chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient is currently pregnant; sick; Covid; Covid; headaches; sinus infection; most of taste and smell for 4 days; most of taste and smell for 4 days; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old pregnant female patient. A 26-year-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number: EL9269) via intramuscularly in left arm on 13Feb2021 at 10:30 AM (at the age of 26 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number: EL9269) via intramuscularly in left arm on 13Feb2021 at 10:30 AM as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was currently pregnant (4 months) at the time of vaccination. Patient did not have covid prior vaccination. On 19Sep2021 at 9:00 AM, the patient experienced Mild headaches, most of taste and smell for 4 days, sinus infection like symptoms, on 20Sep2021 she had been sick with Covid week of 20Sep2021 and 27Sep2021 with covid. Patient visited clinic due to event. The patient did not received treatment. The lab data included Nasal Swab (Bionex) result was positive on 21Sep2021. The outcome of the events were recovered.
Immediate feeling of vaccine - felt pressure in throat, chest and tingling in thighs; less than 5 minutes later I was very nauseous; when I arrived home 20 minutes later pain was beginning in my head and torso and the nausea was still present. I have never had any side effect from any vaccinations other than pain and soreness in the injected arm and once swelling at the site. I have a high threshold for pain. The pain and nausea were so bad I laid down for the rest of the day not feeling well enough to do anything around the house. This intensity lasted the day of the vaccination and all the next day. On the third day the pain went away except for the area surrounding the site but it was minimal by then. The nausea, however, continued through that third day. This is the fourth day and I still have lingering nausea though it is not keeping me from doing minor things around the house. Because these side effects were listed in the pharmacy printout and I at no time felt in any danger I did not seek medical help. I only make note to your organization for future purposes with the vaccine.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/11/2023 HX OF ESOPHAGEAL CANCER J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/24/2023 HX OF ESOPHAGEAL CANCER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/11/2023 ATHEROSCLEROSIS OF AORTA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/24/2023 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/11/2023 ANEMIA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/24/2023 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/11/2023 SHORTNESS OF BREATH J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/24/2023 SHORTNESS OF BREATH
Bleeding nose; Light sensitivity to eye; Special Population : Younger than 18 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Special Population : Younger than 18 years old), EPISTAXIS (Bleeding nose) and PHOTOPHOBIA (Light sensitivity to eye) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Special Population : Younger than 18 years old). On 22-Mar-2021, the patient experienced EPISTAXIS (Bleeding nose) and PHOTOPHOBIA (Light sensitivity to eye). On 20-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Special Population : Younger than 18 years old) had resolved. At the time of the report, EPISTAXIS (Bleeding nose) and PHOTOPHOBIA (Light sensitivity to eye) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This report refers to a case of product administered to patient of inappropriate age (14 year old male) for mRNA-1273 (lot number 007B21A) with associated AEs reported as sensitivity to light and bleeding nose two days after vaccination and causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Added reporter name and Email ID. Updated outcome of the events as recovered. On 03-Jun-2021: Contains no new information.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (14 year old male) for mRNA-1273 (lot number 007B21A) with associated AEs reported as sensitivity to light and bleeding nose two days after vaccination and causal relationship cannot be excluded.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 23-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took the Paxlovid treatment from 15Jul2023 to 19Jul2023.  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-202300256132 Same patient, different drug, different event;
Approximately 4 days after receiving the first Pfizer COVID vaccine, I had a rash.  It was all over my body but primarily on my chest and abdomen.  I have no way of knowing if it is tied to the covid shot but I have had numerous tests. Although the rash is not as pronounced now, it still comes and goes.  And there is a slight redness under my skin.  I have been to several different doctors and had numerous tests.
Acute brain stem stroke; Lost vision in both eyes; Lumps on biceps of both arms; Couldn't swallow; Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN STEM STROKE (Acute brain stem stroke) and BLINDNESS (Lost vision in both eyes) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and LOSARTAN for Blood pressure management, ATORVASTATIN for Cholesterol, POTASSIUM for Hypokalemia.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BRAIN STEM STROKE (Acute brain stem stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (Lost vision in both eyes) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Couldn't swallow) and COVID-19 (Covid-19). In February 2021, the patient experienced NODULE (Lumps on biceps of both arms). The patient was hospitalized on 22-Jan-2021 due to BLINDNESS and BRAIN STEM STROKE. On 01-Mar-2021, BLINDNESS (Lost vision in both eyes) had resolved. At the time of the report, BRAIN STEM STROKE (Acute brain stem stroke), COVID-19 (Covid-19) and NODULE (Lumps on biceps of both arms) outcome was unknown and DYSPHAGIA (Couldn't swallow) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Covid-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
No problems at time of administration.  Pt noted discomfort and especially itching after the dose, and the itching lasted for several months and still occasionally occurs at the site.
