chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days after receiving influenza vaccine, L deltoid became really sore. It continued to get worse through the weekend and beginning of the next week and felt like a shoulder dislocation. Has been having fevers, some warmth and redness in LUE and L shoulder.
Day of vaccination (Monday) and day after vaccination (Tuesday) experienced a sore, tender arm and mild fatigue. Wednesday morning woke up with tender, swollen lymph nodes and sore throat. Arm still sore as well at injection site. Thought sore throat may have been due to acid reflux so went to work at the hospital as usual. Thursday morning woke up with a worsening sore throat with difficulty swallowing, cough, nasal/sinus congestion, ear fullness, fatigue with dizziness, and nausea. Was unable to perform daily functions. Notified employee health at the hospital who advised a covid test and exclusion from work. A rapid strep test was also performed which was negative. Friday symptoms still present but slightly improved. Saturday morning received negative covid test result and approval to return to work if respiratory symptoms improved and under control. Today is Saturday afternoon, now returned to work (arrived late). Experiencing mild symptoms currently similar to the common cold.
Headaches, joint pain, muscle pain, vomiting, nausea, change in smell - everything smells very bitter/burnt rubber., extreme fatigue
Erythema, painful, swelling about 2 cm x 5 cm in diameter area at injection site. Emerged about 48 hours after injection. Denies fever, other skin lesions or rashes, or any other symptoms.
Patient reported almost one month later that their right arm swelled, was red and warm.  It reportedly lasted two weeks.  They did not seek medical care and reported the incident 26 days later.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a six-year-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with the same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Localize pain at injection site. Swelling more than 72 hours. Redness at injection site.
Received first injection Jan 12, 2021. RT Arm pain and mild headache, resolved in 48 hours. Second injection Feb 2 had similar pain in other arm. Then developed adenopathy in  anterior cervical chain of neck. This expanded and pushed against Portocath in lot IJ. On Feb 22, 2021 a CT was preformed that showed several nodes in the neck, largest 4.5 cm, as well as 2.5 cm in rt axilla. No hilar adenopathy. The large node enlarged to 7.5 cm and was biopsied on Apr 9, 2021. The report came back that this is a malignant transformation of Marginal Zone Lymphoma to Large B-cell Lymphoma.
Bilateral mastectomy; Missed the 2nd vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the 2nd vaccination) and MASTECTOMY (Bilateral mastectomy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 2nd vaccination). On an unknown date, the patient experienced MASTECTOMY (Bilateral mastectomy). On 11-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd vaccination) had resolved. At the time of the report, MASTECTOMY (Bilateral mastectomy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Nausea no vomiting, chills, swelling and itchiness at injection site, warm to the touch, and sinus congestion
I woke up feeling head ache with pain in my throat and upper section of my chest while breathing. My blood pressure and pulse was unusually high. I went to Hospital . I was checked for Covid, Chest x-ray and blood test.  Covid test results were negative, and X-ray results was normal with no problem.  All blood test results (including those for heart)  were normal. EKG test result was normal. They ruled out any problem with my  heart, but could not say for sure that it was not a reaction to Covid Vaccine .  However they said it might be a sever allergy.  (However I do slight allergy once a while with some congestion, but I have never had this sort of pain in my trout and upper part of chest).  I was dismissed after 3 hours, and was advised to get in contact with my Primary physician within 3 days
Itching in both hands. Took Benadryl for a day and it went away.
