chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vials were possibly bad, she got a compromised dose), EXTRA DOSE ADMINISTERED (Received 3 rd vaccine) and PRODUCT STORAGE ERROR (improper vaccine storage) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A., 001B21A and 005021A) for COVID-19 vaccination.     Concomitant products included LEVOSULPIRIDE (LEVOGASTROL) from 01-Jan-2014 to an unknown date and VITAMINS NOS for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the vials were possibly bad, she got a compromised dose). 09-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (improper vaccine storage). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received 3 rd vaccine). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, EXPIRED PRODUCT ADMINISTERED (the vials were possibly bad, she got a compromised dose) had resolved and EXTRA DOSE ADMINISTERED (Received 3 rd vaccine) and PRODUCT STORAGE ERROR (improper vaccine storage) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-076202 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: AE contact details were updated.New events were updated, lab details updated On 10-May-2021: Additional event and updated indication added.; Sender's Comments:  MOD-2021-076202:First dose of vaccine case.
I need to get the second shot; had the first one in February 09/2021. When I returned in March, they were no longer there.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I need to get the second shot; had the first one in February 09/2021. When I returned in March, they were no longer there.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I need to get the second shot; had the first one in February 09/2021. When I returned in March, they were no longer there.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I need to get the second shot; had the first one in February 09/2021. When I returned in March, they were no longer there.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications and treatment medications was provided.
Subsequent to receiving vax, the pt developed an injection site reaction characterized by very large circular area 1.5 - 2 inches, of redness, hardness, swelling and pain. From 3-5 days post vax, the injection site redness slowly dissipated, the swelling went down and the hardness resolved. At the time of immunization, the child was diagnosed with recurrent acute otitis media. After 7 days the injection site pain resolved, the pt recovered.
Severe body shaking and jerking, uncontrollable teeth chattering, feeling of complete exhaustion and felt like I was freezing...I could not get warm. Lasted for 8 hours.
Huge knot, swelling, fever, hive at site of injection. Fever of 103. Trouble breathing.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history or drug allergies/drug reactions were not reported. On 03-DEC-2015, the patient was vaccinated with GARDASIL (lot # J003727, expiration date 07-NOV-2015), (dose, route of administration and anatomical location were not reported). There was no concomitant medication reported and no adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Severe headache, body aches, and some chest pain that afternoon of 7/29 after COVID vaccine. Pt took medication for headaches and had no relieve. The next morning went to her daughters whom she was to babysit and was acting funny. Per ER report patient can't recall much of that day but her daughter reports finding patient on the floor . Patient was brought to ER and does not recall much of the ER visit until she was being admitted to the floor for overnight observation.  CT and lab work was ran which was unremarkable.
Pt recv vax on 11/17/98; on 11/26/98 pt exp fever (103), red bumps all over body
Arm was swollen from elbow to shoulder; Arm was red; Arm was hot; Arm aches so bad he can die; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen from elbow to shoulder), ERYTHEMA (Arm was red), FEELING HOT (Arm was hot) and PAIN IN EXTREMITY (Arm aches so bad he can die) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) for COVID-19 vaccination.     The patient's past medical history included Bone injury (trapezoid injury) on 16-Mar-2021. Concurrent medical conditions included Blood pressure high and Cholesterol.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen from elbow to shoulder), ERYTHEMA (Arm was red), FEELING HOT (Arm was hot) and PAIN IN EXTREMITY (Arm aches so bad he can die). At the time of the report, PERIPHERAL SWELLING (Arm was swollen from elbow to shoulder), ERYTHEMA (Arm was red), FEELING HOT (Arm was hot) and PAIN IN EXTREMITY (Arm aches so bad he can die) outcome was unknown.
Patient that got a dose of Bexsero by mistake (Menactra was intended); This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old 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.   Previously administered products included Menactra (1st dose received on an unknown date).   On 21st April 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 21st April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   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 reporter inquired that how soon they could administer Menactra to a patient that got a dose of Bexsero by mistake as Menactra was intended, which led to wrong vaccine administered. This was the 1st dose of Bexsero and the intention was to provide the 2nd dose of Menactra. The reporter refused any information because patient was in the location and they were in a hurry.  The reporter did not consent to follow-up.
3 1/2 hrs post vax cried for 2 1/2 hrs unable to be consoled; had fever (not measured); until next evening, called family MD who recommended continuing APAP; Father had to stop immun series because he had react;
No advers effects reported; Medical assistant reports one expired dose of VARIVAX administered to patient; Medical assistant reports one expired dose of VARIVAX administered to patient; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.   On 01-NOV-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis, lot # N029632 and expiration date on 23-OCT-2019 (dose, strength, frequency and route of administration were not provided) (expired product administered, and poor-quality product administered). There were no adverse effects reported.
