chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of stroke in a 87-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On 20th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced gaze apraxia (serious criteria GSK medically significant) and postictal state. On 24th September 2018, 4 days after receiving SHINGRIX, the patient experienced stroke (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization) and abnormal gait (serious criteria hospitalization). The patient was treated with alteplase (Tpa (Tissue Plasminogen Activator)). On an unknown date, the outcome of the stroke, lower extremities weakness of and abnormal gait were recovering/resolving and the outcome of the gaze apraxia and postictal state were unknown. It was unknown if the reporter considered the stroke, lower extremities weakness of, abnormal gait, gaze apraxia and postictal state to be related to SHINGRIX. Additional details were provided as follows: At approximately 2:30 pm, the patient received SHINGRIX in the right deltoid. The physician reported that the patient was hospitalized at least overnight under a stroke protocol because of an acute event several days after receiving the SHINGRIX vaccine. The patient started walking towards her right side and she experienced weakness in her legs. The healthcare professional thought she had a stroke so they administered TPA and the patient developed a gaze preference and they did a magnetic resonance imaging (MRI) and the MRI was negative and the electroencephalography (EEG) showed some changes but nothing specific. The tests might indicate a post seizure state. The patient was much better on the day of reporting. The patient had no recent infections and no change in medications.
History of Present Illness     Patient is a 71-year-old male with a history of tobacco use, aortic bypass on antiplatelet agents, and cholecystectomy presenting for concerns of a trauma.  Patient was a restrained driver in a car when he had a coughing fit, "blacked out" and hit a tree.  Patient was extracted by EMS on scene and was complaining of neck pain, so was placed in a cervical collar.  He was also hypoxic on scene, so placed on nonrebreather.  He was tachycardic on scene, but was maintaining good pressures.  Patient endorses pain in his neck, shortness of breath, and pain in his lower back, which he states is chronic. (07/29/2021 15:39 CDT XR Pelvis) IMPRESSION:  1. No acute fracture of the pelvis.  2. Lower lumbar disc and facet degenerative change, greatest at L5-S1. [1]  (07/29/2021 15:39 CDT XR Chest Portable) IMPRESSION:  Diffuse bilateral airspace opacities. Differentials include pulmonary  contusion, in the setting of trauma versus less likely multifocal  pneumonia.
patient describes left anterior chest, neck, and left back sharp pain, now described as achey 2 days later. Denies SOB. Given Advil as needed.
After pt waited for 15 minutes following injection, pt had dizzyness, shaking legs, feeling "hazy", "feels heavy",  "sight feels funny", feels "hot inside".  Pt was assessed by EMS had increased bp, cbg and other vitals normal.
Still warm/warm at injection site; Arm itchy at the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Still warm/warm at injection site), VACCINATION SITE PRURITUS (Arm itchy at the injection site) and PYREXIA (Fever) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (High blood pressure was reported), Thyroid disorder NOS (The reporter states that the patient takes thyroid medication) and Cardiac disorder NOS (The reporter states that the patient is on heart medications.).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Still warm/warm at injection site), VACCINATION SITE PRURITUS (Arm itchy at the injection site) and PYREXIA (Fever). At the time of the report, VACCINATION SITE WARMTH (Still warm/warm at injection site), VACCINATION SITE PRURITUS (Arm itchy at the injection site) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinner, high blood pressure medication, thyroid medications and heart medicines.  No treatment information was reported. Patient received the first dose of moderna vaccine on 9 March2021 and had arm itchy and fever at injection site. Started couple days after the shot, maybe next day. Still on going, still warm   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI
At 12 hours, severe shaking and hot/cold which lasted about 8 hours. Hot/cold persisted for 5 days. After the severe shaking stopped, extreme fatigue - cold not walk or get out of bed. Persisted until about 72 hours after  the injection. More moderate weekends until day 5. Mild weakness and mild hot cold through Day 6. At Day 3, severe headache - relieved by ibuprofen. Feeling back to normal by the end of Day 6.
Patient had a swollen, lumpy, red, painful, and itchy injection site. Pharmacist on duty instructed her to go to urgent care. Patient received BACTRIM DS for possible cellulitis. She had informed us at follow up that she was feeling much better by the following day (03/01/19).
Initial report received from a health care professional on 12 March 2012. This reporter also reported another adverse event, which was captured in case number 2012-02847. A 68-year-old male patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UT474AB, on 17 October 2011. On 21 October 2011, the patient started with symptoms of body aches and pain and could not get out of bed for five days. He could barely eat. The patient developed loss of hearing in the right ear. The patient had a magnetic resonance imaging (MRI) of the brain which was interpreted as "OK". He was seen by his physician who diagnosed him with a viral infection behind the ear drum which caused nerve damage. The patient's hearing will not return. The outcome was reported as recovered. Documents held by sender: None.
