chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site soreness that developed to arm soreness with both doses.; Injection site soreness that developed to arm soreness with both doses.; This is a spontaneous report from a contactable nurse, the patient.  A 43-year-old non-pregnant female patient received the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via unspecified route of administration in the right arm on 10Jan2021 at 14:45 PM (at the age of 43-year-old) as a single dose; the patient previously received the first dose of BNT162B2, Lot number: EK5730), via unspecified route of administration in the left arm on 20Dec2020 at 12:30 PM (at the age of 43-year-old) as a single dose; both for COVID-19 immunization. Medical history included asthma, obesity, hypothyroidism, hypoglycaemia, attention deficit hyperactivity disorder. The  patient had allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ibuprofen, liraglutide (SAXENDA). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021 at 20:00 PM, the patient experienced injection site soreness that developed to arm soreness with both doses. The events were reported as non-serious. The patient did not receive any treatment for the injection site soreness that developed to arm soreness with both doses. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events injection site soreness that developed to arm soreness with both doses was recovering.
Headache (throbbing/horrendous) Chills Sore throat Cough Shortness of breath Tightness in chest around heart Fatigue Hallucinations Dizziness Feel like I?m going to pass out Muscle & body aches Muscle Spasms Joint Pain Congestion Runny nose Nausea Diarrhea
three syncopal episodes. Evaluated by EMS- Transported to Emergency room/department or urgent care.
Information has been received from a physician concerning a 40 year old female who was vaccinated with a 1 ml dose of Pneumovax 23 (lot# 655587/0882F). Subsequently the patient experienced arm swelling from shoulder to wrist. Unspecified medical attention was sought, this patient may have sought medical attention in the emergency room. This is one of 3 reports from the same source. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2011, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Developed annular plaque - hot red + raised.  8 cm x 10 cm.  Reaction occurred within 3 hours.
AT ABOUT 1PM, PATIENT BECAME APPEARED TO BE HAVING A SEIZURE WITH HEAD BACK SITTING IN A CHAIR, WAS TONIC, CLONIC AND STIFFENED WITH A SHORT LOSS OF CONCIOUSNESS. CALLED 911  AND ADMINISTERED EPI-PEN X 1 DOSE AT 1:03PM PATIENT WAS ALREADY CONSCIOUS AND TALKING. FELT CLAMMY TO TOUCH AND WAS PALE. BP 144/82 PULSE 97, O2 SAT 98. MOVED PATIENT TO BENCH IN SHADE WHILE WAITING FOR EMS. BP 140/95 PULSE 88 WHEN EMS ARRIVED AROUND 1:20, PATIENT DID NOT WISH TO BE TRANSPORTED TO THE HOSPITAL AS HE WAS FEELING BETTER AND EVERYTHING SEEMED OK. HE REMAINED WITH US AND HAD A CLIFF BAR, COKE AND WATER UNTIL 2:20PM AT WHICH TIME HE LEFT. I FOLLOWED UP WITH HIM AT ABOUT 3PM AND HE WAS STILL DOING WELL. HE WAS ADVISED TO FOLLOW UP WITH PRIMARY CARE PHYSICIAN AND IF HE HAD ANY OTHER SYMPTOMS TO GO TO THE ER/CALL 911.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date in 1976, the patient was vaccinated with a dose of M-M-R lot # was not reported). On 02-FEB-2015, the patient was vaccinated with a dose of M-M-R II lot # reported as : Y298CC (expiration date, route and dose were not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
MODERNA COVID-19 Vaccine EUA - Received vaccine on 12/26 and I still have a red mark on my arm where I received the vaccination.
I had the shot at 5:15pm on Saturday and upon waking the next day I had severe muscle aches, severe pain all over my body.  Tiredness, headache, muscle pain, slight fever. I could barely move from the pain. I couldn't be touched as it was too painful.  I wasn't able to do any activity other than lay in bed.  I kept an ice pack on my forehead.  My temperature was 99.6 I slept through the day and night and woke up Monday feeling 90% better.
eczema; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 88-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: ECZEMA (non-serious), outcome "unknown".  Additional information: The reporter stated that she had 3 Pfizer covid vaccine. The reporter also stated that her doctor was not helpful in telling if this was a good medication for her. The patient found out, when you took you cholesterol pill you couldn't take grapefruit which her provider did not know. The Patient had not taken CIBINQO yet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/05, Pfizer, dose #2 11/08 pt admit to Medicine cc: Cough, congestion, low grade fever and change in mental status dx: COVID19 illness, mild without hypoxia or PNA LOS: 6 days 11/08 COVID swab, result: detected 11/08 pt cc: exposure: unknown 11/08 CTA PE: impression: Segmental and subsegmental pulmonary arteries cannot be confidently evaluated. Otherwise, no acute pulmonary embolism or other convincing acute abnormality in the chest. 11/08 CXR impression: No acute cardiopulmonary abnormality.
