chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller is reporting that an improperly stored vaccine was administered on 25JAN2021; This spontaneous report was received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, (lot #1688504 has been verified to be a valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent, expiration date reported as 18-NOV-2021, but upon internal validation established as 19-NOV-2021) l for prophylaxis (strength and administration route were not provided) (product storage error).  The vaccine was exposed to a temperature above 9 Celsius degrees (C) (13.4 C) for a time frame of 2 hours and 9 minutes recorded by a digital data logger; the vaccine did not experience previous temperature excursions.
The patient stated that she had an adverse reaction to the Fluzone HD she received last year. She reported pain, redness, swelling, itching, and a red rash at the injection site on her left arm that persisted for over 6 months. She stated she still wanted to receive a flu shot this year despite her previous adverse reaction. I counseled her on her options, and risk of cross-reaction, and the patient agreed to receive FluBlok to see if she tolerated this formulation. I also recommended that the injection be placed into her right arm due to previous reaction in her left arm. The patient refused the recommendation and insisted that she receive the FluBlok injection into her left arm. Immediately upon injection into the left deltoid, the patient cried out and stated she was in terrible "excruciating" pain. Approximately half of the pre-filled syringe (about 0.25 ml) was injected into the middle of the patient's left deltoid before the needle was removed. The patient stated that her arm continued to hurt at the injection site for a few minutes, and then the pain subsided and that she was "ok".  She refused to receive the other 0.25 ml remaining in the prefilled syringe. Upon visual and tactile inspection of the injection site no visible or palpable abnormalities were observed. No redness, swelling, bruising, or discoloration was noted. The patient did not report any numbness of the left arm, she stated that her pain had subsided, and that she still had full function of her left arm. The patient was advised to notify her PCP of the atypical reaction and for advice on how to proceed since she only received half of her flu vaccine. I also advised her to receive any subsequent vaccines in her right arm. The patient was notified that we are available at the pharmacy 24 hours/day and to contact us if any further issues/reactions occurred or with any questions or concerns. The patient understood.
Patient received vaccine in left deltoid and parents noticed redness, swelling and tenderness to injection site starting that evening and continuing for next few days.
This spontaneous report as received from a physician refers to unspecified patients of unknown age and sex. Physician reported that VARIVAX (Merck) exposed to 73F for upwards of 4 months and the improperly stored vaccines had been being administered to unspecified patients on unspecified dates(strength, formulation, lot#, dose/frequency, route and duration were unspecified). It was unknown whether the patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information has been requested.
Patient present for booster shot and received Moderna. Patient should have been given Pfizer since the patient was <18 years old.
Chills; Fever (99.8 ºC); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever (99.8 ºC)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol and Triglycerides.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever (99.8 ºC)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) and PYREXIA (Fever (99.8 ºC)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include for high blood pressure, for cholesterol, for triglycerides.
10 minutes, post vax, pt had 1 episode of vomiting and feeling dizzy. Pt was taken back to room to lie down. Pt was given 12.5 mg of promethazine HCI syrup.
Weight loss; Occasionally goes to the bathroom frequently; Fatigue; Sore arm due to COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss), POLLAKIURIA (Occasionally goes to the bathroom frequently), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore arm due to COVID vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included COVID-19 in November 2020.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre filled pen, citrate free. In 2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore arm due to COVID vaccine). On an unknown date, the patient experienced WEIGHT DECREASED (Weight loss) and POLLAKIURIA (Occasionally goes to the bathroom frequently). At the time of the report, WEIGHT DECREASED (Weight loss), POLLAKIURIA (Occasionally goes to the bathroom frequently), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore arm due to COVID vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: lost 6 pounds lost 6 pounds.         Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Swelling, flu-like symptoms, fever, headache. Line extending from injection site to under armpit.
No adverse effect reported; was vaccinated with M-M-R II (expiration date 01-AUG-2019); This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 12-AUG-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) (lot# N020923 and expiration date 01-AUG-2019) subcutaneously (dose and frequency not reported) as routine vaccination (expired product administered). No adverse effect reported.
