chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported that next morning after receiving Shingrix vaccine, he woke up saying that he "had a card game going on in the back of my mind" that lasted the whole day.  He said it was extremely distracting and upsetting that it would not stop.  He also stated that he became very depressed that morning.  He states that he lives alone and became very worried about what he might do.  He said that during cancer diagnosis years ago he had some sad times but said this was like nothing he had ever felt before.  He was so depressed he called his physician's office.  He said that they told him they had never heard of this reaction before and just wait and see what happens.  He said that he had a very rough day with the "card game" going on in his head and the very depressed feeling he had.  He made it through the day and went to bed.  He said the next morning the card game was gone and he had a very bad headache.  He still felt depressed but not to the extent of the previous day.  He said it took 3-4 days for his mood to go back to normal. He did not report this to the pharmacy until he was told by his physician to go ahead and get his second dose.  Upon reporting in great detail what had happened to him and that he was very concerned about getting the next dose, I (pharmacist) advised him to not get the second dose.  I told him that even though I had never heard of this before, I was very concerned for his well-being if it happened to him again.  He was relieved to be told that it was ok to not have to get the second dose.
AFib; large buildup of fluid in my lungs; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included ongoing apixaban (ELIQUIS) and ongoing metoprolol, both for unspecified indication and from unknown date. Within 6 weeks after receiving the 2nd Pfizer C19 shot, the patient suddenly developed AFib. He/She had never had heart problems and all of a sudden the patient had difficulty breathing. Doctor prescribed large doses of Furosemide because of large buildup of fluid in his/her lungs. The patient was still on ELIQUIS, twice a day and 50 mg of metoprolol twice a day. The patient asked, "Have there been other patients develop AFib after receiving 2nd shot of Pfizer C19". Therapeutic measures were taken as a result of large buildup of fluid in his/her lungs, which included large doses of Furosemide. The outcome of events was unknown.  Additional information received on 30Apr2021 from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-043584), license party for apixaban (ELIQUIS) included assessment from Bristol-Myers Squibb.  Bristol-Myers Squibb assessed events Afib and Lung edema were not related to apixaban (ELIQUIS). BMS Medical Evaluation Comment: This patient who received apixaban therapy and COVID-19 vaccine had atrial fibrillation and pulmonary edema. Based on the limited information, it cannot be ascertained with reasonable possibility that suspect therapy contributed to the reported events.
Moderna and Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccine on 2/22/21 and Pfizer Vaccine on 3/15/21 and 10/22/21. Presented to ED on 2/11/22 Covid+, d/c'd 2/12/22. Reported sats of 88-94% Presented to ED 2/16/22 w/increasing SOB and AMS. Placed on BiPAP. 2/23/22 not arousable. Pt began to desaturate and unresponsive. CT head with Acute left basal ganglia stroke. Transitioned to comfort care only, expired on 2/23/22. Treated with medrol dosepack, decadron, zosyn, and ceftriaxone.
Fever of 102F, very fussy for 5 days, post vax, 2nd Prevnar.
Patient is a 61 yr/o female who presents today for  cardiac evaluation   for chest pain, abnormal EKG and prior history of coronary artery disease.  Conference for discussion of abnormal PET scan imaging and recommendationsShe has chest pain and shortness of breath on exertion cardiac cath on 6/29/2016 showed the left main 30 to 40% stenosis distally LAD 40 to 60% segmental stenosis and normal LV function at that time.   61 yo woman previously evaluated in office for CAD, who was involved in a MVA.  She was seen and cleared by NS to have CABG.  She has not been in a neck brace since initial visit.  Patient denies any issues or changes since last visit.
itchy throat, flushed. Gave 50 mg of PO benadryl which resolved symptoms
Mother states on 10/19/2018, one day after flu injection patient had rash to arm at injection site.  On date 10/21/2018 patient report to ER due to hives/rash all over body, dyspnea, Itching/stinging. At home was given Hydroxyzine before coming to hospital. Was admitted to hospital stay x 1 day due to allergic reaction, hives, dyspnea. Release from hospital on 10/22/2018.
Parents wanted to break down vaccines and come back too soon for more vaccines and received them. No complaints or problems. No adverse reaction.
104 Temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (104 Temperature) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-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. On 18-Feb-2021, the patient experienced PYREXIA (104 Temperature). At the time of the report, PYREXIA (104 Temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Narrative:  Pt. reports had sore arm at injection site x several days, and mild flu like symptoms x several days following vaccination; felt better, but then felt feverish and had 1 episode of diarrhea on 2/22. no symptoms on 2/23.
