chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered an expired Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 01-MAY-2023, the patient received Infanrix (left deltoid) .5 mg/ml. On 01-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administered an expired Infanrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-MAY-2023 The patient received inadvertently an expired Infanrix, which led to expired vaccine used. The reporter did not consent to follow-up.
Pt with progressive appearance of worsening sensation of joint stiffness to all joints of L upper extremity (vaccine in L deltoid) with predominant subjective sensation of stiffness to L hand and wrist joint. Objective exam: wnl. 2/22/03 joint stiffness
generalized weakness and sore throat. Monday 11/9/09 I started to develop shortness of breath and tachycardia. Later followed by muscle and joint aches.
small rash at shingles injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's comment: This case was reported by patient via interactive digital media. The patient reported that he/she had a small rash at shingles injection site. Additional Supportive Information: The follow-up would not possible as no contact details were available.
This spontaneous report was received from a physician concerning a 15 month old male patient. On 07-JUN-2013, the patient was inadvertently vaccinated with both a dose of PROQUAD (Merck) (lot number, expiry date, dose and route unspecified) and a dose of MMR II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Nausea, vomiting, and diarrhea. Flu-like symptoms.
Developed severe pain in left arm, shoulder, hand, & posterior shoulder blade & under arm in axillary area - day 2 post flu-shot; gradual increase in pain in arm (left) & numbness in hand, wrist, shoulder & up into (L) posterior latismus dorsi muscle-over next several days, TYLENOL & ibuprofen taken for pain with relief. Elevated arm (L) on pillows at night. Weak hand grip developed. Saw Dr on 10/24/11- awaiting referral to neurologist.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients may have been vaccinated with ZOSTAVAX (strength, dose, route, lot number and expired date unknown) that was stored outside of the original box and exposed to light. No adverse effect. The outcome of administered doses that were outside the original box and expsoed to light and no adverse effect was unknown. No further information was provided. This is one of several reports received from same source. Additional information has been requested.
Potentially 9 patients / received adjuvant only and not the active component; Potentially 9 patients / received adjuvant only and not the active component; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The reporter stated that potentially 9 patients over 3 days received adjuvant only and not the active component of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The identity of the patients was unknown. The lot number and expiry date of the Shingrix vaccine was unknown. The reporter consented to follow up. facilitywas notified of the event. The reporter had limited information and provided what was available.
pt recvd vax; exp pain shoulder joint; by morning was worse & immobility inc to elbow & later that day joint immobility inc to wrist; this cont to today;
Vaccine was administered 35 days after the "use by" date. No adverse reactions. Patient was contacted about the error and reports no adverse reactions.
R arm soreness, more significant than shingrix the first 24 h. Woke me up at night.  Abdominal cramping day3 w/o n/v, diarrhea or other gi symptoms  Fatigue 5 days
This RN administered IM Covid-19 vaccine in right deltoid. No complaints of pain at this time. Consents reviewed and signed prior to vaccine administration. Precautions and contraindications to receiving vaccine reviewed and understanding verbalized. Patient verbalized that she has MS and wanted that documented in her Note. Escorted patient to observation area to be monitored for 15 minutes. Patient (RN) 13:50H Observation room: 13:56H Developed numbness and tingling of her both arms. Sitting in chair: She was placed on POX monitor sats 100%HR100, RR 26. Breath sounds clear bil lung fields. Good air entry.She said she is okay. Patient denies itchiness or difficulty of breathing. 169/112 mmHg. Warm well perfused.. Pulses 2+ 14:00H 158/100 mmHg, fully awake, conversant sats 100%, RR 22, HR 112. Breath sounds clear, good air entry to bil. lung fields. 14:07H Patient said she feels pressure on her throat and dizzy. SOB/ shortness of breath. Patient was placed flat on the floor. She is conversant all through out , fully awake, alert and knows all her personal information including her DOB. 911 called and on their way 14:10H Epi auto injector administered by RN @ Left upper thigh. Covid vaccine Team: RN, present on Patient's side. Patient's PCP/neurologist contacted. Red patches on her neck noted after Epi shot was given. 14:15H Patient verbalizes she feel better but her tingling of both arms and legs still present. No more shortness of breath. Red patches on her neck fading. 14:17H 911 team arrived. Report given to the team. Patient answers all the questions asked and refused to be brought to Emergency facility. 14:20H Patient more stable, verbalizes tingling and numbness lesser or mild 14:30H 911 team left. Patient refused to be brought to any Emergency or Hospital facility. 14:45H Sats 100% R/A, HR 88, RR 20, BP 153/90 mmHg Rt arm 15:00H Bp 140/93 mmHg, sats 100%, HR 80, RR 20 . Now she said she has headache. Waiting for the ambulance at this time. 15:06H Patient verbalizes headache and recurring numbness and tingling on her limbs: upper/lower limbs. Patient was placed in stretcher at this time.911 was called again at this time. Covid vaccine team at bedside. MD happened to be around and stay at bedside. 15:10H Patient, fully alert/awake, warm , well perfused Sats 99% R/A, HR 80, RR20, BP 147/87mmHg. Breath sounds bil clear, good air entry. 15:13H 911 team arrived , report given. 911 team take over Patient and to be transported to Hospital.
