chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on arm; Sleepy; Light tingle in right fingers / arm; Tip of tongue felt numb; High pitched sound; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), PARAESTHESIA (Light tingle in right fingers / arm), HYPOAESTHESIA ORAL (Tip of tongue felt numb), TINNITUS (High pitched sound) and RASH (Rash on arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029M21A) for COVID-19 vaccination.     No medical history information was reported.     On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced SOMNOLENCE (Sleepy), PARAESTHESIA (Light tingle in right fingers / arm), HYPOAESTHESIA ORAL (Tip of tongue felt numb) and TINNITUS (High pitched sound). On 14-Mar-2021, the patient experienced RASH (Rash on arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) ongoing since an unknown date at an unspecified dose and frequency. On 06-Mar-2021, PARAESTHESIA (Light tingle in right fingers / arm) and HYPOAESTHESIA ORAL (Tip of tongue felt numb) had resolved. On 07-Mar-2021, SOMNOLENCE (Sleepy) had resolved. On 19-Mar-2021, RASH (Rash on arm) had resolved. At the time of the report, TINNITUS (High pitched sound) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided.
Intermittent ringing & loud buzzing of Left ear; This is a spontaneous report received from a contactable other Health care professional. A 58-Year-old non-pregnant female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Mar2021 at 16:00 as single dose in arm left for covid-19 immunization. Relevant medical history included Allergies to medications, food, or other products: Sulfa. Concomitant medications included an unspecified medication. Past drugs included Amoxicillin with allergies to amoxicillin, Vicodin with allergies to vicodin, Codeine with allergies to codeine. On 08Mar2021 at 11:00, the patient experienced Intermittent ringing & loud buzzing of Left ear. The patient did not take any treatment for the event. The outcome of the event was not resolved.  Information on the lot/batch number has been requested.
All tendons and muscles throughout entire body aches.  Gradually getting worse each day. Face has irritating itching like I was allergic to medication.
This spontaneous report was received from a health care professional refers to a 2 month old patient of unknown gender. On 24-JUN-2015 the patient was inadvertently vaccinated with PNEUNOVAX 23 (dose, route, frequency and lot 3 unspecified) instead of the intended doses of PREVNAR 13. No adverse effect reported. No product confusion reported. The outcome of wrong drug administered was unknown. There was no product quality complaint involved. Additional information has been requested.
Booster dose SHINGRIX caused near syncope, extreme weakness, fever, chills, vigor.
No additional AE reported; Caller reports expired dose of PROQUAD was administered. No temperature excursion on the vaccine. No additional AE reported, no PQC reported. Please note vaccine was administered to a set of twins with same initials, this AE is for twin #2; AE for tw; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 12-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T034825, expiration date 11-APR-2022 (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.  This is one of 2 cases notified by the same reporter. The other case refers to the patient's twin.; Sender's Comments:  US-009507513-2204USA004793:
pt recv vax & had an unspecified adverse exp;no further info was available @ the date of this report;
Fever 101F. Body aches. Fatigue, headache unable to go to work and because I'm still running fever on day two I will not be going in tomorrow.
appendix removal; trying to reschedule their 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (appendix removal) and PRODUCT DOSE OMISSION ISSUE (trying to reschedule their 2nd dose) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SURGERY (appendix removal) and PRODUCT DOSE OMISSION ISSUE (trying to reschedule their 2nd dose). At the time of the report, SURGERY (appendix removal) and PRODUCT DOSE OMISSION ISSUE (trying to reschedule their 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
PATIENT COMPLAINED OF NAUSEA AND VOMITTING, ALSO SWELLING AND ITCHING AT THE SITE OF INJECTION. ON EXAM THERE WAS A 5CM INDURATION ON THE DELTOID OF LEFT ARM. PATIENT WAS TREATED WITH DIPHENHYDRAMINE 25MG
Rash consistent with measles from head to toe spared palms and creases. Had fever 103 degrees F for one day. Stated 9 days after immunizations.
Several patches of  itching skin rash on left arm, left foot and ankle, right arm, and right and left hands.
muscle stiffness, headache, tired, nasal congestion, swollen arm took tylenol
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with ROTATEQ which had been exposed to temperatures outside of the recommended range, (lot # K013868, expiry date 27-MAY-2016; lot# K020182, expiry date 25-JUN-2016), orally, (dose and frequency not reported). No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
I have swelling under my arm (lymph node) after receiving second dose of the Shingrix vaccine.
