chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 2nd dose of pediatric COVID19 Vaccine, no history of any ADR, tolerated 1st dose fine.  Approx. 10 minutes post vaccine administration patient complained of lump in throat and trouble breathing, although did not seem in acute distress.  Patient was sitting in waiting  area, but did have a lollipop.  Mother was not aware of any allergies to food/vaccine/med.  It is unclear if the reaction was due to ingestion of lollipop.  There was no local reaction present at vaccine site.   Gave patient water and 25mg of diphenhydramine, observed for 20 more minutes.  Patient reported nausea with no emesis.  Spoke with mother about follow-up with doctor and seeking emergency services if signs/symptoms worsened.  Patient and Mother left the store after waiting a total of 45 minutes post vaccination.  Spoke with mother on the phone 1 hour later to follow-up, patient had improved and had no further complaints.
Developed varicella.  Follow up on 12/14/2001: "No other information given."
Patient called to report that upon arriving home after her vaccination, soon developed hives on bilateral lower extremities
This is a spontaneous report from a non-contactable consumer or other non HCP Pfizer colleague. A female patient of an unspecified age (in her early 20's possible) received meningococcal group B injection intramuscular at 0.5ml, single, 3 dose series on an unspecified date during the University outbreak 2014-2015 school year for immunization for prevention of Meningitis serogroup B. The reporter was not sure if it was TRUMENBA or BEXSERO that was given. The patient medical history and concomitant medications were not reported. The patient experienced felt sick after getting the shot on an unspecified date with outcome of recovered. No follow-up attempts are possible. No further information expected.
Systemic: Fainting / Unresponsive-Severe, Systemic: MOM SAYS HE HAS HISTORY OF FAINTING AFTER VACCINES-Severe, Additional Details: MOM SAYS HE HAS A HISTORY OF FAINTING AFTER VACCINES. SHE DID NOT TELL IMMUNIZING PHARMACIST BEFOREHAND, ONLY AFTER I FOUND PATIENT LYING IN THE AISLE, RESPONSIVE, BIT LIP DURING FALL SO A LITTLE BLOODIED. I ASKED MOM IF HE HAS A HISTORY OF THIS AND SHE SAID YES HE HAS FAINTED AFTER A VACCINE BEFORE. SHE DID NOT TELL ME OF ANY ISSUES BEFOREHAND. EMS CALLED, ARRIVED, PATIENT STABILIZED AND TRANSPORTED TO ER. ATTEMPTED TO FOLLOW UP TODAY BUT NO RESPONSE OR CALL BACK FROM PROFILED NUMBER.
Client c/o tightness/soreness in chest at 2:05pm, approx. 5 mins. after receiving 2nd dose. Client initially declined having V/S taken then agreed at 2:18p: BP 130/70, HR 68, RR 14, SO2 99. Client reported this was the same reaction after the 1st dose and it resolved. V/S @ 2:25pm: BP 112/62, HR 70, RR 14, O2 99 and client statement "I tend to have lower blood pressure." EMS was offered and declined by client. Client stated "feeling better" at 2:36pm and left site with a steady gait, unassisted and unaccompanied. She reported her parents were waiting in the parking lot and would drive with  them.
The patient has not received their second dose, and it has been more than 36 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The patient has not received their second dose, and it has been more than 36 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient has not received their second dose, and it has been more than 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient has not received their second dose, and it has been more than 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was given.
Went to ER on 11-02-08 with seizure and fever. Sent home with no work up done. Had another event with fever & seizure on 11/15/08 and was admitted.  12/23/08 Reviewed ER medical records of 11/02/2008. FINAL DX: febrile seizure Records reveal patient experienced generalized shaking, was unresponsive total of 20-25 min.  Had cold s/s of cough & congestion x 3-4 days prior to vaccination.  Fever of 39.1 in ER.  Tx w/antipyretics.  No further seizure activity.  D/C to home w/PCP follow up.
