chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client stated her face and tongue felt, "tingling and thick" within 5 minutes of receiving a Pfizer COVID vaccine (LOT FC3183) in the left deltoid intramuscularly. Lead RN made contact with client who was in no apparent respiratory distress and had a calm demeanor, she stated her tongue felt thick and dry. Skins were warm, dry and normal color for ethnicity. Client denied any shortness of breath (SOB), chest pain (CP), difficulty breathing, dizziness or HA. She stated she otherwise felt fine and denied having any difficulty swallowing and was able swallow sips of water without difficulty or incidence, client was speaking coherently without any slurred or affected speech. A first set of vitals were taken at 1447: BP 120/70, HR: 68, RR 20. Client denied any pertinent medical history, denied any allergies to medications/foods/environment. Client denied any history of anaphylaxis and stated the feeling was similar to "being at the dentist with anesthesia". At 1449 client was given 50mg oral Diphenhydramine. Client continued to be calm and in no apparent distress other than stating her mouth and face were tingling. Client continued to be able to converse coherently and without affect. At 1456 client ambulated to the zero gravity chair without incidence and a second set of vitals were taken: BP 110/72, HR: 62, RR: 18, skins warm, dry and normal color. Client continued to deny any other symptoms such as SOB, CP, difficulty breathing, dizziness or HA. Client stated symptoms of thick tongue and tingling were not worsening. She continued to speak coherently without slurred or affected speech. EMS was activated at 1457. At 1503 care transferred to EMS. Client continued to deny any progression of symptoms, she stated the tingling of mouth and tongue continued and were "not worsening or getting better". EMS advised client to go to ER by medical transport. Client expressed concern regarding not having health insurance. EMS convinced client to go to the ER. Client agreed and ambulated to EMS gurney chair without incidence.  She remained in no apparent respiratory distress, skins were normal for ethnicity, client continued to speak clearly. At 1510 client was taken to ER by EMS transport.
Reporting system indicates adolescent received a pediatric dose for first immunization.  CDC card also shows pediatric dose.  Contacted family and will follow CDC guidelines to not repeat dose but to assure adolescent/adult dose at second shot in series.  Family provided with written documentation at second shot clinic received 12/18/21.
8-4-08, received PEDIARIX, HIB and PREVNAR #2, RV5, hives occurred approximately 24 hours after administration. 10-20-08, received PREVNAR # 3. Hives occurred within several hours after administration.
Information has been received from a certified medical assistant concerning a 15 year old female patient with no pertinent medical history and no known drug allergies who on 14-JUN-2011 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 666987/1016Z, expiration: November 2012) in her right arm. Secondary suspect therapy included a dose of VARIVAX (lot # 669098/1567Z, expiration: November 2012) (route and dose not reported) on 14-JUN-2011. Concomitant therapy included DTAP and MENACTRA. There were no concomitant pharmaceutical therapies. The certified medical assistant reported that on 14-JUN-2011 post vaccination the patient had seizure type activity with the muscles of her arms tightening and clenching of the fists. There was no incontinence or other symptoms usually associated with a seizure. The patient might have fainted for a few seconds. The patient was seated at time of vaccination. The patient was observed and monitored and her vital signs were checked but no treatment was needed. At the time of reporting, the patient had recovered. Upon internal review, seizure type activity with the muscles of her arms tightening and clenching of the fists was determined to be an other important medical event. Additional information has been requested.
(L) upper arm - pain from neck to shoulder blade. Deep pain in muscle upper arm at site of injection. Initial redness/lump - now resolved.
Pfizer Adult covid vaccine at day 33 of refrigeration was administered, which is past manufacturer limit of 31 days in the refrigerator for storage. Patient was offered revaccination through guardian. Proper labeling of vaccine refrigeration times has been enforced.