COVID pos on 8/18/2021 hospitalized 8/20/2021and put on oxygen, remdesivir and dexamethasone then discharged 8/29/2021
Redness and swelling moving out and away from injection site. Cellulitis dx. Rx cephalexin 500 mg.
Had fever 104.2 by 9PM chills-took pt to the ER; MD stated that it was a vax rxn;
No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder on that day). On 19-Feb-2021, the patient experienced BACK PAIN (Sore back, got progressively worse) and MUSCULAR WEAKNESS (Still experiencing muscle weakness in lower back). On 23-Feb-2021, the patient experienced HEADACHE (Headaches). On 24-Feb-2021, the patient experienced DISORIENTATION (Little disoriented). On 23-Feb-2021, BACK PAIN (Sore back, got progressively worse) had resolved. At the time of the report, DISORIENTATION (Little disoriented), MUSCULAR WEAKNESS (Still experiencing muscle weakness in lower back), ARTHRALGIA (Sore shoulder on that day) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Advil, Tylenol and Arthritis cream. No concomitant medications were provided by reporter.
No additional AE reported; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 03-FEB-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S010729; expiration date 01-DEC-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). It was confirmed that the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not experience a temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Initial information regarding an unsolicited valid non-serious case received on 09-Oct-2018 from a consumer. This case involves an unknown gender four months old patient who experienced diarrhea, gastroenteritis, vomiting, very irritable, inconsolable crying, abdominal rash, fever, hard nodule at the injection site in the left thigh, redness and swelling, while he/she received vaccine DAPTACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was ACT-HIB, lot UI944AA, expiration date: 14-Nov-2019 and VARIPOX. On 18-Sep-2018, 24-Sep-2018 and 08-Oct-2018 respectively the patient received a dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, lot C5180AA, expiration date: 06-Apr-2019 via intramuscular route in the left thigh. On an unknown date, the patient developed a non-serious diarrhea (diarrhoea), gastroenteritis, vomiting, irritable (irritability), inconsolable crying (crying),abdominal rash (rash), fever (pyrexia), hard nodule at the injection site in the left thigh (injection site nodule) and redness and swelling (vaccination site inflammation) following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine. It was also reported that was diagnosed with gastroenteritis and HCP encouraged oral hydration. It was an actual medication error due to inappropriate schedule of drug administration (was administered before the interval of 6 to 8 weeks doses). Other relevant tests included no lab data. Final diagnosis was redness and swelling, hard nodule at the injection site in the left thigh, fever, abdominal rash, inconsolable crying, very irritable, vomiting, gastroenteritis and diarrhea. It was not reported if the patient received a corrective treatment. The patient outcome was Recovered / Resolved for event redness and swelling, hard nodule at the injection site in the left thigh, fever, abdominal rash, inconsolable crying, very irritable and the outcome for other event (vomiting, gastroenteritis and diarrhea) was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Diarrhea; This is a spontaneous report from a non-contactable healthcare professional (patient herself). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1686, expiry date not reported), via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included buspirone hydrochloride (BUSPAR), escitalopram oxalate (LEXAPRO), and trazodone. The patient experienced diarrhea on 06Jan2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 4 year old patient who on 03/28/1997 was vaccinated with a dose of varicella virus vaccine live.  On 07/19/2000 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced a breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
13:45 pm rashes and hives on the arm injected  01:00 am woke up with stiff muscles, & vomiting for 3 hours on and off. Fever of 101. Hot and cold flashes
Pt presented to clinic with a local inflammatory reaction within 24 hours, post vax. It consisted of a 13cm X 7.5cm area of induration, warmth and redness. The child is happy and not limited by reaction. Recommended compresses to are and placed child on Keflex in the event of a cellulitis instead of a local reaction.
