chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the shot then the patient got shingles was fine until then. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
tongue was swelling; mouth felt like it was stretching/she sounded funny; This is a spontaneous report. A contactable female consumer (Pa-tient herself) of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not re-ported.The patient stated that last Saturday she had taken first dose of covid vaccine. After vac-cine she sat in her car for about 15 minutes. She Said her mouth felt like it was stretching, and tongue was swelling. Had called fiance said she sounded funny. she stated that she came across an article which stated that if one is allergic to vaccine then one should not get the second dose of the vaccine.The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL, 0.5 mL. The patient experienced "headaches, wheezing, dizziness and joint pains" after the vaccination. The physician did not know if this was the patient's first, second or third dose, and did not know if she got any shots of GARDASIL after this experience. Follow-up information was received from an employee at the physician's office who stated that the vaccine was not administered at the office therefore she could not provide additional information. This is one of several reports from the source. Additional information has been requested.
Within a couple of hours the area began to itch.  Pain at injection site in deltoid area of left arm started within 4-5 hours of the injection..  Became hot to touch.  Over next 12-24 hours redness progressed to entire upper left arm.  Area was swollen.  Area remained swollen and very painful through evening of September 16.  The Pharmacy suggested taking Advil and using ice to the area.  I only took the Advil.  I felt the ice would be too uncomfortable so did not use it.  As of today, September 17, the area remains red, less swollen and less painful.  It is itching again.
20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a rash across my chest, headache, nausea, numbness/tingling in both hands and lightheaded.
We keep smelling/tasting this funk; We keep smelling/tasting this funk; This is a spontaneous report from a contactable consumer. This consumer reporting same events under the same suspect product for four patients. This is 3 of 4 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. Medical history included, 4 of us had COVID-19 and lost our taste and smell. The concomitant medication was not reported. The patient reported, was lucky to have received both doses of the Pfizer vaccine. However, they have a lingering side effect they can not find more information about. They keep smelling/tasting this funk, or something rotten can't really explain. Smell it randomly could be a bagel or egg or self. For the other girls, it's the same thing that has this smell/taste i.e. every time they drink tea or eat onions keep smelling/tasting this funk. The outcome of events was unknown.   Information about batch/Lot number has been requested.
After the second dose i had swelling in the arm and my arm was in a lot of pain, I could not even pick up my arm at all. I was struggling for a long time and since the second dose it is the same until now. I went to the doctor but i have another appointment soon to see what is wrong with the arm. I just had ibuprofen and other home remedies. The right arm is the worst than the left arm
Pt was inadvertently administered a dose of Pfizer Bivalent Covid-19 Vaccine when the patient had not received any other vaccines, including a primary series. Patient should have received 1st dose of a pfizer covid-19 primary series vaccine.
Patient developed swollen tongue which formed ridges along the edge of the tongue.  She also described of swollen tongue. She did feel very warm and she sounded a bit muffled.  I checked her blood pressure and pulse which were low but normal to her.  Swelling did improved but then got worst and improved again.  She felt better when she left but still had some ridges not as define. I called her an hour later and she reported feeling better after taking some Benadryl.
sore arm x24-48 hours; This is a spontaneous report from a non-contactable healthcare professional. A female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 22Apr2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 22Apr2021 the patient experienced sore arm x24-48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event sore arm x24-48 hours was recovered on 24Apr2021.   No follow-up attempts are possible. No further information is expected.
On the day of injection Tylenol was given for aches in the left arm of the shot.  Arm ached for 5 days after and itched for 10 days after the shot.  On the 7th day after the injection patient developed a rash on her left arm at the site of the shot and postules as well.  A postual was also an inch down away from the shot site.  This lasted 3 days then cleared.