fever 101 degrees, chills, headache, myalgia, fatigue symptoms started the evening of 02/15/21 and were completely gone the morning of 02/17/21 ibuprofen 400mg was taken the evening of 02/16/21
Information has been received from a physician who is reporting on her 12-month-old female daughter who has no pertinent medical history or allergies who on 04-AUG-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and a dose of varicella virus vaccine live (Oka/Merck) (MSD). On 05-AUG-2007, the patient stopped calling her  parents "ma" and "da", stopped talking, became less active, had problems eating and started sleeping late. It was reported the patient had regressed. On 12-AUG-2007, the patient developed a fever of 101.2F and on 13-AUG-2007 her fever was 101.1F. The patient was treated with TYLENOL. She developed a rash on 13-AUG-2007. On 15-AUG-2007, the rash increased and on 16-AUG-2007 resolved. The rash lasted a total of 4-5 days. On 21-AUG-2007, the patient had a fever of 101F and was given TYLENOL. On 23-AUG-2007 her fever was lower. On 23-AUG-2007, the patient developed a rash on her face. On 24-AUG-2007, the rash spread to her back, chest, abdomen and limbs. On 25-AUG-2007, the rash went away in the morning and then returned in the afternoon. The rash lasted 3 days. The patient sought medical attention with her physician. At an unspecified date diagnostic labs were performed to test the patient's blood for MMR antibodies. At the time of the report the patient's status was not recovered from stopped calling her parents "ma and "da", stopped talking, less active, problems eating, sleeping late and regressed. A product quality complaint was not involved. Additional information has been requested.
erythema, swelling, knot/tenderness, irritability; onset 29JUN95 f/u 30JUN95 w/some erythema & fibrosis; 5JUL95 no redness-some fibrosis; suggested local measurements
Started with headache, sore throat, coughing, congestion, diarrhea, fever 102, dizziness, sore muscles and joints.
PATIENT RECEIVED A PFIZER DOSE 6/7/2021 WHICH AT THIS TIME 3RD DOSES NOR BOOSTERS WERE AVAILABLE YET & PATIENT IS NOT IMMUNOCOMPROMISED
Information has been received from a physician concerning a 12 year old male who on 10-JUN-1998 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 625047/1574E). On 13-JUN-2007 the patient developed chickenpox rash. Number of lesions was unknown. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Developed sinus and allergy type symptoms, upset stomach and diarrhea, very minimal shortness of breath for a short period of time (shortness of breath only lasted 30 minutes before bed on one night). Tested for COVID-19 on Monday, April 5th. Tested positive on a rapid test. Tested at another clinic, got a negative test result. And finally tested positive on a PCR test on 4/9. Symptoms stopped on 4/8.
Bright red at injection site.  Swollen and sore for over two weeks.  Felt strange.  Sensitive to air inside and outside-burning.  Ensuing days awaken to inability to open eyes.  Cranial pressure, aching joints.
Patient was billed correctly for moderna spikevax vaccine. At the time to pull the vaccine, pfizer pediatric was pulled and incorrectly given to the patient at the time of vaccination. No adverse events presented.
Blistering breakout in her groin area; Extreme discomfort; Reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blistering breakout in her groin area), DISCOMFORT (Extreme discomfort) and VACCINATION COMPLICATION (Reaction to the vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included RITUXIMAB (RITUXAN) for Rheumatoid arthritis.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 BLISTER (Blistering breakout in her groin area), DISCOMFORT (Extreme discomfort) and VACCINATION COMPLICATION (Reaction to the vaccine). At the time of the report, BLISTER (Blistering breakout in her groin area), DISCOMFORT (Extreme discomfort) and VACCINATION COMPLICATION (Reaction to the vaccine) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-265564 (Patient Link).
10 minutes after receiving the vaccine, the patient claimed he was feeling light headed and needed to lay down. After speaking, his eyes then went closed, and he clenched his fists and he started coughing up liquid. He was not responsive. He was moved to the ground and turned on his side. He became alert about 3 minutes after becoming unresponsive. He claimed this happens to him when he is at doctor's offices or receiving vaccines/procedures. He claimed it was "normal." He said he felt fine/normal, and this has happened in the past, though he did not mention this to the pharmacist prior to administration. 911 was called and examined him. He was allowed to go home on his own, did not go to the hospital.
Lot 3 expiration had been extended and vaccine had remained in freezer until date of administration.  Vaccine was given 2 days past expiration date.  Moderna was consulted and deemed the vaccine viable so revaccination was not necessary.  No adverse side effects were reported by patient.
The day after receiving the vaccine my arm was sore and red at the site of the injection.  It wasn't terribly painful but noticeable.  The red swollen circle, also warm to the touch, has increased in size daily.  Now two weeks later the warm red circle has expanded to about six to eight inches.  It continues to be sensitive when touched and it appears to grayish in the inside of the red circle.  Should I receive the next dose which is scheduled for March 3rd?
