chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pharmacist discovered that the Johnson and Johnson vaccine had been left out longer that the 2 hours allowed after puncture at room temperature.  The vaccine had been out for approximately 2 hours and 45 minutes.  The manufacturer was contacted, and the pharmacist was told that the literature does not state that this is a reason for revaccination.  The patient has not reported any adverse effects.
temp (at times at 100), nasal congestion, runny nose, coughing, fatigue, mild headaches comes and goes, chills, back and side pain, mild SOB d/t coughing, and wheezing. Symptoms started 11/14/21.
Pt developed large red area approximately 2 inches in diameter on right arm.  Has not resolved yet but is not getting larger. Pt visited hospital due to other issue and dr did not seem concerned or want treatment.
Early in the around 10am on Feb. 24, 2021 my mother was found dead on the floor of the bathroom. She was found with dried blood coming from her nose.
Information has been received from a nurse concerning her daughter (age unknown) with unknown medical history, who was vaccinated (route unknown) with all three doses of GARDASIL (Lot #'s unknown).  Subsequently, on an unknown date, the patient tested positive for "high grade" HPV infection even after receiving all three doses.  Lab diagnostic studies performed was a "HPV test" (results: + for "high grade" HPV).  Outcome unknown.  The patient was seen by a physician for unspecified medical attention.  No product quality complaint was involved.  Additional information is not expected.
Pt recvd vax 21AUG92 & devel flu-like sx, diarrhea which started the day of inject & lasted 3 days & stomach pains;
THE PATIENT, AFTER RECEIVING ONE DOSE OF VACCINE, PASSED OUT AND WAS HAVING DIFFICULTY BREATHING, SHORTNESS OF BREATH, SWEATING. SHE WAS CONSCIOUS AT THE TIME THE EMS ARRIVED.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". Clinical course: Caller is consumer calling for information on Pfizer COVID 19 vaccine gray cap Bivalent. He asks Did they fix problems with the clotting and your vaccine. Follow-up attempts are completed. No further information is expected.
Fever >100 degree F day of/after vaccinations (Trihibit & Proquad) given (9/26/06). On 10/7/06 (day 11 s/p vaccinations) generalized rash on trunk (fine erythematous, blanchable maculopapular rash).
Got vaccine at 10:30 am, took took Tylenol 500 mg with Benadryl 25mg 2 tabs at 11:30 as prophylaxis Around 02:00 am injection site feels sore, chills, Temp 99.9 degrees F, applied warm compress to sore arm 06:00 T=102 degrees, took Tylenol with Benadryl again at 08:30 am, no further fever after, arm still sore but bearable.
warm injection site; sore-to-the-touch injection site; big red blotch a few inches above the elbow; rash above the arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm injection site), INJECTION SITE PAIN (sore-to-the-touch injection site), INJECTION SITE ERYTHEMA (big red blotch a few inches above the elbow) and VACCINATION SITE RASH (rash above the arm) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm injection site), INJECTION SITE PAIN (sore-to-the-touch injection site), INJECTION SITE ERYTHEMA (big red blotch a few inches above the elbow) and VACCINATION SITE RASH (rash above the arm). At the time of the report, INJECTION SITE WARMTH (warm injection site), INJECTION SITE PAIN (sore-to-the-touch injection site), INJECTION SITE ERYTHEMA (big red blotch a few inches above the elbow) and VACCINATION SITE RASH (rash above the arm) outcome was unknown.            No concomitant medication was provided  No treatment medication was provided   This case was linked to MOD-2021-028898 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-APR-2021 contains non-significant information.
This case was reported by a pharmacist and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. The reporter considered the pain to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a painful reaction to the 1st SHINGRIX dose and did not complete the series. It was unknown if the events cause the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporting health care professional consider the events to be life threatening. It was unknown if the reporting health care professional consider the events to result in persistent or significant disability or incapacity. The patient did not die. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events were not result in a congenital anomaly or birth defect. The pharmacist mentioned that they received 1st dose of SHINGRIX and it resulted in pain that lasted about 5 to 7 days. They did not specify when they received the dose and if the pain resolved. Was not able to capture attendee's name or information.
