chrisvoncsefalvay/vaers-outcomes huggingface dataset:
looked like cellulitis; rash at 7 days at the injection site; A spontaneous report was received from a physician concerning a 47-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a rash at 7 days at the injection site and looked like cellulitis.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the physician called to report that the patient got a rash at the injection site 7 days after receiving the vaccine. It was a delayed reaction that looked like cellulitis. Treatment for the events included a steroid, oral prednisone for 5 days with the reaction resolving within 48 hours.  Action taken with mRNA-1273 in response to the events was not reported.   The events, rash at 7 days at the injection site and looked like cellulitis, resolved on unknown date.; Sender'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.
This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 13th April 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX, the patient experienced generalized rash and hives. On an unknown date, the outcome of the generalized rash and hives were unknown. It was unknown if the reporter considered the generalized rash and hives to be related to SHINGRIX. Additional details were provided as follows: The patient did not want to provide date of birth. The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX in February 2018. The patient did not recall the site of injection. Approximately 3 weeks before the date of reporting, the patient developed hives and a rash all over her body, even on her scalp after vaccination with 2nd dose. The patient had reported this to her doctor and they were trying to figure out where the symptoms were coming from. The patient called to see if this could be a possible side effect of SHINGRIX. Consent to follow-up was not given. Emergency visit was required.
Moderna Covid Vaccine - Received 2nd dose of vaccine and acutely developed fever, chills, diffuse myalgia, and fatigue. Patient felt week to the point he could not walk. Denies headache, photophobia, neck stiffness, SOB, chest pain, cough, N/V/D, abdominal pain. Denies recent illness or sick contacts. Wife and patients denied any symptoms prior to receiving Covid vaccination. Past Medical History includes: metastatic clear-renal cell CA; receiving nivolumab/ipilimumab. SoluCortef 15mgAM/5mgPM initiated on 12/31. Last chemotherapy received on 01/22/21; S/P left nephrectomy In the ED, patient was started on vanc/zosyn/azithromycin, SoluCortef 100 mg, IVFluid and levophed (for MAP 62-64). Patient was admitted to the MICU for undifferentiated shock. Hemodynamically stable after weaned off low-dose levophed . Etiology likely infectious vs Adrenal insufficiency vs reaction to COVID vaccine. SoluCortef decreased to 50mg q6H. Acute kidney injury; likely secondary to shock.
ADULT OBSTRUCTIVE SLEEP APNEA, MILD 5/1/2023 ATRIAL FLUTTER, UNSPECIFIED
Left arm swollen, red, warm to touch, "very tight". Patient complained of itching and pain. Benadryl and Motrin advised.
had a mammogram on 21Apr2021 and had a bad reading. She has a 3mm mass or cyst; had a mammogram on 21Apr2021 and had a bad reading. She has a 3mm mass or cyst; This is a spontaneous report from a contactable consumer or other non hcp.    A 74-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ENE202), dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:00 as 2nd dose, single for covid-19 immunisation. Medical history included pain in extremity. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, A female consumer had both doses of Pfizer COVID vaccine on 06Feb2021 and 27Feb2021. She had a mammogram on 21Apr2021 and had a bad reading. She has a 3mm mass or cyst and they are not sure what it is. She was talking to her physical therapist who told her that you have to wait 3 months after your last vaccine for a mammogram because there have been having false readings. She has been wondering if that was true. The outcome of the events was unknown on 21Apr2021.The patient underwent lab tests and procedures which included mammogram abnormal: 3-millimetre mass or cyst on 21Apr2021 Bad reading on mammogram; 3-millimetre mass or cyst.    Follow-up (21May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported information included.  Information on Lot/Batch number is available; Further information has been requested.
Patient reports metallic taste the day after receiving vaccination, and also moderate leg pain x2 weeks. I told her a physician visit might be in order.
Later the same day after the vaccine my left lymph nodule began swelling.  I had a 102.3 fever and severe body aches.  My nodules continue to still hurt so  I went to the ER and had a strep test which was negative but I am still experiencing these issues to date
Redness left upper arm and hives to shoulder, 10-15 min after administration with Hep b#1.  Benadryl 25mg given IM in right deltoid. Observed 45 minutes.  Mom notified.
pt presented in acute respiratory failure with hypoxia, tested positive for COVID; respiratory status worsened and pt intubated with mechanical ventilation; condition continued to decline; pt was extubated and died in the hospital
Moderate to severe lower back pain; This is a spontaneous report from a contactable physician (patient). A 38-year-old male patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 18Dec2020 08:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included vitamin C and multivitamins. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. On 18Dec2020 19:00, the patient experienced moderate to severe lower back pain approximately 9-10 hours after receiving vaccine. He was feeling well prior to that, no strenuous activity. Symptoms progressed over 1-2 hours, then resolved over 4 days with tylenol/motrin use. Therapeutic measures were taken as a result of moderate to severe lower back pain. The outcome of the event was recovered on an unspecified date.  The following information on the batch number has been requested.