Information has been received from a 22 year old female patient with no known pertinent medical history, or no known drug reaction/allergies, who in July 2008, was vaccinated with first dose of GARDASIL vaccine. The consumer reported that three days after receiving the first dose of GARDASIL vaccine she developed swelling of both of her eyes. The swelling resolved one day later after vaccination. The patient sought medical attention by a phone call. Additional information has been requested.
On April 14th I experienced a sudden onset of burning in the face, tingling, a sharp pain in my head followed by almost blacking out. We called an ambulance and my blood pressure was 230/122. I have never been hypertensive in my life before that night. Over the last few weeks I have continued to have uncontrolled blood pressure, constant headaches and pressure in the top of my head along with ringing in the ears and light headedness. I have seen a cardiologist and my primary care doctor, along  with being admitted the night of the 14th. They have run multiple tests and can't find anything abnormal but my blood pressure is still not controlled after being on meds. They have doubled them twice. I have had 3 more episodes where I am completely bedridden for the day. I have always been a healthy person with no need to see a doctor aside from check ups. I exercise regularly.
Instant pain shooting all the way to forearm - sharp/burning pain. Loss of range of motion - initially recurring numbness in arm and fingers with burning and pain - subsided after 2 1/2 mo - still experience pain with limited range of motion. Vaccine injection was given in superior posterior upper arm proximal to shoulder tender to touch still to present.
This spontaneous report as received from a healthcare worker refers to the patients of unknown age and gender with no medical history reported. Since 12-MAY-2015, an unspecified number of patients had been vaccinated with doses of improperly stored GARDASIL 9 lot number: K004205, expiry date: 12-JAN-2017 (route of administration and dose were not reported). Further information was provided that approximately 10 patients had been vaccinated with doses of another improperly stored GARDASIL 9 lot number: L014415, expiry date: 25-JUL-2017 (route of administration and dose were not reported). No concomitant medications were reported. No adverse events were reported. Product quality complaint (PQC) was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Exposed to Covid; Chills; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (Covid19 vaccine, formulation: Solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 21Mar2021 (at the age of 43-year-old) as 1st dose, single dose for covid-19 immunisation. The patient had no medical history. There were no concomitant medications. On an unspecified date in 2021, the patient was exposed to covid with a co-worker for the past two weeks and was held to quarantine for 14 days. On an unspecified date in 2021, the patient experienced chills. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
drove me right into the bone and I went ouch; Intravenous in the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2 (BNT162B2), on 12Feb2020 as dose 1, single (Lot number: EN6200) intravenous, in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Smoke cigarettes" (not ongoing), notes: I was smoking 2 packs a day.; "Equilibrium issue" (ongoing); "high blood pressure" (ongoing). Concomitant medication(s) included: MECLIZINE [MECLOZINE] oral taken for balance disorder (ongoing); AMLODIPINE oral taken for hypertension (ongoing). The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Feb2020, outcome "unknown", described as "Intravenous in the arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "drove me right into the bone and I went ouch".  Additional information: Patient had all 3 shots and booster and it worked. When probed for route of administration: Consumer stated, "Intravenous in the arm, injection in the arm." As of 14Aug2023, the time for administration of dose 1 BNT162b2 was at AM. The Pfizer vaccines that the patient received for Covid worked well. The patient had no triggered effects. The patient got the booster when it was available for extra protection. It was reported that the doses 1, 2 and 3 were wonderful. Reported the prior Vaccinations within 4 weeks was none. Relevant/specific relevant tests were none. As of 06Sep2023, the patient stated that "the only time I had a problem is one of the people that administered it, she drove me right into the bone and I went ouch what were you doing but other then that, the product is, I think it is wonderful". The patient like to have some more this year.  Follow-up (14Aug2023): This is a spontaneous follow-up report received from a contactable consumer. This consumer reported in response to non-HCP letter sent in cross reference case that included: Updated information included: Reporter details, patient details (name and age group), relevant medical history details, concomitant drug details and additional information was updated.  Follow-up attempts are completed. No further information is expected.  Follow-up (06Sep2023): This is a spontaneous follow-up report received from a contactable Consumer. Updated information: reaction detail (added event: drove me right into the bone and I went ouch) and clinical course details.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263551 same patient/drug, different dose/events (Dose 3);US-PFIZER INC-202300263550 Same Patient/Product, Different Dose/Event (Dose 2);
