chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered way beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered way beyond 12 hours after first puncture) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered way beyond 12 hours after first puncture). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered way beyond 12 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.  On 15-Sep-2021, the patient received a dose of Moderna COVID-19 vaccine from an expired vial that was sitting in the refrigerator way beyond 12 hours after it was first punctured. The vial was first punctured on 24-Aug-2021 then placed in the refrigerator and injected to one patient on 15-Sep-2021. The vial did not undergone any previous temperature excursions.
Noticed discomfort in left arm pit lynmph nodes noticably swollen.  Injection site hot, raised and red approx 1 inch diameter.  Injection site symptoms increased till day 6 reaching 1.5" diameter hot raised and red.  Swollen lymph nodes in arm pit also swollen grands in throat giving moderate discomfort.  No indication of fever.
approx 10 mins p/shot pt became pale, flaccid; stimulated & improved over 3-4mins; observed in ofc 30mins w/no residual effects;
Narrative:  The patient presented to the ED with ataxia and decreased reflexes.  The patient or caregiver refer he was administered a influenza vaccines outside the facility about two weeks before the ED visit. There is no evidence of vaccine administration outside facility.
Janssen COVID-19 EUA: 3 blood clots left arm, April 19th 2021, swelling and redness.  Went to Urgent Care and then sent to Hospital.  At Urgent Care diagnosed by Sonagram.  Confirmed at Hospital with CT Scan and blood work. Prescribed Xarelto, 20mg.   Other:  Seen by a Hematologist on 1/20/22 for extensive blood testing; outcome was NO Genetic/Heritary Pre-disposition to blood clots;   Stopped Xarelto/20mg 4/21/22 per Hematologist.
Tdap given 4-6-07 (Friday) Sunday night 4/8/07 T=101, redness noted distal to injection site, swelling, warmth. Monday-no fever until Monday night T=100. 4/11/07 1130 Redness, warmth, swelling, persistent-distral to injection site 3-4 cm. Redness measures 10x 11 cm. Ice/heat, elevation of arm.
Severe joint pain; Wrist pain; Knee and elbow pain; Knee and elbow pain; Raised rash on hands and shin; Raised rash on hands and shin; Raised rash on hands and shin; condition has not improved and seems to be getting worse; Patient is currently breastfeeding; Patient is currently breastfeeding; This is a spontaneous report from a contactable Health Care Professional. A 30-year-old female patient who is currently breastfeeding received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, 3 weeks after the vaccination, the patient experienced severe joint pain, wrist pain, knee and elbow pain (10 out of 10 knee and elbow pain), raised rash on hands and shin. Bloodwork were done in order to clarify that there were no underlying conditions, but patient stated pain was still severe a couple days later. Patient initially went to the emergency room thinking it was bladder infection and mastitis and that was not the case since her condition did not improve and seem to be getting worse. The patient did not recover from the events at time of this report.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021037719 Parent/fetus cases
Nasal congestion; Full body aches; Soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Nov2023 at 08:15 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "anemia" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: PAIN (non-serious) with onset 14Nov2023 at 20:30, outcome "recovering", described as "Full body aches"; NASAL CONGESTION (non-serious) with onset 14Nov2023 at 20:30, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 14Nov2023 at 20:30, outcome "recovering", described as "Soreness at injection site". Therapeutic measures were taken as a result of nasal congestion, pain, vaccination site pain, a self administered Sudafed and ibuprofen.   Additional information: Since the vaccination, the patient has not been tested for COVID-19 and prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient had not known allergies.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Agitation, Headache, Fever, injection site redness swelling and streaking, very anxious with first shot, fever 101.4 after second shot for one day Narrative:
Symptoms of Covid that I thought were gone or nearly gone came back: increased fatigued during the day, cough (dry/tight feeling cough), tightness in chest, dull ache behind my sternum (constant), occasional dizziness and intermittent headaches are back. Were present for 1-2 weeks and then started to improve.
