chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The chemical smell is still there it gets worse when I get active and sweat; This spontaneous case was reported by a patient and describes the occurrence of PAROSMIA (The chemical smell is still there it gets worse when I get active and sweat) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (The chemical smell is still there it gets worse when I get active and sweat). At the time of the report, PAROSMIA (The chemical smell is still there it gets worse when I get active and sweat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow-up received, outcome of the event was updated.
intense headaches; tired for a couple of days; This is a spontaneous report from a contactable Nurse. This Nurse reported for a patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, on an unspecified date for COVID-19 immunization. Reporter was concerned because some of her coworkers, about 5 of them, had previous COVID diagnosis last March also received the vaccine were fine and experienced only intense headaches and tired for a couple of days. She mentioned that one person, until now had headaches and took tylenol for it. The outcome of the event headaches was reported as not recovered and for tired it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Elevated temperature for 100.1 Tenderness at injection site  Treated with cooling measures and Tylenol 500 mg.
Within a minute or two, extreme pain in lower back, on scale of 1-10, a 20. Then the pain jumped to my shoulders, not traveling, while my back pain increased. I tried standing but could not move my legs. The administrator, called 911. By the time they came, I was able to stand, and the pain was subsiding, but never went away totally. Today, about three weeks later, the lower back pain has not totally rescinded. It's effecting me 24/7. The shoulder pain has subsided.
This is a spontaneous report from a physician referring to a female pt in her forties, who received her 1st dose of Lymerix in March of 1999, and experienced lower back pain, which resolved. Also, she experience paresthesias. In April of 1999, she received the 2nd dose and shortly thereafter, she experienced a recurrence of back pain, myalgias, and arthralgias. Treatment included Relafen and Naprosyn. The information received on 8/23/99, reports the symptoms are ongoing. The most recent information received on 8/24/99, does not provide an outcome.
is very sick; She was throwing up constantly; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (is very sick) and VOMITING (She was throwing up constantly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 045A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (is very sick) and VOMITING (She was throwing up constantly). At the time of the report, ILLNESS (is very sick) and VOMITING (She was throwing up constantly) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. The patient called to report that himself and his wife received the booster dose, and wife is very sick and constantly vomiting up every few minutes. Patient callback and informed that his wife is very sick and gave details such as batch lot number for the booster dose, and information about first dose and second dose was provided.   This case was linked to MOD-2021-066503 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up received contain Batch lot number for booster dose and information of dose1 and dose 2 is added.
bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (bladder infection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced CYSTITIS (bladder infection). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) for Bladder infection, at an unspecified dose and frequency. At the time of the report, CYSTITIS (bladder infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. Patient stated that she self-diagnosed herself with a bladder infection and treated herself with augmentin.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: TCR received: added outcome of the event bladder infection from unknown to recovered.
11/24/2022 in mid-morning I began having incredibly intense abdominal and rectal spasms. I talked to my PCP and she gave me a prescription for an anti-spasmodic to get me through the weekend. The pain continued through the next few days. On 11/29/22 I went to the hospital and had a CT and bloodwork. It showed I had diverticulitis which I have had before. I was hospitalized for 5 days. The diverticulitis included an abscess coming off my colon. They drained the abscess. I was sent home with a PIC line for IV antibiotics until 1/17/2023. The symptoms resolved quickly, but the CT showed a lot of signs of infection. On 2/23/2023 I had surgery. They removed 8 ½ inches of colon. After having many CT's, they discovered a fibroid tumor external to the uterus and on a stalk and it had twisted and was dying which was causing the pain. I also had a full hysterectomy. I am slowly recovering.
