chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient recieved firsts dose of shingrix vaccine, was a little nervous about getting a vaccine due to fear of needless. Allergies were confirmed, manufacturer was called to confirm no presence of egg albumin--patient recieved vaccine in left arm. Patient initally seemed okay, spoke to patient for about 5 miutes to ensure ok since patient was extremely nervous. Within 5 minutes or so patient reported being dizzy, spoke to patient again to make sure he was ok and sat to monitor for potential ADR's. Within a few minutes, patient vent into vaso vagal syncpe lost consciousness for a few seconds and regained. Paramedics were called immediatelly to the scene. Patient upon becoming alert was a little confused reporting he "fell asleep" then cintunued feeling light headed. Paramedics arrived within minutes, patient blood pressure dropped significantly (reports he normally has a low blood pressure) upon speaking to the patient he reports this is normal occurence for him upon administrations of vaccinations (or anything injectable). Patient refused hospital admission, paramedics monitored patient until blood pressure went up and patient was released and walked out of the store to go home without paramedic assistance.
Exhaustion. Felt like I did when I had mono but no soar throat. Lasted 48 hours. Started a little before 24 hours after shot.
Vaccine had a low temp excursion.  Declined revaccination as recommended by Sanofi-Pasteur
This spontaneous case reported by a consumer, describes the occurrence of vaccination site reaction (COVID arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014M20A) for COVID-19 immunization. No reported medical history. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Apr 2, 2021, patient experienced vaccination site reaction (COVID arm). At the time of the report, vaccination site reaction (COVID arm): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No relevant concomitant medications  reported. Treatment included paracetamol and ice pack application. This case linked to MOD-2021-066348, MOD-2021-066354 (patient link).
Pt c/o pain and swelling to R arm several hours after admin. PNEUMOVAX. Pt returned to clinic 7/16/09 for eval. Pt still had redness to injection site and had travelled down to arm and elbow.
Two weeks after injection I started to develop a bad outbreak of Varicella Zoster in the  T4 dermatomal distribution. Began taking acyclovir po. Ongoing infection.
Left arm swollen between elbow and shoulder. Temp 102F 9/1/04 pm, 100F 9/2/04 am. Advised to drink fluids, use Tylenol/or Ibuprofen and Claritan.
Red rash on left thigh from hip to knee, red splotches on left upper arm and left upper back. Pt was given 0.1mL epinephrine IM at 2:22 PM. Pt was taken to ER by mom, seen at 4:30 PM at Hospital. Per mom, pt was given Benadryl in the ER and sent home with a Benadryl prescription.
This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The healthcare worker reported that RECOMBIVAX HB dose 0.5 ml, route intramuscular that was exposed to 0C for 30 minutes on 12-FEB-2014 had been administered to an unspecified amount of patients. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1405USA007203, 1405USA007978, 1405USA007990, 1405USA008052 via same reporter link. Additional information has been requested.
dehydration Narrative:  Patient is a 52 year old male who received his COVID-19 vaccine (Pfizer) first dose on 3/29/21. On 4/3/21, he presented to the ED with diarrhea, nausea and dehydration. Patient was admitted and treated for AKI, dehydration, and diarrhea with IV fluids, and supportive care. Patient remained afebrile and creatinine improved from 2.1 mg/dL upon presentation to the ED to 1.4 mg/dL (near baseline of 1.3 mg/dL) on 4/5/21. Patient was discharged on 4/5/21.
