chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt started vomiting during 1st 15 minutes, pt was given 2 teaspoons of liquid Benadryl , given gingerale and unable to tolerated, vomiting continued,B/P 145/83,  Epi shot give Lot#9FM656, Exp 5/1/21.  b/p taken every 10 minutes and pt observed for 30 more minutes.  b/p at 9:25-123/83, 9:35-120/82, 9:45-111/75.  Pt denied dizziness, n/v when released.  Pt advised not to have 2nd Covid dose unless she clears it with her primary.  Pt advised to go to ER if sypmtoms return or worsen.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: 027E22A) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment (Brand: Pfizer) from 23Aug2023 to 28Aug2023.
pt recvd 2nd Hep B vax 29NOV89 & later exp pain radiating down arm to the wrist,& under the arm to shoulder & neck.By 04DEC89 pt had marked improvement w/ slight tingling in left hand. 22JAN90 pt. recovered.
Nausea/vomiting, lightheaded approx 10-15 minutes post injection. Client pale, weak, pulse weak/regular. T. 97.9 B/P 95/55, P-51 R-16. Skin cool, dry, lie down x 5-10 minutes. Set up, ate pretzels, drink water; B/P 100/65 P-48 R-16, color improved. To recheck with mother, sister under /// ///
This spontaneous report was received from a licensed practical nurse and refers to a 7 month old female patient. There were no illnesses at the time of vaccination. Medical history, historical or concomitant drugs were not reported. The reporter informed that on 26-JUN-2018, the patient was vaccinated with improperly stored doses of PEDVAXHIB Injection, dose 3, intramuscular in the left thigh, lot # R000877, expiration date 24-SEP-2020; ROTATEQ liquid, dose 3, oral, lot # N024294, expiration date 26-FEB-2019; PEDIARIX dose 2, intramuscular in the left thigh, lot # 33P194 (expiration date not reported); and PREVENAR 13 dose 3, intramuscular in the right thigh, lot # T81219 (expiration date not reported); all for prophylaxis. The nurse stated that the refrigerator door was left slightly open. The doses were exposed to a temperature of 52.1 F for 1 hour and 25 minutes. There was no previous temperature excursion, and this call was not made because of a digital data logger.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccines were stored in freezer and required vials were taken out to place in fridge as needed.  Concomitant medication information was not reported Treatment information was not reported
day of immun tenderness, swelling (mild) color;day 2 inc tenderness, inc swelling, warmth;day 3 same;day 4 inc swelling;hard & indurated;
This non-serious spontaneous case, initially received from other health professional (nurse) on 29-Jan-2018, concerning a 25-year-old, adult male patient. The patient's historical condition included cellulitis of L (left) upper extremity (unspecified date). The patient's current conditions included Crohn's disease and ankle pain (since an unspecified dates). The patient's historical drug included budesonide for an unknown indication. On an unspecified date in 2013, the patient was administered with influenza vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, manufacturer, trade name and expiry date: not reported). On an unspecified date in 2013, after the vaccination, the patient had severe allergic reaction with nausea and vomiting, for 2 days. It was reported that, patient was not on STELARA at the time of vaccination. The patient made a visit to the physician for the events. The patient had recovered from the events nausea and vomiting. The outcome of the event allergic reaction was not reported. The reporter considered, the causality of the events as not related to the suspect vaccine. Follow-up received from other health professional (nurse) on 15-Feb-2018: It was reported that, the patient made a visit the physician for the events. The outcome of the events nausea and vomiting was resolved. The patient's physician reported that, the events were not related to the flu vaccine. Hence, the "As Reported Causality" for the events was changed from not reported to not related. The narrative was amended accordingly.
Joint pain, fatigue, unrestful sleep and memory problems.  Had reproducible symptoms with each anthrax vaccination beginning in 2003.  With AVA #4, symptoms began to effect daily functioning.  Diagnosis: Chronic fatigue syndrome.  Symptoms: Insomnia, joint pain, multiple joints, fatigue, malaise >60 days, cognitive deficiency.
