chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient experienced numbness in arm a few minutes following COVID vaccine. He was instructed by the pharmacist to sit for 30 minutes for monitoring instead of the usual 15 minutes. After about 30 minutes, he said he was experiencing difficulty breathing (he was alert and orientated and was able to talk but he said he was laboring to breathe). EMS was called. No treatment was given on site by EMS and the patient elected to be brought to the hosptial.
The pt developed a high fever ranging between 101-103 deg. F. eight hours post vaccination. Went to the hospital and received Tylenol and got CBC was normal and blood culture was negative to date.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. This report was about COVID-19 treatment. Patient received the vaccine. Other medications in 2 weeks were reported as No. Patient received anti-viral treatment from 30Sep2022 to 05Oct2022 for COVID-19 treatment. Known allergies included allergic to Bactrim. Other medical history was reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient returned to the pharmacy on 10/07/18 to report adverse reaction after receiving FLUAD on 09/28/18. He states 12 hours after vaccination, he felt "painful on both sides of body" and when he tried to stand up from bed "both legs gave out". These symptoms lasted for estimated 7 days and today (10/07/18) has been the first time he has felt better and able to go out. Patient states he was at his doctor's office recently and was advised to let the pharmacy know what happened so we could report it. When asked if he had any current disease states or health problems he replied "No, nothing".  However, patient briefly mentioned he was scheduled for a radio nuclear assay and when asked for what reason he stated "I don't know, I guess I will ask my doctor". Patient appeared not to be in distress, was walking and speaking normally.
Injection site initially was slightly painful and became more painful the day following the injection.  Side effects included:  muscle soreness, chills, headache, fatigue, upset stomach (slight).
This spontaneous report as received from a registered nurse refers to a 58 year old female patient. The patient's concurrent conditions included rheumatoid arthritis. The patient was vaccinated with PREVENAR 13 on an unknown date in July 2016. The patient had no drug reactions and no allergies. On 06-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 subcutaneously (dose, lot# and expiration date were not reported). The patient's concomitant therapies included methotrexate and sulfasalazine. On 06-SEP-2016 (reported also as following PNEUMOVAX 23 administration), the patient developed redness, warmth at the injection site and her arm was very painful. The patient received an unspecified treatment for the events. None lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information is not expected as there was no consent for further contact.
Child stated she felt itchy inside her body the night of 8/23/02. Rash noted to body night of 8/24/02 with worsening and appearing like hives on 8/25/02 with spreading to neck area. taken to ER on 8/25/02 and treated with prescription for Prelone. Given Prelone and Benadryl in ER.
Narrative:  Patient admitted for pneumonia due to coronavirus disease 2019; other specified sepsis; acute respiratory failure with hypoxia. Patient passed away in 08/15/2021
Pt received Varivax vax in 1997, pt now has symptoms of varicella on 3/00.
I administered the Moderna vaccine and had the patient sit down for 15 minutes for observation.  5 minutes later the patient complained of flushing in the chest and face.  His face was slightly red on one side.  The patient stated he was breathing normally, but wasn't sure if it was an allergic reaction.  As a precaution I offered 50 mg of diphenhydramine to the patient, and he accepted and took it by mouth.  I offered to call paramedics, patient refused.  I observed the patient for 20 min more, and at the end of the 20 min the patient felt better and went home.
very mild tenderness at injection site; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced no side effects to report so far besides very mild tenderness at injection site on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approximately 22-hours after receiving this influenza vaccine, an area of patchy redness was noted over the left deltoid. By 35-hours after administration, this area of redness  and warmth over the left deltoid (immunization site) was approximately 3.5''x2.5''.  Prescription strength 2.5mg hydrocortisone cream was applied to the site  at 35-hours after administration of the vaccine, and 5mL dose of children's cetirizine (Zyrtec) antihistamine was given when initial redness noted at 22-hours after administration  of the vaccine and again at 46 -hours after administration of the vaccine.  Redness, warmth, and mild swelling peaked by 48-hours s/p vaccine administration and daily dose of oral cetirizine and topical hydrocortisone was continued until 72-hours after vaccine adminstration. The redness and warmth continues to lighten in color at this time.
Constant muscle spasms throughout my body, especially at night. What started as painless muscle spasms that mostly effected my sleeping is beginning to turn into painful muscle cramping.   I?ve also had lingering chest pain that comes and goes and radiates into my arm and back. Enough to take me to the emergency room.  I am otherwise a completely healthy person and have not had issues like this until after the vaccine.
On 6/25/01, within 12 hours, post vax, the pt developed a fever of 102F and incessant and inconsolable crying for  30-45 minutes.
