chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received flu shot at off-site IMZ clinic on 10/24/18. Reports that immunization felt different than other immunizations that she has previously had. Considerably more painful than previous immunizations. Arm was more sore than usual following injection and not just at injection site. Describes a pain that starts in her shoulder joint and tingles throughout her elbow and sometimes into her hand. Pain has been consistent for the past 2 weeks and she has become concerned that this could be something serious. She Googled her symptoms and fears that her discomfort could be from the immunization being administered too high in the arm. She has not sought medical attention, but is wondering if she should.
The employee had attended two vaccines clinics at rehab center and received the Pfizer Bivalent Booster on 10/06/22 and then received the Pfizer Bivalent Booster again on 10/11/22, 5 days later.
starting 12 hours after injection: 12 hours of flu like symptoms including temp/nausea/sore muscles/headache, 25 hours of 100+ temp,  30 hours of 99+ temp,  48 hours of headache
Hives all over body after 20 hours since vaccine dose, high fever and fatigue after 12
The PROQUAD expired on 09/02/2020 and it did undergo a previous temperature excursion; No additional AE/PQC; patient in their office received and expired dose of PROQUAD roday in their office; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-SEP-2020, the patient was vaccinated with improperly stored and expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml injection, rHA, lot # S006830 has been verified to be a valid lot number, expiration date 02-SEP-2020 (frequency reported as "once", anatomical location and route of administration were not provided) for prophylaxis. On 20-AUG-2020, administered dose of vaccine experienced the temperature excursion of - 14.9 degrees Celsius (C) for 109 minutes. No adverse effects were reported.
A few hours after the shot, patient started to feel horrible. He was having trouble breathing, skin and eyes were red. He was very sweaty. He was antsy and jittery. His arm was in major pain also. He had no appetite and was tired but restless. He was very on edge. Patient said he didn't know why he felt so bad when he felt fine in the morning.
On the 5th day I started experiencing very itchy back which lasted for 3 days. On the 7th day  I had very fast heart rate in the middle of the night. The next morning, on day 8th my shoulder in the place of injection got red and hot.
Pt received 5 yr kindergarten shots. Tolerated procedure well.  5 minutes post administration pt became weak, disorientated, pale, poor tone, eyes open but not responding to voice.  Respirations shallow, HR 60, mucus membranes normal, hands warm, good capillary refill.  Remained in this state for approximately 40 minutes.  O2 administered  Glucose wnl, no seizure activity.  Gradually regained color, HR 80 and became talkative in one hour after receiving immunizations.  Left office on her own.  Dx prolonged vasovagal response.
Fever (100.5), chills, welts on arm and body specifically left side where I had both flu and pneumonia shots. Arm red and very swollen 1 week. Spent 2 days in bed sleeping. Acute abdominal distress began on 3rd day. Still recovering from both.
patient had syncopal event approx5 minutes after vaccine injection.  Did not lose consciousness - placed on floor on back with legs elevated - color returned within minutes and patient was smiling and laughing. Family declined '911' being contacted
Felt extremely weak - a bit disoriented. Blacked out for four hours. Did not seek treatment.
The Tinnitus in my left ear has worsened and the Tinnitus in my right ear is noticeably louder than prior to receiving the first dose on 3/20/21.
got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; This is a spontaneous report from a contactable consumer and a physician. This consumer reported similar events for 5 patients. This report is the fifth of 5 reports.  A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patients got covid within a few days of getting the immunization. Also, the reporter assumes that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown.   Information about Lot/batch number is requested.  Follow-up (21Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (27Apr2021): New information reported from a contactable consumer includes: patient details, relevant medical history, concomitant medications, suspect vaccine details, and reaction data (onset, seriousness, outcome of COVID; new event shortness of breath).  Follow-up (13Jul2021): The is a follow-up spontaneous report received from product quality complaints group. New information received included: investigation results were received from Product Quality Complaint group.   Follow up attempts are completed. No further information is expected.  Follow-up (22Jul2021): Further information was received from a Product Quality Complaint Group. This report included that: Investigation findings- Summary of Investigation for Lot number EN6200 were added in the narrative.  Follow-up (07Oct2021): New information received from a contactable consumer: reporter details updated. This is also a follow-up report being submitted to amend previously reported information: the reported information from date 27Apr2021 to 22Jul2021 were not belong to this patient, the information will be reported in another report.  Follow-up (18Oct2021): This is a follow-up report to notify that the case 2021317618 and case 202101389497 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number case 202101389497.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317500 same reporter, product and event; different patient.
