chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLUZONE QIV PFS at a high temperature of 72.7F out of range for 7 weeks with no reported adverse event; patients were administered post excursion with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 47 years old male patient who was administered influenza quadrival A-B vaccine [FLUZONE QIV] post excursion at a high temperature of 72.7f out of range for 7 weeks with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2023, the patient received a dose 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection expiry date: 30-jun-2024 lot UT8055JA via intramuscular route in unknown administration site for immunization and exposed to a high temperature of 72.7f out of range for 7 weeks with no reported adverse event (product storage error) (unknown latency) and was administered post excursion with no reported adverse event (poor quality product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone qiv pfs at a high temperature of 72.7f out of range for 7 weeks with no reported adverse event and was Unknown for the event patients were administered post excursion with no reported 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 the 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.; Sender's Comments:  US-SA-2023SA305541: US-SA-2023SA305537:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 4 (booster), single (Lot number: GH9699) at the age of 75 years, in right 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) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (02Jan2023) Positive, notes: I tested positive again on 02Jan2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.
I'm a long-time platelet donor. Since receiving my celiac disease diagnosis 6 years ago, my iron numbers have stayed up, as I am able to absorb nutrients better. However, since the vaccinations, my hemoglobin levels have dropped. Before the vaccinations, my hemoglobin levels were always in the 14-15 range, but since receiving the vaccinations, the levels have dropped to the 12-13 range. As a result, I have been deferred several times from making donations. Also, because of the lower iron levels, I have been tired more often.
My arm swelled and it is still swelled; This was more like a tingling like needle tingling in my hands and it was also like went through my body; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, my arm swelled and it is still swelled, this was more like a tingling like needle tingling in my hands and it was also like went through my body on an unspecified date. Reported as, "I had the Pfizer shot on Saturday and I had some, a little bit side effects from it, of course my arm swelled and it is still swelled this morning, but last night I had like tingling in my hand, and in my (incomplete sentence), and in one of my down one of my legs and it was like a tingling through my body and I read and read everything they gave me the information on the vaccine for Pfizer and that was not in there but it could be, it says it's some kind of muscle, you could have some muscle sore or muscle pains but this was more like a tingling like needle tingling in my hands and it was also like went through my body last night, and then it went down my leg so". Outcome of the event swelling arm was not recovered and unknown for paraesthesia.  Follow-up attempts completed. No further information expected.
Shingles; Rash; Severe pain; Tingling; Burning; Vomiting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles), rash (Verbatim: Rash), pain (Verbatim: Severe pain), tingling (Verbatim: Tingling), burning sensation (Verbatim: Burning) and vomiting (Verbatim: Vomiting). The outcome of the shingles, rash, pain, tingling, burning sensation and vomiting were not reported.   It was unknown if the reporter considered the shingles, rash, pain, tingling, burning sensation and vomiting to be related to Shingles vaccine.     It was unknown if the company considered the shingles, rash, pain, tingling, burning sensation and vomiting to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and 3 months later experienced rash, severe pain, burning, tingling and his or her pain was so bad as he or she was vomiting. Follow-up would not possible as no contact details were available.
Information has been received from a medical assistant concerning a 11 year old female with no known drug reaction/allergies or pertinent medical history who on 12-AUG-2009 was subcutaneously vaccinated in the right upper arm with her second dose of VARIVAX (Merck) (lot# 664450/0692Y) and had an adverse reaction. The patient was also vaccinated with her second dose of GARDASIL on the same day. The patient did not have any reaction after the first dose of GARDASIL. Post vaccination the patient went home and became dizzy, and light headed, slept for 4 hours. The patient woke up and went to sleep again. The patient's mother took a pen and circled the injection site since it was red, stiff and warm to the touch. Since then the redness had increased outside of the pen mark at the injection site. At the time of the reporter, the patient's events persisted. The patient was being seen by the doctor for followup. Additional information has been requested.
