chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported and described the occurrence of mild ulcerative colitis in a 52-year-old female subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified). The subject had been passing bloody mucus intermittently for 3 years before a diagnosis of ulcerative proctitis was made at colonoscopy. She improved on sulfasalazine and hydrocortisone enemas, but after stopping medication the subject had recurrent rectal bleeding and coincident uveitis. She was then treated with oral prednisone and the sulfasalazine was restarted. The sigmoidoscopy showed more extensive friability and exudate and the subject was hospitalized for intravenous hydrocortisone. The subject was also started on Mercaptopurine (6-mercaptopurine) at 50mg/day. She improved quickly and was discharged on sulfasalazine, tapering doses of prednisone, and an increase in 6-mercaptopurine to 100mg./day. The sigmoidoscopic appearance had been normal for 4 months when symptoms worsened, with loosening of the stools and reappearance of blood per rectum. On flexible sigmoidmoidoscopy, mucosal friability and edema were again found in rectum and rectosigmoid. The subject stated that her exacerbation had followed an Influenza vaccine shot. After 3 more months on 6-mercaptopurine during which the dose was reduced to 50mg/day because of leukopenia, the subject was much improved, having formed stools with normal mucosa throughout at colonoscopy. After 9 months on 6-mercaptopurine, the subject was in remission. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. After the next vaccination with Influenza vaccine the events recurred. The reporter considered the events were almost certainly related to vaccination with Influenza vaccine. Please refer to case B0589174B for adverse events following the next vaccination with Influenza vaccine.
Fever rash on left arm.  Advil for fever.    Nothing done cor rash
7/13/21: 1ST VACCINE SHOT AT 9AM; PAIN AT INJECTION SITE 9:10AM; SWELLING 9:30AM; INCREASE FEVER AND SWELLING WITH FIRM HARDNESS ALONG ENTIRE LATERAL- POSTERIOR RIGHT HUMERUS FOR 6 HOURS.  8/3/21: 2ND VACCINE SHOT AT 10:30AM;  PAIN AT INJECTION SITE 10:40AM; SWELLING AND HARDNESS AT INJECTION SITE 11AM; PAIN AND SWELLING AT INJECTION SITE FOR 5 DAYS STRAIGHT BUT NO FIRM HARDNESS.
Weekend of 9-3-21 felt overly tired.  Eye's started to become red and bloodshot.  Throat starting to become sore and hurt slightly to swallow.   9-8-21: Feeling exhausted and sinus's starting to hurt.  Overall not feeling well. Throat continuing to hurt and feel's like burning -sensation at times. Start to have dry/non-productive cough during the night and occasionally during the day.  Begin taking 60mg -Pseudoephedrine HCL 4x's / day along with 400mg Guaifenesin 4x's /day.  Gargle with warm salt water 2-3x's per day.  9-13-21: Wake up to discharge in left eye that progressively becomes worse throughout the day.  Still feeling tired and throat sore and dry cough.  Schedule visit to Immediate care.  9-30-21 Visit to Primary Care: Prescribed Predisone 40mg for 5 days and Albuteral Sulfate inhalate
had both your vaccines last year had Covid in Jan and got boosted with your vaccine on 7May and I still got Covid; had both your vaccines last year had Covid in Jan and got boosted with your vaccine on 7May and I still got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 07May2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "had both your vaccines last year had Covid in Jan and got boosted with your vaccine on 7May and I still got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2022) Positive. Subject: Patient Assistance. Customer Verbatim: The patient had both your vaccines last year had Covid in Jan and got boosted with your vaccine on 7May and the patient still got Covid. Took 2 tests and both were positive. The patients only symptom was a little phlegm in his/her throat.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Myocarditis and pericarditis hospitalized in the PICU. Left chest pain starting after booster vaccine for COVID. Treatment , NSAIDs, colchicine and IVIG.
Pt had a vasovagal episode in waiting room. Notes that she did not eat much lunch and had no snack before coming to the office. Has never passed out in the past. Pt fell onto carpet floor, hit her head. Pt with some nausea, but no vomiting and no visual changes. Pt was placed in supine position with knees flexed. Ice to forehead and post neck. Pt was given water to drink once nausea resolved. Pt was transferred to exam table. Dizziness resolved on its own. Pt was able to stand and walk with no dizziness. The next morning, 10/17/09, pt felt nauseous when she stood up out of bed and vomited twice- dry heaves. Felt nauseaous from 8-10 am. Mom gave her mint tea, 11:15 felt nauseaous again. Pt was cautioned on signs and symptoms of dehydration and advised BRAT diet as well as small, frequent sips of electrolyte-rich fluids.
Rash starting 4 days, post vax. Started on head and continued down rest of body over the next couple of days. On 5/22/01, rash resolved. No treatment. Low-grade fever X 2 days. Fever responded to treatment with Tylenol. Parent spoke to MD who referred case to health dept.
Flu injection given at 820 AM. Pt states she developed hives on arms and chest at 1000 AM. Took 2 Benadryl tablets. Feeling better. Rash improved. Per Dr, pt told to take Prednisone 60mg today and call in the AM with update.
