chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of a monovalent vaccine; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of a monovalent vaccine) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of a monovalent vaccine) and NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of a monovalent vaccine) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of a monovalent vaccine).    Patient relevant medical history conditions, allergy, concomitant diseases and risk factor were unknown. No concomitant medication was reported.    HCP stated no AEs were reported. No treatment information was reported.
Vision changes; Seeing halos in left eye; This case was reported by a consumer via call center representative and described the occurrence of visual disturbance in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 49R79, expiry date 2nd April 2022) for prophylaxis.   On 25th June 2020, the patient received Boostrix (intramuscular) .5 ml. On 25th June 2020, less than a day after receiving Boostrix, the patient experienced visual disturbance and vision halo. On an unknown date, the outcome of the visual disturbance and vision halo were not recovered/not resolved.   It was unknown if the reporter considered the visual disturbance and vision halo to be related to Boostrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the Boostrix (Tdap) vaccine and she stated that within hours of receiving the vaccination, she began to have visual changes. She reported about seeing halos in her left eye.  This symptom s had not cleared up. The reporter did not consent to follow up.
Vaccine was administered 3 days outside of the BUD (while under refrigeration).  Error was discovered after administration.  Patient was notified and given further guidance. No adverse events reported at this time.
Patient was suppossed to get a meningitis vaccine for her school requirement and I accidentally gave her a MMR vaccine.
irritability, dec appetite & emesis x 2 1/2 days parents were able to keep down clear fluids & did note some inc ear touching; dx OM;
Symptoms 12/21/2021- antigen test 12/22/2021 PCR on 12/28/2021- Positive Covid Case. Isolated until the 12/21/2021- 12/31/2021. 4-5 days having issue with breathing talked with pomologist. Added Med 12/24/2021 Albuterol 108 mcg two puffs every 4-5 hours, Prednisone tapper 8 day treatment,
Moderna Covid Arm (at injection site: muscle hard, somewhat itchy, then ~2" red patch appeared)
Off and on fever and chills body aches and on and off headaches in a localized spot
herpes zoster polyneuropathy; herpes zoster polyneuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by physician for herpes zoster polyneuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster polyneuropathy was unknown.     Upon internal review, polyneuropathy was considered to be medically significant.  Additional information has been requested.
tenderness; fever; vomit; Initial information received on 08-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4 months old female patient who experienced tenderness, fever and vomit ,while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot number not reported at an unknown dose via unknown route in unknown administration site for immunization.  On an unknown date (latency: unknown) ,the patient developed a non-serious events of  tenderness , fever (pyrexia) and vomit (vomiting) .   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events (tenderness, fever, vomit).  At time of reporting, the outcome was Unknown for the event tenderness, was Unknown for the event fever and was Unknown for the event vomit.
Recieved vaccine at 525 pm 1 Feb. Sore arm at injection site, body aches, chills, low grade fever, headache, nausea, and fatigue. Woke up at 6 am on Feb 2, with symptoms. Lasted until about 10 pm 2 Feb. Took tylenol and motrin for symptoms.
Palpable swelling in Right axillary accompanied by tender and swollen lymph nodes with mild pain in the upper arm, back, and right side.  Palpable swelling and mild pain persist after six months with little to no change in size. No special treatment prescribed.
Patient received the first dose 3/26/21 and believes she conceived 3/10/21. She began spotting on 4/5/21 and the bleeding continued getting heavier until 4/19/21.  The OB confirmed miscarriage on 4/28/21.
Pt. had itching of the ears immediately following vaccination. Slight facial flushing. No redness or swelling of the ears. No other symptoms. Pt has history of multiple allergies. Vital signs stable. PT. monitored for 30 minutes. Ears still itching, facial flushing resolving. No other symptoms and vital signs stable. Pt stated ears are still itchy, but it could be from the elastic on her mask. PT stated she felt fine and was instructed to f/u with PCP. PT had her own epipen and was advised by RN to take it, but she refused. Stated that she knew when and how to self adminster epipen if needed.