A report was received from a health care professional on 11/19/03 concerning an 81 year old female vaccinee who experienced nausea and vomiting, and was diagnosed with pancreatitis, which resulted in hospitalization for 3 days, after receiving Fluvirin vaccine on 10/22/03. Concomitant medication taken at the time of the event included hydrochlorothiazide, potassium chloride, pantoprazole, simvastatin, fluoxetine hydrochloride, amiodipine besilate, primidone and calcium polycarbophil. On 10/22/03, the vaccinee was administered Fluvirin and later that day she experienced nausea and vomiting and was subsequently hospitalized. The vaccinee was diagnosed as having pancreatitis with a lipase level of 6,686. With bowel rest and IV fluids she improved and was discharged from hospital on 10/25/03. The vaccinee is now eating well and had one episode of pain but is otherwise feeling well. She is to maintain a low fat diet. The vaccinee had recovered at the time of the report. Following review of the patient's history and other possible causes of pancreatitis, the hospital gastroenterologist considered the pancreatitis to be likely related to the vaccine, however, there was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up on 01/15/04: "Further information received from a health care professional on 01/02/04 indicated that further concomitant medication taken at the time of the event included valdocoxib.  The vaccinee has a medical history of hyperlipidemia, hypertension (for which the vaccinee was taking hydrochlorothiazide), gastroesophageal reflux disease, tremor and has allergies to ampicillin, codeine, diazepam, rofecoxib and levofloxacin.  The reporter has assessed the relationship of the vaccine to the pancreatitis as probable.  Follow up pending. Update 2, 10 February 2004: Further information received from a health care professional on 10 February 2004 indicated taht the vaccinee's initial amylase on 22 October 2003 was 1175 u/l. (normal range 30u/l-110u/1). WBC was 19/2 and by day 4, 35 October 2003, lipase was down to 90 u/l (normal range 23 u/l-300u/l). A GI scan showed mild prominence of the pancreatic head, no masses, a cyst in the left lobe of the liver and mild intrahepatic biliary dilatation. The vaccinee was also treated with antimetics. There was no recent change in the vaccinee's medication. No follow up pending, all information received.
severe headaches; night sweats; severe bone crunching chills; light headedness/feeling faint; fever; muscle and joint ache/pain; muscle and joint ache/pain; nausea; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162b2 (lot: EK 9231), via an unspecified route of administration in left arm on 26Dec2020 12:30 at single dose for covid-19 immunization. Medical history included subclinical hypothyroid, Premature ventricular contractions (PVC's), Migraines. Concomitant medication included metoprolol succinate (TOPROL), fesoterodine fumarate (TOVIAZ), levothyroxine, omeprazole, "multi v". The patient experienced severe headaches, night sweats, severe bone crunching chills, light headedness/feeling faint, fever, muscle and joint ache/pain, nausea on 28Dec2020 02:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received the urgent care, lab tests for these events. The patient's results of covid tests (Nasal Swab, covid swab) were Negative on 31Dec2020 and 05Jan2021. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
felt pressure on their feet; like someone hit us with a baseball bat", they couldn't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2021 as dose 1, 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: DISCOMFORT (non-serious), outcome "not recovered", described as "felt pressure on their feet"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "like someone hit us with a baseball bat", they couldn't walk".  Additional information: Caller stated that now they are on May but since the month of Mar they are still with the same symptoms. Question: Caller stated that the location where she and her husband received the vaccine provided phone number and stated that she was calling about the side effects that they have been experiencing and asked what should they do about it. Caller (female 53 years old) and her husband (male 61 years old) received their first dose on 19Aug2021, they felt pressure on their feet. She stated "like someone hit us with a baseball bat", they couldn't walk.  E-transmitting AE as caller disconnected the call before transfer. Caller stated that information about the shoulder side effects "is all over Google". She has already contacted her primary physician and they told her to contact Pfizer. She was very concerned because "we are just going in circles and circles, no one is doing a damn thing about it". She expressed her concerns about herself and her husband, and asked if they loose their jobs "then who is going to maintain them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200743105 same reporter/product/event different patient
Information has been received from a physician concerning a 13 year old female who on 27-JUN-2011 was vaccinated intramuscularly with the first dose of GARDASIL. The reporter stated on 27-JUN-2011, the patient experienced seizure like symptoms. She was sitting on the exam table, fell off the table and hit her chin on the counter as she fell. The patient was anxious and had not eaten all day. The patient split her chin open and it was considered to be disabling. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Upon internal review, seizure like symptoms is considered to be other important medical event. Additional information has been requested.