This spontaneous report as received from an other health professional refers to a 65 years old female patient. The patient's medical history included drug allergy to sulfa, drug allergy to iodine, drug allergy to codeine, ULTRAM and drug allergy to hydrocodone. The patient had no pertinent medical history. The patient was vaccinated intramuscularly with dose 1, 0.5 ml, PNEUMOVAX23 (no lot number was provided) on 30-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The health professional reports that the patient who received a dose of PNEUMOVAX23 on 30-OCT-2012, developed myalgia, redness and swelling of the arm within 20 minutes following vaccination. The health professional reports that the patient returned to the practice on 02-NOV-2012, and that the arm appeared bruised, red and swollen down the upper arm. And past the elbow onto a portion of the forearm. No warmth or fever noted. The outcome of the adverse events, was reported as not recovered/not resolved. Additional information has been requested.
pt recv vax 25FEB97 pt recv vax & 12MAY97 pt devel chickenpox consisting of 60 lesions;It was reported pt devel new lesions over the course of 12 days;
Initial case was received from a non-healthcare professional on 09 April 2014. A patient of unknown demographics whose medical history and concomitant medications were not reported had received a YELLOW FEVER VACCINE (dose, route, batch number and anatomical site of administration not reported) on an unknown date. On an unknown date, the patient developed intense pain at the injection a few days later that lead to inflammation. The patient described the reaction as waves of heat and numbing and the event went on for 4 months in some manner. No laboratory details or corrective treatment was reported. The outcome of the event was unknown. The list of documents held by sender: none.
A physician reported the occurrence of limb swelling in an 18-month-old male who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The subject's medical history, concurrent medical conditions, and concurrent medications were not specified.  On 09/25/2002, the subject received injection of inactivated poliomyelitis virus vaccine (IPOL).  Later that day, and unspecified time post-immunization, the subject developed swelling from his groin to his knees.  The physician thought the subject had "bug bites".  Two days later, the physician determined the "bug bites" to be hives.  As of 10/01/2001, the hives persisted and the limb swelling had improved.  The reporting physician considered the limb swelling to be probably related to Infanrix administration and the hives to be unrelated to Infanrix administration.
Received MENACTRA 10/22/2008 @ about 1pm.  Upon awakening 10/23/08 @ 7:30am- felt body aches also headache and felt faint and sat down.  states he "couldn't see anything"  X 10 seconds, mid abdominal nausea X 10min.  Also some pain in mid abdominal fro 30-45 minutes.  Then laid down to sleep X 4hours.
DIED IN SLEEP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age.  The patient's weight, height, and medical history were not reported. Patient had children. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient died in her sleep from an unknown cause of death. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210429895.; Sender's Comments: V0: 20210428967-COVID-19 VACCINE AD26.COV2.S- Died in sleep. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This case was reported by a nurse and described an adult subject of unspecified gender who had a decreased response to vaccination with hepatitis B vaccine, manufacture unspecified for prophylaxis. On an unspecified date several years before Sept 2 2005, the subject received a dose of hepatitis B vaccine, dose number not provided. Several years later, on or before 9/2/2005, a hepatitis B surface antibody titer was less than 4 mIU/ml.
sore right arm injection site; slight fever of 99 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right arm injection site) and PYREXIA (slight fever of 99 degrees Farenheight) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore right arm injection site) and PYREXIA (slight fever of 99 degrees Farenheight). At the time of the report, VACCINATION SITE PAIN (sore right arm injection site) and PYREXIA (slight fever of 99 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 99 degrees fahrenheit (abnormal) 99 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported
fever of 102, headache, body aches sore arm took advil and tylenol much better the day after although still feel tired
c/o dizzy, SOB, chest pain, difficulty swallowing, eyes swelled.  Took Benadryl 25 mg per advice of OB/GYN Provider; Symptoms subsided 1/2 hour after BENADRYL, po.
Pre-administration in system was not performed which would mark expired vaccination. Education to staff member provided. Expired MMR vaccine administered at 450pm 3/10/23. No adverse reaction noted 3/13/23.
Arm tenderness last for a couple of days - not sever.   Pain in neck shoulders and whole spine lasted for about 24 hours started 2 days after vaccine. Also could not seem to stay awake this day - slept on and off for about 14 hours.  That evening started having blood in urine lasting into the next day - wasn't sure if covid vaccine related so went to Dr.  That issue was most likely kidney stone according to lab work.  Also had severe abdominal cramping the third evening after vaccine - took ibuprofen and rested and the next morning it was better.  Cramps came up periodically but not as severe as the day before. It has been a week now and all side effects seem to be gone.
