chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling at the injection site; pain in the body; Headache; very sensitive from her elbow to her shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date unknown) for prophylaxis.   On 3rd June 2020, the patient received the 1st dose of Shingrix. On 4th June 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, general body pain, headache and sensitive skin. On an unknown date, the outcome of the injection site swelling, general body pain, headache and sensitive skin were unknown.   It was unknown if the reporter considered the injection site swelling, general body pain, headache and sensitive skin to be related to Shingrix.  Additional information was provided as follows: The patient experienced events a day before reporting. The reporter consented to follow up. No expiration date was provided.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, patients were vaccinated with a doses of improperly stored PROQUAD (Merck) (route, dose and frequency were not reported) lot # L014401 expiration date 23-OCT-2016 (also reported as "23-OCT-2106"), lot # L024123 expiration date 30-DEC-2016 and lot # L021601 expiration date 10-DEC-2016. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
BP 98/62 (pulse 81), 114/75 (pulse 86).
Patient got a third dose on 12/30 even though they did not qualify for one. We believe our staff gave this "3rd" dose thinking that patient's dose was their second. Patient had got 2nd dose at our location but had not gotten first dose at our location.
day 2, sore arm at injection site, slight headache - gone by day 3 day 6, rash at injection site (shoulder) and swollen. Lower back pain, could hardly walk. Has happened before but this came out of no where. No new or out of the ordinary activity to cause the onset. May or may not be related.  day 7, back pain continues. Went to my chiropractor.  Noticed some itching on breast. Injection site still red and itchy and tight. day 8, rash/bumps  on breasts. stomach, lower back, upper thighs, bumps on arms. Injection site starting to itch again and feels tight and swollen. Getting some relief on back pain.
Patients states he woke up the day after vaccination at 3am with aches all over his body. His muscles, bones, feet and hands ached.  He states he also feels like he has a fever but did not check with a thermometer. His eyes also felt like they were burning and has slight labored breathing. He took 25mg of Benadryl prior to the vaccine and at 3am the next morning. He will continue with scheduled Benadryl and APAP until symptoms improve.
69-year-old female with history of prior anaphylactic reaction to medications and flu vaccine, epilepsy, PTSD and prior stroke without residuals, chronic leukopenia presented with lip swelling, throat swelling following a second Covid vaccine.  Patient had similar reaction following her first for Covid vaccine which was treated with antihistamines and prednisone but did not require hospitalization.  Pt was admitted for care and management.   On admission patient was hemodynamically stable.  She was treated with IV Benadryl, Pepcid and prednisone.  Significant improvement in her symptoms.  Patient was discharged on 4/22/21 on prednisone additional 4 days course.
I started getting a dry throat on 5/7 and tested negative for Covid on a PCR test. I took another test the following day at home and was negative. By Monday, I was still having cold like symptoms but I had tested negative on a PCR and a Rapid so I just thought it was a cold. I was going to have visitors on 5/12, so I went ahead and tested again that Thursday and it was positive. I then went for another PCR on the same day, 5/12, which confirmed my positive results. I had a telehealth appointment with a doctor on 5/13, and he advised that I monitor and treat symptoms at home since I was at the tail end of the recommended time frame to prescribe antivirals and my symptoms were not severe. I have tested a few times since then and am still testing positive but the positive indicator seems to be lightening each time and my symptoms have been basically gone since the end of last week with the exception of the occasional cough.
interesting looking at her COVID history. tested positive 9/8/2021 (symptoms started 8/21) underwent treatment at hospital, have several negative swabs and then re-swabbed positive on 11/21/2021.  - Supplemental oxygen to maintain SpO2>92%.  Encourage self-proning.
Pt recvd vax 4DEC92 & 2 hrs following vax pt exp diarrhea; w/in 3 hrs shoulder was sore; the following fingers in lt hand ached & exp generalized aches; diarrhea lasted for 1 day 7 the achiness lasted 3 days;
30 minutes after vaccination, the patient's face developed a red, hot rash. The patient reported no other symptoms. She agreed to an IM injection of 50 mg diphenhydramine into the right deltoid. Paramedics were called, but the patient declined further evaluation and care.
Pt recvd 1st DTP/OPV/HIB 6FEB92 @ 2PM approx 8PM mom noticed an increased "moro" reflex; mom called MD;
Immediately had visual disturbance: couldn't focus clearly. And felt tingly-sensation all across chest, deep inside, very uncomfortable and scary, and couldn't get a deep breath. Visual problem lasted about 1 hr.; chest/lung feeling lasted about 5-8 mins., tightness in chest lasted about 10-15 mins.  Later in afternoon had pain/edema at injection site, left shoulder joint pain. As of today, 2/3, it's minimal.
Chills, body aches, headache, soreness at injection site, tired, shivering, side effects preventing me from doing regular activities.