This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 4-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 25th October 2016, the patient received KINRIX (intramuscular) 0.5 ml. On 26th October 2016, 1 days after receiving KINRIX, the patient experienced injection site warmth, injection site pain, injection site induration, injection site swelling and injection site erythema. On 27th October 2016, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site warmth, injection site pain, injection site induration, injection site swelling, injection site erythema and injection site blisters were unknown. The reporter considered the injection site warmth, injection site pain, injection site induration, injection site swelling, injection site erythema and injection site blisters to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to Health department. On 25th October 2016, the patient received the MMRV vaccine as a concomitant medication on right arm (was manufactured by Merck) (batch number M015700, expiry date 26th December 2017). The reporter had a child that received the KINRIX vaccination in her left upper arm at 16:50 pm. The parents brought patient back to the physician's office two days after receiving the vaccination because the patient's left upper arm was red, hot, swollen, painful, hard, tender to the touch, and raised. On 27th October 2016, 2 days after receiving KINRIX, the patient developed injection site blisters. The physician was also notified of this situation. This case has been linked with cases US2016180183, US2016180270, US2016180271 and US2016180187 as reported by the same reporter. No further details were obtained.
Approximately 1 minute after administering vaccine, patient asked for water with complaints of lightheadedness. As he walked up to pharmacy door for water, he collapsed to the ground.  He went in and out of consciousness while laying on the ground for about ten minutes. He had no other complaints other than lightheadedness. He did not eat any food today. He said in the past he had fainted after getting a numbing injection for a dental procedure and believes it may be a similar reaction. The paramedics were called and evaluated him. His blood pressure and HR were within normal limits. He refused to be taken to the hospital for further evaluation.
One eye was more foggy, little bit more decreased vision then normal; One eye was more foggy, little bit more decreased vision then normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 90 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 90 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Eye condition, Dystrophy" (ongoing), notes: Verbatim: Eye condition, Dystrophy; "mother was about blind in one eye and the other eye she can not see clearly out of." (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset 02Apr2021, outcome "unknown" and all described as "One eye was more foggy, little bit more decreased vision then normal".  Additional information: Caller stated her mother was about blind in one eye and the other eye she can not see clearly out of. Caller stated her mother who is 90 years old had her second vaccine Pfizer the same day as the caller but at a pharmacy because she lives further away. She stated her mother had no reactions and her mother has an eye condition, Dystrophy, that she is about blind in one eye and the other eye she can not see clearly out of. Then the caller stated on the first day after her mother's vaccine, that morning, one of her eyes were more foggy, little bit more decreased vision then normal but now her eyes are back to her normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child received varicella vaccine on 1/12/17. 10 days later fever developed 102.0 and had seizure went to ER.
No adverse event; Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date).    Concomitant product use was not provided by the reporter. Patients administered Moderna vaccine monovalent beyond the 30 day beyond use date. Batch number 939902 (BUD - 02Sep2021). No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live significant follow up: Updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Information has been received from a physician concerning a 13 year old female with no pertinent medical history, allergies or drug reactions, who on 02-Oct-2008 was vaccinated with the first dose of GARDASIL (lot no. 660618/0572X). The patient was concomitantly vaccinated with a dose of VAQTA (manufacturer unknown). On 02-Oct-2008, the patient experienced syncope/fainting. The office called Emergency Medical Services, and they administered oxygen to her. The physician reported that the patient was fine when EMS arrived. Subsequently, the patient recovered. The physician felt that the patient's syncope was an another important medical event. Additional information has been requested.
No reactions at time of the shot. Reaction detected when seeing cardiologist for echocardiogram results on 11/15/2021. Listened to heart and determined racing heart. EKG detected paroxysmal atrial fibrillation.
After the first shot on 3/16/21, Pain at site of injection, General weakness and lethargic for 3 days. After the second shot, on 4/15/21, 99.9 fever, flu-like symptoms, swelling and moderate pain in right side lymph nodes in neck and extending through to underarm. Symptoms lasted 3 days, but swollen lymph glands lasted 5 days.
pt became pale & ridged, head drawn back;eyes open pupils fixed & dilated, arm went into contractured postioning w/hands twitching;called 911;BP 110/64, P64, R20;
Numbness/tingling in arm where injection occurred - lasting 10 min or so, then a feeling like the medication was traveling across my upper chest to my other arm, brief metallic taste in mouth
Erythema on left upper arm, temp 100.4 by ear thermometer, mild warmth, pruritic, edema, induration, mild tenderness was on 1/4/18. Erythema improving per mother on 1/5/18 with continued mild warmth, induration, mild edema, no tenderness, continued pruritic. Mother gave TYLENOL and applied hydrocortisone cream.  Recommended may also apply ice, BENEDRYL as needed.
