chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event, the patient was 17 years and 6 months and received the shot before his 18 birthday
This case was reported by a pharmacist and described the occurrence of aura in 41-year-old female subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). Concurrent medical conditions included seizure disorder. On 31 August 2014, the subject received a dose of FLUARIX QUADRIVALENT (administration site and route unknown). On 1 September 2014, less than one day after vaccination with FLUARIX QUADRIVALENT, the subject experienced 5 auras. At the time of reporting, the event was resolved.
pt recv vax 22NOV96 & 27NOV96 pt devel hives all over body;pt presented to MD who felt the hives were e/t vax;tx w/DPH & pt recovered;
After receiving her vaccine client states she has tingling, numbness and pain in the arm she was vaccinated in.  Vital signs obtained by EMS.  BP 114/78, HR 88, 98% O2 sat.  Client stated she feels better.  Client discharged home.
1 day p/vax pt suffered malaise, vomiting & diarrhea; fever devel the following day, responding well to APAP; relationship to vax not clear; could be viral illness;
Erythematous measles like rash on face, trunk, palms and soles.
Per patient's mother, patient has had "multiple health problems" since getting vaccine in November of 2017.
Tinnitus in both ears; This is a spontaneous report from a non-contactable healthcare professional. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via intramuscular route of administration in the left arm on 02Jan2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via intramuscular route of administration in the left arm on 17Dec2020 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021, the patient experienced tinnitus in both ears which started in the left then moved to the right, it was manageable but annoying. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with Zyrtec and Tylenol. The clinical outcome of the event tinnitus in both ears was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
t104, hives duration 2 hrs x 18 hrs; no sz; no source of infect;no neuro deficits.
Injection site pain (severe for 24 hours and mild for next three days), 24 hours of tiredness, chills, feeling unwell, slight fever, dizziness.
Within a few minutes of the vaccine administration: Metallic taste in back of mouth, nausea, sore arm Within the first 3 hours: heavy tongue, nausea, metallic taste, poor memory recall Within the first 8 hours: lethargic, body feeling weighted down, slow thought processing and response rate, extremely fatigued and tired.
Fever beginning 12 hours after vaccine administration. Inability to sleep for subsequent 6 hours. Feverish feeling resolved approximately 6 hours after onset.
Severe headache, chills, muscle fatigue, nausea. Lasted strongly for 48 hours and still bad headache on the third and fourth day after the day of the shot.
Left arm with swelling, slight indurated , warm to touch, Cellulitis- Keflex 375 TID x 10 days.
Monday day 1 Very slight headache Felt a little neuro  within in 20 minutes Slight headache comes and goes  Pain set in bones l. 2nd toe, back, hips, neck, elbow, ankle Some leg muscle pain Lymph nodes little pain and swollen Ears blocked Tired-slept 3 hrs in the afternoon Bedtime falling asleep-heart pounded 3 times Very cold Got very hot during night  Day 2 Heart hurt upon waking, but then burped a lot -heartburn? Tired Air hunger Pain to include where ankle injury was Heart palpitations at rest in a.m. Felt 75% better during day Did chores Got very tired after having a snack-went for a nap at 2:30-4  Wed. Day 3 Heartburn  Air hunger Lymph noes still swollen Ok during day-went out Pain set in by evening Neck, back, shoulders  Day 4 Thurs. - still have back pain-took ibuprofen  Tired
Swollen bladder and thickening of the bladder suddenly on 07May2021.; Swollen bladder and thickening of the bladder suddenly on 07May2021.; This is a spontaneous report from a contactable consumer. A 46-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration, administered in left arm on 10Apr2021 09:00 (at the age of 46-years-old) as a single dose for covid-19 immunization. Medical history included, hypersensitivity with bees, peppers (bell/Jalepeno). Past drug included levaquin. Concomitant medication(s) included omeprazole 40 mg daily. The patient was not pregnant at the time of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration on left arm in Mar2021 09:00 at single dose for covid-19 immunization. The patient had no other vaccine within four weeks prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19, device Date is 12May2021. On 07May2021 16:00, the patient was diagnosed with a swollen bladder and thickening of the bladder suddenly and resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit and the patient was hospitalized with the duration of 3 days with no prolonged hospitalization. Elevated WBC and kidney enzymes but no other traditional symptoms of a UTI. No bacteria growth in culture. Doctor reports the thickening happened in the last month or so. The patient underwent lab tests and procedures which included white blood cell count: elevated, sars-cov-2 test: negative on 07May2021 Rapid SARS Cov 2, renal function test: elevated, culture: no bacteria growth, no other traditional symptoms of a UTI. The patient received treatment for events with IV antibiotics. Outcome of the events was recovering.  Follow-up attempts are needed. Further information is expected.