The patient reported that she began to break out in small hives.  She could not remember the exact day that they began. She said approximately 2 to 4 days after her second dose.  She said she was not aware of any other changes that might explain the break out.  She said they did spread some and complained of itching.  We talked about her taking Benadryl which she said she was already.  We also talked about using some Hydrocortisone cream to help also with the itching.  She does not have a dr and therefore; did not want to go to a dr.  We did tell her she should be seen if they continued to spread in spite of how she was treating them.
Painful area with swelling and redness at site. Rash on chest. Recommended Motrin and Zyrtec.
'My' period has stopped coming; Feel pressure in abdominal area; Body feels different; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0202) via an unspecified route of administration in the left arm on 30Jul2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. On 30Jul2021 at 11:00, after receiving her first injection of Pfizer COVID-19 vaccine, the patient's period had stopped coming. The patient stated that her period had always been regular and on time every month. It was reported that after getting vaccinated the patient's body felt different especially in her abdominal area and felt pressure in that area. The patient further stated that it was too early for her to go through menopause and mentioned that she was not pregnant. The patient was very concerned about the side effect of the vaccine on her hormones and body and stated that, it is now September and has not had her period since July. Therapeutic measures were not taken as a result of the events. On 30Aug2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events period has stopped coming, feel pressure in abdominal area and body feels different was not resolved at the time of this report.
Bell's Palsy; Initial Report Received on 02-Dec-2020  A patient who is registered nurse reported that she, a 60 year-old female (race and ethnicity not provided), had received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed Bell's Palsy.  The patient declined to share her medical history and shared that she was not sick.  No concomitant medications were reported.  At the end of Sep-2020, the patient received her first and only dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) from a medical office.  About 30 days later, the patient began having ear pain and facial paralysis to the left side of her face. She previously had the ENGERIX-B series but did not show immunity when tested. The patient was working and taking care of her parents prior to developing Bell's palsy. The patient received medication but did not share what medications that she had since completed. At the time of report, she was receiving acupuncture treatments to tone her facial muscle.  No additional information was reported. An attempt was made by Medical Information to obtain the lot number, expiration and serial number from the medical office clinic but was referred to medical records instead. No information was received regarding the company's request to follow-up with the medical records department.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Expired Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received and contains non-significant information.
Metal taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 09:30 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Esophageal acid reflux" (unspecified if ongoing), notes: Acid reflux. There were no concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 07Jun2021, outcome "not recovered", described as "Metal taste in mouth". The event "metal taste in mouth" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of dysgeusia.  Additional information: The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jun2021, the patient experienced metal taste in mouth started right after vaccination and still had it after 48 hours of vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were not taken as a result of the reported event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient described increased heart rate and eventually chest pain after 20 minutes of receiving vaccine. Ambulance was called to assist - relayed heart rate and blood pressure was normal and deemed it "situational anxiety". Mom decided to have patient transported to ER.
Symptoms: Intense indigestion, freezing/chills, extreme dizziness, rapid heart beat, very weak, eye sockets hurt, major body aches.
4/13/03 While on ridinf lawn-mower developed shortness of breath and chest pain, sub-sternal stabbing and bil. arm numbness and tingling on both hands.  With rest it improved that evening.  Next day cont. chest discomfort and sorness sub-sternally, with pain also in axilla area of both arms.  Went to ER was given Notrin for discomfort.  EKG done with Right Bundle Branch Blick.  F/U with PMD advised.
Sick at stomach, whelps, itching, felt like I couldn't breath. Received steroid shot, Benadryl, and breathing treatment at medical center. Took po Benadryl the following day.
Pain at injection site-lasted  3 days Muscle aches especially backache, and fever for 24 hours highest was 100.6 celsius Headache on the 3 day Fatigue
Inflamed administration site, red, hot, and itchy. Counseled patient to take some diphenhydramine according to OTC box directions and apply a towel cooled by water. Follow-up with us or primary care provider if inflammation does not reduce in 8 hours.