This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received SHINGRIX. On 26th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th January 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. In February 2018, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in an unknown deltoid. The patient experienced flu like symptoms which started the day of vaccination and lasted for approximately about 2 weeks. All questions were asked. The reporter provided limited information.
the temperature reached 55.5 degrees f for 92 hours with no reported adverse event; vaccines were out of range for a cumulative period of 94 hours, this was not realized until yesterday, by which time some of the vaccines had been administered with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case 2022SA465778 (CLUSTER).  This case involves an unknown age and gender patient, reported temperature reached 55.5 degrees f for 92 hours and vaccines INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] were out of range for a cumulative period of 94 hours, this was not realized until yesterday, by which time some of the vaccines had been administered with no reported adverse event.  Concomitant vaccine: shingles vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.  On 08-Nov-2022, the patients received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at dose of 0.7ml total, Strength: high-dose (formulation: unknown) (lot number: UJ933AC and expiry date: 30-Jun-2023) and 0.5 ml suspension for injection (lot: UT7695KA) (expiry date, strength: unknown)  via intramuscular route in unknown administration site for Immunisation and the temperature reached 55.5 degrees F for 92 hours with no reported adverse event (product storage error) and vaccines were out of range for a cumulative period of 94 hours, this was not realized until yesterday, by which time some of the vaccines had been administered with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, MA is checking stability of vaccines due to a refrigerator malfunction on 04Nov2022.  She states some patients received the vaccine post excursion, what is the protocol for these patients? HCP states that after the power outage, they thought the refrigerator was working properly, but there was an "auto reset" feature that they were unaware of, so products did not return to stability recommendations.  Medical Assistant reports 1 FLUZONE HIGH-DOSE QUADRIVALENT was given.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for both events.  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.  Additional information was received on 02-Dec-2022 via other healthcare professional: case is upgraded from non valid to valid , number of number and dose of suspect updated. Text amended accordingly.; Sender's Comments:  01359841:
Patient presented to the pharmacy on 10/2/19 saying she will not be getting any other injections here. When asked what she meant, she pulled up her sleeve to expose her left arm.  It was red, hot, and swollen at and below injection site. She said she began to have fever and chills on 10/1/19 around 8AM and today could not hardly move her left arm so she sought medical care. She  was given an oral antibiotic and topical steroid ointment as Urgent Care staff told her they were afraid it may get infected.
102.9 fever, extreme body aches, fatigue  -- since my first vaccination I have had extreme right shoulder pain, swelling in my armpit, painful stabs in my right shoulder, and the feeling of nerve pain around the right side of my body along my trunk.  I have been diagnosed with calcific tendinitis and have undergone 2 injections of steroids into my right shoulder.  The first injection was in October 2021 and the second was 2/28/22.  I had some relief with first shot; however, I have had minimal relief from the second.  My range of motion with my right arm is limited.  I have been treating with Dr. at Orthopedics for the shoulder pain.  I have undergone mammogram and ultrasound due to the selling and pain in my right armpit.  No one can tell me when this pain will leave that started within 10 mins of my first shot.  I feel I have permanent damage from them in my right shoulder and arm.  I have no history of right shoulder pain prior to these vaccinations.
Patient received Moderna COVID-19 vaccination. About 10 minutes after injection patient was not looking well. I escorted him to a private area where he continued to be light headed, pale in appearance, and communicated in short sentences. While sitting patients BP was 60/40 and pulse was thready. He was placed on the floor with legs elevated and EMS called. Lungs were clear and normal, heart tones normal as well. No sings of angioedema at any point of his episode. 3 minutes later BP increased to 80/60 with a stronger radial pulse, and a recheck again about 5 minutes later resulted in a BP of 110/72 with regular radial pulse. EMS arrived and assessed patient. He refused transfer to hospital. He was given time, water, and a small meal as he had not eaten or drank much of anything through is night shift. After about 30 minutes he was able to ambulate through the auditorium and stated he was feeling much better. We encouraged him to take the remainder of the day off but he declined and returned to work. He stated he would return if any symptoms were to reoccur or if he had any concerns. He will have his next dose of vaccine in clinic.
Initial report received from a consumer in the USA on 15/Mar/2006. A 35 year old female patient with an allergy to latex developed a rash on her right shoulder of the injection site to the mid humerus, redness and itchy under her arm, pain to the top of her shoulder and swelling of her right hand the day after receiving the injection of Decavac, lot number U1597CA (expiry date 20/May/2007) in the right deltoid on 14/Mar/2006.  The patient, who is the reporter had no illness at the time of vaccination and has received "many" previous doses. Treatment included the use of Flexall, over the counter Motrin and heat to the site. It was not reported if the patient was seen by a physician. Recovery status was not reported. Follow-up information received on 31/Mar/2006 from a physician. Per the reporter, the patient did not report this adverse event to him but she did recover from these adverse events eight days post-vaccination. No further information is expected. A corrective version was created on 02 April 2007 with the LRD of the previous version(31 March 2006) in order to document "yes" to medically confirmed in the record.
