chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 5 minutes of the administration of the shot, I realized that maybe I had been given a sedative. My left arm muscles felt more relaxed, and there was no pain at the injection site. The right arm felt, at the time what I thought was normal as per the first two covid shots. I worried that my left side was permanently, or at least in a long-term way, relaxed more than I thought it should be. It remained smaller, and less stressed/puffed out than the right side. Pretty normal size, and maybe a little inflamed. but the right side was hard to compare with  prior shots because usually the two sides reacted virtually the same.   Please check my post-vaccination VAERS survey form. I believe I was more worried about this shot due to the unusual reaction in my body. I was very concerned that my heart was going to be adversely affected. My stress and worry level frequently raised my blood sugar levels.  The first intake nurse seemed OK, to me, but the second took my hot pink card, I believe, and gave me a white one (that is, if it wasn't taken at the second vaccine administration site),   The second, male intake nurse had set out a shot to be administered to me. After taking my hot pink card, (I think0, he DEFINATELY switched out the shot for a different one, that was in a separate area from the first shot that had been set out for me. I wasn't sure, but maybe the syringe looked slightly slimmer, more narrow. The first intake nurse was VERY corrective of what he had done by her attitude, facial expression, and firm, but controlled tone of voice. She did not yell or scream in a way that anyone other than us three at the table would hear.  He/they directed me to table at the far end of the room. I thought he was an ex-boyfriend, but his hair looked different. I might have seen him in a car near looking "not well at all" for as long as I had known him. His hair was done like what I had seen two people do their hair (both of them were familiar to me in places). Dark black, plastered to the head, short bowl-type cut . . .  I cannot remember now, specifically, but I believe he was the one to administer the shot. I blanked out for a sec and did not pay attention for a minute or so.  I sat behind a lady who looked like a former Board of Directors Member. I thought I had seen her at the Post Office on a few weeks/month earlier Her hair was not looking like its stylish best either, like someone else, but looking female, and her height. Like the guy at the far end of the room, who I thought administered the shot.  A man, about 5'9" walked in afterward, and decided that he would wait until tomorrow to get his shot. His hair was about the same color as the lady in front of me, who also weighed more than I had seen looking in quite a long time.  I noticed him because I see him occasionally crossing the street. and because I thought I was going to wait another day before getting the #3 COVID shot myself.
Excessive sweating, fever, body ache, headache, blisters on the scalp and redness of the armpits
I had to cancel her case today because she showed up without COVID-19 testing and then tested positive. Can you add her on to 11/30/2021? It's a Tuesday, which should work for her dialysis schedule and will be 21 days after today's test. She will not require another COVID-19 test since she tested positive this time.
Pt given booster covid dose today, booster dose given earlier than recommended. Pt not reporting any symptoms: tiredness, fever, pain
A dose of FLUBLOK QUADRIVALENT was inadvertently given to a 12 year old, no AE; Initial information was received on 28-Sep-2020 regarding this unsolicited valid non-serious case from a pharmacist.  This case was linked to case 2020SA267036 (same reporter).  This case involved a 12-year-old patient who was inadvertently given a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  Relevant medical history, medical treatment, vaccination, concomitant medications and family history were not provided.   On 26-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2003, expiry date: 19-May-2012) via unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration.   Reporter wanted to know if any data available on use of Flublok quadrivalent for pediatric patients and whether the patient needed additional flu vaccines this season.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Later in the day following vaccination began having inflammation in the thumb joint, and wrist. Five days after vaccination patient continued to experience swelling, redness at site, and was unable to lift arm above shoulder without pain. Now she has painful base of index finger with joint swelling
Client, 4 month old, received Pediarix( DtaP, Ipv, Hep B), PCV13, and Hib. No reaction observed at the time when vaccine given. Mother of child reported that client started with rash on torso, arms and legs. No respiratory distressed observed. Symptoms re-evaluated and rash started to diminish. EMT called per clinic protocol. Transferred care at the time of arrival.
18 year old patient came into office to restart Hepatitis B series. After administering vaccine it was found the lot had expired 10/2016. the patient had no adverse reactions. Age of patient at time of event: 18 years.
