chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.  It was reported that on 14-Oct-2021, the vial was removed from refrigerator and was not opened before vaccination and temperature was not compromised.
"A mother reported that her 15 month old daughter received Prevnar and IPV vaccines on 10/20/00. On 10/30/00, the child experienced a 'seizure type episode'. Approx. 4 hours later, she had 'unexplained tremors' while in an ER. Convulsion is considered to be "Medically Important".
inadvertent administration is reported in a pt who recvd .5cc fluogen lot# 01872P, exp 30JUN93; pt recvd expired fluogen vax 11OCT93; pt did not exp soreness or other apparent sx;
The patient experienced no symptoms; Nurse reports that on 18-JUN-2020 a 2 month old was administered a dose of PNEUMOVAX 23; This initial spontaneous report was received from a registered nurse, referring to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not disclosed.  On 18-JUN-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered via intramuscular as prophylaxis; lot number T007790, expiration date reported as 03-DEC-2020 but upon internal validation was established as 03-DEC-2021 (strength, dose number, and anatomical vaccination site were not provided) (product administered to patient of inappropriate age). the nurse reported that the administered dose was not due to a product packaging related confusion. The patient did not experience any symptoms. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
2 hours after vaccine given, patient developed (L) eyelid swelling; 3 hours after vaccine given patient developed lower lip swelling. Given ORAPRED (15mg) and BENADRYL (12.5mg) po. Transported to ER via EMS. At ER given IM EPI.
This spontaneous report as received from a medical assistant refers to a 4 year old female patient. Certified medical assistant called to report temperature excursion involving VARIVAX (Merck) stored at to 9.5F for 2 hours on 11-APR-2014. The patient received injection with involved product VARIVAX (Merck) (0.5 ml, subcutaneously, lot# not reported) on 21-APR-2014. It was not clarified which dose in the complete series of VARIVAX (Merck) was administered on 21-APR-2014. No adverse effect was reported. The case is linked to MARRS# 1404USA013313 (same reporter link). Additional information has been requested.
Soreness and swelling at injection site within hours of injection. by 1/18/2014 at 0400, patient was experiencing joint pain, nausea, sharp headaches, body aches and photosensitivity. Patient self-treated with ibuprofen and additional rest with minimal improvement by 4:00pm 1/18/14. Tenderness, redness and mild swelling at injection site continues.
tested positive for Covid on 14May2022; tested positive for Covid on 14May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE; PROPRANOLOL; IUD NOS; MIRENA; AJOVY [FREMANEZUMAB]. Past drug history included: Prilosec otc, reaction(s): "Known allergies: Prilosec OTC".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "not recovered" and all described as "tested positive for Covid on 14May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (14May2022) Positive; (21May2022) Negative; (25May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information:Adverse event: Initially tested positive for Covid on 14May2022. Started Paxlovid 15May2022, treatment stopped on 19May2022, Lot number=FX4466. Tested negative 21May2022. Runny nose and slightly irritated throat 25May (almost imperceptible but took a test anyway). Tested positive 25May.Adverse event country. Adverse event start date: 25May2022.Adverse event start time: 07:00 AM. Ae resulted in: None of the above. If patient recovered: Not recovered. If treatment ae: No. Known allergies: Prilosec OTC. Other medical history: Migraine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Heart palpitations came and went at random but the instance that happened that night (07/04/2021) was especially strong. This issue had other issues like muscle twitches throughout my body and  that is with the heart palpitations. That night went to the ER and had a blood test where they were looking for troponin to see if I had an attack. Only a small elevation showed up and was diagnosed with tachycardia. Was advised to stay away caffeine  and other stimulants. No treatment given at that time. Later went to Urgent Care with an episode. Was given an EKG 12-lead test, ECG, TSH Reflex Free T4, Basic Metabolic Panel, and CBC w/Differential. All came back normal. 10/29/2021 Cardiologist did a Holter Monitor Extended test(2weeks), and found episodes of rare PAC, Brief Paroxysmal Atrial Tachycardia. Scheduled for January follow-up to check on heart health and wellness.
