of breath, chest pain, fever, sleeping all day/night.  02/13/2021- Same as the day before, but breathing became an issues.  02/14/2021- first ER visit, labs and CT performed. High WBC and blood clot testing. DX bronchitis the following week all the same concerns and getting worse with breathing. Feeling drunk all the time and no energy. Felt like pressure on chest and ended up at 2nd ER visit on 02/14/2021. More labs, CTs, Xrays, dx Pleurisy. Continue to see family PCP and no confirmed dx. Ultrasounds of lungs, arm, neck in May. Symptoms returned in Sept 2021
Patient had the 1st Hepititus B shot on 11/27/2002.  On Sat. 11/30/02, patient was taking a nap and when he woke up at 2:45 p.m., he was having a very difficult time taking a breath.  Patient then was not breathing at all and we could not get him to respond to us.  We called 911 and went to the Emergency Room with him.  By the time we had arrived at the hospital, patient was breathing on his own but, he was wheezing and very short breathed.
This spontaneous report was received form a medical assistant and refers to multiple patients of an unknown gender and age. No information regarding the patients' concurrent conditions and medical history was provided. On an unknown dates (reported as multiple unspecified dates), multiple patients were vaccinated with improperly stored GARDASIL lot # K011325, expiration date: 08-APR-2017 (dose and route of administration were not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. This is one of the reports received from the same reporter. Additional information has been requested.
Dizzy; Very weak; Had fatigue as if she had cheap drunk feel; Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the left arm), DIZZINESS (Dizzy), ASTHENIA (Very weak) and FATIGUE (Had fatigue as if she had cheap drunk feel) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the left arm). On 03-Mar-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Very weak) and FATIGUE (Had fatigue as if she had cheap drunk feel). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Mar-2021, PAIN IN EXTREMITY (Soreness in the left arm) had resolved. On 09-Mar-2021, DIZZINESS (Dizzy), ASTHENIA (Very weak) and FATIGUE (Had fatigue as if she had cheap drunk feel) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.  No relevant concomitant medications were reported.  Reportedly, soon after second shot the patient had soreness in the arm which increased by 03-Mar-2021 and it lasted for six days.
CHRONIC KIDNEY STONES; FEVER; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and smoker, and the patient does not have any no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient did not have any no known previous medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZ1A expiry: not reported) dose was not reported,1 total, administered on 04-JUN-2021 15:00 to left arm as prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021,at 9 PM after 6 hours of vaccination ,patient was feeling sick, he got fever and steadily got worse over 3 days. Patient went back to the normal before fever broke .On 5-JUN-2021  afternoon, he experienced the abdominal pain and pain steadily got worse. Patient experienced the pain in lower abdomen ,groin and shooting down his legs. Pain got worse and spread a little further. On 11-JUN-2021,following week patient went to the doctor. Patient reported that he was going to the doctor 6 to 8 times. Patient went to the hospital to get the ultrasound (NR: not provided) on lower abdomen, groin and chest. Ultrasound test results were normal. Patient had done a CAT scan (computerised tomogram) (NR: not provided) and found the Chronic kidney stone. Patient had the chronic kidney stones and was hospitalized. Patient reported that he was not having kidney stones before the vaccination. Patient did not remember when he went to the hospital. Patient told that he was prescribed with steroid. Patient reported that he had done with first round and at the time of reporting he was on the fourth day of second round. Patient told that, steroid not helped to his symptoms. Patient was also prescribed with muscle relaxer and Percocet as per need. Patient took only 3 pills of Percocet since 3 weeks ago because patient not like to take medicine. On 09-JUL-2021 the patient received the call from hospital to request a MRI on him. Patient reported that he was healthy like a horse before and now he felt like he was ready to die. Patient stated that pain had not recovered . Number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from chronic kidney stones. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210722902-COVID-19 VACCINE AD26.COV2.S-Chronic kidney stones. This event(s) is considered unassessable. 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).