No adverse effect reported; received improperly stored VARlVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not provided.   On 12-SEP-2019, the patient vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (single dose, lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020(which lot was given to the patient was unknown); vaccine dosage detail not reported) for prophylaxis (product storage error). The storage temperatures of the varicella virus vaccine live (oka/merck) (VARIVAX) were -14 Celsius degrees to -10 Celsius degrees (-9.74 Celsius degrees) for unknown duration. There was no previous temperature excursion. Data logger was involved. The varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effects noted.
Local swelling (R) deltoid where she had IM Tdap. Rx= ADVIL PRN.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection (lot#, expiry date, route, dose not specified). Other suspect therapy included FLUZONE given on same day. Concomitant medications were not reported. The patient was diagnosed with a severe infection (hospitalization). On an unknown date, the patient was hospitalized (sought medical attention) at an unspecified facility on an unspecified date. It was not known if the infection was limited to the injection site or if it was a systemic infection. The patient subsequently recovered. Causality of the event was unknown. No further information provided. Product quality complaint was not reported. Additional information has been requested.
A few hours after the vaccine patient started with papular rash to the back of the bilateral arms and bilateral cheeks. The next morning pt continued with the rash on the cheeks, spread to the ears, and few spots on the legs. The cheeks were erythematous, eyes looked a little puffy. Pt was brought into office for eval, otherwise appeared well, afebrile. Mild pruritic rash noted with pink papulovesicular rash on the bilateral upper arms, papular on the cheeks and few papularvesicular lesions on the legs, consistent with papular acrodermatitis. Pt was treated with benadryl for itching and advised to monitor and f/u with any changes.
arm developed instant temporary bruising on the bicep, forearm and pad of palm on her right arm! Not the arm she got the shot in. 5 minutes after he shot her arm turned blue and purple, like widespread bruising. No one had seen that happen before. and like 4 hours after the shot the discoloration completely went away. Never discomfort, swelling or fevers ar any other side effects, just crazy bruising all down her right arm. I yelled "she's turning blue!" it was scary! But she was totally fine after.
rash began on rt leg, spread to stomach, chest, & back; phoned clinic on 29JUN93 instructed to take pt to MD; MD seen on 29JUn93; said rash is from the shot; prescribed DPH; phoned 30JUN93 mom states rash is gone; no booster due to reaction
This spontaneous report as received from a medical assistant via a company representative, referred to a currently 65 year old female patient. On an unknown date, the patient was vaccinated with one injection of PNEUMOVAX 23 (lot # K004930 with expiry date: 16-MAR-2015; dose and route of administration unspecified) for prevention of pneumonia. On an unknown date, after receiving the PNEUMOVAX 23, the patient developed severe injection site reactions including redness and hardness at the injection site. The patient sought medical attention via calling the office. The outcome of the events was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source. Additional information is not expected as the reporter did not grant permission to be contacted.
Chest pain, palpitations, dizziness that is intermittent developing about a week after vaccination
He tested positive for COVID Sept 27, 2021.  Cold started on September 20.  Progressed to extremely severe body pain, headache, nausea, confusion, shortness of breath.    The body pain and headache isn?t as severe and breathing issue has improved 10/4/21.
Continued, nonstop nausea/diarrhea, headache, joint pain (back, hips, knees), circulation issues (in mornings hands don't open and close well)
Fever of 102/103,  pain, tenderness, redness, hardness,swelling at injection site, fatigue, headache, muscle pain, joint pain, overall itchy ness and swelling, chills, stomachache, numb fingers
Severe migrating joint pain over the course of a week causing decreased mobility, moving from left shoulder to left elbow to left wrist, left hip and left knee (each for about a day at a time).   Chest/neck/face rash for 3 days post-vaccine. Neurological symptoms for 11 days (the feeling of warm water running down left leg). Significantly increased amount of menstrual blood/clots during April and May menses.
