chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Began having Urinary problems within a month when I have never had a history of urinary problems. They began September 11th and I believed it was UTI as I have never had one before and got antibiotics, but I had to go back less than a month after as it occurred again. I was told to follow up with my primary as it was not normal to have two so close together, specially after never having one before and that the symptoms I was describing sounded much more severe than a UTI and may be kidney stones as the pain was more severe than a UTI. I did and my primary informed me the cultures they did never showed any bacteria at all, but the urine test showed very high amounts of blood. He had me do a new urinary test and blood work as well as a CT Renal Scan. Both times I had sudden stabbing pain in my urethra accompanied with blood clots. Not red tinged urine, actual blood clots. This was followed by about 5 hours of intense pain that and constant sensation to urinate that did not respond to pain medication, heat, or numbing AZO pills. Then it just went away. Both times, I went to the urgent care the morning after as it occurred at night when the urgent care was closed. My primary has now made a referral to a Urologist.
stabbing pains in the lymph nodes and foot; stabbing pains in the lymph nodes and foot; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient historical vaccine included BNT162B2  via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stabbing pains in the lymph nodes and foot on an unspecified date. The outcome of the evens was unknown.  Additional Context: The caller had both shots, she got the second done a couple of weeks ago. After the vaccine, the caller had stabbing pains in the lymph nodes and foot. The caller had those other symptoms before with the first dose.The caller has had bad side effects from other vaccines before.  Information about lot/batch number has been requested.
1 week after first dose, red rash /skin irritation appeared over injection site and across lateral shoulder. Swollen, red and warm to touch, mildly itchy. Rash is approximately 2 inches by 4 inches. Rash still present the following day.
Breakthrough case admission after 2 vaccines Pfizer 3/6/21 lot# EN6199;  Pfizer 3/27/21 lot# ER8732
administerd 5-11 year old dose instead of 12 + Pfizer.  No change in treatment or outcome.  Repeating booster dose not recommended at this time by the CDC.  Nurse assisting inadvertently grabbed 5-11 y/o Pfizer dose instead 12 + dose; she did not follow proper procedure of scanning vaccine before administering so realized her mistake afterwards when trying to document.
About 2 hours after the vaccine the patient experienced throbbing pain and a knot in her arm for the next 4 weeks. She did not report to the doctor. However, she did get some Prednisone 10mg taper dose on 11/30 and Doxycycline 100mg twice daily on 12/4.
Little itchy on redness area; Redness over injection site which is big about 2.5 cm diameter and still there; Soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Little itchy on redness area), INJECTION SITE PAIN (Soreness of left arm) and INJECTION SITE ERYTHEMA (Redness over injection site which is big about 2.5 cm diameter and still there) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INJECTION SITE PAIN (Soreness of left arm). On 10-Apr-2021, the patient experienced INJECTION SITE PRURITUS (Little itchy on redness area) and INJECTION SITE ERYTHEMA (Redness over injection site which is big about 2.5 cm diameter and still there). At the time of the report, INJECTION SITE PRURITUS (Little itchy on redness area), INJECTION SITE PAIN (Soreness of left arm) and INJECTION SITE ERYTHEMA (Redness over injection site which is big about 2.5 cm diameter and still there) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported  No treatment medication details was reported   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up information was received on 20-May-2021: Changed events outcome from unknown to recovering/resolving.
Patient had a sore left arm; Drug exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore left arm) and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylaxis.    Patient was taking Prenatal vitamins.  Concurrent medical conditions included Asthma and Allergy (patient takes over the counter allergy medication).   On 28-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and INFLUENZA VACCINE (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 28-Oct-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient had a sore left arm). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, VACCINATION SITE PAIN (Patient had a sore left arm) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported. Company Comment: This is a spontaneous case of Maternal exposure during pregnancy concerning an adult female patient with no relevant medical history, who experienced the non-serious expected, event of vaccination site pain, which occurred on an unknown date after a dose of mRNA-1273 BIVALENT .222 (original and omicron BA.4/BA.5, received as the fifth dose of COVID-19 vaccination schedule. Patient received Influenza vaccine on the same day of vaccination with mRNA-1273 BIVALENT .222, which was considered as a co-suspect drug. The benefit-risk relationship of mRNA-1273 BIVALENT .222 (original and omicron BA.4/BA.5) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-743819, US-MODERNATX, INC.-MOD-2023-743824 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743819:Same patient, PFS vaccine dose US-MODERNATX, INC.-MOD-2023-743824:Same patient, Monovalent dose
Site on arm is red, lifted, itchy, hot, burns when in sunlight. Slightly growing area.