@2330 pm developed chills, abdominal pain, flank pain bilaterally. Chill progressed very rapidly, could not get warm with socks and 4 blankets on. Also was hard to speak d/t shakiness, speech changed as well, also muscle cramping on the legs. Was given heating pad by husband and took Ibuprofen 400 mg. Symptoms subside after 2-2.5 hr. On 10/10/18 morning symptoms returned: chills, muscle aches and cramps, abdominal discomfort, was nauseous, vomited x2. Could not take anything by mouth due to nausea, did heating pad, Mylanta and 2 hr later took Ibuprofen. Started slowly to feel better 10/10/18 after 8 pm.
Left arm pain radiating to fingers, especially painful when raising arm over head.  Onset in 48 hours, after injections; continues to persist 1 month later.  Physical exam 1 week later - no redness, no swelling at site.  Temperature 98.4.  Patient declined f/u visit at this time (reports continued symptoms by phone).  Has been applying moist heat, massage and gentle exercise.  Still has left arm pain. Telephone follow-up to patient.  She reports pain in Left arm was completely resolved by mid-January, 2008.
Flushing childs, nausea, body aches day of vaccine 09/09/2021 hand numbness that has prolonged tips of fingers and ache in arm pit down the back of right arm
I am still feeling nauseous prior; some amount of light headedness like dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Apr2021 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "I am still feeling nauseous prior"; DIZZINESS (non-serious), outcome "unknown", described as "some amount of light headedness like dizziness".  No follow-up attempts are possible. No further information is expected.
Information has been received from a 57 year old male pharmacist with no allergies or medical history who in 2003 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg(yeast) Concomitant therapy  included aspirin and vitamins (unspecified) In approximately 04/2004 the patient had a titer drawn that was negative. Unspecified medical attention was sought and no treatment was required. He also reported that he had a melanoma on his forehead removed on 07/19/2004 with a follow up procedure needed on 07/22/2004. The reporter did not feel that this was related to therapy with hep B vaccine rHBsAg(yeast) A product quality complaint was not involved. Additional information has been requested. The pharmacist also reported that three other employees had negative titers after therapy with Hep B virus vaccine rHBsAg(yeast) Reference:WAERS0407USA02237, 0407USA02240, 0407USA02241.
Body ache, intense, then onset fever and chills, temp reached 103.2, could not get relief from NSEDS. Continued into the night, chills and sweats, fever continued thoughout the next day, too far to a hospital, treated with cold baths and towels.
Rash first occurred. Turned to bruise the next day approximatley 3 inches in diameter.  Patient is now having pain 3 days later. The rash has disappeared but bruise remains.
pt recv vax NOV96 & FEB97 pt blood test revealed a lack of seroconversion;
07/30/04-DTaP administered. 1 hour later had vomiting, hives, facial swelling -responded to Benadryl and resolved. 8/2/04-presented with large, red, warm swelling in leg. Dx cellulitis (right leg). Rx for Augmentin given. 2 pt's same day developed cellulitis one of the DTaP vials in lot was broken.
immediate swelling and redness at injection site, serious cramping on right side of body where injection was administered lasting more than one month after injection.
CAN NOT DRIVE; NOT ABLE TO OPERATE HEAVY EQUIPMENT AND TOOLS; STROKE; This spontaneous report received from a consumer concerned a 56 year old adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no underlying medical condition or concomitant use of medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total was administered in left arm on 29-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 56 years old. No concomitant medications were reported.  On 02-NOV-2021, in morning, the patient was unable to wake up from the bed, had slurred speech, symptoms of facial palsy, and numbness in his left side limbs. The patient also had stroke and as derived consequences the patient can not drive nor can operate heavy equipment and tools (that are precisely tasks associated to the patient's work activities). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from stroke and the outcome of can not drive and not able to operate heavy equipment and tools was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220638528- covid-19 vaccine ad26.cov2.s-stroke. 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). Therefore, this event(s) is considered unassessable.
