chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy; A spontaneous report was received from a consumer concerning a 64 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy/ facial paralysis.  The patient's medical history, as provided by the reporter, included rheumatoid arthritis.  Concomitant product use was not provided.  On 03 Mar 2021, approximately 10 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch 025A21A) via unknown route in left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, the patient experienced symptoms of Bell's palsy. At the time of this report, she is still experiencing symptoms on the left side of her face.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, Bell's palsy was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.; Sender's Comments:  MOD21-060392:
pt arm w/red area to rt deltoid about size of fifty cent piece;pt states very painful & hurts to touch;area started about yesterday @ noon;
A report has been received from a Health Professional concerning a 33 year old, Female subject who had been receiving Nasal FLUMIST (INTRANASAL) started on 28-Jan-2014. The outcome of the event of EXPIRED FLUMIST is unknown. The report was considered the be non-serious.
Woke up at 12:30 AM with severe shaking, shivering and chills. Also had intense cramping in legs and thighs. Was freezing and couldn't get warm after donning socks and a robe under the covers.  Continued for close to three hours. Took tylenol right away. After two hours took a xanax to try to sleep and calm the shivers. Am still experiencing a headache two days later.
second shingrix vaccine today on 11/30/2022. He said he received his first shingrix dose 1 week and 7 months ago; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 7 months ago and 1 week ago).   On 30th November 2022, the patient received the 2nd dose of Shingrix. On 30th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 30-NOV-2022 Reporter's comment: The reporter was the patient and he reported that the he got his second shingrix vaccine today (the day of reporting). No further information was reported to the agent by the patient. The reporter did not consent to follow-up. Additional Supportive information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Narrative: Pt is 75y.o. male who died on 05/03/2021 with h/o COPD on 2.5 L, CAD (CTO proximal LAD - 2013), HTN, DMII, HFpEF, OSA on CPAP. Pt received Moderna Covid-19 vaccination on 02/27/2021. Unlikely that Moderna Covid-19 vaccine caused/contributed to pt death.
facial flushing and metalic taste in mouth and nasal burning followed by dull headache and feeling tired
Patient had approximately 4 inch round welt around site where injection was administered. Site red, raised and painful.. Presented to clinic for c/o nausea, body aches, joint pain, dizziness, weakness, numbness, tingling, chills, low back pain, headache, vomiting and diarrhea x 3 days post injection. No fever.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 08-APR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL 5 mg/0.5 ml injection, lot # J013777, expiration date 11-AUG-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 316 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius) and another lasting for 220 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine box had a written expiration date of 12/31/2022 and a BUD of 12/30/2022 .  Vials were labeled with an expiration date of 12/31/2022, and BUD of 12/30/2022.  Upon checking  the lot number with the expiring log  today, 12/05/2022, it was noted that the lot # FT1551, expired on 11/30/2022
One day post vax, the pt experienced pain at the injection site. As of 01/12/2001 the pt continued to experience this pain.
felt really tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt really tired".  Additional Information: The reporter's (grandmother) grandson felt really tired today and received the vaccine the same time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within first couple of minutes receiving the vaccine pt came back to registration to state she was feeling weak and lightheaded and sat down at the table put her head down on the table.  Pt then states she is feeling warm and nauseated.  Bag given to pt to get sick in if needed and ice packs applied to forehead and back of neck while she sat in a chair and laid her head on the table.  Vitals signs were 138/90, pulse 82 and sats 97%.  Pt given water bottle to drink from as well.  Pt continued to report feeling hot and started with tingling all over and wanted to lay down on floor.  A blanket was used to lay pt on floor and bunched up to support  her head.  Benadryl was given at 1325 50 mg orally.  After some time pt went back and forth with being hot then chilled and nauseated and not.  Pt had been given snack of some pop tarts as well at some point and vitals were retaken before pt left.  124/78 with a pulse of 76 and sats o 99%.  Pt reports feeling a little better and states she is just going to go home and take some Tylenol.  Pt's husband was here with her and drove her home.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received BOOSTRIX for prophylaxis. Concurrent medical conditions included meat allergy (the patient was Alpha-gal positive). On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. The reporter considered the pain in arm to be possibly related to BOOSTRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was Alpha-gal positive and believed that was why she reacted to BOOSTRIX. The patient received her vaccination with BOOSTRIX about a year ago and after receiving the vaccine, she literally felt as if she had broke her arm. The patient sought medical attention and ultimately took predispose to help resolve the issue. On an unknown date, the patient did have an x-ray as well to ensure she did not have a broken bone. Lab Comments: LAB test done on an unknown date.
