chrisvoncsefalvay/vaers-outcomes huggingface dataset:
parosmia; Metallic taste in her mouth; loss of sense of taste; loss of sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), AGEUSIA (loss of sense of taste), ANOSMIA (loss of sense of smell) and PAROSMIA (parosmia) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, DULOXETINE, FUROSEMIDE, OMEPRAZOLE, IBUPROFEN and Elitriptan for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth), AGEUSIA (loss of sense of taste) and ANOSMIA (loss of sense of smell). On 04-Feb-2021, the patient experienced PAROSMIA (parosmia). On 09-Jan-2021, DYSGEUSIA (Metallic taste in her mouth) had resolved. On 04-Feb-2021, AGEUSIA (loss of sense of taste) and ANOSMIA (loss of sense of smell) had resolved. On 27-Sep-2021, PAROSMIA (parosmia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Magnetic resonance imaging: normal (normal) MRI of brain.  Everything returned normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-333434 (Patient Link).; Sender's Comments: This case concerns a 51-year-old, female patient with unknown medical history, who experienced the unexpected non-serious events of dysgeusia, ageusia, anosmia and parosmia. The events ageusia, anosmia occurred after receiving the first dose whereas parosmia occurred after second of Moderna mRNA-1273 vaccine. The rechallenge is applicable for the parosmia events, as the events appeared after second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a pharmacist refers to a currently 67 years old female patient. On 04-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # K009198, expiry date: 27-SEP-2015, 0.65 ml, subcutaneously. The pertinent patient's medical history and drug allergies/reactions were not reported. The concomitant medication included cortisone (reported as used "sometime in the past (unspecified date)"). On an unknown date the patient developed an injection site reaction of redness and pain. The injection site area also felt hard. The patient sought a medical attention and called the pharmacist. There was no laboratory tests performed. The outcome of the events were reported as not recovered/not resolved. The causality between ZOSTAVAX and the events was not reported. Additional information has been requested.
Choking sensation in my throat that lasted for about 5 to 6 hours; Disoriented; Brain fog; Pain at the injection site; Fatigue.
Patient came back to show her left arm, where she was vaccinated, has a red patch about 3 inches long and one inch wide that is slightly swollen. It has gotten more red since the vaccination. The patient is not experiencing arm pain or itchiness.
LOSS OF APPETITE; HEADACHE; FEELS WARM TO THE TOUCH; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included skin allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no drug use or drug illicit usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 14:00 for prophylactic vaccination. Concomitant medications included levothyroxine for drug used for unknown indication.  On 06-MAY-2021, the subject experienced feels warm to the touch. On 06-MAY-2021, the subject experienced chills. On 06-MAY-2021, the subject experienced fatigue. On 07-MAY-2021, the subject experienced headache. On 09-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 11-MAY-2021, treatment medications included: ascorbic acid, ibuprofen, and nicotinamide/pyridoxine hydrochloride/riboflavin/thiamine hydrochloride. On 12-MAY-2021, the subject experienced loss of appetite. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, and fatigue on 12-MAY-2021, had not recovered from headache, and feels warm to the touch, and the outcome of loss of appetite was not reported. This report was non-serious.
Hives on forehead, cheeks and behind ears about 1 minute, post vax.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years 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 included: "Asthma" (unspecified if ongoing). The patient did not have any known allergies. Concomitant medications and other medications in 2 weeks included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; REPATHA; SYMBICORT; ZETIA; BYSTOLIC; BABY ASPIRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Nov2022 to 04Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
vaginal blood clots for 7 days, dizziness, nausea, headache, arm pain, fever, body aches, weakness
Patient complained of blurred vision & dizziness after leaving the  observation room. BP 87/58, HR 94, R 18, T 98.6, O2 sat 97%. Patient was given water and crackers.  Vitals were rechecked. BP 110/69, HR 93, R 18, O2 sat 95%.  Patient stated she was feeling better and was discharged and escorted to family car driven by sister.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 4 year old male patient (child). On 17-JUL-2014 at 09:12 am, the patient might have been immunized with a dose of PROQUAD lot number J015596, expiration date 05-JUN-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Information has been received from a medical assistant concerning a 4 year old female patient who on 01-MAR-2001 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
First two days, swollen supraclavicular node. I still have this. Two weeks later, swollen node under right armpit. I still have this. I had ultrasound and mammogram of breasts. No cancer. One month later I had abdominal pain so my doctor ordered a ultrasound and CT scan. It showed enlarged spleen at 15cm and several pericical lymph nodes measuring 1cm. Waiting to see a hematologist on this issue. Then, July 6th I had a sudden episode of tachycardia reaching 150 bmp. Blood pressure 170 over something. Near syncope. Went to hospital several times until I was admitted. The high heart rate abated but returns as soon as I stand. This comes along with postural hypotension as well according to discharge diagnosis. The hospital did EKG, echocardiogram, 24hr holter, x-ray, chest CT, blood work, and nothing showed up except my EKG was abnormal one time. They didn't really explain. I went to my cardiologist because I couldn't hardly walk after these episodes. The dizziness was so bad and I felt like if pass out if I stood. Dr. said I have POTS, (Postural Orthostatic Tachycardia Syndrome) and they're gonna do more testing. I'm seeing an electrophysiologist soon as well as getting a sleep study. I have started on antidepressants and any anxiety meds since from all this stress. I still have all the symptoms except I can walk now around my house and a little outside.
