chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Autoimmune reaction; Off label use; This case was received via another Manufacturer (Reference number: 22K-163-4425755-00) on 14-Jun-2022 and was forwarded to Moderna on 14-Jun-2022.    This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune reaction) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune reaction) (seriousness criterion medically significant) and OFF LABEL USE (Off label use). At the time of the report, AUTOIMMUNE DISORDER (Autoimmune reaction) and OFF LABEL USE (Off label use) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  The daily dose of SPIKEVAX was reported as 1 in 1 once.  The reporter's causality for the event of Autoimmune reaction was not provided. The reporter's causality for the event of Off label use with Humira was no reasonable possibility.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning unspecified age male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of autoimmune disorder, which occurred unspecified days after first dose of mRNA-1273 vaccine. Additionally non serious event off label use is also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness is assessed as per regulatory authority's report.; Sender's Comments: This is a spontaneous case concerning unspecified age male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of autoimmune disorder, which occurred unspecified days after first dose of mRNA-1273 vaccine. Additionally non serious event off label use is also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness is assessed as per regulatory authority's report.
Extreme fatigue started at 6:00 am on Friday. Nausea and light headedness followed as the morning went on. Around 12:00 I started having chills and recorded a 101.7 temperature. All of those symptoms continued throughout the day. At around 3:00pm I started having chest pains and increased heart rate with no physical activity. Around 6:00pm I started having a extreme headache. I took a dose of Tylenol around 9:00 and went to bed. When I woke up on Saturday morning, I felt back to normal.
herpes zoster; post herpetic trigeminal neuralgia; bell's palsy; post herpetic neuralgia; Seventh Nerve Palsy of the right eye; Information has been was received from a lawyer regarding a case in litigation and refers to a female patient (pt.) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 19-SEP-2017, the pt. was inoculated with zoster vaccine live (ZOSTAVAX), for routine health maintenance and for the prevention of shingles (herpes zoster) (dose, route, anatomical site, lot #, and expiration date were not provided). On an unspecified date (reported as shortly after receiving the vaccine), the pt. suffered painful lesions, facial pain and blurry vision and was diagnosed with herpes zoster, post herpetic trigeminal neuralgia (trigeminal neuralgia), Bell's palsy, post herpetic neuralgia (PHN) and seventh nerve palsy of the right eye (facial paralysis). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt. also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt. sustained severe and permanent personal injuries. The pt. suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered herpes zoster, trigeminal neuralgia, Bell's palsy, PHN, and seventh nerve facial paralysis to be disabling events.  Upon internal review, the events Bell's palsy and facial paralysis were determined to be medically significant.
No adverse event; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 21-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).      Patient's age was reported as 21 Year 1 Month. No concomitant medications were reported. completion date was reported as 18-Aug-2022. The vaccine from the vial with lot number O70H21A was administered to the patient in between a period of 08-Apr-2022 to 15-Dec-2022. No treatment medications were reported.
Red, swollen, irritated area; Red, swollen, irritated area; Red, swollen, irritated area; Vaccine was administered about 2 inches below ideal site; This spontaneous case was retrieved on 06-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1558272-1), reported by other health professional and concerned a 73-year-old female patient.  The patient's concurrent condition included chronic kidney disease stage two (S2CKD). The patient's concomitant medications were not reported.   On 13-Aug-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as '1', route of administration: intramuscular, anatomical location: left arm and indication: not reported) about two inches below ideal site (explicitly coded as 'Vaccine administered at inappropriate site'). The batch number reported was 312832.  On 14-Aug-2021, one day after receiving Fluad Quadrivalent, the patient experienced red, swollen, irritated area.   The outcome of the events of 'localized erythema', 'local swelling' and 'skin irritation' was unknown.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Case updated on 14-Sep-2021: Correction made to information received on 06-Sep-2021: Regulatory authority removed from the intermediary field and Report Sent to Regulatory Authority by Reporter changed from 'yes' to 'unk' in the general tab as the case should be re-submitted to FDA since the suspect product was recoded from Fluad (TIV) to Fluad Quadrivalent upon batch number mapping. No changes in the narrative.  Company comment: A 73-year-old patient was administered Fluad Quadrivalent, about two inches below ideal site. One day after receiving Fluad Quadrivalent, the patient experienced red, swollen, irritated area (location unspecified). Causal role of the vaccine is assessed as possibly related. Product administered at inappropriate site is assessed as unrelated per company's conventions.; Sender's Comments: A 73-year-old patient was administered Fluad Quadrivalent, about two inches below ideal site. One day after receiving Fluad Quadrivalent, the patient experienced red, swollen, irritated area (location unspecified). Causal role of the vaccine is assessed as possibly related. Product administered at inappropriate site is assessed as unrelated per company's conventions.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced shingles, fever, sweating, chills and influenza-like symptoms. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown and the outcome of the fever, sweating, chills and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the shingles, fever, sweating, chills and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced flu like symptoms (fever, sweating and chills) within approximately 6 to 12 hours of receiving the SHINGRIX. The event lasted for approximately 12 hours and resolved. The following day, the patient reported an outbreak of Shingles. The patient's doctor prescribed a 7 day course of Valtrex as treatment. The health care professional was not able to provide further specifics at the time of reporting.