Pt had onset of soreness and increased pain to injection site. Progressed the next day to: Increased pain and swelling to injection site; urticaria to left upper arm; lethargy; muscle pain to left upper am; tachyarrhythmia; chest pain; difficulty breathing at night; expiratory wheezing was worse; mental status alteration.
This spontaneous report was received from a pharmacist concerning a 61 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 20-MAY-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque forming units, lot # M037013, expiration date: 22-NOV-2017, as prophylaxis (Dose and route were not reported), which experienced a temperature excursion of 15 to 46 Fahrenheit degrees for 12 hours. There were no previous temperature excursions and a digital data logger was involved. No adverse effects were reported. The patient's concomitant medications included sterile diluent. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1707USA009292: US-009507513-1707USA009293: US-009507513-1707USA009294.
Case number PHEH2014US005905, is an initial spontaneous report from a pharmacist received on 20 Mar 2014. This report refers to a 17-year-old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M12127, expiry date: Aug 2014) intramuscularly at a dose of 0.5 ml that reached 34 Fahrenheit (1.1 degrees Celsius) for up to 24 hours on24 Feb 2014. No adverse event was reported following the maladministration.
Vaccine was given at 1:30 pm and advised to wait 30 mins for observation.  At 1:59pm complained of swelling in mouth and dizzy.  called 911. Benadryl 100mg was given IM in left deltoid.  B/P 150/88  Hear rate 102. At 2:11 pm complained of feeling  shaky and could feel swelling in nose and throat. Gave Epinephrine 0.5 cc IM in Right Deltoid. B/P 160/92 Heart rate 108.   2:20pm reports feeling better bur still feels swelling but no trouble breathing. 2:28pm B/P 142/58 Heart rate 88 No wheezing.  Ambulance arrived at 2:32pm and transported to hospital.
This case was reported by a nurse and described a female pt in her mid thirties who accidentally had hep A vaccine inactivated (Havrix) sprayed into her eye. On 24Feb05, the pt's child received a dose of Havrix (dose number not provided; lot VHA814A2). During the vaccination, the vaccine inadvertently sprayed into the pt's left eye. The nurse reported that she had the pt rinse her eye out. On 25Feb05, the nurse contacted the pt who informed her that she had rinsed her eye out for an additional 15 minutes at home. The pt stated that her eye stung at the time, but reported no difficulties afterwards. The event resolved. In the nurse's opinion, the event was unrelated to vaccination with Havrix.
Fever 103.2, Palpitations, Chest Tightness, Chest Pressure, Confusion, Anxiety, Stiff Left Arm, Shortness of Breath, Elevated D-Dimer levels, Abnormal EKG: Right Bundle Branch Block, Resting Heart Rate 125 bpm - 165 bpm, fatigue, body aches, chills
4 month immunization prepared and given, 2nd week in physician's office and administered combo DTaP/IPV (KINRIX) with medications.
Swollen arm is tender red -> fever. Patient took BENADRYL -> got better.
Puffy swelling eyes, accompanied with severe itchiness and small lesions under eyes. I took 25 mg of Benadryl and swelling stopped and receded within the hours only to return in 4 hours.
5 cm area of redness over left bicep adjacent to injection site. Swelling, redness and warmth consistent with cellulitis.
This is a spontaneous report from a contactable consumer (patient). A 68 years old female patient received first dose of PREVNAR 13, via an unspecified route of administration in 2014 at the age of 65 years old for immunization. The patient medical history and concomitant medications were not reported. The patient wanted to know if she needs a booster of pneumococcal 13-val conj vac (dipht crm197 protein) if she received the first dose in 2014 when she was 65 years old. The patient stated she had breast cancer for 2 years in 2017 but now her treatment was done. The outcome of the event was unknown.
received dose from vials beyond 30-day use by date; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration 07-may-2021  No concomitant medication was reported   No treatment medication was reported
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756542A, A0756544A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
pt recvd vax & had rxn at inject site; pt devel pruritic, sharply demarcated raised, red area;
Diagnosed with COVID 19 virus after being fully vaccinated. I had to get the antibiotic infusion.
