chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He's not having  any issue. Two issues. #1 He was boostered 86 days after Regeneron treatment for COVID #2 His second dose was 9/21/2021. So he was boosted way too soon and within 90 days of Regeneron.
She nearly fainted after the vaccine.  They had not advised her to sit still for 15 minutes - but she had to in order to not faint.
During a flu clinic at a local business a patient was administered a pneumovax and fluzone. The pharmacist. The patient requested that he get a pneumonia shot because he had revieved one in 2014 and needed another  and when the pharmacist asked if he was over 65, the technician that was helping out and going over patient questionaires with the pharmacist  at the flu clinic said 66. The pharmacist then administered the pneumovax and fluzone to the patient thinking the patient was over 65.  The prescriber and patient was then notified of the error.
ActHib vial was inadvertently mixed with a Merck vaccine diluent, rather than the diluent that is supplied with the ActHib vaccine and administered to the patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via physician via regulatory authority (GMI) (reference number- 00636420 and 00636271) and transmitted to Sanofi on 10-Jun-2021.  This case involves a 15 month old male patient who received 0.5 mL fourth dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ437ABB, expiry date: 03-May-2022, total, drug interval dosage: once] via intramuscular route at the right thigh, on 09-Jun-2021, for prophylactic vaccination which was inadvertently mixed with a Merck vaccine diluent, rather than the diluent that is supplied with the HIB (PRP/T) VACCINE [ACT-HIB] (product preparation error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of actual medication error due to wrong diluent used. (Latency: on the same day)  At the time of report, reporter wanted to know the recommendations on what to do will be upon that ACT-HIB was reconstituted with the wrong diluent, that for a Merck vaccine, rather than the supplied diluent, and then administered to the patient and additionally asked how to proceed.   At the time of report, reporter wanted to the protocol/side effect of giving Hib reconstituted with Merck diluent and wanted to know if patient need to revaccinated.  At the time of report, no adverse event reported.  At the time of report, event outcome was not applicable.   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 the 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.
Received vaccine late Wednesay afternoon (5:30PM). Thursday/next day- originally developed fever of 101.2, chills, headache, body aches. The next day (Friday evening) developed hives throughout body. Started on left foot and neck, small area on left side of rib, and small area on right foot.  Hives continue to spread after having taken benadryl and hydrocortisone cream. Hives now covered face, whole chest area, on back, feet, neck by Saturday morning. Went to urgent care and saw provider who confirmed hives due to delayed reaction to covid vaccine. Prescribed prednisolone.
Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No relevant concomitant medications were reported. On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any AEs after the vaccines were given. No treatment medication reported.   This case refers to patient-15 out of 26 patients.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on an unknown dates an unspecified number of patients received doses of ROTATEQ (orally, dose, frequency and lot # not reported) that were improperly stored. No adverse experiences reported. No further information provided. This is one of several reports from the same source. Additional information has been requested.
Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (LPN). This case is linked to case 2018SA166717. This case involves a patient (age and gender was not reported), who was vaccinated with only PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was also reported that they do not know which one received only dtap/ipv and which one received full dose. It was unknown if any adverse event was occurred or not following the vaccination. 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  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. Documents held by sender: none.
About 3 hours after the injection I began to feel tired and lethargic. 10 hours after the injection I began to feel more cold than normal.  12 hours after the injection I realized I had a fever and it took about 3 hours to break. By the next morning, today, I felt sore all over my body, like I had been non-stop throwing up. I had a raging headache in my right eye. Still feeling very lethargic. 27 hours later I still feel not myself.
Pharmacist gave a dose of the Moderna vaccine that had been opened for more than 6 hours; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and gave a dose of the Moderna vaccine that had been opened for more than 6 hours.   The patient's medical history was not provided. No concomitant medications were provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient received the vaccine that was opened for more than 6 hours. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, out of specification product use, was considered recovered/resolved on an unknown date.; Reporter's Comments: This report refers to a case of Out of specification product use (gave a dose of the Moderna vaccine that had been opened for more than 6 hours) for mRNA-1273. There were no reported AEs associated with this case.