Started with flu like symptoms, after 3 days my left arm would swell slightly, become red/warm, and itchy at injection site.  At 1 week I began feeling extremely worn down, exhausted, short of breath after moving at all, coupled with a slight fever and continuous nausea.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Since 25-JUL-2014, the patients were vaccinated with ROTATEQ (lot#, expiration date, route, frequency and dose were unknown) which had been improperly stored. No adverse effects were reported. This one of several reports from the same reporter. Additional information has been requested.
woke up at 2am; chills; sweating; body ache; skin sensitivity; vomiting; extreme fatigue; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 25Mar2021 12:00 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRON 2CARE4; PRILOSEC [OMEPRAZOLE]; DOXEPIN; BUPROPION. Vaccination history included: Bnt162b2 (Dose 1, Single, Administration time: 12:15 PM, Vaccine location: Left arm), administration date: 04Mar2021, when the patient was 28 years old, for Covid-19 immunisation, reaction(s): "extreme fatigue". The following information was reported: FATIGUE (non-serious) with onset 25Mar2021 16:00, outcome "recovering", described as "extreme fatigue"; MIDDLE INSOMNIA (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "woke up at 2am"; CHILLS (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "sweating"; PAIN (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "body ache"; SENSITIVE SKIN (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "skin sensitivity"; VOMITING (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of fatigue, middle insomnia, chills, hyperhidrosis, pain, sensitive skin, vomiting. Additional Information: The patient has not been diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination. The patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021348086 same patient/drug, different doses/events
On 1/2/2021, patient experienced itchiness and soreness at injection site left deltoid. The following day, patient noted redness, swelling, and warmth to touch. Denies bruising or numbness/tingling to left upper arm. Denies shortness of breath, no fevers, etc.
Itching; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08May2021 at 12:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient had known allergies to shellfish, sulphur and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included metformin hydrochloride/ sitagliptin phosphate monohydrate (JANUMET); olmesartan (MANUFACTURER UNKNOWN); hydrochlorothiazide (MANUFACTURER UNKNOWN) and loratadine (CLARITIN); all for unknown indications, from unknown dates and unknown if ongoing. On 08May2021 at 13:00, the patient experienced itching. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itching was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Presented to ER on 1/16/17 with (R) leg pain and warmth to upper thigh. Sitter had child transported to ER, by EMS due to crying/? unable to move leg.
episode 1  exercising knees gave out and vision was distorted for 30 minutes gradually returning to normal. left eye  MRI, EKG, Blood Work, ultrasound of neck episode 2  distorted vision in both eyes lasted 30 minutes ocular migraine, TGA confusion treated for stroke at ER for blood work. EKG, CT Scan Chest X-ray, strength test.  vision had spot in central vision.  Eye Doctor confirmed eye and nerves are fine, referred to neurologist if spot in vision remained.  have another MRI scheduled thru Neurology 9/28/21
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 11:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 73.37  Concomitant products were not provided.  On 27-Mar-2021 vials were moved to clinic. On 23-Mar-2021 the vaccines were moved to fridge. On 28-Mar-2021, the vial underwent the excursion on the following timings: at 10 AM temperature was 35. The vaccine beyond use date was reported as 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician concerning a 4 year old female who on 15-MAR-2007 was vaccinated with a 0.5 mL dose of ProQuad. Concomitant vaccination administered that day included a dose of poliovirus vaccine, a dose of DTaP (+) tetanus toxoid and a dose of hepatitis A (manufacturer unknown). Subsequently the patient developed a fever of 103 and blisters at injection site that lasted 3 days. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. It was reported that the patient had a similar experience after vaccination with varicella (WAES#0706USA01159)
?Moderna COVID-19 Vaccine EUA? Localized raised bumps with itch at injection site. Self-report as minor and no additional symptoms. Took 25mg OTC benedryl by mouth at advice of medical provider.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. NO concurrent conditions, medical history or concomitant medication were reported. On 07-DEC-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L0124458 and an expiration date of 11-FEB-2017 (route and anatomical location of administration were not reported). The sum of hours in excursion was 8 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported not product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
I have been vaccinated with the Pfizer vaccines, 1 Pfizer booster; positive Covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), as dose number unknown, (booster), single (Batch/Lot number: unknown) for covid-19 immunization; 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I have been vaccinated with the Pfizer vaccines, 1 Pfizer booster"; COVID-19 (medically significant), outcome "unknown", described as "positive Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took your drug Paxlovid last week for 5 days after a positive Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional info: Patient reported, I took your drug Paxlovid last week for 5 days after a positive Covid test. I am a 71 year old female with no underlying conditions except my age. I had been vaccinated with the Pfizer vaccines, 1 Pfizer booster, and 1 Moderna booster. I was pretty sick with typical Covid symptoms and your drug seemed to help since I recovered within a week. However, I had an extreme nasty taste in my mouth the entire time I took Paxlovid. It was at times unbearable but I did not stop usage. Try to fix this issue. CEP Number:  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
He got his vaccine, he did not feel the shot.  There was no pain and he started having some pain afterwards.  Around 10:00 PM his wife was in the ER and he could not see her and waited to see her, and around 7:30 he started coming home and he started having chills.  He was shaking some, and got off the freeway, came home, got inside the house and started shaking like a human vibrator and his feet was shaking like he was dancing, and was moving.  His grandson told him to sit down, and continued to shake and was cold.  He went a laid down and his family got him some blankets and they took his oxygen level and his pulse rate was 139, he had no fever, and was sweating like a pig.  He was feeling really bad, but cold at the same time.  He started feeling some chest discomfort, not pain but felt something different.  He was shaking from the cold, extreme cold, freezing cold.  He called his doctor who did not give him anything to take.  He did not take anything as he could not swallow as he was shaking so bad.  His wife is on oxygen at home, so his family put him on some oxygen and it did help some.  He is not having the chills anymore, and he has loss of appetite, but that is not unusual for him.