3 days of high fever, body aches, chills, sweats, sore throat, swollen lymph nodes + tonsils, headache, fatigue. Day 3 given 10 mg dexamethasone. Most symptoms began resolving day 4 but chills and sweats persist.
Starting 01/25/2022 or so, I had a sore throat, body aches, fatigue, cough and congestion. My symptoms were mild. I tested positive on 01/26/2022 via a PCR test. Due to the risk factors, my doctor prescribed PAXLOVID. I got better quickly and the PAXLOVID seemed to stop the symptoms. Within a couple of days, my acute symptoms were gone (sore throat and cough). I do have some long term symptoms: joint pain and fatigue.
(R) leg red and edematous from knee to hip. Skin taut. Tx at private clinic with SEPTRA 200/40/5mg 2 tsp BID; KEFLEX 250/5ml 1 tsp QID. 8/2/10 redness and edema down.
Warm next day, following day patient said arm was swollen to the size of an 1/2 orange, itchy with red scales Swelling has gone down but still itchy and red. Sent patient to see PCP.
PATIENT REPORTED TO THE PHARMACY ON 4/25/202 IN THE EVENING. PATIENT STATED THAT HE EXPERIENCED MOD-SEVERE PAIN AND NUMBNESS/TINGLING IN HIS LEFT ARM AFTER HIS VACCINATION. WHEN HE PRESENTED TO THE CLINIC, THERE WAS NO ERYTHEMA AND PATIENT STATED THAT HIS PAIN/NUMBNESS WAS SUBSIDING. PATIENT'S PCP WAS NOTIFIED AND PATIENT WAS DEEMED TO NOT NEED FURHTER CARE AFTER VACCINE OTHER THEN STATING HE WOULD NOT BE RECEIVING THE 2ND VACCINE.
Headache, Sedation, Myalgia, UrticariaPruritus, chills and fatigue. pain at injection site
OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE AT FLUCTUATED TEMPERATURE BETWEEN 19 TO 43 FAHRENHEIT; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced out of specification product use, and incorrect product storage at fluctuated temperature between 19 to 43 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage at fluctuated temperature between 19 to 43 Fahrenheit was not reported. This report was non-serious. This case, from the same reporter is linked.
Distant dermatologic spread of vesicular/pustular lesions on arms, legs, and trunk. Afebrile. Right axiillary adenopathy with lymphangitic spreading rash prior to diffuse rash.
Patient reported numbness and tingling to the corner of the left side of his mouth approximately 45 minutes after vaccination given.
Persistent Fever: 100.0 @ 9:31pm on 4/19/21, 102.7 @ 3:35am on 4/20/21, 100.0 @ 8:51am on 4/20/21, 100.7 @ 10:38am on 4/20/21, 99.1 @ 12:41pm on 4/20/21, 101.0 @ 4:42pm on 4/20/21, 101.0 @ 6:35pm on 4/20/21, 100.0 @ 7:58pm on 4/20/21, 100.8 @ 2:21am on 4/21/21, 101.4 @ 3:27am on 4/21/21, 100.9 @ 6:50am on 4/21/21, 101.6 @ 10:28am on 4/21/21, 99.1 @ 11:40am on 4/21/21, 99.0 @ 1:35pm on 4/21/21, 100.0 @ 5:12pm on 4/21/21, 100.1 @ 6:01pm on 4/21/21  Persistent diarrhea starting around 2:30am on 4/21/21 and conintuing to current (2:50pm on 4/22/21)  Headache from 7:00m on 4/19 until 4/21/21  Sore throat developed on morning of 4/22/21  Body aches, chills, sour stomach have been persistent 4/19/21 - 4/21/21, sour stomach continues on 4/22/21
8 days post yellow fever vaccination (SQ) member noted a small area of redness at the site  of his vaccination. By this afternoon the area of redness had increased to about 2"x 2". There was no pain, burning, itching, or swelling. The rash is macular, red mottled in character with a few 1/2 - 3/4" areas of lighter tan coloration. There is no palpable pain or in duration. While there had been no issue at the time of his vaccination, two days later he noted significant pain at the site while his blood pressure was being taken. He has never had difficulty with any vaccinations in the past. The day earlier he received a Typhoid vaccination in the same arm (but IM in the deltoid). He denies any systemic symptoms. Symptoms: Rash, Focal.
