chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a bad reaction; Initial information and a live follow up was received regarding an unsolicited valid non-serious social media case from a consumer on 14-Oct-2020 and 21-Oct-2020. (Both processed together)  This case involves patient who experienced bad reaction (adverse reaction), while he/she received Influenza vaccine.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced bad reaction (adverse reaction), (unknown latency) following the administration of Influenza vaccine.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.  No further information was provided.
Arm opposite (left arm) to the one where the injection was put was hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 48 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL taken for migraine. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm opposite (left arm) to the one where the injection was put was hurting". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The arm where the injection was given, it's not that one that hurts, it's the other one, not in any other part of the patient's body, nothing just her arm was hurting really bad on the left side.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Subsequent to receiving one dose of varicella virus vaccine live the pt was diagnosed with chickenpox. 7 pruritic lesion were noted to be located on the pts lower back, shoulder and upper chest.
No additional AE reported; PEDVAXHIB was administered subcutaneously on two different patients, who are twins; This spontaneous report was received from a medical assistant and refers to a 15-month-old twin of unknown gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 25-JAN-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, lot #U012705, expiration date: 16-SEP-2023 administered subcutaneously for prophylaxis (intramuscular formulation administered by other route). No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA007760:
Hot to touch; Throat felt closed/glands swollen; Headache; 2nd dose given after 35 days; Lips feel different; Low grade fever; Nauseated; sore arm; Body is red/pinkish; Throat felt closed/glands swollen; Vomited; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days), PHARYNGEAL SWELLING (Throat felt closed/glands swollen), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot to touch) and ASTHENIA (Weakness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Weakness). On 07-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Throat felt closed/glands swollen), ORAL DISCOMFORT (Lips feel different), VOMITING (Vomited), NAUSEA (Nauseated) and LYMPHADENOPATHY (Throat felt closed/glands swollen). On 08-Apr-2021, the patient experienced FEELING HOT (Hot to touch), ERYTHEMA (Body is red/pinkish) and PYREXIA (Low grade fever). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days) had resolved and PHARYNGEAL SWELLING (Throat felt closed/glands swollen), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot to touch), ASTHENIA (Weakness), ORAL DISCOMFORT (Lips feel different), ERYTHEMA (Body is red/pinkish), HEADACHE (Headache), VOMITING (Vomited), NAUSEA (Nauseated), LYMPHADENOPATHY (Throat felt closed/glands swollen) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-072924 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021 contains non-significant information: updated reporter information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072924:
Pt immediately stated that the injection hurt. Instructed the pt that this specific rection wasn't normal so this RNN felt we should stop the injection. Pt stated that he wanted to go ahead & push through the pain. This RN told him that I did not recommend that. The pt stated that he wanted this RN to go ahead. This RN injected an additional very small amount of the vaccine but the pt again complained of pain. This RN instructed the pt that I did not feel comfortable going any further & that I was going to stop the injection & pullout the needle. Total amount given 0.01 ml. Seconds later the pt bowed his forward replied to the question of how he was feeling that he was feeling very dizzy, nausea. This RN held the pt up by his chest while opening the door & calling for help. The pt shortly thereafter became unresponsive. Rapid Response called.  attempted to wake the pt & noted that he had no pulse. The pt was moved to the exam table by this RN & 4 - 5 other nurses. The pt began   to open his eyes Care of the pt was transferred to their care. Pt was wheeled to the ED.   ED note:  getting his pneumonia vaccine when he had a syncopal episode.  He states that the nurse was giving the injection gave the shot in a more proximal position than usual on his arm.  He states that the shot initially did not inject fully and there approximately 1 minute worth of readjusting the needle under the skin.  He states this was a very painful experience stated that the pain became overwhelming and he syncopized.  Syncopal episode was witnessed, he did not hit his head.  Per chart review the patient did not have a palpable pulse initially.  However, on reassessment the patient awoke and had a pulse before any CPR was initiated.  Patient denies chest pain or weakness.
Patient developed red rash on left arm.  Rash is sized like a tennis ball, and is red, swollen and tender to touch.