Caller stated that close to midnight his heart start beating very fast and he couldn't sleep.  The next day his heart rate would speed up throughout the day. A few minor aches and pains around the neck and shoulder and more tired than normal.
pt sat down 10 minutes after shot. when she got up to talk to her husband she felt lightheaded and fainted.  she was flat on the ground . after a few minutes she came to , opened her eyes, she was coherant , still lightheaded, headache and bump on her head . paramedicts took her to hospital
Red, warm reaction on skin; started night of immunization date as dime sized circle, by next morning was slightly bigger than a half-dollar. At this point patient thought it was a reaction to the barrier/sticker we apply to the skin. Pt came in 4 days later and showed photos from the weekend where it grew to about 5" diameter top to bottom, and 6" left to right. Patient also felt lethargic during peak reaction. It is now starting to resolve and patient has an appointment with PCP this week to follow up.
Patient received Pfizer for a booster dose and had Moderna for the 1st and 2nd. dose
racing heart; This is a spontaneous report from a contactable consumer, the patient. This 75 year old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1 , single dose via an unspecified route of administration in the left arm on 25Jan2021 at 15:00 (at the age of 75 years old) for COVID-19 vaccination.  There was no relevant medical history. There were no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021, the patient had a racing heart. The event was reported as non-serious. There was no treatment received for the event. The clinical outcome of racing heart was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Large egg shaped lump at the injection site; Itchy Injection site; Red injection site; Vaccine injected in the fat cell of left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Vaccine injected in the fat cell of left arm), INJECTION SITE MASS (Large egg shaped lump at the injection site), INJECTION SITE PRURITUS (Itchy Injection site) and INJECTION SITE ERYTHEMA (Red injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE INDURATION (Vaccine injected in the fat cell of left arm). On 13-Mar-2021, the patient experienced INJECTION SITE MASS (Large egg shaped lump at the injection site), INJECTION SITE PRURITUS (Itchy Injection site) and INJECTION SITE ERYTHEMA (Red injection site). At the time of the report, INJECTION SITE INDURATION (Vaccine injected in the fat cell of left arm), INJECTION SITE MASS (Large egg shaped lump at the injection site), INJECTION SITE PRURITUS (Itchy Injection site) and INJECTION SITE ERYTHEMA (Red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Patient experienced vasovagal symptoms, dilated pupils, increased HR, syncope, and had pale skin tone within less than 1 minute of administration.
An hour or so after the injection, I started feeling jittery and a little hyper.  By 5 hours after the injection,  my heart started pounding a little and by the time I went to bed around 11:00, my heart was pounding heavily.  My heart rate was normal but my pounding heart made it hard for me to sleep and I also could feel the throbbing in my fingers and toes.  The next day the pounding lessened when I was moving around but it was heavy again when I tried to sleep.  The pounding lessened over the next two days, however my blood sugar was and still is at the present hard to regulate.  I am hypoglycemic and usually regulate my blood sugar well with my diet.  However, since the shot, the pounding seems to be connected to my adrenals working harder to regulate my blood sugar according to  advice from a doctor I talked to.  My low blood sugar is much more frequent  even though I am still eating the healthy diet that I was using before the injection.
Large swollen area, hard lump, very itchy.  By 12/7/12 the spot was the size of a softball and very red, hot, and hard.  Still red, hard and itchy on 12/10/12 but spot is finally down to the size of a quarter.
MRI brain performed showing large area of tumefactive demyelination; two weeks of vaccination with new onset seizure; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. lot unknown reason=Not available/provided to reporter at the time of report completion. Relevant medical history included: "Autism spectrum disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Known allergies were reported as none. Other vaccines in four weeks was reported as no. It was reported Covid prior vaccination: No and covid tested post vaccination: Yes.  The following information was reported: DEMYELINATION (hospitalization, medically significant) with onset 13Dec2021, outcome "recovering", described as "MRI brain performed showing large area of tumefactive demyelination"; SEIZURE (hospitalization, medically significant) with onset 13Dec2021, outcome "recovering", described as "two weeks of vaccination with new onset seizure". The patient was hospitalized for demyelination, seizure (hospitalization duration: 5 day(s)). The events "mri brain performed showing large area of tumefactive demyelination" and "two weeks of vaccination with new onset seizure" were evaluated at the physician office visit and emergency room visit. It was reported Patient presented to hospital within two weeks of vaccination with new onset seizure. MRI brain performed showing large area of tumefactive demyelination. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (Dec2021) showing large area of tumefactive demyelination; sars-cov-2 test: (14Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of demyelination, seizure which included IV steroids.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Demyelination and Seizure 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.
