chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick as a dog/still sick a month later/made me sick; lost 20 pounds/She's lost 18 pounds; can't hold anything down; can't get rid of my headache/ plagued with headaches; can't quit throwing up/throwing up water and bile; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog/still sick a month later/made me sick), WEIGHT DECREASED (lost 20 pounds/She's lost 18 pounds), ASTHENIA (can't hold anything down), HEADACHE (can't get rid of my headache/ plagued with headaches) and VOMITING (can't quit throwing up/throwing up water and bile) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 039C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-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 ILLNESS (sick as a dog/still sick a month later/made me sick), WEIGHT DECREASED (lost 20 pounds/She's lost 18 pounds), ASTHENIA (can't hold anything down), HEADACHE (can't get rid of my headache/ plagued with headaches) and VOMITING (can't quit throwing up/throwing up water and bile). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Headache, at a dose of 6-8 Excedrin a day. At the time of the report, ILLNESS (sick as a dog/still sick a month later/made me sick), WEIGHT DECREASED (lost 20 pounds/She's lost 18 pounds), ASTHENIA (can't hold anything down), HEADACHE (can't get rid of my headache/ plagued with headaches) and VOMITING (can't quit throwing up/throwing up water and bile) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has stated that she underwent MRI scan to her brain but can't found anything No concomitant medications were reported. Patient has stated that it hits her hard and felt angry and she felt plagued with headache and had headache prior to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Updated Reporter information, Updated patient details, Updated treatment partial frequency, Added patient lab details, Added suspect start dates and lot numbers, Added events.
I have the chills. I feel numb in the bottom half of my face and my tongue. I do not have a lot of energy. It's a familiar feeling I get when I am around cats.
pneumonia; pneumonia; COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2014 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine (PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE]), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 2021, described as "COVID"; DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant) all with onset 2021, all described as "pneumonia". The patient reported that she had Prevnar 13 in 2014 and the Pneumovax 23 in 2016. Last year (2021), the patient had a bad case of COVID and got pneumonia, then this spring, she had the Omicron version of COVID and pneumonia in one of her lungs. The patient was asking if Prevnar 20 covers forms of pneumonia that the other pneumonia vaccines did not cover. Asked if Prevnar 20 covers bacterial or viral pneumonia. The patient also asked if it will e advisable for her to get Prevnar 20 even though she already had the other two vaccines and still got pneumonia. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore breast; Sore nipples; Severe irritated sore nipples; Swelling in the arm; Patient had sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Sore breast), NIPPLE PAIN (Sore nipples), SKIN IRRITATION (Severe irritated sore nipples), PERIPHERAL SWELLING (Swelling in the arm) and PAIN IN EXTREMITY (Patient had sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FLUOXETINE HYDROCHLORIDE (PROZAC), ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), IRON, MAGNESIUM and CYANOCOBALAMIN (B12-VITAMIIN) for an unknown indication.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swelling in the arm) and PAIN IN EXTREMITY (Patient had sore arm). On 14-Sep-2021, the patient experienced BREAST PAIN (Sore breast), NIPPLE PAIN (Sore nipples) and SKIN IRRITATION (Severe irritated sore nipples). On 12-Sep-2021, PERIPHERAL SWELLING (Swelling in the arm) and PAIN IN EXTREMITY (Patient had sore arm) had resolved. At the time of the report, BREAST PAIN (Sore breast), NIPPLE PAIN (Sore nipples) and SKIN IRRITATION (Severe irritated sore nipples) outcome was unknown.            Concomitant medication included acid reflux pill which the patient used to take when she had acid reflux.  Treatment medications were not administered by the patient and no further treatment information was provided.   This case was linked to MOD-2021-320224 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up document received and patient's date of birth was updated.
initially stored in the refrigerator JUNE 02 2022 and the vaccine was given on 11 July 2022; Moderna Vaccine was given beyond the refrigeration use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR (initially stored in the refrigerator JUNE 02 2022 and the vaccine was given on 11 July 2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Vaccine was given beyond the refrigeration use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (initially stored in the refrigerator JUNE 02 2022 and the vaccine was given on 11 July 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR (initially stored in the refrigerator JUNE 02 2022 and the vaccine was given on 11 July 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. The vial was initially stored in the refrigerator on 02 Jun 2022. The vial did not undergo any temperature excursions. No treatment medications were provided.