3 days later had facial; The night of vaccine was unable to move my entire left side untill next morning and just felt as if got ran over with body aches; The night of vaccine was unable to move my entire left side untill next morning and just felt as if got ran over with body aches. 3days later had facial; This is a spontaneous report from a contactable other hcp reported for herself. A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 15Jan2021 14:00 (at the age of 44-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included none. Had no known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks and in two weeks. No covid prior vaccination and covid was tested post vaccination. The patient experienced the night of vaccine was unable to move her entire left side until next morning and just felt as if got ran over with body aches on 15Jan2021 14:00, 3 days later had facial on 18Jan2021. The patient underwent lab tests and procedures which included covid-19 (Rapid antigen nasal swab): negative on 30Jan2021. No treatment received for AE. Clinical outcome of event was recovered on an unspecified date.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Originally having fatigue, body aches, chills, fever, and decrease appetite for 1-3 days after vaccine.  Now having post menopausal bleeding which is heavy and with cramping and passing blood clots.
A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; chills; mild headache; Tired/fatigue; muscle pain on the arm; joint pain; Feeling nauseated; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain.   The patient's medical history, as provided by the reporter, included prior COVID-19 infection. It is not clear if the patient had prior A-Fib. No relevant concomitant medications were reported.   On 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 25-Jan-2021, patient was feeling fine right after first dose of the Moderna vaccine.  On 26-Jan-2021, the patient felt difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain.  Lab details was not provided by the reporter.  Treatment for the events included rubbing gel.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tired, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
A rash appeared at the site of injection. Patient was advise to use take Benadryl and use hydrocortisone cream.
This 83 year old woman received the 2nd dose of vaccine on 3/24/21 and died early May 2021
extremely dizzy like vertigo; everything was spinning; extremely dizzy like vertigo; everything was spinning; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had first Covid Vaccine on 20Jan2021 and patient didn't have any problems, it was late in the day and then on 22Jan2021 like not even 48 hours later, patient became extremely dizzy like vertigo, everything was spinning and that went on for several days and patient was still dizzy but not as extreme as what patient was and patient read all the papers that if this could be a side effect but patient was just wondering they said if it was really bad then go to emergency and patient didn't think because it got a little bit better each day. Outcome of events was recovering.   information on the LOT/Batch number has been requested.
Swelling in the lymph nodes underneath her arm pit that traveled to her left breast and left side of neck; Rash under the left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in the lymph nodes underneath her arm pit that traveled to her left breast and left side of neck) and RASH (Rash under the left arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced LYMPHADENOPATHY (Swelling in the lymph nodes underneath her arm pit that traveled to her left breast and left side of neck) and RASH (Rash under the left arm). At the time of the report, LYMPHADENOPATHY (Swelling in the lymph nodes underneath her arm pit that traveled to her left breast and left side of neck) had not resolved and RASH (Rash under the left arm) was resolving.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-409831 (Patient Link).
46 year old male - PMH of Asthma and recently being tx for a sore throat and flu like sx and was taking mucinex since May 2nd.   Pt declared an emergency, pt reports chest tightening, throat closing, + dizziness  after covid vaccine this afternoon.+ hives on abd and back,  pt reports sx began right away and progressively got worse. pt was feeling sob on presentation to the clinic. Lungs diminshed throughout received 50mg IM of benadryl x 1 and an albuterol neb tx and oxygen applied at  2L-NC. pt reports improved hives and breathing at this time. DOE, resp slightly labored lungs with wheezing throughout.
I felt at time of injection at the injection site and surrounding area burning sensation that lasted approximately 30 minutes or so, approximately 2-3 inches around the injection site swelled, became hard, warm to the touch and red, worsened and became more red as the day went on and became hot to the touch and lasted until 11/16/13 when it was more pink than red and still swollen but less than it had been.
pt recv vax; c/o arm sore and tight about 2 days p/ shot; ached all over in joints by 2nd wk; c/o pain in lt shoulder blade, up into neck; arm sore and stiff;
Nausea as well when she is standing and walking; Gets dizzy when she is standing up for walking, she cannot walk for more than 5 seconds; she cannot walk for more than 5 seconds; Swelling under armpit; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0187; Expiration Date: 31Aug2021), via intramuscular route of administration, administered in Left Deltoid muscles on 27May2021 16:39 (age at vaccination 29-year), as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 29May2021 the patient experienced swelling under armpit and patient gets dizzy when she is standing up for walking, she cannot walk for more than 5 seconds, on 31May2021. The patient also experienced nausea as well when she is standing and walking on an unspecified date. It was reported as, the pharmacist stated patient has a swelling under armpit, patient got the vaccine on friday, it started on saturday morning and still has a swelling no change since then from one week, that's the number one complaint. Second complaint is dizziness, she says that it started on monday, she gets dizzy when she is standing up for walking, she cannot walk for more than 5 seconds and when she stands up she get dizzy and it started on monday and till now past five days she still has that and it's not getting better. Third is nausea as well when she is standing and walking when she is sitting down she doesn't get nausea or dizzy. The seriousness of the events was reported as non-serious. The clinical outcome of the events was unknown.  No follow up attempts are required; Information about Lot and Batch number was obtained.