Autism. Developmental delayed in speech and cognition. Symptoms similar to mercury exposure. Chronic diarrhea. Pt also received hep B on 08/14/96 and Varicella vaccine on 08/14/1997. Speech and cognifitive deficits related to autism.
This spontaneous report as received from a pharmacist refers to a newborn patient of unknown age(unspecified gender). On 02-NOV-2012 20:51, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
constipation; had a headache; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (constipation) and HEADACHE (had a headache) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (constipation) and HEADACHE (had a headache). At the time of the report, CONSTIPATION (constipation) had not resolved and HEADACHE (had a headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Feelings of having a fast beating, fluttering, pounding heart; Thought I was having an heart attack.; pounding heart; injection site pain/really bad arm pain on arm that injection was given; Feelings of having a fast beating; tiredness; severe headaches; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: Ff2587 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 20Sep2021 (at the age of 49-years-old) at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took morphine and experienced allergies. The 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 and since the vaccination, patient has not been tested for COVID-19. The patient had feelings of having a fast beating, fluttering, pounding heart, thought he was having an heart attack, had injection site pain/really bad arm pain on arm that injection was given, tiredness, severe headaches, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell on 20Sep2021. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. No treatment was given for the events. The outcome of the event feeling unwell was recovered and outcome of rest of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Per patient, approximately 15 to 20 minutes after administration of Flucelvax, he experienced a swelling in his lips and gums that resulted in significant pain and discomfort. The next day, patient woke up with red blotchy rash all over his body. Did not report to MD or RX until 2/9/20.
Warmness; Irregular beats; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warmness), HEART RATE IRREGULAR (Irregular beats) and HEADACHE (Headaches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced FEELING HOT (Warmness), HEART RATE IRREGULAR (Irregular beats) and HEADACHE (Headaches). On 19-Mar-2021, FEELING HOT (Warmness), HEART RATE IRREGULAR (Irregular beats) and HEADACHE (Headaches) had resolved.            Concomitant product use was not provided by the reporter.  Patient experienced symptoms two days after the second dose of vaccine and resolved after approximately 12 hours. She had no other issues since then.  No treatment information was provided.      Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Updated patient medical history, event start date, event stop date, events outcome.
On the evening of January 20, 2022 I started experiencing pain in my left arm. The next morning (1/21/22) while applying deodorant I noticed a raised area in my left armpit. I took photos and contacted my doctor. I took Allegra and ibuprofen for pain/allergic reaction management. In addition to the pain I was experiencing tenderness and some redness. The next morning (1/22/22) I noticed more swelling in my armpit and down my inner left arm into my antecubital area. There was pain in my inner arm and shoulder joint. I continued Allegra and ibuprofen. The morning of 1/24/22 I noticed my left breast was significantly larger than my right and it felt somewhat engorged. I was concerned that the swelling kept getting worse so I contacted my doctor again and told him I wanted to be seen. I was seen that afternoon, given a PE and prescribed prednisone and clindamycin. The next day 1/25/22 I noticed the swelling in my left breast was reducing and as of today 1/28/22 is almost completely resolved. There is still a small area of swelling under my left arm.
This spontaneous report was received from a nurse at physician's office via company representative regarding a patient of unknown demographics. Information on pertinent medical history and concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis (dosing details not reported). Patient had syringe malfunction while receiving GARDASIL 9, resulting in an incomplete dose being administered. No adverse events were reported. Additional information has been requested.
flu; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient) via social media. This case involves a patient with unknown demographics, who got flu (influenza), when the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), family history, concurrent condition and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect  INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient got flu (influenza).   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Patient came in today to get preventive vaccines.  While discussing vaccination, patient states her blood pressure went up, had low pulse rate, irregular heart beat, occasional itchiness on injection arm since 2nd dose of pfizer in 1/2022.