Shortness of breath - still continuing today on June 26th, prescribed albuterol inhaler. Tightness of chest. Lightheaded. Difficulty finding words. Sensitivity to noise.
upper torso  rash; Migraine like headache, 24 hours after injection; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer reported for herself. A 56-years-old female patient received second dose of BNT162B2 (formulation: Solution for injection, Lot Number: en6205), via an unspecified route of administration, administered in Arm Right on Mar2021 09:15 AM (at the age of 56-year-old), as dose 2, single for COVID-19 immunization. It was reported that the patient was not a pregnant at the time of vaccination. The patient's medical history included autonomic nervous system imbalance from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ropinirole hydrochloride (REQUIP) levothyroxine sodium (LEVOTHYROXIN) sertraline hydrochloride (ZOLOFT) bupropion hydrochloride (WELLBUTRIN) oestradiol (IMVEXXY) all from taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (formulation: Solution for injection, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Right on 13Apr2021 09: 00 (at the age of 56-year-old), as dose 1, single for COVID-19 immunization and experienced migraine, Macrobid [clarithromycin] and experienced drug hypersensitivity, bioxan and experienced drug hypersensitivity, Levaquin and experienced drug hypersensitivity experienced allergies. The patient experienced upper torso rash and migraine like headache, 24 hours after injection both on 14Apr2021 23:45PM. The patient did not take any treatment for events. The clinical outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2021454773 similar report from same reporter.
Patient received first Moderna dose. Pt had vaccine card as proof. Per CDC guidelines, if first dose of Moderna was given under the age of 18, complete the series with a second Moderna, so we gave the second dose.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The patient stated that, experienced sore arm after 1st dose of Shingrix. The reporter did not consent to follow up.
Patient reports light pressure on his throat; no shortness of breath, nor flushing. The patient refused transport to hospital. EKG and Blood Pressure was performed and cleared by EMS. Blood Pressure read 156/98 Heart Rate 106 Oxygen level 97
Lymph node in left arm pit severely swollen. Swelling remained for 6 days (same swelling after the 2nd dose, swelling remained for 3days then) very sore to the touch for the first 2 days then slowly less tender until swelling was gone.
high pitched cry & intermittent involnutary shaking for 1st 24 hrs;
SHAKING; SORE ARM; HEADACHE; NAUSEA; VERY SICK; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced very sick. On 16-MAR-2021, the subject experienced shaking. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, headache, and nausea on 18-MAR-2021, had not recovered from sore arm, and the outcome of very sick was not reported. This report was non-serious.
Arthralgia, NauseaVomiting, Fatigue Narrative: Nausea, diarrhea, fatigue, jaw pain on opening and closing; encouraged to COVID test, negative:
Hive like allergic reaction showed up on my lower arms yesterday morning.  By the end of the day,  it was all over my arms.  This morning it is now on my legs and my arms are still covered with bumps.  The rash is very, very itchy.
This was my first pregnancy. I was convinced to get the shot so I did on august 5, 2021. Two weeks later, before my 28 week appointment, I hemorrhaged blood. I was rushed to the hospital where the doctor on call determined that we needed to have an emergency cesarian due to the fact that my baby and I were losing so much blood. She was born at 27 weeks gestation, original due date was November 16, 2021. She weighed 2lbs 6.9oz, 14.96 inches long.
Swollen at injection site for days, extremely lethargic, malaise, loss of appetite.
Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who was vaccinated with an 0.5 ml expired vial of ACT-HIB (Batch number: UI803AA (Vial), expiration date: 21-Sep-2018 (vial) and (Batch number: U5859AB (diluent) and UI8038AA (box), route and site of administration were not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 and PEDIARIX for Immunisation. It was a case of actual medication error due to expired product administered. It is not reported if the patient experienced any adverse event. 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. Documents held by sender: none.
swelling in her leg; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (051529).  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in her leg".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
First time excursion started on 15Dec2022; 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First time excursion started on 15Dec2022), POOR QUALITY PRODUCT ADMINISTERED (16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First time excursion started on 15Dec2022), POOR QUALITY PRODUCT ADMINISTERED (16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (First time excursion started on 15Dec2022), POOR QUALITY PRODUCT ADMINISTERED (16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (First time excursion started on 15Dec2022) and POOR QUALITY PRODUCT ADMINISTERED (16 doses of the vaccines between the 15Dec2022 and the 21Dec2022).    No concomitant medication details was reported. Date and Time of Last Administration was reported as 17-Dec-2022 for Moderna COVID-19 vaccine bivalent. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine and also no reports of side effects had been reported to them. No treatment medication details was reported.  It was reported that Excursion took place 15Dec2022 through 27Dec2022. Maximum temperature reached was 46.5F. Excursion cumulative duration was 19.3 hours. First time excursion started on 15Dec2022.
Diffuse body erythema, in thigh area. Blancher no true hives, no wheezing.