developed a polyethylene glycol (PEG) allergy; This is a spontaneous report from a contactable consumer (Patient).   A 88-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration, on as unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced developed a polyethylene glycol (peg) allergy. Caller asked about the efficacy of the booster vaccine. If not efficacy will that allergy be affected when she had the booster. Caller stated that this was not satisfactory, she would like to hear more from research staff about it, seems to be there has to be more information coming up and she would like to know how to keep in touch with this. Further Explained that there was no information regarding anyone reporting developing the PEG allergy after receiving the Pfizer Covid-19 vaccine and that our contraindication for not receiving a dose of the vaccine was anyone who had a severe allergic reaction to a previous dose or any ingredient in the vaccine. Referred to HCP, explained there was no further information to provide. Survey offered. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
This is my second shot of Moderna, I got hives (rashes) throughout my body after 4 days taking the shot. It lasted for 4 days. I didn't have that side effect after the 1st short. I took chlorpheniramine maleate tablets for the first two days when I got the rash. Then I stopped using it as I  had headache and drowsiness.  I got pain and a red swollen arm for about a week.  I got chills the next day after the shot and lasted almost two weeks. I got low fever the next day and lasted 3-4 days.
About 18 hours after The shot I had headache and nausea and a low-grade fever of 100. That persisted throughout the day along with extreme fatigue. About 36 hours after the shot I started joint pain in my right knee which progressed to pain in my finger joints wrist and ankles. Had moderate muscle pain in arms and legs. I was more or less bedridden for the first day and only moderately improve the next day. Not back to normal until almost 72 hours after the shot.
liquid from the vaccine running down arm / liquid leaked from vaccine needle; She stuck the needle in; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (She stuck the needle in) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 14-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (She stuck the needle in). At the time of the report, ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (She stuck the needle in) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Pharmacist took the needle out of the patient's arm and said the liquid from the vaccine came running down out of the arm down the chair. Also, pharmacist stuck the needle in, and its like it dripped all the way down the patient's elbow and down to the chair. Pharmacist was not sure how much came out, but said it seems like a lot came out. The patient had not experienced any symptoms. No treatment medications were reported.
1st Dose 1/1/2021, 2nd dose 1/23/2021:  I have been dealing with chronic headaches on a monthly basis starting soon after (appx 8 days after 2nd dose) getting my 2nd dose. I have been in close contact with my PCP and OBGYN regarding these reoccurring headaches. The first headache started 2/1/2021 and lasted 6 days and nothing (Excedrin, Advil, Tylenol, muscle relaxer & even tried a massage) but nothing  helped. This seemed to correspond with  menstrual spotting that is why I have been working with both my PCP & OBGYN.  We have not been able to narrow it down to what is causing it and since it started soon after my vaccine I thought I should notify someone incase others are having the same issue.
Hair falling out after both shots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair falling out after both shots) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair falling out after both shots). At the time of the report, ALOPECIA (Hair falling out after both shots) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-294688 (Patient Link).
Initial unsolicited report received from consumer on 06 Feb 2017. The case was linked with 2017SA021390 (Same reporter). This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date in "November". The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed flu (a week before of this report). The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Mom noted red knot on arm and leg on 7-1-9 - C/o sore, hot to touch and can't walk good - Warm compress tid, BENADRYL, ELOCON cream
Fever (101.8), body aches, stiff neck, joint pain, nausea
numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; Dizzy; little taste in mouth; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; This is a spontaneous report from a contactable consumer (patient).  A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 77-years-old) as single dose for protection. There were no medical history and concomitant medications reported. The patient experienced Dizzy, little taste in mouth, numbness at injection area, swelling came back 1 week later, 4 inches and round in shape on 21Jan2021 and itchy in Jan2021. It was reported that the patient got her vaccination on 21Jan2021. When she got it, she felt a little dizzy, and a little taste in her mouth that disappeared. She did experience numbness at the injection area and swelling that disappeared after two days. Then, after one week, the swelling came back. She still has it. It is 4 inches, and round in shape on 28Jan2021. She wants to know if this is life threatening. Her next vaccine is on 12Feb2021. Her height has went down. She got it at the Hospital. She doesn't have a prescribing doctor. She experienced the dizziness and taste in her mouth occurred while in the recovery room, it lasted a couple of hours. The arm numbness and swelling started a few hours later and lasted two days. Right now it is itchy, but she tries not to scratch her arm. The initial injection wasn't itchy when she had the numbness and swelling. It was just numb and swollen the first time. This time, it is itchy and swollen. She got the vaccine because she wants to be safe, for protection. The patient underwent lab tests and procedures which included body height: her height has went down in Jan2021. The outcome of events, dizzy, little taste in mouth on 21Jan2021 and numbness at injection area on 23Jan2021. The outcome of swelling came back 1 week later, 4 inches and round in shape was resolving and was not recovered for event itchy.   No follow-up attempts are possible. No further information is expected.
having a cough before Moderna Vaccine and after 1 dose still experiencing cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (having a cough before Moderna Vaccine and after 1 dose still experiencing cough) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Cough.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (having a cough before Moderna Vaccine and after 1 dose still experiencing cough). At the time of the report, COUGH (having a cough before Moderna Vaccine and after 1 dose still experiencing cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, SARS-CoV-2 test: negative (Negative) tested negative for COVID-19 virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
Varicella vaccine breakthrough. Diagnosed with varicella 8/26/06. Had 6 lesions no fever.
