chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aggravated her arthritis,severe swelling in the joints,knee swelled,can't use the left leg; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (aggravated her arthritis,severe swelling in the joints,knee swelled,can't use the left leg) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 016B21A, 016C21A and 027H21B) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Pre-diabetes, Osteoporosis and Osteopenia. Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRITIS (aggravated her arthritis,severe swelling in the joints,knee swelled,can't use the left leg). At the time of the report, ARTHRITIS (aggravated her arthritis,severe swelling in the joints,knee swelled,can't use the left leg) outcome was unknown.            Patient take healthy diet. Patient reported that she did not take any medication and had to ice it.  Company comment: This case concerns a 55-year-old female patient, with reported relevant medical history of Rheumatoid Arthritis, who experienced, unexpected, non-serious, AESI of Arthritis (reported as Aggravated her Arthritis), the same day after receiving mRNA-1273 vaccine as a second booster dose. It was reported that the patient had swelling of joints, was not able to use her left leg, and had to ice it. The outcome of the event was unknown. The patient's relevant history of Rheumatoid Arthritis remains to be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This case concerns a 55-year-old female patient, with reported relevant medical history of Rheumatoid Arthritis, who experienced, unexpected, non-serious, AESI of Arthritis (reported as Aggravated her Arthritis), the same day after receiving mRNA-1273 vaccine as a second booster dose. It was reported that the patient had swelling of joints, was not able to use her left leg, and had to ice it. The outcome of the event was unknown. The patient's relevant history of Rheumatoid Arthritis remains to be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report
Red itchy rash on right arm a week afterward.  Period came a week early and is heavier.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Additional Details: post vaccination after receiving the modern avaccine, the patient waited for 15 minutes, however returned to the pharmacy complaining of experiencing fast heart beat, along with rapid breething. The patient acknowledged improvement as time went on, however, as precautionary measures EMS was called and the patient was escorted out of the pharmacy. Event after this are unknown
Patient returned to vaccination site 7/3/2022 for the sibling's booster. Patient received 1st dose of PD Moderna 6/28/2022. Hives and urticaria all over the body started on 7/1/2022 (as verbalized from the mother). No outside treatment happened. No medications given by the parents. Advised to check with PCP, and provided education to the parents that no mRNA vaccine can be given in the future due to allergic reaction.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received second dose of TRUMENBA, via an unspecified route of administration, on an unspecified date. The patient medical history and the patient's concomitant medications were not reported. The patient experienced rash at the injection site, fever and body aches on an unspecified date with outcome of unknown. Follow-up (02OCT2015): Follow-up attempts are completed. No further information is expected.
Immediately after vaccination, eyes rolled back, color became gray/green, leaned to left; mother supported her - nurse attempted to assist her to put head between knees and her back jerked and stiffened twice and her fingers were extended and hands shaky; she didn't recall what happened; described self as feeling "daze-y" Records received 05/01/2009 - DOS 04/21/2009. Seizure and R hand weakness post-adminstration of Gardasil and varicella.   Review of systems unremarkable other than Hx of ADHD and depression.  RX Prozac and Dexedrine.  Headaches past 2 weeks. Discharge Dx: Seizure.
The patient scheduled and arrived to the pharmacy for a booster (3rd) COVID vaccination.  She initially could not find her card and being a family member of the pharmacy, we looked at the scheduler to determine that she was indeed due for her 3rd booster dose. She received the dose without incident.  Upon entering the vaccine into database, it was discovered that this patient had already received a booster dose on November 3rd.  Upon discussing with her, she then remembered the 3rd dose.  She is not immune suppressed and therefore does not require a 4th dose of vaccine.  The patient was monitored for 24 hours and reports no adverse response to her dose.  A new, correct vaccine card has been provided for the patient.
Left neck palpable, mobile, approx 8-10 mm in diameter, lymphadenopathy of anterior chain/supraclavicular noted 8 days after first vaccine that gradually decreased in size over the following two weeks to approximately pea sized. Lymph nodes became enlarged again to 8-10 mm in diameter the day following 2nd vaccine dose and again gradually decreased in size and still around pea sized currently. Made future appointment with my PCP after initial symptoms, was scheduled 1.5 weeks out for 1/22/2021. Contacted my work and PCP prior to appointment on 1/20/2021 to discuss improving symptoms, was reassured that as size of lymph nodes were decreasing, no further lab/diagnostic testing needed at that time so 1/22/2021 visit was canceled since I was about to receive the 2nd dose on 1/23/2021 so symptom monitoring was recommended. Was seen by my PCP for annual physical 2/10/2021 where lymph nodes were palpable, small in size. Continued monitoring was recommended at that time.
