chrisvoncsefalvay/vaers-outcomes huggingface dataset:
-temp elevation. urticarial diffuse rash developed 1 hour after receiving flu vaccine. Parent brought baby back to the office to be examined. Ck after injection no change in respiration's, muscle tone  activity. Treatment: prescribed Orapred 2-5 P.O. BID X 5 days. Child examined 11/2/05. No rash noted - resp-distress, - change in behavior, eating well. Follow-up appointment scheduled in 1 week.
Arm vaccine was delivered immediately became so sore the arm could not be moved.  Became very weak and fainted.  5 minutes later patient vomited.  1 hour later patient had a severe headache accompanied by fever of 101 for the following 2 days.
Developed ear pain and tinnitus in both ears two days after receiving the 2nd dose of vaccine.  I had COVID-19 in November of 2020 and experienced tinnitus, but it slowly went away.  After receiving the second vaccine dose, it came back and it has not gone away.  Ear pain has gone away, but not ringing in ears.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA301010. This case involves a patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used as patient was given a FLUZONE vaccine from a prefilled syringe, that was also expired. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
got covid positive; got covid positive; sore throat; runny nose; This is a spontaneous report from a Pfizer via a contactable consumer.  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced got covid positive, sore throat (oropharyngeal pain) (non-serious) on an unspecified date, runny nose (rhinorrhoea) (non-serious) on an unspecified date.   The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the events were reported as unknown.  Information on the Lot/Batch number has been requested.
Red hives/rash covering back and abdomen. Not brought down with Benadryl. Still present 48hrs after initial rash seen and has since spread to legs, feet, neck, face, and shoulders. Red, blotchy, raised rash.
Improperly stored PROQUAD were administered to 10 patients; No additional adverse symptoms reported; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # S013712 and expiration date 01-NOV-2020 (dose and route were not provided), reconstituted in sterile diluent (STERILE DILUENT), for prophylaxis. It was unknown if the sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was stored at proper temperature. No additional adverse events symptoms were reported. The temperature excursions were reported as follows:  measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD)(Lot # S013712, expiration date 01-NOV-2020)  Temperature  Total time in the range 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celcius (C) to -l0 C) for 30 minutes Total time in the range 15 F to 46 F (-9 C to 8 C) for 7 hours;  Total time in the range 47 F to 77 F (9 C to 25 C) for 9 hours  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005479:
2 days after 1-09 4 month shots of DTaP (with Hib/IPV/Prevnar/Rotateq) had about 48 hours of neurologic symptoms (namely poorly responsive, no social smile, maybe a little hypotonic in muscles) but without fever, rash, or other sequelae.  Presumed due to pertussis vaccine we are suspecting.
Patient developed fussiness and swelling to right thigh three hours after being given immunizations. Went to ER: Painful local reaction to immunizaitons.
Booster shot administered around 11:45 am 01Dec2021.  Onset of headache by 4 pm 01Dec2021. Headache continued through 18:00 on 02Dec2021 (ibuprofen used to manage pain).  Swelling of lymph nodes in left armpit (injection site, left shoulder) observed around 9 am 02Dec2021.  Swelling on scale of softball. Consistent aching pain/discomfort (~7 on a 1-10 scale) with occasional sharp spikes. Difficulty lifting/moving arm. Lymph node can easily be located and is very firm. Pain/swelling persists as of this report.  Red rash/hives on neck observed around 8 am 03Dec2021. Worsened and spread to chest throughout the day. Itchy and hot. Benadryl used to manage itch. The rash was 95% cleared by 8:30 am 04Dec2021.  I experienced all three of the above reactions after my second dose as well, so they were not entirely unexpected. I am reporting for informational purposes. If my lymph node swelling does not go down in a week I will follow up with a doctor.
pt came in reported his head hurts on the right side in the back after he received the second moderna. the pain recurred since and each time is more painful. he said yesterday he took a "pain killer" and it went ago.  I advised pt to contact his doctor asap.  I will report to VAERS and contact his doctor also.
Gross blood on outside of stool x1 within 2d of receiving vaccine. No fissure.
This is a spontaneous report from a contactable other health care professional (patient, reported for herself).  A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: EW0178 and expiry date: unknown), via an unspecified route of administration, in left upper arm on 09Jun2021 11:50 AM (at the age of 38-year-old) as dose 2, single for covid-19 immunization. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: EW0186 and expiry date: unknown), via an unspecified route of administration, administered in arm left on 19May2021 11:00 AM (at the age of 38-year-old) as dose 1, single for covid-19 immunization. The patient's concomitant medications were not reported. Patient had not received any prior vaccination Within 4 weeks. Patient stated that she didn't experience any events for the first dose, but she got her second dose vaccine yesterday and she experienced headache, joint pain, tiredness, fever and chills, all on Jun2021. She confirmed that she took paracetamol (TYLENOL) and Ibuprofen as treatment, but nothing helped her. Patient stated that instead this morning, she was supposed to got to work today she didn't went to work. Outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
With each successive immunization of GARDASIL, father reports that patient developed cold sores on her lips and inside the mouth 2-3 days post injections. Dates of GARDASIL. (see below) * #1 9-11-2009, #2 4/22/2010 #3 6/9/2011. Incident was not reported by father until after GARDASIL #3 was given, but father reports that cold sores on lips & inside of mouth occurred after each GARDASIL dose was given.