Patient mistakenly received another dose of Pfizer Covid19 vaccine primary series instead of the intended Pfizer Covid19 bivalent booster as requested.
Arm is swollen and warm with a large erythematous rash below injection site.  Several oral temperature readings 95 and below.  My husband called 911 after an hour of extreme dizziness, weakness, and chills.  I knew I was going to pass out if he tried to get me up.
Pt vac w/FLUOGEN developed brain stem disorder, weakness of extremities & hypertension, bilat ptosis, difficulty speaking & swallowing. Admitted to Hosp BP 217/87, P 70min, R 20min, BS 225 mg/DL.  Botulism suspected. Tensilon test neg.
Outbreak of widespread acne like pustules that have mostly resolved within a week aside from a few of the more severe ones.
After first moderna dose patient had numbness, tingling, and tongue and mouth felt large( but no visible swelling). She described it as the feeling of being numb from getting dental work done. This symptom went away the next day and she was not sure if it was from the vaccine, so she proceeded with dose two. Overnight after her second dose she had the same reaction as well as a fever of 100.4 overnight, she called be about 3pm today 03/12 to let me know, and states she is feeling better. I advised her to get rest and drink plenty of fluids and if it gets worse to get medical attention. I also encouraged her to do V-safe with CDC which is included in her paperwork.
Itchy welt at injection site; Itchy eyes (exactly at 1pm on 4/20 and 4/21 for approximately 1 hour); Vivid dream (dream vs reality - felt as if my entire body had muscle aches due to vaccine, but I couldn't tell if it was really happening or of it was just a dream)
PHARMACIST ON BEHALF OF PATIENT REPORTED THAT PT RECEIVED THE MODERNA VACCINE 4/21/21 AND ON 4/28 HAD A RASH AT INJECTION SITE. PT REPORTED USING RUBBING ALCOHOL AS TREATMENT. PT DID NOT TAKE ANY ORAL MEDICATIONS. PT REPORTED RASH LESS "REACTIVE" THIS MORNING AND NOT ITCHY ANYMORE. PT DID NOT WISH TO PROVIDE EMAIL ADDRESS.
Uncontrollable shivering  without chills started 11hrs afterwards exactly and spontaneously like a light switch  Foot cramps both feet same time within 13hrs along with nausea  Capable of lying in fetal position and eventual easing of these symptoms around 4AM Nausea and arm/shoulder tenderness  with pea-sized knot at injection site - first 24 - 36 hrs. Pea-sized knot dissipated to injection sight bruise (oddly into bullseye-ish  looking shape) Dull headache and queasiness lasting 48 hrs after injection.
rash / extended below ears to below chin near Adam's apple / described red bumps along front neckline and cheeks.; itchy; irritated; and burning (pain); redness; hives; blisters that are very symmetrical/ bilateral.; affected area reported as dried up and not as dark; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th October 2020, 2 days after receiving Shingrix, the patient experienced red rash, pruritus, skin irritation, pain burning, erythema, hives, blister and dry skin. On an unknown date, the outcome of the red rash, pruritus, skin irritation, pain burning, erythema, hives, blister and dry skin were not recovered/not resolved.   It was unknown if the reporter considered the red rash, pruritus, skin irritation, pain burning, erythema, hives, blister and dry skin to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose intramuscularly in right arm. After receiving 1st dose of Shingrix, the experienced rash, rash described red bumps along front neckline and cheeks, rash extended below ears to below chin near Adams apple, affected area as itchy, irritated and burning (pain) with redness, hives and blisters that are very symmetrical or bilateral. The affected area reported as dried up and not as dark. The itching and burning (pain) were slightly present. The reporter consent to follow up.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 14-DEC-2013 (at the age of 64 years), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot #, expiration date, dose and route of administration were not specified). On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a nurse for shingles. The outcome of the event not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
bouts of  tachycardia at rest >100bpm  lasted for about 3 hours
BREAKTHROUGH COVID: FULLY VACCINATED AND BOOSTED, COVID POSITIVE. PT DIAGNOSISED WITH Covid pneumonia,Hypertension on hydrochlorothiazide, AND Overactive bladder and urinary frequency. She otherwise denies any CP, SOB, fever, chills, diarrhea, focal neurological deficits, hallucinations, altered mental status or any other acute complaints.  Covid positive 8/23/22 treated with Paxlovid. Was prescribed Nystatin for oral thrush following her paxlovid, which she is no longer taking.