she recently gave a 3rd dose of ROTATEQ to a 9 month old; This spontaneous report was received from a nurse practitioner (discrepant information, also reported as physician) and refers to a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as recently), the patient was vaccinated with a third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, route of administration defaulted to oral (dose, frequency, strength, lot #, and expiry date were not provided) administered for prophylaxis (product administered to patient of inappropriate age). The reporter stated she did not realize that the vaccine should not to be given after 32 weeks of age per prescribing Information (PI).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007064:
Mild pimple looking rash started on 1/5/21. Felt better after few days. Rash/ papules looks like pimple started spreading rapidly all over the body with itching on 1/14. Benadryl PO x 1 dose.  Valacyclovir and Zyrtec started on 1/16. Prednisone started on 1/21.  Cellulitis 1/22. Keflex PO. Started tapering down prednisone but rash started coming back 1/29.
0900 Prickly sensation to back, hand swelling.  Patient given Benadryl cream and 2 tablets of Motrin with signs and symptoms subsiding. 1254 began again with hand swelling, prickly back and numbness at joint of right knee down to foot.  Patient went to ER, given Benadryl and Decadron (16mg).  Discharged to home, to continue Benadryl.
Narrative:  No other information documented in chart other than patient expired at home 5/15/21 within 42 days of covid vaccination
Prolonged menstrual bleeding (Jan 19- continuing.)  Prior max 10 days before treatment Oct 2019 GYN visit not available until Mar 7
24 hrs later - severe neck pain, "my body is disintegrating"; severe nausea + headache - jaw pain - body aches - seen at urgent care, lab normal, dx probable vaccine event had also just started birth control 3 days prior.
Flu like symptoms: myalgia, fever beginning 3-4 days after vaccine.  Diffuse muscle aches to presentation 12 days after vaccine. Follow-up Information 17-JAN-2008: Pt was diagnosed with salmonella sepsis
p/vax pt exp facial swelling & hives all over the day;12-15hr p/vax pt awoke w/facial swelling, eyes swollen & closed & hives covering entire body;
This spontaneous report was received from a medical assistant regarding a 9 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 05-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Urticaria development on chest  two days after receiving the vaccine and still intermittently present to date (approximately two weeks post vaccine).
25 minutes after shot started having tightness in my throat, then heart pounding. Pulled into ER on my drive home. Received medications, prednisone, benadryl and pepcid and was observed a few hours. Ok now. Still glad I got vaccine since I am in health care.
Initial unsolicited report received from a pharmacist via nurse on 06-Aug-2018. This case involves a female patient (age was not reported) who was vaccinated with a dose of IMOVAX RABIES (Batch number, expiration date, dose, dose in series and route of administration were not reported) in the hip/gluteal region on an unknown date. It was a case of actual medication error due to product administered at inappropriate site as it may affect the immune response and titer levels. It was reported that the doctor only order four total dose for this patient for day 0.3.7 and 14 instead of five. It was not reported whether the patient experienced any adverse events or not. 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. Documents held by sender: none
Patient c/o of feeling shaking and pulse racing. Vitals taken 206/93 P98 sao2 98% on RA. at 4:05PM. 4:06 PM vitals 209/88 P 94 sao2 99%. Pulse increased to 110 at 4:10 PM. Patient transferred to urgent care via w/c. Patient checked and left with nursing staff for evaluation.
Pt recvd pneumococcal vax following vax pt devel an unspecific adverse reaction; no further details were provided;
Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Ep6955), via an unspecified route of administration in right arm on 07Jan2021 at 08:00 as a single dose (at the age of 33 years old) for COVID-19 immunisation. Medical history included asthma, recurrent pneumonia, chronic sinusitis, birch pollen allergy, some nuts allergy, and dust allergy. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received treatment with BENADRYL for the reported event. On 07Jan2021 at 08:45, tingling tongue. The clinical outcome of event tingling tongue was recovering.  No follow-up attempts are needed. No further information is expected.
