chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tinnitus; burning tongue; electrical flashes on my scalp, face, arms, legs, hands, and trunk; migraine headaches; sensation of heat on the inside of my brain and ears; burning brain; headache; nausea; fever; aches; blood dripping from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (blood dripping from the injection site), PAIN IN EXTREMITY (aches), TINNITUS (tinnitus), TONGUE DISCOMFORT (burning tongue) and HOT FLUSH (electrical flashes on my scalp, face, arms, legs, hands, and trunk) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029az1a and 016bz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 03-Mar-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE HAEMORRHAGE (blood dripping from the injection site). On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (aches), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever). On an unknown date, the patient experienced TINNITUS (tinnitus), TONGUE DISCOMFORT (burning tongue), HOT FLUSH (electrical flashes on my scalp, face, arms, legs, hands, and trunk), MIGRAINE (migraine headaches), FEELING HOT (sensation of heat on the inside of my brain and ears) and SKIN BURNING SENSATION (burning brain). At the time of the report, VACCINATION SITE HAEMORRHAGE (blood dripping from the injection site), PAIN IN EXTREMITY (aches), TINNITUS (tinnitus), TONGUE DISCOMFORT (burning tongue), HOT FLUSH (electrical flashes on my scalp, face, arms, legs, hands, and trunk), MIGRAINE (migraine headaches), FEELING HOT (sensation of heat on the inside of my brain and ears), SKIN BURNING SENSATION (burning brain), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-056018 (Patient Link).
Client reported that about two hours after receiving the second dose of Pfizer COIVD vaccine he developed ?brain fog and motion sickness.? The client stated these symptoms lasted through the next day. Client described the motion sickness as when you ?get off a roller coaster.? The client stated the symptoms occurred intermittently. The client was unable to recall if he felt dizzy or nauseous. The client denied experiencing any shortness of breath or other signs or symptoms of anaphylaxis. The client didn't follow up with any doctors or take any medications. The client denied any chronic conditions, medications, or known allergies. The client doesn't remember if he ate before receiving the second dose.
On 2/5, 8 days after the 1st Vaccine, I got a rash on my left arm, headache and stiff neck. I have had the rash for 11 days now, it is still not completely resolved. No headache, some neck stiffness.
it was just a needle in arm and hurt a little bit but that is fine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 10:00 (Lot number: EN6206) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "it was just a needle in arm and hurt a little bit but that is fine".  Additional information: No previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. No Medical History (including any illness at time of vaccination). No Relevant Tests. Caller reporting on the Pfizer COVID vaccine and who wants to report he has an adverse reaction after the vaccine. It was reported that after the first and second dose he was fine, it was just a needle in arm and hurt a little bit but that is fine.   Follow-up attempts are completed. No further information is expected.
morning p/shot had itch @ site of shot, very hot & red patch size of a silver dollar;applied cold compress several times a day
pt recv vax 3JUN97 & 21JUN97 pt exp a vesicular chickenpox rash which started as two lesions;reporter stated that on 23JUN97 had about 25 lesions & no fever noted;24JUN97 pt exp fever;pt MD same day dx w/chickenpox;
Vaccine given July 28.  The mother noted "knots" on her legs and she was fussy.  Then Aug 6 the mother noted a round lesion and brought her to see her regular primary care provider.  She was treated with a topical antifungal for possible ringworm.  It did not get better, and the mother brought her to see me today, Aug 12.  I noted an oval, red/pink papulovesicular eruption, sharply demarcated, with a small "blister" in the center.  It is not tender and very slightly warm to touch.  It is located on the upper lateral left thigh, consistent with the location of the Prevnar.  Photo was taken.
Injected high on arm and placed intra-articularly into shoulder joint (left arm). Immediately felt in shoulder and within an hour started to have shoulder pain and limited range of motion. Significant pain has continued and limited ROM. No e/o septic shoulder noted with no erythema and no systemic e/o infection.
