chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported an increase in blood pressure and heart rate starting 4 days after the 1st dose of Shingrix. Patient has no medical history of heart disease. Average BP and HR rose to 170/100 and 110-130, respectively. This led to 2 emergency room visits. The patient's PCP and cardiologist found nothing outstanding except for elevated BP/HR. The increase lasted ~2 months  before their PCP prescribed Losartan 25mg PO daily. As of today, patient is still managed on Losartan. BP/HR levels have returned to normal.
High fever  of 101.5 degrees, Loose bowel movements, left arm soreness for 3 days, fatigue for 2 days, body aches for 2 days  All symptoms  resolved over time without treatment  Patient had covid in latter part of March 2020 with moderate symptoms
Reporter indicated that 28 pts recvd the Engerix-B series; 8 pts have tested neg; (3 pts tested pso p/1st booster dose, 1 pt borderline p/1st booster dose;
Patient received expired vaccine on 07-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 07-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial did not undergo any temperature excursions. Vial was initially stored in refrigerator on 07-Apr-2022. patient was given vaccine that Expired on Second.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up received contain non significant information
First dose: 10Apr2021, second dose: 02May2021, had a positive Covid test yesterday, 03May2022; First dose: 10Apr2021, second dose: 02May2021, had a positive Covid test yesterday, 03May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0158), in left arm and on 02May2021 as dose 2, single (Lot number: EW0173) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: 067F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "Smoker" (unspecified if ongoing), notes: caller use to be a smoker. Concomitant medication(s) included: WELLBUTRIN taken for major depression. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "unknown" and all described as "First dose: 10Apr2021, second dose: 02May2021, had a positive Covid test yesterday, 03May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive; (04May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Reaction/Event as reported by primary source: Pfizer Covid Vaccine/Moderna: This morning, 04May2022, had severe muscle weakness, For about four or five days had severe pain in that arm and was not able to move arm up or down. Outcome of reaction/event at the time of last observation: Unknown. The patient received three doses of Vaccine that were all Pfizer. Patient states everything taste metallic. The patient has only taken one dose of Paxlovid around noon on 04May2022. The patient won't take the night time dose until around 2000, at least 8 hours between doses. Covid symptoms got patient really, really bad, just started yesterday, 03May2022. This morning, 04May2022, the caller had severe muscle weakness. Everything taste metallic. The patient received the Flu vaccine at the same time the patient received Moderna dose on 17Nov2021. For about four or five days the patient had severe pain in that arm and was not able to move arm up or down. The lymph nodes in armpit were huge for day. Patient states it is not a good idea to get the Flu vaccine while getting booster dose Moderna Vaccine, was pretty bad. Flu Vaccine: NDC/lot/expiration: Unknown, patient does not have this information to provide because the information was not provided to the patient.
Information has been received from a physician concerning a 12 month old female who on 15-JUL-2009 was vaccinated with a dose of MMR II. Secondary suspect therapy given on 15-JUL-2009 included doses of VARIVAX (Merck) (MSD), HEXAVAC (manufacturer unknown). Concomitant therapy given on 15-JUL-2009 included doses of Hib conj vaccine (unspecified carrier) (manufacturer unknown) and PREVNAR. On 17-JUL-2009 the patient developed a measles like-rash, the rash followed the typical pattern of a measles rash. The patient also had low grade fever.  Initially it was thought that it was an allergic reaction and the patient was treated with prednisone and an antihistamine. The patient was scheduled to be seen in the office on 23-JUL-2009. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Patient had MMR and Varicella vaccines, both in left thigh, at drs office on 6/12/12. Per dad, about 1 to 1 1/2 weeks later child had a large, red, swollen, warm, hard spot on thigh where shots had been given. Dad stated child not feeling well and threw up once so mom took child to ER where he was diagnosed with a infection and antibiotic was prescribed. Dad stated child was given antibiotic and had followup appointment with dr.  Dr. stated everything was fine.  Dad stated child is fine now.
Fatigue, sleeplessness, chills (brief). Intermittent sharp headache pain on left side near left ear, continuing.