Child received vaccines and left immunization room.  Fell to floor in waiting area.  Patient pale.  Heart rate 60's.  911 called.  Cool cloth to forehead.  Patient was cohearent (able to tell us where he was and what year it was).  Moved patient out of way of public.  Emergency personnel arrived.  Heart rate 80-90's and color less pale.  Assembly EMT they decided no ER trip necessary.  Patient stood and became dizzy. Heart rate dropped to 60's again.  EMT transported to hospital via ambulance.  RN supervisor notified.
Her first vaccine was hard hot; Her first vaccine was painful for several days.; Her first vaccine was hard hot; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site induration were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth and injection site induration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hard, hot and painful at site for several days. For the tolerability of 2nd dose, refer case US2020AMR063770 reported for same patient.
T/C with mother 8/14/15 stating that left arm red, 2" diameter, itching, swelling. Seen by ER Dr 8/16-antibiotics given.
Pain started in buttocks; then numbness in legs, then progressed up back to mid back pain, then to neck fullness and tightness, pain on both sides of neck, jaw and chin, feeling of something popping in neck and then Bell's Palsy of right side of face, difficulty speaking, eating, numbness of tongue; right eyelid unable to close, more pain on both sides of neck and back of head; cold and hot sensations on limbs today and no improvement of facial paralysis; hearing cricket noises in right ear at times, burning pain in patches of face.
Initial report received from a company representative who had received the original report from a nurse on 16 November 2010. A 6-year-old male patient had received a 0.5 mL dose of FLUZONE (lot number U3744AA) from a multi-vial bottle on 08 November 2010. Approximately 5 days post-vaccination, the parents noticed a facial muscle "tick" in the patient. It was not reported whether the patient required medical evaluation or treatment. The patient's recovery status was not reported. Follow-up information was received from a health care professional on 28 December 2010. The event recovered on an unspecified date. No additional information was reported. Documents held by sender: None.
Left arm edema, syncope, rash - presented to ER 08-02-08.  Immun given on 07-31-2008.
Patient got sick; More than 35 days have passed since he received the first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Patient got sick) and PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days have passed since he received the first dose of the Moderna Covid 19 vaccine) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient got sick) and PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days have passed since he received the first dose of the Moderna Covid 19 vaccine). At the time of the report, ILLNESS (Patient got sick) and PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days have passed since he received the first dose of the Moderna Covid 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient medical history information included no allergies. Patient never tested positive for COVID-19. No treatment information was provided.
the patient was inadvertently administered a dose of PNEUMOVAX 23 that was expired.; This spontaneous report was received from a physician assistant referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On 20-NOV-2019, the patient was inadvertently a dose of expired vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R006465 with expiration date 24-OCT-2019; strength, dose detail and route were not reported) for prophylaxis (expired vaccine used). The outcome of the event was unknown. The causality assessment of the event was not provided.
Less than a week after I received the COVID-19 vaccine, I noticed a shift in my menstrual cycle. I started with only 18 days in my cycle which is off of the baseline for me. My flow is unusually heavy and the symptoms associated with my cycle are accentuated which is not my average normal.
See note enclosed; Patient gave verbal permission; She received a Pneumovax injection yesterday on her left deltoid. It later in the day developed some discomfort, and by this morning. There was redness and swelling. Through the day the redness and swelling has extended down the arm into axilla. There is also itching. There is no fever, chills, or sweats. She is generally pretty healthy, with an elevated cholesterol, history of Graves' disease and osteoporosis.
two days after vaccine 3x3 rash that is red, also arm at site of injection is achy
Acute onset progressive weakness approximately 20Mar2014 -> typical course for Acute Demyelinating Polyneuropathy. Received Tdap on 7Mar2014. Recovering - still residual weakness/neuropathic pain.
The patient's mother reports a rash started 2 hrs after the vax. The patient was seen in the ER with an urticarial rash which was treated wtih DepoMedrol and Benadryl. On 10/10 at office visit, patient still covered with urticarial lesions. The patient was placed on Orapred, Benadryl and Calamine Lotion. On 10/11 the mother of the patient states the rash is improved.
