chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received pediatric 6m-5y vaccine after the BUD; Vial was initially stored in the refrigerator on 23-Dec-2023 and was administered after BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received pediatric 6m-5y vaccine after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 23-Dec-2023 and was administered after BUD) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received pediatric 6m-5y vaccine after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 23-Dec-2023 and was administered after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received pediatric 6m-5y vaccine after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 23-Dec-2023 and was administered after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received pediatric 6m-5y vaccine after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 23-Dec-2023 and was administered after BUD).    No concomitant medications were reported.  Total 42 Dose were administered after 30-day Use By Date. Vaccine was administrated on 26-Jan-2023, 27-Jan-2023, 30-Jan2023, 31-Jan2023, 2-Feb-2023, 6-Feb-2023,8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. Vial size was reported was 0.4 ml per vial. Vial did not undergo any temperature excursions. No treatment information was provided.  This case was reported for patient 34 of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
Atopic reaction around eyes, mouth, and scalp following first dose administration of Pfizer-Biotech Covid-19 vaccine.
I had an inadvertent introduction of Biothrax into my eyes this morning during a mass immunization. My eyes were flushed with 500 mL NaCl afterward. Contact lenses destroyed and I will wear normal glasses.
This spontaneous report as received from a registered nurse via company representative refers to a 12 year old non-pregnant female patient. The patient's medical history was not reported. In approximately June 2015 (reported as 2 months ago), the patient was vaccinated with her first dose of GARDASIL (route, site of administration, lot # and expiration date were not reported). In approximately 2015 (reported as after receiving GARDASIL), the patient experienced vaccination site erythema and vaccination site was swollen. On an unknown date, a phone call from the patient was placed to the nurse. The patient was advised to treat the injection site with ice and to take ibuprofen as needed. The outcome of events was reported as resolved in approximately 2015. The relatedness between the events and GARDASIL was not reported. Additional information is not expected, because there was no consent to contact the reporter.
I had very slight nausea soon after the first shot, then started having chills and whole body ache from the night (12/18/2020) for 24 hours followed by spontaneous internal hemorrhage (lower GI, significant blood in stool) in the morning  and in the afternoon of 12/20/2020.  The hemorrhage lasted for about 24 hours.  It started slowing down on 12/21/2020, then stopped.    I was evaluated by Dr., (GI) who was not sure if the bleeding was vaccine induced vs. coincidence on 12/23/2021.  Since the bleeding stopped, she cleared me for the 2nd vaccine and advised me for close monitoring for any other episode of bleeding.  I had some fatigue for about 4-5 days since the first shot, then I felt normalized.    Soon after the 2nd vaccine (in about 5-10mins) on 1/8/2021, I started having some discomfort/pain in lower rib region where spleen is.  Initially I felt like some chest pain, but it was more near spleen region, I think... I also had slight intermittent dizziness for about 2 hours after the 2nd injection.  The discomfort in left lower chest/rib improved and resolved in an hour or so.    Then, similar pattern started including chills and whole body ache on the night of 1/8/2021 followed by internal hemorrhage again (significant blood in stool) in the morning and in the afternoon of 1/9/2021.  The bleeding slowed down on 1/10/2021, then stopped.   I reported it to again my GI doctor on 1/11/2021 who ordered CBC to monitor my platelet level.  The result showed down trending from my baseline.    I think the COVID vaccine transiently affected me with internal hemorrhage and lowering platelets/likely potential thrombocytopenia given the clinical symptoms (spontaneous internal hemorrhage).   Platelet level is improving at this time and I feel normalized today.
ringing in my ears got extremely loud again; This case was reported by a consumer and described the occurrence of ringing in ears in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tinnitus (tinnitus and working with an audiologist for the past year).   On 15th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and all of progress in reducing the volume of my tinnitus evaporated.  The ringing in ears got extremely loud again, within a day and had stayed loud for the past 3 months.  The patient had to start over on tinnitus therapy. The patient was very hesitant to get the second shingles vaccine shot and would not be able to stand the tinnitus if it gets any louder.  The reporter asked was the first shot effective enough on its own.