Was not feeling well the following day from noon to bedtime. Headache and general not feeling well. The following day the same reaction occurred not as severe.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurt), PAIN (pain spread across the chest, mostly over the left breast area), INFLAMMATION (pain feels muscular and inflamed) and MYALGIA (the pain feels muscular) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 046B21A) for COVID-19 vaccination. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), PREGABALIN, PREDNISONE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), CELECOXIB (CELEBREX), CYANOCOBALAMINE, BELIMUMAB, LANSOPRAZOLE, IRON and RIBOFLAVIN for an unknown indication. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm hurt), PAIN (pain spread across the chest, mostly over the left breast area), INFLAMMATION (pain feels muscular and inflamed) and MYALGIA (the pain feels muscular). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (left arm hurt) had resolved and PAIN (pain spread across the chest, mostly over the left breast area), INFLAMMATION (pain feels muscular and inflamed) and MYALGIA (the pain feels muscular) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient described the pain feels muscular and inflamed and has spread across the chest, mostly over the left breast area. The patient explained they have Lupus and are on a lot of immunosuppressing medications. This case was linked to MOD-2021-290995.
Pt called on 9/30/11 stating after receiving flu vaccine on 9/20/11, she had body aches throughout body. States she has arthritis but she doesn't know if its the vaccine or her current disease state causing the pain.
on 1/20 the day of vaccine:  poor appetite by 7pm. left arm site bruised, slightly swollen and sore enough not to be able to raise by 9pm.  felt fatigued, but had Insomnia.  Around 2:30am, chills with uncontrollable whole body shaking, restless legs, body aches, heart palpitations, extreme headache, nausea.  1/21 was able to nap/doze off throughout the day, but symptoms persisted along with photophobia.  Kept taking 500mg acetaminophen to ease the extreme headache. Chills/body shaking, palpitations, photophobia gone in evening. 1/22 still experienced lower back ache, headache, nausea, left arm pain in morning.  Around 12:20 only had sore arm, fatigue and poor appetite
Patient was given the bivalent booster when she should have been getting the 1st dose of primary series. No side effects or adverse reactions have occurred
Initial unsolicited report received from consumer via other company, Pfizer (under reference number: 2017022711) on 01 Feb 2017. This case involves a female patient (age not reported) who was vaccinated with third dose of INFLUENZA VACCINE (flu shot) (batch number, expiry date, dose, route and site was not reported) on an unspecified date. Patient had also received pneumonia shot and PREVENAR 13 on an unspecified date (reported as patient not even had a cold). The patient's medical history and concomitant medications were not reported. On an unspecified date, within 12 hour post vaccination; the patient had experienced bronchitis. Patient had also vaccinated with first and second dose of Flu shot previously on an unspecified date and had bronchitis within 12 hours of taking it. Laboratory data and corrective treatment was not reported. On an unspecified date, the patient was recovered from the event (reported as it takes six weeks to get over it). List of documents held by sender: none.
stomach is acting up; lost his appetite; feeling weird; feels like he is getting the flu; he is cold; Diarrhea; stiffness in arm; itching; sore; has the chills; feels "queasy"; tired; aching really bad; injection site itching; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu) and FEELING COLD (he is cold) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE (First Covid-19 vaccination and type and date taken unknown.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Prophylaxis.    On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu), FEELING COLD (he is cold), DIARRHOEA (Diarrhea), MUSCULOSKELETAL STIFFNESS (stiffness in arm), PRURITUS (itching), PAIN (sore), CHILLS (has the chills), NAUSEA (feels "queasy"), FATIGUE (tired), MYALGIA (aching really bad), INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE PAIN (injection site pain). At the time of the report, ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu), FEELING COLD (he is cold), DIARRHOEA (Diarrhea), MUSCULOSKELETAL STIFFNESS (stiffness in arm), PRURITUS (itching), PAIN (sore), CHILLS (has the chills), NAUSEA (feels "queasy"), FATIGUE (tired), MYALGIA (aching really bad), INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE PAIN (injection site pain) outcome was unknown.            No relevant medical history provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27-May-2021 via TCR. Events updated
lips became swollen; This is a spontaneous report from a contactable consumer (patient). A 98-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) (at the age of 98-years-old) as DOSE 1,SINGLE for covid-19 immunisation.  Medical history included she had a history of allergies her whole life, lips became swollen years ago after taking a blood pressure medicine from an unknown date.  The patient's concomitant medications were not reported. The patient stated she had a history of allergies her whole life. On 20Jan2021, she was given the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. An hour after, she said her lips became swollen. She said she had the same reaction years ago after taking a blood pressure medicine. She was told to take Benadryl, and it went away after. However, that night, her lips swelled again so she took another Benadryl and it went away. She was told not to get the 2nd dose so she didn't. She said it had been 8 months and she wanted to socialize. She said that her daughter read something about taking Benadryl or steroids prior to receiving the booster. The patient would like to know if that was advisable. Therapeutic measures were taken as a result of lips became swollen included Benadryl. The outcome of the event was resolved on an unspecified date.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
This case was reported by a healthcare professional and described the occurrence of swollen thigh (injection site) in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccinations given on 21 August 2008 included the 4th dose of IPV; Sanofi; the 2nd dose of MMR II (Merck); and the 2nd dose of VARIVAX; Merck. On 21 August 2008, the subject received the 5th dose of INFANRIX (.5 ml, unknown, left thigh). On the evening of 24 August 2008, three days after vaccination with INFANRIX, the subject experienced a swollen thigh (injection site) and injection site redness. The reporting nurse stated that the subject presented to the emergency room on 24 August 2008, and was also seen in the physician's office on 25 August 2008 with entire thigh swelling and redness. A product complaint was lodged for this report, as the nurse inquired if GSK had changed the formulation or if there were "hot" lots with the company's DTaP vaccines. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX. Follow-up information received on 21 October 2008 indicated that events began 1 day following vaccination with INFANRIX on 22 August 2008. Additional events of cellulitis versus hypersensitivity reaction were reported. INFANRIX was reportedly administered intramuscularly. The events resolved and were considered by the reporter, possibly related to treatment with INFANRIX. It was additionally stated that all four previous DTaP shots were Aventis brand.