Large localized reaction with vesicles after subq VARIVAX vaccination 3x4 cm - afebrile.
DEVELOPED HEADACHE, MOIST, PRODUCTIVE COUGH, ELEVATED IRREGULAR HEARTRATE. FOLLOWING UP WITH PCP
Same day as vax the pt experienced pain which lasted through day 4. On day 4 the pt experienced a 1-2 inch red skin with nodule or abscess deep in the tissue. Day 7-11 the pt's symptoms are resolving. No fever was noted.
Patient described warmth and swelling that started 2 days following vaccination; Followed up with provider at that time. Reported to pharmacist on 5/5/20 @ 7:10 am
Patient stated that night of getting flu shot around 8:00pm she starting feeling very chilly and fatigued, which continued through all day the following day. She has since recovered.
Prior to vaccination  pt reported that she developed hive for  her fist two doses of Moderna. Patient reported symptoms subsided afte taking 25mg of Benadryl she was observed at the clinic and sent home. Staff RN consulted with an allergist who recommended patient pre medicate with 25 mg  Benadryl oral 30 minutes before Moderna Booster.   At approximately 1233( 10 min post vaccination) rash/hives on chest noted. Pt denied difficulty breathing/SOB. O2 within normal limit at 100% on RA.  even and  unlabored breathing. All other vitals were within normal limits  Pt reported slight headedness, that subsided 5 min later. Pt was provided with water and legs were elevated. At 1242 pt rash/hives improved. Pt was closely monitored for 30 minutes post vaccination with no deterioration. Upon discharge pt was advised to seek medical help if symptoms come back or worsen. Pt verbalized understanding.
patient received first dose around 60 days ago and still had not gotten second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient received first dose around 60 days ago and still had not gotten second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient received first dose around 60 days ago and still had not gotten second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient received first dose around 60 days ago and still had not gotten second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. The treatment information was not provided.
adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 16-year-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 17-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in left deltoid (strength, exact dose and route of administration was not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
About 45 minutes after receiving vaccine in right arm the right side of my face became tingly and numb. Starting with my chin and going to the forehead and across to the right ear.  That feeling started to dissappear around 2 pm and I was left with a headache, mild nausea, and an uncomfortable feeling in my right eye.  The next day I had a slight headache and the right eye still feels uncomfortable.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves Child female patient who experienced tick with lots of eye blinking, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot UT6259NA via unknown route. On an unknown date, the patient developed a non-serious tick with lots of eye blinking (eye disorder) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. (Other relevant tests included No lab data.) Final diagnosis was tick with lots of eye blinking. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for tick with lots of eye blinking. List of documents held by sender: none
pt recvd vax 29APR93 &4 hrs p/vax devel mild periorbital swelling & a skin rash which MD felt was a mild angioneurotic edema; pt subsequently recovered; No further details were provided;
Violent shivering, migraine headaches, 100 plus fever, body aches, fatigue. Took ibuprofen and Tylenol. Symptoms mostly gone in 48 hours
The patient presented with a raised area on her left arm about 1.5 inches in diameter which was warm to the touch. Additionally the patient had a bruised area on her left arm underneath that area about 1 inch in diameter. She didn't notice anything wrong with her arm until the day following the immunization after she was done showering. She states that the area isn't itchy or painful.
severe soreness of arm - began at 2pm and progressed throughout the night  Fever and chills - began around 10:30pm, fever of 100.7°, broke at 8am Nausea and vomiting - began at midnight and lasted until 6am Muscle/joint soreness - began at 10pm, still ongoing Headache/migraine - began at 4am, still ongoing but lessening  No treatment except ibuprofen for headache and joints
Chills, fever and little nauseous, sore arm. Chills and fever lasted for1 1/2 days,, nauseous about  2 1/2 days, sore arm 3 days. Almost back to normal, no treatment.