The day of getting my vaccine, I had received the shot at 1:30pm on 4/30. I had no symptoms besides a sore arm at the injection site. I woke up at 4:00am on 5/1 with a fever of 99.9F and chills. I decided to take a hot shower because I couldn?t get warm. At the end of my shower I suddenly got a ?sickly? feeling in my chest, similar to symptoms of a chest cold. My vision started going black, almost like when you stand up too quickly. I experienced a sudden throbbing headache out of nowhere. My ears were ringing with partial hearing loss, and I started getting very nauseous. I stumbled out of the shower and immediately vomited.
low responder to the Pneumococcal vaccine and has to get extra.; This is a spontaneous report received from a non-contactable consumer (patient's mother) via Team. A 15-year-old male patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (Solution for injection in pre-filled syringe; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number, unknown for immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient was low responder to the pneumococcal vaccine and has to get extra on an unspecified date. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Pt recvd Engerix-B vax @ 730AM & became lightheaded, dizzy mins post vax; 12noon exp flu-type sx; took ASA; BP inc to 160/58; tx w/DPH; exp chills, weakness & numbness of hand & leg, palpitations & tachycardia; 6PM vomiting;pain rt leg;
Soreness & redness started evening on day of injection & worsened over 2 days, 4 x 6 cm area of erythema & swelling around site with medial streaking.  Already on Zithromax for resp infection.  Given Prednisone 20 mg BID x5d.
Flu Vaccine x 2 weeks ago at a pharmacy 9/28/2021 #3 Pfizer (booster due to high risk child at home. yesterday c/o (L) sore arm + took Tylenol. last night c/o pin prick rash - developed hives @ torso/back + shoulders. No fever no SOB etc. advised antihistamine + follow-up
Patient reports feeling a "marble-sized" lump near her left collarbone this morning that is mildly painful to touch (rates it 3/10).  Denies any other associated symptoms - no fevers, flu-like symptoms, difficult breathing, chest pain, redness/warmth at site and does not affect ability to perform activities of daily living.  Has not done anything for it.
Hives, one large raised itchy patch (11/2 inches x 4 inches) and multiple smaller raised hives over inner/front thigh and around lower trunk. He took two Benadryl. We got medical advice. There was no problem with chest tightness or breathing nor any other symptoms.
A skin rash originating under breasts with red skin lesions spreading  all over torso  very similar to pityriasis rosea  without a herald patch and minimal itching. Continuing to spread even after 2 weeks
Pt received BOOSTRIX (L) arm) and ZOSTAVX (R arm) and reports pain (intermittent) and worsened after hot shower. Redness on and off. Reports swelling after injection and "itched" symptoms maintained one month after injection and reports pain as constant "burn" and "aching". Difficult to lift arm. Has taken some ibuprofen.
but anyway he had got infected with covid, as well as his 16 years old daughter and a 45 years old female.; he had got infected with covid, as well as his 16 years old daughter and a 45 years old female.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose numbre unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary series immunization completed, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "but anyway he had got infected with covid, as well as his 16 years old daughter and a 45 years old female."; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "he had got infected with covid, as well as his 16 years old daughter and a 45 years old female.". The lot number for bnt162b2 was not provided and will be requested during follow up.
