chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of taste; loss of smell; symptoms similar to a sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SINUSITIS (symptoms similar to a sinus infection) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SINUSITIS (symptoms similar to a sinus infection). At the time of the report, AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SINUSITIS (symptoms similar to a sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    This case was linked to MOD-2021-016188 (Patient Link).
Fever - 103 deg F, night of day on which the immunization was given. Local reaction-redness, swelling -BIL.
Cellulitis-like reaction (red, hot to the touch, inflamed, tender, painful) in left arm at injection site reaction down to his elbow.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-JUL-2016, the patient was vaccinated  with ZOSTAVAX 19400 PFU, 0.65 milliliter (ml), once, subcutaneously. Concomitant medications were not reported. On 07-JUL-2016, the patient experienced swelling and redness that localized at injection site. The patient sought medical attention and was seen in the pharmacy. NO treatment was given to the adverse events. The outcome of swelling and redness that localized at injection site was unknown. Product quality complaint (PAC) was not filed. Causality assessment was not provided. Additional information has been requested.
Patient states that after he left the PHD IZ Clinic, he kept a previously scheduled PCP appointment. At that appointment, he was told that his BP and HR were both elevated. He denies ever having issues with BP or HR in the past. He is feeling better this morning
Acute onset of vertigo brought on by rapidly rotating head to right or rapidly going from lying to standing.  Do NOT occur in absence of these rapid head movements.  Episodes last approximately 3-5 minutes.  No intermittent headache, nausea, vomiting, or other symptoms.  This has continued daily since onset 3 days ago.
HAVE LIMITED MOVEMENT OF MY LEFT HAND, VERY, VERY WEEK. SOMETIMES SHAKES VILANTLY
She got her vaccine, didn't have any reaction at all until early Monday morning when she had real pain in her arm, and had a big red knot.  She called her doctor who put her on antibiotics for 5 days and a Z-pack, and after it went away it left a really red blotch on it.  It is now just going away at this point.    She did have some other vaccines after that and had normal fever for 12 hours after the COVID vaccine.
Both feet were so swollen I could no longer tell I had ankles.  Some minor discomfort in left foot
Within 3 weeks of vaccine pt developed a tremor in her right hand and numbness began in both heels.  Pain and numbness began to creep up both legs over the course of time , month or so.  Both feet became numb.  By October , Shooting pains up to knees and painful to the touch.  Pain increases with walking or trying to engage in any activity. Pt was unable to participate in usual activities.  She was very athletic and active prior.  Could not complete a swim practice because pain was debilitating.  She still is unable to run any distance or take long walks with out pain and weakness flaring up.
Information has been received from a medical assistant concerning a 49 year old patient who on 13-NOV-2009 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23. Subsequently, the patient experienced redness, warmth and swelling at the injection site. The patient visited the office for medical attention. No laboratory diagnostics studies were performed. At the time of the report, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Dizziness, headache, lower back pain, achy feeling on skin and joints, tinnitus in both ears, slight hearing loss in right ear.
Tachycardia, shakiness, shivering from cold, jaw discomfort, throat feeling of swelling, elevated BP, dizziness - given food and water, uncomfortable laying down, when symtoms did not subside after one hour was given 25mg Benadryl which helps relieve fast heartbeat and throat discomfort.
Vomiting, lethargy, headache, body aches, hives, chills, fever, shortness of breath
I received the Covid19 vaccine on 12/22 @ 7:00 pm.  On 12/23 ~1200 pm, I had a headache that lasted for about 12 hours.  I took Tylenol and Motrin and it went away the next day but came back again on 12/24 @ 6:00 pm.  On 12/25, 12/26, and 12/27, I just felt unwell.  No symptoms but felt unwell and had shortness of breath while walking.  I usually walk about 10 miles daily without issue but on those 3 days, I had to take breaks and was not able to walk an talk at the same time.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Nov-2021 at 1:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 03-Nov-2021 at 1:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  The excursion time on initial supply was 10am, temperature was 35, total 117 doses were administered for that day, vaccine was not frozen prior to administration. Vaccine moved to fridge on 05-Oct-2021 and moved to clinic on 03-Nov-2021. 06 vials were sent to the clinic. BUD date was 05-Nov-2021. Vials only punctured right before administration.  Vial was stored on cooler 1 , on 22-Oct-2021, Excursion duration At 8 AM: 32, 9 AM: 32 and 10 AM: 32.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient was seen lying on his side and appeared pale. Patient stated he was hungry, dehydrated and sleepy due to lack of food and sleep. Paramedics were called with no abnormal findings of vitals. Patient left pharmacy after 15 minute observation period with a caregiver.