Pt with complaint of numbness, tingling in right upper extremity. Noted onset at 19:00 on 8/12/00. Right upper extremity with swelling noted at bicep, and is warm to touch. He was instructed to take 2 Tylenol, avoid constricting garments to affected site and seek medical help in 3 days if swelling.
fever up to 37.8 degree C; This is a spontaneous report from a non-contactable consumer (patient). A 34-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiry date: not reported), via an unspecified route of administration in left arm on 12Feb2021 (at age of 34-years-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to sulfonamides. Concomitant medication(s) included acetaminophen (ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the bnt162b2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration Date: Not reported), via an unspecified route of administration in left arm on 21Jan2021 (at age of 34-years-old) as dose 1, single dose for covid-19 immunisation. On 13Feb2021 at 12:00, the patient experienced fever up to 37.8 degree c. The patient underwent lab tests and procedures which included body temperature: up to 37.8 centigrade degree on an unspecified date. No therapeutic measures were taken. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a consumer regarding a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date at an unspecified time, the patient was vaccinated with PNEUMOVAX 23 injection (lot#, expiry date and dosage details not reported) for prophylaxis. On an unknown date, the patient was in "rehab" (adverse event). The type of rehabilitation or need for rehabilitation could not be confirmed. The outcome of the event was unknown. The reporter had questions about the need for re-vaccination with PNEUMOVAX 23. The reporter did not provide any causality assessment. No product quality complaint (PQC) was involved.
32 months old male patient received a dose of Flublok Quadrivalent vaccine, No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA277265 (same reporter).  This case involves a 32 months old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1903 via intramuscular route in the left deltoid on 03-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  Flu clinic visit on 03-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
The Vaccination Team was in the Community at a health event. Client reported not having a flu shot in the past year. Client was administered a flu shot. When entering vaccination in (health medical record) it was determined the client had received a flu vaccine from another provider on 09/29/2023
redness and induration and burning sensation in the area which began about 4 days after vaccination (but below level of the shot). Persisted despite 2 d of ice treatment but seems to be resolving
Severe tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ventricular tachycardia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization, reaction(s): "chest tightness", "tachycardia". The following information was reported: TACHYCARDIA (non-serious), outcome "recovering", described as "Severe tachycardia". Clinical course: After 2nd dose, she experienced severe tachycardia warranting a call to rescue. Patient was not hospitalized and was stabilized by rescue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202300003553 Same reporter /patient, different dose/event;
First arm was just sore, then dizzy spells and nausea, severe pain under the arm,  swollen lump under the arm, fever went up to 103 and severe headache. All of these symptoms lasted a full week however fever came down to 100. Missed a whole week of work.
late for the second dose, first dose February 2 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (the patient received 1st dose of Engerix B on 2nd February 2022, batch number: 9ax5p).   On an unknown date, the patient did not receive the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 30-AUG-2022 Reporter's Comment:The reporter reported that, a patient was late for the second dose of Engerix-B. No adverse event was reported. No expiration date was provided. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Engerix-B, which led to incomplete course of vaccination.
didn't hurt until 1 day+ later; all the symptoms of flu; all muscles and joints sore all over; all muscles and joints sore all over; chills; headache; sore throat; ear ache; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: en6203, expiration date not reported) via an unspecified route of administration, on 02Mar2021 19:15 (at the age of 71-years-old), at dose 2, single for covid-19 immunization from Pharmacy or drug store. Medical history included asthma. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: en5318, expiration date not reported) via an unspecified route of administration, on 10Feb2021 (at the age of 71-years-old), at dose 1, single for covid-19 immunization and experienced sore at injection site. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient didn't hurt until 1 day/ later (as reported) described as pain, patient woke up with all the symptoms of flu, all muscles, and joints sore all over, chills, headache, sore throat, and earache on 04Mar2021 06:00. Therapeutic measures were taken included Nuprin and a heating pad. The outcome of the events was recovered on an unspecific date in 2021.    No follow-up attempts are possible. No further information is expected.
Patient receives immunization 4/30/12 and broke out in a mild rash. 5/15/12 in reviewing symptoms with mother rash resembles a chicken pox type rash.
Pt was 12 years of age at time of vaccine administration, but received Peds Pfizer vaccine rather adult vaccine.  No adverse reaction occurred.  The mistake was realized when the pt returned for the second dose and received the adult vaccine as the second dose.   The situation was explained to the parent and she had no concerns.                                                                           Pt received Pfizer adult dose as 2nd vaccine dose 01/04/2022 per protocol.