Patient was sitting in the waiting area after receiving her moderna shot.  She started coughing  uncontrollable and then fell to the floor,  The technician said she couldn't breath so we gave her an epipen and called 911,  The paramedics came and took over.
Fatigue and muscle soreness starting around 6 PM. Chills and vertigo started around 7 PM. Fever and severe headache around 8 PM. Symptoms persisted until next morning. 400 mg ibuprofen administered 2 AM, 9/30/2010 - fever broke soon after.
Local urticaria approx 3cm diameter. Pruritic. At injection site. Resolved in 1 hour after cold pack applied and  children?s Claritin given.
Fibromyaglia Flare Up. Very bad migraine (worst ever) that lasted 3 days until I started a course of Methylpred to try to reduce the pain.  Nausea.  Body Aches.  Fatigue.  Dizziness.
Significant and severe swelling, stiffness in shoulder, pain in shoulder and upper arm, limited range of motion left shoulder.
8/11/2011 Rash - macular, papular over arms, legs, trunk, face. No fever Temp 97.3 ax.
headaches and dizziness have gotten worse; headaches and dizziness have gotten worse; This is a spontaneous report from a contactable consumer (patient herself).  A 74-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0182, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 11Jun2021 as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure (for about 15 years), diabetes (called it diabetes and pre-diabetes, for about 4 years) and pre-diabetes (about 4 years), anxiety (for about 15 years), pacemaker (inserted 2 years ago) and sinus problems (for 5-6 years). Patient had chronic headache dizziness. Patient had no family medical history relevant to adverse event. Concomitant medications included metformin hydrochloride for diabetes; amlodipine for high blood pressure (been on medication for years); losartan for high blood pressure (been on medication for years); hydrochlorothiazide, as water pill for an unspecified indication (been on medication for years); lorazepam (been on and off this medication for 15 years); vitamin D. Patient received no other vaccinations within four weeks prior vaccinations (within 4 weeks). On 11Jun2021, patient had taken the dose. On an unspecified date Jun2021, patient stated that it seems like she had been a little dizzy and had headaches all week and stated that since receiving the vaccine, her headaches and dizziness had gotten worse. Patient stated she had a sinus problem, so she was not concerned. Patient normally takes one paracetamol (Tylenol), and it will go away. Patient noticed it more this morning (17Jun2021) when she took her walk and stated that she gets like that sometimes because she takes other medications; this time though it feels like it was lingering longer. Patient stated she had been getting them every day. On 17Jun20201, around 05:30 she took a lorazepam, and it went away, and she went back to sleep until around 12:30 when it started again. When it started again, she took a paracetamol (Tylenol). Patient was concerned about headache today (17Jun2021). No relevant tests were performed. Patient had no emergency room and physician office. Patient stated that she had had this problem with headaches and dizziness before the vaccine and now that she was looking at the side effects, she thought it might be something she needed to report. Patient asked if this was something to be concerned about and should she go to the doctor or emergency room for her symptoms. Patient was notified to consult with healthcare professional or seek emergent medical attention if needed. Patient has an appointment on 21Jun2021 (Monday) with her neurologist. The outcome of both the events was unknown.    Follow-up (17Jun2021): This is a follow-up spontaneous report from a contactable consumer (patient).
Pt recieved vaccine on 8/18/21 then  on 08/20/21 had chest pain we then went to the ER. his Troponin levels kept climbing he was then admitted to hospital  his chest pain was severe his troponins kept climbing he was not responding to typical treatment for pericarditis and started to have some ventricular beats that sent him to ICU  he then was diagnosed with MYOPERICARDITIS and recieved  Immunoglobulin.l He was in Hospital for 5 days. He has to wear a heart monitor for 1 month and can not have activity for 3 months. his troponins are still not at normal level as of 8/20/21 but he does not have chest pain. He just was able to return to school on 8/30/21 with no activity. he is on Motrin 600mg tid. when he walks his heart rate is still elevated in the 110-120's just brisk walking. but he is not in pain.