Patient displayed local site reaction including redness, inflammation & cellulitis radiating in a 8 mm circumference. Patient went to ER on 9/22/12 and was treated for cellulitis with cephalexin 500mg 4 times a day for 10 days.
chest tightness, dizziness, lightheaded, achy across shoulders, hoarseness 15-18hr 3hr p/vax given;
Pt. presented for 'rash' which appeared 1-2 days after immunization (by report). Upon exam, the pt. was noted to have palpable purpura of bilateral lower extremities consistent with HSP.
headaches started several days to a week after the first vaccine. Headaches have continued now even after 2nd vaccine. Constant headache
Night of and next morning of vaccine: fever of 103.8 F recorded, and associated shivering  From 2nd day after shot: claims of: pounding headache, no appetite, nausea and eating caused more nausea  Claimed that marijuana usage alleviated some of the nausea and appetite issues
NO ADVERSE EVENTS TO REPORT ACCORDING TO PATIENT'S GUARDIAN.   THIS REPORT IS TO NOTIFY AN ADMINISTRATION ERROR. THE PATIENT AT THE TIME OF THE 1ST & 2ND DOSE  WAS 16 Y/O, THEREFORE NOT MEETING THE CRITERIA SETFORTH BY THE CDC AND FDA AGE APPROVAL.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 88-year-old, elderly patient of an unspecified gender. It was reported that, FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 07-Nov-2018, the patient was administered FLUAD (TIV), [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805542 was crossed linked to original case 201804863 due to same reporter.
Pt extremely somnolent & lethargic p/vax & difficult to arouse x 2-3 hrs; low grade temp; pt seen in offce & was nl;
Patient was given a second dose of Pneumovax in error.  Two doses were 2 years and 9 months a part.  (Prevnar 13 was ordered0
Client was given a full dose (0.5 mL) of Moderna vaccine for her 4th booster instead of a booster dose. Client advised her doctor wanted her to have a full dose and RN administered by mistake. Client reports she did not feel well after her dose, but no different than she has with her other doses.
Fever of 105, extreme dizziness to the point of being unable to stand on own, swelling in eyelids and face, and difficulty breathing. Called family doctor to confirm if this was a reaction to the HPV and they said to go to the ER, which we did. Today is one week after injection, and dizziness still occurs. The other symptoms are no longer visible.
Fever (101), chills, headache, muscle and joint pain. Nausea, diarrhea.
The evening of the second shot I had a high fever (over 102) and chills, which I expected.  But when I tried to get out of bed, I could not move at all. Couldn?t even lift a finger. I was paralyzed.  At first I thought it was about ten minutes but I believe it was about a half hour or so before the paralysis was over.  For months later I had confusion and several neurological problems.
On day 5 and eating normally I developed extremely low blood sugar and felt Shakey for over an hour, and had lesser episodes of  low blood sugar over the next week. I also felt chilled throughout that week. I have not experienced low blood sugar in over 40 years and never to that extent
Rash: Swelling - Information has been received from a pharmacist concerning her 12 month old . Caucasian son who was vaccinated with varicella virus vaccine live.  Approximately one week post vaccination, the patient developed a local reaction described as a large, red, raised rash.  Follow up information from a physician reported that on 28 Feb 2000 the patient was vaccinated IM in the right upper with a first dose of varicella virus vaccinelive (lot 631480/1008J).  There was no past medical history or illnesses at the time of vaccination.  On 29 Feb 2000 the patient developed local swelling, quarter size red.  On an unspecified date the patient recovered.
Patient presented 3 days after Tdap & MCV4 vaccination with a large erythematous area surrounding injection site. Patient was treated for cellulitis.
