chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; The online tool showed the expiration date to be 3/12/2023 Vaccine administration on 15-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The online tool showed the expiration date to be 3/12/2023 Vaccine administration on 15-MAR-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The online tool showed the expiration date to be 3/12/2023 Vaccine administration on 15-MAR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The online tool showed the expiration date to be 3/12/2023 Vaccine administration on 15-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The online tool showed the expiration date to be 3/12/2023 Vaccine administration on 15-MAR-2023).    No concomitant medication were reported. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2023: Live non significant follow up received
This case was reported by a consumer and described the occurrence of dermatomyositis in a 44-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 25 April 2006 at 12:00 the subject received 1st dose of ENGERIX B (20 mcg, unknown route, left arm). On 26 April 2006, 1 day after vaccination with ENGERIX B, the subject experienced flu-like symptoms. He sought medical attention at a doctor's office. Approximately 2 years after vaccination with ENGERIX B, in December 2008, the subject was diagnosed with dermatomyositis. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved. The vaccination course with ENGERIX B was discontinued. The consumer reported that he was told by physicians that dermatomyositis is sometimes associated with hepatitis B vaccinations.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, unspecified number of patients were vaccinated with MMR II (lot# unspecified) (dose, frequency and route were not reported) which were exposed to temperature range:-0.7C Time frame: 15 minutes Temperature Range:-0.5C Time frame: 15 minutes. No adverse effects were reported. No concomitant medications were reported. No adverse events or Product quality issue (PQC) were reported. This case is linked to case # 1401USA000286, 1401USA000288, 1312USA011848, 1402USA010745, 1402USA010746 and 1402USA010747 (same reporter link). Additional information in not expected.
Strong body aches; Headache; Slight sore arm; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9267) via an unspecified route of administration in the right arm on 22Feb2021 at 14:45 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, arthritis, gastroesophageal reflux disease (GERD), high cholesterol and penicillin allergy (PCN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), vitamin (MANUFACTURER UNKNOWN) and esomeprazole magnesium (NEXIUM); all unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021, the next AM, the patient experienced a slight sore arm. On 26Feb2021 at 03:00, Thursday night the patient woke up with strong body aches and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight sore arm and strong body aches was resolved on an unknown date in 2021 while that of the event headache was resolved on 01Mar2021, after the duration of 3 days.  No follow-up attempts are needed. No further information is expected.
Narrative:  1/13/23 at 17:09 - Pt presented to ED with left chest pressure, productive cough, and congestion x 1 week. Pt also reporting 5 days of malaise, intermittent chills, some wheezing, some runny nose, and postnasal drip. Pt tested COVID positive while in ED. Differential diagnosis includes occult coronary syndrome pneumonia COVID-19 Troponin unremarkable EKG shows A. fib which is chronic in nature no STEMI BNP slightly elevated at 336 creatinine normal Elevated CPK Sodium low at 128 most likely due to dehydration Lab COVID-19 positive Chest x-ray shows right lung pneumonia While in ED, Pt received now dose of oxymetazoline nasal spray, Solumedrol 125mg IVP, albuterol inhalation, guaifenesin 400mg, ceftriaxone 1 gm IV and now dose of azithromycin 500mg IV. Pt admitted 1/13 for community-acquired pneumonia and remained inpatient until 1/16/23. Pt admitted to medical floor d/t COVID+ diagnosis and CXR revealed RLL pneumonia - multiple comorbid conditions and concern for respiratory decompensation. Principal diagnosis (reason for admission after study) = Acute community acquired bacterial pneumonia of the right lower lobe. Additional diagnosis included: COVID, chronic afib/a-flutter, ulcerative colitis, Type II DM with hyperglycemia. depression/insomnia, constipation, elevated CPK, and IDA. HOSPITAL COURSE: Patient admitted to SDU for initial treatment of acute bacterial community acquired pneumonia. Patient responded well to IV ceftriaxone and azithromycin for 3 days. Patient did not meet inpatient criteria for the treatment of Covid 19. At the time of discharge URI symptoms that patient had presented with had improved. Patient was subsequently discharged with a 10 day course of doxycycline and was instructed to follow up with his pcp in 1-2 weeks. return to the ED for any worsening shortness of breath, chest pain, orthopnea, swelling or near syncope.
