chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced flushing in the face and complained of feeling very warm. She then asked if she could have some water. Paramedics provided on site vitals where blood pressure was found to be 165/101 on the first account and 163/101 on the second account after a 15 minute additional waiting period. The Patient explained that she regularly has high blood pressure for which she abstains from taking her prescribed medication. Patient was guided to go to the emergency room if her condition did not improve and to follow up immediately with her primary care provider to control her blood pressure.
Patient said  1 week since his vaccine, his arm still hurts and not getting better.  Pain radiated down and up to his shoulder.  He has been putting cold compressed and taking Tramadol and Ibuprofen and they don't seem to work.    I recommended patient to see is doctor and patient said he has appointment in 1 to 2 weeks.
Patient, per mother's report-received vaccines at clinic on 10/1/13. Eve of 10/1-right thigh started having redness. 10/2 very hot, more red and patient with fever that eve. Patient unable to sleep and c/o pain. Presented to clinic 10/3. Mother concerned worsening. Mom concerned patient's appetite diminished as well. Dr saw patient 10/3, ordered KEFLEX 250mg/5ml 4mL PO TID, 10 days. And OFU 10/4/13.
Pfizer vaccine was administered outside of Facility- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------- I95.9 HYPOTENSION 4/21/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I95.9 HYPOTENSION 4/21/2023 AMYLOIDOSIS, UNSPECIFIED I95.9 HYPOTENSION 4/21/2023 HYPERVOLEMIA I95.9 HYPOTENSION 4/21/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 4/21/2023 AMYLOIDOSIS, UNSPECIFIED
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 27 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 15-NOV-2013, the patient was vaccinated with MMR II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
I started having a runny nose on 4/16/22 and on 4/17/22 I had a sore throat, cough, runny nose, and a headache. I decided to take an at home test on 4/17/22 and tested positive for COVID-19. This lasted for about 5 days.
This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Excessive urination) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 032M20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced POLLAKIURIA (Excessive urination). On 11-Mar-2021, POLLAKIURIA (Excessive urination) had resolved. Not Provided. Concomitant medications were not provided by the reporter. Treatment information was not provided.
6/12/2021 customer called to report Fever and Chills on 5/29/2021, then complaint of continuous weakness every day since the day after the vaccine was administered.
Small bowel obstruction due to postoperative adhesions. Patient developed increased respiratory distress after multiple NG tube placement attempts, he then developed hypoxia and respiratory arrest.  Patient received 15 minutes of CPR, 4 doses of epinephrine, and 2 doses of bicarbonate, and 1 cardioversion. Patient initially required ICU support along with a hypothermic protocol and 3 pressor support. Patient slowly stabilized and hypothermia reversal began and support was slowly weaned. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Urticaria versus E. minor (doubt) given prednisolone and Benadryl.
Information has been received from a registered nurse referring to a 25 year old patient of unknown gender. The patient's concurrent or historical condition was not provided. On 25-MAY-2016 the patient accidentally received the first dose of RECOMBIVAX HB (dose, route, lot # and expired date unknown) as a pediatric dose. On 29-JUN-2016 the patient received a second dose of RECOMBIVAX HB (dose, route, lot # and expired date unknown) (product use issue) as an adult dose. No adverse effects reported. Additional information has been requested.
Received flu vaccine and 15 month immunizations 12/09/2003 at 13:00.  Noted increased swelling to right thigh.  Swelling below right knee to upper thigh.  Bruising at one injection site noted.  Treatment: Ice, hist.
This clinic client became nauseated and fainted aproximately 5 minutes after receiving vaccines. After the incident patient rested in the clinic for 30 minutes. Upon leaving the clinic the patient c/o knee pain which resolved itself and in checking with mom the next day patient had no further complaints regarding his knees.
Feeling miserable all day; Headache; Nausea; Body ache; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling miserable all day), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Body ache) and FATIGUE (Fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced FEELING ABNORMAL (Feeling miserable all day), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Feeling miserable all day), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
During 30 min post vaccine observation, patient had mild chest pressure without SOB, dizziness, or chest pain.  Patient reported a fast heartbeat.  VS stable at 30 minute mark and instructed to go to ED for any worsening symptoms.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. NO ADVERSE REACTION REPORTED.
Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician by phone. This case is linked to cases 2019SA082205, 2019SA082209, 2019SA082210 and 2019SA082211 (same reporter). This case involves a 2 months old female patient who experienced upper leg was very swollen site reaction, while she received vaccines ROTATEQ, PREVENAR 13 and PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On 15-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ095AA. On an unknown date, the patient received a 0.5 ml dose of suspect PREVENAR 13 not produced by Sanofi Pasteur lot X49142. On an unknown date, the patient received a 0.5 ml dose of suspect ROTATEQ not produced by Sanofi Pasteur lot R034700. On an unknown date, the patient developed a non-serious upper leg was very swollen site reaction(vaccination site swelling) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, PREVENAR 13 and ROTATEQ. No Lab data was reported. Final diagnosis was upper leg was very swollen site reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for upper leg was very swollen site reaction. Documents held by the sender: none.