Rash, itching, swelling. Patient went to ER. Dr prescribed antibiotic and steroid.
Sharp R Breast pain (opposite side of where shot was given); Pins and needle-like pain at nipple and entire breast.; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203) via an unspecified route of administration in the left arm on 01Mar2021 at 08:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and poly cystic ovarian syndrome (PCOS). Concomitant medications included metformin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and dulaglutide (TRULICITY) all started from an unknown date for unspecified indication and unknown if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not tested positive for COVID-19. On 01Mar2021 at 23:45, the patient experienced sharp R breast pain (opposite side of where shot was given) and pins and needle-like pain at nipple and entire breast. No therapeutic measures were  taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test on 21Apr2021 which included the polymerase chain reaction (PCR) test and the result was found to be negative. The clinical outcome of the events sharp R breast pain (opposite side of where shot was given) and pins and needle-like pain at nipple and entire breast was recovered on 08Mar2021, seven days post the second injection date.   No follow-up attempts are needed. No further information is expected.
Tiredness, fever, chills.  My fever was approx 100 but I felt as if I were freezing.  I was fully dressed and under covers but was still unable to get warm.  Nausea, no appetite, headaches, and mental fog.
double pneumonia; A spontaneous report was received from a healthcare professional concerning a 71-year-old, male patient who received a Moderna's COVID-19 vaccine (mRNA-1273) second dose.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, terazosin, clopidogrel, atorvastatin.  On 13-Feb-2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  Caregiver reported on spouse's symptoms following dose 2 of vaccine. On 13-Feb-2021, after second dose of vaccine, patient experienced slight fever of 99.2 Fahrenheit, joint pain, and typical cold symptoms. On 14-Feb-2021, patient felt fatigues and slight fever. On 15-Feb-2021, patient felt not right. On 17-Feb-2021, early morning, fever was 99.8 Fahrenheit, and he sounded like has fluid overload. Called ambulance because patient felt like he could not breathe. At hospital oxygen saturation was 67%. Polymerase chain reaction COVID-19 test  was negative. Patient got admitted to intensive care unit. No treatment information was provided.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, double pneumonia, felt like he couldn't breathe, feeling not right, fever, typical cold symptoms, joint pain, and fatigue were considered 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 event, a causal relationship cannot be excluded.
Patient presented to emergency department on 11/18/2021 with progressive weakness of lower extremities. He was found to be COVID-19 positive. He was admitted to intensive care unit due to need for insulin drip caused by hyperglycemia. He was treated with supplemental oxygen and dexamethasone for COVID-19 infection during admission. He was discharged home on 11/30/2021.
COVID-19 Lot # FE3590 Vial PAA165959 Exp 2/22 was placed in the freezer after we received it.  It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2022 at 0830.  There were 22 patients who received the COVID vaccination during this time frame.  The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Case number PHEH2015US021106, is an initial spontaneous report from a nurse received on 16 Oct 2015. This report refers to a 32 years old female pregnant patient. Medical history and concomitant medications were not reported. Her last menstrual period (LMP) was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) 0.5 ml intramuscular on 01 Oct 2015 The case was assessed as non-serious. No adverse event was reported.
She got her vaccine, the shot was very painful at the time of the vaccine.  It got sore pretty quickly.  She went home and felt very tired and weak, and had a headache, nausea, felt like she was going to throw up but did not.  She had extreme abdominal cramping, the pain from that was very severe and she had not had anything to eat.   She has an ostomy and gets that reaction if she eats something that didn't agree with her, but she had not eaten anything.  She could not move for hours and just laid on the couch.  She could not get up to take anything for her symptoms due to not being able to move.  The next morning it started to get better and ease and she knew it was going to clear.  She was surprised that this happened and thinks that this should be documented and out there for people who have this type of condition to inform them.  It took about a day and half for her to be back to her normal pre-vaccine condition .    She had the pneumonia vaccine a few months prior but had no discomfort from that or the flu vaccine.
