chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date place in refrigerator was 04Nov2021 and adminitated on 15Nov2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 04Nov2021 and adminitated on 15Nov2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date place in refrigerator was 04Nov2021 and adminitated on 15Nov2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 04Nov2021 and adminitated on 15Nov2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place in refrigerator was 04Nov2021. No temperature excursion was reported. Date place in refrigerator 04-Nov-2021. No adverse event.
Pt walked up to received 2nd scheduled dose of Moderna vaccine. However, pt received a second dose of Pfizer vaccine. Authorization from Dr. and on-site pharmacist, that verification of patient being fully vaccinated . Pt. Monitored for 15minutes with no adverse events.
Approximately 15 months post vax  with varicella virus vaccine live the pt developed herpes zoster from breast to back moderately extensive. Physician noted a group of vesicular eruptions at mid-anterior thorax left side extending up to her back. The pt was irritable, crying and unable to sleep well at night. On a scale of 1-10 the pts pain was quantified as a 9. A rash did not occur at the injection site or elsewhere within 42 days of the vaccination. THe pt recovered 8 days afer being seen on 08/02.
Patient developed flu like symptoms (muscle aches, fever) ONLY at night.  Symptoms resolved with use of APAP.  First shot given on 12/07/06, symptoms started 01/08/07 and lasted until 01/28/07.  Second shot was administered on 01/16/07.  Patient went to MD on 01/19/07 to get labs drawn, LFTs on this date were as follows AST 90, ALT 108 (uncertain if patient has ever had baseline tests drawn).  MD requested retest, this was done on 1/26/07; AST 198, ALT 311.  Patient had liver ultrasound that revealed no abnormalities.  Patient had labs drawn again on 2/8/07; AST 51 ALT 90.  Patient is to go back for retesting in about a month.
w/in 24hr of vax pt devel low grade fever, malaise, h/a, myalgia & an inj site rxn characterized by redness, warmth & induration;this is 1 of 3 pt from this facility who had adverse exp p/vax;reporter unable to specify the # of pt w/exp
Diffuse rash day one to present.  Oral OTC antihistamines for the first 6 days the Medrol dose pack on day 7.
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On unknown dates (reported as " from 24-JAN-2018 until 6-FEB-2018), the patients were vaccinated with an improperly stored dose of GARDASIL 9 with lot # N010497, expiration date on 15-JAN-2020; (Strength, route, dose, frequency, and anatomical location were unknown) and an improperly stored dose of PEDVAXHIB lot # N003698, expiration date on 31-OCT-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 0 C to 1 C (1.4C) degrees Celsius for 30 min. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects were reported.
Patient stated that she had a history of syncope with previous vaccinations due to anxiety.  Staff observed patient for 30 minutes after vaccine was administered taking vitals every ten minutes. Vitals were stable and patient left after thirty minutes without incident.
Information has been received from a RN concerning a 10- year old white female who on 03/14/1996 was vaccinated with a dose of varicella virus vaccine, live. On 06/09/2004 in the PM, the pt experienced a "breakout", and on 06/10/2004, the "breakout" continued. The outcome was reported as not recovered. Additional inoformation has been requested.
Ringing in ears worse and louder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in ears worse and louder) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017b21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa) and Soy allergy. Concomitant products included AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for Cystitis, ALPRAZOLAM (XANAX) from 2020 to an unknown date for an unknown indication.   On 03-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in ears worse and louder). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, TINNITUS (Ringing in ears worse and louder) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: abnormal (abnormal) minimal damage. On an unknown date, Magnetic resonance imaging head: normal (normal) normal.         treatment medication includes steroids.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-117049 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: updated patient demographics, added patient medical history, added  lab data, concomitant medication, treatment medication.
Right Arm pain for two days only.  Still having side effects going on 4 th day symptoms listed:   Headaches, Dizzy, Nausea, leg pain (both) , stomach pain, - feels like motion sickness but not on a boat.