Pt given 1st Gardasil, when checking out pt c/o of dizziness to mom.  Pt passed out and was unresponsive for 2-3 min.  Pt came to and taken back to room and examined by Dr., who sent pt to hospital for outpt observation.
Pt recvd MMR vax AUG92 & approx 5 wks following vax pt exp lethargy & a h/a; 3 to 4 days p/ had grand mal sz; PE revealed papilledema; lab eval CSF revealed 25 WBC's; MRI & CT scan were nl; MD felt had encephalitis due to vax;
Burning pains everywhere that come and go at random, sometimes lasts days. Neurological. First day of "adverse event" was July 3rd, but the night before I had thrown up but felt fine. On July 3rd, had first time bad Acid Reflux, took OTC Prilosec which helped over the course of a few days. Someone suggested trying Claritin for the random burning, but it does not help. Strong back pain. Random bouts of nausea (trying not to throw up to avoid Acid Reflux again). Difficulty eating and drinking as a result of symptoms. Sleeping a lot more than usual. Weak in general. A few days ago started to feel better, still kept diet specific to avoiding Acid Reflux. Overnight, horrible burning in limbs and random parts of body came back. Slept and napped for about 18 hours yesterday as burning was ongoing. Can sleep through pain. Pain is instant upon waking up. Sometimes (like right now as I write this) burning is tolerable, sometimes it is unbearable and crying hurts too. Muscle spasms and twitching occasionally, sometimes in frequent in a session. Primary doctor agrees that all of these symptoms are from the vaccine.
Started getting chills and a sore throat.  After a couple of hours got very tired/sleepy and a fever. Also, got very irritated.
Patient described the administration site as "red" and a "hard bump." The bump then spread as hives all over body. Patient reported rash and visited doctor on 3/4/15 and was treated with Benadryl.
Patient admitted to hospital for chest discomfort, fever, body aches. Patient in stable condition. Further tests pending. Pain worse with lying flat. Relieved with leaning forward, worse with deep inspiration, described as somewhat sharp. Diffuse ST elevation, predominantly in inferolateral and high lateral leads. Echo revealed global hypokinesis with an EF in the 35% range. Troponins were elevated. He has no real shortness of breath, just feels washed out. No real PND or orthopnea or lower extremity edema.
Increase redness, swelling upper (L) arm including (L) shoulder area, warm to touch with erythema (L) deltoid / tx -warm compresses, BENADRYL Ibuprofen.
Fever, rash, arthralgias, myalgias, dry cough, SOB beginning 24 hrs after injection lasting >1 wk.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 15-APR-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sick as a dog; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick as a dog) and FEELING ABNORMAL (Feeling bad) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 29-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad). On 30-Apr-2021, the patient experienced ILLNESS (Sick as a dog). At the time of the report, ILLNESS (Sick as a dog) and FEELING ABNORMAL (Feeling bad) outcome was unknown.            No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-101610 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received on 20-May-2021 and does not contain any new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101610:Son Case
NSTEMI and subsequent STEMI later in the week. Not Fatal . Overall good health 2 years later.