This spontaneous report received from a healthcare worker refers to 7 patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored PROQUAD (incorrect product storage) (lot # L024125, expiry date 30-DEC-2016) (dosing regimen and frequency unknown). It was reported that the PROQUAD experienced a temperature of 19.9 degrees Fahrenheit for a 525 hours time frame. It was also reported that there was no previous temperature excursion. It was also reported that the healthcare worker called to report because of a data logger. No adverse effects were reported. No product quality complaint was reported. The action taken with the therapy with PROQUAD was unknown. The outcome of the events was unknown. This case is linked to case number 1606USA008705 via same reporter link. Additional information has been requested.
Experienced vaccinator , RN was vaccinating the VR and during the attempt to deploy the syringe, the needle separated from the syringe.  The Vaccinator was certain that the needle separated prior to the actual deployment of the syringe.  The Vaccinator wasted the dose and removed the needle from the VRs arm and administered a new dose.  The Vaccinator discussed the situation with CPT  who then discussed the incident with the VR.  The VR demonstrated understanding of the situation.
Information has been received from a physician referring to a patient of unknown age and gender. On 20-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # L008660, expiration date 10-NOV-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 920, 34 and R.; 168, 32 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Muscle twitching; Arm pain/tingling; Soreness/achiness; Burning/numbing sensation from site of injection to hand; Swelling at site of injection; Redness at the site of injection.
Syncope, flushing, sweating, dizziness. Water given. BPs 90/38 (pulse 78), 120/64 (pulse 82).
pt recvd vaxs 6MAY92 @ 4PM & @ 715PM pt became pale, vomited & had a fever of 102; taken to hosp where pt was observed to be hyporesponsive & very pale (but not totally hypotonic); adm for observation; given IV fluids & vasopressers;
Information has been received from a registered nurse via filed representative referring to a patient of unknown age and gender. There was no medical history or drug reactions/allergies reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot# were unknown), followed by a dose of GARDASIL 9 (dose, route and lot# were unknown) in December 2015 (reported as "2 months before the third dose of GARDASIL 9"). On 26-FEB-2015, two months after the second dose, the third dose of GARDASIL 9 (dose, route and lot# were unknown) was vaccinated. No adverse effects were reported. Additional information has been requested.
Information has been received from a pharmacist concerning an unknown age and gender patient. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On 14-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # K012424, expired date 05-JUN-2016) (dose and frequency were unknown) intramuscularly. The patient has not experienced an adverse effect. Additional information has been requested.
Expired vaccine was stored in refrigerator; No adverse event; expired Moderna Covid-19 vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine.    On 06-Sep-2022 at 10:30 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Sep-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022. The vial size was reported as 5.5 ml. Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). The vial did not undergo any temperature excursion.   No treatment details were reported.
On 4/17/2021 patient was exposed to a covid positive person. She started developing symptoms of body aches on 04/18/2021.On 4/19/2021 she started having ear pain, head aches and congestion. On 4/20/2021 she was tested and starting having more body aches and a temp of 101.  4/22/2021 she received positive covid results.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Tested negative for 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received anti-viral treatment with Paxlovid from 02Jul2022 to 06Jul2022. Patient did not received other medication in 2 weeks. Paxlovid rebound, tested negative for 2 days after and then milder. Symptoms occurred and tested positive again  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received COVID vaccine 12/22 at 1100. Noted hive on right wrist, opposite arm of vaccination at 1700; hive- 1 cm in dimeter, red raised in middle, not itchy. Benadryl at bedtime and when woke up red outline was present  but not raised, 24 hours later completely resolved. Some fatigue and slight headache within the first 12 hours, resolved. Also reported mild chills and mild fever lasting less than 12 hours.
LL at site, site DTaP swollen, pink rash diffusely and wasn't to hot. Sterile abscess.
Pt came to ER c/o difficulty breathing and cough.  Onset 2 days prior.
Syncope - this patient got dizzy about 5 minutes after receiving the injection.  She told us and we sat her down - she then became very pale and nauseous along with the dizziness.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gerd" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies: Cipro", notes: known allergies: cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive; (01Jun2022) Negative; (03Jun2022) Negative; (06Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 27May2022, rapid test was positive, the patient started paxlovid as a treatment for Covid-19 and 01Jun2022 and 03Jun2022, the negative rapid tests after completion of medicine. On 06Jun2022, the symptoms recurred/ rapid test was positive twice. No other medication received in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective and Covid-19 cannot be ruled out.
pt recv vax 6OCT98 & no apparent immed rxn;pt presented to triage w/70mm erythema & 40mm induration to vaccine site tx by MD for cellulitis lt arm;
Severe case of vertigo upon arising.  Got Dr. appointment 10/13/09.  He prescribed meclizine.  Caused loss of income due to inability to work.
Patient experienced loss of short term memory and difficultly forming words in sentences. She did not seek medical care and the condition improved on its own. 5/14/22 still having some memory difficulty but has improved.
pt devel bumps around 6PM on day of vax 24AUG93; described as raised white bumps which fade & come out somewhere else on body; extreme itching; mom called MD on 25AUG93; felt it could be due to vax;
Blood in urine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on left arm on 12Jan2021 10:00 at a single dose for Covid-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included clopidogrel bisulfate (PLAVIX), losartan (reported as "losortan") and rosuvastatin calcium (CRESTOR). The patient experienced blood in urine on 12Jan2021 10:00. The event was not treated and reported as non-serious. The outcome of the event was not recovered. The patient received vaccine on workplace clinic.  Information on the batch number has been requested.