On 7/22/22 at 11:00, this patient presented with 3 other siblings for physical exams and immunizations. This patient did not have any record of immunizations. No record of immunizations, except for Covid Pfizer was noted. So medical provider ordered for patient to get patient immunizations updated for school purpose. At this visit, patient was vaccinated for Tdap, IPV, Hep A, Hep B.  He received the IPV and Hep A in his left deltoid IM and the Tdap and Hep B in his right deltoid IM. There was no adverse reactions noted after injections, patient tolerated all injections well. Pt only complained of pain due to needle injected into his deltoid muscle, but he was observed for 20 minutes after these injections and did well, no adverse reactions observed by this RN and no other complaints from this patient upon discharge from the clinic after receiving injections.
Within 2 hours of receiving booster shot, the following symptoms began: (1) rapid heartbeat, (2) neck pain, (3) joint pains (shoulders, elbows, wrists, fingers, hips, knees, ankles), (4) severe headache emanating from base of neck up through to forehead & eyes, (5) severe facial swelling.  Initial treatments included 200mg Benadryl, 800mg Advil around the clock; Emergency Room visit necessitated on 23 October due to surge in all symptoms and continued non-responsiveness to over-the-counter treatments; Began 5-day methylprednisolone pack on 24 October with 60% reduction in swelling, 50% reduction in joint pains, 90% reduction in headaches; All symptoms returned 01 November; Began 10-day prednisone on 03 November
MILD ITCHING BEGAN 10 MINUTES AFTER RECEIVING INJECTION, PROGRESSIVELY WORSENING.  DENIES DIZZINESS, WEAKNESS, SHORTNESS OF BREATH, CHEST PAIN OR DISCOMFORT, NAUSEA, VOMITING, WHEEZING.  NO RASH, SWELLING OF FACE OR THROAT, OR BODY,  NO FAST HEART BEAT OR DIFFICULTY BREATHING.
Shingles in eye; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles in eye) in a 47-year-old male patient 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 HERPES ZOSTER (Shingles in eye). At the time of the report, HERPES ZOSTER (Shingles in eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Samcyclovir   This case was linked to US-MODERNATX, INC.-MOD-2021-065635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065635:Cross-linked
Numbing; Tingling/ pricking swollenblue hands; pricking swollenblue hands; pricking swollenblue hands; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Aug2021 at 12:15 as a single dose for COVID-19 immunisation. Medical history included Hasimoto's disease. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown date for unspecified indication and unknown if ongoing. On 01Sep2021 at 18:45, the patient experienced numbing, tingling and pricking swollen blue hands. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbing, tingling, pricking swollen and blue hands was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a 32 year old female with a history of migraine headaches, PENICILLIN allergy, hypersensitivity to "quinones" and SULFONAMIDE allergy who on 06-JUN-2008 was vaccinated IM with the first dose of RECOMBIVAX HB (lot# 656680/0218U) (site not reported).  Concomitant therapy included RELPAX and KLONOPIN.  On 06-JUN-2008, the nurse reported that the patient experienced numbness and tingling of her face and tongue, a flushed feeling and nausea within 20 minutes of her vaccination.  There was no swelling or shortness of breath.  The patient sought medical attention at the office.  The patient recovered within 6 hours of the onset of symptoms without requiring treatment.  No further information is available.  Follow-up information was received on 04-AUG-2008 by the caller stating that she had received a second letter from product safety.  The caller has filled out the first letter and has no additional information to report.  The caller does not want to be contacted further.
Pain in Back between shoulder blades; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in Back between shoulder blades) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced BACK PAIN (Pain in Back between shoulder blades). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Pain in Back between shoulder blades) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.
5 to 6 hours after receiving BEXSERO IM in left deltoid the left arm became swollen and red from shoulder to elbow. Pt. also developed generalized body aches, low grade fever, chills and nausea lasting 48 to 72 hours.
Pain and limited range of motion in left arm for 4 days, pinkeye in right eye for 3 days, extreme fatigue for 2 days
muscle soreness in arm Narrative: Patient stated that he had some muscle soreness after vaccination for one day. Symptom resolved.
