chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the authors in a published literature article, regarding a 41-year-old male patient who presented a clinic for an evaluation of recurrent sinus infections (for the past 30 years), septic thrombophlebitis of the right internal jugular vein and multiple periodontal abscesses. He reported having had 4 episodes of bacterial sinusitis in the last year requiring extended course of antibiotics, 2 episodes of hand, foot and mouth disease and 1 hospitalization for pneumonia. Laboratory evaluation revealed low IgG, normal IgG, CD3 and CD4 lymphopenia and nonprotective pneumococcal titers following immunization with PNEUMOVAX 23 (route, dosage and lot number unknown). The patient complained of headaches, episodic dyspnea, right sided facial pressure, postnasal drip and nasal congestion. He denied having fever or chills, chest tightness, cough, wheezes or skin rashes. A physical examination including his vital signs and spirometry were normal. Significant findings included low IgM, a poor pneumococcal polysaccharide antibody response to 1 of 23 serotypes after PNEUMOVAX 23, 5 of 14 serotypes after PREVNAR vaccination and low numbers of CD3+ and CD4+ T cells. White blood cell count: 4.3 10000/micro-l Lymphocyte count: 0.79 1000/micro-l. Bone marrow biopsy was negative for malignancy. Because of a poor post vaccination polysaccharide antibody response, intravenous immunoglobulin (IVIG) replacement therapy was initiated. Due to debilitating headaches following the IVIG infusions, the patient was transitioned to subcutaneous gamma globulin. With subcutaneous immunoglobulin replacement, he reported a significant improvement in the frequency of infections. Initial immunological work-up demonstrated a low IgM level with low-to-normal IgG and IgA levels. The patient has been followed with subsequent lab studies to ensure these values continue to remain in the normal range. It was unknown if the patient recovered from his poor pneumococcal polysaccharide antibody response. Additional information has been requested.
Patient reported a drop in heart during the 15 minute monitoring period. heart palpitation, fatigue, headache. Symptoms are continuing to this day. Was seen at Hospital Ed, and again on Friday at the ED.
A literature report was received on 13Jun01, concerning a 70 year old male pt who experienced giant cell arteritis which led to hospitalization immediately after receiving influenza vaccine on an unk date. On an unk date, the pt developed a common cold with headache which he was able to relieve with aspirin. Despite this infection he was vaccinated against influenza 5 days after the onset of symptoms. Immediately after vaccination he developed a newly located severe headache, fever, facial oedema and high blood pressure. Ten days after vaccination, his headache became so severe that he had to be hospitalized. Initially, only chemosis and facial oedema were found. The C-reactive protein level was 29.5 mg/dL (reference value, less than 1 mg/dL). His headache was relieved with opiates, but antibiotics were ineffective. On the third day of hospitalization, he also developed blurred vision, proptosis, pain on eye movements, and weakness of the right upper limb. Magnetic sodium (1000 IU/d) was begun. On the fifth day of hospitalization, the pt developed proptosis and chemosis of the right eye, bilateral ptosis, spontaneous nystagmus, weakness of the right abducens muscle, ad peripheral facial palsy on the right side, and his visual acuity further deteriorated. The C-reactive protein level further increased, and levels of thrombocytes and immunoglobulins were elevated in samples of serum and cerebrospinal fluid. The blood sedimentation rate was 94/92 mm/h. Cerebral angiography on the eleventh day of hospitalization revealed recanalized carvernous sinus thrombosis and tortuous temporal arteries, which, along with the clinical and laboratory findings, led the physician to the suspicion of arteritis temporalis. Giant cell arteritis was confirmed by the temporal artery biopsy findings. Overall 4 of the 5 criteria were fulfilled. Treatment with antibiotics and heparin was discontinued. Corticosteroid therapy was initiated and relieved all the described abnormalities during the following days. The pt's recovery was almost complete. All previous serological abnormalities had normalized. Only slight weakness of the right upper extremity persisted.  The reporter had assessed the relationship of the influenza vaccine to the event as likely. That the common preceding vaccination contributed to the GCA was also stated to be quite likely. The physician stated that it can not be definitely excluded that the influenza-like symptoms at the onset were already the initial manifestation of GCA. The physician stated that the GCA was responsible for most of the abnormal findings although it could not be definitely excluded that facial nerve palsy and plexopathy were due to the initial vial infection before the vaccination. Impaired visual acuity, bilateral ptosis, abducens paresis, proptosis and facial oedema were assumed to have been caused by the carvernous sinus thrombosis.