Saturday, 2 days after I started having pain in the back of my throat and on my tongue.  Not like a sore throat but pain then I noticed a small white bump on the back of my throat.  The next day, Sunday I had small white bumps or blisters on the side and bottom of my tongue and the cheek of my mouth.  These were painful.  They started going away on Tuesday and by Wednesday 1/6/21 they were almost gone.
Student had  Flu ( Quad), and Gardisil 9, tdap (unknown manufacturer) Men ACWY ( unknown manufacturer)  on 10/21/19 . Student came to health office with c/o  left upper arm  pain and a approximately a 2 inch swelling and redness on left deltoid.
Nausea after 12 hours; Fatigue for two weeks; sinus congestion 24 hours; 2-3 headaches a week; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 16Mar2021 at 15:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease(COPD).Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included umeclidinium bromide/vilanterol trifenatate (ANORO) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 23Feb2021 at 16:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 17Mar2021 at 3:00, the patient experienced nausea after 12 hours, fatigue for two weeks, sinus congestion 24 hours, 2-3 headaches a week since the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, fatigue, sinus congestion and 2-3 headaches were resolved with sequelae on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
The first shot in July I had an instant headache for a few days. On the 4th day I had swelling in my face near my nose that went into my mouth and lips that lasted for 3 days. The second shot the next day my face was completely swollen. My lips and mouth felt like I had novocaine. I took antihistamines and they worked. That lasted for 3 days.
Pt presented with uti antibiotics given, pt tested positive for covid upon discharge to a snf, asymptomatic.
Beginning the morning of 9/16/17, patient's arm began hurting and had redness on her shoulder. Complains she can't lift right arm.
9/4/21 Developed rash at elbow and lower left arm. 9/7/21 rash worsens on left arm AND spreads to right arm. 9/10/21 rash continues left and right arms AND spreads to throat and chest area.  9/11/21 rash continues both arms, throat and chest areas AND expands to include abdomen. 9/15/21 face itches with redness but no obvious rash.
Fever, chills, sore throat, headaches, runny nose, body aches. Burning sensation during the vaccination. Stomach/gut distress.
Within 20 minutes of injection, the pt began feeling tightness in his chest, difficulty swallowing and swelling under chin. Also complained of pruritus and tingling.  Pt was given epinephrine and Benadryl with no change in symptoms. Second injection of epinephrine and oxygen started with IV fluids. Pt responded to treatment within 15 minutes of second epinephrine dose. 100% recovery.
Vasovagal symptoms, mild tingling/paresthesia in bilateral lower extremities. No objective neuro deficits. No anaphylaxis. Patient monitored for several hours, no major complications.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Headaches" (unspecified if ongoing); "Seronegative rheumatoid arthritis" (unspecified if ongoing); "Sjogren's Syndrome" (unspecified if ongoing); "Sweet's Syndrome" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Chronic Fatigue Syndrome" (unspecified if ongoing); "Fatty Liver Disease" (unspecified if ongoing); "Degenerative Disk Disease" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Carpal Tunnel" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Fentanyl, reaction(s): "Known allergies: fentanyl"; Imitrex, reaction(s): "Known allergies: Imitrex"; Cytomel, reaction(s): "Known allergies: Cytomel"; Abilify, reaction(s): "Known allergies: Abilify"; Buspar, reaction(s): "Known allergies: Buspar"; Reglan, reaction(s): "Known allergies: Reglan"; Haldol, reaction(s): "Known allergies: Haldol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccines cannot be excluded for suspected LOE. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Dizziness, Headache, Myalgia, NauseaVomiting, FATIGUE/INJECTION SITE PAIN/CHILLS/FLUSHING Narrative:
Patient presented on 12/17/21 for monoclonal treatment and upon arrival she was hypoxic and brough to emergency room.  She was admitted for supplemental oxygen, remdesivir and dexamethasone.  O2 needs increased from 3L to 15L the following day and was started on heated high flow o2.  Currently continues on HHFO2 at 50LPM and 80%Fi)2.
ACCIDENTLY GAVE PT A SHINGRIX SHOT WHEN HER AND HER MOM SWICHTED PLACES.
Chills, headache, dizzy, fever, joint pain. Pt has call into doctor.
Received IPV and DTAP slumped over in swing with eyes open on the way home.  Called doctor at 2:00PM.  Swollen, itchy face, hives, rapid breathing.  Fever 101, swelling at site.