Extreme Drowsiness; Fever like symptoms; disorientation confusion; disorientation confusion; nausea; This is a spontaneous report from a contactable consumer (patient). This 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 23Feb2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, no allergies and no concomitant medications. The patient had not been diagnosed with COVID prior to vaccination and had not received any other vaccines in four weeks. The patient previously received the first dose of BNT162B2 in the right arm on 26Jan2021 at 08:00 (at the age of 34-years-old) for COVID-19 immunisation. On 23Feb2021 at 12:00 the patient experienced extreme drowsiness, fever-like symptoms, disorientation confusion and nausea. No treatment was provided for the events. The clinical outcomes of extreme drowsiness, fever-like symptoms, disorientation confusion and nausea were recovered on unspecified dates. It was also reported the patient had not been tested for COVID since vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; Headache; excess stomach acid and stomach ache; excess stomach acid and stomach ache; soreness at site of hip replacement; soreness at site of hip replacement; hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 02Jun2022, outcome "not recovered"; ABDOMINAL PAIN UPPER (non-serious), GASTRIC PH DECREASED (non-serious) all with onset 02Jun2022, outcome "not recovered" and all described as "excess stomach acid and stomach ache"; HOT FLUSH (non-serious) with onset 02Jun2022, outcome "not recovered", described as "hot flashes"; HIP ARTHROPLASTY (non-serious), ARTHRALGIA (non-serious) all with onset 02Jun2022, outcome "not recovered" and all described as "soreness at site of hip replacement"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, headache, abdominal pain upper, gastric ph decreased, hip arthroplasty, arthralgia, hot flush.  Clinical course: Anti viral details, Paxlovid, Treatment start date: 26May2022 and Treatment stop date: 31May2022. Indication: Treatment of COVID-19. Headache, excess stomach acid and stomach ache, soreness at site of hip replacement, hot flashes treatment included Zofran.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain in msucle in upper left arm and shoulder a day after the injection. I was to come back the following week for a pneumonia shot, but was in too much pain. Had to take over the counter meds for pain. Pt. has appointment with physician on 11/26 due to prolonged pain in left arm from injection given on 10/17/2018.
Became argumentive in car on ride home. Began wheezing and having shortness of breath within hours. Coughing lasting several days.
On 12/6/99, the pt experienced erythema multiforme. The condition was resolving at the time of the report. Unspecified medical attention was sought. No further information is available. Follow up data states the patient recovered several weeks later. It was noted "clinically, patient did well".
Fever at 101 degree Fahrenheit overnight; Still have fever; Lot of chills; Really weak like unwell; Really weak like unwell; Arm hurts, where I have the shot it's hurting me and bothering me a little bit; Arm hurts, where I have the shot it's hurting me and bothering me a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 20Aug2021 (Lot number: FD8448) at the age of 56 years 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: PYREXIA (non-serious) with onset 21Aug2021 01:00, outcome "not recovered", described as "Fever at 101 degree Fahrenheit overnight; Still have fever"; CHILLS (non-serious) with onset 21Aug2021 01:00, outcome "unknown", described as "Lot of chills"; ASTHENIA (non-serious), MALAISE (non-serious) all with onset 21Aug2021 01:00, outcome "unknown" and all described as "Really weak like unwell"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 21Aug2021 01:00, outcome "unknown" and all described as "Arm hurts, where I have the shot it's hurting me and bothering me a little bit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, asthenia, malaise, pain in extremity, vaccination site pain. Additional information: Report was related to a study or programme. Consumer stated, had a lot of chills all night, still have fever right now, feel like really weak like unwell and arm hurts, think that was normal where she has the shot it was hurting her and bothering a little bit. But concern was this if she feels this way do anybody get sick, herself or if any problems, if she can drink something to lower her fever, have not done anything because she was scared to do anything. Consumer was informed about the role of Pfizer Drug Safety and requested to probe. Consumer stated, just wanted an answer about what to do. Okay, you can go ahead. Started feeling them last night at around would say 1 o'clock in the morning. Her age was 56. Start date of events, consumer stated, 21Aug2021 (21Aug2021) it was after 1 o'clock so it was today. It was just being the same all night lots of chills, the fever and the fever was not going away. So she does not know. Treatment: have not taken anything. Consumer stated, her question was what should she, should she isolate from people or can be next to other people that will be fine or not. Consumer was informed about Pfizer Medical Information.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
Edema, redness, hot at touch on right thigh (cellulitis). Tx AUGMENTIN 200/5ml q 12h. CLARINEX 2.5 po.