red rash all over my body, face swelled and eye almost swelled closed steroid injection at emergency care and rx for predisone 20 mg tabs 2 daily for 5 days
10 days past her 1 yr. shots she started running a 100,5 temp. she had vomiting and loose stools..she also developed a rash all over..i was told the rash would go away in a few days and to give tylenol for temp.,and to call if she was not better in a wk..
Redness and erythema of 4 1/2x 6cm at injection site.
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 7/25/2022 -- RECURRENCE OF SAME SYMPTOMS
w/in 24 hrs of vax pt had 12 hrs of unconsolable, shrill, shrieking crying; pt was given APAP; pt had mild fever elevation up to 102;
Given Pfizer as second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given Pfizer as second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Given Pfizer as second dose). At the time of the report, WRONG PRODUCT ADMINISTERED (Given Pfizer as second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
Weak and very tired and spacy, chest muscles sore, heart beating, next day had a terrible night, still achy and tired. Dizzy and tired, still achy. Trouble sleeping. Still out of it and arm was getting worse. Achiness started to get worse along with fatigue. Saturday another terrible night with no sleep. Splotchy itchy red marks on arm. Saturday feeling weak and dizzy like last time, possibly lack of sleep and anxiety. 5:30pm weak and exhausted. Warmness at injection site, itch and burning sensation. Warmer than the other arm. Still inflamed. Inside of elbow on the same arm, it was red, warmer than the other side. Lymph nodes could have been it. Sunday arm was swelling, and I iced it the night before. Severely exhausted, chest and back were hurting. Arm was hot again on Sunday. Forced myself to walk around and achy and burning across my back and in my legs. Bad sleep again. Tuesday- still felt terrible and leg was kicking like crazy after the vaccine (restless leg). Wednesday left arm was still warmer than the right. Thursday still very achy, went worse as the day goes on. Neurontin at night makes the pain worse during the day because the medication wore off. Thursday into Friday worst pain almost cried. Friday afternoon, pain started again, still achy but not as bad. Tomorrow 10/27/2021 is two weeks. Achiness still comes and goes. Fatigue is better.
Woke up with a sore arm at injection site.  Went downstairs to get Tylenol for pain, standing at cabinet got extremely hot and dizzy.  Fainted and fell on the floor.  Couldn?t get up without extreme dizziness for 15-20 minutes.  Now my left armpit lymph node is swollen and tender to touch.
Could not move arm for two weeks. Trouble breathing when walking. Walking my dogs down the street makes me out of breath.
Father described pronounced swelling, pain and redness at injection site with moderate relief of S/S with ibuprofen.
- Layed down for shots - Reports does faint - ask to stay on mat after - finished. He sat up in chair - Became pale - fell to knees & side of chair - pt remained responsive to verbal communication.
After Varicella shot leg got red. By last night, swollen and red. Came in 9-12-07 (R) leg red, hot, swollen 2"x2" round diameter.
Patient stated that she received the Zostavax vaccine on Tuesday, 08/02/11 at 3pm. She felt fine on the day she received the vaccine, but she began to feel some flu-like symptoms when she woke up the next day. Patient also stated that the injection area was slightly red but it was not bothersome initially. It was Thursday morning, when she started to itch the area, and the pain had intensified. By the time she went to bed that night, the redness had spread further down her lower back arm. The patient came to the pharmacy on 08/05. She had developed tiny little blisters in the center of the injection site and she was in a lot of pain. Patient was referred to her primary health care provider for suspected shingles. Patient came back to the pharmacy a couple of hours later with a prescription for Valacyclovir. She had been diagnosed with Shingles by her primary physician.
Received shot on 5/8/01. On 5/9/01, felt flushed, that night my temperature was 101.2F, with hot/cold flashes and night sweats. Fever broke, continued to feel flushed. On 5/11/01, right arm felt hot with red spots to about my elbow. Seen by MD at 18:00 and received antibiotics.