next day fever and palpitations.  Coming and going for days.  on 2/4/2021 started having LLE and RLE numbness and tingling.  Went to ED given hx of CVA.  Testing all normal.  Started to resolve 2 hours later.  Continues to have pain at injection site (today is 2/8/2021)
This case was reported in a literature article and described the occurrence of posterior uveitis in a 29-year-old male subject who was vaccinated with Hepatitis B (manufacturer unspecified). On an unspecified date the subject received 1st dose of Hepatitis B (unknown). Ten days after vaccination with Hepatitis B, the subject experienced posterior uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis B vaccine between 1982 and 2009. It appeared that all subjects recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Patient said she is experiencing a high level of fatigue. She discovered a on 7/09/2021 she went to the DR and found out she had shingles.
The patient presented to the oncology clinic 4/20/21.  Owing to worsening ascites (presumed due to hx cholangiocarcinoma) we obtained a same-day CT showing an incidental finding of a extensive multifocal thrombus in the abdominal aorta.  Given her history of stroke currently on Plavix, we referred the patient to the ED for inpatient management of this thrombus.  She is currently admitted to the hospital and pending evaluation and treatment.
Patient received vaccine the afternoon of 11 Aug 08. Patient notice local redness, warmth, swelling and pain the following morning. I evaluated the patient that day and noted normal reaction to the vaccine but advised the patient to return if his symptoms worsen. He returned to me on 14 Aug 08 with redness extending to elbow, arm limitation, increase in pain but afebrile. Patient was treating symptoms with Motrin 400mg. I started patient on anti-histamines (Hydroxyzine 25mg). Since patient also required anti-malarial medications for his deployment, he started Doxycycline 100mg earlier then expected.
Expired vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 032B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer, Erectile dysfunction, Hyperlipidemia and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), TADALAFIL for Erectile dysfunction, ATORVASTATIN for Hyperlipidemia.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 10:38 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 10:38 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration). On 24-Jan-2022 at 10:38 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) to be not related.    Patient received their Moderna COVID 19 Vaccine 4 days beyond the recommended expiration date. No treatment medications were reported.
Day 1 - redness, warmth and burning  about 2 inches X 2 inches. Day 2- fire red, hard, hot, burning, itching, painful to touch, increasing in size. Day 3-  5 inches X 4 inches fire red hard, itching, burning, painful continuing to spread, tingling to top of arm. Day 4- 7 inches X 5 inches, remains red, hot, hard, swollen and painful, by end of day redness started to decrease. Day 7 slight itching and redness remains, Benadryl, ibuprofen, Claritin and Tylenol taken, no other treatment.
Blisters on hands; Blisters on fingers; Blisters on palms; This spontaneous case was reported by a health care professional and describes the occurrence of BLISTER (Blisters on hands), BLISTER (Blisters on fingers) and BLISTER (Blisters on palms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (Blisters on hands), BLISTER (Blisters on fingers) and BLISTER (Blisters on palms). At the time of the report, BLISTER (Blisters on hands), BLISTER (Blisters on fingers) and BLISTER (Blisters on palms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Medication was available.  No Concomitant Medication was available.