Systemic: Patient experienced temporary paralysis from the shoulders down lasting approximately 20 minutes-Severe
Fever up to 103, chills, body aches, nausea. Treated with tylenol 500 mg rotating 2 hours with ibuprofen 200 mg, and zofran 4 mg for nausea. Symptoms began at 7 pm on 1/26 and starting feeling better 1/28 at 8am
Medication Error. Patient was given DTaP instead of the Tdap that was ordered. Parent notified.
I have increased swelling and hypertension and sciatica - all these things I have never had before.  I have been taking Tylenol for sciatica - as needed - usually about 500  mg/day which helps.  Estimated date of delivery - May 27, 2021; my first pregnancy - high risk for age/weight and comorbidities; Prior to vaccine - had an ER visit for bleeding but that resolved itself.
When I arrived at work I was fine with in minutes my whole body felt as though it was spinning and I went to the ground, I began to sweat and got sick.  I laid on the floor for about 15min they symptoms got somewhat better enough to sit up.  I was sent home by my boss who also offered me a ride because I looked so awful. At home I went to bed but continued to throw up and have chills.  I slept the rest of the next 2 days.  I have continued to not feel well since the body aches and nausea  as well as short of breath being the worst at this point.   I felt in the beginning I was going to die it was so bad.  I'm not one to just go to the doctors so I went home to bed.  I have been short of breath
Covid vaccine administered to patient 8 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Hives appeared on 9/4/21, present all over the body. Very itchy. Benadryl helped symptoms subside.
2 days after receiving the Shingrix, the patient developed an itchy rash to the back of her neck. since that time, she has continued to have itchy rashes to her neck, arms, legs, buttocks. these last about 4 days.   Oral steroids initially seemed to help but the rash recurred. of note, her father had rash with Shingrix.
This spontaneous case, initially received on 08-Jan-2018, reported by a pharmacist, concerning a 58-year-old adult female patient. This report linked to case 201800042. The patient's medical history was not reported. The patient's concomitant medication included sertraline 50 mg. On 06-Jan-2018, 58-year-old adult (under 65 years of age) patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 178602 and expiry date: 30-Apr-2018) (explicitly coded as inappropriate age at vaccine administration). It was reported that, the patient did not experience any adverse event. The reporter assessed this case as non-serious.
Full body rash. Appeared 5 days after injection. Rash still there 6 days after initial onset of rash (date of report) bright red and splotchy. No fever, no congestion appeared with the rash. Was brought to doctor to look at the day after initial onset and on the date of this report.
The biggest symptom I experienced was pain and swelling in my breast glands and armpits. It traveled into my armpits from right to left. I have noticed swelling in other parts of my body. My knees, legs and arms. It was lasting pain at the injection site. The lymph node swelling has not gone away. It continues to come and go. Most recently, I have been exposed to a seasonal virus. It activated the lymph node swelling again. it is more on left side. It is intensity that comes and goes. I read that this was pretty common. This has now been going on for seven months. It concerns me, I can not rule out any other source yet. This started with the vaccine. When I had my out break out my shingles years ago. I am having new pains in the same area of my old symptoms of the shingles virus. I believe this is causes this reaction in my body. I think that is related to the shingles virus and the Epstein barr.
booster; pain from the booster dose; felling congested, not well; felling congested, not well; discomfort; running nose; lethargic; headaches; more uncomfortable pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "chronic pain" (unspecified if ongoing), notes: she has chronic pain from her mid-30s diagnosed with fibromyalgia; "fibromyalgia" (unspecified if ongoing), notes: she has chronic pain from her mid-30s diagnosed with fibromyalgia. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN (non-serious), outcome "unknown", described as "pain from the booster dose"; NASAL CONGESTION (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "felling congested, not well"; DISCOMFORT (non-serious), outcome "unknown", described as "discomfort"; RHINORRHOEA (non-serious), outcome "unknown", described as "running nose"; LETHARGY (non-serious), outcome "unknown", described as "lethargic"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "more uncomfortable pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  additional information: Caller said that she had no symptoms with the first 2 doses.   The lot number for bnt162b2 was not provided and will be requested during follow up.
about 2 minutes after receiving  her 3rd pfizer dose, developed rapidly progressive symptoms of cough/sob/throat swelling. received 2 puffs of albuterol and one epipen. moderate improvement of symptoms. transported to Emergency Department
Three days after receiving vaccine, patient went to doctor's office with bad side pain. Patient was diagnosed with colon infection.
Night after injection: sore arm, October 24--body aches, chills, October 25-runny nose, cough, aches, chills; October 26 deep persistent cough, congestion, pain when cough, sore throat, coughing interrupting sleep; all symptoms continuing October 27, October 28
I felt very tired, got a low grade fever, and had chills. My arm was quite sore and I was having trouble moving it. I couldn't raise my arm enough to undress and put on pajamas before bed. The next day the fever and chills were gone but my arm was still very sore and became visibly red and swollen -it was a three inch long rectangle around the injection site that was red and swollen. The injection site itself also feels hotter than the rest of my skin. Now (10/03/21), four days after the injection my arm feels sore/bruised, like what I normally would feel after previous Tdap injections, instead of the reaction I had to this most recent one. The pain, and redness are receding. The swelling on the skin is improving, just more slowly than the pain and redness.  Now it feels like that there is swelling in the muscle itself as it is hard and large (in comparison to my non-injected arm).