This case was reported by a physician via call center representative and described the occurrence of shingles in a 55-year-old female patient who received SHINGRIX. In February 2018, the patient received SHINGRIX. On 20th February 2018, 14 days after receiving SHINGRIX, the patient experienced shingles, rash and burning skin. The patient was treated with VALTREX and triamcinolone. On an unknown date, the outcome of the shingles, rash and burning skin were not recovered/not resolved. It was unknown if the reporter considered the shingles, rash and burning skin to be related to SHINGRIX. Additional details were provided as follows: The physician reported that after receiving a dose of SHINGRIX the patient developed an active shingles infection. The physician did not have the lot or expiry date for the SHINGRIX given, it was given at a pharmacy. The patient was treated with VALTREX 1 gm TID and triamcinolone cream.
This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with MMR II lot number L027591, expiration date 23-JUL-2017 (route was not provided). Concomitant therapy information was provided. On unknown dates, there was incorrect product storage as MMR II were administered to an unspecified number of unspecified patients following a temperature excursion that was originally reported on 21-MAR-2016. The temperature was 62 F for 2 hours and 12 minutes. No adverse event was reported. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a patient who was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (Lot3650087/0815P).  On 14-OCT-2005 the patient developed severe itching and injection site pain, heat and puffiness.  Unspecified medical attention was sought.  She took aspirin for two days, and used ice packs.  Subsequently, the patient recovered.  No other information was available.  There was no product quality complaint.  The nurse requested a lot check be done on the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality Control Quarantines/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
varicella type rashes and lesions on her right upper arm and left leg. Also suffered shingles on her arms; varicella type rashes; This spontaneous report was received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, historical drugs and concomitant therapies were not reported.  In or around 28-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).       On an unknown date (shortly after receiving vaccine live (ZOSTAVAX), the patient experienced varicella type rashes and lesions on her right upper arm and left leg. Also suffered shingles on her arms (herpes zoster). As a result of the manufacture, marketing, advertising, promotion, distribution of vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. She suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental aguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of herpes zoster was unknown.     The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Vomitting; Loss Consciousness with tonic/clonic episode; Temp 96.1
Numbness in legs and tingling in feet. Several days after and still now intermittently after walking.
ON JAN. 25 HAD IMMUNIZATIONS, THEN NOTICED DRASTIC CHANGE, SLUGGISH, JOINTS OF LEGS HURT. 1/27/07 LOW GRADE FEVER. 1/29/07 THEN VIOLENT OUTBURSTS UNABLE TO CALM, 1/30/07 THREW FOOD, NOT NORMAL BEHAVOR AT TABLE, THEN HIT FATHER WITH OBJECT CAUSED LACERATIION, 1/31/07 HITTING TEACHER, CRYING UNCONTROLLABLY, PINCHED CHILD, PINNED BOY DOWN ON GROUND. FOCUS AND LISTENING SKILLS POOR, NOT FOLLOWING INSTRUCTIONS.
Approximately 2 minutes after vaccination and sitting in the pharmacy lobby per protocol, the patient experienced syncope and convulsions lasting less than 1 minute. The patient then regained consciousness and after hydrating and additional monitoring was able to leave under the supervision of his significant other.
Fever all night day of vaccine, fever next day, general malaise through Sunday. Diarrhea through next week, random cough and acid reflux/ chest pain  up to 3 weeks later.
giant urticaria @ vax site; urticaria on body 2-3 cm diameter on the rest of the body treated w/Pred;
Started Sunday 1/17 or Monday 1/18 itchy arm at and around injection site Monday 1/18 started getting soreness in armpit Monday 1/18 onwards - this soreness spread to shoulder and upper part of back, upper chest/collarbone area, neck (all on left side; neck up to the voice box area) Wednesday 1/20 I noticed my left deltoid muscle got stiff and tight feeling, and it was quite swollen. It was NOT red; still somewhat itchy, but not horribly so. Swelling seemed to extend to my shoulder. Has had no negative impact on breathing; sore and tight feeling.  Taking ibuprofen since 1/20. Helps a little, but still sore/swollen. I called my doctor, but no doctor visit at time of submission (tt nurse, waiting for Dr to call.
Left arm went numb about 4 hours after injection and remained numb for 12 hours.  Severe muscle aches began 4 hours after injection. Extreme dizziness and nausea. Fever, chills, vomiting started 10 hours post injection. Fainting upon standing. Severe chest pain started 12 hours post injection. All symptoms are continuing except for the numbness in the left arm.