Skin rashes after the 1st vaccine; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced skin rashes after the first dose of the vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
a bottle of moderna was used for vaccination after it was supposed to be pulled from the fridge and discarded.  12 days "expired"  per manufacturer recommendations for storage and handling. manufacturer recommends re-vaccination for proven efficacy in opposite arm.  pt. stated he did not want a 3rd dose despite strong recommendation for re-vaccination.
Patient received both flu and covid vaccinations (one in each arm) on 9/30 around 2pm.  She states that around 11:30pm when she was ready to go to bed, she had ringing in the ears.  This lasted all night long leading to restlessness and unable to sleep.  When speaking to her today 10/1 at 1:15pm, she states she still had the ringing in the ears along with the typical muscle aches and soreness at injection site.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Pt experience light headness. Instructed him to lower his head. Pt recovered after 15min.  Pt was contacted the next day for f/u.  He stays he is doing fine.
Diagnosed as contact urticaria/dermatitis. Began the night of Nov 22, itchy eyes and throat, skin. Eyes and throat issues quickly went away, but itchy/irritating feeling on scalp, ears, neck, and shoulders continued. Bright red welts would form wherever skin was scratched, appeared to look like dermatographia. Symptoms are now from the waste up, including hands. Sought treatment after being unable to sleep due to symptoms. On December 7th, doctor suggested I take Allegra and Pepcid, which helped symptoms tremendously. Symptoms still return towards the end of 24 hr Allegra dose. Doctor then prescribed Prednisone on December 15th, I am currently on the second day of a five day treatment. Skin irritation still breaks through occasionally. I did have "COVID Arm" rash appear about a week after Moderna dose this spring, but no other skin issues until after this booster shot.
her back felt like it was about to break; her muscles still feel kinda sore; her sinus was messed up; she was feeling really bad; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (her back felt like it was about to break), MYALGIA (her muscles still feel kinda sore), SINUS DISORDER (her sinus was messed up) and FEELING ABNORMAL (she was feeling really bad) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concomitant products included IRON, CYANOCOBALAMIN (B12-VITAMIIN), SPIRONOLACTONE, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D [VITAMIN D NOS], ZINC and ASCORBIC ACID (VITAMINE C) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced BACK PAIN (her back felt like it was about to break), MYALGIA (her muscles still feel kinda sore), SINUS DISORDER (her sinus was messed up) and FEELING ABNORMAL (she was feeling really bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR) at an unspecified dose and frequency. At the time of the report, BACK PAIN (her back felt like it was about to break), MYALGIA (her muscles still feel kinda sore), SINUS DISORDER (her sinus was messed up) and FEELING ABNORMAL (she was feeling really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Shortness of breath; Pressure in chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Relevant past drug history , Name of Drug as Reported: No, Reaction: Allergy. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset 28Oct2021, outcome "unknown", described as "Shortness of breath"; CHEST DISCOMFORT (non-serious) with onset 28Oct2021, outcome "unknown", described as "Pressure in chest". Therapeutic measures were not taken as a result of dyspnoea, chest discomfort.  Additional Information: The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 after vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pfizer have permission to contact the reporter about this event. Pfizer do not have the permission to contact patient's healthcare provider about this report.  Follow up (24Dec2021): This follow-up is being submitted to notify that the lot/batch number for one dose is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt reported: "lightheaded, tunnel vision, felt like I was going to pass out. Need water"  VSS, taken while he was lying down.  Water given.Pt has history of anxiety.  Taking meds.  States "his problems with needles but no problems with last dose of Anti-covid vaccine."  Instructed to make sense that he tells this history prior to taking vaccines
Sunday evening, January 24, 2021 ? I noticed I had a red rash/patch (that is warm to the touch) about 2  inches under my vaccine injection site.  It is roughly 2? in diameter, however it is not a perfect circle.   I may have had it all weekend, but I did not notice it until Sunday evening.   Additionally, my  arm/muscle became very sore the evening of the vaccine, but I knew that was a common side effect.