I awoke the next day with such all-over, debilitating body ache, that I could barely move.  I could barely walk.  I treated myself with 2-Tylenol every 4-hours and 1-Advil every 6 hours.  I awoke on 4/30 with the symptoms having lifted.
On 9/14/2004 client received Dtap #5, IPV #4 in right arm and MMR #2, HEP A #1 in left arm. On 9/15/04, mom states child's right arm was red and hot. On 9/16/04, mom states child's right arm was red and hot down to her elbow. Mom took child to ER, ER doctor prescribed Keflex and Benadryl. Child was afebrile.
Flushing of skin. Reddness in neck and left arm. Itching in left arm and left side of neck. Given 50mg Benadryl po.
Female patient 33 years old vaccinated with second dose Pfizer EW0179, administration time 4:11 pm. Reports sweating in lower and upper extremities. Saturation 98%, P: 77/min, B/P 90/60, Dxt. 74. Temperature: 33.2 C
DIED; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number were not reported, expiry Unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20220412702-COVID-19 VACCINE AD26.COV2.S-Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient received .3 ml of Pediatric Pfizer(orange cap).  No adverse events noted.
I started off with typical symptoms: swollen lymph node (right armpit), migraine, chills, body aches/ joint aches in knees and legs and a fever. I had taken Tylenol extra strength every 4-6 hours which seemed to help. A day and a half after my second vaccine (4/23 2:00 AM), I started having diarrhea and vomiting (intensely). I had two vasovagal syncope episodes, each about 30 min from each other, I am not sure how long I was unconscious either time. It is 4/23 today at 12:14 PM and I am still not able to stand without fainting or vomiting. My fever is gone now, but I am still having hot flashes/ chills/ body aches/ nausea.
Mild headache, mild vertigo, aches and pains, in particular upper body joint pain through the shoulders (that felt different from fibro fog), and congestion. Waking up the next day I had some pretty severe congestion and was experiencing gross motor control problems, I felt like everything was in slow motion. The next day I woke up and the body pain was much better. I was fatigued. Cognitively, I was not thinking straight. Waking up Tuesday, I was still tired but acting more like myself with a mild headache.
day of: queasiness, tightness at site of injection 1 day after: heaviness/weighed down, headache, queasiness, sore arm 2 days after: muscle aches, loss of appetite. night time: arm hurts 3 days after: loss of appetite, arm has raised rash about 3"x4" near the site of injection -hurts like a bruise, itchy, warm/hot 4 days after: rash symptoms same as above 5 days after: rash is beginning to dissipate, still itchy at times
Mom stated left arm was red and swollen injection area and warm to touch. Nausea and vomiting. Mother was instructed to use cold compress on area and Tylenol and Motrin alternating.
12/28/21 presents to ED for "acute onset n/v for 1 day". PMHx of "HTN, DM 2, HLD, breast cancer, hiatal hernia, frequent falls, SDH, SAH
This spontaneous report as received from a registered nurse refers to an approximately 6 month old patient. In August 2013 the infant was vaccinated with a dose of VAQTA (dose, lot# not reported). No adverse effects reported. Additional information is not expected.
Administered incorrect dose of hep A - and there was a syringe failure - so only half dose was administered (disconnected at hub).