33 year old woman was given flu vaccine during routine office visit. She was healthy at time of visit, with normal labs. She was also given dT. Flu: given 10/16/8 Vaccine manufacturer Sanofi: vaccine lot number 42847. dT: given 10/16/8 Vaccine manufacturer Sanofi U202MBA. Within 24 hours pt developed fever to 102, tachycardia to 148, and headache. She took OTC Motrin. She proceeded to hospital ER and was told she had a reaction to flu vaccine. She required IV fluids and was told that she was hypokalemic given oral K. She was D/C from ER to home. She was evaluated by me today 10/22/8 and still had minimal residual headache.  11/4/08 Reviewed PCP medical records & vaccine records of 10/16-10/22/2008. FINAL DX:flu shot reaction, fever. Records reveal patient experienced nasal drip, HA on 10/16.  Seen in ER on 10/17 w/flu-like symptoms of fever, loose stool x 1, generalized aching, weakness, nausea, poor appetite, tachycardia & HA. Tx w/IVF & meds.  Improved & d/c to home.  RTC 10/22 felt chilled, HA resolving.  Not to receive flu vax in future.
menstrual cycle flow has increased; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (menstrual cycle flow has increased) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (menstrual cycle flow has increased). At the time of the report, HEAVY MENSTRUAL BLEEDING (menstrual cycle flow has increased) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking vitamins.; Sender's Comments: Very limited information regarding this event/s has been provided at this time Critical  Further information has been requested
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient c/o fast heart rate 4 min post vaccine. Assessed patient A&ox3 zero c/o sob, or chest pain. v/s at 10:43am BP 142/68 HR 112 RR 20 SPO2 96%. Provider recommending to monitor patient for 15 min.  v/s at 11:08 BP 140/60 HR 110 RR 18 SP02 97% No new complaints but patient states still feeling like her heart will beat really fast then slow down. Provider recommending to monitor again for another 15min patient refused to wait for another 15 min because she needed to use the restroom and did not want to stay for further observation. Provider advised patient that she needs to make an appointment with a provider today patient agreed, but left vaccine site against medical advise from the provider to stay for further observation. Left vaccine clinic at 11:20 am.
Information has been received from a physician concerning a 12 year female who on approximately 12-FEB-2007 was vaccinated intramuscularly with a dose of Gardasil. On approximately 12-FEB-2006 the patient fainted after the administration of Gardasil. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
accidentally mixed ActHIB with sterile  water instead of the diluent/No AE; Initial information was received on 02-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA002810, 2020SA002811, 2020SA002455, 2020SA002456 and 2020SA004004 (same reporter).  This case involves a patient of an unknown demographics who received HIB (PRP/T) VACCINE [ACT-HIB] which mixed with sterile water instead of the diluent.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot UJ175AAA, expiry date- 26-11-2020) via unknown route in unknown administration site.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Following 1st dose Moderna, 8 days later she developed rash on abdomen, side, and behind her knees, and in the bend of her elbows.   She was seen in an UC and was prescribed Methyiprednisolone.
This case was reported by a nurse via sales rep and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUARIX TETRA for prophylaxis and PNEUMOVAX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX, FLUARIX TETRA at an unknown dose and the 1st dose of PNEUMOVAX. On an unknown date, 1 day after receiving SHINGRIX and 2 days after receiving FLUARIX TETRA, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX and FLUARIX TETRA. Additional details were provided as follows: Specific administration dates were not provided by health care professional. However, the health care professional stated that the patient received FLUARIX and PNEUMOVAX concomitantly on one day, then SHINGRIX the following day. The subsequent day, the patient reported a fever of 103 degree F and significant local reaction-redness and swelling around the PNEUMOVAX site of injection. On Day 4, the patient came to the clinic to be seen by the health care professional. At that visit, the patient's temperature was 99.4 degree F and the reaction was described by the health care professional as low-grade. The patient did not require an emergency room visit or hospitalization as a result of this event. It was unknown if the reporter considered the fever to be related to PNEUMOVAX as well. Lab Comments: Lab test was done on an unknown date.
Approximately 30 mins after injection I started to feel my heart racing.  Checked my pulse and it was reading 130bpm.  This continued on for approximately 60mins. I then started with a migraine that lasted 36hrs.  Starting on 12/25/2020 I felt a lump in my throat and have been periodically choking on food and liquids. It feels like my thyroid is enlarged.
A rash on neck and chest; Shortness of breath; Swelling of left hand and arm; Fever of 100.7; Dizziness; Tiredness; Injection site pain; Boil on inner thigh; Headache; chest hurts; pink eye; muscle pain; Pressure in ears; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 50-years-old non pregnant female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot number-Not reported), via an unspecified route of administration, administered in Arm Left on 29Apr2021 13:45 (age at vaccination 50 years) as DOSE 1, SINGLE for covid-19 immunisation . Medical history included systemic lupus erythematosus, diabetes mellitus, endometriosis , Penicillin, pork, onions, nickel, latex allergy  from an unknown date and unknown if ongoing. Concomitant medication included duloxetine hydrochloride (CYMBALTA). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 29Apr2021 14:45,patient experienced a rash on neck and chest, chest hurts, shortness of breath, swelling of left hand and arm, fever of 100.7, pressure in ears, dizziness, tiredness, pink eye, injection site pain, muscle pain. boil on inner thigh, headache. The reporter assessed the events as non-serious. The patient underwent lab tests and procedures which included body temperature increased: 100.7 on 29Apr2021.Patient did not receive any treatment for the adverse events. The outcome of all events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient experienced fever and chills about 4 hours in the wee hours of the night. It was worth it though. The follow-up would not possible as no contact details were available.