neck pain; second dose was on 3/24/2021; swollen lymph nodes / flare up; tired/ super tired; did not feel good; Achy / body aches; fever; headache; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 24th March 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 24th March 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after receiving Bexsero, the patient experienced enlargement of lymph nodes, tiredness, feeling unwell, general body pain, fever, headache and drug dose administration interval too short. On 2nd April 2021, the patient experienced neck pain. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the enlargement of lymph nodes, tiredness, feeling unwell, general body pain, fever, headache and neck pain were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, tiredness, feeling unwell, general body pain, fever, headache and neck pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the mother of the patient. The patient received 2nd dose of Bexsero, before than the recommended interval, which led to shortening of vaccination schedule. The patient received his 2nd dose of Bexsero and the night of the vaccination he was achy, tired and had a headache, had swollen lymph nodes and fever with body aches. The patient did not feel good and this event resolved within a couple of days. On 25th March 2021, the patient had a little fever and on 29th March 2021, the patient was still super tired. On 2nd April 2021, 9 days after vaccination, the patient experienced a flare up and his lymph nodes in his neck were swollen.  The neck pain and tired feeling lasted for a day or two and then he was fine.   All of his symptoms have since resolved. The reporter consented to follow up. For tolerance after 1st dose refer case US2021AMR100254.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100254:same reporter
Receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired doses). On 04-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medications were provided.  The vial was initially stored in the refrigerator on 03 Feb 2022 at 3 PM.  The vial did not undergo any temperature excursions.  Reporter wanted to knowthe next steps for correcting the medication error and asked whether she should revaccinate the patients.  Reporter asked  information regarding validity of the doses.
Yellow skin; Flu-like symptoms; She had body aches and a low grade; Itching; Hives; normal not feeling well; This is a spontaneous report from a contactable consumer (patient reported for herself). A 52-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Deltoid Right on 07Feb2021 around 13:00 (at the age of 52-years-old), as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family Medical History Relevant to AE(s) was none. Patient Medical History (including any illness at time of vaccination) was none. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in right shoulder on an unspecified date in Jan2021 (three Sundays prior to the second dose) around 2:30pm (at the age of 52-years-old), as single for covid-19 immunisation and within a few hours of vaccination she experienced itching and hives which she thought it was dry skin. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No Prior Vaccinations (within 4 weeks) first COVID vaccine. AE(s) following prior vaccinations were none. On 07Feb2021, within a couple hours of getting the shot, she started experienced itching and hives, flu-like symptoms and body aches and a low grade on 08Feb2021. She experienced yellow skin on 09Feb2021 and had the normal not feeling well on an unspecified date in Feb2021. The clinical course of the events as follows: She reported that she got hives all over, itched really bad and turned yellow after the second dose. It was noted that she also had the normal not feeling well and flu like symptoms. The caller does not have the card from where she got the vaccine, the (Facility name) has that information. She explained the flu like symptoms started the next day and she did not feel good. She had body aches and a low grade, this was on 08Feb2021, though it was what she expected, and she still went to work. At this point she was not 100 percent but was better. She described the hives as a cluster rash on parts of her body. She stated they were all gone now. The yellowing of the skin started on 09Feb2021 and which lasted for like 24 hours and was now gone. She was yellow and wanted to know what was going on with that, she would like more information on this side effect. Treatment: she took an allergy pill to treat the events but did nothing for the flu like symptoms. AE(s) did not require a visit to Emergency Room and Physician Office. Relevant Tests were none. The patient recovered from the event Itching on an unspecified date in 2021, resolved from Hives and Yellow skin on 10Feb2021. The outcome of the event Flu-like symptoms was resolving, and the outcome of other events was unknown at the time of this report.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
I had an extreme sudden onset of GERD acid reflux. Symptoms include runny nose, ear pain, vomiting, lump in throat, and acid regurgitation. Symptoms are  still existing.
1st shot (3/11/21) - headache, muscle aches, shortness of breath, fatigue, began the day after the shot and are still ongoing, using over-the-counter medications - ibuprofen and acetominaphen 2nd Shot (4/1/21) - Same symptoms but the headache, muscle aches and shortness of breath are much worse.  Still using OTC medications.