This spontaneous report as received from a pharmacist refers to an unspecified patient. In approximately 2012 (about 2 years ago) the patient was vaccinated with the first dose of ZOSTAVAX (lot #, expiration date, dose and route unspecified). On 17-OCT-2014 the patient was vaccinated with the second dose of ZOSTAVAX (lot #, expiration date, dose and route unspecified). No adverse effect reported. Additional information has been requested.
Client called today to report that 2 days after receiving Zostavax vaccine she came down with shingles. They started on her right thigh, progressed to right hip and buttocks and down her right leg.  The lesions are almost all scabbed over as of today. She did visit her doctor, but did not take any medications to treat the rash.
patient experience vasovagal event, hearing became temporarily impaired, sweaty, and patient vomited.  Administered and ice pack to back of neck and gave a bottle of water since he was still conscious.  He seemed to recover within 30minutes and walked out of store with father.
FOLLOWING MORNING DEVELOPED BODY ACHES, JOINT PAIN, CHILLS, LETHARGY, AND HEADACHE THAT LASTED 36 HOURS BEFORE RESOLVING.
This spontaneous report was received from a pharmacist refers to a 59 year old female patient. The patient had no pertinent medical history, drug allergy/reactions or concomitant medications. On 04-MAR-2016, the patient was vaccinated with one dose of ZOSTAVAX (lot # L029482 and expiry date 06-NOV-2016) (dosing details unspecified) subcutaneously for shingles. Approximately on an unknown date in March 2016, the patient experienced "redness and swelling at the ZOSTAVAX injections tie that was the size of a fist and the site was also itchy as well". She sought medical attention. on 06-MAR-2016, the patient presented to the pharmacist and the pharmacist recommended the patient to take BENADRYL for the redness, swelling and itchiness, but the pharmacist does not know if the patient had indeed taken any BENADRYL. No lab diagnostic studies were performed. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was reported as not recovered/not resolved. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
A report has been received from a Pharmacist concerning a 11 year old, female patient. Patient's relevant history and concomitant disease were not reported. Patient's concomitant medication was not provided. The patient has received nasal FLUMIST Quadrivalent started on 12-DEC-2014. Te patient experienced nose bleed which started on 12-DEC-2014. The patient recovered from the event of nose bleed on an unspecified date. The report was considered to be non-serious by reporter.
Swelling and pain at injection site (worse at 1 day after shot still bad at 3 days out). Tingle/itch in face developed at day 3. fever (unable to report reading for 24 hours).
pt recv vax 230PM;4APR96 mom gave APAP;7PM pt felt hot & had 3 episodes of jerking & eyes rolling back;each episode lasted 1-2mins;last temp not taken;called hlth dept 5APR96 @ 2PM;examined by MD 6APR96;no problems found;no tx
Initial and follow up information has been received from a pharmacist concerning a 68 year old female consumer who on 29-MAR-2008 at 10:00 was vaccinated SQ in the right arm with a dose of zoster vaccine live (Oka/Merck) (lot # 659763/1875U). Subsequently, on 29-MAR-2008 the patient developed redness, soreness and swelling at the injection site. (Previously reported as a general reaction at the injection site). The patient was treated with cold compresses and BENADRYL. The redness, soreness and swelling at the injection site had resolved as of 04-APR-2008 and the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Narrative: Developed significant urticarial rash 2.5 hours after first dose of Pfizer vaccine, requiring systemic steroids. No anaphylaxis.
On 02/07/2022 Patient was administered 0.25 ml Moderna booster that was in fridge for 33 days which is over 30 days recommended. I emailed Moderna about it and was notified  that The vaccine administered on February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. No repeat dose is needed
Left thigh, within 24 hour developed small area of redness. By 48 hours larger circular area of redness with induration 2 inches X 5 inches. No fever.