Severe swelling of arm, hot to the touch, itching and sore...started 20 hours after vaccine and still continues 2/8/19 but not as severe. Low grade temperature, nausea, chills, joint aches...started 20 hours after vaccine and lasted two full days.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose, unit and route not reported, lot # K026247 and expiration date 29-JAN-2017) (confirmed not GARDASIL). The vaccines were exposed to 34 F for 30 minutes, previous temperature excursion included 55 F for 16 hours and 34 F for 2 hours. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The day of the she c/o itching at the site - red area appeared 3 days later 15mm x 20 mm now. Started small welting after - no fever, no swelling in arms. FNP doesn't think related to shot.
Patient came to see me on 1/2/2020. She is not sure exactly what vaccine she was given, but was told it was preservative free.  Within three hours of administration the patient was bedridden with high fever, chills, shivering violently, severe fatigue, vomiting  headache,  very forgetful & spacey.  Exacerbated insomnia and anxiety.  Although she no longer had a fever or vomiting, all of her symptoms were continuous since the injection. She was given a homeopathic remedy by another physician which helped temporarily.
Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Oct2021 (Lot number: FP3590) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "type 2 diabetes" (ongoing); "Cholesterol" (ongoing); "High blood" (ongoing); "prostrate" (ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus (ongoing); SIMVASTATIN taken for blood cholesterol abnormal (ongoing); LISINOPRIL taken for hypertension (ongoing); TAMSULOSIN taken for prostate infection (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, date: 03Mar2021, Anatomical site of injection: right arm, Batch/Lot number: EN6203, 03Mar2021 sore arm for 5 days), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (Dose: 02, date: 25Mar2021, Anatomical site of injection: right arm, Batch/Lot number: ER8733, 25Mar2021 1. Sore arm for 1 day), administration date: 25Mar2021, for COVID-19 immunization, reaction(s): "sore arm", "type 2 diabetes", "head had preception problems". The following information was reported: CHILLS (non-serious) with onset 18Oct2021, outcome "recovered", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient's medical history and Relevant tests were provided as none. No specific relevant test for thromboembolic events with Thrombocytopenia  No follow-up attempts are possible. No further information is expected.  Follow up (03Dec2021): New information received from a contactable consumer. This consumer (patient) reported in response to - Non-HCP letter follow-up activity that includes:  Historical vaccine, reporter's phone number, lab test. outcome of event.  Follow-up attempts have been completed. No further information is expected.
Felt younger after vaccination.; This is a spontaneous report from a from a contactable consumer (pfizer colleague). A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) at the age of 57 years via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown, if the patient had received any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. On an unknown date, the patient experienced felt younger after vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event, felt younger after vaccination was unknown 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.  Amendment: This follow-up report is being submitted to amend previously reported information: Age at Vaccination added 57 Years.
This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 57-year-old male patient who received ENGERIX B (batch number 7N5M5, expiry date 16th November 2020) for prophylaxis. This case was associated with a product complaint. On 14th January 2019, the patient received the 1st dose of ENGERIX B. On 17th January 2019, 3 days after receiving ENGERIX B, the patient experienced weakness, jaundice, elevated liver enzymes, stomach cramps, stool discolored, urine coloring orange, appetite lost, nausea and loose stools. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the weakness, jaundice, elevated liver enzymes, stomach cramps, stool discolored, urine coloring orange, appetite lost, nausea, loose stools and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the weakness, jaundice, elevated liver enzymes, stomach cramps, stool discolored, urine coloring orange, appetite lost, nausea and loose stools to be related to ENGERIX B. Additional details were reported as follows: The patient was diagnosed with jaundice and had elevated liver enzymes. The patient would like to investigate the remaining 6 doses that were in the same box to see if there was something wrong with this batch of vaccines. The reporter would returned the remaining 6 doses of the vaccine to the GlaxoSmithKline. The reporter requested a credit for 6 doses of ENGERIX-B and results of the investigation. The patient required the emergency room visit.