Soreness, swelling and pain, along with a hard, warm spot at the injection site. Unable to move arm more than a few inches in any direction. A feeling of fatigue and nausea.
Patient is a 46 y.o. female. Chief Complaint Patient presents with ? Allergic reaction     allergic reation to covid vaccine      Patient had a covid vaccine    Patient works for dermatology and cosmetic.   The patient is a CMA Had filler injections on the face. Jaw line and Nasolabial folds on 12/29/2020 Juviderm and Define Resilin .    Has had facial fillers for three to four years.    No other implants or silicone in other body locations    No history of sulfa allergy   No history of anaphylaxis.      About 120 after the Moderna vaccination, was in the car still in the parking lot got a flush feeling and got hot chest tightening, heart pounding.  Weird taste in the month.  Did not feel like she was going to vomit.   Then got shaky.  Face feels numb and swollen.  Is not itchy.    No hives.       Patient husband was driving, turned around  And then pulled up.  The RN on the observation deck gave EPI pen in the left thigh while she was still in the car.            Driving home from getting Covid vaccine. Felt flushed, weird taste in mouth, chest tightening, palpitations, face swelling.    Is patient concerned about a specific cause for the current symptoms? Yes Covid vaccine  Onset of symptoms: 2:25pm 1/3/2021. Symptoms include: hives, rash or generalized itching, throat or tongue tingling, itching, or swelling and facial swelling. Rash distribution:  Face. How are symptoms changing over time? worsening.   Patient describes symptoms as severe. Has patient tried any treatment for these symptoms? Yes epi in left thigh What makes the symptoms better?   Epi made breathing better  What makes the symptoms worse? nothing   Associated symptoms:   o Fever No   o Sore throat No   o Recent illness No   o Exposure to person(s) with similar rash No   Objective: BP 106/72  | Pulse 77  | Temp 97.8 °F (36.6 °C) (Oral)  | Resp 14  | SpO2 97%    General:well-hydrated, well nourished, no acute distress HEENT: swelling where fillers have been used around the lips, nose, cheeks Neck: nontender, no masses Lung: clear to auscultation bilaterally  Heart: regular rhythm, tachycardia noted and no murmurs, clicks, or gallops. Extremities: extremities normal, atraumatic, no cyanosis or edema Skin: flushed on face and neck and chest  No urticaria No other rashes  Neuro: alert, orientation normal, speech normal pupilary response normal bilaterally extraocular motions normal tongue midline no facial weakness or asymmetry  we have pictures in her medical record.   this appears to be a dermal filler reaction.  the patient did receive epi as the first nurse who responded while she was in the car saw the facial eyelid swelling and redness and administered IM epi.     Once we were able to move the patient into the clinic is was apparent that the person had no anaphylaxis symptoms.  she was not itching, did not have hives, no stridor or wheezing or hypotension.     she was discharge on a Medrol dose pack.  advised not to get a second vaccine dose.
Symptoms started at 5:45pm on 12/8/21 starting with lumps in the mouth and on the tongue, hives, throat tightening, welts on the arms and legs.  Patient took diphenhydramine and symptoms abated after approximately 12:30am on 12/9/21.
swelling on the face; dizzy; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration in the left arm (upper shoulder) on 11Jan2021 at a single dose for COVID-19 immunisation. The patient has no other medical history and no concomitant medications. The patient stated that she got the first shot for the covid vaccine yesterday in the evening and now she is feeling swelling on the face. When she got up in the morning, she felt swelling on the face. She is asking on what she has to do. She also felt a little dizzy. She was dizzy when she got up in the morning, she did not feel anything yesterday, she felt everything today. The outcome of the events was not recovered. She has had no positive test for covid before the vaccine. She had a negative test a few days ago this month in Jan2021. She got the test on a Monday and got the results on Friday.