chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the end of day when my nurse was documenting our wasted doses of COVID vaccine she noticed the lot numbers were different and we both quickly realized I must have grabbed a monovalent vial by mistake. I drew up all 6 doses from that multi-dose vial. The patient was given a monovalent 12+ COVID vaccine in error whereas should have been given a Bivalent 12+ COVID vaccine booster.
red  knot at the site of injection; itchy knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (red  knot at the site of injection) and VACCINATION SITE PRURITUS (itchy knot at the site of injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE MASS (red  knot at the site of injection) and VACCINATION SITE PRURITUS (itchy knot at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (red  knot at the site of injection) and VACCINATION SITE PRURITUS (itchy knot at the site of injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
This spontaneous report was received from a registered nurse referring to her husband, a 60 year old male patient. The patient had no relevant medical history, concurrent conditions or drug reactions or allergies. Concomitant therapies included omeprazole and losartan (manufacturer unknown). In August 2017 the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU) for prophylaxis (route, dose, units and lot number were not reported). On an unspecified day of 2017, 10 days after onset therapy, the patient experienced numbness and tingling in his right arm, right flank, and right foot. It was also reported that the patient felt weird. On an unspecified day of 2017, the patient was seen at the emergency room and tested negative for Lyme disease and tested positive for anaplasmosis which was treated with intravenous steroids and oral prednisone (manufacturer unknown) for an unspecified amount of time. The full course of treatment was taken and then discontinued. The primary reporter stated that two weeks after the emergency room visit, the patient was treated with doxycycline for two weeks to treat the diagnosis of anaplasmosis and then, on an unspecified date, was tested negative for anaplasmosis. The patient had a "full cardiac workup and stress test", magnetic resonance imaging (MRI), and unspecified "bloodwork" that came back negative for cardiac or other diagnosis. At the time of this report the patient was on muscle relaxants and gabapentin. The outcome of hemiparaesthesia, feeling abnormal, human anaplasmosis and hypoaesthesia was reported as not recovered. Causality assessment was not provided. Upon internal review, hemiparaesthesia was determined to be medically significant.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The reporter stated that the patient had initial shot of SHINGRIX and was convinced that he had the second when he was hospitalized briefly. The reporter stated that there was no indication that the patient had this second shot of SHINGRIX, but this had happened. The reporter asked, what would be the consequences of a third shot of a SHINGRIX.
Varicella was given IM instead of Sq. Patient's mom presented to clinic on 8/23/19 with her son (the patient) and stated that her son had developed pain and a bump on the arm in injection site. A provider within the clinic examed the patient and determined it was given incorrectly and with ice/heat he would be okay. The mom was advised to call back if it did not improve. To my knowledge they did not call back or present to clinic again for this concern.
On 8/3/00, the pt noted joint discomfort in both knees, right ankle, and left MCP joint of index finger. Also developed rash, described as red spots, over chest and abdomen. On exam, few scattered small slightly erythematous circular spots on chest and back. Slight swelling of MCP joint of left hand. Pt felt symptoms were fairly mild and was tx with Tylenol and Motrin.
I did have some local redness around the injection site. The local redness went away after about a week. My wife got COVID-19 from work. I came down with symptoms of COVID-19 on 10/16/2022. We ended up going to a separate telehealth doctor to get a prescription for PAXLOVID. I was able to receive a prescription for PAXLOVID. The symptoms that I was having was a sore throat, congestion, fatigue, and also the beginning of a fever on Monday. Since taking the PAXLOVID, my coughing and congestion have settled down and my sore throat is starting to improve as well.
Patient reports flu like symptoms for 24 hours. Including chills, fatigue, muscle aches, and joint pain (generalized).
Swelling - lg amount, redness, warm to touch. Ice and ibuprofen.
On 1/16/21 I felt numbness on my left face and abnormality in taste. Went to Kaiser Downey Urgent care. Diagnosed with Bell's palsy. Covid test done with negative result.