reported flu-like sx starting 6-8 hrs p/inject lasting 3-4 days; also c/o swelling size of baseball @ inject site rt elbow; no redness or fever @ site; did  have tenderness @ site & some weakness in rt arm; ? cellulitis vs ? allergic react
Initial and follow up information has been received as part of a pregnancy registry from a nurse practitioner concerning a 17 year old female with asthma, who in January 2007, was vaccinated with a 0.5mL dose of Gardasil (Lot# 653938/0954F). Concomitant medications included albuterol inhaler ("last used winter during allergy season") and Qvar. On 27-NOV-2006 the patient became pregnant. On 23-MAY-2007, the patient underwent a lab test that was positive and revealed that she was 23 weeks and 5 days pregnant. The patient's last menstrual period was 27-NOV-2006 and her estimated date of delivery was 03-SEP-2007. The patient had two previous births resulting in elective abortions. On 11-APR-2007 an alpha-fetalprotein test was taken and the results were negative. On 02-MAY-2007 an ultrasound was taken and the results were negative. The patient experienced pre-eclampsia resulting in a premature delivery by caeserian section on 12-JUL-2007. The infant was born normal and no congenital anomalies. The infant was a male with a low birthweight of 1510 grams, a length of 43.5cm, a head circumference of 31cm and an Apgar score of 8/9. At the time of the report, the patient's outcome was unknown. The pre-eclampsia and premature delivery were considered to be other important medical events. Additional information has been requested.
This spontaneous report was received from a consumer refers to a currently 45 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medication was not reported. On 11-NOV-2018 the patient was vaccinated with GARDASIL 9 dose 1, intramuscular, for prophylaxis (reported as to prevent HPV cancer) (strength, lot # and expiration date were not provided). On 11-NOV-2018, 1 day after onset of therapy, the patient experienced nausea.  On 12-JAN-2019, the consumer had not yet received her second dose of GARDASIL 9. The outcome of nausea was reported as recovered on an unknown date. At the time of the report the causality between GARDASIL 9 and the adverse event was not provided.
Fatigue, muscle aches and joint pain started around 4pm. 2/5/21. Bad chills started around 9pm 2/5/21. Chills wore off around midnight. Muscle ache, and join pain were accompanied by headache until about 9am 2/7/21. Experienced mild chills and hot flashes until 6pm 2/7/21. From 4pm 2/5/21 until 8pm 2/7/21 experienced fatigue. 5am 2/8/21 side effects are gone.
Left  side headache and neck pain for 1 hour after receiving vaccine Pain started 5 minutes after injection
Felt like fainting, rash, eyes and ears hurt, anxiety worse, tired and weak. Dizzy, depression worse, sensitives worse.
Information has been received from a physician and a licensed practical nurse concerning a pt who was vaccianted in a different office with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed cellulitis. Unspecified medical attention was sought. After several days, the pt recovered. No product quality complaint was involved. Additional information has been requested.
930AM 12OCT92 MD office w/nausea, weak; hx of heart disease; BP 162/50-sent ot ER expired 1152 12OCT92 w/prob dx of myocardial infarction;
This spontaneous report was received from a pharmacist via public representative refers to the two anonymous patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23. Concomitant medication included unspecified flu vaccine. On an unknown date, the patients became sick after vaccination. The outcome of the event was not reported. The reporter did not provide the causality assessment. No product quality complaint (PQC) was filed. No further adverse event information was provided. Additional information has been requested.
8:47am: Pt given influenza vaccine to L deltoid IM 8:50am: Felt difficulty breathing, throat closing sensation, able to talk, placed pt on the exam table to lie down, Pulse 101, Pulse ox 92% 8:52am: Given epipen to R thigh IM, called 911/security 8:54am: BP 109/66 P: 95 Pulse ox 95% 8:55am: Given oxygen mask non rebreather 8:56am: 99/66 P: 91 Pulse ox 99% 9:01am: 100/63 P: 94 Pulse ox 99%, oxygen mask removed, pt reports feeling better.  Temp 97 F  9:03am: Fire department and Security arrived 9:08am: EMS arrived, evaluated pt 9:14am: EMS left, pt transferred via stairchair to Hospital EMS
Developed mild swelling, mild itchiness and redness on left lower arm , not on injection site after 8 days of vaccination.
Lower extremity swelling, persistent shortness of breath and chest pressure for about a month. Received 2nd Covid vaccine on 4/1/2021 and a couple of days later started to have this chest pressure and shortness of breath. Was seen in the clinic on 4/9/2021 with upper respiratory symptoms and cough along with chest pressure. Covid/Flu/RSV PCR test was negative on 4/9/2021. Chest heaviness and shortness of breath persisted, though slowly improving. CTA on 5/7/2021- Showed large burden of pulmonary emboli extending from the lobar to the subsegmental pulmonary arteries and consolidation in the lateral right lower lobe is likely pulmonary infarct.  Patient is being treated with Eliquis. Placed in Observation overnight 5/7/2021-5/8/2021.
