chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive PCR test for COVID-19.; sore throat; Positive PCR test for COVID-19.; dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Nov2021 (Lot number: FD0810) at the age of 46 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 05Apr2021 (Lot number: ER8735) as dose 2, single and intramuscular, administered in arm left, administration date 14Mar2021 (Lot number: EN6208) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "dose 3"; COVID-19 (medically significant) with onset 06Jan2022, outcome "recovering", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Positive PCR test for COVID-19."; OROPHARYNGEAL PAIN (non-serious) with onset 06Jan2022, outcome "recovering", described as "sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: Nasal Swab; (05Jan2022) negative, notes: Nasal Swab; (07Jan2022) negative, notes: Nasal Swab; (08Jan2022) positive, notes: Nasal Swab; (08Jan2022) negative, notes: Nasal Swab; (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, oropharyngeal pain.  Clinical course: Positive PCR test for COVID-19. Symptoms: sore throat. Date below reflects date of first symptoms. Date of PCR test was 08Jan2022. Test results received 09Jan2022.  Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.
Seizure at 1030 hrs. At 0028 hrs. Presents with general malaise, BP 138/78, P 68 bpm, R 8, skin is pallor and cool to the touch, pupils are equal and reactive to light.
Patient started to have grittiness in her eyes and her eyelids swelled up slightly starting the evening of 9/5. She used Visine eye drops several times during the night and her eyes were extremely sensitive to light on 9/6 and 9/7. By 9/8, her eyes were completely back to normal. The patient did not experience an injection site reaction.
Got Vx and it did't work/suspected vaccination failure; It did'nt work; so much pain, can´t stand it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with medication unknown (Pill (Medication Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-Dec-2022 Reporter's comment: The case was received the patient via interactive digital media. The patient stated that oh my god, he/she was in so much pain everyday that he/she could not stand them none of the pills he/she took helped. The patient stated that what was wrong with the people how could they give a vaccine and then it did not work and did not know why you did but the patient need some help something had to get rid of this pain. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 61-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 18-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804115 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up report received from reporter on 14-Nov-2018: The med info number (SEQ18-04086) was updated. No new information was received. Hence, no changes were done in the narrative.
redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no historical condition was reported.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling). At the time of the report, INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe muscle pain and soreness on opposite side of vaccine.; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Range of motion highly affected not responding to self treatments or other meds; This is a spontaneous report from a contactable nurse reporting on herself. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Dec2020 at 11:00 AM (at the age of 34 years old) as a single dose for COVID-19 vaccination. Relevant medical history included anxiety. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, the patient experienced severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected. not responding to self treatments or other meds. The events resulted in a physician's office visit. The patient did not receive any treatment for the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back. The patient received treatment for the event range of motion highly affected but it was not responding to self-treatments or other medications. The outcome of the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
cant seem to stay awake; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (cant seem to stay awake) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL, ATORVASTATIN, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and ANTACIDS for an unknown indication.    On 26-Feb-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 SOMNOLENCE (cant seem to stay awake). At the time of the report, SOMNOLENCE (cant seem to stay awake) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.
INITIAL REPORT OF REDNESS, SORENESS AT INJECTION SITE - APPROXIMATELY 7 DAYS AFTER VACCINATION REDNESS WORSENED AND 10 DAYS POST-VACCINATION AFTER ICE THEN HOT BATH THE SWOLLEN AREA BEGAN TO DRAIN A YELLOW/GREEN DISCHARGE .  APPOINTMENT SCHEDULED FOR 1/4 WITH PCP FOR EVALUATION OF POTENTIAL INFECTION
Pain in left side of neck 04/09/20121. Signs of Bell's Palsy 4/13/2021/ Seen at Local ER 4/14/2021. CT scan of head done. Stroke ruled out. Diagnosed with Bell's Palsy. Left side of face droopy.  Eyelid not closing completely.  Difficulty eating.
This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient got shingles after getting SHINGRIX. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test details were not provided at the time of reporting. The reported did not consent for follow up contact.
PNEUMOVAX RA 10/30. T 103 10/31, red and pain at site. Seen 11/2, still temp 102 and red, hot area at site.
Temp through the evening/night 99.5+, woke in the AM, went upstairs to let dogs out. Started to feel dizzy, passed out, woke approx 5-10minutes later with contusion to back of head. Went to ED, still dizzy and nauseous. X-rays/CT done. DX-Closed fx of skull w/severe concussion, laceration to scalp requiring 3 staples.
The pt developed fever up to 102 deg F; severe aching and soreness all over body; feet sore enough to interfere with mobility; numbness in hands; arms and legs, red rash-like bumps all over body and face. Treated with Celebrexa and Allegra.
