chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE, start date: 23May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was treated with Paxlovid from 02Jul2022 to 07Jul2022 for the Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from Nurse. This case involves a male patient who received first dose of IMOVAX in the emergency room on the day of exposure on 26th or the 27th of June 2018 and scheduled for his second dose of IMOVAX on day 5. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to missed dose as patient arrived at the health department on the 30th of June for day 3 injection on the schedule but the health department was closed. It was unknown whether patient had any adverse event. 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.
sore arm; tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "tiredness".  Additional information: Patient received the first dose the week before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/numbness in her feet up to her knees; little blue squares vibrating and pulsating on her wrists to her finger tips; Severe pain in her right hip; she was ready to pass out; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302) via an unspecified route of administration, administered into the left arm on 06Mar2021 09:45 as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. There were no concomitant medications. On 07Mar2021 at 17:30 patient's stomach had been getting harder all day long, she had severe diarrhea and when she was in the toilet she noticed numbness in her hand, numbness in her feet up to her knees, severe pain in her right hip. She also saw little blue squares vibrating and pulsating on her wrists to her finger tips, she was ready to pass out and thought that she might be having hallucination (AS REPORTED). She was trying to lift her hip off the toilet and just wanted to get to the floor to curl up in the fetal position. Then suddenly all these effects went away and she was fine the rest of the night and has been fine ever since. The patient was asking if these could be side effects of the vaccine or if it was just a part of her IBS. Outcome of events recovered on 07Mar2021.
Intense itching started Saturday night. I got hives and they haven't stopped since Saturday.  I went to the clinic on Monday and they prescribed methylprednisolone. I have continuously taken 2 benadryl every 6 hours. I went to the ER. They game me a steroid shot and prescribed Famotidine 20mg tablets. The doctor said to continue benadryl every 4 hours and to continue methylprednisolone pack until completion. The welts vary in size and now they are from my knees all the way to my scalp. I have them all over my legs/arms/back/stomach/face and scalp. It's an intense itching and burning.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310464, 2020SA310557, 2020SA310558, 2020SA310559 and 2020SA277871 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  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
pt devel inject site rxn w/ redness, itching, and a knot.  This is 1 of 4 patients from this site and lot# to report adverse reactions.
temperature excursion for holding onto a pre-drawn dose of Menactra; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient (age unknown) who reported temperature excursion for holding on to a pre-drawn dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number:U6455CC and expiry date: 15-Nov-2020.  The patient's past vaccination(s) included MENACTRA with last year. The patient's past medical history, medical treatment(s) and family history were not provided.   It was a potential medication error due to incorrect product storage.  Vaccine was not administered to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Disgeusa; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Disgeusa) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Papillary thyroid cancer. Concurrent medical conditions included Blood pressure high and Osteoporosis. Concomitant products included PREDNISONE from 06-May-2022 to 11-May-2022 for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced DYSGEUSIA (Disgeusa). On 14-May-2022, DYSGEUSIA (Disgeusa) had resolved.            No treatment information was provided by the reporter. Disgeusa Device Date reported, 15May2022.
Lymph nodes above the collar bone have swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes above the collar bone have swollen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph nodes above the collar bone have swollen). At the time of the report, LYMPHADENOPATHY (Lymph nodes above the collar bone have swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Pt developed an injection site reaction characterized by swelling, redness and pain.  Pt experienced extreme fatigue and flu like symptoms for two days.  Pain and swelling remain at injection site.
Only problem pt had to allergies was to bee stings; otherwise pt had no problems w/inject; about 1 hr p/inject 10AM; pt called mom that pt felt weak, queasy & felt like fainting; PMD saw pt & thought that this may be a rxn to MMR; BP 80-60;
5/17/2022 patient developed a softball size redness, bruising, swelling and heat from injection site.  5/18/2022 Patients redness continued and progressed to be a bit bigger in size, redness, and bruising still present.  5/19/2022 Patient parents took child in to hospital to be evaluated.  Antibiotics where prescribed, but not taken.  5/28/22 redness, swelling, heat, and bruising resolved.
Terrible pain in left thigh, shoulder, and chest. (Opposite side of injection site), severe headache for over 12 days. panic attacks, anxiety attacks, visited ER on 08/14.