At the injection site, there is pain, warmth, swelling, redness, itching.
Right leg hard, redness, swollen. Cried for 4 hors after injection.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's current condition and medical history was not provided. On 27-APR-2016 the patient was vaccinated with ZOSTAVAX (vial, dosing regimen unspecified) lot # K020801, expiry date-31-JAN-2016. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two reports from the same reporter. Additional information is not expected as the reporter did not wish any further contact.
patient complained of tenderness on opposite deltoid(Left) from where the injection was given.  Pain does not radiate down to arm.  She was not having any shortness of breath or an rash at site or any discoloration.  Nurse states patient was nervous prior to vaccine.  Patient had great finger gripping.  Vital signs were 131/84, Pulse-79, respirations-18 and Pulse ox-98%. Dr. assessed patient and patient was observed and released from clinic in stable condition.
A report has been received from a Physician concerning a Child, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced BLOODY NOSE which started on 03-Sep-2012. The reporter explained the child was worked up prior to receiving FLUMIST and the nose bleed occurred prior to the child getting FLUMIST. The outcome of the event of BLOODY NOSE is unknown. The report was considered to be non-serious by the reporter. Summary of follow up of information received by AstraZeneca/MedImmune 21-Sep-2012: The case become non valid as the event of bloody nose occurred prior to receiving FLUMIST.
Fever, chills, shaking, shivering, debilitating headache, nausea from 1am til about 7pm, then slight fever and headache, then just headach now 36 hours later.
Fever; Chills; soreness; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and PAIN (soreness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and PAIN (soreness). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and PAIN (soreness) outcome was unknown.        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.
REDNESS AROUND BOTH EYES; SWELLING AROUND BOTH EYES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included some seasonal allergies, and dust allergies, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced redness around both eyes. On 09-MAR-2021, the subject experienced swelling around both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the redness around both eyes and swelling around both eyes was not reported. This report was non-serious.
Nausea and vomiting; Nausea and vomiting; severe muscle pain; Fatigue; Severe Diarrhea; Hot Flushes; Chills; A spontaneous report was received from a consumer, concerning a 33 year old female patient who was participating in the mRNA-1273 Emergency Use Program and developed diarrhea, hot flushes, chills, muscle pain, fatigue, nausea, and vomiting   The patient's medical history and relevant concomitant medications were not reported.   On 03 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025I20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced severe diarrhea, hot flushes, and chills on 06 Jan 2021.  On 07 Jan 2021 she experienced muscle pain and fatigue.  On 08 Jan 2021 she felt nauseous and experienced vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events diarrhea, hot flushes, chills, muscle pain, fatigue, nausea, and vomiting were not reported.; 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 describes severe burning at the time of injection, severe pain immediately following the injection and for 5 days following injection. Also describes metallic taste in mouth almost immediately followed by a sore throat. Fever, chills, extreme sweats, nausea, dizzy spells, and headache also reported.  Patient states could not move arm for 5 days following vaccination. Also reports that symptoms were so severe she was in bed for 4 days.
Information has been received from a physician concerning a teenage female who within the last year was vaccinated with a dose of GARDASIL vaccine. Concomitant therapy included tetanus toxoid (manufacturer unspecified). Two to three months later the patient she had symptoms of numbness and after MRI demyelinating lesions were discovered. Additional information is not expected.
She stopped sleeping through the night immediately following her vaccinations.  She started waking up multiple times a night screaming every single night.  This went on nightly until she was treated for the vaccine injury.  She also developed eczema, sensory processing disorder, a speech delay, difficulty with emotional regulation, and the inability to sit still and focus.    Since we had no idea her issues were being caused by her body's inability to detox the heavy metals in the vaccines she received, she went on to receive 4 doses of both the DTaP and HIB vaccines.  When she was 3.5, we did a heavy metal detox with her under the supervision of her medical provider.  Two week into the detox, all of her above-mentioned symptoms disappeared completely overnight.  She currently has markers of dyslexia and other learning challenges, and it is unclear to us whether or not these things are lingering effects of her vaccine injury.
