chrisvoncsefalvay/vaers-outcomes huggingface dataset:
neck hurt in the side of the injection (left) to the top of the head, on her ea; still on a lot pain / Achy; run a low grade fever; Saturday afternoon started just feeling bad; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of NECK PAIN (neck hurt in the side of the injection (left) to the top of the head, on her ea), FEELING ABNORMAL (Saturday afternoon started just feeling bad), PAIN (still on a lot pain / Achy) and PYREXIA (run a low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (Saturday afternoon started just feeling bad). On 28-Mar-2021, the patient experienced NECK PAIN (neck hurt in the side of the injection (left) to the top of the head, on her ea), PAIN (still on a lot pain / Achy) and PYREXIA (run a low grade fever). At the time of the report, NECK PAIN (neck hurt in the side of the injection (left) to the top of the head, on her ea), FEELING ABNORMAL (Saturday afternoon started just feeling bad), PAIN (still on a lot pain / Achy) and PYREXIA (run a low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications:- 1 pill a day for diabetes
Patient now painful, erythematous local reaction with myalgias.  At school on post-vaccine day 1 she developed two erythematous, slightly raised, sore lesions that felt like bruises" around the injection site.  One was 2cm x 1cm and the other 1.2cm in diameter.
Patient was given varicella vaccine in left arm SC instead of ordered ZOSTAVAX at 1200 pm. Injection given by employee.
READ FIRST The purpose of this report is to report a potential vaccination error. On 12/21/20 at the Hospitals while vaccinating front line healthcare workers, 5 people were vaccinated with diluent only.  The error was discovered and the 5 people were called back and received a proper covid-19 vaccination.   No adverse vaccination reactions occurred as of 12/31/20.
Skin rash   Began on scalp, became infected (due to itching).  Went to derm to resolve infection and was prescribed doxycycline.  Rash resolved on scalp but simultaneously appeared on right hip, interior of right thigh and right elbow.    Went back to derm and was prescribed prednisone and antihistamines (May 19).    Rash did not resolve with conclusion of steriod; remained on antihistamine.  Very itchy and would randomly become hive-like (raised, extremely itchy, blotchy).   Went back to derm and received 2nd round of steriod (July 12) while continuing to take antihistamines.   Rash resolved.    Rash came back on right arm (~ Aug 12).  Remained on antihistamines as rash continued to enlarge/spread and itch.  Began 3rd round of steriod ~ Sept 15 w/antihistamines.   Concluded this morning (10/5).  Rash resolved/healing but remaining on antihistamines.   If it comes back, derm said next step is to conduct a biopsy.
This spontaneous report was received from a registered nurse refers to an multiple unspecified patients of unknown age. Patient's medical history and concurrent conditions were not reported. On unspecified dates in January 2016 multiple unspecified patients was vaccinated with VARIVAX (Merck) (L026405, exp.date: 15-JUL-2017; L034370, exp.date: 08-SEP-2017; L029471, exp.date: 06-UAG-2017; L033138, exp.date: 31-AUG-2017; L034366, exp.date: 08-SEP-2017) and these doses were exposed to -5.8C in a time frame of 1 hour and 40 minutes. The previous temperature excursion was reported as -1.4C for 4hours and 12 minutes. No adverse effects was reported. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
8cm splotchy edematous area on rt upper arm; full ROM w/o pain;
fluzone highdose quadrivalent was administered to 5 pages of incorrect age group with no reported adverse event; fluzone highdose quadrivalent was administered to pregnant with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA330943(CLUSTER).  This case involves an unknown age female patient who was exposed to vaccine Influenza Quadrival A-B High dose HV Vaccine [Fluzone High-dose-Quadrivalent] in context of administered to incorrect age group and pregnant patient with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was unknown. The events occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On an unknown date, the pregnant patient at incorrect age group received a dose of suspect Influenza Quadrival A-B High dose HV Vaccine (lot number, strength, expiry date, dose not reported) via unknown route in unknown administration site as prophylactic vaccination with no adverse event (product administered to patient of inappropriate age) (exposure during pregnancy) (unknown latency).  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  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 the 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.
Information has been received from a male with history of about 6 cases of shingles, and no drug reactions or allergies, who in May 2006, was vaccinated with ZOSTAVAX, 0.65 ml injection (lot # not reported). Concomitant therapy included Valtrex. In September 2008 two years went by, the patient developed another case of the shingles. The patient sought unspecified medical attention. Routine labs were performed. The patient's shingles was not recovered. No further information was provided. Additional information is not expected.
Severe back pain, leg pain in nerve area of back, side, legs/lasting 6-8 hours. The patient was awful!  Follow up- Unknown manufacturer!
Pt received a child dose hep A vaccine .5 instead of adult hep A which is 1 ml.