Rash which started 24 hrs later 7" diameter itchy, healed 24 hrs later. Rash was on abdomen only.
10 patients administered vaccine after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (10 patients administered vaccine after temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (10 patients administered vaccine after temperature excursion). On 05-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (10 patients administered vaccine after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  It was stated that, the number of vials/doses was 50 doses and the vaccine distributed from freezer to vaccine clinic for immediate use. On 05-AUG-2021, the single vial was punctured at 8:45 and it was given to 10 patients.   This case was linked to MOD-2021-373651.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable for this report. The healthcare professional did not have patient's specific information. The healthcare professional reported that for every 5 patients she vaccinates with SHINGRIX, about 2 of them or roughly half, complained of a sore arm after the fact. The reporter did counsel them ahead of time that this would occur but they state it was more sore than they expect it to be. It lasted about 1 or 2 days and then resolved. The reporter just stated this as a general statement.
A lot of pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247) via an unspecified route of administration on the left arm on 04Feb2021 09:15 at a single dose for COVID-19 immunization. Medical history included high blood pressure and coronary artery (disease). Concomitant medication included valsartan, rosuvastatin calcium (ROSUVASTIN) and acetylsalicylic acid (BABY ASPIRIN). On 04Feb2021 14:30 the patient experienced a lot of pain at the injection site. No treatment was received for the event. Event was reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the event was recovering.
Within hours post vax, the pt developed itching on her thighs. On 10/28/99, she developed bruises on her legs from her knees up that were a result of scratching. She was seen by a dermatologist, who prescribed oral Benadryl and topical cortisone ointment. The dermatologist noted blisters on her leg, popped one and had the wound cultured. The dermatologist prescribed erythromycin. The itching spread up her stomach and extended to the area under her breasts. She was treated with Zyrtec, Claritin, and cortisone cream which provided some relief.
Swelling from deltoid muscle down to elbow, redness, pain, Slight fever, chills, joint  pain. The swelling and pain lasted 4 days. The joint pain and general malaise lasted 2 and 1/2 days.
Received half dose Moderna  Booster instead of the first dose; Received half dose Moderna  Booster instead of the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 13-Dec-2021, the patient experienced UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose). On 13-Dec-2021, UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
nausea, malaise, h/a w/in 36hrs of inj; treated self w/stay-at-home rest; fever one degree above nl;pt later found had a URI @ time had vax
Both palms covered with petechial rash within 15 minutes of injection. Mild swelling of left palm. Took one tablet of her own Benadryl 25mg at 2:45pm with some relief. Took 2nd dose of Benadryl 25mg this morning. Rashes 90% improved. Left hand swelling resolved. Singular nontender left cervical node became more pronounced this morning. She noticed the lymph node 2 weeks after her 1st dose.
Mild swelling and redness at injection site with thick red, raised rash on upper arm above the site. By later evening, red, raised rash covering entire upper body. Next day rash was on inner thighs scattered lightly on legs, and hives on bottom and medial feet. Palms of hands were itching and "underground" hives were noted. Benadryl 25 mg po has been given every 6-8 hrs since beginning of rash. Rash has been slowly resolving and today is mildly scattered over body (mostly upper) and feet and palms of hands are still off and on red and itchy, but no longer have hives. Hydrocortisone 1% cream is also being used, but only when itching has been extreme.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient stated that "I was forced to get this vaccine and yet I still got covid twice. What good is a vaccine that lets you still get the sicknesses. Why make something that really does not work mandatory. If you want to impress me make a vaccine that works." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000217268. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received on 24-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: Case was considered as valid since it was received from JNJ managed page.; Sender's Comments: V1:Follow up information in this version updated : Product quality complaint investigation result. Upon review following information was amended: Case was considered as valid since it was received from JNJ managed page. The follow up information does not change the causality of the previous reported event.   20220229986- covid-19 vaccine ad26.cov2.s-Suspected clinical  vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient had a black out right after she received her Meningitis Vaccine.  Patient fell on the floor, but was responsive.  It took patient around 15 minutes to be able to stand up without feeling dizzy.  Patient's O2 saturation was above 99 percent the whole time.  But blood pressure was around 90/60.  Eventually patient's blood pressure went back up to 110/70 and patient was not having dizzy spells anymore.  Put in a note in her chart to call her to make sure she is doing better the next day.