chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She said that she got all of her vaccine doses + booster /She said that she recently tested positive with the covid19 virus.; She said that she got all of her vaccine doses + booster /She said that she recently tested positive with the covid19 virus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid 19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She said that she got all of her vaccine doses + booster /She said that she recently tested positive with the covid19 virus.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: Patient got all the vaccine doses including the booster shot, however, she got tested positive with covid-19. The patient mentioned that she was immunocompromised. Patient wants to know where she can get Paxlovid in (Withheld).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient reports that after her first dose of the COVID-19 mRNA vaccine (Moderna), she developed intense itching in her throat and ears between 15 and 30 minutes later while on her drive home. Patient took a dose of diphenhydramine when she got home. The itching lasted for several hours then resolved without further intervention. Per patient, she has had similar allergic reactions to various things in the past.  Reaction recorded in patient's allergy section and reported through VAERS.
Fever, required alternating tylenol and motrin. One epidose of vomiting.
This spontaneous report was received from a registered nurse referring to a 7 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M018958, expiration date on 03-MAR-2018, lot #N004815, expiration date on 07-OCT-2018 or lot #M045546, expiration date on 12-JUN-2018, for prophylaxis (strength and dose were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1712USA010085: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
This spontaneous report as received from a 53 years old male clinical supervisor with no pertinent medical history and no drug reactions allergies. On an unknown date the patient was vaccinated with M-M-R II (dose, lot number, dose and route unknown). No other co-suspects were reported. No concomitant medications were reported. The reporter thinks he received M-M-R II as a child (unspecified number of doses) and currently (on an unknown date) his measles antibody titer is "low". The reporter does not have a vaccination record from when he was a child so he is not positive if he received M-M-R II in the past. There was no treatment given for the event. At the time of the report, the outcome of measles titer antibody is low is not recovered. The reporters relatedness for measles titer antibody is low is unknown for M-M-R II. Additional information has been requested.
No adverse event; patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)).    No concomitant drug was reported. No treatment drug was reported. This case contains information for the 3rd of 27 adult patients described by the reporter.
Patient reported headache after getting the vaccine.  She says that she did not take her blood pressure medication this morning.  Her blood pressure was measured in the 180s/100.  I recommended further evaluation by a medical professional.
A few minutes after receiving second dose of COVID19 vaccine pt reports he palpitations and a sense of warmth throughout entire body. Slight HA level 1 out of 10. Denies SOB or chest pain.    Pt then given water. HR 86  and BP 114/62.  After a minute pt reports he is feeling fine and the sensation resolved.   After another few minutes pt reports he has intermittent chest "squeezing" sensation lasting a few seconds. PA-C was notified and then evaluated pt right away.  Pt left after 30 minutes of observation and left in apparent stable condition.
The resident received is vaccine around 11:00 am and tolerated it without any difficulty or immediate adverse effects. He was at therapy from 12:36 pm until 1:22 pm when he stated he was too tired and could not do anymore. The therapist took him back to his room at that time and he got into bed himself but stated his legs felt heavy. At 1:50 pm the CNA answered his call light and found he had taken himself to the bathroom. She stated that when he went to get back into the bed it was "abnormal" how he was getting into it so she assisted him. At that time he quit breathing and she called a RN into the room immediately. He was found without a pulse, respirations, or blood pressure at 1:54 pm. He was a DNR.