Lot number ???:  Vol 0.3ML  Hives: Hundreds of raised skin tone itching bumps between knees and neck on all parts except gentles  Still occurring, Has not subsided 24 hours later.  Treating with OTC 1% Hydrocortisone.  Little effect.
Wife called and reported since 11/14 evening time patient was feeling extremely dizzy and has been throwing up. It continued into the morning (11/15) and patient was still feeling dizzy, nauseous and vomiting. Told wife to make sure patient stays hydrated due to constant vomiting and that if it persists to call PCP on next course of action.
injection done too low; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (injection done too low) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (injection done too low). At the time of the report, ACCIDENTAL UNDERDOSE (injection done too low) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. Other medication in 2 weeks. Paxlovid started on 04Jan2023 and stopped on 08Jan2023 for COVID 19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother called in the office due to inconsolable crying after vaccination (over 3 hours). Advised mother to bring the patient in to the office.  Patient was seen at the office @ 5:30 pm. General appearance: ill-appearing, uncomfortable due to pain, tearful, irritable 6/10, crying.  Skin: site of injection: Right 2 injection sites no swolling or iduration, Left 2 injection sites (Dtap/IPV from the record) remarkable swolling and tenderness, size 5x3cm. Tylenol infant 1.25ml given at 0545PM. Instruction for Tylenol given as well. Advised mother to continue Tylenol every 4 hours for 24 hours. Call to the office if patient's symptom is not resolved or other symptoms appears next 24 hours.
This spontaneous report was received from a Physician and refers to unspecified patients of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since September 2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004890 with expiry date 10-NOV-2017) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M004890 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 8 hours and a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for a cumulative time frame of 16 hours on different days since 29-SEP-2016 to 13-FEB-2017. Maximum individual time frame was reported as 60 minutes. There was no previous temperature excursion. The call was not because of data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005436: US-009507513-1705USA005435: US-009507513-1705USA005437: US-009507513-1705USA005438: US-009507513-1705USA005439: US-009507513-1705USA005462: US-009507513-1705USA005463.
No additional adverse event; Rotateq was improperly stored and administered; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's, pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 20-JAN-2021, the patient was vaccinated with improperly stored dose of  Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dose, route of administration, anatomical location and vaccine scheme were not provided), lot number: 1687012 has been verified to be a valid lot number, expiration date was on 08-JUL-2021 as prophylaxis (product storage error). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 50 Fahrenheit (°F), for a time frame of 1 hour.  A digital data logger was involved. There were no previous temperature excursions reported.
Achy feeling spread from site of vaccination (arm) to entire chest. For a week and a half, couldn't run or do any exercise as the flexing of muscles, arm movement, and any touch or pressure to my chest resulted in my ribcage feeling like it was about to crack. (Pushups were impossible). Breathing was not affected, just hurt a bit on very deep breaths. I will not continue vaccine.
This spontaneous report was received from a Licensed Practical Nurse referring to an unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since 12-NOV-2015, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot Number reported as L026403, expiration date 15-JUL-2017), dose, route and anatomical location were not provided. No concomitant medication was reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Whelps to lt forearm; 2-3cm in size; states noticed them last noc when got up to use bathroom; denies itching; adviced to go to Pharm & buy DPH;
Redness near injection site; patient indicated that what I was observing on the 16th was "secondary" and it had been worse and that she had already taken BENADRYL. Area of redness appeared to be 3 inches in circumference and located a few inches away from injection site on the 16th.
Made my husband and I sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient was sick and did not took second dose.  The follow-up could not be possible as no contact details were available Additional Supportive Information: The case had been linked with US2022AMR116798 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022AMR116798:Same reporter (Husband case)
severely swollen, red, warm & rash @ inj site rt leg 21SEP97 tx amoxicillin & DPH;
Shortness of breath; Fatigued; Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes; Slurred speech for 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes), DYSARTHRIA (Slurred speech for 20 minutes), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigued) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 26-Dec-2020 and Transient ischaemic attacks. Concurrent medical conditions included Colon cancer and Diabetes.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HYPOAESTHESIA (Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes) and DYSARTHRIA (Slurred speech for 20 minutes). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and FATIGUE (Fatigued). At the time of the report, HYPOAESTHESIA (Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes), DYSARTHRIA (Slurred speech for 20 minutes), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications includes Blood thinners.  No treatment information were reported.