Everything was fine for the first couple of weeks after vaccine, but shortly before Thanksgiving I noticed I was experiencing clitoral discomfort. It looks like I have a cyst or lesion on the hood of my clitoris. I did see the doctor and we treated it as something else we thought was related but the lesion or cyst is still there and I need to get a follow up to get that resolved. Since I have Vulvodynia, I usually have problems like adhesions and discomfort but this is different. First treatment didn't resolve cyst so now I have to go back. I did read a journal article on this called TITLE by AUTHOR.
swelling to lips, throat pain after vaccine was administered. Benadryl 50mg IM given. Patient waited in clinic 1 hour after vaccination
Sudden onset of chest tightness, shortness of breath, right arm pain. Since this event, continued shortness of breath.
Mother reports that child now has 2x2 inch red, swollen, warm area on arm where varicella vaccine was administered.
rash started yesterday 2-3 spots itches off and on no fever today 30 erythematous areas with small pustules
Within on day of getting flu vaccine a rash started on the torso which caused itching and then spread over the whole body. The severe itching and scratching has caused sores and scabs, almost 3 months now.
Exhaustion; Feel discomfort; Soreness at the site of injection; Tired; Swollen armpit on the side of the injection; Appears to be possibly swollen lymph nodes; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 40's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ANTACID [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Exhaustion"; DISCOMFORT (non-serious), outcome "unknown", described as "Feel discomfort"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at the site of injection"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Swollen armpit on the side of the injection"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Appears to be possibly swollen lymph nodes"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Clinical course: After second vaccine injection in the early afternoon, experienced exhaustion in the evening and, at night, started to feel discomfort and soreness at the site of injection (upper left arm). Still very tired the next morning. Woke up on second day with swollen armpit on the side of the injection. Felt uncomfortable. Appeared to be possibly swollen lymph nodes. Patient stated in follow-up that after booster shot of the Pfizer COVID vaccine, the site of injection started to hurt one hour later and felt exhausted the rest of the day. Also got a headache in the evening. These were similar symptoms to those experienced after second dose.  Additional information: Patient stated that I am in my 40s and female. No other medication taken other than OTC antacids and vitamins.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Immediately after the 1st shot, I felt tired. My arm was very sore and achy later in the afternoon. By 4pm that day, I was exhausted! The next day left SI joint  and neck started killing me! The SI joint and neck continued to hurt (scale of 1-10, the pain was about an  8) and then by the 3rd day after the shot my left knee started hurting me.  By the 4th day, I was fighting a cold. I started to get phlegm in my lungs, and it felt like bronchitis was coming on. I used acupuncture, and chiropractic for the pain (neck, SI Joint and knee), which helped. I was able to fight the "cold" with herbs and rest. Nerve pain (neuropathy) came on by the 2nd day after receiving the shot. I felt tremor- like reactions in the major muscles of my body. The majority of the nerve pain went away after the 4th week,  post vaccination but numbness and tingling is still continuing in feet and fingers. Numbness and tingling in extremities has been consistent since I received the vaccination.  My insomnia also worsened for a week or two after the shot. I believe the shot over-stimulated the CNS, causing me to go into a sympathetic nervous system state. My body was in shock after the vaccine!
numbness in the left foot after the covid-19 vaccine.  I still have the numbness from April 17, 2021, to this day.
Early the morning of 3/25/21, the day after I received the first vaccine, I woke up with a bad case of heartburn/acid reflux which kept me up for several hours. This happened again several weeks later, along with feelings over the next month and a half like something was stuck in my throat, throat irritation, ulcers in parts of my throat that I had not gotten in before, burned palette from acid reflux, hearburn etc. I had never experienced any acid reflux or heartburn previous to this. I went to my PCP several times, ENT doctor twice, and a GI doctor. I have been on pantaprozole (40mg) since May 13th without improvement. In fact my symptoms have gotten worse. I restricted my diet to only water, cheerios, baby rice cereal,  raisins, bananas, eggs, potato, protein shake, biscof cracker, applesauce) for a month and a half with no improvement. I have increased the pantaprazole to 80mg and down to 20mg and symptoms worsened with each.
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, the patients were vaccinated with improperly stored doses M-M-R II (lot # L009544, expiration date: 19-MAR-2017, dose, route of administration and injection site were not reported). 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.
