chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 9/24/09 at approx. 9AM patient reported having SOB and wheezing at approximately 7PM on 9/23/09 while sitting in a parked vehicle. Symptoms subsided approximately 9:30PM the same evening without treatment. According to patient, he had a childhood history of Asthma thought to be caused by allergies. Pt. has history of difficulty breathing while smoking but has not smoked for 5 years. Patient opted not to seek treatment.
Seen in clinic 7/7/2022 with 2-3 month hx of left shoulder pain, new diagnosis made of left adhesive capsulitis.  Pt didn't specifically link it to the vaccine, but the timing raises the possibility of a causal link.  He is having similar but much milder symptoms in the right (non-vaccinated) arm, however, so may be unrelated.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication. On or about 03-APR-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-MAR-2017, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
LIFE-CHANGING INJURIES; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced life-changing injuries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of life-changing injuries was not reported. This report was non-serious.
COVID-19; Jittery and anxious; Jittery and anxious; This spontaneous case was reported by a patient and describes the occurrence of NERVOUSNESS (Jittery and anxious), ANXIETY (Jittery and anxious) and COVID-19 (COVID-19) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 22-Apr-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2022 at 12:15 PM, the patient experienced NERVOUSNESS (Jittery and anxious) and ANXIETY (Jittery and anxious). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19, at an unspecified dose and frequency. On 27-May-2022, NERVOUSNESS (Jittery and anxious) and ANXIETY (Jittery and anxious) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Company comment: This spontaneous case concerns a 76-year-old male patient, with no relevant medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after receiving the mRNA-1273 vaccine as 4th dose. Twenty nine days post vaccination, patient took Paxlovid for 5 days. No lab test reported. Clinical course was not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgment.; Sender's Comments: This spontaneous case concerns a 76-year-old male patient, with no relevant medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after receiving the mRNA-1273 vaccine as 4th dose. Twenty nine days post vaccination, patient took Paxlovid for 5 days. No lab test reported. Clinical course was not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgment.
No adverse events following vaccine.  Pt. turned 65 9/1/07, given Tdap instead of Td on 9/26/07.
Daughter had previous reactions on her shoulder, with the most recent and worst being in 2019 when she developed a cellulitis from her flu vaccine. When I asked if the mist was an option, they suggested they had 20 doses and could save one for her.  She got the mist in the afternoon of 10/7/21 and woke up with a very sore throat, headache and stomach ache on 10/9/21. After taking her to the pediatrician on 10/11/21 to be evaluated, they tested her for Strep throat and Covid, both of which were negative. After continuing to feel the same with no improvement, I took her back on 10/15/21. She was very lethargic, complaining of the same symptoms. They suggested that it was still viral but since no one else was sick in our home, she had missed a full week of school. They ordered labs to check for mono, tick born illnesses, a thyroid panel, CBC, and some others. They monitored her until 10/18/21 at which point it was ten days from onset with no change so they prescribed Amoxicillin. In the interim, lab results came back showing a very high TSH level.  Again, she was still complaining of the same severity of headaches, a sore throat, and a little less stomach ache. No one else was sick in my home of six people. When asked where her throat hurt, she pointed to the front of her neck.  Amoxicillin was discontinued after three full days at their recommendation
After patient received vaccine she started complaining of body aches, fatigue, and decreased appetite. Patient has had symptoms for 1 week
About 30 min after shot legs became weak and it was difficult to walk or stand.  This lasted most of the day until early evening.  The second thing I noticed was the pink cheeks a couple of hours after the shot and every day for about 4 days.  The only time this has happened is when I would take steroids for allergies.  Is there a steroid in the injection?
Patient woke up with myalgia at the back of her neck, mild swelling and tightness of her fingers. She was treated with NSAIDs and BENADRYL which decreased her symptoms.
10/05/2003 admitted for UTI, 10/7/03 home (not related). 10/15/03 admitted loss of mobility, 10/23/03 home. 10/28/03 ER UTI, vomiting, home. 11/6/03 Vomiting, weakness admit, died 11/21/03.