Patient was being monitored after receiving J&J shot for 15 minutes as recommended by the CDC. Shortly after receiving the shot, she approached the counter feeling dizzy and unwell. I immediately grabbed a chair and sat her down to prevent a head injury if the patient were to faint. Once she sat down, her eyes rolled in the back of her head, and she seemed to be unconscious. She was awake but was definitely not 100 percent with it. I gave her water for hydration and glucose tablets for possible hypoglycemic episode. She came back around after approximately 15 seconds. I let her rest, monitored her symptoms. She was in a foggy state at this point and doesn't really remember completely. I asked if she would have liked me to contact EMS and she declined. I then suggested to have her mother pick her up to prevent another episode while driving home alone. She rested, and I monitored her. After about 15 minutes she was feeling better and I suggested to walk around. I gave her a brief cognitive evaluation to make sure there were no signs/symptoms of stroke or anything to be concerned with. Her mom arrived approximately 30 minutes later. I explained what happened and the patient was feeling much better. She left her car here, and I advised her to notify us if anything else happened.
Shortly after getting vaccinated my skin started flaring with rashes. I have always had dyshidrotic eczema however only on the palm of my hands and the eczema is different with blisters. Once getting vaccinated I had a large red rash on my arm . Over the months it has spread higher up my arm, chest, shoulders, and legs. They have also cause my nipples to also become dry and patchy. The gynecologist also stated that she did not know the cause for it after several visits. The topical steroids given to me by my dermatologist for my current eczema does not work. Phototherapy has not helped either. These flare ups are debilitating constantly itching and getting intense urges to scratch.
FEVER OF 103, EXTREME SORENESS, SWELLING AND REDNESS (WHICH WENT DOWN PAST ELBOW). PATIENT STATES TOOK ORAL PAIN RELIEVER. SYMPTOMS SUBSIDED. PATIENT WILL CONTACT FAMILY PHYSICIAN.
Shaking chills, rigors by 7pm same night. Fever to 102. Could not get out of bed for 24hours straight. Right arm became extremely hot hot hard swollen and very painful by next day. Rigored again night 2.    felt
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. Ten patients received BOOSTRIX that was exposed to temperature of 30.4F. Two lot numbers 3P9CL exp 15Apr2016 or HM4FY exp 06Dec2016.
So I had the shot on March 28, 2021 and let's see if I can remember the date, I'll get my calendar which will help me a little bit, so it started the end of April 2021. I noticed a difference in my breathing, I had not been active and I just didn't feel very good. On the 28th of April I was feeling very weak, feeling like a wimp, I couldn't do anything without feeling very exhausted. Then on May 5 2021 I told my husband I just was not feeling right, I had to sit down just when getting dressed. I went to the bathroom and I felt like something was really wrong, I could not even walk around without feeling tired. On May 5 2021 I called my son who is an RN and he took my BP and heart rate, but my oxygen was 91 and then 87 again when he tested again. He said he felt I had a pulmonary embolism, they called my cardiologist. The DR told me to go to the hospital and they did an EKG and took me to an ER room to do a chest x-ray. They said there was something on my chest so they did bloodwork. He then said I had blood clots on both my lungs. Then later on that night they did ultrasounds of my legs. They found a deep vein thrombosis. They then broke the news that I was not going home, that they were going to admit me. I ended up in a monitored room for four days. They put me on oxygen and wires. 4,000 units of heparin drip w/ 2,0000 units per hour. They then switched me to Luvanox and Coumadin. They could not figure out why this happened to me. They found no infections, nothing cancerous or anything. They sent me home with blood thinners (coumadin) all the time. Then two weeks later I woke up in the middle of the night with a lot of pressure on my chest and I went to the ER again. I was never admitted, they just checked me. Then two weeks later again it happened and I went to on call, they took pictures of my heart and everything again and they could not find anything. They did a study of sleep on me and they found I have a sleep apnea problem. They are recently now working on my sleeping problem and I will be admitted and studied over night on the machines. In between all this I also went to my PCD and now that is to current, up to date is what has been happening recently.
Pharmacist did not verify the vaccine was diluted properly before the administering technician drew up 0.2mL of Pfizer Pediatric Covid 19 vaccine.  0.2mL of UNDILUTED VACCINE was administered.  Patient currently ( after1.5 hours) has no side effects from the high dose.  Patient's parents and primary care provider have been notified.