Patient has been having pain in her right scapula that she attributes to receiving her second shingles vaccine. Reports pain and swelling  started 48 hours post vaccine that continued to spread down her arm. Patient went to the emergency room as well as several doctors where they have done multiple testing with no remarkable results for what can be causing the pain. Patient has also begun to have trouble with stuttering and pain is not subsiding after being 18 days since receiving the vaccine. After speaking with the patient she agreed to a follow-up appoint with the doctor to reassess her symptoms.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
This spontaneous report as received from a pharmacist as a part of Market Research program refers to a female patient in her 60's. On an unknown date, the patient was vaccinated in the arm with ZOSTAVAX (dose, route and lot number were not reported). On an unknown date the patient experienced injection site reaction - large red circle on arm. The outcome of the event was reported as recovering/resolving. The reporter considered injection site reaction to be related to ZOSTAVAX. Additional information has been requested.
Dose 1: Start Date/Time: [Pfizer] 18Jan2021 09:00 AM/ Dose 2: Start Date/Time: [Pfizer] 4Feb2021 09:00 AM; a lump at the injection site that a magnet will stick to; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 67-years-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3249), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as dose 2, single (at the age of 67-years-old) for COVID-19 immunization. Medical history included atrial fibrillation (Afib), high cholesterol (blood cholesterol increased), high blood pressure (hypertension), mitral valve replacement in Mar1999 (taking anticoagulants for mitral valve replacement), Known allergies includes penicillin, vancomyacin, any pain medication. Concomitant medication(s) included warfarin; sotalol; famotidine; amlodipine; cetirizine. No other vaccine administered in four weeks. The patient had not diagnosed with covid prior vaccination. Patient is non-pregnant. The patient previously took vancomycin and experienced drug hypersensitivity. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1685 via an unspecified route of administration, administered in Left Arm on 18Jan2021 09:00 as dose 1, single for COVID-19 immunization. On 04Feb2021 at 04:00 the patient experienced a lump at the injection site that a magnet will stick to. Patient received dose 1: start date/time: [pfizer] 18Jan2021 09:00 am/ dose 2: start date/time: [pfizer] 04Feb2021 09:00 am (Inappropriate schedule of vaccine administered). Post vaccination, patient had not tested with COVID. No treatment received for the reported events. The outcome of reported event (Vaccination site lump) was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient was fine up until leaving the building at which time he became light headed and then blacked out, falling to elbows and then hit head to floor. He came to immediately and was walked back to the pharmacy with his family. He lied down with feet elevated x20 minutes, was given some water, and continued to be confused with what happened within the last hour or so. Repeated the same question of "what happened" even after being told just a minute ago. Paramedics came and BP and pulse were normal and head seemed otherwise unharmed. He was then taken the hospital though since he remained very pale and kept asking the same question of "what happened". He could remember what happened yesterday and memory was intact for most everything except for the previous few hours.
I have read that the covid vaccines can bring the onset of PMR. I was diagnosed with it after receiving my vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "not recovered", described as "I have read that the covid vaccines can bring the onset of PMR. I was diagnosed with it after receiving my vaccines". Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical course: She had read that the covid vaccines can bring the onset of Polymyalgia rheumatica. She was diagnosed with it after receiving her vaccines. She was on low dose prednisone for about a year after tapering off. Then maybe 6 months started feeling it again. Tapering off in about 3 months. It was now back.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Dose administered >12 hours post puncture; Dose administered from a vial that was punctured and stored at room temperature beyond 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered from a vial that was punctured and stored at room temperature beyond 12 hours) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered from a vial that was punctured and stored at room temperature beyond 12 hours). On 11-Oct-2021 at 12:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 11-Oct-2021, PRODUCT STORAGE ERROR (Dose administered from a vial that was punctured and stored at room temperature beyond 12 hours) had resolved. On 11-Oct-2021 at 12:00 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in refrigerator on 02-Oct-2021 and the vial was first punctured on 10-Oct-2021. Post puncture vial was stored in room temperature for 30 hours.  No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-348407 (Patient Link).