Sinus pressure that could be felt in my teeth and headache began about 2 hours after vaccine. It has been almost a week and these sensations remain.
This spontaneous report as received from a pharmacist refers to a 50 years old female patient with allergy to nuts and fish. The patient's medical history included shingles. The patient was vaccinated with a dose of ZOSTAVAX (dose, route not provided, lot number reported as H013024, expiry date: 09-OCT-2013) on 06-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 07-NOV-2012 the patient developed rash, warmth and redness in the surrounding area of the injection site. The patient had not sought medical attention. The treatment with BENADRYL was given for the adverse events. The outcome of rash, warmth and redness in the surrounding area of the injection site was unknown. Additional information is not expected.
1st dose 3 years ago, has not received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date about 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up. The reporter did not know the specific date of the 1st dose of Shingrix. No vaccine data was provided. This case was linked with US2021227430, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021227430:Same reporter.
On 6/16/21 & on 8/16/21-- went to ER= AFib with RVR. Racing heartbeat, sob, lightheaded, dizziness, trembling--went to ER at about 3:30pm on 6/16/21.
the following day I could barely move my arm without sharp pain, had to call out of work  the second day same, possibly worse, arm pain, and a fever, chills, fatigue. In the evening, nausea and vomiting Third day (today), fever broke, arm about 60% better, still fatigue
Pt seen in office the following Monday 07/25/2005 for follow up. Over the weekend pt experienced fever a max of 104.5, no breathing problems since Friday 08/22/2005. Pt had respiratory arrest that required rescue breathing and a visit to ER that evening where pt was given Tylenol, pt did received injections in ambulance en route. There is a 3-4 cm slightly raised area on right thigh with mild echymatic changes in the surrounding tissue. There is a rash over entire body mostly concentrated on pt's back. Treated fever with alternating doses of Tylenol and ibuprofen, treated rash recommended Benadryl routinely until resolved.
SHORTLY WITHIN 2-5 MINS AFTER ADMINISTERING THE ROTARIX, PREVNAR 13, AND HAEMOPHILUS INFLUENZAE, THE 2MTH OLD MALE INFANT STARTED TO GO INTO DISTRESS. HEARTRATE DECREASED BRADYCARDIA, LETHARGY, AND DR. HAD TO ASSIST WITH RAISING BABY'S HEARTRATE. GIVING CHEST COMPRESSIONS/ RESUSCITATION. CHILD WAS MONITORED AND SENT TO HOSPITAL FOR OBSERVATIONS.
no adverse effects; patient received unspecified dose of Rotateq that was improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 20-AUG-2019, the patient was vaccinated with improperly stored unspecified dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S009940, expiration date 04-OCT-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 34.1 degrees Fahrenheit for 4 hours and 30 minutes. The digital data logger was involved in recording the temperature excursion details. Administered dose of vaccine experienced previous temperature excursion of 34.7 degrees Fahrenheit for 3 hours and 2 minutes. There was no adverse effects reported.   This is one of several reports received from the same reporter.
Dizziness, body ache, fatigue, nausea, swelling/redness around injection site. Resolved.
Patient self- scheduled for COVID vaccination. Patient completed consent for booster dose Pfizer covid vaccine form and attested that he meets the vaccine eligibility criteria to receive booster. Author confirmed his full name and birthday. Also confirmed if this was a 2nd booster dose and patient verbalized "yes, it is 2nd booster" Author verified with patient for any previous side effects. Patient denied any side effects. Patient did not bring vaccination card. Second booster was administered. Patient tolerated well, waited for 15 minutes observation. No side effects noted. Upon reviewing the immunization record, author found that patient had 4th dose of Pfizer vaccine on April 27, 2022 which is less than 4 months of recommended time frame.