Initial and follow-up information has been received from a physician and a front office employee concerning an 18 weeks old male with no pertinent medical history or allergies who on 22-APR-2010 was vaccinated orally with the first dose of ROTATEQ (lot# 664883/1523Y). Concomitant therapy included PENTACEL (lot# SPC#3469AA) and PREVNAR (lot# E44520) which were both vaccinated on 22-APR-2010. On 25-APR-2010 the patient had an inconsolable episode for 3-4 hours in the early afternoon. Then at 1:00 am the patient's mother opened the patient's diaper and there was a string of mucus with blood. The physician believed the patient may have had intussusception episode on the afternoon of 25-APR-2010 that self resolved by the time the patient's mother contacted him around 1:00 am through phone call. It was reported that the patient was not experiencing any known symptoms. The physician also reported that no testing were done, so it was unknown if the patient experienced intussusception. Based on symptoms of the child being inconsolable along with the tiny amount of bloody mucus in diaper, the physician suspected that it was self-resolving intussusception. These adverse events were not considered to be disabling or life threatening by the physician. Upon internal review, intussusception was determined to be an other important medical event. No further information is available.
burning sensation; swelling in her left arm; peripheral swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in her left arm), PERIPHERAL SWELLING (peripheral swelling) and BURNING SENSATION (burning sensation) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient Medical History was not provided.  Concomitant products included DUPILUMAB for Atopic dermatitis.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in her left arm). On an unknown date, the patient experienced PERIPHERAL SWELLING (peripheral swelling) and BURNING SENSATION (burning sensation). At the time of the report, PERIPHERAL SWELLING (swelling in her left arm), PERIPHERAL SWELLING (peripheral swelling) and BURNING SENSATION (burning sensation) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient iced and rubbed for swelling in her left arm that didn't go for 4 days then after one week  it returned .
pt recvd vax; devel 8 vesicular lesions & T of 102; 5 wks later, maculopapular rash became vesicular on all her extremities;
allergic reaction; right arm is puffy and red, like hives; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) and URTICARIA (right arm is puffy and red, like hives) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CLOPIDOGREL BISULFATE (PLAVIX).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction) and URTICARIA (right arm is puffy and red, like hives). At the time of the report, HYPERSENSITIVITY (allergic reaction) and URTICARIA (right arm is puffy and red, like hives) outcome was unknown. Not Provided          Other concomitant medications were reported as silvotrax, high blood pressure medication, trazadone. Treatment medication was reported as paracetamol.
Patient fainted after getting the vaccine; she woke up and stated she was fine. Called EMS and they spoke to her but she did not want them to come . Followed up with patient next day and she stated she was fine as well
Information has been received from a medical assistant concerning a 5 year old female patient who on an unknown date was vaccinated with varicella virus vaccine live.  It was noted that on 01/20/2005, the patient developed breakthrough varicella.  There was no product quality complaint reported.  No additional information was provided.  Unspecified medical attention was sought.  Additional information has been requested.
Patient presented to ER with rash. Vaccine for "chicken pox" received about ten days earlier
Received vaccine on 9/26/2022. Patient passed away within 48 hours.
Patient came in for a Pfizer COVID Bivalent booster. Received a primary in error.
This spontaneous report as received from a 61 year old female consumer reporting on herself. Current condition included hypothyroidism. On 03-DEC-2013 9also reported as a couple of days ago) the patient was vaccinated with ZOSTAVAX, 1 dose in the left arm for prevention of shingles (route and dose number unspecified). Concomitant therapies included Synthyroid and hormones (unspecified). On 03-DEC-2013, (also reported as yesterday), when the patient woke up noticed a rash, pain, tenderness and feeling a knot at the injections site. The redness at the site of the injections is approximately 2' by 2' in the left arm. The patient outcome was unknown. The patient did not seek medical attention and lab test were not performed. Additional information has been requested.
Patient started shaking , sweating , and claiming that has pain in her chest and started having difficulty breathing. Patient was coherent she was conscious the whole period of time we discussed , she answer questions , knew her name and her date of birth . We gave cold water , check her heart rate and pulse , until the paramedics came I decided to administer Epinephrine injection 0.3 mg (lot # g201105x) and expiration date 02/2022 because patient kept sweating and becoming more anxious because she had difficulty breathing.
Inject site knotted & was painful; 3-4 days later knot disappeared, pain remained 30DEC91; consulted MD cortisone shot given;
Fever, Chills, Nausea, Headache, redness in arm, diarrhea, myaligia
redness,  itching, swelling at the injection site that started 10 days following the injection.
1 of 4 pts vaxes from the same vax lot#; pt exp a fever of 103.5 an inject site react consisting of swelling & local rash & screaming @ noc; required an office visit; pt recovered;
Beginning 3/18/21: Initial headache.  Fever greater than 103 F.  Severe myalgias.  Profound fatigue and lassitude.  Drenching  night sweats.  E.R. visit followed by 5 day in patient hospitalization.  Discharged from hospital approximately 3/9/21.   Symptoms not yet resolved.  Patient has persistent fatigue and severe occipital headaches.
8 days after injection I experienced slight itching/mild cellulitis near injection site for a few hours. Currently 17 hours after initial episode I have a mild cellulitis without pain/itching/burning/etc. Only blotchy/redness near injection site.
Developed debilitating arthralgia and questions if influenza---nasal caused it. She developed symptoms 8 months following each dose (in April of the next year). Seen by an allergist with no causal relationship found. Dx axonal neuropathy.
2/6 & 2/7 sore arm, 2/12-2/13 body aches, 2/14-2/15 ping pong sized lump under left armpit & left side lymph nodes in neck swollen, sore jaw on left side.  Nausea, headache, congested, runny nose, face/eyes swollen/itchy.
Patient had  reported fever, chills, sweats, severe right upper arm injection site pain, difficulty breathing, and chest pressure 4 hours after the vaccine administration.  Patient had gone to the emergency room on June 15, 2021.
Chills, general aches, headache, sore arm on day 1 Headache, sore arm and red hot area around injection site on day 2
1st Covid Dose (3/10/21 3pm) after 2 hours - polyuria (15+ times within 12 hours), a little sore arm
Inflammation of sinuses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUSITIS (non-serious), outcome "unknown", described as "Inflammation of sinuses".  Additional information: Caller's Pfizer booster shot appointment is tomorrow and she was prescribed with high dosage steroids for inflammation of sinuses (has not started yet taking it yet). Asking how long she should take this after getting her booster dose tomorrow. she has a caller on the line that has an appointment for the Pfizer Covid vaccine booster tomorrow and she has a prescription for steroids that she has not started yet. Agent relays the caller is asking should she wait to start the steroids until after the booster. Agent relays she is transferring to medical facility since the caller needed steroids after both doses of the Pfizer Covid vaccine. Caller declines to make a report, states it has nothing to do with the Covid vaccine, nothing. States she has inflammation of her sinuses and it's nothing to do with Covid vaccine. Caller states she doesn't want to do anything to screw up the booster. Caller clarifies she has not started taking the steroids yet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
coughing; headaches; sore right arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore right arm), COUGH (coughing) and HEADACHE (headaches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore right arm). On 29-Apr-2021, the patient experienced COUGH (coughing) and HEADACHE (headaches). The patient was treated with BENZOCAINE at an unspecified dose and frequency and MENTHOL for Cough, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore right arm) had resolved and COUGH (coughing) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt reported that 48 hrs after receiving the vacine she developed generalized hives and itching.Pt went to a local ER on 5/8/2008 where txt was intiated - by pt report prednisone dose pak and an injection for itching (name unknown)
Unknown number of patients have received improperly stored doses of VARIVAX.; no adverse events; This spontaneous report as received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On unknown dates, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (Strength, route, dose, frequency, and anatomical location were unknown) with lot # R017642 and expiration date 20-JUN-2020. The administered doses of the vaccine experienced the temperature excursion of 25.5 F  degrees Fahrenheit  for 1hour and 30 minutes. There was a digital data logger invloved, but there was no previous temperature excursion.  Follow-up information was received from the medical assistant on 09-APR-2019, regarding a male patient who is reported to be under 10 years of age. There were no reported adverse events following the administration of varicella virus vaccine live (oka/merck)(VARIVAX) (No adverse event).  This is one of two reports received from the same reporter.
facial swelling (nose and ears); hives; itching; This is a spontaneous report from non-contactable healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0162), via an unspecified route of administration on 17Sep2021 (at the age of 57-year-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included HYDROXYZINE. On an unspecified date on Sep2021 the patient experienced facial swelling (nose and ears), hives, and itching. The reaction started around midnight after the vaccine. The patient had taken Hydroxyzine HCL 25mg before the vaccine and then one after the vaccine, then a third one the morning before reporting to the Urgent Care. At urgent care she received a Benadryl shot and the symptoms started to go down but it took about 3 days to completely stop. The urgent care visit happened the morning of 18Sep2021 the morning after receiving the vaccine. The patient recovered from the adverse events on an unspecified date on Sep2021.   No follow-up attempts are possible. No further information is expected.
PATIENT CAME INTO PHARMACY TO COMPLAIN OF BRUISING AT SITE OF INJECTION. SHE SAYS IT GOT ALOT BETTER AND COMPLAINED THAT IT WAS SORE IN THE BEGINNING.
Erythematous hot area 8cm in diameter of Rt. mid thigh with vesicular x3 scattered in central region.
HISTORY OF PRESENT ILLNESS Informed by nursing staff that member with s/p covid-19 booster vaccine on 12/14/21, yesterday she was found to be febrile 102.5F, tachycardic in 170`s, SOB and O2 sat 92%. She was seen by NP, PCP Dr. made aware and member was sent to the ED at hospital. As per ED record, Labs/UA; unremarkable, CXR; negative, COVID-19 PCR; negative, and dx of adverse effect of COVID vaccine, then she returned to the facility last night. Member was seen and examined in bed. Member is non-verbal, unable to provide any complaints or participate in the review of systems. No acute respiratory distress noted at present, v/s stable.  REVIEW OF SYSTEMS
First day 07/09/2021- nothing Second day 07/10/2021- massive injection site pain headache nausea dizzy fatigue  Third day 07/11/2021- little fatigue mild headache  07/12 - 07/14/2021 weakness after mild activity sixth day 07/15/2021- woke up with pain under armpit left side walnut sized lymph node under armpit hurts to even rest arm down seventh day 07/16/2021 - still have pain in armpit on left side with walnut size lymph node on left side still, with itching at injection site and hot to touch. Also have painful swollen lymph nodes on right side of neck in left shoulder blade and in armpit on right side. eighth day  07/17/2021- injection site now has a red rash is hot to touch and itchy. Still have swollen lymph nodes in both armpits one in right side of upper neck, near left collar bone and in left shoulder blade. Feeling miserable.
pt devel rash on chest/mid section;swollen glands of neck;inc T102;rash dec except for small area rt arm;rt hand swollen from wrist to 1st knuckle;tylenol;saw MD;h/a;fatigue;exhaustion; swollen feet;saw MD again;methylprednisone dose pack
Right after the vaccine, I got sick. I thought I had covid, felt like crap for about 5 days. I got better, then everything was normal until about one and a half later, my leg started hurting and aching. I thought it was just me being old, until a mth and half later, I couldnt even stand or walk on my leg. When I got in there, that is when the embolism happened. They told me that I came right on time, cause the clot lodged in my lungs. Felt like I was having a heart attack. I was at that hospital for 3-4 days, I left then went home, then the very next day, I had to go to another hospital.  Hospitals: Hospital , then I went to Medical Center
This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.