9/27/11 - 09:15 - pt reports pain & swelling at injection site. Advised to apply ice to site. 15:45 - pt reports pain worse & spread to upper chest area. Advised to seek medical attention. 18:00 - contacted pt - reports pain & swelling reduced. Did not seek medical attention. Wife is with him to watch: advised to seek attention if sx worsened.
Noise in inner ear, plugged sensation, pressure build up in ear canal. Ear examination shows normal results but issue has remained constant for over 2 months now.
10 MINUTES OR SO AFTER RECEIVING PFIZER VACCINE, PATIENT DEVELOPED TINGLING AND NUMBNESS ON HER LEFT ARM. SHE RECEIVED COVID VACCINE IN LEFT ARM.
Seen at clinic by PA 12d. Post vaccination with macular rash (5mm) over entire trunk. PE unremarkable except for rash.
Caller was Pharmacist. Caller reported AE for Patient.   As confirmed by Caller at current call time, Patient who was administered 1st GARDASIL 9 Dose 'a year ago' for Corresponding 3 Dose GARDASIL 9 Series had not yet been administered Correspondi; No adverse event; This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  In February 2022 (reported as "a year ago"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (route, lot number and expiration date were not reported), for corresponding 3 dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series. By the time of reporting, the patient had not yet been administered corresponding 2nd hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose.    No adverse events were reported.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen) and PAIN IN EXTREMITY (arm is sore/ARM HURTS) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The patient's past medical history included Asthma, GERD, Overactive bladder, Hypothyroidism, Constipation and Mitral regurgitation. Concurrent medical conditions included Pain, Allergic reaction to drug, Allergy to chemicals and COPD. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 04-Nov-2014 to an unknown date for Allergy, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from 25-Feb-2021 to an unknown date for GERD, LEVOTHYROXINE from 05-May-2008 to an unknown date for Hypothyroidism, OXYBUTYNINE [OXYBUTYNIN] from 02-Mar-2008 to an unknown date for Overactive bladder, TRAZODONE and oxybutazone. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen) and PAIN IN EXTREMITY (arm is sore/ARM HURTS). On 08-May-2021, PERIPHERAL SWELLING (arm is swollen) had resolved. At the time of the report, PAIN IN EXTREMITY (arm is sore/ARM HURTS) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product included pain medication. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: added patient details. relevant medical history. concomitant medication.2nd dose details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Follow uP:  child had jerking movements, arched back, eyes rolled, no fever.  Hospitalized for observation only.  Had normal EEG-done since incident.  Follow UP:  child had jerking of body-arched back, eyes rolled, no fever.  Treated at medical center.
Patient was under 18 years of age when vaccine administered. At this time, vaccine only approved for individuals 18 years of age and older.
Chills, fever, sweats, nausea, headache, body aches, joint pain
Patient called clinic at 2:44PM to report that her right deltoid had some mild itching, she removed the Band-Aids and noted that her deltoid was red warm and had raised area about 3 inches in diameter. No fever or breathing symptoms. Patient advised by provider to put cool compresses to site and take BENADRYL per boxed directions to help with the symptoms, patient to go to ER immediately if any breathing symptoms or wheezing starts.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 23Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 13May2022 at 13:00 as dose 4 (booster), single (Lot number: 057MZIA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "previous breast cancer" (unspecified if ongoing); "penicillin" (unspecified if ongoing), notes: Allergic to penicillin and penicillin related antibiotics. Concomitant medication(s) included: OLMESARTAN; EFFEXOR; HYDROCHLOROTHIAZIDE; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN D [COLECALCIFEROL]; ZIRTEC. Patient also received Multi-vitamin in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 21Jun2022.
On Dec 1 Pt said she had fever, chills, cough and was weak Pt says its flu like symptoms
Nausea and cold sweats, unable to catch my breath - panting like running a marathon. Then sudden onset total numbness in arms and legs and uncontrollable muscle contraction in my hands - I couldn?t move my hands and they clenched into tight fists on their own. Total time for event around 10 minutes.