Left thigh swollen to knee, firm, warm and tender to touch, no fever, temp 97.8 deg. F., redness. On 03/28/2002 he was put on Keflex.
Tested positive for COVID. Fatigue, aches, headache, congestion, cough. These symptoms lasted about a week then fatigue for another week. Received Paxlovid treatment on first day of symptoms and testing positive with home test. Also took Advil for headache.
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA220773, 2018SA220774, 2018SA220775 and 2018SA218532 (same reporter). This case involves a four years old patient (four years three months old, gender not reported) who experienced patient received a dose of PENTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on 24-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
He seemed to be stiff (arms out stiff) and was not coherent sitting in the chair. We called out his name and he came to. Acknowledged us. He broke out in a sweat all over is body and said both arms were tingling. We set him in the back room and gave him a old pack and water. We took his blood pressure and heart rate. It was 100/76 and 57 bpm. Waited 10 minutes and it was 107/78 with a heart rate of 56 bpm. He said he was a runner and this was normal for him. Also give him a candy. After about 40 minutes he said he was feeling good and had a ride home.
became unresponsive, intubated in the field with CT images revealing a diffuse SAH, IVH, cerebral edema, brain compression, possible aspiration pneumonia o Admit to NICU s/o Doctor o Consult Doctor for CC o Neuro checks q1h o SBP < 110 o Mannitol 50g IV x1 stat than 3% HTS for NA goal 145-155 o EVD placement ASAP o Amicar 5g stat o COVID PCR negative o Labs/ medications as ordered o SAH protocol o Plan for cerebral angiogram and possible coiling in am with Doctor.
About an hour after the 2nd dose, I started to feel faint/dizzy/tired/nauseous.  After a day, I noticed arthritic pains in both shoulders.  The left arm joint pains went from shoulder to finger tips (prior, I was being treated for stiff finger joints in my left hand).  Since the shot, most of the problems have gotten better, but I'm still left fatigued most of the time, and have slightly increased swelling in my left hand fingerjoints.
Several large bumps on face.  At first I thought acne, but now doesn?t look like acne
A report has been received from a Health Professional concerning a 30 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient experienced positive influenza A. The patient recovered from the event of tested positive for influenza A on an unspecified date. The report was considered to be non-serious.
Pt woke 1 hour after going to sleep screaming uncontrollably. After calming down, was in a "dazed state" and did not respond to Mom for about 20 mins. held her head cocked back at an angle. No color change. No tonic-clonic activity. After finally becoming responsive, went back to asleep and slept hard the rest of the night.
This spontaneous report was received from a physician, reporting on her daughter, a 13 year old female patient. Medical history and concurrent conditions were not reported. In 2013 (reported as on an unspecified date last year) the patient was vaccinated with the second dose of GARDASIL (dose, strength, lot number, expiration date and route were not reported) for vaccination. Co-suspect and concomitant therapies were not reported. The physician reported that on an unspecified date, since dose two of GARDASIL was administered her daughter was diagnosed with molluscum contagiosum. Diagnosed by a dermatologist. At the time of the report the outcome was unknown. Patient seek medical attention with a dermatologist. Additional information has been requested.
Just a round circle. It was warm to the touch and had a small lump at the site of the injection. It was very sore for 3 days especially if you bumped your arm. But, I had no sick symptoms at all so it was worth getting the injection. Of note: on my 1st injection I had no problems.
ear ringing; Fever; headache; arm soreness; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 07Jun2021 at 18:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously 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 17May2021 at 12:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jun2021 the patient experienced fever, headache, arm soreness and fatigue. On 10Jun2021, on day 3, the patient experienced ear ringing. No therapeutic measures were taken as a result of the reported events. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, headache, arm soreness, fatigue and ear ringing were 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.
MALIASE SORE THROAT LARGE HIVES ON FACE AND TRUNK ITCHY ENTIRE BODY
fever; chills; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 14Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. In Jan2021 over the weekend, patient had fever and chills and took Tylenol and seems to be fine now. The patient asked will she get the same reaction to her second dose? Will she be ok after the symptoms pass? The outcome of the events was recovered.  Information about lot/batch number has been requested.
Red, sore, swollen, bumpy patch at injection site.  It is hot to the touch as well.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age (reported as older than 60 years of age). No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in approximately 2013, reported as 4 years ago, the patient was vaccinated with the first dose of ZOSTAVAX one dose (dose, route of administration, lot# and expiration date were not reported). On an unknown date, after vaccination the patient developed shingles. On 11-OCT-2017, the patient was vaccinated with the second dose of ZOSTAVAX. No adverse effects were reported after the second dose of ZOSTAVAX. The outcome of shingles was reported as recovered on an unknown date. No causality assessment was provided by the reporter.