I only had a sore arm in the afternoon after the vaccine, and the next day it was still sore, but after that the soreness went away. No further health problems noticed between the 3rd dose and up until my embolism. I walk frequently 3-4 miles a day and had no issues doing that. I went out of town for a job for a day and I came home and noticed that the bottom of my foot was asleep and had numbness in the foot and lower leg and that was on October 11. I contacted my PCP on Wednesday and asked him if it was something that needed to be checked. I did an office visit on Thursday October 14. I had no swelling in feet, or legs, and had a good strong pulse in my foot. He didn't think it was a heart related problem and he said it could be a back problem. So, I had a back x-ray that same day and the results of the x-ray was just minor degenerative disc, which is normal for someone my age, and he said that could be causing it, but no other significant findings with that x-ray. That following weekend, I left Friday and returned Sunday because my wife and I drove out of state, which was 5 1/2 hours there, and 5 1/2 hours back, and on the night of October 18, I started having some lower chest pains that continued off and on throughout the night. On October 19, I ended up going to the ER, where they ran several tests. They did a CT, ultrasound, chest x-ray, ultrasound on leg, and found the blood clot in left leg, and the CT scan showed blood clot in my lungs. They put me on Heparin, and I was in the hospital from October 19-October 21. I was given Eliquis, and I've been taking a double dose of those 2 times a day for 7 days, and I'm cutting back to 1 tablet for the next 30 days. I have a follow up with my PCP on November 4, and a cardiology appointment on November 23. The blood clot could've been caused by car ride even though we would stop to walk around, so I'm not sure.
RUE DVT in brachial vein at site of injection.  Patient complained of RUE pain and swelling on 4/28. That evening the team ordered a RUE venous duplex. The venous duplex noted a DVT in the proximal aspect of one of the two brachial veins.  He was vaccinated during an inpatient psychiatric hospitalization.   He was evaluated by the medical team on 4/29 and noted to be in stable condition. On discharge he was prescribed xarelto 15 mg BID with food for 21 days with instruction to follow up with PCP in 1-2 weeks. After 21 days of therapy plan was to switch to xarelto 20 mg daily with food until 7/22/21 for a total of 3 months of therapy. The adverse event did not prolong his hospitalization.
3/20/2021, Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, she experienced an adverse reaction with the following symptoms: rapid heart rate and chest pain and has history of asthma. Assessment : Time of assessment; Alert and oriented. Actions taken: Vital signs taken. At 6:04 Pulse 76, BP 119/83, O2 100%  6:34 pulse 73, O2 99% BP 132/78, Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered; Name, Date Dose VIS Date , Route, Pfizer COVID-19 Vaccine 3/20/2021  5:50 PM 0.3 mL, 12/11/2020, Intramuscular Manufacturer: Pfizer, Inc.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Severe
"Feeling bad", took ASA, went to bed.  Woke up with rt upper arm swollen, red and hot to touch.  Covered entire upper arm.  Had flu-like s/s w/fever.  Cont'd ASA and Claritin OTC.  S/s continued thru 9/24/2011.  Felt better 9/25.  Today 9/27,  feels "OK", rt upper arm still red, hot and swollen.  Not as bad as onset.
Approximately 40 hours after injection, I began to experience unexplained fatigue and a reoccurring low-grade headache. This condition, as of this writing , has lasted 48 hours. However, I am not severely affected by this condition, and have treated it with rest and occasional ibuprofen.
Angioedema; A spontaneous report was received from a physician concerning a 71-years-old, female patient who received Moderna's COVID-19 Vaccine and who experienced angioedema of lip, mostly upper, part of lower, and into cheeks.   The patient's medical history included angioedema. Concomitant product use was not provided by the reporter.  On 13 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient woke up with angioedema of the lip, mostly upper, part of lower, and it went into cheeks. Patient reported the same thing happened to her a fewyears ago with no known cause.   Treatment for the event included a shot of prednisone and oral prednisone.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event angioedema of lip, mostly upper, part of lower and into cheeks was unknown.; Reporter's Comments: This case concerns a 71-year-old female patient with a significant medical history of angioedema, who experienced a serious unexpected event of angioedema. The event occurred approximately 6 days after first dose of mRNA-1273, lot # 039K20A. Treatment for the event included a shot of prednisone and oral prednisone. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. However, patient's prior medical history of angioedema may have been contributory.
pt felt weak and needed to sit almost to the point of collapse.  pt exhibited pallor and numbness described as "pins and needles" in both hands. Pt also stated he felt very overheated suddenly
Received zoster vaccine on 2/6/19 and on 2/12/19 reports that she developed swelling and redness with itchiness, joint pain and N/V to the injection site and extremity in general. She did see a PCP and reported the reaction to them and was advised to no receive the second injection. To my knowledge she did not receive any treatments for the reaction.
Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago). On 19-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago) had resolved.        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.   No concomitant medications were reported. Treatment medication was not provided by the reporter.  On 06-Sep-2021, the vial was initially stored in the refrigerator.  Technician immunizer gave a second shot of a previous-date vial. The vial was punctured and exposed at room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F), for more than 24 hours (between 24 and 26 hours), as it was first punctured on 18-Sep-2021 morning. The vial did not undergo any temperature excursions.  There was no records of patient taking any regular medication. The pharmacist would like to know if the patient needs to get revaccinated or not. Or if there were any steps they need to take.
Headache, shaking, vomiting, chills, fever 102.7, joint pain.
I have had and still have continuous liquid diarreha. I had have accidents and is up at 4am on the toilet.
This spontaneous report was received from a registered nurse and refers to a 43 year old male patient. The patient's concurrent conditions and medical history were not reported. On 23-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 87 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
got the vaccination / got shingles / about 2years or so afterward /suspected Vaccination failure; shingles on the left side of my face; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In March 2020, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient got the vaccination, but she got shingles on the left side of her face about 2 years or so afterward. That was last March and there was still some reminders once in a while till the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Patch with size of fist coming and going at injection site; Rash at injection site; Redness at injection site; Itchy on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy on her left arm), RASH (Patch with size of fist coming and going at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 112-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PRURITUS (Itchy on her left arm), RASH (Patch with size of fist coming and going at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, PRURITUS (Itchy on her left arm), RASH (Patch with size of fist coming and going at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.
Right upper arm pain, heat, swelling. Redness 2 inch circumference around injection site.
Client called with c/o pain and swelling at site. Very limited arm movement. Fever above 102, and chills. Has had some tingling to arm that injection was given.
Severe swelling for 3 weeks, limited arm movement, pain to touch and when arm is extended, arm feels limp due to limited mobility.
2 weeks after injection patient developed a sore shoulder. Then noticed a lump. It is tender to the touch, but not tender otherwise. Denies signs of infection.
1 day after Td vaccination, pt developed swelling, erythema, tendernedd on the vaccine site.  Temperature elevated to 99.3.  Induration 6x6 cm L/deltoid area.
7APR97 tired;8APR(& 7AM cont loose stool w/abd discomfort;8PM lt arm very sore sl swollen & warm;9APR97 arm blotchy breaking out 2x4 around inj;loose stool nl color;10APR97 better arm solid reddened area listless;nausea on 9APR:
On Friday 4/16/21 evening, I had my left tonsil spontaneously rupture without any provocation. I was not eating or drinking but felt like I had something in my throat. I coughed it into a tissue, and it was a blood clot the size of a nickel. My tonsil had 2 places that it was oozing blood and continued to bleed for about 1.5 hours. It eventually tapered off and the redness/bruising disappeared over the next 48 hours. There was no pain, no warning - just a mouth full of blood. The tonsil that ruptured was on the same side as where I received the injection and I had swollen lymph nodes under my arm on that same side until Sunday 4/18. I can't help but think it was related to the vaccine as I had no other cold/hay fever/allergy symptoms of any kind to explain a bleeding tonsil.
a dose of Quadracel was inadvertently administered to an 18 month old/ No AE; Initial information was received on 15-Jun-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves an 18-month-old female patient who was inadvertently administered a first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] [lot C5635AA, expiry date: 18-Jun-2021] via an unknown route and administration site for on 15-Jun-2020 prophylactic vaccination.  Medical history, medical treatment, previous vaccination and family history were not provided. It was reported that, on an unknown date, the patient received Hepatitis as concomitant vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration.   At the time of report, no adverse event was 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.
Patient received the vaccine in her (L) deltoid on Monday, 10/5 and developed a 5x5 cm red and indurated area at the site of injection noted at 7:30 AM the following morning. She took OTC ibuprofen on Tuesday 10/6 while at work with relief of most of the pain. By report it was still raised and warm through Wednesday. She was off work on Wednesday for an unrelated migraine. She was not examined in employee health until Thursday afternoon by which time the (L) deltoid was normal appearing.