Weakness of lower extremities, pain in back and chest, paresthesias, hospitalized 5 days for Guillain-Barre Syndrome. Rx plasmapheresis.  01/04/2008 MR received for DOS 10/27-11/01/2007 with D/C Dx: Guillain-Barre Syndrome.  Pt presented to ER with c/o progressive weakness and pain in the back x 9-10 days with paresthesias. Pt recently lost bladder and bowel control and was admitted. Txd with plasmapheresis with improvement of sx.
Arm was sore; Headache; Body aches; Fever 99 degrees Fahrenhe; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever 99 degrees Fahrenhe) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Polio (Left leg and hip, small weakness in left arm from post polio).    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever 99 degrees Fahrenhe). At the time of the report, PAIN IN EXTREMITY (Arm was sore), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever 99 degrees Fahrenhe) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 99 (Inconclusive) 99.         Concomitant product use was not provided/unknown by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the eventns; therefore, action taken with the drug in response to the events is not applicable.
Day 1 (4/5/2021): extreme exhaustion and nausea Day 2 (4/6/2021): extreme exhaustion, nausea, fever (101), chills, sweating, whole body and muscle aches, vomiting, disoriented, unbalanced, light headed, head ache Day 3 (4/7/2021): extreme exhaustion, nausea, fever (101), chills, sweating, whole body and muscle aches, vomiting, disoriented, unbalanced, light headed, head ache, vertigo, injection site is a hard, swollen, and red Day 4 (4/8/2021): extreme exhaustion, nausea, vomiting, whole body and muscle aches, disoriented, unbalanced, lightheaded, head ache, vertigo, injection site is a hard, swollen, and red Day 5 (4/9/2021): extreme exhaustion, nausea, whole body and muscle aches, disoriented, unbalanced, lightheaded, head ache, vertigo, injection site is a hard, swollen, and red
received Imm on 7/28, tues pm noted pain, swelling, and warm to touch left arm Deltoid area.  Had fever and stomach ache take to er 7/29 received benedryl and use warm compresses.
Itching started on Saturday evening.  Constant generalized itching.  Patient tried Benadryl which made itching worse.  Swelling at injection site - possible lymph node enlargement.  Amlactin cream applied to skin has helped per patient.  No hives, no fever, no difficulty breathing.
Patient presents following referral for seizure like activity 15 min after HPV9 #3 (given 8/7/2019 at Immun Clinic) - reported while waiting his 15 min post vaccine recommendations, he felt like he was falling asleep, unable to keep eyes open, his heart was racing/pounding in chest, he felt his mouth open and lost feeling in his body.  He states he went unconscious slumping back into a chair and was told he placed on floor by staff.  His next memory was 3 days later on Friday/Saturday - he was intubated and in ICU.  He reported he was stress out day of vaccination, but not more than normal; he did not have breakfast and at an apple for lunch with no hx hypoglycemia; he denied any pertinent PMH or family hx seizures but did report hx seizure like activities after wisdom teeth surgery (thought due to benzodiazepines) and again after use of Percocet (was stressed with both episodes). ER note Medical Center notes pt on intravenous Ativan, Keppra and fentanyl on arrival  for airway protection (intubated)and has prior hx of seizure like disorders - was released on 8/10/2019 (normal CBC, CMP, KC, CKMB, Troponin I, CXR, CT head, MRI brain w/wo contrast normal, EEG abnormal due to presence of diffuse slowing of cortical activity, consistent with a non-specific encephalopathy. No epileptiform discharges in this recording.
Pt got vaccine (Tetanus) on 11/10. Started with (L) arm, armpit numbness & tingling that radiates down her arm to her fingertips. Pt went to her PCP & got MOTRIN, ATIVAN script -> no effect. Pt went to urgent care center 11/26 when PCP couldn't see her & got script for RELAFEN. 11/28 today pt's symptoms = numbness & tingling to (L) arm that radiates to fingers, fine motor problems to (L) hand; pt has full ROM & no other s/s any reaction. Good sensation to hands. Pt has hx MS but MD spoke with her neuro MD & she doesn't think this is MS related.