Dizziness and fever. Pain on her shoulders. Caller adv that it feels like arthritic pain. Per caller she has been having the symptoms since her first shot and it continues. After the first dose she went to her pcp who prescribed her cortisone shots. Adv her to go back to her pcp since she is still having the symptoms.
parotitis secondary to MMR?;swelling & tenderness above parotid gland & jaw angle rt side;
4 vx given after delayed delivery due to inclimate weather; This case was reported by a other health professional via sales rep and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In February 2022, the patient received Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. In February 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The age at vaccination was not reported. One to 2 years old patient received dose of Havrix pediatric from a shipment that had delayed delivery due to inclimate weather from 3rd February 2022 till 7th February 2022 but was still showing a good temperature tag alert in the box upon delivery to office.The Glaxosmithkline agreed to return and replace these vaccines on 9th February 2022 due to this longer than normal delivery window even though tag alert was still showing ok after 5 days in transit with this delivery on 7th February 2022. The reporter stated that, on 16th March 2022, learned from the GSK Vaccine Service Center that these 4 Havrix pediatric doses were not returned with rest of claim, and confirmed from the pediatric office on 17th March 2022 that these vaccines were administered to patient around the second week of February. The office was not extremely concerned due to good Glaxosmithkline temperature tag alert upon delivery. No adverse events or patient issues were reported after administration. There seems to be some internal Glaxosmithkline confusion with the temperature tag alerts after 4 days in transit. No evidence given that there was any temperature excursion during delayed delivery to compromise vaccine stability. The reporter consented to follow up. This case was 1 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR049401:Same reporter.
This spontaneous report as received from a nurse refers to a 8 week old patient of an unknown gender. On 16-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
I had a reaction begin on 1/28/2021. I was 21 weeks pregnant with a baby girl. Everything has been healthy so far. I had started amoxicillan Tuesday (1/26) for a UTI in pregnancy from a high level of Strep B in my urine. On 1/27 before bed I noticed a hard lump where my vaccine had been. On 1/28 when I woke up the bump had developed into a red mark that itched. I reached out to my obgyn who said to report if it worsened.. On 1/29 the red mark had grown in size but was less red. It disappeared on 01/30.
This spontaneous report was received from a healthcare worker and refers to 9 unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of (Oka/Merck) VARIVAX (Lot# L008271; expiration date 11-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received from 23-OCT-2015 from a certified medical assistant. The medical assistant noted that the number of patients who were vaccinated with improperly stored doss of (Oka/Merck) VARIVAX (Lot# L008271) was 8, not 9 as previously reported. Follow-up information has been received on 27-OCT-2015 from the certified medical assistant. The reporter provided that the patient of unknown age and gender was vaccinated with the improperly stored dose of (Oka/Merck) VARIVAX on 01-SEP-2015. It was also reported that the vaccine was 1656 hours out of range. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product and event details and analysis were updated.
Patient complained of vaccine site feeling burning & on fire. area red, scattered red raised macula rash with itching on upper arm and axilla at 4:40pm. Cetirizine 10mg oral given, ice pack applied at 4:45pm. Redness and burning improved at 5:10. No signs of respiratory distress or signs of anaphylaxis. Reported to physician. Patient to take Cetirizine for next few days.  Ambulated to car without any incident, daughter driving.
a 63 y.o. male has history of HFrEF due to ICM, mod-severe MR, CKD II-III, DMII, MI X2 with PCI and  LV thrombus on warfarin. He is currently listed for heart transplant.  Patient complaints of loss of appetite, generalized weakness, mild productive cough, and mild dyspnea since Saturday.  He denies fever, chills, sore throat, nausea, vomiting, abdominal pain, diarrhea, loss of taste or smell.  Patient denies any recent weight gain or weight loss.  He initially went to Emergency Room where he was tested positive for COVID 19.  He was given Tylenol then was transferred for higher level care.    Unknown contact information for provider who cared for the patient.   Review of Systems  Constitutional: Positive for appetite change and fatigue.  Respiratory: Positive for cough and shortness of breath.     Pt remained on warfarin, was started on remdesivir and steriods. Pt was diuresed for fluid overload and developed AKI, lasix were held. Pt had worsening oxygen requirements overnight and was re-started on diuresis. Pt coded and underwent about 1 hour of CPR and was pronounced at 11:28 am.