This literature report (initial receipt 05-Nov-2013) concerns a 6 year old male patient. The patient had no previous medical history. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, the patient experienced symptoms of cough and fever for ten days post influenza vaccination. The patient was noted to be limping and collapsed to the floor with complaints of headache, back pain, and lower extremity weakness. The patient was admitted to a local hospital and underwent lumbar puncture. He was diagnosed with Guillain-Barre Syndrome (GBS). He underwent five days of intravenous immunoglobulin therapy, but was still noted to have impaired motor function, left greater than right, with intact sensation in bilateral lower extremities. The patient was admitted to acute inpatient rehab three weeks after diagnosis secondary to his inability to ambulate. While in rehab, the patient underwent electromyography testing which was consistent with severe axonal motor neuropathy. Acute Motor Axonal Neuropathy (AMAN), a pure motor variant of GBS was diagnosed. The patient was admitted at wheelchair mobility level. At the time of discharge, 12 weeks after admission to acute inpatient rehab, he was able to ambulate a distance of 15 feet using a posterior walker utilizing bilateral hip-knee-ankle-foot-orthoses requiring moderate level of assistance. He was able to transfer with supervision and performed activities of daily living with minimal assist. Outcome was not reported. Reporter's comment: The author stated that the AMAN GBS had a possible onset ten days after influenza vaccination.
Case number PHEH2015US022797, is an initial spontaneous report from a health care professional received on 04 Nov 2015. This report refers to a 31 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1582040 at a dose of 0.5 ml intramuscularly on 02 Nov 2015. It was reported that the patient received vaccine that had been stored at 8.2 degrees Fahrenheit overnight before administration. The case was assessed as non-serious. No adverse event was reported following this maladministration.
Per pt, week ago arm's hurting then went to hands (left) then now both knees hurt especially right knee (very bad). Two days ok, but now hurting (pneumonia shot).
After patient was given vaccines, pt cried out once and then held breath. Pt lips began turning blue. I left room a got Dr. and we returned 5 seconds later to find patient limp and cyanotic on exam table. Dr roused baby by turning him over at which point he gasped and began crying and his normal color returned. We checked pulse ox which registered at 96%. Injection sites had redness 5 inches in diameter on each thigh. We observed patient for 20 mins in office. There were no additional symptoms and redness had resolved without treatment before patient left the office.
Woke up with face feeling numb. Seen in clinic on 11/06/09 with Bells Palsy after hospital discharge. Patient admitted to hospital after significant epistaxis and anemia from 10/31 to 11/2/2009. Epistaxis started before vaccine was given seen in ER and admitted on 10/31/2009. Given prednisone 50mg daily for 1 week in addition to iron tab that he was taking at time of discharge.  12/03/09 for DOS 10/31/09 - 11/03/09 Final DX: Iron deficiency anemia, constipation  Pt presented with constipation, decreased appetite, fever, encopresia, lethargy and cough.  Tx: IV fluids. Pt felt better and discharged home.  1/7/2010 PCP medical records - Duplicate Hospital records, discharge summary received. Service dates 10/31/09 to 12/8/09.  Assessment: Bells Palsy. Iron deficiency anemia. Previously hospitalized for anemia and epistaxis. Viral illness. Presents with allergic conjunctivitis, oral candidiasis. (L) Facial nerve palsy. Encopresis, constipation.
Painful vesicular rash on Rt mid back, abdomen and flank. Received vaccine 3 days prior to rash. Had cold symptoms prior to rash outbreak.
Erythema 4-5cm, sl firm; no tx; (local soft tissue rxn);
Pt. received vaccinations 9-5-14 approx 1 PM. Severe pain onset evening, chills, temp 101 degrees. Severe pain in LUA at injection sites. Pain relieved, full shoulder arm motion observed 9-8-14. Pt seen by me 9-8-14 about 9:30 A.M. Recommended no further vaccines until allergy testing completed.