Client called facility today reporting  N/V/D, stiff neck and fever through out the night into today.
Mother in hospital with blood clots in both lungs on a ventilator. She has been hospitalized since 4/16/21
Eustachian tube dysfunction occurred 2 days after vaccine. 5 weeks off work, unable to drive due to dizziness. I had fullness and pain in my left ear, constant headache from pressure, ear drum vibrations to sound
While RN BSN CCM was conducting educational facts about the covid 19 vaccination. Observed patients body went stiff and fell backwards in sitting position in his chair and started to exhibit seizure like symptoms in his chair for approximately 8-10 seconds. RRT called immediately and arrived 1 minuted after. Pt had beads of sweat dripping off forehead. Temp obtain  86.6. Sp02 95% Attempted to obtain BP vitals but machine did not complete cycle before pt blacked out again. ED transferred at 1055.
I woke up at 04:00 am with severe migraine; fever and chills. Migraine left 01:00 or 02:00 that afternoon. The fever and chills lasted through the next day - body ache and soreness throughout both of those days. For those two days I did not work. (Ended the 8th when it was time for me to go to bed.) I did have heart palpitations the night of the 9th that I did go get ER  -they gave me a dose of Ativan and they sent me home. That took care of the heart palpitation symptoms.  I followed up with my provider the following week.
Slight sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight sore arm) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Slight sore arm). At the time of the report, PAIN IN EXTREMITY (Slight sore arm) outcome was unknown.            No concomitant medications reported. No treatment reported.  Patient had taken two Moderna vaccines and also the booster. Patient was considering whether or not to take the fourth dose. Patient wanted to know what is the risk of taking another booster, patient does not want it to damage the body. Patient would like to know what will be the risk of taking another dose.   This case was linked to MOD-2022-578357, MOD-2022-578383 (Patient Link).
Infant developed high fever approximately 3 hours after vaccine given. Fever got up to 105 and infant was brought to ER. Infant had generalized tonic clonic seizure while at ER. 1st seizure lasted about 1 minute and a dose of Valium was given. Continued contracture of hands and feet, so 2nd dose of Valium given. Total episode lasted approximately 15 minutes. Has been hospitalized x 24 hours thus far. Temp down to 100.7 as of approximately 3:00 PM on 6-5-14.
A day after vaccination, my daughter started experiencing random involuntary jerking.  Mainly her left arm.  3 days after vaccination on 8/31/17, we went in for a routine vision test.  The jerking was observed at the office.  I mentioned that it had happened after Doses 1 and 2.  And the doctor said it should be reported.  I followed up recently and realized that the office did not report; that I should.  I was instructed to report for each dose separately, which I've done.  The jerking resolved like in the past, after about 2 weeks, but would happen infrequently after resolution.  I have not seen it in quite some time; hopefully it is done.