Sharp chest pain that was attributed to heartburn/acid reflux from 1 day after injection until present (04/08/2021-04/13/2021).  Fever and chills 1-2 days after injection (04/08/2021-04/09/2021)  Muscle pain at injection site 0-3 days after injection (04/07/2021-04/10/2021)
anaphylaxis; throat tightness; hoarse voice; tingling lips; This case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a 64-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 4MA5A, expiry date 30th June 2020) for prophylaxis.   On 14th October 2019, the patient received FluLaval Tetra 2019-2020 season. On 14th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced anaphylaxis (serious criteria GSK medically significant), throat tightness, hoarse voice and tingling lips. The patient was treated with famotidine (Pepcid), decadron (nos) (Decadron) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis was not recovered/not resolved and the outcome of the throat tightness, hoarse voice and tingling lips were unknown.   It was unknown if the reporter considered the anaphylaxis, throat tightness, hoarse voice and tingling lips to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient had an anaphylactic response including throat tightness, hoarse voice and tingling lips. The side effects occurred the same day and she went to the emergency room (ER), received treatment and her symptoms improved. The patient returned to the ER on 19th October 2019, with the same symptoms. The patient was not admitted overnight and there was no additional update on the patient's symptoms currently.  The reporter consented to follow up.
about 1 minute after receiving the vaccine, the patient began feeling nauseous and appeared to have a seizure/convulsions. She was assisted and was lying down in the waiting room until paramedics arrived
Extreme itching all over my body, including feet, arms & legs, body, and head & scalp This itching lasted for weeks.  Finally went to my primary care physician on 3/10/21, who prescribed a course of prednisone.  This treatment greatly mitigated the itching, but it did continue at a much reduced level for weeks.  Even now (7+ months after receiving the vaccine) I still have some itching. My physician advised me NOT to take any further COVID vaccines.
A few days after the first covid vaccine patient started to experience left ear fullness and slight tinnitus. This lasted for approximatley 2-3 weeks. He was told he may have  fluid in his ears and was treated with OTC medications for allergies, reported by patient to myself. After his second vaccine he developed tinnitus in the left ear. He went see his physician and they were unsure what the corelation was but he was then treated for stress and placed on Wellburtrin. After this trail and the tinnitus not getting anybetter, he stopped taking his Wellburtrin and began seeing a serious of ENT/ Audiologist - all could not determine the cause of tinnitus (they rule out MRI/neck/HL etc.). After a month of seeing ENTs/ PT he reported to me for severe tinnitus. He was wearing a HA at this time and we used sound enrichment and counseling to help cope with the onset of tinnitus. However, even after working with him for 7 months, referring to specialist along the way, attending counseling, PT, TMJ, etc. He ended his life by suicide due to the tinnitus on 8/16/21.
Complained of "Left arm tingle"; no other symptoms; Observed 30 minutes in recovery; symptoms subsided by the end of 30 minutes.
On 5/27/99, post vax, the pt experienced arm pain at injection site. The next day, the  pt experienced chills, body ache, headache, and nausea. Six days later, the pt was generally better but had an arm ache, and minor headache. No treatment was received.
FEVER; CHILLS; MUSCLE ACHE; This spontaneous report was received from a patient and concerned a 65 year old  female. The patient's height, and weight were not reported. The patient's past medical history included prone to side effects. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 04-MAR-2021 at 11:30 AM to left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, around 6:30, the subject experienced fever, chills, muscle ache (right arm more than left arm, though the shot was given left arm). Since prone to side effects, she stayed at the vaccine facility for 1 hour after vaccine administration to make sure she did not experience anaphylaxis.  Action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, and muscle ache was not reported. This report was non-serious.
Pt recvd vax IM instead of SC on 30APR92 & on 8MAY92 pt devel delayed protracted rash; 11MAY92 sl rash was reported to come & go; pt was also sl fussy;
I had my vaccination 09/30/2022. On 12/29/2022 I started to experience coughing sneezing and my temperature went up to 99. I took an at home COVID-19 on 12/29/2022 and it was COVID-19 Positive. I contacted my physician on 12/29/2022 and they sent prescription for Paxlovid but because I wasn't having severe symptoms I chose not to get the prescription. I still presently have residual symptoms and feels like a cold on 01/03/2023.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient was revaccinated 6/3/22.