injection site itches; swollen at the injection site; red at the injection site (square of redness); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itches), INJECTION SITE SWELLING (swollen at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site (square of redness)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historic events reported.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itches), INJECTION SITE SWELLING (swollen at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site (square of redness)). At the time of the report, VACCINATION SITE PRURITUS (injection site itches) was resolving and INJECTION SITE SWELLING (swollen at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site (square of redness)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was self She applied ice and took a Benadryl oral pill at night. concomitant medications report was not included by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Broke out in hives on trunk and extremities. Also began using a new liquid soap at the same time. Took 50 mg Benadryl and hives resolved, but broke out again the next day. Has continued to use soap.
Tingling in my left arm, hand, fingers, left leg only, genitalia Pain at injection site Tired feeling at hour 5 after
Case completed 2 dose Pfizer vaccine series on 2/18/21, and was admitted to hospital on 8/24/21 for Respiratory failure related to Covid diagnosis.
I was very tired; very sore arm for 24 hours; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: EL9263) via an unspecified route of administration, administered in arm left on 06Feb2021 at 11:30 as dose 2, single (at the age of 77-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (Dose: 1 Batch/Lot number: EL1284) on 16Jan2021 (at the age of 77-years-old) for COVID-19 immunisation. History of all previous immunization with the Pfizer Vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations) were not available. On an unknown date in Feb2021, after the second shot, the patient was tired and had very sore arm for 24 hours and nothing since. The events were not resulted in emergency room and physician office visit. Relevant tests were reported as none. The clinical outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Given Hepatitis A, Td, influenza 10/31/02, given Yellow Fever typhoid, MMR 11/1/02. 11/02/02 Started having N/V/ diarrhea; continued on Sunday 11/3/02 but also awoke that morning (11/3/02) with SOB and full body rash.
Patient reported light-headedness on day of vaccine administration (6/8/12) and the day following administration. On the day following vaccine administration, patient developed redness at injection site which eventually progressed to a quarter-sized area with swelling/itching 3 days post-administration (6/11/12).
Patient states the vaccine was given in a different area than the deltoid muscle. She had immediate pain and pain has persisted since then.
Recurrent/chronic (daily) urticaria beginning 2 weeks after vaccinations continuing through the present (11/20/2018).
Stomach ache 8:00 pm. 7:30 am nausea, vomiting, general malaise continued 'til 10:30 am.
Digestive issue; Loose stool; Dehydration; Dizziness; weight lost; Head ache; Chills; Whole body ache; This is a spontaneous report from a non-contactable consumer (patient, self-reporting). A 63-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Er2613 and expiration date was not reported) via an unspecified route of administration in the left arm on 22Mar2021 at 14:45 (at the age of 63-years-old) as a dose 1, single for COVID-19 immunisation. Medical history included unspecified immunity deficiency (bad immune system), the patient was allergic to dairy (milk allergy) and codeine. Other medications that the patient received within two weeks of vaccination included magnesium, vitamin b-12(MANUFACTURER, K2 with D3, vit C and better bitters. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Mar2021, the patient experienced headache, chills, whole body ache, digestive issue, loose stool, dehydration, dizziness and weight loss and it was day four only very slight improvement. The patient underwent lab test procedures weight and result was lost on 26Mar2021. The clinical outcome of indigestion, loose stools, dehydration, dizziness, weight loss, headache, chills and general body pain was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's "Age at Vaccination/Units" captured as "63 years" per vaccination date=22Mar2021 and DoB.  2. For History "allergies: Dairy": Coding updated from "Dairy intolerance" to "Milk allergy" per MedDRA.  3. For History "Bad immune system": Coding updated from "Unspecified immunity deficiency" to "Immune system disorder".  4. For "Past Drug Event": Reaction Coding updated from "Allergy" to "Drug allergy".  5. "weight" captured as Lab Data with Result "lost" and Test Date "26Mar2021".  6. No Drug Code for Con-Med "B-12" and "VIT C", coded out in Product tab.  7. Con-Med "K2 with D3" coded in tab as "D3 +K2".  8. For event "Digestive issue": Please review if need update the Coding from "Indigestion" to "Functional gastrointestinal disorder" per MedDRA.  9. Initial information need review: List of any other medications the patient received within 2 weeks of vaccination: Magnesium, B-12, K2 with D3, Vit C, Better Bitters
Hives, shortness of breath, chest tightness. Shot at 10:42am, hives and shortness of breath started around 220pm. Tylenol, benadryl, and water taken orally to help with symptoms.