On December 1, 2022 I began having sharp pain on l left side below ribs, which was worse when I ate or drank fluids. Pain was consuming, I couldn?t work, vomiting, stand or function at all until I was given blood thinners upon admission to hospital on 12/10/2022
Immediately after I felt dizzy, the back of my throat started to tingle. I experienced slight chest pain. I started itching as with the 1st dose. Breathing remained within normal limits. Today is day 4 after dose 2 administration, I'm itching even more from head (scalp) to toe. It is becoming unbearable. I just took 2 25mg Benadryl PO tablets as per pharmacist. Will continue to monitor
patient got dizzy a few minutes after the vaccine administration, fell on the floor but he was conscious and he was able to get up later on. We continued to monitor him. No emergency call 911 was made
Asthma attack; Bladder infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (Asthma attack) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma attack) (seriousness criterion hospitalization) and CYSTITIS (Bladder infection). At the time of the report, ASTHMA (Asthma attack) and CYSTITIS (Bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed. The treatment medications included steroids, antibiotic, and asthma medication.  Very limited information regarding these events (PT/Asthma and Cystitis) has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events (PT/Asthma and Cystitis) has been provided at this time. Further information has been requested.
Pt developed immediate pain and swelling at injection site lasting 5 days. Unable to move arm, very painful.
Red, swollen area on right arm around injection site.  Treatment so far with hydrocortisone and Benadryl.
3/20/21 received J/J COVID vaccine left upper arm. Subseqeunt soreness and local sight reaction that blistered mildly then resolved. Mild fever that resolved after first couple of days. Past couple of days has noted a "divet" in left upper arm over area of vaccination; concerned that this is a vaccine reaction. Mild tendernss along the divet, but no weakness. Able to fix hair/shower and wash hair normally.
arm where the vaccine was given became swollen; arm where the vaccine was given became swollen, red; arm where the vaccine was given became swollen, red and hot; This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2020, the patient received the 2nd dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. In December 2020, less than 2 weeks after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced swelling arm, erythema of extremities and extremities hot feeling of. On an unknown date, the outcome of the swelling arm, erythema of extremities and extremities hot feeling of were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities and extremities hot feeling of to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was vaccinated with Bexsero on unknown arm. The patient had reaction after vaccination, the arm where the vaccine was given became swollen, red and hot. No details on how soon after injection these symptoms developed. No information on whether events resolved or not. The patient was also administered allergy shots in the opposite arm on the same day. Attempted to follow up with HCP but unable to contact. Voicemail left with HCP office to obtain patient initials and lot and expiration date
This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 41-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 39-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 28Jan2021, when the patient was 39-year-old, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset 22Apr2022, outcome "unknown", described as "ST cough"; PLASMA CELL MYELOMA (medically significant) with onset 22Apr2022, outcome "unknown", described as "mm aches". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2022) Positive, notes: Covid test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of plasma cell myeloma. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event plasma cell myeloma cannot be excluded. 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.
The vaccine was given by a nurse, on my left arm I did not feel any pain but the day after I notice I had a red rash that would not go away, prior to this I have done laboratory tests at this same location, she gave me a bandaid and that is were I got the bad rash it is inflamed itchy and very red it is almost 2 weeks and the rash does not go away. I feel nauseous ill to my stomach irritable confused and very weak.
A nurse reported that a 53 year old female vaccinated on 11/10/1999, post vax, on 11/11/1999, she felt "sick to stomacn" and developed an injection site reaction characterized by a 3.5" circle of redness and warmth. The pt recovered.
Greatly swollen Lymph Node under the injection arm. Went to urgent care at Hospital and was instructed to take Vitamin C and Zinc. Warm compress and to alternate between Ibuprofen and Acetaminophen. Monitor after a few days and if the swelling does not go down, go to my primary care practitioner to make sure it is not cancer or cancerous.
Information has been received from an office manager concerning a female who was vaccinated IM with a 0.5 ml dose of GARDASIL (dose# unknown). Within minutes the patient fainted. Unknown medical attention was sought in the physician's office. The patient was quickly recovered. This is one of two cases from the same source (WAES# 0804USA03629). Additional information has been requested.
6PM DAY OF IMM., HE WAS COUGHING FOR 5-10 MIN.  AFTERNOON OF 8-18, 2:30 PM, HE C/0 OF ITCHING AT INJECTION SITE.  GRANDMOTHER OBSERVED RED, RAISED, HOT AREA, UPPER L ARM, LARGER THAN A SILVER DOLLAR.  HE ALSO C/0 ITCHING IN HIS THROAT AND THAT HIS HEAD FELT HOT.
Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Ist dose, single), for COVID-19 Immunisation. The following information was reported: THYROIDITIS ACUTE (medically significant), outcome "unknown", described as "Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination". The patient underwent the following laboratory tests and procedures: Thyroid function test: Unknown result, notes: hyperthyroidsm & hypothyroidism was evaluated. Duration of duration of the hyperthyroid phase was also evaluated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event thyroiditis acute and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available.   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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200708586 Same article/ Event/drug and different patient
Patient presented with a rash on her chest, neck, and face that occurred 5 days after the Shingrix shot. She went to the Dr and it was 75% resolved. She had not SOB, wheezing, etc.  She declined treatment for the rash at that time. She was given prednisone to take with the 2nd shot.