Information has been received from a nurse practitioner (NP) concerning a 14-year-old female with no medical history or allergies who on 13-NOV-2006 was vaccinated SC in the right arm with the first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot #650388/0914R). There was no concomitant therapy. The NP reported 15-NOV-2006, the patient developed a 3-4 inch area if redness, swelling, warmth and discomfort at injection site of her right arm. On that same day, the patient was examined and ice compresses and ibuprofen were prescribed. No laboratory/diagnostic tests were performed. Follow-up appointments were scheduled for 16-NOV-2006 and 17-NOV-2006. At that time of this report, the patient's events persisted. Additional information has been requested.
Severe hives on face, hands, feet, arms, ankles. High levels of discomfort and agitation.
Client stated after her shot her throat swolled up and she couldn't eat nothing but soup for the next couple of months. Used her own epi pen twice.  No trouble breathing , only trouble swallowing. Never went to doctor or hospital. RN
Interchange of vaccine products; Revaccination with different COVID-19 vaccine; she started feeling numbness in the arm that was injected; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (she started feeling numbness in the arm that was injected), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     It was unknown if the patient had any relevant medical history/conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for COVID-19 prophylaxis: Pfizer (All previous COVID-19 and received were all Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer.    On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HYPOAESTHESIA (she started feeling numbness in the arm that was injected). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, HYPOAESTHESIA (she started feeling numbness in the arm that was injected) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  Caller wanted to know that, is it normal to have the adverse event and since all previous doses were Pfizer, does that make a difference if the patient received Moderna for the last dose.   Reporter did not allow further contact
Pt arrived for 2nd dose of vaccine today patient stated that she did have a previous reaction of hives, rash, and itching for 2 weeks status post 1st vaccine dose. 12:20- Pt given 2nd dose of vaccine by this nurse and began monitoring on stretcher. 12:33-Pt stated she was experiencing some dizziness and itching to the left posterior neck 1235-Pt stated she was now experiencing itching to the back and noticed some increased work of breathing and redness to her left side of the neck. Patient stated: " Hard to breath and it feels like I am unable to take a deep breath." 1237-Provider and medics on duty notified and patient assessed and patient's VSS and lungs clear to auscultation. Provider ordered Benadryl 25mg oral liquid to be given to the patient. 1237: Patient given Benadryl 25mg Benadryl by nurse. Patient observation continued and it was found that after calling patient's mother that the patient did have a reaction to the Typhoid Vaccine in the past with a noted PEG Allergy.  Patient denies any other allergies but does take allergy injections and her last dose was 2/8/21.  Provider spoke with patient and patient's mother who came to pick up the patient that the recommendation at this point would be to follow up with either Urgent care of Emergency room due to the known PEG Allergy. Mother arrived and pt was to be transported via private vehicle to Urgent care. Patient strongly encourage to establish with a PCP and after speaking with the Lead provider it was noted that the patient could go home with mother but monitoring should occur at home and the patient should take another dose of Benadryl 25mg four house after the initial dose of Benadryl.  Patient and mother educated of this and communicated understanding. 1337: Provider gave detailed discharge instruction to the patient and when also when to follow up if any swelling, increased itching, hives, or worsening of shortness of breath should occur. Pt should take additional precautionary dose of Benadryl 25mg at 1630. 13:40-Patient denied any further itching and redness had decreased.  Patient discharged home with mother and mother also stated that if needed there is an Epi Pen in the house and readily available if needed.