(L) arm hot to touch, chills. Swollen (L) shoulder. Pain with decreased (L) shoulder and decreased ROM. No fever, pruritus head, upper trunk body, arms, thighs without lesions. Seen 10/14/14/.
the pain started in the shoulder blade around to the front under the lt arm;the pain moved into the joint in the rotator cuff;pt is currently doing physical therapy & still is unable to raise lt arm;
I had no side effects except a sore arm with both doses of the vaccine. Only this week I started to experience ringing in my ears (tinnitus) and I have never had that before. The only reason I thought it was related to the vaccine was that my husband experienced the same symptoms recently as well and he received both doses of  Moderna vaccine in January. I find it very strange that we are experiencing these symptoms now after more than a month of getting a second dose of the vaccine.
Hives covering entire back, back of neck, behind ears, back of upper legs (thighs).
Pfizer-BioNTech COVID-19 Vaccine  itching at site of injection, resolved after 10 minutes
Patient states that arm is still sore and it has been over 1 month since her shot.
she was really sick; she thinks the nurse put the bolus really close to the bone in her deltoid, she had a black bruise; high fever; Indication: to help with chronic sinus infections; This spontaneous report was received from a currently 55-year-old female patient reporting on herself. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies.  In 1999 reported as " a long time ago when the patient was 33-years-old", she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her deltoid unspecified side to help with chronic sinus infections (product use in unapproved indication) (dose, frequency, route of administration, vaccination scheme, lot number and expiration date were not reported). Subsequently, the patient had high fever (pyrexia), she was really sick (illness). She further stated, she thought the nurse put the bolus really close to the bone in her deltoid. So, she had a black bruise (vaccination site bruising).    The outcome of the aforementioned events was unknown.  Causality assessment was not provided by the reporter.
I received the vaccine 3/12 around 3:00 p.m.  On 3/13 around 4:00 a.m., I woke up with a sharp, localized pain in my right, lateral thigh area.  Within a 15 minute period of time the localized pain moved down my thigh, past my outer knee area, and to my calf.  After approximately 15 minutes the sharpness of the pain subsided.  As far as I know I have had no lasting side effects from this.  I have CRPS/RSD in that leg, specifically in that region, so at the time and with the fever I had, I didn't think too much of this.  REACTION AFTER VACCINE INJECTION:  As an aside, I had some unusual reactions to the vaccine immediately after the injections.  Within 5 minutes of getting the vaccine, I developed numbness in my lips, tongue, and palate and a 'lump' in my throat that made it hard to swallow.  It took approximately 2 hours fpr these reactions to resolve.  I have had these reactions before when I accidentally ingested sugar substitutes.  Also, at approximately 15 minutes post injection, both my ears felt internal pressure (as if I had submerged in deep water) and I could not hear well.  I have never had this reaction before.  This took about 1 hour to resolve leaving me with a moderate headache for 3 days.
This case was reported by a physician via call center representative and described the occurrence of feeling bad in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of adverse reaction. On 28th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st March 2019, 1 days after receiving SHINGRIX, the patient experienced feeling bad and injection site reaction. On 3rd March 2019, the patient experienced red blotches. On an unknown date, the outcome of the feeling bad, injection site reaction and red blotches were unknown. It was unknown if the reporter considered the feeling bad, injection site reaction and red blotches to be related to SHINGRIX. Additional details were reported as follows: The physician reported that a patient who had a previous reaction to ZOSTAVAX received the first dose of SHINGRIX. The patient developed an injection site reaction and reported feeling crummy the day after vaccination. Three days later, the patient developed three erythematous blotches on the arm distal to the injection site. At the time of the call the reporter stated that the blotches had resolved. No additional information, lot or expiration provided. The physician stated that the patient received the vaccination at a pharmacy and he took report on the reaction but did not have the vaccine information or site at the time of the call.