Patient received first dose of Moderna COVID-19 vaccine on 6/15/21. Approximately one week later, he began experiencing an itching sensation throughout his back. He received his 2nd dose on 7/20/21 as scheduled. As of a phone check-in on 7/28/21, the itching had not resolved. The patient had COVID-19 in December 2020 reported on 7/28/21: "I had it when I had COVID, and then about a week after I got the first shot, it came back.". The patient reports that the sensation is similar to what he experienced when he had the COVID-19 infection. He reports that he has seen one doctor at the Health Center regarding this side effect. Following are quotes from the patient during a phone call check-in on 7/28/21: "I feel like my skin is like really dried because when I touch it, it's painful." "It started like maybe 2 weeks after I started to get COVID, and then it started to go away and was gone by March or April [2021]." As of 7/28/21, he reports that it "has not gotten worse and it has not gotten better."
Pt was seen in ER on 7/18/21 and tested positive for Covid-19 after a previous exposure to another positive person. Pt was discharged with a script for Ivermectin at that time. Pt returned to the ER on 7/20/2021 with worsening symptoms and was admitted with acute hypoxic respiratory failure secondary to Covid with PNA. Pt gradually started requiring more and more oxygen and was intubated on 7/24/21 and  transferred out of our facility.
Order was put in for Prevnar 13 to be administered not realizing it was for 6 months and older.
15 min after ZOSTAVAX numbness (L) side of cheek - client very nervous about vaccine (Dental work 6 months) tingling in jaw up to eye. Hx HTN, B/P 140/108 HTN meds asap - decrease 5 min after report decrease 178/80 - numbness to cheek.
3/9-11 - sore throat & headache was seen Dr her family Dr, 3/11 -> 3/12 developed red raised rash - red bumps & hives on her hands to her upper arms bilaterally, also on her feet & ankles also hips, parent gave her TYLENOL. She also had c/o great fatigue starting on Thursday. No fever - 3/14-11 rash light on hands & elbows & ankles.
Breakthrough symptomatic COVID-19 infection, positive PCR 10/7/21.
Approx 24hrs after pt had swelling of fingers and abdomen both hands and discoloration around eyes (lasting 3-4 hrs) No resp. distress, no hives.
Muscle ache, can barely move; A spontaneous report was received from a consumer concerning a female patient of 76 years of age ,who was administered with Moderna's covid-19 vaccine and experienced muscle ache and can barely move.  Patient was diagnosed with covid-19 infection on November 15.Concomitant medications included Simvastatin, Multivitamin, Calcium, Vitamin D, and a blood pressure medicine.  On 14-FEB-2021,prior to the onset of events,the patient received mNRA-1273(Lot number:039K20A) for prophylaxis of covid-19 infection.  On 15-FEB-2021,patient started experiencing Muscle ache and can barely move.Treatment medication included Tylenol.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.
After #3 Anthrax shot, left arm began to swell from site of shot down to mid forearm. Swelling began approx 24 hours after shot. Left hand also began tingling. Still swollen, possibly, 2 days later.
I suspect this to be a local skin reaction to his immunization shot. Rash, red in color, three inches by an inch and a half. Rash, feverish to touch.
ENLARGED HEART; This spontaneous report received from a patient concerned a female 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, intramuscular, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JAN-2019, Laboratory data included: Stress test (NR: not provided) Normal. On JAN-2021, Laboratory data included: Echocardiogram (NR: not provided) Normal. On 09-AUG-2021, the patient experienced enlarged heart. Laboratory data included: Cardiac imaging procedure (NR: not provided) Enlarged heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of enlarged heart was not reported. This report was non-serious.
Patient presented to the hospital on 10/22/22 with shortness of breath. He tested positive for COVID on 10/23/22 and claims he's been sick for 10 days although his history is inconsistent. Patient is discharged on 10/29/22.
Mom states vaccines administered yesterday, child was fine.  Today she reports unconsolable crying for 3.5 hours.  Tylenol given yesterday and today.  No fever.  Child "cried himself to sleep" per Mom's statement.  Also slight redness left thigh
pt recv vax 28FEB96 & had a petit mal sz & another one while sitting in MD's waiting room;pt was seen by MD who discovered an ear infect;pt had another sz;mom called MD r/t sz,vax & ear infect;MD increased pt's med