Five minutes after receiving the Janssen vaccine, this patient was observed to be diaphoretic sitting in the post vaccination observation area by this nurse.  Patient was alert and oriented x 3.  Patient reported that he felt nauseous and felt like "passing out".  Vital signs were assessed by this nurse and paramedic.  Patient's vital signs were normal.  Symptoms resolved shortly after vital sign assessment and 5 minutes after first reported.  Diaphoresis resolved.   Nausea resolved.  Patient denied "feeling like passing out".    Family escorted and drove patient home after he completed his 30 minute observation.  Patient encouraged to call 911 or his PCP if symptoms reoccur.
This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
pt devel a local react onsisting of swelling, redness & blotchy following immun;
The following day I was shaking uncontrollable head to toe.  I could feel nothing but pain.  If 10 was the standard before, this was 20-25.  a month later a storm came and I had the exact same pain issues and the same pain levels.  I went to see my rheumatologist and told him my issues.  He sent me to a neurologist and scheduled an appointment with a pain clinic.  The rheumatologist gave me a prescription for gabapentin after than, 300 mg two times a day, and it has seemed to help, but my pain problems are getting worse.  It is now 3 months later and I am quickly loosing the ability to hand the pain.  I have been in none stop pain for the last 18 hours.  I am taking a 7.5mg/325 mg pill of Tylenol three that I got from the pain clinic, but it is barely holding the pain back.  I have never felt pain like this in all my days.
Two days after vaccination developed increased pain in the foot, extending into the calf ,associated with swelling and discoloration., Worsening  over the next 10 days with subsequent death on 02/05/2022. Became weak, falling, back pain, shortness of breath, subsequently became cyanotic and arrested. At autopsy, found pulmonary emboli throughout. Suspected DVT not confirmed.
Patient experience chest pain, diaphoresis ,  shortness of breath and dizziness 30mins after receiving his 4th moderna covid booster. Patient's wife came back to pharmacy requesting for help. We immediately called paramedics as I went to assist the patient. Upon arrival, patient state his symptoms were improving. Paramedics arrived and transported patient to hospital for further evaluation.
103 fever lasting 2 days. Extreme muscle pain and leg swelling for about a week after receiving the vaccine.
Cheeks super red; Cheeks super itchy; Tingling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Cheeks super red), PRURITUS (Cheeks super itchy) and PARAESTHESIA (Tingling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced ERYTHEMA (Cheeks super red), PRURITUS (Cheeks super itchy) and PARAESTHESIA (Tingling). At the time of the report, ERYTHEMA (Cheeks super red), PRURITUS (Cheeks super itchy) and PARAESTHESIA (Tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided  No treatment information was provided   Reporter did not allow further contact
Narrative: COVID infection following COVID vaccine series 02/11, Moderna , dose #1 03/11 , Moderna, dose #2 09/29 pt cc: cough, diarrhea, fatigue, myalgias,  rhinorrhea, exposure: unknown 10/01 SARS-COV-2 Variant Sequencing result: pending 10/01 COVID swab, result: detected 10/9 clinically resolved
pt had fever of 104 (w/mom giving APAP q 4 hrs) during noc p/recvd vax on 12JUL93; taken to ER, xrays done, mom was told to cont giving APAP & that pt had react to vax;
2/7/2022 PROGRESS NOTE 71 yo gentleman w/ h/o COPD, recently diagnosed right humerus fracture, tested positive for COVID-19 ~1/15/22, who was admitted to emergency department 1/26/2022 with acute hypoxemic respiratory failure due to COVID-19, Covid pneumonia and acute left lung PE   Acute hypoxic resp failure due to COVID-19 pneumonia, acute left lung PE and probable COPD exacerbation: ---   Fully vaccinated with Moderna COVID-19 vaccine (3/17/2021 and/15/21) ---   Did not received a booster shot yet ---   Tested positive for COVID-19 ~ 1/15/22 ---   CT chest pulmonary angio at admit revealed extensive bilateral GGO ---   The CT scan also revealed LLL PE ---   On steroid since admit, currently on prednisone 60 mg daily as of 2/3/22, plan for 2-week taper at