Sore arm, chills and hot flashes, headache/migraine, body aches. Fully recovered.
The patient broke out with hives about 30 minutes after receiving the vaccinations.  I spoke with the patient around 7 pm on 10/21/20 and she said after taking benadryl and zyrtec the hives are starting to go away.
headache; sore arm; muscle pain; stomach upset; tiredness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd July 2021, 1 days after receiving Shingrix, the patient experienced headache, pain in arm, muscle pain, upset stomach and tiredness. On an unknown date, the outcome of the headache, pain in arm, muscle pain, upset stomach and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, pain in arm, muscle pain, upset stomach and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient had received dose of Shingrix shot yesterday and now she had experienced headache, sore arm, muscle pain, stomach upset, tiredness. The reporter did not consented to follow up.
Pt vaccinated with DT developed chills & fever - arm swollen, arm achy & red, heart pounding.
On 9/15 he received a high dose flu shot in his left arm. Lot# UI679AA exp: 4/9/16 Following the administration the next day the area was red and event had a bruised look to it. It then became itchy and he also has developed a pain radiating to the anterior shoulder and down his tricep area. The pain has remained relatively stable. He notes some days he thinks that it is getting much better then the next day is it painful again. There is still an area of redness at the injection site. He had full ROM but lifting his arms above the head does elicit the pain and also can cause a tingling in his hands. He denies any injury to the areas. He does have history of a SLAP tear that he recovered from month ago. The recent pain does not limit his activity, he is still playing golf and doing his yard work with no issues. He has tried ibuprofen at night and it does help him sleep better.
When driving home following 15 minute wait period I felt my throat tighten, ears flush and heart rate increasing.  I immediately began to monitor my heart rate with my Watch.  My resting heart rate is in the 60?s.  At the time I looked at the watch my heart rate was already in the low 100?s but was rapidly escalating until in a matter of a few minutes had reached 140 bpm and my head began to have a full sensation and I was  becoming very shaky.  I pulled over into the parking lot of a restaurant and asked them to call 911.  As they were talking with the dispatch my pulse started to decline so I cancelled the request.  I stayed at the restaurant until friends to could come pick me up.  By the time they arrived my pulse was in the low 100?s.  I took 2 Benadryl.  I monitored my BP through the night and it did not return to the 60?s until 1:00 am.   I took (2) 25 mg Benadryl at approximately 4:00 pm,  took another 2 at around 9:00 pm when my heart rate started to escalate and then a final 2 before going to bed at 1:00 am.  My pulse dropped back into the 60?s while I was sleeping and stayed that way through the night.  I woke up with no further symptoms nor side effects from the shot.  The throat tightness and flushing of the ears resolved after the first dose of Benadryl.  I had no adverse reactions or significant side effects from he first dose of Pfizer.
Directly after injection there was difficulty breathing for 10-15 seconds, after that symptoms resolved.
experienced inefficacy from Pfizer COVID vaccine; This is a spontaneous report from a non-contactable other health professional (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported to experience inefficacy from Pfizer COVID vaccine. The patient further reported that it may be the timing. Sometimes, he was getting the blood after the first shot and it was still going up so it's possible this was still going up but it seems kind of low a month later (as reported). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported Drug ineffective cannot be ruled out
Awoke with chest pain after receiving vaccine that day prior. It was across mid chest with no other s/s. It began again that night around 7pm the next day and was resolved this Am when I awoke.
Pt developed pain at approximately 4 PM that started at left deltoid injection site and travelled into left shoulder and into left side of neck to just below left ear. On 10/23/01, pt developed fever and chills. She took one dose of Tylenol. She experienced chills for 2 days. On 10/29/01, the pain in shoulder began to subside but is a little more noticeable again on 10/30/01.
Since day of vaccination:pain, redness, itching at inj site along with body/bone ache and temp 100.7 Patient was seen on 8/31/09 in FHC for above complaints continuation.Affected area measured 15cm large, Thelnol was given and ice was applied.
Severe Joint Pain, Headache, High Fever, Dizziness, Nausea  Lasted about 24 total hours  Advil and Tylenol helped headache and reduced fever slightly