Sore arm with no rash on it; severe burning on skin with no rash; pain in lower left abdomen, mild and persistent stomachache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm with no rash on it), ABDOMINAL PAIN LOWER (pain in lower left abdomen, mild and persistent stomachache) and SKIN BURNING SENSATION (severe burning on skin with no rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Previously administered products included for an unreported indication: shingles vaccine (She had Shingles vaccine 5 and 2 years ago. She experienced not a unique reaction, after the first dose of the two series shingles vaccine and two years ago.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm with no rash on it), ABDOMINAL PAIN LOWER (pain in lower left abdomen, mild and persistent stomachache) and SKIN BURNING SENSATION (severe burning on skin with no rash). At the time of the report, PAIN IN EXTREMITY (Sore arm with no rash on it) and ABDOMINAL PAIN LOWER (pain in lower left abdomen, mild and persistent stomachache) had resolved and SKIN BURNING SENSATION (severe burning on skin with no rash) was resolving.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medication included an unspecified antidepressant.  Patient did not took any treatment for the events.
Manufacturer:  GlaxoSmithKline Biologic Severe joint inflammation in all joints lasting 6 weeks.  Unable to take over the counter anti-inflammatory medications due to side effects.  Heat and ice packs did not offer any relief.  I did not seek medical attention because I am unable to take anti-inflammatory drugs due to the side effects.   After 6 weeks the inflammation subsided in all joints except the elbow joint in the arm in which the vaccine was given.  It is still very tender and inflamed.
Fatigue, Chest pain, shortness of air, irregular heart rate. Cardiac MRI 06/30/21 showed mild myocarditis and pericarditis, 30 day monitor showed ectopy, PVC's, colchincine and then metoprolol controlled symptoms, also in august had visual peripheral field vision shimmering like prism for 5-10 min x2, diagnosis new onset migraine, possibly from colchicine
red blood cell problems; This is a spontaneous report from a contactable consumer or other non hcp (patient's daughter). This is the report for the reporter's father. A male patient of an unspecified age received a dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced red blood cell problems. The patient underwent lab tests and procedures which included red blood cell was unknown results. The outcome of event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].
Rash localized to arms L>R. Dr. didn't think it was an allergic reaction but possibly sun sensitivy fruom vaccine
Developed large area of redness at site of KINRIX vaccine with few small vesicles adjacent to site. Area was 4 x 5 cm large.
Patient had 2 minute generalized tonic-clonic seizure 10 hours after receiving vaccines. Mom reported subjectively warm to touch 4 hours prior to seizure & antipyretic given. No fever at ER visit.
PASSED AWAY; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, therapy start date was not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date earlier this week, the patient unexpectedly passed away. On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed or not. 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 20230572578.; Sender's Comments: V0:20230560836 - Passed away. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I have a large red circle around the injection site and it is growing daily.  Hot to touch.
Headache, Myalgia, Arthralgia, NauseaVomiting, Chills, Shaking Cold, Fatigue Narrative:
I developed a headache, burning of my face and upper gums   45-60 minutes after the vaccine. As the day went on I developed slight swelling of my upper lip.  The burning of my face lasted until the following day but then would come and go.  The swelling of my upper lips lasted  4 days.  Last Thursday 1/7/2021 my face was burning and lasted the day.
Became dizzy immediately upon administration.  Lips, tongue, and throat began mildly tingling after about 10 minutes. I stayed for about 15 more minutes in the waiting room to make sure it wasn?t anything serious. I thought maybe it was in my head and didn?t want to bother anyone.  I drove home and it got worse. At 3:00 I started feeling a tightness in my throat. This has happened to me before so I knew the symptomology well. I took 25mg Benadryl at that time and called adverse events hotline. They said if it didn?t get better or got worse to go to ER.  The Benadryl helped reduce the tingling sensation, but throat swelling sensation continues to get worse and I got a horse voice.  I went to ED around 5:00. I was simply treated with IM Decadeon and sent home.  Within approximately an hour after administration of Decadeon, all symptoms had subsided and I successfully made it through the night with no further complications. Throat swelling and tinglinf are now completely resolved at 7am the next morning.