discharge ---   Continue apixaban ---   D/c heparin drip at 7 pm tonight and start Eliquis ---   Not a candidate for Tocilizumab or baricitinib, presented outside window for treatment ---   Currently on 2 L NC O2 supplement at rest ---   CRP < 1.0 for more than 6 days ---   D-dimer 1.07 --- > 1.0 yesterday. ---   Procalcitonin level was 0.11, thus superimposed bacterial infection less likely ---   Hemodynamically stable. ---   Full barrier isolation discontinued ---   Wean off O2 supplement if able ---   Home O2 eval today, required 6 L with exertion unstable on his feet, recommend out of bed to chair and PT OT every day for deconditioning   Acute LLL PE: ---   Precipitated by COVID-19 infection ---   Admit bilateral extremity ultrasound negative for DVT ---   Admit CT chest pulmonary angio revealed nonocclusive LLL PE ---   TTE on 2/4/2022 revealed EF 65-70%, mild pulmonary hypertension, moderate TR, no right heart strain. ---    Continue Eliquis, plan for 3 months for provoked PE   COPD with acute exacerbation ---   Precipitated by COVID-19 pneumonia ---   On O2 supplement and steroid since admission ---   On prednisone 60 mg po daily as of 2/3/2022, 2 week taper at discharge---   Schedule albuterol inhaler ---   PTA inhalers   Hx of nocturia Urinary frequency: ---   History consistent with BPH.  ---   UTI ruled out. ---   Tamsulosin 0.4 mg po qhs, initiated 2/3/2022   Proximally minimally displaced right humerus fracture: ---   Continuing nonoperative management and immobilization with sling.  ---   The patient scheduled to follow-up with orthopedic surgery as an outpatient.   Depression:  ---   PTA fluoxetine 40 mg p.o. daily ---   PTA Effexor 150 mg p.o. daily   GERD:  ---   PTA pantoprazole 40 mg p.o. daily   Code status:   Full Code  Prophylaxis:   Heparin drip  Disposition:   PT/OT recommending TCU.    Insurance does not cover TCU, will need to discharge home with home O2, home health when medically ready, O2 requirement is too high presently with exertion
Patient mistakenly given expired Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number XH2DF, expiry date 7th May 2022) for prophylaxis.   On 9th May 2022, the patient received Shingrix (intramuscular). On 9th May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  The reporter is the Healthcare professional (practice administrator). He reported that a 60 year old female patient was mistakenly given Shingrix two days after the expiry date. The reporter had nothing else to report. Might follow up with prescriber at reporter's address/email/phone. The reporter consented to follow up. Additional Supportive Information:  The patient was mistakenly given Shingrix in unknown arm two days after the expiry date, which led to expired vaccine used.
On day 8, a red, itchy, warm rash appeared around the injection site. It's now day 13 and the rash is still there, more prominent if anything, but is no longer itchy.
Left arm swelling B/W elbow and wrist 2 x normal size. Red/warm to touch. Uncomfortable, painful to touch. Family provider seen on 1/4/01. Dx reaction to immunization, question pneumonia vaccine and or tx. Resolved by 1/8/01.
Dizziness, AO x 4. Given water and crackers. BP 154/90 (pulse 71).
Developed severe anemia and was very ill from August 2021-December 2021.  Also was having a problem with blood clots in my arms.
1. Swelling of left arm.  2. Rash on left arm, spreading to chest.  3. Water eyes.  4. Coughing.  5. Increasing blood pressure and pulse 141/91 to 182/103.
Red spot below injection site itching; Red spot below the injection site the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Red spot below injection site itching) and VACCINATION SITE RASH (Red spot below the injection site the size of a silver dollar) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Red spot below the injection site the size of a silver dollar). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Red spot below injection site itching). At the time of the report, VACCINATION SITE PRURITUS (Red spot below injection site itching) and VACCINATION SITE RASH (Red spot below the injection site the size of a silver dollar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details was not provided. Treatment medications were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up received and no new information.