On the evening of 5/7/2023, I experienced some burning sensation while urinating at about 6 PM. I didn't give it much thought, but on 5/9/2023 at around 5:30 PM, when I urinated, I noticed just before I flushed the toilet that there was a lot of blood in my urine. I wanted to see my doctor, but by then, it was too late. I then decided that I would see him the next day. About an hour or so later, I needed to urinate, but I was unable to do so. I had some sort of blockage that made urination impossible and caused me extreme pain, and there was blood slowly coming out of my urethra. I stuffed a towel in my underwear to absorb the blood, gathered some personal items, and then drove myself to the ER. It took about 30 minutes or more before I was attended to. The attending staff gave me a container and asked me to provide a urine sample, which was impossible. The only thing I could do was provide five or six drops of blood into the container. They then decided to do a CT scan. After the CT scan was done, I was taken back to the ER, and a catheter was inserted into my urethra, and I finally got some relief. They also drew blood for testing. After this, I waited until about 4 AM the following day, when they finally took me to a room in the urology department and hooked me up to an IV. More blood samples were later taken. At about 8:15AM, the urologist finally arrived and began flushing out my bladder through the catheter. I saw lots of blood clots being washed out. The urologist worked for at least half an hour doing this. At this point, I hadn't had anything to eat or drink since the noon of the previous day, so I was relieved when the urologist told me I could drink or eat whatever I wanted. After that, I had more blood samples drawn. The urologist also instructed the nurses to flush out my bladder about every four hours or so. On 5/11/2023, the urologist informed me that the bladder was all clear and that I could go home later that day, which I did at about 2 PM. I wore a catheter and a bag at home for about six days. I finally had the catheter removed on 5/17/2023. A camera was also inserted into my urethra and bladder that for further examination. Despite having undergone a CT scan and having had a camera inserted into my urinary tract, no one could determine what the cause of the bleeding was. I am scheduled to undergo further testing later today. I was told by my urologist that one possible cause of the bleeding could have been constipation and resulting straining, but I could not recall having been constipated. In fact, when I was in the ER, I had diarrhea. I have also been put on FLOMAX, PROSCAR, MIRALAX, and senna. I also got a fungal rash in my crotch area while I was in the hospital, and I was prescribed clotrimazole-betamethasone topical cream and AUGMENTIN to treat it.
sore / around the injection site area; swollen /  around the injection site area; his left arm is hard /  around the injection site area; warm to touch around the injection site area; This case was reported by a pharmacist and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 9974P, expiry date 9th May 2022) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site induration and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site induration and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site induration and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The patient received the vaccine in his left arm. The patient's left arm was hard, sore, swollen, warm to touch around the injection site area following administration. It was almost like size of pharmacist's palm of her hand.  The reporter was unsure when the symptoms began following vaccination.  The patient still had the symptoms at the time of reporting. The reporter was the one who administered Shingrix to patient.
New onset atrial fibrillation  that resolved in 1-2 hours after treatment in ER with Amlodipine and Metaprolol.  Observed overnight. No symptoms since.
area size of fifty cents, blister like on lt shoulder-burns & itches; pain started 10 mins p/flu vax; seen by MD no tx;
Child was admitted to the hospital on 10/24/00 with Herpes Zoster. Child was treated and discharged on 10/27/00 to home. The follow up received on 3/19/02 states no problems noted at time of vaccination. One year later in 11/00 child developed multiple blisters covering her L thigh. She was admitted to hospital-she was febrile (T103) and had severe itching in blister area. The blisters spread to her back, only. Cultures were taken and she was started on antibiotics and was given a "vaccination." She began to get better within hous. Mom relates all this information.
Pt recvd measles vax 21JUL92 & following vax exp a systemic reaction, sore throat, muscle aches & pain; @ the time of the report 18AUG92, sx persisted; no further details were provided;
L upper arm- erythematous mac raised.  Confluent rash surrounding.  Approximately 4cmx2.5cm.  Left upper arm in area of Dtap injection site.
Multiple vesicular lesions in different stages of healing on trunk and thigh - crust on two - less than 10 lesions total.
