chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient received a dose of Boostrix that had already expired on 24/Sep/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis.   On 27-SEP-2023, the patient received Boostrix. On 27-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: a patient received a dose of Boostrix that had already expired on 24/Sep/2023).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2023 A nurse called to inform that earlier that day, a patient received a dose of Boostrix that had already expired on 24th September 2023, which led to expired vaccine used. The reporter did not consent to follow-up. This case had been linked with US2023133458, reported by same reporter.; Sender's Comments:  US-GSK-US2023133458:Same reporter 2nd patient
I injected the PEDIARIX and Flu into (R) thigh the PCV 13 and ACTHIB into his left thigh and then the pt. held his breath and passed out. Less then 2 sec. later pt took a big breath.
Swollen arm with itching and reddish skin around the injection point, pain in the upper left chest and left shoulder, feeling of chill, prolonged tiredness,  lack of muscle strength in the legs. All these symptoms occurred the next day and persist until the time of reporting.  The muscle surrounding the injection point seems to get hardened.
Nurse reported ROTATEQ was administered after improper storage. Requested follow up letter be sent to different RN, as reporter is covering for clinic currently. See additional AE cases 02453315, 02453385, 02453409, 02453432, 02453446, 02453464, and; This spontaneous report was received from a Registered Nurse referred to a specific patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On 06-JUL-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1908339, 18-NOV-2023, orally, (strength, dose number, and frequency were not reported) as prophylaxis (product storage error). The vaccine experience a temperature excursion of 51 Fahrenheit Degrees during one hour. The vaccine had no previous excursions.          This is one of several reports from the same reporter.
new onset vertigo, general malaise, fatigue. i do not believe it to be vaccine related- more either autoimmune or thyroid related.
p/vax pt exp legs paralyzed & couldn't hold up head; called ER & was advised to watch pt & call back if no improvement in symptoms; better following morning
11/6/12 - Pt. woke up with fever, redness and tenderness in area of left bicep. Injection site was sore, hard, and swollen. Treated pain and fever with 600mg Ibuprofen on own. 11/7/12 - Woke up with fever up to 101.7 degrees F and continued with same symptoms in left arm. Again, took 600mg Ibuprofen. 11/8/12 - Fever 99.9 degrees F; continued arm symptoms. Dr. started her on Cephalexin 500mg BID x 7 days.
Initial report received from a company representative who received the original report from a health care professional on 01 November 2010. A male pediatric patient fainted after receiving FLUZONE (lot number not reported) on an unspecified date. Outcome was not reported. No other information was provided. Documents held by sender: None.
12 days p/vax mild nausea, high abd discomfort lasted 2 days; 2 months p/vax dx w/type I or juvenile diabetes;only poss onset trigger for diabetes insulin dependent;
About 24 hours after vaccine, pt noticed red bumps & itchy at injection site. Progressed over body with bumps. Day 7 & 8, weak & tired. Has not experienced SOB.
On Monday I had the COVID vaccination. I noticed no side effects on Tuesday other than tenderness at the injection site. On Wednesday, I noticed light bruising up and down my arms. Thursday morning around 10 AM, I started to have side effect - some so severe they must be documented. At 10 AM, I felt lightheaded and had brain fog. By noon my head was pounding with a headache followed by an upset stomach. At 2 PM things started getting bad and continued to worse. It was not the headache or stomach that need to be noted but a sudden and severe onset of depression and anxiety. - Depression like I have not felt in years when I was at my worst. Throughout the day the depression worsened and by 7 PM, I was unable to stop crying and was overwhelmed with anxiety and  PTSD panic attacks. While I have the training to understand  this is temporary, - I am very worried about what I?m feeling , because there was no warning or mention of this side effect. I have the resources needed for this but people that are more fragile need to prepare for the sudden o set of critical/ debilitating depression.
Pain to upper arm, numbness to the tip of left hand?s fingers,  numbness to  mouth lower lips and swollen /pain to  left arm armpit.
I did not have an adverse reaction to the vaccine. I developed a neuropathy on left anterior shin. It hurt so bad, and it was very difficult to sleep. I took Advil but it did not help. Later I developed a rash on my left anterior thigh. It looks like I have several bit marks all over my thigh.  The rash was a purple a red color that would burn and itch. I got an appointment with my dermatologist. He prescribed creams but it did not help. What does help is a warm bath with a little bleach. I soak for about 15 minutes, and I will take the bath about once week. The rash will go away for a few days and come back. It is all getting better but is not going away.