2 week old patient recived a dose of an expired dose of Act-Hib vaccine, no adverse event; a 2 week old patient was administered a dose of Acthib, no advesre event; Initial information was received on 18-May-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (practice manager/office staff).  This case involves a one week and four day old (also reported as 2 weeks) male patient who was vaccinated with the 0.5 ml first dose of expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ183AA and expiration date 12-Feb-2012) via an intramuscular route in the right thigh on 15-May-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  The patient did not receive any other vaccine.  It was an actual medication error case due to expired vaccine used and inappropriate age at vaccine administration.  No adverse event was reported at the time of reporting.  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.
body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and HEADACHE (headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A, 030B21A and 003F21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL], GUAIFENESIN (MUCINEX), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), AZELASTINE HYDROCHLORIDE (AZELASTINE HCL), VITAMIN C [ASCORBIC ACID], ZINC, COLECALCIFEROL (VITAMIN D3), ACETYLSALICYLIC ACID (ASPIRINE), PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]), EZETIMIBE, SIMVASTATIN (EZETIMIBE/SIMVASTATIN), MONTELUKAST, ZALEPLON and CYCLOBENZAPRINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (body aches) and HEADACHE (headache). At the time of the report, MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-411468, MOD-2021-411494 (Patient Link).
She noticed big red circle on left arm at ivaccination site after 8 days; 17 year old daughter received 1st dose of vaccine; Patient had a sore arm on the same day; A spontaneous report was received from a consumer concerning a 17-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and patient had a sore arm on the same day and she noticed big red circle on left arm at injection site after 8 days.    The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 4 Mar 2021, approximately same day prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number:027A21A)  intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 4 Mar 2021, the patient had a sore arm on the same day and she noticed big red circle on left arm at injection site after 8 days. Treatment for the events included diphenhydramine HCL.   Action taken with mRNA-1273 in response to the events was not reported.   The events,17 year old daughter received 1st dose of vaccine was considered resolved on 4 Mar 2021. On 4 Mar 2021, the outcome of patient had a sore arm on the same day and she noticed big red circle on left arm at injection site after 8 days, were unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 027A21A) with associated AEs reported of vaccination site pain and injection site erythema.
Patient reports that on 11/23/16 she woke up with a swollen arm and knot at injection site.  States by late PM on 11/23/16 the pain had moved up her neck.  On 11/24/16 noticed swollen lymph node or gland on the right side of neck.  States area very painful to touch on 11/24/16.  Reported all above symptoms to local health department on 11/28/16.  States all symptoms have resolved except for swollen gland in neck which is improving but still tender to touch.  Denies any follow up with PCP; treated self with Ibuprofen and Nyquil at home.  Denied fever or any other symptoms of illness.
Delayed lip swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Delayed lip swelling) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Delayed lip swelling). At the time of the report, LIP SWELLING (Delayed lip swelling) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that patient stated that she had a they delayed lip swelling after receiving a COVID-19 vaccine and did not had Botox. The reporter was unsure if it was Moderna COVID-19  Vaccine.  No treatment medications were reported.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Information about the patient's pertinent medical history and drug reactions/allergies was not reported. On an unspecified date in 1990, the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). Concomitant medications were not reported. The reporter stated that, following the administration of the hepatitis B vaccine (recombinant) (manufacturer unknown), the patient had a terrible reaction (adverse event following immunization), partial paralysis, muscle and joint pain (myalgia, arthralgia), which all lasted about a year then resolved. Additionally, it was unspecified when those events occurred. It was also reported that, the hepatitis B vaccine (recombinant) (manufacturer unknown), on an unspecified date, triggered the start of plaque psoriasis. However, the location of where the psoriasis developed was not specified. The patient was prescribed, for the past years, DOVONEX cream and ointment as treatment for the plaque psoriasis. The reporter confirmed that the patient's psoriasis was still present. The reporter considered the partial paralysis a significant disability. Upon internal review the paralysis was considered serious as medically significant. Additional information has been requested.