Patient presented for second Moderna booster. Eligible per CDC guidelines, age >50 years; Last booster dose >5months prior.  Patient was inadvertently administered 0.5ml of vaccine rather than recommended 0.25ml booster dose of vaccine.  Patient notified of error.   No adverse events noted after injection, patient waited for 30 minutes prior to leaving clinic.  No adverse events have been reported to clinic staff by patient since administration.
No additional AE details provided.; Medical assistant calling reported he inadvertently administered PROQUAD and VARIVAX concomitantly to a patient.; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. The medical history, drug reactions or allergies and concurrent conditions were not reported.  On 14-JUN-2022, the patient was administered inadvertently a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # W004030, expiration date 02-AUG-2023 (dose, route of administration and anatomical location were not provided) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039949, expiration date 16-DEC-2023 (dose, route of administration and anatomical location were not provided) (accidental overdose). No additional events were reported.
Shortness of Breath, decreased oxygen saturation, irregular heart rhythm, hypertension, Positive for COVID, bilateral pneumonia
hands were swelling every morning, only able to close hands halfway; feet look like they're swelling a little bit; Thumb, index, and middle finger are really sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands were swelling every morning, only able to close hands halfway), PERIPHERAL SWELLING (feet look like they're swelling a little bit) and PAIN IN EXTREMITY (Thumb, index, and middle finger are really sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 002B21A) for COVID-19 vaccination.     No medical history reported by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (hands were swelling every morning, only able to close hands halfway), PERIPHERAL SWELLING (feet look like they're swelling a little bit) and PAIN IN EXTREMITY (Thumb, index, and middle finger are really sore). The patient was treated with IBUPROFEN ongoing since an unknown date for Swelling, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Swelling, at an unspecified dose and frequency and MAGNESIUM SULFATE (EPSOM SALT) ongoing since an unknown date for Swelling, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (hands were swelling every morning, only able to close hands halfway) had not resolved and PERIPHERAL SWELLING (feet look like they're swelling a little bit) and PAIN IN EXTREMITY (Thumb, index, and middle finger are really sore) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received, contains non significant information On 15-Jun-2021: Follow up received, contains no significant information On 06-Jul-2021: Non significant follow up - narrative updated as patient stated that she calling on behalf of brother for safety follow-up.
Nausea and vomiting within 24 hours of injection mild abdominal cramp, headache and low grade fevers. These symptoms lasted 24 hours. Hive-like swelling and tenderness with heat and erythema at injection site that lasted greater than 4 days.
The arm and shoulder was sore, which is not abnormal. I noticed around Nov, my shoulder socket seemed sore. It progressively got worse. I could feel heat on my skin by that shoulder. I couldn't lift it to put my hair in a ponytail, couldn't reach behind to undo my bra. I had to put my left arm in first when I put on a jacket. Couldn't, and still can't sleep on that side. I went to a chiropractor and he was really afraid to touch it. I found Osteo Biflex online and started taking it. It seems to have helped a lot. I noticed when I got the shot that the injection site seemed high.
patient came back to pharmacy to check with pharmacist if tingling on left side of face near teeth-line may be an adr from vaccine. counseled pt on possible adrs and common complications. also made sure pt knew that if this continues to visit provider for check up whether related to vaccine or not. patient did not show s/s of anaphylaxis or any topical reactions or systemic reactions other than tingling on side of face that she wanted to check if related to vaccine. she believed may be tooth related. no injection site reaction either
Patient was given Pfizer covid vaccine instead of Moderna vaccine. No treatment necessary, no further action required.
Around the end of December 2021, I experienced shortness of breath, which continued to worsen. On 12/29/2021, I went to the hospital. I was then admitted into the ER.