This case was reported by a consumer and described the occurrence of pruritus all over body in a 35-year-old female subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to eggs, asthma and sulfa allergy. Concurrent medications included CLARITIN. On 24 July 2012 at 11:00 the subject received unspecified dose of Hepatitis A vaccine (unknown, right arm). In July 2012, within a couple of days of vaccination with Hepatitis A vaccine, the subject experienced itching all over body, throat a little swollen and asthma symptoms acting up. At the time of reporting the outcome of the itching all over body, throat a little swollen, asthma symptoms acting up were unspecified. This case was assessed as medically serious by GSK.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE DVT, UNSPECIFIED VEIN ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/30/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Recieved vaccine on 10/26/2021. Developed weakness, fatigue, pleuritic CP on 11/4. Presents to hospital on 11/8with workup notalble large pericardial effusion without tamponade. Started on colcicine. Underwent placement of pericardiocentesis 450cc amber fluid removed and placement of pericardial drain x 3 day. Pt recovered and was discharged to home on 11/11.2021
rash with hives and blistering; rash with hives and blistering; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash with hives and blistering) and RASH VESICULAR (rash with hives and blistering) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (rash with hives and blistering) and RASH VESICULAR (rash with hives and blistering). At the time of the report, URTICARIA (rash with hives and blistering) and RASH VESICULAR (rash with hives and blistering) had not resolved.            No concomitant medication was reported. No treatment medication was reported. It was reported that patient had the booster on the 13th and on the 24th developed a rash with hives and blistering. They also wanted to know if there was a cure for 'moderna skin'.   This case was linked to MOD-2022-449904, MOD-2022-449887, MOD-2022-449904 (Patient Link).
Pt admitted for symptomatic anemia (Hgb 3.8) and found to be COVID positive. Tested due to SOB and fatigue, which resolved after transfusion. Pt was otherwise asymptomatic. Received 1 dose of Moderna COVID vaccine, per System records, on 6/30/21. Tested positive for COVID-19 on 12/27/2021.
On 03/23/2021 I took an at home pregnancy test with a positive result. 03/25/2021 I went for my first HCG pregnancy test. On 03/27/2021 my HCG levels had dropped 10 points. On Thursday, my HCG had gone back up 20 points. I had blood work on 04/06/2021 and my blood work was at level 7.8.
Four days after vaccination the patient developed a fine papular rash approx. 4cm in diameter on her left outer arm at the site of one of the vaccines. No pustules.
Pt with maculopapular rash developing 3-4 days after receiving anthrax immunization. Pt did not tell techician had a rash and was rechallenged on may 2nd 2008. Rash improved but still persisting 4weeks after that injection. Rash has cleared substantially with only residual rash left on legs and arms. Was present entire body excluding face, hands and feet. No systemic sx's.
Pt. called on 10/7/13 and stated she had a prickly rash on her shin/knee and under arm/shoulder area that following a line. She also states she had diarrhea and told her she could have a rash around the injection site but since it had spread she should she her PCP in the morning to access the rash.
Patient reported having elevated blood pressure evening of receiving the vaccine. Her BP was 177/82. Patient states she does not have hypertension and usually runs 130/80s. Patient's BP was 140/80 the next morning after vaccination. Instructed patient to continue to monitor BP and if it elevated again then she needed to be seen by ER. Patient was understanding of treatment plan.
Swelling at immunization site. RA. Given Diphenhydramine 12.5mg/mL, 3.5mL per mouth every 8 hours.
Headache, Myalgia, Arthralgia, Fever, arm pain Narrative:
PT COMPLAINED OF HALLUCINATING. COMPLAINED OF PAIN AT INJECTION SITE, SHE DIDN'T KNOW WHERE SHE WAS OR WHO SHE WAS WITH, SHE FELT TIRED, TALKING OUT OF HEAD, HAD RASH AROUND INJECTION SITE.
Severe headache, blur vision, nausea that does not go away, burning of nose, and persistent cough with mucus.
Severe muscle and joint pain started around 9pm and continued until 7pm following day (22 hours total)
Patient sneezed/coughed and then passed out in chair about 5 minutes after vaccine administration. He slumped over in his chair, I ran over to him and held him up. I shook his shoulders and shouted his name. Patient was shaking, he had his eyes open but was not coherent. After about 20 seconds patient came to and was able to tell me his name, birthday, where he was at, etc. He was very sweaty, dizzy, lightheaded, and shaky. We had called 911 and gotten patient water and a chocolate bar. He improved rather quickly. All checked out well with the paramedics. Patient felt much improved and left about 40 minutes after his shot was administered.