The patient was brought to the ED by EMS on 2/9/23 for evaluation of shortness of breath and difficulty breathing that has been going on for the past few days. EMS reports she had 88% SpO2 on room air with wheezes, so they administered a nebulizer treatment and placed the patient on 4L supplemental O2 with improvement. A COVID PCR test performed in the ED resulted positive. She was admitted 2/9/23 - 2/21/23 for acute hypoxic respiratory failure, COVID-19 pneumonia, and decompensated newly diagnosed congestive heart failure. She was started on diuretics and steroids during admission. The patient has received the primary COVID vaccine series and one booster.
PT. HAD NO MAJOR ADVERSE EVENTS PER FATHER. PT. RECIEVED A VACCINE THAT WAS ADMINISTERED PAST RECOMMENDED EXPIRATION DATE.
Pt experienced severe flu-like Guillain Barre Syndrome, hemorrhagic episode and now has chronic fatigue, immune deficiency syndrome, fibromyalgia, encephalomyelitis and more to imagine...etc. Gulf War Syndrome/Illness.
Stiff neck 15 mins after injection, headache at 30 minutes, blood pressure dropped upon standing, blood pressure went way up 45 mins after injection, passed out twice, loss of strength in limbs, nauseous, disoriented and confused, extremely sedated, transported to ER for 4 hours. Currently
flu symptoms; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a non-health professional via social media.    This case involves a male patient (of an unknown age) who get flu symptoms within a weeks (influenza), while he received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious get flu symptoms within a weeks (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M044717 with an expiration date of 19-JUL-2019, (doses, route of administration were not reported). Administered doses of GARDASIL 9 underwent a temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 11 hours, which was detected by a digital data logger. There was the previous temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 45 minutes reported. No adverse symptoms were reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007586:
Pfizer vaccine was not removed from the freezer at the 14 day cutoff when it is supposed to be moved to warmer fridge temperature. THis vaccine was kept int eh freezer and thawed at the 19 day mark. The vaccine does not have stablitity data published after 17 days but was not yet expired or out of freezer temperature at any time other than to thaw.
2 hrs after rec'd vaccine started neck pain Rt side radiated from injection site up neck - very painful to move head in any direction. 4/30/01 came to clinic with pain in neck. Injection site no redness, no swelling. Dr checked pt said it was probably muscular, to apply heat, rest and take motrin. Ret'd on5/4/01 but left without being seen.
Information has been received from a physician concerning a 7 year old male pt who on 23Nov98 was vaccinated with a dose of varicella virus vaccine live (624656/1324E). On 18Apr04 the pt experienced a chickenpox rash with 13+ lesions. No other symptoms were reported. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Patient became pale and had an episode of syncope for 5 sec. Then patient tensed up and arms shook for 5 seconds. Patient then became alert and layed on table until stable enough to sit up. Patient was observed for 20 min before leaving the office.
EMPLOYEE FEELS DISORIENTED, DIZZY, ANXIETY, SWEATING, HEART PALPATIONS.
Moderate swelling of eyelids and surrounding skin; Warmth/inflammation of cheeks and ears; Moderate swelling of surrounding skin; Warmth/inflammation of cheeks and ears; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune rash and had known allergies to sunscreen and cold temperature. Concomitant medications included dupilumab (DUPIXENT), loratadine (CLARITIN), plantago ovata (METAMUCIL) and fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF); all from an unknown date for an unknown indication. 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 02Apr2021 at 07:00, the patient experienced moderate swelling of eyelids and surrounding skin and warmth/inflammation of cheeks and ears. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of moderate swelling of eyelids and surrounding skin and warmth/inflammation of cheeks and ears were recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Immediately p/vax developed moderate erythema, & swelling at inject site size of small orange. MD notified advised to apply ice for 20mins, Tylenol. Call clinic in AM if tx is needed.
4/24/21 site of injection was swollen, red and sore 4/25/21 woke up at 3:30 am feeling feverish and had a feeling of nausea; got out of bed and was extremely dizzy and bumped into wall and stumbled on way  to bathroom.  Went back to bed and woke at 5:00 am feeling somewhat better and discovered body plastered with hives from knees to chin.  Was tired most of the day and felt off balance.  By the next day was feeling almost normal but still had rash from hives.   4/26/21 Hives clearing up and feeling no more adverse side effects of vaccination. Contacted doctor to let them know what had happened after my visit on 4/23 and was advised to contact disease control and report this.  Also informed me that I should not receive the 2nd shot.
approx. 15 minutes after vaccine, had left ear fullness, lip swelling and difficulty swallowing. Given EpiPen x1 IM right thigh with improvements in symptoms. 911 called and transferred to hospital.