2 weeks after 1st dose-pain in both big toes lasting 5-7days; 2 weeks after 1st dose-pain in both big toes lasting 5-7days ending with dark purple color under both big toe nails.; This is a spontaneous report from a contactable consumer(patient). A 72-years-old elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in Left Arm on 12Mar2021 at 19:00 as 1st Dose, Single for COVID-19 immunization.The patient's medical history was reported as none. The patient's Concomitant medications included vitamins nos (VITAMINS NOS) taken for an unspecified indication.The patient did not suffer from covid prior vaccination. The patient did not perform covid tested post vaccination.In Apr2021,2 weeks after 1st dose-pain in both big toes lasting 5-7days ending with dark purple color under both big toe nails. No treatment was received for the events occurred. The outcome for the events was recovered with sequelae.  Information on Lot/Batch number was available. Additional information has been requested
Approx. 1 min. after vaccinated pt co muffled hearing, blurred vision, swearing and in & out of conscious.  Patient did not recall moving from chair to elevate feet.  Vital signs at time of incident BP 98/52, Pulse 46, oxygen 97%.  Patient waited for 30 minutes after episode and was evaluated by EMS.
Throat swelled, lips swelled, asthma attack, severe chills, nausea, eyes red, headache.
Patient with 3 COVID vaccinations who admitted to hospital with complications of COVID.  Provider D/C note:  ""75-year-old female patient, with past medical history of OA, glaucoma, hypothyroidism, questionable multiple myeloma Patient is hard of hearing an a poor historian; friend is deaf and unable to provide information. Has been cough and been short of breath ""for a couple months.""  Symptoms have been worse than baseline over the past 3 days. Chest and abdomen hurt only when she coughs. Has been sitting in a  chair intermittently  at nights--unable to assess length of time this has been occurring   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  Acute hypoxic respiratory insufficiency most likely from pulmonary edema, COVID positive   ? Pulmonary edema vs Covid pneumonia with exercise hypoxemia - congestive heart failure with preserved ejection fraction fluid restriction, strict I/O; echocardiogram; IV furosemide; oxygen per protocol; echocardiogram ? CTA of the pulmonary no pulmonary embolism, evidence of anasarca IV diuretic dex were continued, patient lost nearly 3 pounds ?   COVID-19 virus infection - continue Decadron initiated in ED call though hypoxia is not most likely due to COVID-19 ?   Leukopenia - monitor CBC; consider need for further workup, possibly outpatient ?   Elevated liver enzymes - monitor CMP, improve ?   Elevated troponin - telemetry monitoring, a flat ?   Acquired hypothyroidism - continue levothyroxine; checked TSH, within normal limit ?   Osteoarthritis - acetaminophen prn ?   Macrocytic anemia - check inpatient anemia labs; monitor CBC ?   Impaired hearing - talk so patient can hear   Condition at the time of discharge- Vss, on 2 liters of nasal cannula oxygen   Constitutional:  Elderly, on 2 L of nasal cannula oxygen HENT:  Normocephalic, Atraumatic, Pupils Reactive, Normal oropharynx, Nose normal.  Left sided Port-A-Cath, no evidence of infection Cardiovascular:  Normal heart rate, Normal rhythm, No murmurs, No rubs, No gallops.  Respiratory:  Normal breath sounds, No respiratory distress, No wheezing, No chest tenderness.  GI:  Bowel sounds normal, Soft, No tenderness, No masses, No pulsatile masses.  Extremities:  Intact distal pulses, No edema, No tenderness, No cyanosis, No clubbing.  Neurologic:  Alert & oriented x 3, Normal motor function, Normal sensory function, No focal deficits noted. Skin:  Warm and dry"
Serum creatinine found elevated July 2021. Kidney Biopsy 10/25/21 confirmed acute tubular eschemia.