35 yo woman with a remote history of B-cell ALL s/p myeloablative umbilical cord blood transplant, complicated by iron overload from blood transfusions and heart failure with reduced ejection with recovered EF to 40% and LV thrombus in the past. Now admitted with 2 months of worsening palpitations frequent PVCs. It is unclear the etiology of the worsening arrhythmias and EF.  There were no ECG changes, troponin elevation, or chest pain symptoms to suggest myocarditis or pericarditis. Patient had reduced LVEF from prior (baseline 40%) and had worsened palpitations ~3 weeks after Pfizer COVID vaccine administration
Information has been received from a woman in a physician's office concerning a 29 year old male patient who on 02/19/02 was vaccinated with Varivax. On 03/08/02, the patient presented to the physician's office with less than 20 disseminated, excoriated lesions, a mild headache and slight cough. The patient did not seek medical attention. Additional information has been requested
Deep nerve pain; Lower back pain to back of thigh and buttocks.; was really exacerbated after shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pain (She had a little bit of pain before shot).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced nerve pain (Verbatim: Deep nerve pain), low back pain (Verbatim: Lower back pain to back of thigh and buttocks.) and exacerbation of pain (Verbatim: was really exacerbated after shot). The outcome of the nerve pain, low back pain and exacerbation of pain were not resolved.   It was unknown if the reporter considered the nerve pain, low back pain and exacerbation of pain to be related to Shingrix.     It was unknown if the company considered the nerve pain, low back pain and exacerbation of pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023 The Pharmacy intern reported that the patient experienced deep nerve pain from lower back pain to back of thigh and buttocks. It was worse in the morning.  She had a little bit of pain before shot but it was really exacerbated after shot and continued to be about the same, for every day for the last 2-3 months.
Small red bumpy rash on mid on back; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 10:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 12Apr2021 at 13:00, the patient experienced small red bumpy rash on mid on back. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event small red bumpy rash on mid on back was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sudden unexpected death. No symptoms preceeding discovery of apneic infant. COD - Sepsis due to beta hemolytic strep as per autopsy report.
On 9/19/2014 MA administered 3 vaccines on patient left arm. Patient came back on 9/22 because she had a reaction to vaccines her left arm was swelling, severe pain on palpation, redness, warm for 3 days associated with fever. Symptom started after injections.
first testing positive for Covid (severe symptoms: fever is 103 every day/ bad headache/ pain/ sick); first testing positive for Covid (severe symptoms: fever is 103 every day/ bad headache/ pain/ sick); This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 at 20:30 as dose 1, single (Lot number: EL3246), in right arm, on 05Feb2021 as dose 2, single (Lot number: FM981D), in right arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 06May2022 at 16:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "bladder cancer" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fentanyl, reaction(s): "allergies", notes: Known allergies: Fentanyl and other narcotics. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "first testing positive for Covid (severe symptoms: fever is 103 every day/ bad headache/ pain/ sick)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: after taking Paxlovid for five days; (Jun2022) Positive, notes: first testing positive; (20Jun2022) Positive, notes: tested positive again 11 days from first testing positive for Covid; Body temperature: (unspecified date) 103. Therapeutic measures were taken as a result of vaccination failure, covid-19. The clinical course was reported as follows: After taking Paxlovid for five days, the entire course, and testing negative, 11 days from first testing positive for Covid, I tested positive again, and had more severe symptoms. My fever is 103 every day, even taking Tylenol. I have a bad headache. I did not need to take any other medication for pain or fever while taking Paxlovid. But then when I became sick the second time, it was more severe symptoms. I need to use an inhaler because of restricted breathing.  No follow-up attempts are possible. No further information is expected.
pt w/pain to lt deltoid muscle secondary to Td inj;pt tx prev for allergic rxn to vax; pain cont p/9months, no abscess noted by ultrasound;
Pt experienced more than three days of moderate fever (100.4), fatigue, and significant localized pain at the injection site. Pain was sufficient to impair use of the arm.
First Moderna Covid 19 vaccine, on second day had muscle spasm and achy. Lasted a day and resolved quickly.   I took 2nd dose Moderna vaccine 2/2/21.  On 2/3/21,  I had severe muscle pain, fever/chills. Became very jittery, had numbness and tingling in my arms and upper legs.    I had severe spasm in my diaphragm/abdomen (seemed to last forever) and all of my muscles ached. I felt weak and had difficulty moving my legs.   I thought about going to the ER but what could they do?  I just took a lot of aspirin, tylenol and some old expired  muscle relaxer that I found in the cabinet. I have a high pain tolerance and gave birth naturally (8 lbs 11oz)  without any medication/epidural etc.  This pain/spasm was like labor