Information has been received from a physician concerning a 21 year old female with attention deficit/hyperactivity disorder and a history of depression who in January 2007, was vaccinated with a first dose of GARDASIL.  The physician stated the patient received three doses of GARDASIL but the dates of administration of the second and third dose were unknown.  Concomitant therapy included CELEXA and ADDERALL tablets.  In February 2007, the patient developed hair loss.  On unknown date, the patient visited the office.  In January 2009, the patient was examined and was diagnosed with alopecia areata.  The patient was prescribed topical steroids and unspecified pulse systemic steroid therapy.  The patient has noticed slight improvement in the symptoms.  The physician added that thyroid levels, antinuclear antibody, sed rate, complete blood count, and comprehensive metabolic panel results were normal.  Additional information has been requested.
Previously had a PCV13 inoculation  on 4/20/15.  Not sure I should have been given another now.  Looks from CDC website that maybe I should have been given PPSV23.   Within hours  the lymph nodes under my right armpit began to swell and the next day I developed shingles.
Lump; itching; Redness; This spontaneous case was reported by a patient and describes the occurrence of NODULE (Lump), PRURITUS (itching) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (Lump), PRURITUS (itching) and ERYTHEMA (Redness). At the time of the report, NODULE (Lump), PRURITUS (itching) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0169, expiration date: unknown) via an unspecified route of administration on 22Apr2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chest pain. Stated never had it before any chest pain nothing and wanted to know about what should be done. Outcome of the event was unknown at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Body started hurting; chills; pain in joints; pain in muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body started hurting), CHILLS (chills), ARTHRALGIA (pain in joints) and MYALGIA (pain in muscles) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PAIN (Body started hurting), CHILLS (chills), ARTHRALGIA (pain in joints) and MYALGIA (pain in muscles). At the time of the report, PAIN (Body started hurting), CHILLS (chills), ARTHRALGIA (pain in joints) and MYALGIA (pain in muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 10 Nov 2021, patient felt chills, pain in joints and muscles.  No concomitants and treatment drugs are provided.
Shaking Uncontrollably, Sweats, Dry mouth, sore all over, injection site was swollen, memory loss, confusion
Initial misuse report received on 07 October 2013 from a health care professional. A patient, whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number, expiry date and site of vaccination was not reported). It was reported that the patient received 2 doses of vaccine, 1.5 months apart. No reaction was reported. List of documents held by sender: none
3 pm 9/27/2011 pt. called w/ complaints of throat sore & feeling of closing. 438 pm 9/27/2011 pt. did not want to to ER called back stating she feels better.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with the third dose of GARDASIL (Lot# not reported). Subsequently, the patient felt heaviness in her arm and she felt weak, so the physician had her lay down. The patient's mother never informed the office that the patient had the same reactions when she got her first and second doses of GARDASIL. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-AUG-2010, a health care provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 07-NOV-2014 the patient was treated by the physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
No additional AEs; the patient received improperly stored vaccine; temperature between 36F and 49F with highest of 53F over 2-3 weeks period; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JAN-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) 0.5 ml injection, lot # T031820, expiration date 10-MAY-2022 (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was stored in a temperature between 36 degrees Fahrenheit (F) and 49 F with highest of 53 F for over 2 or 3 weeks. The reporter stated the data was insufficient to evaluate temperature excursion. There was no previous temperature excursion reported. Digital data logger was involved. No adverse events (AEs) were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
pt recvd vax; 5- 7 days later had a pos test for infectious mononucleosis &  a swollen neck; sore throat;