Approx. 10 hours after getting Tetanus booster I started having servere chills and body aches the entire day. The night after that I had a fever of 102.7 most of the night but temperature went back dowm to approx. 99.3 by the next morning. I felt better but still had moderate chills and body aches. The second night after vaccination I had a fever of approx. 100.5 most of the night. By the next morning my temperature was back down to 97.8 which is normal for me.  My arm is still very sore where I received the vaccination.  It is now 3 days after vaccination and I feel better but am wondering if I'm going to be feverish again tonight.  I would describe my symptoms as like have a bad case of the Flu.  I've only been this sick a few time in my life.   I felt fine before I recieved the vaccine.   It is now 3 days after I received the shot and I hope I continue to get better.  I had previously received a Tetanus booster 5 years ago and had arm pain and mild chills but nothing significant.
1552:Pt c/o Left arm numbness.Pt assessed and able to lift arm above head and grasp firmly. Pt unable to feel pinch on Left arm from fingers to shoulder. VSS(ventricular septal rupture). Monitoring patient longer than 15 min fir observation.  1624: Pt states the numbness is going away and is feeling better. She is using her cell phone and VSS.  1629: Pt moving arm without difficulty.  Ok to go home.
Ringing in the right ear for 1 hour Feeling a pressure in the left ear, similar to ear infection pain for 3 days
#2 Hep A onset following AM 101.5 degrees, some nausea, fatigue. Fever later 103 degrees. Okay by 6/17 no c/o sore throat, etc to suggest viral syndrome.
Fever after Second Shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after Second Shot   ) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after Second Shot   ). At the time of the report, PYREXIA (Fever after Second Shot   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications was not provided.
09:45 Patient complained of left side of face feeling tingly, ear felt clogged; stated she didn't have this before; BP 128/80, Pulse 88. 10:45 No change; BP 130/78 and P 74. 11:30 Patient stabilized. I feel better; referred to family doctor. 11:45 I feel like it is resolving; only arms have a little tingling.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, feeling unwell and crying. On an unknown date, the outcome of the injection site pain, feeling unwell and crying were recovered/resolved. The reporter considered the injection site pain, feeling unwell and crying to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was not reported previously to anyone. The injection site pain was severe and made the patient cry. The patient required emergency room visit. The patient needed to be seen in the doctor's office. The physician recommended observation and if the events did not resolve the patient was asked to return. At the time of reporting, the patient did not come back to the office. The field representative had limited information.
Patient came to the pharmacy stating she had severe reaction about 7pm when she got home. Her arm was hurting, she couldn't move it, and also was nauseated. The nauseating feeling went away that night but the pain in her arm persisted. She contacted her PCP for advice and they instructed her to go to the ER. She then made an appointment and saw her doctor on 11/16/17. He said from physical examination it seemed like nerve damage. He gave her a prednisone shot and a PERCOCET rx.
PT HAD SWELLING AND LIGHT REDNESS WITH SWELLING ON THE ARM. PT STATED THAT SHE TOOK TYLENOL AND MOTRIN TO HELP WITH THE PAIN BUT WAS STILL IN PAIN. WE CALLED HER PRIMARY DR AND DISCUSSED THE SITUATION WITH THEM. DR OFFICE SAID THAT WHAT WE TOLD HER IS WHAT THEY WOULD HAVE TOLD HER AND SHE SHOULD CONTINUE USING TYLENOL OR MOTRIN FOR PAIN AND ALSO SHOULD USE COLD PACK. IF SHE IS STILL CONCERNED ABOUT THE SAME THEN SHE COULD GO AND GET CHECKED BY THE DR. CALLED AND TOLD THE PT THE SAME AND SHE WAS OK WITH IT.
Administered sub-Q MMR and Varicella vaccine to (R) arm. Child developed 2 hives adjacent to inj. site immediately. Dr notified and pt was evaluated. Child given 1 1/2 tsp children's BENADRYL and mom instructed to call if hives worsen.
it was rpt by MD concerning a pt vax & lab evaluations revealed pt did not seroconvert
Just minor problems with the first and second dose; Mentioned having chronic migraines; Pain where we had received the shot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Just minor problems with the first and second dose), MIGRAINE (Mentioned having chronic migraines) and VACCINATION SITE PAIN (Pain where we had received the shot) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (HCP is allergic to Advil (Ibuprofen)). Concomitant products included METOPROLOL for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-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 VACCINATION COMPLICATION (Just minor problems with the first and second dose), MIGRAINE (Mentioned having chronic migraines) and VACCINATION SITE PAIN (Pain where we had received the shot). The patient was treated with SUMATRIPTAN for Migraine, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Just minor problems with the first and second dose), MIGRAINE (Mentioned having chronic migraines) and VACCINATION SITE PAIN (Pain where we had received the shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-387043, MOD-2021-387017 (Patient Link).