"noted that the moderna booster was not the bivalent booster but the original moderna. called the pt and informed her and she voiced no problems. provider was informed and office manager "
Rash at injection site 1 week after vaccine received. Rash about 3 inches in diameter, warm to the touch, slightly itchy.
2 minutes post vaccine administration, patient complained of scratchy throat and stated "feels thick to swallow".  Medical provider was called for evaluation, vitals signs obtained, Order given by medical provider to administer  Benadryl 25 mg IM.  Patient evaluated for 30 additional minutes. Patient denied symptoms, patient taken home with family member and instructed to follow up with PCP. Patient verbalized understanding.  Timeline:  Vaccine administered  1050 Symptoms presented   1052 Vitals obtained                 1055  BP 104/72, P 74, R 24, O2 sat 99.1 Provider evaluation      1100 Medication                         1103 Patient discharged         1140
Patient states, that he felt fine going home with only a sore arm. Later that night, around midnight, we woke up and felt extremely weak. He reports no fever or muscle aches. For 3 days, he had to stay in bed, ate and drank a small amount, and had to crawl to go to the bathroom. After 3 days, he woke up, and felt fully recovered and was able to go back to normal activities.
lightheaded; elevated blood pressure; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Jan2021, the patient experienced lightheaded, and elevated blood pressure. The patient underwent lab tests and procedures which included blood pressure measurement: elevated. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
MMR vaccine reconstituted with Menveo liquid component; Menveo liquid portion (exp APR-2022) reconstituted with MMR, administered; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 33-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA710A, expiry date 30th April 2022) for prophylaxis.   On 13th October 2022, the patient received Menveo. On 13th October 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and expired vaccine used. On an unknown date, the outcome of the wrong solution used in drug reconstitution and expired vaccine used were unknown.   Additional Information: GSK receipt date: 13-Oct-2022 Reporter' s comment: The consumer stated that the patient received MMR vaccine from Merck (not priorix) with liquid component of Menveo. The consumer wanted safety information from GlaxoSmithKline. Referred patient to GlaxoSmithKline medical information. The healthcare professional's contact information was sent to safety team by email. The reporter consented to follow-up via email. Additional supportive information: The patient inadvertent administered expired liquid meningococcal CWY component of Menveo with MMR powder, which led to wrong solution used in drug reconstitution and expired vaccine used. The case US2022AMR147374 was identified as duplicate of US2022147498. The case US2022147498 was deleted from the database and all the future correspondence would be added in this case which stands as a case of record for this patient.
COVID 19 Pfizer vaccine dose given beyond use date.  There were no signs or symptoms of side effects.  There was no treatment necessary.
Client notice pain, swelling & heat & redness vaccine administered. C/O headache & nausea 5/25 scale 1-10 rated 3.
Pfizer-BioNTech COVID-19 Vaccine EUA Fever, Chills, Joint Pain, Muscle Pain, Headache  Symptoms lasted for 36 hours
A vial of Pfizer-BioNTech vaccine was punctured at 10:00 am on 7/22/2021. Vial was in refrigerator and stayed there between 8 and 30 degrees Celsius until 4:47 pm on the same day. At 4:47 pm, 2 doses were drawn from vial and administered one to, and one to another patient. 4:47 pm was 47 minutes past the 6 hour use by time listed on the fact sheet from the CDC and the manufacturer. Per CDC guidance on their "COVID-19 Vaccine Administration Errors and Deviations" fact sheet, Pfizer manufacturer was contacted on 7/22/2021, and again on 7/23/2021. On 7/23/2021, a representative of Pfizer's medical team, RN was spoken with. She verified that according to Pfizer's studies, the Pfizer COVID-19 vaccine maintains viability for up to 24 hours at 8-30 degrees Celsius in refrigerator. Additionally she stated that I, and my colleagues should use our clinical judgement due to this information being outside of the fact sheet recommendations, as to if patient's dose of Pfizer's COVID-19 is valid, or needs to be repeated. No adverse effects were stated although a report was escalated to Pfizer's safety department out of an abundance of caution, and waiting to hear back.