Administered Pfizer Covid-19 vaccine. At time of vaccination patient bled and within one minute had a pea sized nodule under the skin at site of injection. Patient said her arm did not hurt and could not feel the nodule. I cleaned up the patient's arm to wipe away the small amount of blood and changed bandages from the inject safe bandage to a coverlet bandage. Monitored the patient for 15 minutes and patient had no other adverse reaction.
pt had a positive COVID test on 1/28/2022 and was hospitalized; did not need O2; dx with COVID pneumonia and A Fib with RVR; dc'd to home on 2/3/22; 2/4/22 pt presents with extreme weakness and inability to ambulate; requesting PT rehab placement; O2 supplementation 1 L via NC; 2/8/22 admitted to facility; 2/22/22 pt was found pulseless and breathless; CPR started, EMS called; EMS stated pt remains in asystole; pt died in the facility
This spontaneous report as received from an other health professional refers to patients of unknown age and gender. In August 2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M043310) for prophylaxis reconstituted with sterile diluent. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA001045: US-009507513-1709USA001289: US-009507513-1709USA001288: US-009507513-1709USA001287.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 05-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot #M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Bradycardia
Information has been received from a healthcare worker concerning a patient who in October 2007, 18-DEC-2007 and 07-JAN-2008 was vaccinated PO with the first, second and third 2.0 ml doses of ROTATEQ. On 07-JAN-2008 the third dose was administered 20 days after the second dose. The patient was not experiencing any known symptoms. There was no product quality complaint. Additional information has been requested.
Left shoulder joint pain, popping, catching, and discomfort. As per SIRVA information the shot was administered too high and too far back on shoulder near the joint instead of further down on the arm in the deltoid muscle as has been administered in the past.
Beginning 04/21/2021 at approximately 2:00 a.m. and ending 04/21/2021 at approximately 5:00 p.m.: chills, fever, aches.  Beginning 04/22/2021 at approximately 6:00 a.m. and still ongoing as of 04/23/2021 at 3:22 p.m.: swelling and discomfort in armpit (presumably in lymph node)
Pt. states prolonged muscle soreness after vaccine. Pain has slightly improved. Pt. has tried ibuprofen and warm compresses.
Asthma became worse, Preznol Oral Therapy Nebulizer - never used nebulizer and rarely used rescue inhaler, which now is used regularly.
Patient called me at 9:00 pm 8/15/2021. She got her vaccine on Thursday and had a fever Saturday.  Today she woke up with a swollen arm with a welt going up toward the shoulder 6" long and 3" wide. . Trouble moving arm. Had COVID-19 on October 31st. Lungs are burning.  I told her to call the emergency room and talk to them. I told her if she needed to go to the emergency room and couldn't get a ride that I would take her.
I felt tired, had muscle pain, shivering, fever, stomach pain, and nausea. It lasted around 12 hours.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L016427 with expiration date: 13-APR-2017, lot # L038018 with expiration date: 19-SEP-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35.6 degrees Fahrenheit for 10 minutes and 36.6 degrees Fahrenheit for 10 minutes. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.
Patient came to pharmacy about 2 months later and said that arm still sore. About Jan. 4th she contacted store mgr and said in severe pain, and had nerve damage to her arm.
Patient claims she had a reaction to the shingles vaccine. The first night, 5/8, she had a fever (100.5), chills, headache, nausea and extreme leg pain. Yesterday 5/9, she still had a low grade fever and then today 5/10, she just has a headache and she feels fatigued.
Covid-19 infection. Symptoms: tiredness, congestion, headache, fever, chills, sore throat. Treatment: 5 day course of Paxlovid Outcome unknown at this time
5 minutes after vaccine given she C/O throat tightness. HR 100. No stridor. Left department against advised and then went to ED for worsening sx with 30 minutes of vaccine. Refused to stay in department or have us transport to ED.