1 of 2 pts exp swelling @ the site of inject (arm 2 x nl size) from deltoid to the elbow; appeared as cellulitis; pt was treated w/erythromycin & DPH; instructed to immobilize & elevate extremity; pt recovered;
Gradual onset of abdominal pain, nausea, vomiting and congestion.  Sept 2014 abdominal xrays (2) and ultrasound were normal. Labs normal. Symptoms progressed in frequency and intensity. 15-20% weight loss. Hospitalization in Nov 2014 and Dec 2014. Xray and CT Scans identified SB dilation with possible SB obstruction.  Obstruction not responsive to medical therapies to include high dose prednisone.  March 2015 SB resection surgery, approx. 30 cm.
Itchiness and swelling, redness, firmness around injection site., about 3 inches in diameter, two days after receiving vaccine.
Arm, bicep to elbow is swollen and shooting pain to my wrist.  Also throbbing pain in my armpit.
Patient and friend presented for COVID vaccine.  PN student assisting with vaccine.  Nurse gave PN student bivalent vaccine without reviewing screening sheet to observe last dose.  Vaccine administed by PN student.  Asked for vaccine card, pt returned document without COVID vaccine noted.  Pt. asked if it was her first dose and she verified it was her first injection.  Will be considered the 1st primary dose.  Will need to get 2nd dose as monovalent, and 2 months later repeat bivalent booster.  Pt. informed and verbalized understanding.
Yesterday at 4:45pm i started feeling extremely tired and shaking of cold sweats. Every single joint of my body hurt like if i lifted heavy weights..  I then took an 800 ml of ibuprofen (DUEXIS ) and went to sleep.. This morning felt better but my eyes feel irritated like when you have fever. Temperature is normal  Working from home so I stop every other hour to relax my eyes...  No headache or body pain.  Just a little tired.
Actually got vaccine on Wednesday, 11.14.18. Tinnitus worse after vaccine. Got tinnitus last May, was diagnosed by Dr. but we did not correlate the vaccine with the tinnitus at that time but it is much worse now, ringing in my ears is very loud and started on Thursday 11,15.18, evening. Reported it to my daughter on Friday morning but did not think that much about it until evening. Seems to be worse in the evening. Other side effects are typical, slight runny nose and feeling a little feverish and tired on Thursday and Friday but by Friday evening I felt better. I did have a flu shot on Monday and I called my pharmacist to see if it would be ok to have the shingles shot on Wednesday since the time frame between shots was exactly 6 months. Will call my primary 1st thing in the morning.
Red Raised Rash after 45 minutes then went away within an hour, 2 hours after vaccine had fever, body aches, headache, fatigue, chills, shortness of breath, chest pain, nausea, diarrhea. Next day low appetite and loss of taste and smell. These symptoms continued and worsened and I went to ER on 04/04/2021. They gave me IV fluids to lower my heart rate and after an hour or so was sent home to rest.
FLUMIST QUADRIVALENT (Intranasal) started on 17-Dec-2014. The patient reported that patient received expired FLUMIST QUADRIVALEN on 17 Dec 2014. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT to a patient is unknown. The report was considered to be non-serious.
Blood pressure that?s usually normal spiked up to 151/109 for approximately 8 days, with lowest reading at 143/104 until the 8th day when it began going back to normal
This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-JUL-2018, the patient was vaccinated with first dose of GARDASIL 9, (dose, lot # and expiration date were not reported) for prophylaxis. On 18-JUL-2018, immediately after receiving the GARDASIL 9, the patient experienced injection site reaction: swelling, irritation and itching at the injection site. The patient was treated with ice in the office. The outcome of the events was unknown (also reported as ''it sounded like the patient was okay when she left that day but it could not be confirmed if she recovered and what date she recovered so outcome was unknown''). The causality assessment between therapy with GARDASIL 9 and the events was not reported.
Sore Arm, about 1 hour after shot, lasting 3 days Tiredness, fatigue.  Tiredness same day, lasting 5 days. Fatigue 24 hours after-36 hours after (slept for 11 hours, day after shot) Headache 6 days