Initial report was received on 29 September 2011 from a consumer, who was also the patient, at which time this case was assessed as non-serious listed. Based upon follow-up information was received on 29 February 2012 from a consumer, who was also the patient, on 29 February 2012, it was determined this case now meets seriousness criteria (Other-Medically Significant) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. A female patient had received an injection of influenza vaccine (manufacturer, lot number, date, route and site of vaccination not reported) over 30 years ago and an unspecified amount of time later had a seizure. The patient's past medical history was originally reported as an allergy to flu shot, seizure (fractured her skull twice by her husband which caused her to have seizures), smoker for 63 years, measles, mumps, gun shot wound, rabies from gun shot before 12-years-old, hospitalized 5 times at age 42 due to seizures, low blood pressure, weight loss, heart attack on 15 May 2011, stent placement for clogged artery and spot on her lung. Concomitant medication included furosemide, potassium chloride, atenolol, phenytoin, ZOCOR, PLAVIX and will restart baby aspirin after biopsy. The reporter clarified that the patient did not have an allergy to the flu shot, she had a seizure after receiving the flu shot. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Nose bleeds; This is a spontaneous report from a contactable healthcare professional. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 23Apr2021 at 15:15, (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unknown route of administration in the left arm on 12Apr2021 at 15:15 as a single dose for COVID-19 immunisation. On 27Apr2021 at 07:00 the patient experienced nose bleeds. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported event. Since the vaccination the patient not been tested for COVID-19. The clinical outcome of the event nose bleeds was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fatique, Neck tightness, Chills, Fever 102.3, bone  pain fingers/hands, shaking legs, unstable walking.
Pt called later reporting a sore arm to the nurse who recommended using ice on it; Pt came in on 12AUG91 to have it checked; Pt had large amount of swelling & inflamation; MD noted wheal & flare;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on an unknown date in 2009 (route of administration was not provided). No other co-suspects were reported. No concomitant medications were reported. The patient received the second dose of GARDASIL On 18-SEP-2012 (route of administration was not provided). No adverse event was reported. No treatment information was reported. Additional information has been requested.
Moderna bivalent Pink cap was administered when Moderna bivalent Blue cap should have been administered.
1/5, 3pm- extremely sore arm. 5pm extreme fatigue. 7pm sever knee pain. 9pm, coughing fit, vomiting, chest tightening, phlegm in throat that I couldn?t clear, full body heat wave, tingling legs, fever spike.
Feeling very bad, extreme fatigue, fever/chills, pt did not check tempature, injection site redness, (basball sized) hot to touch, extreme soreness/tenderness.
Headache, Fever, Chills, soreness in left arm, neck, and head. 48 hrs
Breakthrough case admission after 2 vaccines Pfizer 2/3/21 Lot# Em9810;  Pfizer 2/24/21 Lot# EN6202
- 24 hours after felt typical, fatigue, achs, and nausea - 4 days after my second dose I got severe upper back pain for two weeks (no prior history of back pain ever)  - 10 days after my second dose I began to have severe acid reflux after anything and everything I ate. These symptoms have lasted for over seven weeks and are so bad to the point I cannot eat or sleep and have sought out emergency medical attention. In this same time period, I got what my doctors believe is Eosinophilic Esophagitis where my throat is now chronically inflamed, making it difficult to swallow. I am also experiencing extreme fatigue, anxiety, and mood swings when I never had a history of this.  I have tried taking several medications and PPI's with no success as well as trying every type of diet and lifestyle change possible with no success. I have not recovered from this and expect it will be some time before I do.
Pt. developed fever within 24 hrs of 1st year vaccinations.Additionally, pt. developed an "abscence" type seizure with respiratory distress.Pt. was subsequently hospitalized. Pt remained groggy 12/8 thru 12/10 at home Fatigued thru 12/27.
It has been a month since my first injection and I still feel pain at the injection site...especially when the arm is in use.
no adverse event; Vaccine given 1 day beyond BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) and NO ADVERSE EVENT (no adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy and Seasonal allergy (Seasonal Allergies).    On 23-Feb-2023 at 3:33 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 23-Feb-2023 at 3:33 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) 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)) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) to be related and NO ADVERSE EVENT (no adverse event) to be not related.    Concomitant medication information was not reported.  It was reported that Moderna bivalent booster dose was administered on 23-Feb-2023, which is 1 day beyond the beyond use date.  Patient was notified about the incident at the time of initial discovery of event as well as notified when the lot assessment was completed.  No treatment information was provided.
15-year-old female patient, seen by me, at Health department for immunizations on 10/25/23.  MMR Dose # 2 and Varicella Dose # 2 inadvertently given with Proquad instead of separately with MMRII and Varivax to patient.  Proquad administered subcutaneously in right arm without difficulty.  Patient tolerated well. Proquad vaccine information was entered into EHR and vaccine record prior to administration.  Proquad was counted as a valid dose completing both series of MMR and Varicella for this patient. Per current protocol Proquad indicated for children 12 months to 12 years of age only.  Dr. notified.  Per consult with Dr., immunization series considered completed for MMR and Varicella; repeating individual doses of MMR and Varicella not necessary/recommended.  Phone call to notify patient and Mom with only contact information on file-attempts x 2 unsuccessful.
2 week old male infant received a dose of Pentacel, no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a two weeks old male patient who was vaccinated with a 0.5 mL dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ071AAB, expiry date: 13-Jun-2020 via intramuscular route in the left thigh on 03-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It is an actual medication error case due to Inappropriate age at vaccine administration.  Symptoms none reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.