My upper respiratory infection symptoms started on 11/30/2022 in the morning with a slight cough. The mucus was green and thick. I did a Telehealth with my doctor on Monday 12/12/2022. The first week I called my doctor who prescribed me medication for Sinus infection but I didn't take it. I contacted the pulmonary doctor to see if I can take the medication my doctor prescribed originally. So, he advised me to take the medication which I started taking from 12/08/2022. My symptoms started over the weekends with fever, nasal/chest congestions, and headaches. Along with the antibiotics, I also took MUCINEX DM, and I did Sinus washes 2 times per day. I took 3 times COVID-19 home testes which were all negative. I am still recovering from Sinusitis.
dizziness; no energy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and ASTHENIA (no energy) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and ASTHENIA (no energy). At the time of the report, DIZZINESS (dizziness) and ASTHENIA (no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not provided. No treatment information was provided.
Pfizer Peds Vaccine given to 12 year old. Should have received adult dose of Pfizer vaccine.
Narrative:  90y.o. MALE with a h/o HFpEF (EF 56% 1/12/21), COPD on 2L Home o2, paroxysmal a-fib, CKD stage 4-5, DM2, HTN, HLD, Hypothyroidism, who presented to the ED with SOB, weakness and weight gain on 9/21. Pt was transferred to hospice on 10/9/2021. Pt died on 10/10/21. Pt had received covid vaccines on 2/3/21 & 3/4/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
8 cm oval area of erythema (L) anterior forearm lower half. This may not be related to immunization which was given in the deltoid muscle.
- Day after first injection (9/24) throbbing headache (similar to concussion headache)/ Rotating sites of pain in head - Headache sustained all day and night with ringing in my ears (especially at night) / going on 6th day - Headache gets worse towards afternoon/ evening -Headache has sustained for the past 6 days -6th day after 1st injection (9/29) noticed swollen lymph nodes in my right armpit- tender to touch
Background: Patient was seen at the Emergency Department for a work related back injury on Oct. 7 2021 and was diagnosed with strain of upper thoracic spine (right side). Pt was then prescribed Norco (for pain) & Valium (for muscle spasms), one dose of each was administered while at the ED. Pt was subsequently discharged with home rx of Norco & Valium, but prior the adverse event noted in this VAERS report, pt has not taken additional doses of either.  Adverse Event: At approx. 1630 on Oct. 26 2021, Patient began to experience unexpectedly severe pain and muscle stiffness in shoulder nearest to injection site. Over the next ~1h, pain and muscle stiffness progressively radiated from left shoulder, across upper back, and to right shoulder. Once pain and muscle stiffness reached right shoulder, the pain got significantly more pronounced. Patient then took previously prescribed Valium which helped with the muscle stiffness. After another hour the pain and muscle stiffness had mostly subsided, but both remain (although less severe) for another aprox. 24 hours. Pt was seen in person by a qualified healthcare professional two days later (Oct. 28 2021).  Treatment: Valium (Rx)  Outcome: Resolved with Treatment. Pt continues to have occasional muscle stiffness and pain in shoulder. Presumed to be related to previously mentioned muscle strain.
severe breast pain, breast tissue formed into a large lump, menstruation began early - I took the first shot right before my menstruation and that night plus the following night I experienced the feeling of my breast being stabbed over and over. A few days later I found a large lump ontop of my breast over the nipple area. I went to a obgyn doctor who felt the lump and concluded it was probably breast tissue but wanted to re-check after the second Covid shot which I will get on the 15th of June.
The patient is a 82 y female who was admitted on 10/25/2021 pmhx htn, breast cancer, copd, former smoker, was admitted for acute hypoxic respiratory failure due to covid 19 infection,  she was placed on respiratory protocol, decadron, abx, remdesivir. acute hypoxic respiratory resolved, covid 19 infections, pneumonia improved. Pt is medically stable will be discharged home stable condition, resume home medications, follow up pcp.
This spontaneous report as received from a pharmacist refers to a patient of unknown age who on 27-AUG-2012, was vaccinated with first dose of VAQTA 1 ml intramuscular (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient received the second dose of VAQTA early on 27-SEP-2012, 1 ml intramuscular (lot number not reported), the patient was not experiencing any known symptoms. No treatment information was reported. At the time of the report, the patient's outcome for the adverse events was unknown. Additional information has been requested.
nausea, fever (not measured by patient), muscle aches for 2 days after Pneumovax given 3/14 07