It was very odd; I had  O reaction for 2 weeks, then suddenly after 2 weeks, the area around the site of injection became VERY puffy and red and itched like crazy. (About the size of a softball) This lasted for at least a week. After a couple of days, white pustules appeared in the inflamed area, which looked even stranger. The weirdest part is that this only happened with the 2nd shot?not the first, or any subsequent. Nor did I have a fever or bodywide aches, other than normal FMS &  localized arthritis. The affected arm was VERY hot though, and stayed that way for at least a week. It gradually faded the next week (week 4 after shot).
Fatigue Apathy Unusual tiredness Body aches Headache Accelerated pulse Confusion
OBSTRUCTIVE SLEEP APNEA 5/2/2023 OSTEOARTHRITIS OF RIGHT KNEE
Patient got COVID; 110 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient got COVID) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced COVID-19 (Patient got COVID) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (110 days after the first dose). At the time of the report, COVID-19 (Patient got COVID) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (110 days after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information included antibody infusion therapy.  This case concerns a patient who had covid-19 after the first dose and missed receiving the of the second dose reported as 110 days since first dose (missed dose).  Based on biological implausibility, a causal relationship between the reported event of COVID-19 and mRNA-1273 use is assessed as unlikely.  The event of missed dose is assessed as not applicable.; Sender's Comments: This case concerns a patient who had covid-19 after the first dose and missed receiving the  of the second dose reported as 110 days since first dose (missed dose). based on biological implausibility, a causal relationship between the reported event of COVID-19 and mRNA-1273 use is assessed as unlikely.  The event of missed dose is assessed as not applicable.
fever started two days after vaccination; ranging from 99.1-100.5 for the first months, with headache a few times a week, tiredness. Fever persists till today (6/14/2021), ranging from 99.1-99.5. Still headaches and tiredness.
Redness, raised welt, itchy, painful area, approximately 8cmX10cm around the injection site.
Per parents, PT was "shaking in the morning of 1/28/03 for a few seconds then had a blank stare." Mom states legs were shaking only dad unsure "lasted only seconds until eyes rolled back."
it was rpt from health care professional concerning pt who was vax  & exp cellulitis just beneath the axilla; pt sought medical attention;
Patient is a 75 year old female with a PMH significant for CAD, HTN, Ventricular tachycardia s/p AICD placement in 2019, left ventricular wall aneurysm on Xarelto, type 2 diabetes mellitus and GERD who presents to the emergency department with progressive weakness and SOB. She was diagnosed with COVID19 on 1/13/2022 and has been taking mucinex and tylenol at home. Since that time she states she has been more weak at home and this morning had what she believes was a panic attack and felt as though she could not breathe. She states there has been several times this week that she has felt her heart has been racing and noticed her HR was in "cardio zone" for several hours at a time which(while sitting still) on  her watch which indicates faster HRs than usual. She denies h/o atrial fibrillation. She has been on xarelto for about a year due to concern of "something in the bottom of her heart". Upon chart review, it appears there was an ECHO performed in 12/2020 which mentioned a lateral wall aneurysm located in her left ventricle. No personal h/o thrombus or DVT. She denies fever, chills, CP, abd pain, changes in bowel or bladder habits or swelling in extremities. She has had a productive cough with dark colored sputum for the last week or so. Fever up to 100 several days ago but none since.   In the ER, patient found to be in atrial fibrillation with RVR. HR was up to 140s. She was given 10mg IV dilt and started on a dilt drip @10mg/hr. She was also hypoxic on room air and placed on supplemental oxygen with improvement in saturation. CXR with cardiomegaly but no acute abnormalities. Laboratory studies significant for mild leukocytosis, anemia (chronic), hyperglycemia and elevated BNP of 4243. Admission was requested.  PT IS INPATIENT AT THIS TIME.
A non-serious spontaneous report of administration to 70 year old was received from a registered nurse/health professional concerning a 70-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 14-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.            No concomitant medications reported by investigator.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.