FAINTED; This spontaneous report received from a parent. The reporter obtained the information from news/media. 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) dose, 1 total, start therapy date were not reported for prophylactic vaccination. 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 parent reported that the patient had fainted in doctor's office 10 minutes after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fainted was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422263-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
I was mandated by my employer, to get the vaccine. Three days after the 2nd dose,, 10/03/2021 (Sunday), I developed cellulitis around injection site, and have subsequently been placed on Bactrim for 7 days as of 10/04/2021, following a visit to a urgent care facility since I could not get an appointment at short notice at my general practitioner?s office
COVID-19; COVID-19; Covid obviously cold symptoms, headache, temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; VITAMIN C [ASCORBIC ACID]; MAGNESIUM; ZINC; ZOLOFT. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 22Aug2022, outcome "not recovered", described as "Covid obviously cold symptoms, headache, temperature"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical Course: Patient received treatment for Covid-19 with Paxlovid from 15Aug2022 to 20Aug2022. Patient received other medication in 2 weeks that also included multi, probiotic and Life extension.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
soreness / injection site.; redness / injection site.; raised, swollen injection site.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and within hours of the injection she started having soreness, redness and raised, swollen injection site.  The patient stated that these symptoms persist. The reporter consented to follow up.
CAN HARDLY MOVE; COMPLETE BODY ACHE; ARM HURT VERY BAD; FATIGUE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pancreatic cancer, sulfa allergy, penicillin allergy, narcotic allergy, codeine allergy, and macrobids allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 12-MAR-2021, the subject experienced can hardly move. On 12-MAR-2021, the subject experienced complete body ache. On 12-MAR-2021, the subject experienced arm hurt very bad. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 14-MAR-2021, was recovering from can hardly move, and had not recovered from fatigue, complete body ache, nausea, and arm hurt very bad. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Patient states she started having pain in her left arm at the injection site 6 hours after the injection.  Staff gave it to her on 11/11/20. At 48 hours post injection she said her left arm was hot and  red and swollen from the injection site to the elbow.  She just came in today 11/16/20 to tell me.  She states she is improving but the arm is still red and swollen.  Her primary concern is she still has some heaviness, numbness, and tingling.  She states she is afraid she has nerve damage.  She has NOT notified her doctor but was going to show him at her appt next Tuesday.  I am recommending that the calls her doctor today.
Pt recvd a series of 3 Engerix-B on 14NOV90, 20DEC90 & 7MAY91 & was a non-responder; pt converted post booster dose;
Pt stayed after vaccination due to a prior reaction. Pt stated that her arm was itching at injection site. I looked and pt had redness and rash starting on right upper arm. Small hive was visible as well. Pt stayed and was monitored for another 25 min. with no worsening reactions. I suggested benadryl and to seek medical attention if any worsening reactions accrued.
About a day after the vaccine, patient experienced sharp acute hip pain which lasted a few days. Currently the pain is subsiding.
Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling in my cheeks.; My left arm also was extremely hard, sore, and tender/swollen.; My left arm also was extremely hard, sore, and tender/swollen.; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular on 22Dec2020 16:00 at single dose at arm (for confirmation) for COVID-19 immunization. Medical history included anxiety. The patient's concomitant medications were not reported. On 22Dec2020 17:00, Shortly after receiving the vaccine the patient felt a flushed feeling in her cheeks. The patient's left arm also was extremely hard, sore, and tender/swollen. About an hour afterwards, 18:00 I got a pulsating headache that lasted for 3 days. It was only mildly relieved with Tylenol and ibuprofen. It felt similar to a migraine and accompanied with some nausea on 23Dec2020 day 2. The patient received treatment for the events. The outcome of the events was recovered on an unspecified date in Dec2020.
began fever 11PM, sz @ 1115PM taken to hosp by amb;temp in ER 108 R;APAP had been given @  approx 7-730PM;also had high pitched cry;
TRANSIENT CEREBRAL ISCHEMIA 11/14/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
had the expected local reaction of soreness, redness, and swelling the day following vaccination, which completely resolved within a day or two.  then developed another similar local reaction at the injection site exactly 1 week later (swelling, redness), which resolved within 48hr or so
Bells Palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included sickness (it had been over 6 years since he/she had any kind of sickness) and respiratory disorder (it had been over 6 years since he/she had any kind of respiratory sickness).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bells Palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.   It was unknown if the company considered the bell's palsy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient was a healthy person. The reporter stated that he/she went ahead and got the shingles vaccine.  After the shingles vaccine he/she got bell's palsy 2 weeks later. The reporter further stated that it was coincidence. The follow up would not possible as no contact details were available.
did not receive full dose (2nd dose); This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (did not receive full dose (2nd dose)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Colon cancer.    On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (did not receive full dose (2nd dose)). On 07-Oct-2021, ACCIDENTAL UNDERDOSE (did not receive full dose (2nd dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter  The patient was complaining that she feels she did not receive a full dose of the vaccine. The patient reports that during the second dose, the pharmacist had one syringe with 0.5 mL, and one syringe with less than that. The patient said she wanted the syringe with 0.5 mL in it, and the pharmacist apparently said that was for another patient who was bigger and larger, who needed a full dose. The patient asked the pharmacist to open up a new vial. She believes she received 0.3 mL of a vaccine, instead of 0.5 mL.  The patient said she was running late for her chemo appointment, and said she is dying of colon cancer. She also reports she has A plus blood type, and that she was told that is the blood type that coronavirus affects the most. She is going into getting her colon operated on, so she wants to make sure she does not get COVID when she is in the hospital.  The patient believes she did not receive a full dose for the second shot, and said she did not get any side effects from this dose.  Treatment information was not provided.   This case was linked to MOD-2021-347404 (Patient Link).