Information has been received from a healthcare worker referring to a female patient of unknown age. Concurrent conditions, medical history and allergies of the patient were not reported. The patient received her first dose of GARDASIL (lot #, expiry date, dose, route unspecified) five years ago (in 2010) on an unspecified date. On 11-MAR-2015 the patient was in the physician's office asking to receive her second dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Itchy arm with bumps for a few minutes. Treated at hospital with steroids and pain meds. Not admitted, released to go home. Symptoms resolved completely within a few minutes of starting meds
So sick feeling; Hardly knows what is going on - didn't know what she was doing; Shortness of breath; Feeling very cold; heartbeat is going faster (usually it is in 67/68 and now it is in 70); Said she woke up that first morning and didn't know if she was up stairs or down, she was very; Headache; Chills; Feeling real sore; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (So sick feeling), DISORIENTATION (Hardly knows what is going on - didn't know what she was doing), DYSPNOEA (Shortness of breath), FEELING COLD (Feeling very cold) and HEART RATE INCREASED (heartbeat is going faster (usually it is in 67/68 and now it is in 70)) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Macular degeneration.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (So sick feeling), DISORIENTATION (Hardly knows what is going on - didn't know what she was doing), DYSPNOEA (Shortness of breath), FEELING COLD (Feeling very cold), HEART RATE INCREASED (heartbeat is going faster (usually it is in 67/68 and now it is in 70)), CONFUSIONAL STATE (Said she woke up that first morning and didn't know if she was up stairs or down, she was very), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Feeling real sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 400 milligram twice a day. At the time of the report, MALAISE (So sick feeling), DISORIENTATION (Hardly knows what is going on - didn't know what she was doing), DYSPNOEA (Shortness of breath), FEELING COLD (Feeling very cold), HEART RATE INCREASED (heartbeat is going faster (usually it is in 67/68 and now it is in 70)), CONFUSIONAL STATE (Said she woke up that first morning and didn't know if she was up stairs or down, she was very), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Feeling real sore) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: 70 heart beats per minute (High) Heart rate increased.         Concomitant product included Shots for macular degeneration. Action taken with mRNA-1273 in response to the event was not applicable.
Patient started to have pain about 2 days later and this soreness does not go away until 3 weeks later so plan to see Doctor soon. Have a 1 cm diameter size of swollen rash on the injection area. And he gets FLUZONE HD annually and complained it happened only this year.
got the shingles after getting the vaccine./ Suspected Vaccination failure; got the shingles after getting the vaccine.; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The patient had shingles after shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
ADMINISTRATION OF VACCINE NOT STORED PROPERLY (LEFT AT ROOM TEMPERATURE FOR UNKNOWN AMOUNT OF TIME); PRODUCT STORAGE ERROR; This spontaneous report received from a pharmacist concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, expiry: 03-SEP-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the subject experienced administration of vaccine not stored properly (left at room temperature for unknown amount of time). On 29-JUL-2021, the subject experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine not stored properly (left at room temperature for unknown amount of time) and product storage error was not reported. This report was non-serious.
Intense and excruciating lower back pain around the area of the kidneys lasting more than two months. Vision problems; long distance vision problems, specially focusing and constant cognitive problems while typing in a computer, constant mistakes; skipping letters or placing the wrong letters.
Felt sharp pain in chest approx 3 days after shot. Shortness of breath, fatigue, fever, night sweats, muscle soreness. Hospitalized after for 3 days due to a pericardial effusion and acute pericarditis.  3/16/2009 MR received for DOS 9/8-11/2008 with D/C DX:  Acute pericarditis with pericardial effusion.  Pt presented with 1 1/2 week hx of feeling feverish, chills and stuffy nose which later progressed to shortness of breath and dull chest pressure which radiated to the mid back. (+) night sweats. PE (+) for T=100'F, jugular venous distention, pericardial rub.  Tx with NSAIDs and colchicine to f/u as outpt.
Flushing, angioedema, urticaria, dizziness; light headedness; bad taste in back of mouth ; nausea
Weak left leg muscles inability to walk correctly falling for lack of balance. Muscle wasting and muscle tingling. Soreness and pain in the left leg both above and below it in the knee.
I tested positive for Covid-19 on January 15, 2023. I experienced chills, flexibility was off, fatigue, fever of  101. 00, bad cough. I was taking Tylenol for my symptoms and also Paxlovid.
I started breaking out in Hives on 10/3/2021, many blood tests done and results were positive ANA blood test, autoimmune disease. Doctor stated vaccines triggered my system into overdrive causing daily hives
Pt recvd vax 18OCT93 & devel chills & fever of 102; that evening fever spiked to 104; pt arm, from shoulder to elbow, turned red & was swollen, painful & very hot to the touch; taken to MD had h/a & a tight feeling or aching in chest; weak