Arms, legs and body was paralyzed; Nerve pain that travel from her head to the back; Excruciating pain,Pain is still remaining; Not being able to get up from bed; Lightning pain in the back; A spontaneous report was received from a 76 year old female patient  concerning herself, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced excruciating pain and the feeling of not being able to get up from bed, because her arms, legs and body was paralyzed, nerve pain that travel from her head to the back and patient had lightning pain in the back.  The patient's medical history was not provided.   Concomitant medications were not reported.   On 26 Feb 2021, the patient received the first of two planned doses of mRNA-1273 intramuscularly on left arm for prophylaxis of COVID-19 infection.   On 01 Mar 2021, after receiving the first dose of the mRNA-1273, the patient experienced excruciating pain, feeling of not being able to get up from bed, because her arms, legs and body was paralyzed (Other Important Medically Significant). This pain was still remained, kind of nerve pain that travel from her head to the back and also the patient had lightning pain in the back.   Laboratory investigation details was not provided.  Treatment details included Tylenol for pain.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, excruciating pain, feeling of not being able to get up from bed, because her arms, legs and body was paralyzed, nerve pain that travel from her head to the back and lightning pain in the back was not recovered/not resolved at the time of reporting.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Administration of the vaccine was unremarkable beyond a mention of pain/discomfort during administration.  Roughly 1 minute post she began experiencing dizziness, complained of nausea then became verbally unresponsive; exhibiting all the signs of a seizure- including an absent gaze and muscle tensing/spasming most noticeably of her legs and hands- which abated after 1 to 2 minutes.  She did not sustain any physical injuries .  She continuously refused any additional care. Stating "heck no" at the suggestion EMS come even just to check her out.  She gradually recovered over the next 20 minutes before requesting to use the restroom.  I had a female associate accompany her as she was more comfortable with a female staff member and that staff member could alert me if her condition changed at all. She then remained at the pharmacy for approximately an additional 10 minutes and seemed completely lucid and oriented.  While marked as 'no' on her VAR she and her companion then recounted several past seizures matching this one.  None of which were associated with a vaccine.  She further stated that she has been medically evaluated but no definitive diagnosis was made.  At this point she asked to leave.  I offered follow-up care/evaluation one last time and she declined.  At this point she left under her own power.
Sore boobs - very unusual fir me as I'm in menopause and haven't had sore boobs in several years
Increased resting heart rate from 60 to 80 1-2 weeks after second dose.
Hands trembling uncontrollable; All the side effects; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Hands trembling uncontrollable), VACCINATION COMPLICATION (All the side effects) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Lung scarring and Aortic aneurysm enlargement.  In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Hands trembling uncontrollable), VACCINATION COMPLICATION (All the side effects) and HEADACHE (Headaches). At the time of the report, TREMOR (Hands trembling uncontrollable) and HEADACHE (Headaches) had not resolved and VACCINATION COMPLICATION (All the side effects) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Relevant concomitant medications were not provided.  Treatment medication was not provided.   Reporter did not allow further contact
Tiredness - 11 pm 4/26 Fever (101.7) 8 am 4/27 Chills - 8 am 4/27 Muscle soreness - 8 am 4/27 Nosebleed 6:15 pm 4/27
blurred vision 20 minutes after; Lightheadedness; Felt high all that first night; difficulty breathing; Asthma attack; Headache; Nausea; fog brain; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 59-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: EN6199), via an unknown route of administration in left arm on 02Apr2021 (at the age of 59-years-old) as single dose for COVID-19 immunisation. The patient's medical history included known allergies from grass and some trees. Concomitant medication included meloxicam for an unknown indication from an unknown date. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: unknown), via an unknown route of administration on an unknown date as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021, the patient experienced blurred vision 20 minutes after, light headedness, felt high all that first night then felt great, day 3- fog brain. Now (5 and 6 days) she had difficulty breathing comes and goes, worst ever Asthma attack (inhaler), headache comes and goes, nausea comes and goes. The patient visited doctor or other healthcare professional office/clinic visit. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received Albutetrol as treatment. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
I started with a headache the evening of and flip flop feeling in my heart and in my chest, each day I would have some dizziness, flip flop in my chest and my heart rate would spike my BP 198/100. My heart rate was 128 resting. The dr recommended extra hydration and electrolytes and I continued having dizzy spells. I was at dentist and he pulled out a clot out of my mouth and He asked if I was on blood thinners. I'm suppose to have a cardiac consult.
Pain in arm below the injection site. Unable to bend arm back without pain. Has lasted for 2.5 weeks. Has been taking TYLENOL. Also feels shoulder pain.
This spontaneous report was received from a pharmacist and refers to a non dialysis patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 19-DEC-2017, the patient was inadvertently vaccinated with a dialysis dose of RECOMBIVAX HB (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. No causality assessment was provided by the reporter.
Diabetes; heart disease; Asthma; This is a spontaneous report received from a contactable nurse (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 intramuscular on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 1, 0.3 ml single, dose 2 intramuscular on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient asked about the Pfizer Covid 19 booster shot if she could get it 6 months rather than 8 months. She was diagnosed with heart disease, diabetes and asthma on an unspecified date in 2021. Added that she was already done with her two doses of the vaccine last February. The Pfizer BioNTech COVID-19 Vaccine was administered intramuscularly as a series of two doses (0.3 mL each) three weeks apart. A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine. Patient wanted to know if the booster shot had the same dose compared to her first two doses. The clinical outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events diabetes mellitus and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
day p/vax pt exp area of induration, erythema & warmth on lt arm area assoc w/pruritus
swelling in groin & face w/mouth sores & lymphadenopathy on same side as inj;pt in the past w/o problems;treated w/DPH;