Patient received Menactra, and had routine blood draw 1/4/07. 48hours later developed pain in Right arm. Greatest in lower arm. Movement of wrist triggers pain through extremity. No fever, swelling, redness. Treatment Ibuprofen, heat, rest, observation.
Moderna COVID-19 Vaccine EUA Bad rash, very red, all over the body appeared 2 days after receiving vaccine, no pain or itching. Rash lasted 5 days
Arm hurt the next day after shot in the afternoon. Muscles were sore. Visited local ER. Also visited ER. Also visited Doctors Office. Patient contacted pharmacy and information was taken 4/29/2022.Patient states that she is still in pain.
Flu like symptoms lasting for about 18 hours, beginning about 12 hours after injection. Fever, muscle aches, extremely tired, mild headache.
I contracted COVID sometime after the November holiday, around 2 months after taking the vaccine. The first symptoms were head congestion beyond my normal sinus problems. I tested myself for COVID and came back negative. It did not go away during the day and I tested myself again. I also had a big headache. When I went to bed and got up the next day, the headache and the congestion were worse. I tested myself again and this time it came back positive. I went to urgent care. They tested me for COVID, RSV, and Flu. Covid came back positive. They gave me PAXLOVID which I took for 5 days and told to stop my blood pressure medication for 10 days. The PAXLOVID made my symptoms a lot less and after the 5 days I was feeling a lot better. Then 2 days after I got the congestion again, and then I called my doctor again and told me to isolate for 20 days. I am feeling better now but my voice is still cracking.
My normal sinus issues seemed to be magnified.  I have a headache that seems to never go away even taking medication for it.  My head swells causing my glass to sink into the side of my head.
Redness and firm area of swelling onset few hours after vaccine, at maximum erythema 25mm, swelling 20mm diameter. Headache reported day of vaccination and 2 days after vaccination, relieved by Tylenol and Benadryl.  At day of reporting VAERS, pt vaccine site remain swollen/firm, redness improved but still present.
This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot No. and expiration date were not described). On an unspecified date in 2015, the patient was inadvertently administered with another dose of ZOSTAVAX (dose, lot #, expiration date and route were not reported) (extra dose administered). No adverse events were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Severe redness, pain, and swelling at injection site. Raised, blistered, red spots on same arm but not near injection site.
Significant swelling to R axillary lymph nodes. Size of entire palm, significantly tender. No redness or warmth
PATIENT IS DIAGNOSED WITH RA WITH NO FLARE UPS WHILE ON ENBREL.  SINCE VACCINE, PATIENT COMPLAINED OF FLARE UPS AND INFLAMMATION/PAIN IN JOINTS.  PATIENT HAD ALL 3 MODERNA VACCINES.
No Adverse event or treatment needed.  patient received the monovalent pfizer instead of the bivalent pfizer booster
I personally was down and out for three days with dizziness; fatigue; extreme nausea; This is Spontaneous report from a contactable consumer. This consumer reported similar events for self and 3 patients (Three friends). This is a First (Self) of Four reports. This report included:  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose number unknown, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient kept hearing various communication sites that the side effects of the booster shot in 5% of the people were sore arms and swollen gland. Patient personally was down and out for three days with dizziness, fatigue and extreme nausea on an unspecified date. The outcome of events was unknown.   The lot number for BNT162B2 was not provided and will be request during follow-up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101224287 same, reporter and drug , different patient;US-PFIZER INC-202101224288 same, reporter and drug , different patient;US-PFIZER INC-202101224286 same, reporter and drug , different patient
Received flu vaccine (Fluzone?) in my left arm from my employer while working my afternoon shift 02/11/2011. Awoke the next day with my arm very sore and developed numbness in my 4th and 5th fingers over the next few days. There were no outward signs of injury such as redness or swelling and my co-workers and employer seemed skeptical regarding my complaints. I also reported my symptoms, by fax, 03/04/2011 to our hospital's Employee Health. I looked up what I could find about these symptoms following vaccine administration and found little at that time, but what I did read made it sound as if side effects were transient. My symptoms continued for over a year, and I finally sought medical intervention. I was pretty sure my symptoms were not going to be "temporary" by then. So by June of 2012 I had completed a EMG and my doctor thought my symptoms would be alleviated with a surgical transposition of my ulnar nerve. This was completely ineffective.  I recently had a repeat EMG. My hand and arm have worsened. My entire left hand, arm, and shoulder are weak and atrophied now, and the pain and numbness have continued. The EMG indicates that I have a left brachial pathoplexy and have lost a great deal of enervation. In fact, 50% at the bicep. I am referred to neurology and awaiting an appt. as soon as I can get in.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 30-NOV-2016, the patient was inadvertently vaccinated with partial dose of M-M-R II, subcutaneously (dose, lot # and expiry date not reported) for prophylaxis due to leakage from needle (underdose, needle issue). No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as consent to contact was not provided.