Patient,had received second dose of Moderna COVID vaccine and was waiting the 15 minutes post injection for observation.  Patient reported that she felt her tongue swelling and had difficulty swallowing.  Patient anxious, but in no respiratory distress.  BP 130/72.  Patient was instructed to take some slow deep breaths. Patient continued to c/o tongue feeling thick and she had hacking cough and c/o difficulty swallowing.  Patient was given Epinephrine 0.3 auto injector to right thigh at 1:32 pm by RN. BP 150/92, P 90 R 20,  Patient also given Diphenhydramine 50mg IM to left deltoid by RN, Supervisor.  Patient remained alert and oriented. BP 176/92 at 1:37 pm.  EMS arrived on site and monitored patient with EKG, Pulse oximeter, BP and pulse.  Patient had some shaking.  She remained alert and oriented.  Patient refused transport by ambulance to ER.  She did agree to go to ER by private car.  Patient's husband resent and to transport patient by car to  Medical Center.  EMS followed patient to hospital.  Confirmed that patient was taken to Medical Center ER, by RN.
After receiving Hep A injection, pt felt dizzy and stomach "felt funny". Pt laid down on exam table and "passed out" for a couple of seconds and waited in room for 10 minutes. Pt recovered quickly. BP was taken 90/60. Pt left with mother feeling well.
Tooth extraction; Racing heart, heart rate was in the 130s; This spontaneous case was reported by an other health care professional and describes the occurrence of TOOTH EXTRACTION (Tooth extraction) and PALPITATIONS (Racing heart, heart rate was in the 130s) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic lymphocytic leukaemia, Heart rate abnormal in 2019, Dizziness in 2019, White blood cell count decreased in 2019, Laziness in 2019, Heart rate high (for about 3-4 min) in 2020, Glare in 2020 and Difficulty focusing eyes in 2020. Concomitant products included METOPROLOL SUCCINATE, IBRUTINIB (IMBRUVICA) from 29-Aug-2019 to an unknown date and IBRUTINIB for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTH EXTRACTION (Tooth extraction) and PALPITATIONS (Racing heart, heart rate was in the 130s). At the time of the report, TOOTH EXTRACTION (Tooth extraction) and PALPITATIONS (Racing heart, heart rate was in the 130s) outcome was unknown.        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.   Treatment medication include Baby Aspirin.
pt recv vax & w/in several hr post vax pt exp severe h/a, fatigue, sensitivity to light & an achy feeling;pt was seen by MD for h/a & given Ibuprofen;sx lasted approx 36hr & then resolved;
I thought I was just getting a cold. It started as a scratchy throat that developed into a sore throat. Then I started getting a runny and stuffy nose. I was sneezing for a while and it developed into coughing where I would spit up phlegm. I had a slight headache but no fever. I tested for COVID-19 on November 08, 2022 and it was positive. I called my doctors office the next day and spoke with the nurse who gave me instructions over the phone. I went to the doctor at the end of November to see if I was all clear and they said that I seemed to have recovered. I was not prescribed any medications, I just took over the counter Mucinex.
Presented with Covid symptoms; dx PTA on 9/2 and hospitalized from 9/2-9/9..had been improving but then worsened over last few days; admitted 9/23 to tele with Covid PNA; 9/23 zithromax, rocephin, Vit C, zinc started; 9/24 Baricitinib, steroids, lovenox started 9/29 maxipime started; O2 flucuated between 5lPM on arrival to NRB on 10/2; 10/2 Cr rising; nephrology consult; appearing headed to multiorgan failure; pt decided on comfort care/hospice;
Received DTaP #5 & IPV #4 on 5/4/12, then on 5/6/12 presented to local ER with lg local rxn vs cellulitis & given KEFLEX severe behavior outbursts & tantrums noted during this time & lasted 3 1/2 wks. Seen in office 5/18/12 with multiple labs checked & neg/nl. Mom worried about "encephalopathy"
Pain at injection site, low-grade temp, myalgias, generalized mild malaise, fatigue.  Sore injection site started within an hour of injection.  Other symptoms started ~12 hrs later.  These symptoms, largely relieved with Ibuprofen, continued for ~48 hrs.