About a week after my second dose I developed fever and flu like symptoms. I took 2 covid tests and they came out negative. My flu like symptoms worsened and persisted for several weeks. On 04/21/2021 my neck began to hurt and swell, mostly on my right side. The following day the pain worsened to the point of calling out of work and seeking help at an urgent care. At this point, the lymph nodes in my neck appeared to swell on both sides. Swallowing became difficult and I struggled to eat mashed potatoes. In the following days my neck began swelling more and it became difficult to drink water. The pain level rose to a 7 out of 10 and my throat was so swollen that when I tried to drink water or protien shakes part of them would go up my nose and down the wrong pipe in my throat. It became difficult to talk and my lymph nodes seemed extra swollen. I went to an emergency room in  but the doctor was unsure of any treatment and sent me home to rest. I declined lab tests. I had sever chills, sweating and fever. On 04/30 My symptoms began to improve and on 05/02/2021 I was able to eat again. At this point I'd lost 13 pounds and was weak.
Information has been received from a medical assistant concerning a female patient who was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 654998/0827F).  On an unspecified date the patient developed a rash (site unspecified).  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Follow-up information was received on 20-SEP-2007 via a telephone call.  Medical assistant confirmed that a female patient developed a rash following vaccination.  This is one of several reports from the same source.  Additional information has been requested.
Pt complained of chest tightness  15 mins after receiving vaccine. She noted that she has seasonal allergies, had same symptom and was seen by her PCP and received ABx. She denies any other symptoms. Pt assessed and evaluated by NP and EMT. BP - 139/76, H
Redness/swelling @ upper arm - 8" length 5th" width Benadryl/Tylenol.
Severe reactions including hospitalization; This case was reported by a pharmacist via sales rep and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID 19 VACCINE.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was given Shingrix a few weeks after Covid vaccine and had severe reactions including hospitalization. The reporter agrees to follow up from GlaxoSmithKline. This case has been linked to the case US2022AMR033567 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR033567:Same reporter. Patient 2 of 2.
?COVID arm? - red, swollen, itchy lesion appeared at the injection site 7 days post vaccine.
parent denies adverse reaction R/T wrong dose admin 0.5ml instead of 0.3mL.
A serious spontaneous report of "inadvertent eye exposure to H1N1 LAIV" and "blurred vision has become exacerbated" has been received from a registered nurse/health professional concerning a 46-year-old male subsequent to H1N1 vaccine intranasal. Neither relevant medical history nor concomitant medication have been reported for this patient. On 26-Feb-2010 or 27-Feb-2010, the patient received the H1N1 vaccine, intranasal for an unknown indication. While vaccination, the patient inadvertently received a portion of the H1N1 LAIV dose in the eye. Immediately after inadvertent eye exposure, the patient started experiencing blurred vision. The blurred vision was exacerbated and was not resolved at the time of report. The outcome of "inadvertent eye exposure to H1N1 LAIV" was resolved while the outcome of "blurred vision has become exacerbated" was not resolved.
5 minutes after the shot I felt a rapid heart beat that lasted about 5 minutes and then subsided When I left the site my face was very flushed and I had a small red mark on my check, from the flush, that subsided quickly too Although I understand this is not a substantial reaction and it did resolve I am a little concerned about what to expect from the second shot. Can you tell me if this is a common reaction?   I really want to know about people who complained about this and then received the second shot, what was their reaction then. Thank you so much
Pain in arm; All "my" joints aching; Fever 99.8; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 12:00 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Medical history included charcot-marie-tooth disease (CMT neuromuscular disease), celiac disease, known allergy to gluten and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC) and naproxen (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 23Apr2021, the patient experienced pain in arm, all her joints aching and fever 99.8. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 23Apr2021, the patient underwent lab tests and procedures which included body temperature and the result was 99.8 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in arm, all her joints aching and fever 99.8 was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.