Patient had headaches, nausea, decreased appetite, muscle soreness,  malaise and anorexia. Patient can hardly get up from his bed for 6 days. The next week, patient still felt very weak and has lost 15 pounds. Within 3 weeks of the flu shot, patient complained of hearing loss mostly on the right side.
Patient had an initial response 2 days after the vaccine, with general malaise,  dry mouth, headache and itching hands as well as local discomfort at the injection site that seemed to resolve spontaneously. On April 3rd he had non-specific changes in his hands that he attributed to cold weather that led to discomfort when running them under warm water. By monday APril 5th he was having worsening sensitivity in his hands and feet to heat, touch and experienced numbness. he also began to have difficulty walking. He went to the ER April 6th and was discharged April 7th after undergoing MRI of the brain and spinal cord, labs and lumbar puncture, with a presumptive diagnosis of early Guillain-barre Syndrome. His symptoms continued to worse, loss of gait was more pronounced as well as loss of balance and new off sensations in his tongue. He was admitted to the hospital, continued to undergo diagnostic workout. Results from tests on APril 6th came back positive for Anti nuclear antibodies and high protein in his CSF. He was treated with 3 days of infused Immunoglobolin therapy and was discharged on April 11th with a diagnosis of likely GBS. His symptoms continue to worsen slightly, but with less day to day decline
Initial Report Received: 24-Sep-2018 Patient is a female patient (age and race not provided) who was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. The patient, a consumer, reported that she did not receive her second dose of HEPLISAV-B as it was not yet available in her area. Relevant medical history and concomitant medications were not provided. The patient received the first HEPLISAV-B injection on 13-Aug-2018 (lot #/expiration date not reported.  The patient did not receive her second dose yet as it was not yet available. No further information was provided. The reporter did not provide a seriousness assessment for the event. Company comment:  The company assessed the event of incomplete course of vaccination as non-serious. The event of incomplete course of vaccination is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of incomplete course of vaccination as non-serious. The event of incomplete course of vaccination is listed per HEPLISAV-B USPI.
p/vax pt exp redness, warmth, induration, & swelling at inj site;
infant death reported 3 days after 2 mos immunizations; autopsy revealed no etiology for death; reported as SIDS; child a 34 wk preemy growing up with history of respiratory distress; prescribed apnea monitor but unaware of its use at home
Extreme pain in joints, muscles, and skin immediately following second shot. Development of Type 1 diabetes a few months later.
Pt Feels itchy with past history of anaphylaxis to peanuts.  Pt Monitored no treatment or transport.
The pharmacist realized 15 minutes after giving the vaccine that she had drawn up an adult dose of Moderna instead of the pediatric dose of Pfizer. Mother of patient was contacted on 12/17/21 and no adverse reactions have occured.
On 08/11/20, the donor called the center to disclose that he thought he might be having a reaction to the Rabies booster that he received on 08/10/20.  He stated that he felt fine upon leaving the center.  However, later that evening, he began to experience soreness of his left arm at the injection site, fatigue, headache, a localized rash on his chest, and a fever of 102 degrees Fahrenheit. He stated that the only symptoms he was experience on 08/11/20 included left arm soreness at the injection site and the localized rash on his chest.  He stated his rash had not spread beyond his chest.  He denied any difficulty breathing or swallowing. On 08/12/20, the donor contacted the center and stated that all signs and symptoms had resolved except the rash.
Had a TIA.  Partial paralysis on the left side. Partial paralysis to left arm, leg, left side of face and slurred speech.