Tested and treated for lymes; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (reported as 7/10) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was given the vaccine on an unspecified date, reported as 7/10, and came back on an unspecified date, reported as 7/12, with fever, headache, body aches and altered mental status. The patient was tested and treated for lymes and was hospitalized. The nurse stated "not sure if related to vaccine but started 2 days after". The outcome of the event was recovered. It took 3 months for the patient to return to baseline.  The information on the lot number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
High fever 103 - 104 degree arm inflamed edematous Pt took ibuprofen in his own
Felt a sore throat on Friday, headaches and body aches throughout the weekend, then severe body aches and cold symptoms on Monday. Called my supervisor and was told to go to urgent care and follow their recommendations. After waking up again at about 9am, I felt much better. Urgent care/medical facility didn't test me because I was fully vaccinated, and I returned to work that afternoon. My symptoms were almost completely gone by Tuesday. I realized several days later that my senses of taste and smell had been severely impacted. Taste seems to have recovered but certain smells seem very different than they did before (particularly "clean" smells like conditioner and body wash).
Sudden onset vision changes - felt like my eyes were looking in different directions; vision skewed; felt pressure in my head, dizziness and felt like I was going to pass out. I thought I was having a stroke. The feeling passed after about 5 minutes. Did not seek treatment.
Pt came to clinic hours after injections complaining of severe back pain, tremors, being hot. She was checked in and found to have temp of 101. After being placed on stretcher vitals were checked. BP 125/84, HR 133, Sao2 98%, resp  26. Temp 5 minutes after arrival 103.4. 2:40pm- Ibuprofen 200mg tablets (x2 ) and 200mg liquid given PO. 2:42pm- benadryl 25mg given PO. 2:49pm Albuterol 0.083% given per hand held nebulizer for complaint of chest tightness. Ambulance called. 3:03pm Epinephrine 0.3mg SQ given for chest tightness as albuterol did not relieve the symptoms. 3:08pm Ambulance arrived and took patient to ER.
After receiving the vaccine I had a fever of 104.2 degrees, chills, a lot of joint pain, very tired, and headaches. I would also freeze and then break out in a sweat. At one point the sweating was so bad that I had to change my clothes because my clothes were soaking wet. I had loss of appetite as well. My skin would also hurt over my entire body. I felt like I had the flu. I took ibuprofen and Tylenol as needed. Those symptoms lasted for about 48 hours.
Itchy skin, (face, right shoulder).  3 bite like hives on right upper arm, itchy eyes.  Dry mouth and lips.  Right side of throat felt strange.
I WAS TOOK THE VACCIN THEN AFTER THREE DAY I WAS SO SICK. I HAD FLUE FOR TWO WEEKS. RUNNING NOSE, HEADACHE, FEVER, LOOSE APPETITES, SNEEZING, COUGHING AND ITCHING THE WHOLE BODY  SINCE THEN NEVER TAKE ANY VACCINE. NOW I AM WORRY ABOUT MY HEALTH. IT IS SO HARD ME TO TAKE THE VACCINE AGAIN.
Vaccines given 05-1-12 at 4:30pm, by 10:00pm she had large & small whelps all over legs starting at injection site & on her butt. BENADRYL given whelps gone 30 mins. On 5-2-12 with worsen whelps BENADRYL give and taken to Dr. At 12pm whelps spread to face & arms baby very fussy and heavy raspy breathing child taken to ER. BENADRYL at 7pm prednisone started.
Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Immediately after Flulaval vaccination, patient with MS noticed numbness and tingling beginning in feet and working its way up her legs to the thighs over a period of 15-20 minutes.  Checked with her neurologist, who prescribed Prednisone for use if symptoms did not resolve.  Approx 75 min after onset, sx started to resolve, pt was able to leave.  She did not use Pred and was feeling normal next day.
Information has been received from a female who in June 2008 and August 2008 was vaccinated with her first and second dose of GARDASIL (lot number, route and site not reported). The patient stated that she experienced injection site soreness each time she was vaccinated with GARDASIL. Each time the pain went away with in 24 hours. Additional information has been requested.