THE PATIENT PRESENTED WITH TIGHTNESS IN HIS CHEST AND DIFFICULTY TAKING A DEEP BREATH. NO HISTORY OR ADVERSE REACTIONS TO VACCINES. ON SITE EMS AND PHYSICIAN WAS REQUESTED. BP 98/61  HR 73  OS 97% ON ROOM AIR. HE HAD GONE TO HIS PHYSICIANS OFFICE APPOXIMATELY 2 MONTHS AGO WITH THE SAME SYMPTOMS AND WAS PRESCRIBED ALBUTEROL INHALER. DR ON SCENE SAID NO WHEEZING, HOWEVER CHEST IS TIGHT AND PATIENT COUGHS WHEN TAKING A DEEP BREATH. PATIENT HAD ASTHMA AS A CHILD. PATIENT TRANSPORTED TO HOSPITAL ER BY EMS
Injections slightly sore several hours after injection.  Arm sore/stiff 7 hours after injection.  3"x4" area around injection site swollen/warm by 10AM day following injection. Arm very sore/stiff. Tire/slightly dizzy day following injection. Diminished apatite day following injection.  4"x5" area around injection site swollen/warm by 6pm day following injection. Arm sore/stiff. Body temp increase 1.5 degrees by 8pm day following injection.  5"x7" area around injection site swollen/warm 9am 2 days after injection. Slight reddening  of area around injection site, very sore. Diminished apatite continues 2 days following injection.  400mg ibuprofen before bed 2nd day after injection.  No change 3rd day after injection. Injection site still swollen/warm/sore and slightly reddened. Occasionally dizzy when walking/turning head, diminished apatite.
5 days after receiving my first dose of the vaccine I passed out, had elevated blood pressure (with no past history) of 157/91, elevated liver enzymes, and elevated lymphocytes
After being fully vaccinated and double boosted, I got a breakthrough COVID19 infection.  I received my 2nd booster (Moderna) on 4/15/22 and had a positive covid19 test result on 7/13/22.   Symptoms were upper respiratory (sinusitis, sore throat, coughing, fatigue, headache and earache).  I had a previous swollen lymph node near my ear and was prescribed an antibiotic (Moxifloxacin) by my doctor on 7/7/22.  On 7/14/22, at my request, my doctor issued me a Paxlovid prescription.  I have had no adverse reaction to the vaccines.
8 days post vax, the pt experienced a grand mal seizure that lasted 2 hours. ER report states the the vax had no correlation with seizure and was only febrile induced. The pt experienced a high fever and became unresponsive, his eyes were fixed and dilated and he started drooling. He was taken to the hospital. Within 2 miles from home the pt started convulsing. He was totally anesthetized and his breathing was administered with a bag respirator. He experienced developmental delays and was diagnosed with central auditory processing disorder. He can not distinguish who is speaking in a crowd or a classroom. He is under vision, occupational and speech/language therapy.
Urtcaria developed-upper arms, waist, thighs and axilla-day after INFLUENZA vaccine treatment - MEDROL Dose Pack - XYZA  *Note-pt was being treated for second degree burn with Silvadene
Yes, Pfizer vaccine. I wanted to report the night of getting my first dose I developed a headache and bodyaches as expected but it was followed by extreme shivering that lasted multiple hours. It woke me up out of my sleep and was unchanged mild headache and heat.
On the 9th day (3/13/21) after my first Moderna shot on (3/4/21) , my upper right arm began to Itch at the injection sight in the morning.  By afternoon, the itching stopped, and a rectangular, solid red spot appeared over the shot area: approximately 1.75" by 3".  I iced the area 3 times a day, for 7 days.  It was gone on (3/21/21).  I got my second shot on (4/1/21). For precautionary reasons, I got the shot in the other, left arm this time and iced the area 1 time a day for 7 days.  I did not get any reaction  to the injection site after the second shot, except for being sleepy for 48 hours.
Extreme outbreak with cold sores.  (Assuming it triggered my herpes simplex virus) A total of about 5 blisters on my face
Heart rate increased rapidly with chest tightness and some shortness of breath. Symptoms lasted from 7:52 PM 12/17/2021 to around 10:00 AM 12/18/2021.