Had a fever of 101 the nights following each of my first two previous Moderna vaccines, as well as soreness at the site of the injection.  All was resolved in about 24 hours.  The reaction to this 3rd dose was MUCH greater, even with 100 mg/Tylenol every 6 hours.  The vaccine was administered at 2:30 pm.  last Sunday.  By midnight I had a fever of 102 with tremendous chills, and shakes so bad I could hardly walk or hold a cup of water.  I also had nausea and diarrhea so was up all night.  The next morning my fever was down to 100, and I was mostly just tired with minor body aches.  Fever was gone by the afternoon.  I slept well that night and was fine by the next day.
Immunization given Mon. 6/16/08, Tues 6/17/08 arm hurt, achy.  Wed 6/18/08-felt dizzy and fainted, later in day doing fine.
Patient positive for COVID-19 on 04/17/21 after completing vaccination. Asymptomatic. Positive previously on 12/29/2020.
Tingling to upper arms, neck, and face; pale, faint-like feeling, nausea.  11/24/09 Medical records received for DOS 11/6. S/P vaccine BP decreased, resp increased, dizziness.  Tingling hands and chest area. Pale, lips white, radial pulse not felt.
Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure.  She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck
99F fever; fatigue; strong headache; chills; soreness in left arm, across top of chest, and right arm throughout the night; soreness in left arm, across top of chest, and right arm throughout the night; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) reported for herself. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0151), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 11:30 (age at the time of vaccination was 50-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications. No allergies were reported. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration administered in arm on 25Mar2021 as dose 1, single for COVID-19 immunization and experienced slightly sore arm after first dose. It was reported that after second dose, around 6pm (roughly 7 hours after injection) the patient experienced strong headache, then chills, soreness in left arm, across top of chest, and right arm throughout the night, fatigue on 15Apr2021 18:00 and 99F fever next morning on 16Apr2021. The patient underwent lab tests and procedures which included body temperature: 99 Fahrenheit on 16Apr2021. No treatment was received for all the reported events. Outcome of all the events was reported as recovered on an unspecified date at this time of the report. No follow-up attempts are possible. No further information is expected.
Extremely painful injection site for 48hours with swelling; Extremely painful injection site for 48 hours with swelling; Very tired; Slight headache; Mild fever; Nauseous for 48 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 01Sep2021 at 13:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Concomitant medications were not reported. On 01Sep2021, the patient developed extremely painful injection site for 48 hours with swelling. The patient was very tired, had slight headache and mild fever. The patient was feeling nauseous for 48 hours. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely painful injection site for 48 hours and nauseous for 48 hours was resolved on 03Sep2021; while that of the events swelling at the injection site, very tired, slight headache, mild fever was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt came in for Dose 2 of covid vaccine and did not have her card with first vaccine. Moderna was administered. Upon entering information into the state immunization registry, it was determined that the patients first dose had been Pfizer on 12/31/2020. Contacted CDC who indicated that no further dose is necessary.
a little swollen in the arm which lasted for an hour or two; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (a little swollen in the arm which lasted for an hour or two) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis (psoriatic arthritis for 22 years and has been on 9 different biologic medicines) and Immunocompromised. Concomitant products included IXEKIZUMAB (TALTZ) for Psoriatic arthritis, PREDNISONE and OXYCODONE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (a little swollen in the arm which lasted for an hour or two). At the time of the report, PERIPHERAL SWELLING (a little swollen in the arm which lasted for an hour or two) had resolved.            No treatment medication was provided   This case was linked to MOD-2021-318119, MOD-2021-318145 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow Up Received on 14-Sep-2021 contains No New Information On 15-Sep-2021: Follow Up Received on 15-Sep-2021 contains No New Information
Started with stiffness moving across my shoulder and my neck getting stiff and feeling of nausea.  By Thursday night: stiff neck, migraine, nausea, pain to touch on both arms back and head. Nausea started to lift enough Friday afternoon that I could take Motrin without throwing up.  Slept all day Friday and Saturday.  Pain started to subside by Saturday night.  Migraine still present through most of the day Sunday.