11/14/02 pt c/o upper pain, upper edema, limited ROm to L arm after receiving pneumonia vaccination 11/13/02. Pt advised to call MD apply warm clothes to affected area and elevate extremity. 11/15/02 pt now c/o redness to area. She saw MD 11/15/02 and wasput on Cepro.
One week after injection, injection site became red again & feels hard to the touch. Slight tenderness.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. NO ADVERSE REACTIONS REPORTED.
I experienced soreness and a extremely large bruise, itching and a rash. I took a picture of it and sent it to my doctor the next and was placed on Zinc along with Claritin. During meeting, she asked that I meet with her again if the hives (rash) did not go away within a week along with the bruise; however, the soreness lasted a bit longer. She told me that my Mast Cell Disease reacted to the vaccine but not to be concerned with it unless my breathing was erratic. After a month to six weeks it subsided.
About 48 hours after shot: sore, swollen lymph nodes, also stabbing pains in the lymph nodes (neck, armpits, left side of chest and groin); About 48 hours after shot: sore, swollen lymph nodes, also stabbing pains in the lymph nodes (neck, armpits, left side of chest and groin); About 24 hours after shot: swollen hands and feet but was gone by the second morning; The morning after: some joint pain, severe pain in spine but only lasted a couple of hours; The morning after: some joint pain, severe pain in spine but only lasted a couple of hours; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 10Apr2021 at 13:15 (Lot Number: EW0150), at the age of 52-year-old, as a single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included heart pounding/palpitations and migraine. The patient did not have any allergies to food, medications, or other products. Concomitant medications included propranolol, iron, ibuprofen, and unspecified multivitamin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 06:30, the morning after, patient experienced some joint pain, severe pain in spine but only lasted a couple of hours. On 11Apr2021 at 13:15, about 24 hours after the shot, the patient experienced swollen hands and feet but was gone by the second morning. On 12Apr2021 at 13:15, about 48 hours after shot, the patient experienced sore, swollen lymph nodes, also stabbing pains in the lymph nodes (neck, armpits, left side of chest and groin). Therapeutic measures were taken as a result of some joint pain and severe pain in spine and included treatment with TYLENOL. No treatment was received for other events (swollen hands and feet; sore/stabbing pains in lymph nodes and swollen lymph nodes). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events some joint pain and severe pain in spine was recovered on 11Apr2021 (unspecified time). The clinical outcome of the event swollen hands and feet but was gone by the second morning was recovered on 12Apr2021. The clinical outcome of the events sore, swollen lymph nodes, also stabbing pains in the lymph nodes (neck, armpits, left side of chest and groin) was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt concerned about mild headache, chills, and fatigue after first dose of covid vaccine yesterday afternoon. Denies pain at injection site L. Deltoid. Denies NVD. States he feels a little dizzy when he stands. Denies chest pain or shortness of breathe.
Dizziness/nausea when sitting & standing so far going on 5 hours.   Does not change with eating or drinking water.
~18hr after vaccine: pain, swelling , stiffness, inflammation, and limited motion of left hand and wrist; D/C lipitor, hold allopurinol 2 weeks after vaccine: Sx persistent: restart allopurinol, continue indocin. 3 weeks after vaccine: Sx persistent; Levaquin 500mg 1QD.
This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 02-SEP-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported);  On 05-JAN-2017, the patient was vaccinated with a second dose of RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported); On 31-MAY-2017, the patient was vaccinated with a third dose of RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported); On 05-SEP-2017, the patient was vaccinated with a fourth dose of RECOMBIVAX HB for prophylaxis, lot number M042322  and expiration date 21-FEB-2017 (dose and route of administration were not reported). No adverse effects were reported.
pt recvd vax & t 100.9; pt devel red face & hives on arms, back & chest;
She started tilting her head to left (torticollis) in the afternoon after the vaccine (vaccine was in the morning). It progressed where it became more consistent that she was tilting her head. No know injury. She saw physical therapy and did stretching exercises which led to resolution of the torticollis over several weeks.