Information has been received from a nurse referring to a 5 year old female patient with a known gelatin and tree nut allergy. The patient had no pertinent medical history. On 15-OCT-2015 an unspecified allergist had conducted a scratch test on the patient with the M-M-R II and the patient had a reaction to the scratch test. Then the allergist had made the decision to split up the full dose, 0.5mL, of the M-M-R II into 4 separate doses and the first dose of 0.05mL, was given on 15-OCT-2015 subcutaneously for MMR at the allergists office. There was no concomitant therapy. On 15-OCT-2015, immediately after receiving the vaccine, the patient experienced anaphylactic reaction with "tongue swelling, sneezing, coughing, clearing her throat, hives around the injection site and hives around her mouth." The nurse reported that the allergist had given the patient epinephrine, BENADRYL, an unspecified steroid and ZYRTEC as treatment. No test was performed for the event. The patient felt better later on that day after receiving the treatment. The causality between the events and the vaccination was not reported. Upon internal review, anaphylactic reaction was considered to be medically significant. Additional information has been requested.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: muscle pain in upper shoulder/neck area-Medium, Systemic: Unable to Sleep-Medium
sore throat; muscle weakness; fatigue; Initial information received on 20-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who experienced sore throat, muscle weakness and fatigue while receiving vaccine typhoid VI polysaccharide vaccine [Typhim VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect typhoid VI polysaccharide vaccine Solution for injection strength, dose not reported lot V2A556V expiry date: 31-Oct-2024 via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious event "sore throat" (oropharyngeal pain), "muscle weakness" (muscular weakness) and fatigue (unknown latency) following the administration of typhoid VI polysaccharide vaccine.  It was reported "Patient who is working received a Typhim Vi vaccine from overseas. Label states it is imported by Sanofi. She asked on whether Typhim Vi is an inactive vaccine and states that it is an inactivated vaccine. She concurred. Caller also mentioned that she experienced sore throat, muscle weakness and fatigue after being administered of this product".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events sore throat, muscle weakness, fatigue.  At time of reporting, the outcome was Unknown for the events sore throat, muscle weakness, fatigue.
Menactra mistakenly for HIB with no adverse event; Initial information received on 30-Dec-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 2 month old patient of unknown gender who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U6745AB; expiry date 21-Oct-2021) mistakenly for HAEMOPHILUS TYPE B (HIB) VACCINE [HIB] (lot and expiry date unknown) (wrong product administered) both via unknown route in unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported.   On 29-Dec-2020, the patient was given correct vaccine and had no reaction to the vaccine.   This was an actual medication error case due to the wrong product administered (latency: same day). At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
8-7-14- C/O Fatigue- weak feeling. 8-8-14 C/O more fatigue Sx-severe muscle weakness-Fever- uncontrolled crying, contusion- SOB- Went to ER-was in ER 4 hours-Had blood work- IV to bring fever down.
I sat in the observation area for less than 5 minutes before I had a tightening under my left arm and then a large palpitation. I have had continued palpitations and arrhythmia for the last two weeks.    I also became nauseous the following day that would come and go. It is still difficult to want to eat and I have lost 6 lbs.
Pain in the arm immediately after shot was received and continued for couple of days. Then after 7 days , itching started at the injection site and a red rash was observed. The whole right hand (which was the one injected with vaccine) started paining after the rash was obeserved.
Person 1st dose was Pfizer. Person received a Moderna dose for 2nd dose by mistake. No symptoms at time of incident.
Major allergic reaction 6 hours after PNEUMOVAX 23 val 0.5 MLX 10CC right arm totally disables. Forward movement 10% max. Major pain, swelling, little fever as of this writing its been 48 hrs with movement of my arm about 65%. Not happy off to see my Dr. Dr. at pharmacist had me on Excedrin and Benadryl, Ice pak.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 32 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". It was reported that patient contracted covid and was started PAXLOVID on day 4 of symptoms. Covid test was negative on day 11 (06Jul2022). On day 14 (08Jul2022), symptoms returned and my rapid test was positive again. Therapeutic measures taken as a result of drug ineffective, covid-19 included anti-viral PAXLOVID from 29Jun2022 to 04Jul2022.  Product Quality Group provided investigational results on 12Jul2022 for BNT162b2: Conclusion of Previously Completed Investigation (FCISIOffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF2587 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Based on the available information available, there is causal association between the events drug ineffective, covid-19 and the suspect drug BNT162b2 cannot be excluded . The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. Concurrent conditions or pertinent medical history were not reported. The physician read on an unspecified website that on an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL or GARDASIL 9 (it was unknown which one of both vaccines the patient received) (lot#, anatomical location and frequency were unspecified) intramuscularly. Concomitant therapies were not reported. On an unknown date, the patient experienced severe muscle pain all throughout her body (myalgia). At the time of the report, the outcome of myalgia was unknown. The relatedness of GARDASIL or GARDASIL 9 with myalgia was not reported. This is one of several reports from the same source. Additional information is not expected since the physician did not wish further contact.