Pfizer Dose 1 3/9/21 (EN6199) Pfizer Dose 2 4/8/21 (ER8737) COVID Positive 8/23/21 COVID Negative 9/6/21  9/6/21: Patient is a 73-year-old female who presents to the ED today for altered mental status, high blood pressure and headache.  Patient states her headache started approximately 7 hours prior to arrival.  Patient states she was also having trouble finding words.  Per patient's daughter she was significantly more confused than earlier in the day.  Patient currently has COVID pneumonia, and missed dialysis on Saturday.  Patient has a past medical history significant for ESRD on hemodialysis Tuesday Thursday Saturday, hyperlipidemia, hypertension, CHF, sleep apnea, hyperparathyroidism, anemia, leukopenia, vitamin B12 deficiency.   Upon arrival to ED patient was given azithromycin and Rocephin for community-acquired pneumonia.  Patient also had a chest x-ray that revealed bilateral pneumonia that has progressed since 08/23/2021.  Head CT was performed due to trouble finding words, confusion and showed no new intracranial hemorrhage or other acute findings.  Patient's laboratory findings were significant for WBC 4.46, HGB 10.5, HCT 32.7%, glucose 112, BUN 59, creatinine 10.62, potassium 6.2.  Patient was given 1 time dose of Kayexalate.  Dr. consulted in the ED and recommended dialysis treatment in the morning.   Patient was seen and examined in the ED, patient is sitting comfortably in bed.  Patient is confused, but answering questions.  Patient states she continues to have a headache that she states is all over.  She describes the pain as aching.   Patient also complains that she overall does not feel well.  Patient denies any chest pain, or shortness of breath at this time.  9/13/21: This 73-year-old female with history of end-stage renal disease, along with breast cancer and left arm lymphedema was having dialysis. She has been sick during dialysis days recently.  Blood pressure has been noted to be low and some bradycardia.  Review of her home medicines is somewhat unclear, but it looks like she has had both carvedilol and labetalol filled recently, is taking both of these twice a day, even on dialysis days. We tried to decrease the carvedilol on dialysis days, stop the labetalol and add Norvasc.  She tolerated the most recent hemodialysis. She has developed left arm swelling, pain; has an ultrasound showing a superficial phlebitis of the cephalic vein with no signs of deep vein involvement. We discussed blood thinners, but will not treat superficial phlebitis unless symptoms get worse, suggesting it is going into a deep vein thrombosis.  She will use warm compresses when she gets home.  She is seen the day of discharge, doing quite well.  She is afebrile.  Oxygenation 97% on room air. Blood pressure is 155/83.
Took the shot felt a burning itching flowing through veins down into wrist; Felt a fiery itch flowing into and around heart.; Had a sudden onset stabbing headache on right forehead; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Took the shot felt a burning itching flowing through veins down into wrist), PRURITUS (Felt a fiery itch flowing into and around heart.) and HEADACHE (Had a sudden onset stabbing headache on right forehead) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Took the shot felt a burning itching flowing through veins down into wrist), PRURITUS (Felt a fiery itch flowing into and around heart.) and HEADACHE (Had a sudden onset stabbing headache on right forehead). At the time of the report, BURNING SENSATION (Took the shot felt a burning itching flowing through veins down into wrist), PRURITUS (Felt a fiery itch flowing into and around heart.) and HEADACHE (Had a sudden onset stabbing headache on right forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.   Reporter did not allow further contact
Swelling at shot sight,  nausea & acheing by 9:30pm same night.  Next day lymph glands under L. arm & at top of left leg swollen & painful and for several hours left side of face simi numb.  3rd day  all my taste buds were highly irritated on top of my tongue, around the edges and in the floor of my mouth;  my lips, cheeks and tongue were all swollen.... and this went on for a full week after the other symptoms disappeared.  No taste for another month.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-2021501800 (same reporter/drug/AE, different patients). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "Has fatigue and a headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very irregular menstrual cycle that has yet to regulate after 7 months. Headaches. Stomach aches. Chest pain. Back pain. Palpitations. Irregular heartbeat.
red rash w/petechia generalized over whole body, itching; generalized swelling esp feet, legs, hands; severe pain all joints, muscle pain & spasm; skin hot to touch, burning sensation of skin esp feet & legs; h/a extreme fatigue; tingling
I contracted COVID-19 on 06/05/2022 with symptoms of sore throat, cough, and fatigue. I was given monoclonal antibodies on 06/07/2022. I was ill for 5 days before my symptoms began to resolve. I am fully recovered with no lingering symptoms.
Large red rash (baseball size) around injection site that appeared two weeks following injection.  No rash until that time.  Rash still appears two days following notice.
The day after my second shot, and still to this day, I have had extreme pain in my legs, back, neck and shoulder.  I cannot bend over. I cannot dress myself. I cannot drive.  I have been unable to go to work.
Two days after vaccination, patient lost his sense of taste, with no impact on sense of smell.  Minimal improvement since.
This spontaneous report was received from a consumer, referring to her daughter, a 20 year old, non-pregnant female patient. Concurrent conditions, medical history, historical or concomitant drugs were not reported. On an unspecified date in 2009 (reported as "at age 12"), the patient was vaccinated with a dose of GARDASIL Injection, for prophylaxis (strength, dose number, dose, route, anatomical location, lot # and expiration date were not reported). The reporter informed that on an unspecified date in July 2017, the patient underwent a pap smear test and the result was abnormal. The patient sought medical attention. The outcome of this event and its relationship with GARDASIL were not provided by the reporter. This is one of several reports coming from the same source. Sender's Comments: US-009507513-1807USA007802.