Information has been received from a patient's mother concerning her 12 year old daughter who in approximately 1995, at the age of 1, was vaccinated with a 0.5 ml dose of Varivax. "Three years ago", in approximately 2003 at the age of nine, the patient developed chicken pox. Subsequently, the patient recovered. No further information was available. There was no product quality complaint involved. No further information is available. No further information is available.
Patient signed consent form for Influenza vaccine with name and date of birth verified. Patient wrote her age as 68 on the vaccine consent form patient given a HD Fluzone vaccine.
7" length x 6" width. Redness, with heat at injection site. Rec' pt use ibuprofen for pain 6-8 hours. Up to 800mg, ice packets for comfort.
My side effects on the 1st 24 hours is the general side effects but after 48 hours I'm having diarhea
Patient said that about 1 week after she received Prevnar 13 in her right arm, her arm became "swollen" and "black and blue". She said the reaction lasted for approximately 2 weeks. She has had no additional problems since the reaction resolved.
Site: Bruising at Injection Site-Medium, Systemic: dark bruising from bicep to below elbow, area spreading-Medium, Additional Details: patient presented to the pharmacy on 10/9/22, stating he has had bruising/blood under skin since he received the flu shot on 9/23/22. There was older yellow bruising in the deltoid area and dark skin areas extending from bicep toward elbow and below and patient said the area had been growing since receiving the flu shot. Patient stated he is on eliquis, blood thinner. I advised him to go to ER to have it looked at as he seemed concerned.
Patient had a large swollen area on her arm - warm to touch, went to ER and was given antibiotics for oral use
adult patient received a pediatric dose; adult patient received a pediatric dose of ENGERIX-B in the thigh on Friday; adult patient received a pediatric dose of ENGERIX-B in the thigh on Friday; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 34-year-old female patient who received HBV (Engerix B pediatric) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis.   On 29-SEP-2023, the patient received Engerix B pediatric (unknown thigh) 10 ug. On 29-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient received a pediatric dose), adult use of a child product (Verbatim: adult patient received a pediatric dose of ENGERIX-B in the thigh on Friday) and vaccine administered at inappropriate site (Verbatim: adult patient received a pediatric dose of ENGERIX-B in the thigh on Friday).  The outcome of the underdose, adult use of a child product and vaccine administered at inappropriate site were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-OCT-2023 Adult patient received a pediatric dose of Engerix-B in the thigh, which led to underdose, adult use of a child product and vaccine administered at inappropriate site. The reporter consented to follow up.
I tested positive for COVID-19 on 2/18/23. I noticed that the kit had expired, so I took another test on 2/19/23 and still tested positive. I had congestion, sore throat, coughing, sneezing, fever, and drainage. I contacted my doctor and was prescribed PAXLOVID, but because of my health condition I was only able to take one pill a day instead of two. I recovered and then all the symptoms came back. I contacted my doctor, and they told me that I was probably having a PAXLOVID rebound case. This lasted for about 5 days.
Little dizziness; Feels fatigued; Second dose in right arm; Blood and water leaking out of his arm; A spontaneous report was received from a consumer concerning a 40-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mixture of blood and water was leaking out of arm, received second dose in the right arm (got two doses), fatigue and dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, after the vaccination the needle was pulled out and mixture of blood and water was leaking out of arm (Injection site bleeding) followed by the patient received second dose in the right arm, on 28 Feb 2021. On 01 Mar 2021, the patient experienced fatigue and little dizziness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event blood and water leaking out (Injection site bleeding) and patient received second dose in the right arm (Inappropriate dose of vaccine administered), fatigue and dizziness was not reported.  The outcome of the event, patient received second dose in the right arm was not applicable. The outcome of the events, blood and water leaking out (Injection site bleeding), fatigue and dizziness, was not reported.; Reporter's Comments: This report refers to a case of Inappropriate dose of vaccine administered  for mRNA-1273, lot #010A21A with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the Vaccination site bleeding, a causal relationship cannot be excluded.
J96.00 ACUTE RESPIRATORY FAILURE 4/11/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.00 ACUTE RESPIRATORY FAILURE 4/11/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE