chrisvoncsefalvay/vaers-outcomes huggingface dataset:
57 YO female pt presented to outside institution on 5/22 with acute respiratory failure, found to be COVID positive, also w AKI on admission (Cr 4.9). Denies cough, sputum production or fevers at home prior to presentation. She was intubated on arrival to outside institution 5/22 and admitted to ICU. She has been treated with dexamethasone 6mg IV and Remdesivir x1, convalescent plasma. Treated with empiric vanc/zosyn since admission for possible superimposed bacterial PNA. Also were empirically treating for PE due to elevated D-dimer though no CTPE. Transferred to this institution on 5/28. Pt is s/p mRNA vaccination on 4/13 and 5/4, but on immunosuppression with mycophenolate + sirolimus + prednisone...
Appx one week after my first dose, I noticed pinkness in an area on my arm NEAR injection site, but not including injection site. Itchiness, warmth, and tenderness when gently pressed area of skin about 5" x 3"
7/30- 1st jab! 7/31- RA flare-ups in both hands (all digits) & @ the site of previous injuries: R torn rotator cuff, hips, knees, wrists, ribs, neck; Site of injection is warm & swollen; Overall warmth; No concept of time; Malaise; Strange taste in mouth/smell; Face/tongue numbness; Eyes are sensitive to light; Heart feels floppy. 8/1- *new symptoms only* Glands swollen in neck affecting tinnitus & breathing; Thyroid bit feels attacked; Chest feels heavier; Pressure at the base of skull; Chills/sweating. +Soreness & overall warmth at site reduced. 8/2- ER for tests. <Sent paperwork to you  on 8/12 in large, manila envelope> 8/3- *Profuse sweating; Vision foggy; R shoulder fatigue; Pins & needles in R hand; Difficulty breathing w/exertion. +Face not numb; Bad flavor reduced; Headache intermittent; Heart feels less floppy; Throat is mostly open; More energy. 8/7- Feeling more normal than not; Urine is warm. 8/8- Unexplained retching; Woozy; No food allowed. 8/9- *Intense pains in intestines (most intense where my appendix used to be); Confined to bed; No food allowed. 8/10-*Retching returns. 8/12- Food/drinks are SPICY! 8/15- Huge, painful belly bloating from gas build up from any food. Belly is hot to the touch upper R quadrant (gall bladder). 8/16- Numbness in L hand (4th & 5th digit) up to mid forearm. 8/18- Muscle tightness in back & RA flare-up in hands has returned. +Belly heat has diminished. 8/19- *Vibrating, tingling senation from feet to hips (after cleaning the turtle tank for an hour) which eventually spread all over my body; Numbness in face (jaw); Lack of coordination of left hand (fingers/thumb); Bursts of rapid heart rate, but not an increase in blood pressure; Panic!; Distress! <Nearly called the ambulance to take me to the hospital>  I feel weak, tired, & disinclined to eat. I try to force myself to eat at least 1 "meal" a day.  8/20-8/21- Pooping nothing but bile
ascending paresthesias w/weakness b/l legs;resp compromise resolved over 4wk period;
Initial and follow up information has been received from a registered nurse and a physician, respectively, concerning a 65 year old white female who on Nov 10 2004 at 9:00am was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). The physician reported that the patient developed left upper arm swelling, redness with cellulitis on Nov 14 2004 at 7:26pm (previously reported as the next day). The doctor sent her to the emergency room where she was treated (unspecified) and released. The patient was initially reported to be recovering but it was also reported by the physician that it was unknown if the patient recovered. The physician also reported that the patient was previously vaccinated at least one time per the patient, with pneumococcal 23v polysaccharide vaccine (date not reported). There was no product quality complaint involved. Additional information has been requested.
Severe premature ventricular contractions after dose 5 which was a bivalent Pfizer vaccine that your system would not let me select. Extensive testing including blood work, EKGs, echocardiogram, 24 hour Holter and stress testing. Treatment with combination calcium channel blockers was not successful. Adding beta blockers was not successful. Currently taking 50 mg twice daily of Toprol with some small margin of relief. Six months post vaccination premature ventricular contractions burden has been reduced by approximately 50% but is still present.
Bad headache; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 13:15 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation.  Medical history included diabetes mellitus, asthma, and GERD. Concomitant medications included alprazolam; omeprazole; sitagliptin (JANUVIA [SITAGLIPTIN]); all taken for unspecified indications, start and stop dates were not reported.  The patient previously took flagyl [metronidazole]: Known allergies: Flagyll. On 18Feb2021, the patient experienced bad headache, nausea, and vomiting. The patient did not receive treatment for the events. The outcome of the events was not recovered.
Patient received 2nd Pfizer vaccine on 01/13/2021. Patient participates in weekly covid testing at a facility and tested positive for COVID-19 on 09/02/2021.
This is a spontaneous report received from a contactable consumer or other non-HCP. A 30 year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EP7534), on Mar 23, 2021, for COVID-19 immunization. The patient experienced muscle contracture (two days after second dose: a big contracture of the levator scapulae muscle), with outcome of unknown. Additional information: Two days after second dose, patient experienced a big contracture of the levator scapulae muscle. The next day gone. No headache or fever. Since the vaccination, patient tested for COVID-19. Prior to vaccination, patient was not diagnosed with COVID-19. Patient may have taken Advil and other medications/vitamins within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021621233 same reporter, vaccine and AE; different patient.
About 2.5 weeks after 2nd dose, began to have dull headache and ringing in the ear.  (I did have mild side effects  second and third days after each dose, i.e., mild body ache, fatigue which went away after 3 days).  The dull headache was almost daily.  I took 400 mg ibuprofen almost daily and it did make the headache go away.  The headache was mild enough that it did not impede my ability to go about my daily tasks, including working remotely.  As of time of reporting this, it seems like I've not experienced headaches in the past 3 days.  I don't know if it will recur.  That said, the ringing in my ears (both ears) have been constant.  I describe the sound as being in a jungle, low sounding.  The ringing is masked when, say, I'm watching t.v. or in a zoom meeting.  I hear it when it's quiet.  It's not loud enough to impede my daily activities, and so far, it has not impeded my sleep.
Headaches, joint pain, fever , vomiting, Chills, Shortness of breath, muscle pain, vision can't focus
Developed a non-epileptic seizure disorder 2 weeks after the second shot.  The seizures lasted for a few weeks and then went away.  At one point she was having up to 12 seizures in a day.  The timing of the condition makes us question whether the vaccine could have been the cause.   She was diagnosed with psychogenic nonepileptic seizure disorder.  Prior to the vaccine, she had no mental health history and was a healthy and normal teen.
Lost sight in left eye for 1 hour on 4/14/2021. Although the loss of sight and subsequent hospital visits MAY NOT HAVE BEEN DIRECTLY RELATED to the vaccine, the fact that this occurred 6 days following my 2nd dose makes me want to report it in case others have reported anything similar.
administered two doses of vaccine to a consumer; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number TP2N2, expiry date 10th February 2023) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 28th September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 28th September 2021, unknown after receiving Shingrix and SHINGRIX, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details provided were as follows: The registered pharmacist stated that he/she on the previous night shift administered two doses of vaccine to a patient in unknown deltoid, which led to overdose. The registered pharmacist stated that both the doses were from the same lot. The registered pharmacist stated that one dose was administered in each deltoid respectively. The reporter consented to follow-up. This case is linked to the case US2020216289, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020216289:same reporter
Information has been received from a health professional concerning a 60 year old female with a history of asthma and drug hypersensitivity to amoxicillin who on 12-FEB-2008 was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine (lot # 658451/0963U). Concomitant therapy included alprazolam, RELAFEN, OMAPREN, VERAMYST, PROAIR HFA and SINGULAIR. On 12-FEB-2008, the patient experienced a large red, swollen area in her upper arm, white area at injection site, injection site hardness, and burning sensation in her arm and swelling extended to under her arm. The patient previously had a local arm reaction after receiving the Flu vaccine. The patient sought medical attention with an office visit. Follow up information obtained for the physician indicated that patient has recovered. No further information is expected.
Systemic: visual changes-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Left eye vision change after the shot. She sees things like seeing through a broken mirror
Patient received Janssen vaccine on 5/12/21 while admitted inpatient at hospital. After vaccine was administered it was discovered that the patient already received 1 dose of the Pfizer Covid Vaccine on 4/19/2021. Patient had intended to receive the second dose of Pfizer, but Janssen was instead ordered.
Patient felt faint, saw black spots, couldn't hear and was sweaty, She told the pharmacy that she didn't feel well and asked if we had a place for her to lay down. The pharmacist brought her into the immunization room and had her sit with her feet up on a 2nd chair. Gave her a bottle of water and sat with her until she felt better.
Patient had soreness and a little redness within day of shot. Did not pay much attention to it after that then noticed warmth 9 days after shot. At that time she had warmth with a large darker red area around original red ring.
This spontaneous report as received from a registered nurse refers to a 11 year old female patient. Medical history and current conditions were not reported. On 11-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested. Event, Analysis was updated.
Nausea, itchy eyes, face felt swollen, labored breathing, eyes mattered shut next day.
numbness on tongue and upper lip; right foot was spasming; blood pressure was crashing; shaky; chills (freezing like ice); Sore arm; felt feverish but did not have a fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (numbness on tongue and upper lip), MUSCLE SPASMS (right foot was spasming), BLOOD PRESSURE DECREASED (blood pressure was crashing), TREMOR (shaky) and CHILLS (chills (freezing like ice)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (numbness on tongue and upper lip), MUSCLE SPASMS (right foot was spasming), BLOOD PRESSURE DECREASED (blood pressure was crashing), TREMOR (shaky), CHILLS (chills (freezing like ice)), VACCINATION SITE PAIN (Sore arm) and PYREXIA (felt feverish but did not have a fever). At the time of the report, HYPOAESTHESIA ORAL (numbness on tongue and upper lip), MUSCLE SPASMS (right foot was spasming), TREMOR (shaky), CHILLS (chills (freezing like ice)), VACCINATION SITE PAIN (Sore arm) and PYREXIA (felt feverish but did not have a fever) outcome was unknown and BLOOD PRESSURE DECREASED (blood pressure was crashing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient put ice pack on sore arm for 2 hours.; Sender'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.
Pt recv vax on 8/19/96; on 3/3/99 pt exp chicken pox
I have had female hormones tested several years including April prior to my first vaccine. My hormones were always normal and no signs of menopause. After the 2 COVID vaccines, I was in full menopause. I had no family history of early menopause.
~6 weeks after receiving the second dose of his COVID vaccine, Patient developed abdominal pain and constipation that worsened over several days and prompted him to seek treatment in the ED. In the ED he was found to have cardiac tamponade and was hospitalized. A biopsy of his heart tissue revealed that he had eosinophilic myocarditis. He is currently receiving treatment and further studies are being performed to evaluate for possible causes. At this time, it is unclear what role the COVID vaccine played in the development of his condition. While he is outside the window of time in which patients usually develop myocarditis due to the COVID vaccine, our team wanted to report this potential adverse event for the sake of thoroughness.
This spontaneous case reported by a consumer, describes the occurrence of fatigue (I felt tired) and vaccination site pain (soreness at injection site on left arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 25, 2021, patient experienced fatigue (I felt tired) and vaccination site pain (soreness at injection site on left arm). At the time of the report, fatigue (I felt tired) and vaccination site pain (soreness at injection site on left arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. This case linked to MOD-2021-358252 (patient link).
Fevers  Chilly  Joint pain  Body aches  Headache  Abdominal pain  Nausea
One hour and 10 min after vaccine administered. Patient returned to room complaining of lip swelling. No SOB lungs clear B/P 150/80 P 100 reg RR 20 refused ice. 50mg Benadryl given, Dr called at clinic observe for 20-30 and release if no problems. 3:04 returned to work with instructions not to receive vaccine in future and what to do if symptoms return or if resp distress occurs. Patient understood and returned to work.
Information has been received from the parent of an approximately 19 month old male patient with a history of seizure who on 13-MAR-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck).  It was reported that the patient also received two other vaccines within the same visit but specifics were unknown.  The patient's parent reported that after receiving the VARIVAX (Oka/Merck), her son developed a fever that lasted about 4-5 days post vaccination.  It was reported that it cleared on its own.  Unspecified medical attention was sought.  There was no product quality complaint.  No further information is available.
Pain in arm and shoulder is more severe than patient expected.  She went to the Dr and they gave her anti-inflammatories and told her to follow up with the pharmacy.
1 pm 4/29/2021 second dose of vaccine administered into left shoulder.  1:02 pm shot site felt very slightly tingly for a few minutes.  10 pm left shoulder began to feel very sore.  11 pm full body soreness similar in feeling to childhood growing pains, like a deep centered ache in the bones or deep muscle tissue, with the more painful sensations located in the long bones and major joints of all limbs.  12 am 4/30/2021 extreme full body pain (9 out of 10 pain scale) most painful in long bones and joints of limbs so severe it prevented any further movement of body for fear of inducing even more severe pain; heavy sweating, and fever sensations (temperature not recorded). These symptoms continued with the same level of severity and did not start to subside until after 6 am.  11 am severe pain almost completely passed. Moderate soreness still lingering. Painful headache. Still heavy sweating. Severe fatigue.  8 pm most symptoms gone except for severe fatigue.
Tested positive for COVID-19; sweating; headache; sore throat; fever; sore arm; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and HYPERHIDROSIS (sweating) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERHIDROSIS (sweating). On 18-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown and HYPERHIDROSIS (sweating) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt was given a vaccine that expired on 5/30/22. There was no adverse reaction. Ct was monitored for 15 min after
I began to develop a fever since early morning of 13 Dec 2021.; My left arm, where the injection took place, was exceedingly sore; I felt pressure in my stomach as if the food I ate was stuck there and not being digested; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 12Dec2021 at 12:30 (Lot number: FD0809) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Bowel obstruction" (unspecified if ongoing); "Thyroid nodule" (unspecified if ongoing), notes: Thyroid nodules; "Circumcision" (unspecified if ongoing) and "Allergy to antibiotic" (unspecified if ongoing), notes: Known allergies: Cephalosporins. The patient did not take any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL3247), administration date: 09Mar2021, when the patient was 34 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955), administration date: 30Mar2021, when the patient was 34 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021 at 12:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 13Dec2021 at 01:00, outcome "recovering", described as "I began to develop a fever since early morning of 13 Dec 2021"; PAIN IN EXTREMITY (non-serious) with onset 13Dec2021 at 01:00, outcome "recovering", described as "My left arm, where the injection took place, was exceedingly sore"; ABDOMINAL DISCOMFORT (non-serious) with onset 13Dec2021 at 01:00, outcome "recovering", described as "I felt pressure in my stomach as if the food I ate was stuck there and not being digested". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity and abdominal discomfort.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the fever lasted through the day, and in the evening his body temperature was still 99.5 F. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Feeling light-headed,shaky,arm feels weak,heart racing. Feels like passing out,throat dry. Fellow worker says she appears flushed, perspiring. Resp. problem. EMT arrived & found her unconscious was given epinephrine,but refused admission to
Pt developed chest pain early am day following vaccine administration, presented to ED on 4/25 and was diagnosed with pulmonary emboli.  She had recent muscle strain and chest/back pain that she attributed to  lifting heavy objects the week prior to the vaccine (4/15),  and had been mostly staying in bed or on the couch with minimal movement/activity 4/15-4/22 due to those symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of vertigo in in a male pharmacist who administered the SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vertigo, neuritis, inner ear infection, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the vertigo, neuritis and inner ear infection were recovered/resolved and the outcome of the inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the vertigo, neuritis and inner ear infection to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The healthcare professional stated that, he developed vertigo, neuritis and an inner ear infection for 1 week following repeated administration of SHINGRIX to patients. The reporter gave consent to follow up. The healthcare professional stated that, he might have had some exposure to the SHINGRIX on his left hand, which led to inadvertent exposure to vaccine and exposure via skin contact.
Booster administered within 5 months since last dose in series (Pfizer doses on 8/26/21 and 9/21/21)