Headache, Myalgia, Fever, chills, injection site pain/arm pain, rigors, swelling at injection site, fatigue
The caller received the 1st primary series dose (Moderna) and is looking for facilities with the vaccine in stock for her second dose and can´t find one.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT AVAILABILITY ISSUE (The caller received the 1st primary series dose (Moderna) and is looking for facilities with the vaccine in stock for her second dose and can´t find one.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (The caller received the 1st primary series dose (Moderna) and is looking for facilities with the vaccine in stock for her second dose and can´t find one.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT AVAILABILITY ISSUE (The caller received the 1st primary series dose (Moderna) and is looking for facilities with the vaccine in stock for her second dose and can´t find one.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT AVAILABILITY ISSUE (The caller received the 1st primary series dose (Moderna) and is looking for facilities with the vaccine in stock for her second dose and can´t find one.).    No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Arthralgia; Body aches; Rise of blood pressure; Strong Head ache; Body ache; Dizzines; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Rise of blood pressure), HEADACHE (Strong Head ache), PAIN (Body ache), DIZZINESS (Dizzines) and ARTHRALGIA (Arthralgia) in a male patient of an unknown age 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 information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Rise of blood pressure), HEADACHE (Strong Head ache), PAIN (Body ache) and DIZZINESS (Dizzines). On 24-Apr-2021, the patient experienced ARTHRALGIA (Arthralgia) and PAIN (Body aches). At the time of the report, BLOOD PRESSURE INCREASED (Rise of blood pressure), HEADACHE (Strong Head ache), PAIN (Body ache), DIZZINESS (Dizzines), ARTHRALGIA (Arthralgia) and PAIN (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
employee initially complained of itching on arms, noted slight redness bilaterally upper arms. itching progressed to neck slight redness noted around neck area. complained of feeling "hot",Denied difficulty swallowing. Placed in room and Rapid Response called. Given Epi injection in right upper thigh, INT inserted. and Bendryl 50mg IV, solumedrol 125 mg IV, and Pepid 20 mg IV given IVP. placed on EKG and B\P monitor. RR nurse and Covid Nurse at Bedside. employee transported to ER for continued observation. Client remains alert, talking via transfer to ER. continues to complain of some "itching"
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection, lot # L017146 with expiration date 13-MAY-2017, L019124 with expiration date 27-MAY-2017, L012036 with expiration date 07-APR-2017 and L015047 with expiration date 29-APR-2017 (dose and route of administration were not reported). No information on patient's concomitant medications was provided. The reporter could not determine which of the reported lot numbers were administered to the patients and which were not. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Patient was given flu vaccine at a Well Child visit on 1/4/22. Patient suffered seizure on the evening of 1/6/21 that resulted in ED visit via ambulance.
A 45-year-old female patient, with a past medical history of migraines and who was taking blood pressure medication, had received an intramuscular, right deltoid injection of Adacel, lot number C2644AA, on 06 February 2007. Within one hour post-vaccination, the patient experienced dizziness. A few days post-immunization, the patient complained of nausea. She was examined during a doctor's visit and treated with Antivert and niacin "without effect." At the time of this report, the patient had not recovered.
Became clammy, pale, and lethargic but always Alert and Oriented; blood pressure drop to 60/49 with heart rate steady at 65 and respirations 16 even and nonlabored.  Over period of 20 minutes she became pink, dry, warm and feeling back to herself; left pharmacy with a friend taking her home at 1;41 pm with blood pressure 95/74 heart rate 65 and respirations 16.  Follow up call made and she was at home no problems
Left axilla lymph node tenderness, redness and swelling, two or three marble sized nodes.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 15-weeks old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the first dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 14-FEB-2014 at 10:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). It was reported that revaccination was declined. No adverse event was reported for the patient. The outcome was reported as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Patient in office 2/8/15 with rash, redness and swelling 5.5 x 7.5 cm upper (L) arm larger circumference that previous day. Temp high 101.3 on 2/7/15. Exam = (L) deltoid 6x8 cm erythema with induration up to 1cm of edge of erythema, hot centrally, in injection at sup. center, fain erythema inferior and lateral non and edema. Increased pain with elbow flex, minimal with lifting upper deltoid and shoulder clear. Tx = ice, ibuprofen 2/11/15 arm less Increased.
I was recently diagnosed with shingles which began on Wednesday  November 17th, and I was seen by the OB Triage and dermatology departments on Friday the 19th.
Patient reports a 4 by 5 inch red, painful area around the injection site and fever.
PATIENT RECEIVED THE PEDIATRIC DOSE OF ENERGIX-B RATHER THAN THE ADULT DOSE. NO ADVERSE EFFECTS WERE NOTED.
Went to the ER 2 days post booster with a sore neck, spot in back that is sore (brachial muscle), upper part of left arm has dead muscles. Oral steroids given in ER.  Cannot raise arm farther than 6 inches above his waste.  Diagnosed as brachial neuritis.  Parsonage Turner Syndrome.  Current issues include:  neck pain that has not resolved, unable to move arm well due to diagnosis above.  Also having left shoulder pain.  Patient is currently scheduled to try physical therapy, but has delayed due to neck pain.  Has also seen a spine surgeon for neck pain.
Following imms mom had left office, but then came back because he looked really pale and somewhat tired and limp on exam looked really pale and tired. Watch pt. in office on continuous pulse ox, nl with HR around 100 and pulse ox 95% or greater. He fed during timeframe, color started to return to normal, but not yet normal. They left office, nl cap refill. Good pulses. MA in room with mom, color coming back vitals normal. Blanching well.
FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Constant Headaches; light and loud noise sensitivity; light and loud noise sensitivity; sore throat; extreme fatigue; nausea; grapefruit size knot at injection site; gum and teeth soreness and sensitivity; gum and teeth soreness and sensitivity; teeth soreness and sensitivity; pain in joints, knees, back and elbows; pain in joints, knees, back and elbows; vomiting; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Jul2021 14:00 (at the age of 45-years; Lot Number: EW0198) as DOSE 1, SINGLE for COVID-19 immunization (also reported as dose 2 (Lot Number: FC3180)). Medical history included degenerative disc disease and herniated discs. Concomitant medications included pregabalin (LYRICA) and hydrocodone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 18Jul2021 14:45, the patient experienced constant headaches, light and loud noise sensitivity, sore throat, extreme fatigue, nausea, grapefruit size knot at injection site, gum and teeth soreness and sensitivity, pain in joints, knees, back and elbows, and vomiting. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of the events. The events were assessed as serious (disabling/incapacitating). Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Vaccine given in right arm.  Mild discomfort as expected day vaccine was given.  The next morning, I could barely move my arm without intense pain, a constant ache, loss of ROM, muscle spasms and loss of grip strength.  As I was not getting better, I called my PCP on 9/22/15 and was seen by another member of the practice that evening.  Muscle relaxants were prescribed, activity as tolerated, no lifting or use of my arms over my head and out of work for two days.  If no better, to F/U with my PCP.  As I was not getting better, I called my PCP on 9/28/15 and was seen on 9/29/15.  Muscle relaxants were prescribed, physical therapy was ordered, x-rays were done. I was put out of work until cleared.  A foreign body was noted in my right upper arm and a surgical consult was ordered. I saw the surgeon on 10/5/15 and he felt the foreign body was a calcium deposit and was not the cause of my symptoms.  The symptoms are finally starting to resolve and I have a F/U appointment with my PCP on 10/8/15.
I was vaccinated on Mar 30, 2021, and had an itchy rash on where I've been vaccinated one week later, so I applied antiphlogistine and it was healed. Then last week, there was a bean-size nodule popped up under the skin of my wrist, at the same time, the backside of my right thigh tingled, which makes me discomfort and feel pain every time when I change my position( e.g. stand up suddenly).
Wrong diluent used with this vaccine. I used sterile water diluent instead of the one that was provided in the package.
One week after injection, developed a swollen, red, tender, and itchy patch on L arm. Itchiness began 02/21 and progressed overnight to warmth, swelling, and tenderness in addition to severe itchiness. This patch originated at the site of injection and grew in size over the next 3 days to cover approximately half of my upper arm. The patch lasted around 5-7 days, but the severity of symptoms resolved after 3-4 days. Pain was minor (around 3/10) and well managed with occasional tylenol. Itch was the most bothersome symptom and was poorly controlled with itch cream and ice.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 which expired on 05-NOV-2015 (lot#, strength, dose and route were unknown). The patient's concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Pt. c/o Rt. arm numbness after receiving injection (10-20 mins). No loss of sensation or strength on exam. Mild soft tissue edema of whole upper extremity. No airway compromise. Advised BENDADRYL. Follow up as needed.
01/07/2022:Event occurred after 2nd vaccine.   67 year old patient presented to the ED for further management of abdominal pain and headaches.  note of watery, nonbloody diarrhea about 6-7 episodes/day outpatient.  progressive worsening of confusion over the past 10 weeks prior to admission. o Respiratory: negative: cough, dyspnea, pleuritic chest pain. Remains in hospital on 01/13/2022
feeling of malaise; achy legs; mild fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling of malaise), PAIN IN EXTREMITY (achy legs) and PYREXIA (mild fever) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 007M20A, 023M20A, 012F21A and 065K21A) for COVID-19 prophylaxis.     No Known Allergies.  The patient's past medical history included COVID-19 (lasted 6 days, very mild, no symptoms) on 15-Apr-2022.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling of malaise), PAIN IN EXTREMITY (achy legs) and PYREXIA (mild fever). At the time of the report, MALAISE (feeling of malaise), PAIN IN EXTREMITY (achy legs) and PYREXIA (mild fever) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient said that the worst one was probably the 2nd dose of the first two where he had a feeling of malaise, achy legs, and mild fever, No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742282 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742282:New varient 2023-24
Patient's son reported starting 7/29/2018 client developed swelling on face towards mouth and jaw and up towards right ear, some pain at right ear and pain at injection site. Denied rash or any respiratory symptoms. Patient was referred to be evaluated with a PCP or urgent care for symptoms and emergency room precautions were given if symptoms change or worsen. Spoke to client's son 7/31/2018, was seen at Hospital and given MEDROL dose pack and symptoms are improving.