After each of three (3) injections with the Pfizer vax all the "floaters" within my eyes disappeared almost immediately.  While not an "adverse reaction" per se, it was recurrent and unusual enough that I thought it should be reported. I am acutely aware of my "floaters" in daily life and have lived with a physician for many years, so I immediately noticed when they were gone. The "floaters" eventually re-appeared after the first two vaccinations. I attempted to report this reaction through the Pfizer reporting website but could not complete their complex  and indecipherable online forms.
After vaccine later I felt very dizzy and exhausted, a bad headache, I fell asleep in the kitchen standing up.  I laid down.
APPROXIMATELY 12 HOURS  AFTER RECEIVING VACCINATIONS PATIENT CALLED 911 . PATIENT WAS EXPERIENCING HEART RACING, NAUSEA/VOMITING AND SEVERE MUSCLE WEAKNESS. PATIENT THOUGHT HE WAS SUFFERING A CARDIC EVENT. HE RECEIVED CARE WITH EMS, BUT WAS NOT TAKEN TO OR ADMITTED TO THE HOSPITAL. PATIENTS DOCTOR SUSPECTS THE REACTION WAS DUE TO ELIQUIS.
Swelling at injection site w/tingling in hand and petechia distally near antecubital fossa.
Vaginal delivery on 3/4/22; 39 weeks; G2P0010; presented for induction of labor
2nd fuse excruciating ache and pain in left elbow wrist and fingers; 2nd fuse excruciating ache and pain in left elbow wrist and fingers; 2nd fuse excruciating ache and pain in left elbow wrist and fingers; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 46-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 13:15 (at the age of 46-Year-old) as dose 2, single for covid-19 immunisation. The patient's medical history included allergy to cat, smoke, allergies to pollen, allergy to horse and environmental asthma. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:15 (at the age of 46-Year-old) as dose 1, single for covid-19 immunisation and experienced severe ache in neck/ back and rib case. On 15Apr2021 14:00, the patient experienced 2nd fuse excruciating ache and pain in left elbow wrist and fingers. The events led to emergency room/department or urgent care. The patient was treated with poison ivy and oral Cortisone. Therapeutic measures were taken as a result of events. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
received vaccine on 4/22/21 at unknown location; admitted on 5/16; Internal reported event states: Patient presented to the ED on 5/16/21 with shortness of breath, and VQ scan showed high probability of pulmonary embolism. Patient had second dose of Moderna COVID vaccine on 4/22/21, and admitting PA felt PE could potentially be related to the vaccine. Workup still underway to r/o lung cancer given history of smoking, link to vaccine not definitive at this point.
Feeling cold; Feverish; Headache; Sleeplessness; Fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-APR-2023, the patient received the 2nd dose of Shingrix. In APR-2023, an unknown time after receiving Shingrix, the patient experienced feeling cold (Verbatim: Feeling cold), fever (Verbatim: Feverish), headache (Verbatim: Headache), sleeplessness (Verbatim: Sleeplessness) and fatigue (Verbatim: Fatigue). The outcome of the feeling cold, fever, headache, sleeplessness and fatigue were unknown.   It was unknown if the reporter considered the feeling cold, fever, headache, sleeplessness and fatigue to be related to Shingrix.     It was unknown if the company considered the feeling cold, fever, headache, sleeplessness and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2023 The reporter reported that she received her second dose of Shingrix and had since experienced feeling cold, feverish, headache, sleeplessness, and fatigue. The reporter consented to follow up.
Rec'd influenza vaccine 9/21, broke out in rash on neck 9/27, only on (L) side of neck shoulder (1 week after FLUVIRIN, w/o reaction to any flu imm. in past).
high fever joint pain hives foot neuropathy like symptoms ( am not a diabetic) all symptoms gone except feet neuropathy now 5 months later
Fatigue ,aches, chills,  kind of flu like symptoms, significant arm pain, injection site hot, red and swollen, some SOB, no fever
Information has been received from a licensed practical nurse concerning a 9 week old white male. The patient received a 0.5 ml first dose of ROTATEQ (lot #658384/1387U) po on 10-JUN-2008. The mother called the facility on 11-JUN-2008 and 13-JUN-2008 complaining the baby had 48 hrs of cramping and diarrhea. The patent recovered an approximately 12-JUN-2008. The mother did not seek medical attention at the time, but did report findings to the licensed practical nurse on 13-JUN-2008. No further information is available. This is one of several reports from the same reporter.
Severe headaches. I occasionally get headaches but they are easily treated by taking Advil once. At the time I am filing this, I still have a headache after taking Tylenol at lunch time, Advil at 4 pm and Hydrocodone at 10pm.
At some point after the 2nd vaccine the patient had increased weakness and shortness of breath. He presented to the ER and was noted to have acute kidney injury. Patient was admitted from 2/23- 2/27.