Initial information received from a healthcare professional on 05 September 2012. A 92-year-old female patient with a history of TIA (Transient Ischemic Attack) had received an intramuscular (IM) dose of FLUZONE injection (lot number UH721AB) in left deltoid on 05 September 2012. On 05 September 2012, the patient experienced "HA", numbness of face, after FLUZONE, observed in office 20 mins, and discharged without complaint on 05 September 2012. The patient ongoing illness included as none. Laboratory details and corrective treatment included none. The patient's outcome was recovered on 05 September 2012.
Within a few hours of  of receiving the 2023 Flu Vaccine in my L arm, I had soreness in my L deltoid.  This was expected. What was not expected was the pain I experienced with pressure at the location of my L acromion process.  It did not hurt to move my arm, however, any sort of pressure resulted in pain. For example, the seatbelt. As of 10/1/2023, there is still mild discomfort with palpation.
A little over 12 hours after getting my first Moderna shot I experienced severe joint pain in my left knee that caused my entire left leg to become so painful I could not move it at all, as if I pulled an ACL. I decided to ride it out as each day went by the pain subsided more and more to where after 3 to 4 days later the pain was about 90% gone.  I still feel a little bit of soreness on the left side of my left knee cap though.  I am mostly back to where I was before the shot.  During the first few hours of the worst pain I did experience a cold sweat also.  All in  all I am feeling pretty good now however, a bit concerned about my second dose scheduled for March 23rd though, especially considering that I have neve had a negative reaction to a any type of vaccine before and I am not allergic. Great thanks to all!
mom states pt recvd vax 1PM @ clinic; pt arrived home & began crying-high pitched screaming & mom was unable to comfort pt; pt refused to nurse & cont crying 3 to 4 hrs; t99 to 100 x 24 hrs; MD contacted; swollen thigh-hot touch; sz
Patient experienced chest pain and arm numbness 11 days after receiving vaccine on 6/22/21. He went to ER and a chest CT images revealed a pulmonary embolism. He was discharged on 6/22/21 with a  prescription for  Eliquis 5mg BID.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and FATIGUE (Listlessness/tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, Hyperlipidaemia and Prediabetes.Concomitant products included METOPROLOL and LISINOPRIL for Blood pressure high, SIMVASTATIN for Hyperlipidaemia, METFORMIN for Prediabetes.On 22-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and FATIGUE (Listlessness/tiredness). On 23-Jan-2021, PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and FATIGUE (Listlessness/tiredness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes:On 18-May-2021: Updated reporter information and patient demographics. Added medical history, vaccine information and concomitant medications. The duration of the event updated.
No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.   This is one of several reports received from the same reporter.
Body aches, light headedness, chills, fever spikes (99.5 - 100.8), and nausea. Symptoms lasted for about 15 hours consecutively.  The next day in the evening 1 short fever spike and 1 occasion of lightheadedness.
This spontaneous report was received from a registered nurse and refers to a 9 month old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-APR-2016, the patient was vaccinated with PROQUAD lot # L050909, expiration date: 14-JUN-2017 (therapy type, dose and route of administration were not reported). Other suspect vaccine received on 05-APR-2016, included HAVRIX lot # 2PC5H, expiration date: 03-MAY-2018 (dose, route of administration and expiration date were not reported). There were no adverse effects reported. Additional information has been requested.
Burning up a day after my first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning up a day after my first vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning up a day after my first vaccine). At the time of the report, BURNING SENSATION (Burning up a day after my first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
On the 27th I began increased itching and injection site became red, slightly warm, and slightly stolen again. Red area is 3"in diameter
At first getting up in the morning, I immediately felt light-headed and things were closing in. I called my husband to tell him I was feeling dizzy. By the time I got to the toilet I was feeling nauseated and very dry mouth. I peed and was making my way back to bed with my husband's assistance, my legs got very weak and I collapsed to the floor on my butt.  My husband had his arm around my back and was supporting me while I was sitting on the floor.  He said about 10 seconds after I went down my eyes rolled back, I gasped and lost consciousness.  I was out for about 30 seconds before I came out of it. My husband helped me to bed where I stayed until 1:00 p.m. I slept most of the time. I had all the other adverse reactions listed: pain, redness, myalgia, fatigue, headache, shivering.
CHILLS; FEVER; FATIGUE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and fatigue was not reported. This report was non-serious.