Pt had a sudden, unexplained syncopal event with loss of consciousness lasting approximately 2 minutes.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 07-FEB-2014, the patient was vaccinated with an expired dose of ZOSTAVAX, lot # H020000, expiry date 02-FEB-2014 (dose and route not reported) for vaccination. No adverse event was reported. Additional information is not expected.
Immediately after receiving  the Moderna booster dose,  she developed H/A, nausea, and spinning vertigo which has remained in effect for 10 days. Not tolerating the vaccine interchange.
felt weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt weak). At the time of the report, ASTHENIA (felt weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No demographics provided. No dose information elaborated. No medical history, concomitant medication provided.   This case was linked to MOD-2021-201027 (Patient Link).
hard for her to walk; fell; legs gave out; chills; fever of 102.4; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (hard for her to walk), FALL (fell), PAIN IN EXTREMITY (legs gave out), CHILLS (chills) and PYREXIA (fever of 102.4) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 10-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (fever of 102.4). On 11-Feb-2021, the patient experienced GAIT DISTURBANCE (hard for her to walk), FALL (fell) and PAIN IN EXTREMITY (legs gave out). On 13-Feb-2021, GAIT DISTURBANCE (hard for her to walk), FALL (fell), PAIN IN EXTREMITY (legs gave out), CHILLS (chills) and PYREXIA (fever of 102.4) had resolved.            No relevant concomitant medications were reported.  Treatment information was  not  reported.   This case was linked to MOD-2021-214337 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR added included NNI
CLient given Tdap per school requirement (10th grade requirement).  Review imms record brought by dad.  DIscussed with dad and client past possible Td imms given, like if associated with stitches, etc.  None known by family.  Given Tdap.  Discovered after vaccine from PCP that Client had received Tdap 9/28/2006.  Told client and dad that he might have significant boosting affect and advised to take Ibuprofen q 6-8hrs. do decrease inflamation response.  RN also contacted CDC and same information was reinforced.
She received shot on 5/12. Presented to pharmacy 5/21 with app. 5" round rash (circular) on arm where shot was given. Said it has looked like that since she got the shot.
Sick; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Reporter had friends who had the vaccine and then got really sick with COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
CHEST PAINS WAS ADMITTED TO HOSPITAL. DIAGNOSED WITH MYO CARDITIS. MEDICATION GIVEN METOPROLOL (TOPROL-XL)
Within hours, a dull headache, which grew to usual side effects (fever, fatigue, headache, achy). However, 4-5 days later I still have a strong headache / pressure in head, and noticed fatigue and brain fog. Also noticing more PVCs than normal.
4 hrs p/vax pt had shrill unconsolable crying x 3 hrs, t101.6 mom brought pt to ER-pt was checked & sent home;
Medication drawn up for WCC by MA, LPN administered vaccine, after doing vaccine count found that patient was given Td instead of PCV - vials are similar.  Patient's parent informed of mistake.
palpitations,  no dizzyness, stiffness, no sob.  97%ra,  p-68,  170/102.  pt lie down in tent, observed for 15-20min.  fetl better.  no further palpitations.  ambulated around room and to car without event.