Patient Received Pfizer for her second dose. However, her first dose of the COVID vaccine was given at a different clinic and she was given Moderna.  The patient believed she had had Pfizer for both vaccines and was unaware that she received Moderna for her first vaccine, however this was verified  (statewide reporting system) after her dose was given. Patient was made aware. Also noted that patient received her dose more than 60 days from her first dose (outside of timeframe of 42 days).
nausea & feels "faint"   Cool &  calmmy.   TX - mask removed.   laid pupine across truck seat - increased legs.     O Sat increased B/P 134/92.  given H2O  symptoms abated.   after additional 15 mins wait time.  felt "good" & drove off lot.
Woke up second day post injection to swollen lymph node in right armpit, additionally approximately 8 hives on the torso and legs were found and itchy. I have taken benadryl and am not concerned.
Rash; Itching; Hives (On legs, arms, chest and side); This is a spontaneous report from a non-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: FA7485) via an unspecified route of administration in the left arm on 17Aug2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced rash, itching, and hives on legs, arms, chest, and side. The clinical outcome of the events rash, itching, and hives on legs, arms, chest, and side was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information was received from a medical assistant concerning a 30-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date:19-OCT-2017 (also reported as 14-APR-2016), dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5  total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
She feels slightly feverish; not feeling well; tired; This is a spontaneous report from a contactable consumer reporting for herself  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date patient reported she feels slightly feverish and not feeling well. She was not sure if she has COVID,  recorded  a temperature of  97F. Patient also mentioned that if she was over tired she always feels feverish. It was also mentioned that she was scheduled to have her 2nd dose of vaccination on 25Feb2021. At the time of the reporting event outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
I noticed at my annual eye exam, and it was noted I had like 100 or more hemorrhages in my left eye. I was referred to the retinal specialist and I have been getting monthly eye injection to absorb the blood that is pooling in my eye which has allowed me to see better. They regularly complete eye pressure test to see how much blood is pooling. I have done the injections 4 times. It's not working as well as he wants me to get my vision. The specialist is I went from 20/40 to 20/75 to 2400. It has improved this month, but I am not able to determine how much.
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 15-year-old patient of unknown gender. On 18-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) and VARIVAX lot # N027002, expiration date 28-SEP-2019. This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Within 10 minutes of receiving the injection, the patient felt like her chest was expanding and was going to explode. Waited 20 more minutes and finally had some relief from the chest pressure, but then was completely exhausted for 10 days, finally went to urgent care. Urgent care diagnosed her with an allergic reaction to the vaccine. Was told that 10% of the population with allergy-induced asthma have a reaction to the vaccine. Was prescribed a Medrol dose pack and was told to follow up with her primary care physician in 4 days. Due to the Scripps outage, the patient followed up in our office and was told that she would recover within a month's time.
Swelling and tenderness on the day after the vaccine. Swelling was approx 5? in diameter.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), URINE ODOR ABNORMAL (Urine had acidic strong smell patient stated that it was unusual regarding the smell of the urine), CHROMATURIA (Dark yellow color of urine) and FATIGUE (Tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 008C21A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder NOS. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), URINE ODOR ABNORMAL (Urine had acidic strong smell patient stated that it was unusual regarding the smell of the urine) and FATIGUE (Tired). 19-May-2021, the patient experienced CHROMATURIA (Dark yellow color of urine). At the time of the report, PAIN IN EXTREMITY (Arm hurts), URINE ODOR ABNORMAL (Urine had acidic strong smell patient stated that it was unusual regarding the smell of the urine), CHROMATURIA (Dark yellow color of urine) and FATIGUE (Tired) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Customer reported an AE through an email; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient received dose of Shingrix vaccine and experienced adverse event. No other information was available.
Site: Swelling at Injection Site-Severe, Systemic: lymph node/armpit area is tender and swollen-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Vomiting-Mild, Additional Details: extreme fatigue and extreme lymph node swelling and tenderness on same side of injection site