Pt stated that the AM after receiving the flu vac, her arm was "red, hot, swollen, and itching a little".  By the next AM, arm was "less swollen and not as bright red".  Pt stated that she "never had any discomfort" at the site.  Nurse recommended that she apply an ice pack and take some Tylenol or Advil to reduce the redness and swelling further.
Patient received Moderna vaccine from outside facility (unknown) and was seen in the emergency center for hypertension/a fib. Discharged the next day in stable condition. No information regarding vaccination other than date.
This infant had red, swollen skin wheal at the site of the injection, on the left thigh. No fever.
Severe chest pain, difficulty breathing Hospitalized for 24 hours EKG, troponin, ddimer, stress test, CT scan
Started menstrual period early with severe cramps unable to be managed with ibuprofen (rarely have severe cramps and usually easily managed with ibuprofen). I also had severe low back and pelvic pain that moved down my legs for 2 days. Bleeding is heavier than usual.
Fever and swelling of right upper arm 6/13, increase redness and pain, felt weakness on 6/14 on 6/15 seen by MD, temp 100.3, redness and induration 4 x 5cm right upper arm.
Within 30 minutes her right arm burned to finger tips, arm became reddish purple, fingers began to tingle.  Day 2:  headache, nausea, extreme anxiety while watching TV, woke in middle of the night with feeling on something crawling over legs, and chills like was in ice water.  Day 3:  extreme feeling of anxiety  throughout the day, pins and needle tingling in hands and feet up to middle of calves, nausea, weakness in thighs, woke up three times during the night with feeling of something crawling over legs, headache.  Day 4:  pins and needles feeling in hands and feet up to middle of calves, anxiety, feeling of racing heart, headache.  Day 5:  headache, nausea, tingling in hands, up to elbow left arm and feet up to middle of calves, tremor in left hand, weakness in thighs hard to climb stairs, woke with left eye swollen to slit, blurred vision left eye, eyes, burned all day even with eye drops, chest pain 4 separate times.  Day 6:  woke with swollen left eye, headache, tingling in hands and feet up to middle of calves, weak thighs, hard time pushing obese patient to car in wheelchair, numbness in  left side of face, smile intact, blurred vision left eye.  Day 7 - Day 13:  still experiencing headache, left eye blurred vision, left hand and foot tingling, but progressively better.
Information has been received from a physician concerning his 16 year old daughter with no pertinent medical history and no known drug allergies who on 30-JUN-2009 was vaccinated IM with a first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. On 14-SEP-2009 the patient experienced severe, crampy, intermittent left upper abdominal quadrant pain. On 19-SEP-2009 the patient was admitted to hospital. Blood work, computed axial tomography (CT) scan, and abdominal magnetic resonance imaging (MRI) were normal. The test results on the patient came back as positive for Epstein Barr virus. The patient received pain management with hydrocodone and intravenous morphine. The patient was discharged on 20-SEP-2009. At the time of the report, the patient had not recovered. Severe, crampy, intermittent left upper abdominal quadrant pain and positive for epstein barr virus were considered to be disabling. Additional information has been requested.
Dry mouth; My tongue is stuck to the roof of my mouth; I feel like it did something to me/ I am really afraid/ terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Lot number: EW0153) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESTRADIOL. Vaccination history included: Bnt162b2 (Dose 1, Lot number: ER8730, Anatomical location: Left arm), administration date: Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: DRY MOUTH (non-serious) with onset 2021, outcome "unknown", described as "Dry mouth"; TONGUE DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "My tongue is stuck to the roof of my mouth"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I feel like it did something to me/ I am really afraid/ terrible". The events "dry mouth", "my tongue is stuck to the roof of my mouth" and "i feel like it did something to me/ i am really afraid/ terrible" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dry mouth, tongue discomfort, feeling abnormal.  Additional information: The facility where the most recent COVID-19 vaccine was administered was Pharmacy. The patient had got three COVID vaccines Pfizer. The first two, she went on same Friday and the third, she went on different Friday. She got one in Mar2021, one in Apr2021 and then she got one on 10Dec2021 and sometime after the second one she had developed dry mouth and she thought it might be related to the vaccine. The patient thought that she had developed dry mouth from the vaccine and she didn't know what to do with it and if it was going to be permanent or not permanent. She was really afraid if this was going to be permanent than she was damaged, she was afraid and she felt like it did something to her. The patient went to the dentist because her mouth was terribly dry and she tried dry mouth does not help. The mouth dryness was in the middle of the night, like she woke up and her tongue was stuck to the roof of her mouth, terrible it was just terrible and than her mouth was dry but not as bad as day. It was really bad and mean time, she was afraid her teeth didn't fall out because her mouth was so dry. She never had this, never ever. She called her pharmacist. She went to see her dentist. She had tried the only thing, she tried was the toothpaste.  No follow-up attempts are possible. No further information is expected.