11 am the next day felt slight fatigue and slight pain at the injection site.  Around 4 pm, felt more fatigued and fuzzy-headed, similar to mild cold or flu symptoms. As of 9 pm, I am still tired and fuzzy-headed, but not ache-y
Per EMS on site client "Passed Out"   Syncope for 30 seconds following vaccine.  Previous history of syncope with "shots" Anxious with 02 Saturation of 98% pulse 65  Blood pressure 96/66 at 16.55pm.  At 17.00 client stated she felt better with Blood pressure up to 101/71 and pulse 85..  Released by Dr after being reclined in her car seat and reporting she felt better.  Advised to seek medical attention later if needed.  Client verbalized understanding.
One day after vaccines she developed redness around injection site that has gotten larger -> redness of skin covered the lower third of anterior left thigh.
pt recv vax 7MAY95 & the same day pt exp 3 days crying episode w/no fever;10MAY95 pt recovered;
Broke out in hives on my face and neck about 3-4 hours after second dose. This did not happen with first dose.
Broke out with red, fluid-filled spots over entire body on 2/7/02. Diagnosed with chicken pox 2/8/02. Had Varicella 4/28/97 at another facility, but we do not have that information available.
Swelling on lower lip right side 14 hours after injection.  Subsided at 20 hours after injection and then lower lip left side swelling occured.  Both subsided between 26-30 hours post vaccine but 36 hours after vaccine, full upper lip swelling occurred.  Subsided 48-52 hours after vaccine.
Rash; This case was reported by a nurse via call center representative and described the occurrence of rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash that the patient think was related to Shingles.  The reporter requested information regarding the timing of the 2nd dose of Shingrix in patient who developed Shingles after the first dose The reporter consented to follow up.
Lightheadedness; Patient describes nausea and mild dizziness . Patient being sent home with mother who is driver . ER precautions given . Patient advised to follow-up with PCM for persistent symptoms.
Few minutes after getting her vaccines, pt felt dizzy, nauseous, and felt faint. 5 minutes after getting vaccine, pt starting getting abdominal pain. 10 Minutes after vaccine, pt vomited.
Inflamed from shoulder to fingers. Swollen and painful. Required many doctors visits and shots.
Approx. 8 hours, post vax, pt noted tachycardia 120-130, restlessness, then itching of palms, feet and both arms to shoulders. Itching subsided with Benadryl. Slept poorly rest of the night.
Within 1-2 mintues following administration of  HPV vaccine child had syncopal episode w/ upper  body jerking, followed by hypotension and  bradycardia. Child monitored in office for  approx 2 hrs after event. BP/HR/O2 Sat all  stable when child left office.
Site: Pain at Injection Site-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 6 hour after vaccine, patient was awoken from sleep with tingling sensation in tongue. Patient felt tachycardic and felt like body was going to break out into hives. Patient did not have rashes or itching but took benadryl anyway. All her symptoms went away roughly 30 minutes later.
bladder infection; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as Dose 1, Single for Covid-19 immunisation. The patient medical history was not reported. Historical vaccination includes flu shot on an unspecific date and felt abnormality. On unspecified date in 2021 the patient experienced bladder infection. After getting first dose of the Pfizer BioNTech covid vaccine she developed a bladder infection and have been on antibiotics. The leaflet from the pharmacy states that she should not have immunizations while on the medication. Her urologist and internist both said that she should get the second dose of the vaccine when scheduled on 05Apr2021. Asking whether it is ok to get the second dose of the Pfizer vaccine and being on antibiotics. She was also on a blood thinner and a beta blocker. She had a flu shot earlier this year and felt a little something, but she didn't feel anything when she got the first dose of the Pfizer vaccine. Therapeutic measures were taken as a result of bladder infection includes administration of the antibiotics. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Myalgia (5/10 pain) much more than with a typical flu vaccine.  Significant swings in body temperature ranging from chills to sweating for >24 hrs without a definitive fever.
Rash at site of injection about 5 in in diameter. Red and itchy. Showed up about a week after shot and still present today 4/11/2021 but refusing in size and itch.  Also arm very painful for 3 days after injection from shoulder to elbow.
p/vax pt devel low grade fever; sweats; numbness in arms & legs; h/a; shadowing of vision; knee pain; memory loss; flu symptoms; congestion; tx w/NSAIDS; Follow up 02/07/05: The adverse event originally reported on 11/19/99m rec=iccyrred Hykty-Septermber 2004 with similar symptoms. The patient was diagnosed September 2004 with Fibromyalgia(coded only as 729.90m but much more complex an issue accounting for all the reported events). It is very likely the vaccine kicked off a fibromyalgia flare. She is hypersensitive and reactive to over 50 products, including sulfates which there is one listed in the components in the lymerix vaccine.