Unable to function since mid-April.  Debilitating fatigue.  Can't function, work, or walk dog.  Periodic episodes of paralysis.   May 29numbness and tingling in face; then facial paralysis;  went to ER at a local Hospital, had CT scan.  Friday, June 24, 3:30 pm, numb behind right eye 15 minutes.  Next morning eyelid painful.  Fatigue. Wednesday, June 29  11:45 am  Numbness upon waking from nap.  Back of head, tops of both feet.  Lots of numbness in right arm pit, back of shoulder.  Numbness, then weakness, then paralysis in left lower leg, top of left foot.  Roof of mouth numb.  Felt light headed and weak.  Difficulty swallowing.  Numbness continued moving around my body--left lower leg, left foot, right torsofront and back, lips numb and tingling; right side of mouth, as if I had a dental numbing shot;  base of skull, right armpit, right shoulder until around 4 pm.    July 1  Feet and lower legs went numb during dinner, then paralysis.    Woke up in night with balls of feet numb.   July 7  Woke up at 3 am with tightness and pain on right side, between rib cage and hip. I continue to have numbness and paralysis.  On August 1, the right side of my face began tingling, went numb, then was paralyzed.  I was driving and my right eye began watering profusely because I could not blink.  Numbness extended to mouth and throat; I could not swallow.  Lasted for 5 hours.  On August 10, while walking with my husband after dinner, both legs went numb and I had paralysis.    I laid down and had heart arrhythmia and pressure in my chest, two different times.  On August 23, I had tingling and paralysis on right side of face, right nostril, then right leg, from 8 pm until 1 am.  The next morning on August 25, numbness in right nostril and mouth until noon.
Hives, rash all over entire body. Started the night of the vaccine and continued for a week. Then had eczema.
administered dose three; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 4B244, expiry date 20th March 2023) and (batch number 5P9DR, expiry date 20th March 2023) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX) and ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 12th October 2021, the patient received the 3rd dose of Shingrix. On 12th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: On 22nd May 2021, the patient received 1st dose of Shingrix, vial one lot number PN2L, expiration date 7th November 2022 and vial two lot number 7P934, expiration date 7th November 2022. On 22nd July 2021, the patient received 2nd dose of Shingrix, vial one lot number FS(or 5)TT2, expiration date 4th February 2023 and vial two lot number Z9AD5, expiration date 4th February 2023. The patient came in requesting second dose of Shingrix vaccine, stating she had only received one dose of Shingrix previously.  The pharmacist administered a dose on 12th October 2021, but then discovered in the computer system that the patient had already 2 doses previously, which led to extra dose administered. The reporter consented to follow up.
2nd dose 29 days after 1st; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 4th November 2022, the patient received the 2nd dose of Shingrix. On 4th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 6-DEC-2022. Reporter's Comment:  The reporter stated that the administration of Shingrix on 5th October 2022 and 2nd dose on November 4th November 2022.  The reporter stated the time of the call, it was unknown if patient was immunocompromised. No additional details regarding lot number and expiration dates for Shingrix. The reporter gave consent to follow up. Additional Supportive Information: The reporter stated that 2nd dose received earlier than the recommended interval, which led to drug dose administration interval too short.
Crying unconsolably for 4 hrs. Got vaccination (DTAP, s. Pnemo, HIB, IPV) approximately 9:30, slept approx. 1 hr then screamed for 4 hrs and wouldn't nurse. In office at 3:30 pt was calm, no exam, nursed for few minutes.
About 1 minute after receiving the MENACTRA (L arm) HPV vaccine (GARDASIL) (R) arm. Pt's eyes rolled back and she slumped over, no color, came to within seconds.
Moderna COVID?19 Vaccine EUA Vaccination #1 Event: Sore arm and body aches lasting 36 hours Treatment: Ibuprofen Vaccination #2 Immediate event - sore arm and generalized body achiness Treatment: Ibuprofen Event #2 occurred 6 days later: Diarrhea, diaphoresis, and chills lasting about 4 hours; body aches and headache lasting about 18 hours Treatment: alternate Ibuprofen and acetaminophen
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 02/11/2021 and 03/22/2021. They tested positive for COVID-19 on 02/19/2022. I see no evidence that the individual was hospitalized. They died on 02/27/2022. COVID-19 is listed in Part II of the death certificate.
tested positive for COVID-19; tested positive for COVID-19; headache; This is a spontaneous report from a contactable nurse (patient herself). A 31-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot EL1283), via an unspecified route of administration in the right arm on 21Dec2020 at SINGLE DOSE, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccines in four weeks. She had a sars-cov-2 test via nasal swab on 30Dec2020 and was negative. She was re-tested for sars-cov-2 and she was positive (via nasal swab) on 04Jan2021. The patient had her second dose of bnt162b2 on 15Jan2021. She informed that she had headache that started 30Dec2020 and during the 10 days following the positive test. She received the vaccine in a hospital and had doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of events was recovered.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and a repeated sars-cov-2 test via nasal swab positive on 04Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.
The same day I had uncontrollable chills and tiredness.  A few days later, maybe March 1, I had joint stiffness in my hands, knees, ankles and feet.  To this day I still have the inflammation.  It is more pronounced at night, but is still present during the day. I have taken Tylenol, but have not seen any improvement.