Patient felt tingling in her left arm after receiving the Covid  vaccination. While patient was sitting  down to wait her 15 minutes observation time, she felt faint and passed out while sitting in the chair. Her mother who was sitting next to her was able to help her to the ground. Patient knew where she was and who she was but felt dizzy and had arm pain.
asthma; feeling weird sensations in my legs/feel something around my jaw and my chest; feeling weird sensations in my legs; feel uncomfortable; don't feel too well about that; This is a spontaneous report from a contactable consumer (Patient). A 15-years-old male patient received unknown dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date, Caller mother stated that her son was not feeling too well. He had asthma and never had asthma attack. Caller stated, when he first went in there, he did not feel anything. He was a little nervous because he did not like needles, but when she gave me the shot, he immediately started feeling weird sensations in his legs. And then after that, he started to feel something around his jaw and chest. He still feeling that way now. He feel uncomfortable. He did not know if this was supposed to happen after get the first vaccine. He really did not know. He did not feel too well about that. The clinical outcome of the events were unknown whereas he started to feel something around his jaw and chest was not recovered .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm completely numb, face numb, mouth numb, could barely walk. confused. Couldn't swallow kept gagging
Pt had vaccine on 01/07/21. by Jan 11th Pt had cold like s/s. By Jan 16th Pt had Dx positive Covid hospital
On 3/21/08 - mother returned to clinic - noted patient complained of left arm swelling, tenderness, and redness at injection site.
Syncopal episode about 10 min after injection, possible seizure activity for 15-20 seconds. Then generalized weakness, tingling, and dizziness. The patient responded poorly to fluids, Benadryl, Epinephrine, and Decadron. 6/13/08-DC summary received for DOS 5/29-5/31/08. DC DX: Adverse reaction to vaccination. Day of vaccines developed swelling of right arm, felt dizzy and weak. Continued to feel weak for day or 2. Arm swelling and tingling continued as well as weakness of grip on right arm.
Pt received imm on 9/16/10. On 9/17/10 child had sores on throat, chin, tongue, and fever of 100F.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0150), on 23Apr2021 as dose 2, single (Lot number: ER8735) and on 10Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin; Azithromycin, reaction(s): "Known allergies: Azithromycin", notes: Known allergies: Azithromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rebound of symptoms on 06Jun2022, positive test again on 07Jun2022. (note received chemotherapy on 03Jun2022) Initial sx rhinorrhea, congestion, 1 day low grade fever Rebound sx headache, congestion, throat clearing, no fever. Mild asthma. Diffuse B cell lymphoma diagnosed Jan2022, on R-CHOP therapy every 3 weeks. Final chemo 03Jun2022.
Developed body rash right after the vaccine, joint pain. Tested positive for COVID about five months ago.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 31-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot number and expiration date: K004016 and 08-MAR-2015 respectively; strength, and route of administration were not provided). Nonetheless, no adverse effects were reported. On an unspecified dates, PNEUMOVAX 23 vaccine had two temperature excursions; one on 192 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius) and the other one of 1320 hours with a lowest recorded temperature of 33 F (0.555555556). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Gradual stiffness and tightening of both shoulder joints. Reduced flexibility in knees the first night and pain during normal range of motion. 5-minute intervals of paresthesia in both hands and wrists every couple of hours. Nausea the next day.
Developed tingling in tongue with mild swelling and feeling like she was not swallowing normally. No SOB. Face flushed, no itching or hives. A&O x# speaking in full sentences. Given diphenhydramine liquid 25 mg at 11:44 am and 0.3mg epi IM right deltoid .:15 at which time face got more pink and tongue felt tingling still. Patient brought to ER via wheelchair with nurse after verbal report given to nurse.
ill; not feeling well; body aches; fever; flu; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 01Apr2021 (at the age of 52-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was due for his second dose of the vaccine on 21Apr2021; but was ill on 20Apr2021; not feeling well with body aches and fever, but stated he doesn't have COVID, just a flu. The patient was asking if he could receive the second dose of vaccine on the next day. The events had not resolved at the time of the report.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Pt reported fever (99.9-101.7 deg F), swelling, blurred vision, fever blisters and violent chills lasting 4 days post vaccination. Rash appeared on (R) arm four days post vaccination. Treated with Ibuprofen alternating with APAP.
Patient left vaccine clinic after waiting 15 minutes after injection of Pfizer. Patient re-entered building and notified staff member of chest pain with tightness. Blood pressure 180/102, O2 sat 98% on room air. EMS called and upon arrival, patient stated felt improvement. Pt declined transport to hospital.
She presented herself to local Hospital 4/18/22 5am with a lot of bleeding from the rectum, along with hot and cold sweats, nausea, soreness at the injection site, myalgia all over, neck and throat is sore, difficulty swallowing.  She stayed for observation until 8pm. They did not do anything for her there. The bleeding slowed had stopped before she left and it hasn't returned. She is still experiencing all of the rest of the symptoms.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 15-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles (herpes zoster). On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).