This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 15th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th December 2018, 14 days after receiving SHINGRIX, the patient experienced pneumonia (serious criteria GSK medically significant) and cough. On an unknown date, the outcome of the pneumonia was not recovered/not resolved and the outcome of the cough was unknown. It was unknown if the reporter considered the pneumonia and cough to be related to SHINGRIX. Additional details were received as follows: On 15th September 2018, the patient received 1st dose SHINGRIX in the left arm. On 29th December 2018, the patient reported that she started coughing. On 5th January 16, 2019, the patient went to physician and had a chest x-ray. From that it was determined that the patient had pneumonia. The patient did not consent to follow up. The representative unable to obtain additional information.
p/vax pt devel arthralgia/arthritis;stiffness of small joints of hands & hands persisted;
Acute appendicitis -> appendectomy. Stomach pain from 6pm 12th May, gradually increasing in intensity until barely able to walk. Wife drove me to hospital 5pm 13th. Diagnosed and operated on same night. Appendix removed.
Immunized at 14 years old; Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from a physician concerning an 14-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, immunized at age 14 and administered vials that were exposed to room temperature for more than 12 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received a vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours. It was originally thought that the freezer which stored the mRNA-1273 vaccine died on 04 Jan 2021 at 2am, so vaccine administration occurred up until 2pm. After checking freezer temperature logs, it was discovered the freezer had died at 1:11am. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, immunized at age 14 and administered vials that were exposed to room temperature for more than 12 hours, were considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age and Out of specification product use for mRNA-1273. There were no reported AEs associated with this case.
No Adverse Event; First dose of vaccine administered on 02-Feb-2021 and second dose of vaccine administered on 26-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine administered on 02-Feb-2021 and second dose of vaccine administered on 26-Feb-2021) and NO ADVERSE EVENT (No Adverse Event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe). Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine administered on 02-Feb-2021 and second dose of vaccine administered on 26-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine administered on 02-Feb-2021 and second dose of vaccine administered on 26-Feb-2021) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All doses of moderna vaccine given one in once. Humira was citrate free.  No treatment information was provided.   This case was linked to MOD-2022-624399 (Patient Link).
pt recvd vax;started w/ sl fever;apap given; next day, T 103 & had sz;called 911 & to er;had rash on belly,back & face;MD said Otitis med; took to ped next day,ears were ok, had diarrhea on 20jan95 for 4 days;
About 7 hours after  receiving both influenza and pneumovax 23 vaccines, bagan shivering, led to severe chills and shaking, after 3 hours it became a fever and lasted perhaps 2 hours.  The next morning there was a swollen red area, warm, firm and painful , on the shoulder about 2 inches above the injection sites.  The area is still red and slightly larger than the quarter sized area but the pain has decreased and appears to not need any further medical attention.
From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the U.S.A, it was reported that a female patient (age and birth date not reported) received Fluzone SV '2003-'2004 USP, lot number U1260AA, administered intra-muscularly (site of administration not reported) on 10/03/03. The following day, the patient developed pain, edema, redness, and itching at the injection site, as well as pain and swelling in her joints. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302255, 200302256, and 200302258.
Severe diarrhea, starting approximately 10 or 11 hours after the shot.
Chills; Aches; severe body shakes; Temperature of at least 101.0 Fahrenheit; Sweating; Fatigue; Restless sleep; Night sweats; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 22Apr2021 at 18:00 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and anxiety. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (TRI-SPRINTEC), leflunomide (MANUFACTURER UNKNOWN), upadacitinib (RINVOQ) and cyanocobalamin (B 12); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received nitrofurantoin (MACROBID) and azithromycin (Z-PAK); both for unknown indication from an unknown date and experienced drug allergy and previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021 at 17:30 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. On 23Apr2021 at 09:00, the patient experienced chills, aches, and severe body shakes. Temperature of body was atleast 101.0 Fahrenheit measured after the chills, aches and shakes subsided. The patient also experienced sweating, night sweats, fatigue and restless sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with over-the-counter paracetamol (TYLENOL). On 23Apr2021, the patient underwent lab tests and procedures which included body temperature and the result was 101.0 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches and severe body shakes, temperature of body was 101.0 Fahrenheit, sweating, night sweats, fatigue and restless sleep was resolved on unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
reporting a device malfunction- When administering the moderna covid 19 shot to a patient, as Pharmacist was placing needle into pts arm, the safety mechanism activated before getting whole dose in the arm- this resulted in most of the vaccine leaking down the patients arm.  This malfunction could have been due to over-pushing the plunger when injecting air into the vial to equalize the pressure- safety device did not activate then, but perhaps it partially activated (ie- malfunction)..  Since most of the dose was lost and not administered, pharmacist administered another dose into the opposite arm per cdc guidelines.
3mon p/vax became pregnant (LMP 22MAR96);ultrasound was performed @ 17wk & identified cystic hygroma & anasarca;23AUG96 pt miscarried;a limited autopsy exam of abortus confirmed cystic hygroma & anasarca;fetus had short fingers & toes;