It was reported that a 26 year old female received a Fluzone SV '99-'00 vaccination on 10/4/99. Reportedly, sometime after the vaccination, the pt experienced a local reaction of redness and swelling along with itching at the injection site.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 34 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Pt went to emergency room with swelling in neck and stated she "felt like golf balls" in neck.
pt recvd vax;exp small papular lesions on chest & back; sibling vaccinated & exp fever;
Very sore arm, lymph node tenderness in armpit area and on rib cage area adjacent to injected arm site.
stiff neck, chest tightness, peripheral eye flashes, blurry vision, flaky skin, aches, pain/numbness/tingling, swelling all over my body including painful ovulation, headaches, breasts, pinkie toe, gum and shoulder/upper arm in the injected arm which  prevents me from doing certain daily activities of living and routine upper body workouts, depression, anxiety. i talked to my optometrist, pcp, orthopedist and therapist about these.  also did accupuncture and now doing Physical Therapy
Mild to medium fever for  approximately 5 hours. I was attempting to sleep at onset of fever and had difficulty sleeping.
6mo old recvd DTP/HIBTITER 2OCT91 & exp excessive somnolence; slept all day; resolved 21OCT91;
High fever, irritability, followed by measles rash - started on chest and back and spread to face, arms, legs
Soreness, swelling, and inflammation at injection site by end of injection day. Extreme fatigue and generalized muscle aches by next morning. 2nd night best described as moderate flu symptoms; alternating sweats and chills, significant cramping and muscle pain, fever (100.2 vs 97.9 normal), inability to sleep or focus. Still recovering, with muscle aches and cramping, plus continuing inability to focus, though it looks like I'll make it through this.
20 days ago had flu shot. 3rd day after shot started with itchy legs & swelling in thighs. States he gained 10lbs in a few days. Within a week still some mild itching to both lower extremities.
tingling going up and down my left arm right where I had the shot and my fingers; Pain; Feeling very tired; numbness in my fingers down the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; ATORVASTATIN; LISINOPRIL; AMLODIPINE; OMEPRAZOLE; SERTRALINE. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, LOT#: GJ2524), administration date: 24Sep2022, for COVID-19 Immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, LOT#: FK9893, Expiry: 20Jun2022), administration date: 03May2022, for COVID-19 Immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, LOT#: FH8027, Expiry:Feb2022), administration date: 23Nov2021, for COVID-19 Immunization; bnt162b2 (DOSE 2, SINGLE, LOT#: EW0150), administration date: 05Apr2021, for COVID-19 Immunization; bnt162b2 (DOSE 1, SINGLE), administration date: 15Mar2021, for COVID-19 Immunization; Rsv vaccine (about 5 weeks before), administration date: Sep2023, for immunization; Flue shot, for immunization. The following information was reported: FATIGUE (non-serious) with onset 15Oct2023, outcome "not recovered", described as "Feeling very tired"; PAIN (non-serious) with onset 15Oct2023, outcome "not recovered", described as "Pain "; HYPOAESTHESIA (non-serious) with onset 15Oct2023, outcome "not recovered", described as "numbness in my fingers down the arm"; PARAESTHESIA (non-serious) with onset 15Oct2023, outcome "not recovered", described as "tingling going up and down my left arm right where I had the shot and my fingers". The events "tingling going up and down my left arm right where i had the shot and my fingers", "pain ", "feeling very tired" and "numbness in my fingers down the arm" required physician office visit. Therapeutic measures were taken as a result of paraesthesia, pain, fatigue, hypoaesthesia.  Additional information: patient was treated with Tylenol 500 milligrams. She stated she went to the Walk-In Clinic because of the pain she was having doctor could not find anything along with her besides the pain so, he suggested she guess it was from the shot.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient is also a provider who was doing medical observation of vaccine clinic. She presented without her vaccine card saying she was due for her second vaccine. She was medically screened and received her second dose. When entering  the second dose into the medical record, it was noted that first dose was on 3/29/2021. Second should have been given on 4/26/2021 rather than 4/20/21.
swelling; arm was really really hurting,red spot appeared were the shot was that was tender.; little red spot on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was really really hurting,red spot appeared were the shot was that was tender.), VACCINATION SITE ERYTHEMA (little red spot on the injection site) and VACCINATION SITE SWELLING (swelling) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) and FLUTICASONE for Asthma, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY).    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was really really hurting,red spot appeared were the shot was that was tender.) and VACCINATION SITE ERYTHEMA (little red spot on the injection site). On 15-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling). On 09-Feb-2021, VACCINATION SITE PAIN (arm was really really hurting,red spot appeared were the shot was that was tender.) had resolved. On 10-Feb-2021, VACCINATION SITE ERYTHEMA (little red spot on the injection site) had resolved. At the time of the report, VACCINATION SITE SWELLING (swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient was administered Pfizer Bivalent Vax.  She had never received MONOVALENT.
On 12/31: vaccine at 1:05 pm;  arm soreness and fatigue starting around 3 pm. On 1/1/21: nausea  and chills at 1 am, severe headache and light sensitivity at 7 am. (now 8:30 am)
Confusion, Headache, Myalgia, Arthralgia, chills, localized pain around injection site Narrative:  onset of s/s in evening after shot and overnight as described above, period of confusion (resolved). what remains is headache, localized pain and redness around site of injection.