After Dose 1 - next day if lifted left arm over shoulder had very very mild soar feeling in upper arm at site injection; 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), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 18Mar2021 16:00, outcome "recovering", described as "After Dose 1 - next day if lifted left arm over shoulder had very mild soar feeling in upper arm at site injection". Therapeutic measures were not taken as a result of injection site pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received Hydrochlorothiazide tab 12.5mg;  Lisinopril 20mg within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to and since the vaccination. Patient was not allergic to medications, food, or other products.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse (registered nurse, RN) refers to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, improperly stored doses of PNEUMOVAX23 (strength, dose number, dose, frequency, lot numbers and indication were not administered to an unspecified number of unspecified patients. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1406USA000382, 1406USA000549, 1405USA000550, 1406USA000551). Additional information has been requested.
dont want to do anything; Have not been hungry; I just don't feel good; Diarrhea; migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (dont want to do anything), DIARRHOEA (Diarrhea), DECREASED APPETITE (Have not been hungry), MALAISE (I just don't feel good) and MIGRAINE (migraine headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bunion operation (Surgery to remove bunion.) on 06-Jan-2021.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced MIGRAINE (migraine headache). On 24-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced LETHARGY (dont want to do anything), DECREASED APPETITE (Have not been hungry) and MALAISE (I just don't feel good). On 24-Jan-2021, DIARRHOEA (Diarrhea) outcome was unknown. At the time of the report, LETHARGY (dont want to do anything), DECREASED APPETITE (Have not been hungry), MALAISE (I just don't feel good) and MIGRAINE (migraine headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: Additional information received
I experienced joint pain and there is a very good chance at my age that it is arthritis of some kind. My ankles swelled up and when it does that my foot swelled up and I was unable to walk.
Breakthrough case admission after three vaccines Pfizer 4/4/21  Lot# EW0150;  Pfizer 4/25/21 Lot# EW0172;  Pfizer 12/17/21 Lt# FJ8757
Patient reported that he came down with hot and cold chills, vomiting clear mucus, and a moderate headache 2 days ago. He has been trying to rest and let himself recover but it is not getting better and is now 8 days post vaccination.
Pt reports with dizziness, generalized body aches, chills, and malaise. She also had significant swelling and tenderness to the area when the vaccine was administered.
Headache, fatigue, woke up in the middle of the night with chills, muscle aches, weakness. Went back to sleep and woke up again later in the morning still feeling weak, nauseated. Checked temperature and fever was at 101.6.
general weakness My whole body is "soft"; He cannot walk; I cannot sit; I can't do anything; A spontaneous report was received from a Consumer concerning an 85 Year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Asthenia, Walking disability, Sitting disability, and Impaired work ability.  The patient's medical history was not provided. No Concomitant medications used by the patient was reported.  On 25 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient was unable to do anything. His whole body was soft and disabled .Also he was not able to sit,walk and do nothing. All the events were considered as medically significant.   No Laboratory details were provided.  No Treatment details was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were reported as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient is a 39 y.o. male with no significant past medical history who came to the ED with a sudden onset of chest pain that radiated initially to his right shoulder then to his left shoulder, left arm and back with intensity of 7/10 starting Tuesday 4/13/21 associated with sob that is worse when laying flat or taking a deep breath   States he received his second Pfizer vaccine on Sunday, 4/11/2021 at 11 AM and started experiencing fever, chills, headaches, body aches and uncomfortable around 11 PM. He finally decided to take Tylenol x2 on Monday between 2 PM and 11 PM with some relief.  He felt a little better on Tuesday morning and did some work from home but later around 7 PM, he notes a temp of 100.2, experienced body aches which he attributes to Vaccine side effects because his wife was also not feeling well post Vaccine. He went to bed and woke up later with cold sweats, felt pain in his chest and back. He described his chest pain as constant pain/heaviness that "felt like someone is sitting on his chest", he later felt pain in his left arm and back prompting ED evaluation.  He denies similar episodes in the past, denies abdominal complaints, denies lightheadedness or dizziness, palpitations, shortness of breath at rest, orthopnea, PND, syncope, denies urinary complaints, denies smoking, drinks alcohol socially.  States his father has CAD and MI x2 with stent in his 50s, his mother is doing okay with no cardiac history.   In the emergency room, his EKG is consistent with pericarditis, initial troponin noted as 4.24 with repeat noted at 8.91, his LFTs are elevated at 107/123.  He received full dose aspirin, Lopressor 25 mg with improvement in pain.  IMG cardiology is on board with plan for cardiac cath today by doctor.  Echocardiogram showed EF of 35-40% with wall motion abnormalities with initial reading.
Patient stated had a hurt arm about one hour after the vaccination; within a 24 hour period started to develop red blotches going down arms, experienced chills and headache, shoulder and neck pain and stiffness.