about 3 minutes after injection. pt felt light headed, hot and cold sweating. felt weak. vision impairment. resolved after 20 minutes
Developed heart palpitations approximately 10 hours after receiving vaccine. Also insomnia  making it impossible to sleep.  Palpitations seemed to get better by 11 am the next morning but my heart rate was still elevated ( pulse 106-112).  Shortly after that ( around 11:45 am) I became extremely light headed and dizzy and felt like I was going to pass out. I also started to feel nauseous and sweaty.   I rested lying down for two hours before hearing back from my doctor's office.  I was able to control the lightheadedness and dizziness by lying down. The feeling of passing out / nearly fainting went away.  I continued to feel nauseous and my  heartrate was still elected. I started to get a headache as well.  On the advise of a nurse at my doctor's office,  my husband took me to the ER.  My EKG was normal . My heartrate was elevated.  Due to the overcrowding at the ER that day I was made to wait at least an hour and half for further evaluation.  I continued to feel light headed and slightly dizzy. My nausea and headache got much worse .  I was finally taken back to a treatment room and received IV fluids, Zofran and Tylenol.  My heartrate went back to normal and my headache and nausea improved with treatment and I was discharged around 7pm.  I continued to feel very tired and slightly lightheaded that evening. The next morning  I was much more nauseous again and still very weak feeling and slightly lightheaded. I have  continued to feel weak, very fatigued , unwell and nauseous on and off until today, April 14, which is 6 days after I was vaccinated.
Flu-like symptoms:  Exhaustion, sensitive skin, chills, fever, loss of appetite, sore muscles and joints.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 27th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and fever. On an unknown date, the outcome of the pain in arm and erythema of extremities were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities and fever to be related to SHINGRIX. Additional details were reported as follows: On Tuesday, the patient received SHINGRIX. At the time of reporting, the patient had a large red painful area down his arm below the injection site. The patient also experienced fever for 36 hours. The reporter wanted to know, if the patient should use heat or cold for pain relief, but did not realize this constituted an adverse reaction. The reporter asked to call center representative, any thoughts on how to relieve the pain. The contact details of the physician was provided.
ADACEL given 11/6/08. On 11/14/08 patient returned to office with Erythemia, swelling and warmth.
Weakness, fever, chills lasting approximately 12 hours. Motrin 600mg every 6 hours x2
Per mom infant developed increased cough and gagging. The following day, with increased nasal congestion and wheezing. Congestion can last for 4 weeks. Per mom has noted to occur with prior immunization at 4 mo visit. (has nasal congestion last time). This time increased fussiness, temp of 100.1.
The vaccine administrator didn't listen when I told him he stuck the needle into the wrong place, and proceeded to insert the injection despite my protest. I felt an immense pressure in my shoulder, and the sensation of something cold trickling down my arm. The administrator was standing over me during this process while I sat in a metal chair and I'm not sure he wanted to even touch me. My fiance and I received the shot together, however only he experienced a slight fever. I only experienced increasing pain when moving my arm. No other health changes. The pain was immediate and progressively got worse.  My primary care provider assessed me, and agreed that the injection was indeed pumped into my shoulder joint, instead of the muscle. My PCP is also worried about the efficacy of the vaccination, and whether or not absorption was successful. There is possible rotator cuff damage, and chronic pain when performing NECESSARY routine daily activities. I've been ordered on pain medication, as well as physical therapy and have been advised that many vaccine related shoulder injuries never heal, or require surgery.
Subject in pneumococcal vaccine trial, with severe COPD hospitalized for pneumonia. Vaccination took place on 1/27/09. According to physician, the relationship is 'None'.
Mother called around 7:30pm - 745pm describing widespread urticaria with lip swelling and penile swelling. No respiratory involvement occurred. Advised to give oral BENADRYL and head to ER for further evaluation.
Moderna vaccine was administered outside of our facility - reported by patient  I26.99 ACUTE PULMONARY EMBOLISM 7/30/2021 PULMONARY EMBOLISM, UNSPECIFIED. I26.99 ACUTE PULMONARY EMBOLISM 7/30/2021 ALTERED MENTAL STATUS, UNSPECIFIED
This initial spontaneous report was received from a physician referring to a 3 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015, at 17:03 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
you got the shot Thursday. Friday a mouth cold sore developed and was dying by Saturday.  Very quick cold sore episode of just one lesion
Patient developed bilateral leg pain, weakness , numbness and tingling within  36 hours of receiving vaccine. She was admitted to the hospital on 1/22/21 for Guillain - Barre Syndrome. She was treated with IVIG and is starting physical therapy today