mom reported fever 105-106 R noc of shot taken to ER, told was react irritable-high pitch cry;
SHARP PAIN IN STOMACH; LOT OF GAS IN HER SYSTEM; PAIN UNDER ARMPIT; MOTION SICKNESS WHEN DRIVING; DIARRHEA; NAUSEA; METALLIC TASTE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 28-OCT-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 28-OCT-2021, the patient experienced metallic taste. On an unspecified date, the patient experienced sharp pain in stomach, lot of gas in her system, pain under armpit, motion sickness when driving, diarrhea, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste on 29-OCT-2021, and had not recovered from sharp pain in stomach, lot of gas in her system, diarrhea, pain under armpit, nausea, and motion sickness when driving. This report was non-serious. This case, from the same reporter is linked to 20211061246.
developed a cough with a lot of phlegm the day after the flu shot; developed a cough with a lot of phlegm the day after the flu shot; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA350650(CLUSTER).  This case involves a 33 years old female patient who developed a cough with a lot of phlegm the day after the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included SARILUMAB (KEVZARA).  On an unknown date, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Suspension for injection) (lot number and expiry date not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On an unknown date the patient developed a cough with a lot of phlegm the day after the flu shot (productive cough) and (cough)(unknown latency).  It was reported that "Consumer reports that she uses 200mg KEVZARA and the last injection that she attempted the pen malfunctioned. Consumer states that she does not know what happened, when she was pressing, it would not go and when she removed the injection away from her skin the medication deployed. Could Kevzara have a role in me developing a cough the day after I got a flu shot last week? Additional Description of event Adverse events :On Thursday, 02Nov2023, the caller was attempting to inject a Kevzara 200 mg PEN in her thigh when it would not deploy. She does not remember if the device made any click/s. It would not push. The button never when down. She held it to her thigh and it would not do anything. When she removed it from her leg, the medication then came out of the pen. She did not miss a dose because the used the other pen from the carton. The other pen had no problems. The lot and expiry were unknown because she was not at home during the call, and the Kevzara pen is at her home. She had a flu shot on Friday or Saturday last week. she developed a cough with a lot of phlegm the day after the flu shot. She had not been sick or had a cough in 5 years, therefore this cough is unusual for her. She confirmed that the flu vaccination was an injection."  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for both the events.    At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
Intense ringing in ears, primarily left ear; This is a spontaneous report from a contactable healthcare professional, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9266, first dose) solution for injection intramuscular in the right arm on 12Feb2021 at 15:00 (at the age of 33-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included Charcot Marie tooth. Concomitant medication included intrauterine contraceptive device (IUD). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced intense ringing in ears, primarily left ear on 12Feb2021, it began about 3 hours after vaccine and was still occurring 18 hours later. No treatment was provided for event intense ringing in ears. The outcome of the event intense ringing in ears was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
I was having aches, chills, a fever of 102.5 for 24 hours, headache, and congestion in my chest in and my nose. I took a COVID-19 Home Test, and it was positive. I called my doctor, and they gave me Paxlovid. I started taking that and was feeling much better after my fever broke but I do think that the medication helped. I did have really low energy for about two weeks or so after that along with intermittent congestion. Around the 3 or 4 week mark I was about 85 percent better and it was really 3 or 4 weeks before I was back to 100 percent better.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a female patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history and no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date was not reported, administered into left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-JUL-2021, the patient lost sense of smell (suspected covid-19 infection) and suspected clinical vaccination failure. On 28-JUL-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210801295-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related.The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I'm having a delayed reaction; rash all over my body/Rash is pronounced on both arms, both feet, and face/ rash all over her body from head to toe/Rash is pronounced on both arms/Rash is pronounced on both feet/Rash is on the face.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'm having a delayed reaction) and RASH (rash all over my body/Rash is pronounced on both arms, both feet, and face/ rash all over her body from head to toe/Rash is pronounced on both arms/Rash is pronounced on both feet/Rash is on the face.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07EC21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (I'm having a delayed reaction) and RASH (rash all over my body/Rash is pronounced on both arms, both feet, and face/ rash all over her body from head to toe/Rash is pronounced on both arms/Rash is pronounced on both feet/Rash is on the face.). The patient was treated with PREDNISONE for Rash, at a dose of 1 dosage form twice a day. At the time of the report, VACCINATION COMPLICATION (I'm having a delayed reaction) and RASH (rash all over my body/Rash is pronounced on both arms, both feet, and face/ rash all over her body from head to toe/Rash is pronounced on both arms/Rash is pronounced on both feet/Rash is on the face.) outcome was unknown.            Concomitant medications were not provided.   This case was linked to MOD-2021-372576 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant follow-up, patient information, suspect drug information and treatment drug updated.
Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported).  Medical history, concurrent condition and concomitant therapy was not reported. On 16-APR-2008 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-JUN-2009 the patient was treated for a painful rash and blisters that were diagnosed as shingles. The patient was prescribed acyclovir (ZOVIRAX) to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Pt recvd a series of Hep B vax in 1984 w/neg response for HBSAB; 2nd series of Hep B vax given w/Engerix-B & again no antibody response (neg titer);
At the time of the shot I had immediate effects. Tingling, exhasution for 5 days and headaches. Two weeks later I got vertigo. It was severe and required multiple trips to Urgent Care, PT, and my neurologist. In addition, my migraines came back. I had been practically migraine free for years and now they are back and much worse than before. It is impacting my ability to live my life to the level I was prior to the vaccine.
This spontaneous report was received from a Nurse refers to a 22 year old female patient. On 17-FEB-2014, the patient was vaccinated with fourth dose of VARIVAX (Merck) 0.5 ml subcutaneous in one arm and PROQUAD (Merck) (dose and frequency was not reported) instead of M-M-R II in the other arm. No adverse events were reported. No further information was provided. This case is linked to the case 1402USA008801 (same reporter link). Additional information has been requested.
Patient developed a lymph node infection which she believes is due to administration technique. Patient was given Z-pak on 10/16/17 and she believes it is helping.
Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection site. Along with a severe headache, nausea, and chills. The symptoms lingered over the next couple of days. Contacted Employee Heath and manger the following day. Stayed out of work on 1/29/21.
Early Monday morning my arm was itching and I found a maculopapular rash on my left arm .
Fever Malaise, body ache and chills Narrative:  Other Relevant History:
Patient developed a high fever through the night of 6/17 into 6/18.  The highest I saw was 103.2 orally.  She was lethargic and out of sorts/confused.  She had an episode of hysterical crying/laughing.  Her fever broke after 24 hours.
Extreme swollen and painful lymph nodes in neck and underarm on injection side, continuing to increase in size
Huge headache Friday afternoon; high fever; sensitive injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Jul2023 at 08:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "migraines" (unspecified if ongoing); "GERD" (unspecified if ongoing); "sulfur allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Iodine, reaction(s): "Allergies: Iodine"; Codeine, reaction(s): "Allergies: Codeine". The following information was reported: HEADACHE (non-serious) with onset 28Jul2023 at 13:30, outcome "recovering", described as "Huge headache Friday afternoon"; PYREXIA (non-serious) with onset 28Jul2023 at 13:30, outcome "recovering", described as "high fever"; VACCINATION SITE DISCOMFORT (non-serious) with onset 28Jul2023 at 13:30, outcome "recovering", described as "sensitive injection site". Therapeutic measures were not taken as a result of headache, pyrexia, vaccination site discomfort. Additional information: The patient experienced high fever on (also reported at Friday night). No other vaccine received at same date, or within four weeks. No other medications in two weeks. Adverse events did not result in any serious criteria.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed heart palpitations starting September 1. Visited primary care physician who ordered a heart monitor and follow-up. Palpitations worsened and it was recommended I go to emergency room. Emergency room cleared me but scheduled follow-up with cardiologist. Cardiologist ordered several tests, all of which checked out OK although a heart murmur was discovered.
Local reaction still present as of 1/18/21. Redness started at about quarter sized area two days after injection. Ten days after injection, grew to palm sized redness.  Redness continues for over a week as most concerning. In addition, soreness at injection site lasting about 7 days.
Shaking, dry heaving, nausea, feeling short of breath at times, dizzy, loss of appetite, sore throat.
Information has been received from a medical assistant concerning a female patient who on approximately 27-AUG-2007 "one month ago", was vaccinated with a first dose of GARDASIL. Concomitant therapy included contrast dye. On approximately 27-SEP-2007 "one month later", the patient presented with a welt at the injection site. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a medical assistant concerning a female patient with history of gastropharesis, panic disorder, recurrent syncope and allergies to pseudoephedrine and IV contrast who on 28-Aug-2007, was vaccinated IM into the left arm with a first dose of GARDASIL (lLot # 658488/0930U). On 25-Sep-2007 one month after injection, the patient presented with one day sudden onset of soreness, swelling, stinging in arm and weakness down arm and a welt at the injection site. Unspecified medical attention was sought. At the time of this report, the patient recovered. No product quality complaint was involved. This is one of two reports form the same source. Additional information is not expected.