Pt recv vax on 10/5/98; on 10/7/98 pt exp vax site induration, warmth & erythema; pt imp by 10/8/98
at midnight(feb 3rd/4th) I woke up and my stomach was in knots I had a fever(101) and my head and arm were was throbbing. I drank water. put a heating pad on my stomach. Felt terrible at 6:30am Feb 4th. Still feel feverish, fever is currently 99.1 (11:30 am Feb 4th). Head is still throbbing.
I had a cold weeks before my vaccination then I got better. A day after my vaccination I started to get sick again. I got the same phlegm in my throat and cough that got worst. I went into the doctor, and she sent me to get a chest X-ray which was clear. She prescribed me prednisone and FLONASE. It has been up and down I still have the cough today.
Extreme bloating of stomach and chest area. Some swelling in neck and face.   Hospitalized after normal Upper GI series for CT Scan and other testing.  Release from hospital for outpatient Endoscopy . Treated with  colace, miralax for constipation. Did not resolve discomfort.
As per vaccinating nurse " Pt received second dose of Moderna, pt's arm swell few seconds after giving the vaccine. Charge nurse was called. Assessed the injection site. Pt was educated that the vaccine was administered in the right place, to use the ice to reduce swelling. Pt did have any other symptom.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 17-year-old male patient of unspecified race/ethnicity received TRUMENBA (Lot# N11904, Exp date 31Jul2017), via an unspecified route of administration, on 24Oct2016, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced double vision for approximately one week on an unspecified date with outcome of recovered. Patient went to ophthalmologist and the ophthalmologist had no findings.
Pt developed redness on right leg about 3" to 4" around the injection site.
Immediate itching at the injection site followed by headache.  Later that evening fever of 102-104 degrees.  Pain in every joint including jaw and fingers to feet.  Unable to work the following day due to headache, chills, nausea, nerve spasms, that still occasionally remains.
10/1/21 pt had a positive COVID test, ordered by Clinic; 10/4/21 pt came to ED and was admitted with AHRF secondary to COVID pneumonia, likely community acquired pneumonia; decreasing respiratory status requiring intubation with mechanical ventilation; cardiogenic shock - treated; acute renal failure with progress multi-system failure; critical; DNR with full treatment otherwise; 10/11/21 pt had a second positive COVID test in the hospital; family request pt be sent to facility with higher level of care; while making arrangements for Air EVAC, pt went into bradycardia which progressed to asystole and loss of BP; pt expired at the hospital prior to leaving
Approximately 10 minutes after immunizations pt developed hives at the site-and more became apparent as time progressed over face and head.
pt. presents with left sided chest pain.  Medic present.  pt. denies any difficulty swallowing / breathing and/or other s/s.  Pt. waiting an additional 15 mins. to be monitored.  pt. reports feeling better  - symptomps resolved with comfort measure.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 21Dec2021 (Lot number: FF8841) at the age of 49 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 10Feb2021 (Lot number: EL3248) as dose 2, single and intramuscular, administered in arm right, administration date 22Jan2021 (Lot number: EL3248) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 02Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 02Apr2022, outcome "recovering" and all described as "Contracted Covid-19 on 02Apr2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Apr2022) positive. Therapeutic measures were not taken as a result of vaccination failure, Covid-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
used sterile water instead of the sterile diluent (normal saline solution) that comes with the Stamaril/color turned into rose-tinge color upon dilution/ was administered to a patient with no reported adverse event; Initial information was received on 26-May-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 73 years old and unknown gender patient for whom sterile water was used instead of the sterile diluent (normal saline solution) that comes with the stamaril/color turned into rose-tinge color upon dilution/ was administered to a patient with no reported adverse event for yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-May-2023 at 03:16 PM, the patient received a dose of 0.5 ml of suspect yellow fever vaccine (Solution for injection) (lot UJ820AB) (with an unknown strength and expiry date) via subcutaneous route in the left arm for Travel for which the sterile water was used instead of the sterile diluent (normal saline solution) that comes with the stamaril/color turned into rose-tinge color upon dilution/ was administered to a patient with no reported adverse event (product preparation error) (latency- same day).  Reportedly, there were no harmful effects and patient was revaccinated as advised 28 days later.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 25-Jul-2023 from other healthcare professional: age of the patient was added, vaccine administration details were added, product coding (trade name) was updated. Narrative amended accordingly.
Went to the doctors for gastritis in July 2021. Eosinophilic esophagitis - throat soreness and costipation