Pt developed hives on arms, face, neck, torso, legs about 3 hours following the vaccine administration. She reported to Urgent Care in the community for evaluation/treatment
Patient accidently received an expired dose of vaccine.  Expiration date 1/30/2023.  Contacted GSK who advised to administer 2 additional doses of Hepatitis A as they cannot guarantee effectiveness of the dose administered today.  Patient will come back in to have 2 additional Hepatitis A vaccines administered based on vaccine schedule.
Gave Pfizer COVID 6m-4yrs instead of Moderna COVID 6m-5yrs
severe pain in the arm that was vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "severe pain in the arm that was vaccinated".  Additional information: Patient had covid vaccines for over a year and am still struggling with severe pain in the arm that was vaccinated. The pain was chronic and runs up and down the left arm up to the neck and shoulder. Primary doctors won't do much.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/30/2023 URGE INCONTINENCE
Pelvic pain during intercourse  that started about 6 weeks after receiving vaccine. Heavy  menstruation with much more painful cramps than usual even though I have been taking the birth control pill for months.  This was is very unusual while on the BC pill, periods are usually light and nearly cramp free.  I saw my Gynecologist on 1/19 and she performed an exam and ordered a pelvic ultrasound that showed no significant structural abnormalities. No other explanation  for the pain has been found.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with none drug reaction/allergies. On approximately 17-SEP-2013, about a week ago, the patient was vaccinated with a dose of ZOSTAVAX dose, route and lot # not reported. In September 2013 the patient experienced an injection site reaction that was red and 3 to 4 inches in diameter. The pharmacist stated that the patient reported that she started to feel tingling around her mid back, which within 24  hours became a unilateral tingling and burning on the patient's left side. The patient had not developed a rash at this time. The patient had not yet seen her physician. There was none treatment given and no lab diagnostics studies were performed. The outcome of adverse events was unknown. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Tuesday March 2nd, Swollen arm with a raised rash (my arm was the size of a softball) rash went almost the to my elbow. I had cold chills (ran no fever),  dizzy, light headed, woozy, runny nose, eyes ached, head ached, muscle on left side of my neck sore also my gland under my jaw hurt, I was so tired and as the day went on I felt worse . When I went to bed, it felt like I had a softball size knot under my skim in between my arm pit and under arm (left side). There was a short time with my asthma, used my inhaler and it seemed to help. Wednesday March 3rd, Woke up and I was woozy all day and just didn't feel right. I did not feel as bad as the day or evening  before, just tired. My left arm still swollen and rash. Not at all the systems the day before.  Thursday March 4th, I just didn't feel right. My left arm still swollen with the rash. I felt so much better than the 2 days before. Friday March 5th back to almost normal. Swelling had went down some but still had the rash. Saturday March 6th I felt normal, My left arm swelling went back down and still had a rash. Sunday March 7th  swelling gone and I just have a small amount of rash on the sides of my left arm.
Patient developed urticaria on face and scalp. No angioedema, wheeze, SOB, cough, flushing, or n/v/d. Pt did have slight sore throat and nasal congestion starting ~6 hours after recieving vaccine (intranasal H1N1). Urticaria treated with Claritin 10mg and resolved completely within 12 hours with no further sx noted.
Approximately 2 minutes after injection, felt flushed and tingly. This subsided, but developed a cough. Felt fine enough to leave the vaccination area after being monitored for 15 minutes. Cough continued, and developed a scratchy throat that eventually led to swelling of the throat at approximately 30-35 mins post administration. Sought care in the ED, where I was tachycardic and hypertensive. Received IV Benadryl, steroids, and IV fluids. Discharged home, but symptoms returned around 2pm. Sought care in a different ED, where I remained hypertensive and tachycardic. Received additional IV fluids, IV Benadryl and steroids. Eventually was treated with IM epinephrine after my heart rate was decreased to about 100bpm with IV metoprolol.
severe diarrhea for 1 1/2 days -- no treatment other than rest and fluids