BACK BRUISES; NECK SPASM; NECK PAIN; SWELLING OF THE TONGUE; BODY ACHES; DIZZINESS; CHILLS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and smoker, and other pre-existing medical conditions included the patient have no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: COVID-19 PCR test negative (NR: not provided) Negative. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced dizziness. On 26-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced swelling of the tongue. On 01-APR-2021, the subject experienced neck spasm. On 01-APR-2021, the subject experienced neck pain. On 12-APR-2021, the subject experienced back bruises. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, dizziness, and chills on 27-MAR-2021, and swelling of the tongue on 29-MAR-2021, was recovering from back bruises, and had not recovered from neck spasm, and neck pain. This report was non-serious.
Prolonged left deltoid soreness. Vaccinated on 10/26/17, then seen in office on 11/08/17 reporting left deltoid still sore with most movements with no other known triggers to discomfort other than vaccination.
"Long story short, I received my second covid vaccine at ALMC last Tuesday afternoon (6/22/21).  Wednesday morning I had awoken in tears and was in excruciating pain.  My upper back was hurting and had a very hard time getting out of bed.  I tried to relax and take it easy during the day along with some ibuprofen to help.  I informed my lead nurse, in the afternoon that I was not doing so well, but would still try and make it on Thursday.  I did come into work but ended up leaving about 45 minutes into my shift and used my PTO for the rest of the day.  I was prescribed 2 medications to help with muscle spams and pain, but they have not been working.  I did return back to work on Friday and have continued to do so, but I am still experiencing this horrific side effect and I am not functioning to my full capacity.  I was able to see my primary doctor yesterday afternoon as I am having concerns that this is lasting as long as it has been and not much improvement.  We did do xrays (results are not back yet) and I was started on a high dose of steroids to see if that will work.  I am just concerned because it has been a week now and not finding much relief. " - per patient.
Patient experienced syncope and appeared flushed around face. Timing occurred roughly 5-10 minutes after vaccination.
Local soreness to left arm approximately 1 hour after injection. Swollen lymph nodes in left armpit after 2 hours. Night sweats. Both arm soreness and lymph node soreness persisted 18 hours later.
"feeling fine"   Patient received Moderna with 1st and 2nd dose in error as she is only 13 yr old
Pt devel sz which required hospitalization  on 3OCT91 mom report staring, nonresponsive behaviors prior to hospitalization which began about 17SEP91;
I suddenly got a red rash or flush after taking my nightly medications. This has happened a few other times this year, but not so closely after taking the covid-19 vaccine.
Patient was administered potentially undiluted vaccine- stayed for observation period of 15 minutes, no adverse reactions. Pt notified of administration later in the day via phone call.
headache which lasted one week; This case was reported by a physician via sales rep and described the occurrence of headache in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo). On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo), the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo).   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The physician mentioned that the patient had received Men ACWY and Bexsero on the same day and experienced a headache which lasted one week. The reporter did not consent to follow-up.
Slight swelling, Discomfort and burning sensation in under arm; Slight swelling, Discomfort and burning sensation in under arm; Slight swelling, Discomfort and burning sensation in under arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 at 16:45 as dose 3 (booster), single (Lot number: FP4554) at the age of 42 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Borderline ITP" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; TYLENOL; MOTRIN [IBUPROFEN]. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FC3183), administration date: 24Aug2021, when the patient was 41-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0198), administration date: 03Aug2021, when the patient was 41-year-old, for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), LIMB DISCOMFORT (non-serious), BURNING SENSATION (non-serious) all with onset 11Jun2022 at 11:00, outcome "recovering" and all described as "Slight swelling, Discomfort and burning sensation in under arm". Therapeutic measures were not taken as a result of peripheral swelling, limb discomfort, burning sensation.  Additional Information: facility type was vaccine Public Health Clinic/Veterans. Patient did not received any other vaccine in four weeks .Patient received other medications in two weeks was Multi vitamin, Claritin, Tylenol, Motrin. Slight swelling, Discomfort and burning sensation in under arm. Patient has no COVID prior vaccination. Patient was not tested COVID post vaccination. known allergies was unknown.