Case number PHEH2013US006415 is an initial spontaneous report received from a consumer (patient's mother) who is also a healthcare professional on 18 Mar 2013. This report refers to a 12 year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: not reported) on an unspecified date. Three days after vaccination, she developed paralytic ileus. The event outcome, seriousness and causality were not reported.
Swelling at injection site two days after vaccines / no itching. Treated with cephalexin 500 mg tabs 1 tab QID. Diagnosed with cellulitis.
3 days of Fussiness, Tired, Loss of Appetite, Slightly Vomiting and Occasionally arm jerking when falling asleep.
Body and joint aches, exhaustion, abdominal pain, particularly on left side, restless and amped up, and foggy headed. Abdominal pain resolved 48 hours post injection. Pain and pressure in ears, tinnitus, dry eyes.  Unresolved: Exhaustion, Restlessness, foggy headed, pain and pressure in head and ears, tinnitus, body and joint aches, dry eyes 2 weeks post second dose.
Severe joint pain all over especially overnight the night of vaccine and becoming more mild after about 10 AM the next morning. Then mild joint aches on and off for 4 days.
Fully vaccinated, not boosted.  COVID infection breakthrough with inpatient hospital stay on a general medical unit.
Immediately p/receiving OPV/TD/MMR pt said did not feel well; pt sat down in chair; Pt collapsed, was pale, cold & clammy; had no B/P;
19 yo female received COVID Vaccines at 0930, reported to Primary care around 1200 pm with pruritus, erythema and warmth on upper extremities, chest and back.  Airway intact, Lungs CTA bilar, NEURO WNL, VS wnl.  Will tx for mild allergic reaction,  Educated on Anaphylaxis protocol. SM v/u
Psoriasis lesions have developed on both of my lower legs, several places on both arms, down the middle of my back, and on the back of my neck. Three different dermatologists have not been able to give any relief.  The health care professional I am seeing now has done GI Map testing to see if she could find what could be treated.  (I am trying to get reimbursed for the expensive testing from Medicare.) I am now taking eight different supplements to the tune of hundreds of dollars.  So far, there is no relief.
Patient appeared pale, sweating, and complained of dizziness presenting within 5 minutes of vaccination during the recommended observation time. Patient was given a cold cloth around the back of his neck and his blood pressure was taken and it was 82/58.  Patients O2 sat was 98 and pulse was 78. Patient stated that he was allergic to nuts. We asked if he had eaten breakfast this morning and he stated that he had a bowl of cereal. I instructed for someone to have him sit on the ground and to get him some candy  and a sugary drink.  A package of skittles was presented along with a Mountain Dew.  After finishing both the candy and Mountain Dew  (aprox 4 mins) the patient started to get a little color back and he stated he was feeling much better.  A second set of vitals was then taken which were  BP: 106/78 the O2 sat 98 and Heart rate was again at 78.  We instructed the patient to please hang around for 30 more minutes and after that time left with the person he was with.
Child given 3 vaccines (1st doses). Before shots given, cried hard and turned slightly cyanotic with breath holding; fine after. Given shots one at a time and did well. MD walked into room, 5 minutes later and child looked pale, face and extremities. Pulse and heart sounds strong with normal rate and rhythm. Kept him flat. Was alert and no distress. At one point cried hard and held breath and was cyanotic. Cyanosis resolved quickly but pallor lasted 20 minutes, then looked well. Sent home, followed by phone and was fine.
Pt vaccinated with DTP parent described rx as red, raised area about 4 X 2 with 2 tails extending several inches longer that lasted 3 days
4/29 evening - shivers, chills 4/30 all day fever 100.8 fatigue foggy brain headache 5/1  runny nose, sneezing, watery eyes,  fatigue, headache, foggy brain 5/2  non stop runny nose, right eye lid swollen, fatigue
Patient experienced a rash breakout in various areas on body-mainly  concentrated on chest and arms- it was itching and very red per patient. The itch was intense. Patient did not take any medication initially. Eight days later patient experienced another breakout all over body but it was not itching just red with bumps all over. Patient said even her eyes were red.  Patient took OTC Benadryl to alleviate symptoms. She visited a doctor on 2/10/21 and was advised by MD to not get the 2nd dose that she had scheduled because the symptoms may be worse.