At about 10 hours after injection, chills, fever (101.7), swollen lymph glands under left arm, aches in all joints. Lasted 2 1/2 days.
November 8th, 2021: I went for my first COVID-19 Moderna Booster. 2 weeks later, I developed hives over my entire body.  December 20th, 2021: I went to the allergist and we tested for food sensitivities.  December 17th, 2021: I went back to the allergist and was confirmed positive for Milk Protein Allergy.  My instructions were to take up to 4, 10mg cetirizine/daily to control hives and to stop using milk products in my diet. Following the doctor's order, my hives went away and I have had no problems.  September 26th, 2022: I went for my second COVID-19 Moderna Booster. 2 weeks later, I developed hives over my entire body. October 24th, 2022: I went to the allergist again and we suspect the COVID-19 Moderna Booster activated my milk protein allergy.  I would like to add that prior to my first booster, I was an avid dairy user. Cheese, deserts, etc... and I have never had reactions to dairy until after my first covid booster.
15Jan2022 follow up: once patient got up and moving, patient felt better; arm pit sore.; Time of awareness: 14Jan2022. patient in bed all day; aches and eyes hurt; fever; no energy.; Patient in bed all day; aches and eyes hurt; fever; no energy.; Patient in bed all day; aches and eyes hurt; fever; no energy.; Patient in bed all day; aches and eyes hurt; fever; no energy.; Primary immunisation: Moderna; Booster: BNT162B2; dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Jan2022 at 15:00 (Lot number: unknown)at the age of 40 Year(s) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE; Lot number: Unknown; Route of administration: unspecified), for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE; Lot number: Unknown; Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Jan2022 at 15:00, outcome "unknown", described as "Primary immunisation: Moderna; Booster: BNT162B2"; IMMUNISATION (non-serious) with onset 13Jan2022 at 15:00, outcome "unknown", described as "dose number=3"; PAIN (non-serious) with onset 14Jan2022, outcome "recovering", described as "time of awareness: 14Jan2022. patient in bed all day; aches and eyes hurt; fever; no energy"; EYE PAIN (non-serious), PYREXIA (non-serious), ASTHENIA (non-serious) all with onset 14Jan2022, outcome "recovering", and all described as "patient in bed all day; aches and eyes hurt; fever; no energy"; AXILLARY PAIN (non-serious) with onset 15Jan2022, outcome "recovering", described as "15Jan2022 follow up: once patient got up and moving, patient felt better; arm pit sore". It was unknown whether any therapeutic measures were taken as a result of the events.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
During the 15 minute waiting period after vaccination, patient became light headed and fainted. Patient was sitting in a chair, communicated that she was feeling unwell, and did not fall or hit her head. Patient came to in under 30 seconds, and vitals were taken. Patient was laid down and vitals normalized. Patient was dizzy and shaken up, but otherwise alright. Patient was given food and water and supervised for about 30 minutes while resting. Patient felt ok, and got picked up and went home. Patient was dizzy for about a week after this occurrence, but eventually felt better.
10/28/04 About 7 PM got a PPV and tetanus dose. Friday morning, saw doctor who said I had a reaction: swelling, redness, pain. Advised to take Ibuprofen. Called Saturday and asked if Aleve could be taken. Had flu symptoms, pain, more swelling and redness going down arm.
Patient stated before vaccine that she has a history of fainting  after all vaccines. She did become pale and fainted after 2nd vaccine (flu) and continued to take deep breaths and was leaning on friend next to her. She did vomit after a few deep breaths and  said she was ok just needed a few minutes to recover. She has a cold compress of her head and some water and was feeling better after a few minutes. After she was feeling better and left the vaccine room she waited in the store for an additional 15 min for observation.
Developed a red rash with minor itching one week after receiving first injection of Moderna covid vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 70-year-old male patient who received SHINGRIX (batch number B57NG, expiry date 16th April 2021) for prophylaxis. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th October 2018, 3 days after receiving SHINGRIX, the patient experienced generalized rash. On 27th October 2018, the outcome of the generalized rash was recovered/resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine in left deltoid. The patient was developed with a rash over his entire body which was discovered on Friday. The reporter reported that the rash was almost fully resolved on Saturday. The reporter was unable to obtain additional information.