All was fine for the first week. No side affects at all. One week later on Thursday February 11 my left are at the injection site started itching like crazy. I scratched it a lot and felt a small bump. Knowing there are no mosquitoes out this time of year I thought spider bite. After a few hours of itching I looked at my arm in the mirror. There was a faint red rash around the pinprick of the needle, and the lump had grown and was getting hard. On Friday it was the same, large lump under the skin and itching. I found the term COVID arm online and read about it. That?s what I had. By Saturday (today) itching is almost gone and lump has decreased in size.  Just wanted to report in.
Achiv diluent used instead of Hiberix diluent; Achiv diluent used, administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The health care professional reported that Achiv diluent was used instead of Hiberix diluent and administered to patient.  The exact patient and date of administration unknown at time of call. The reporter consented to follow-up. Additional supportive information: The  Achiv diluent was used instead of Hiberix diluent and administered to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Patient still hospitalized. Patient is a 69 y.o. female with past medical history significant for chronic hypoxic respiratory failure on 3.5 L of oxygen in the outpatient setting, type 2 diabetes mellitus, paroxysmal atrial fibrillation, chronic diastolic congestive heart failure, obstructive sleep apnea, presenting to the emergency department as a transfer from the Hospital with chief complaint of altered mental status.  Patient reportedly was hiding under a bed and refused to come out until EMS arrived which is unusual for her.  At a local Hospital Emergency Department, patient was diagnosed with COVID-19 pneumonia, acute renal failure, hyperkalemia, and acute on chronic hypoxic respiratory failure.  Initial labs at the Hospital:  Potassium 6.1, sodium bicarbonate 34, anion gap 8, BUN 29, creatinine 1.55, glucose 203, alkaline phosphatase 120, albumin level 3.4, troponin 19, hemoglobin 10, hematocrit 32.8.  COVID-19 PCR positive.  Repeat BMP with potassium of 5.5, bicarb 32, BUN 28, creatinine 1.44, GFR 46, glucose 209, troponin 17. CT scan of the head showed no acute intracranial process.  One view chest x-ray consistent with COVID pneumonia.  At the Hospital Emergency Department, patient was treated for hyperkalemia with albuterol solution, sodium bicarb, IV Lasix, and Kayexalate.  Patient also received a L of normal saline for clinically appearing dehydrated.  Patient was subsequently transferred to another Hospital for further management.   Upon examination, patient is evaluated at bedside.  Patient reports that she has had a cough for about 3 days with productive sputum and reports mild shortness of breath with activity.  Patient reports intermittent headaches.  Patient states that she started having diarrhea yesterday.  States she has had decreased appetite and has been eating once a day. Patient denies any chills or fevers, no nausea or vomiting, patient does report a sore throat, patient denies any chest pain or abdominal pain.  No leg swelling.  Patient reports chronic skin changes to her bilateral lower extremities and states that she has some scabs on her left lower extremity from a dog scratching her leg.
noticed fever & chills on 25MAy p/vax 24MAY96;did not take temp;rt arm swollen 25MAY, +redness from deltoid to elbow on 26MAY;still has knot +redness from deltoid down w/in 2" of elbow;also c/o nausea;knot about the size of a lemon
A report was received from a health care professional on 11/25/03 concerning a 1 year old male vaccinee who was inadvertently administered 0.5ml Fluvirin vaccine on 11/24/03. On 11/24/03 the vaccinee inadvertently received 0.5ml Fluvirin. At the time of the report the outcome was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up letter returned unopened on 8/3/04. No new information provided.
I was traveling right before, and my flight back was on June 16. I was fine, though looking back I wonder that my mouth didn't feel right. My tongue felt a little tender, but it wasn't bad. I wonder if that was an early symptom. It was a long day and we got back to our house early evening. I had a restless night of sleep and woke up the next morning and it was like a bad cold I had a sore throat, lots of phlegm and just didn't feel well. I took a COVID-19 test and it showed positive immediately. I began calling to try and get PAXLOVID. I felt like I was getting worse fast. It felt like it was going in kind of waves. I would feel better for a bit then get bad again. I was afraid that I would be without resources over the weekend, so I requested PAXLOVID and took it that same evening. By the next day, the second dose on Saturday morning, I wasn't worse. Every dose made me less sick with COVID-19. I did the 5-day course and I did have that very bad mouth issue and my gastric system with PAXLOVID. I was very uncomfortable and it was painful. Right after the next to the last dose, I had pain around 7 on the pain scale. I was clearly not getting worse with COVID-19 and they warned me that I may be tempted not to finish the course of the PAXLOVID, but I finished them all. By the end of the 5th day, I had a lot of phlegm still, but I wasn't sneezing, and it wasn't as bad. The severity felt like a really bad cold, but I've never had a cold that bad. By the end of the PAXLOVID, I knew I was over COVID-19. With PAXLOVID, I knew there was a possibility of rebound. I was careful because I was wondering if I could catch it again from my husband. Luckily, it did not return.
Myalgia, Fever, Diarrhea, chills, sneezing, stuffy nose, weakness, fatigue Narrative: on 8th day after vaccine had flu like symptoms that lasted for 4 days to include: fever, chills, sneezing, stuffy nose, weakness, fatigue, diarrhea.