after her first Covid vaccine, her arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 09:00 (Lot number: ER8734) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "recovered" (11Apr2021), described as "after her first Covid vaccine, her arm was sore". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not have any family history and relevant test. Patient did not receive additional vaccine on same date of the pfizer suspect and not have any prior vaccination. Clinical course: It was reported that after her first Covid vaccine, patient arm was sore, but she was reading that was normal. The patient received second dose of BNT162B2, administered in arm left, administration date 07May2021 (Lot number: EW0183) at the age of 63 years as dose 2, single for covid-19 immunisation and experienced two round oval rash at side and a little swollen and warm on 09May2021, redness at injection site on 08May2021.  No follow-up attempts are possible. No further information is expected.
couldn't sleep for 4 nights; rash/red bumps along the lower part of jaw and upper part of neck; Severe soreness in arm; Headache; Nausea/she was nauseated but she didn't throw up anything; This is a spontaneous report from a contactable consumer (Patient). A 37-year-old female patient received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, formulation: solution for injection; Batch/lot number: WTEL3247; Expiration date: 31May2021), intramuscular in the right arm on 25Jan2021 (at the age of 37 years) at single dose for COVID-19 immunization. The patient medical history included cold/sniffles and sore throat. The patient's concomitant medications were not reported. It was reported that patient had the Pfizer COVID-19 vaccine done Monday night, 25Jan2021. She had a headache and some nausea, but she never threw up or anything. She couldn't sleep for 4 nights. She was not sure if this had anything to do with the vaccine or not. It was wild. She came home from school today and noticed she had a rash. There were these little red bumps that she could felt along the lower part of her jaw and there was a little bit more on the upper part of her neck. The caller washed her face twice a day, morning and night. It was not acne. She did not had this rash or red bumps anywhere else. She mentioned she had not contacted her doctor about this. She just saw the little bumps this afternoon. The caller clarified further she received her first COVID-19 vaccine at 7:10pm. She returned home that night and had a headache. She took Tylenol. Then, she was nauseated but she didn't throw up anything. The next morning, the headache and nausea was gone. The caller stated the next morning her arm was sore. She had taken flu shots where her arm was a little sore before. This was a little more uncomfortable than the flu vaccine but she expected that. Caller stated for next day on Tuesday, she kind of experienced severe soreness in her arm. She recovered a day or two after. She first noticed two red bumps on her chin, she initially thought they were whiteheads. But after she got into better light, she saw there were many red bumps under her neck line and upper neck. There was a mass of them. There was more than 1 or 2 or 3. It was on both sides, but it is not as severe on her right side as it is on her left side. The caller stated she tested positive for COVID-19 a while back. She teaches at a school and the school is very careful. She did have like a cold/sniffles type situation and a sore throat. so she was tested. She was negative and she went to the doctor and was treated for that. The clinical outcome of the events headache and nausea was resolved on 26Jan2021, Severe soreness in arm was resolved in jan2021, for event couldn't sleep for 4 nights outcome was unknown and event rash/red bumps along the lower part of jaw and upper part of neck was not resolved.  No follow-up attempts are possible. No further information is expected.
Sore Arm, overall bodyaches, headache, chills (no fever), weak, runny nose
red rash on face & trunk 7NOV97, pruritus, malaise, afeb, swollen postauricular nodes;
Covid-19; GI bleed; low blood pressure; Dehydration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (GI bleed) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced COVID-19 (Covid-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (GI bleed) (seriousness criterion medically significant), HYPOTENSION (low blood pressure) and DEHYDRATION (Dehydration). The patient was hospitalized from 22-Feb-2021 to 28-Feb-2021 due to COVID-19. At the time of the report, COVID-19 (Covid-19), GASTROINTESTINAL HAEMORRHAGE (GI bleed), HYPOTENSION (low blood pressure) and DEHYDRATION (Dehydration) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication provided. Treatment medications included dexamethasone and remdesivir.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Correction for initial version: As per the initial source document, patient was admitted in hospital for 4 days due to COVID-19 but the case was not coded as serious based on hospitalization seriousness criteria. The correction has been made on 18-May-2021 upon identification. On 12-May-2021: Follow up received included events low blood pressure, dehydration, GI bleed were added