Mom took child to Dr. He said there was an infection. Left arm where DTaP was given was swollen and red. Child was playing when mom reported this to us on 10/3/03.
Onset of sudden chest pain during 15 minute observation period post vaccine. "Hard to breath. BP 122/73  P 90, spO2 96%. Lungs clear. BP 118/74 P 90 SpO2 95%. Color pale. Not diaphoretic.  EMS called. Patient transported to Medical Center ED. 3/25/21 - phoned for followup. All tests in ED negative for heart related issues. May have been a panic attack. OK to get second dose.
He had a high fever of 101.7 with diarrhea  at home and at the hospital it elevated to 104.00 very irritable and crying constantly and pain in the thigh area with congestion and runny nose
He has irritation on his arms.; he got the first shot of the covid vaccine he  started itching; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left upper arm on 31Dec2020 at single dose for COVID-19 immunisation, dexlansoprazole (DEXILANT) oral from 2019 (reported as 2 years ago as of 06Jan2021) to an unspecified date at 30 mg capsule once as needed for acid reflux, oxycodone oral from 2020 (reported as 3-4 months ago as of 06Jan2021) to an unspecified date at 10mg tablet once by mouth as needed for chronic pain from two back surgeries that did not go well, omeprazole oral from 2020 (reported as about a year ago as of 06Jan2021) to an unspecified date at 20 mg capsule once by mouth as needed for acid reflux. Medical history included ongoing low white blood cells has had for a couple of years, and two back surgeries. There were no concomitant medications. The patient previously received Flu shots. The patient took his first dose of the COVID Vaccine last Thursday (31Dec2020) and about 10 minutes after he started itching. That day he had previously taken a PPI medication for acid reflux, Dexilant, and some pain medication, Oxycodone. Since then he has been trying to rule out what is going on and what gave him the itching. Now, every time he takes his PPI medication, either Dexilant, or Omeprazole, he itches. This did not happen prior to getting the vaccine. He asks, how long does the COVID Vaccine stay in the system for? He is supposed to get the second dose in 3 weeks, but he does not want the same results. He was asking if it is normal for his to experiencing itching and how long will it occur. He has to take his medications. He does not want issues with his esophagus, but he also does not want to itch. The itching right after he got the vaccine lasted about a day or so and dissipated by Friday. Saturday he did not have it. Then he took a Dexilant that day, on Saturday, for acid reflux, and he itched until the Dexilant was out of his system. Then yesterday, he tried an Omeprazole and he had the same results. He can not even wear a pajama top or anything on his arms cause it makes him itch. He has irritation on his arms on Jan2021. He also has low white blood cells, which he had prior to getting the vaccine. He started Dexilant originally about 2 years ago. He takes it only when he needs it. Has taken it about 3-4 times prior to getting the COVID Vaccine. He started Omeprazole about a year ago. Only takes this as needed, PRN, even thought the doctor said he should not take it as needed. He does not like to take medicine so he tries not to take things. He has taken flu shots in the past, he gets one every year, and has never had an issue with that. He wants to get the second dose of the vaccine, he just does not want to itch. The action taken in response to the event for dexlansoprazole, oxycodone, omeprazole was unknown. Event outcome of itching was recovered on Jan2020, while for other event(s) was unknown.  Information about lot/batch number has been requested.
PATIENT STATED SHE WAS DIZZY AND WITHIN ONE MINUTE HAD PASSED OUT.   911 WAS CALLED AND EMS CAME TO PHARMACY TO CHECK HER OUT.  SHE CAME TO QUICKLY AND WAS SWEATING AND "OUT OF IT".  SHE WAS ABLE TO SPEAK AND DRINK WATER BY THE TIME THEY ARRIVED.  SHE RECOVERED AND SPENT AN ADDITIONAL 30 MINUTES IN THE PHARMACY AREA FOR OBSERVATION.
pt recv vax 19OCT95 & pt reported immed pain @  the inj site,which remained very painful for 2 days;the soreness has not resolved as of the reporting date;pt also reports having diff raising lt upper arm secondary to the pain;no redness
Felt Flush and hot around 3 min after vaccine given. Had a slight taste change that lasted for a second. Heart rate, normal 60s, increased into the 80s.