Information has been received from a RN concerning an adult (age and gender unk) pt who within the last six months, on an unk date, was vaccinated (route unk) with a 0.5ml dose pneumococcal 23v polysaccharide vaccine (lot650329/0747P). Subsequently, within the last six months on an unspecified date, the pt developed an injection site reaction which included pain, redness, swelling and local heat. Unspecified medical attention was sought. Subsequently, on an unspecified date the pt recovered. No product quality complaint was involved. A lot check has been requested. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill.  Additional information has been requested.
Injection given 8/19/16 in (R) deltoid. 4 x 3 cm. Pustular reaction with induration 14 x 8 cm erythema. Fever.
SLIGHT RUNNY NOSE; ARM ACHE; SLIGHT HEADACHES; This spontaneous report received from a patient concerned a 79-year-old female. The patient's past medical history included lung cancer (the middle lobe of her lung removed), and concurrent conditions included Crohn's disease (her small and large intestines removed), chemo neuropathy, osteoarthritis. Allergies to NSAIDS, oxycontin, and gabapentin. The patient previously received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 213O21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 16-JUN-2021 to right arm for prophylactic vaccination (Dose number in series 1). The patient experienced arm ache with covid-19 vaccine (dose number in series 1). The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-DEC-2021 to right arm for prophylactic vaccination (Dose number in series 2). Concomitant medications included paracetamol for chemo neuropathy, tramadol for chemo neuropathy, ergocalciferol for unknown indication, metoprolol for unknown indication, and pyridoxine hydrochloride for unknown indication. The patient was on oxygen therapy for unknown indication at the time of vaccination. On an unspecified date in DEC-2021 after her booster dose, the patient experienced runny nose, arm ache (right arm but the ache somehow got to her left arm), and slight headache (dose number in series 2). The action taken with covid-19 vaccine was not applicable. The patient recovered from arm ache (also reported as unknown), and slight headache (also reported as unknown), and the outcome of runny nose was unknown. This report was non-serious. This case, involving the same patient is linked to 20211244413.
reported to school nurse on 3/16/21 @ 0900 with "crawling" and itching. Nurse also noted patient to have erythema to upper chest and arms bilaterally. Patient then reported febrile, chills, body aches and sweating on 3/16/21 @ 23:00 and missed work on 3/17/21 due to symptoms. Patient received Benadryl 25 mg 1 tab every 4 hours while at work (09:00 & 13:00), then took Aleve and Tylenol at home for other symptoms (unsure of dosage and frequency)
Lip and tongue swelling, rash over whole body, flushing especially over face and ears. Also, new rash over left arm, some shortness of breath.
Had the moderns vaccine dose 1 april 21, 2021, only had a sore arm for about 2 days after. Around April 29, 2021 a big red perfect circle had formed around it, it is really tender and is sore. I'm just trying to make sure I do not need to go to the doctor or the hospital.  Thanks.
Labored breathing, almost blacked out (I quite possibly did, for a minute or 2), very low BP.
This spontaneous report from a contactable lawyer who reported for herself. This 26-year-old female patient received the first single dose of TRUMENBA intramuscular in the left arm on 28APR2015. The patient medical history was not reported, there were no concomitant medications. The patient experienced sore arm at the injection site on 28APR2015. The patient mentioned that she did not consult her physician and she did  not undergo any laboratory work due to the event. She further mentioned that the event was still ongoing. Follow-up (04JUNE2015): Follow-up attempts completed. No further information expected.
Patient was seated for waiting period after receiving the vaccine. After about 10-15 min  when she got up to approach the counter she went down in from of the register and may have bumped her head.  She stated she felt light headed and a little anxious prior.  9-1-1 was called.  Paramedics examined her and left.  She remained seated for a while longer and left on her own accord.
Rapid pulse, complete weakness on the right side of my body, unable to stand, difficulty gripping objects, chest pains
Severe vomiting, diarrhea, stomach pain.  Trouble breathing... shaking like a seizure.