chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), FEELING COLD (Felt like they couldn't get warm.), LYMPHADENOPATHY (breasts were tender (swollen lymph nodes)), PAIN (body aches) and CHILLS (Chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (light headache) and VACCINATION SITE PAIN (soreness at injection site). On 07-Feb-2021, the patient experienced NIGHT SWEATS (night sweats), FEELING COLD (Felt like they couldn't get warm.), LYMPHADENOPATHY (breasts were tender (swollen lymph nodes)) and CHILLS (Chills). On 08-Feb-2021, the patient experienced PAIN (body aches). On 05-Feb-2021, HEADACHE (light headache) and VACCINATION SITE PAIN (soreness at injection site) had resolved. On 11-Feb-2021, NIGHT SWEATS (night sweats), FEELING COLD (Felt like they couldn't get warm.), LYMPHADENOPATHY (breasts were tender (swollen lymph nodes)), PAIN (body aches) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Tongue is discolored and has rash like appearance; Tongue is discolored and has rash like appearance; This is a spontaneous report from a contactable consumer (patient). A 13-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533) via an unspecified route of administration on 22Jun2021 at 08:45 (at the age of 13-years-old) in left arm as a single dose for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0168) via an unspecified route of administration on 13Jul2021 at 08:45 (at the age of 13-years-old) in left arm as a single dose for covid-19 immunization. Medical history included eczema from an unknown date and unknown if ongoing. There were no concomitant medications. Known allergies were reported as unknown. No other vaccine in four weeks and no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient reported that his tongue was discoloured and had rash like appearance on an unknown date in 2021. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment was reported as unknown. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient developed a low grade fever, broke out in hives, his eczema worsened, and he still had an unknown allergy.
Approximately 30 minutes after receiving the tetanus shot I began having labored breathing and extreme muscle pain in my middle back. My labored breathing continued for approx 4-5 hours and was somewhat relieved by taking 5 mg lortabs, given to me for my ear having been lanced. Soreness was relieved further by using a heat pad in the days after the injection. I am concerned others who may have the same reaction similar, could have a more extreme reaction leading to suffocation. I have in the past had at one point 3 broken (not cracked) ribs, my pain in breathing after my tetanus injection was equally comparable. This is the 4th day since the injection, my back is only slightly sore at this point. I do not feel any permanent was damage was done, but strongly feel this type of reaction should be noted and investigated.
Chart indicated Positve Covid 7/5/2022.  Patient indicated asymptomatic.  Vaccine Booster 2 given and patient observed 30min no adverse response
ACUTE RESPIRATORY FAILURE 4/17/2023 ESRD (END STAGE RENAL DISEASE)
After receiving her 4 month shots, patient became extremely irritable and fussy.  After almost 2 weeks we finally took her to the doctor because she didn't seem to be consolable.  We noticed her doing a strange movement, which was later diagnosed as having infantile spasms.  I believe the shots are related since before she had her shots she was extremely happy and very easy going. Per follow up report- Patient is now only three years old. She is still going to a neurologist to monitor her progress. She receives an EEG on a yearly basis as well as a MRI.
Flu; Initial information regarding an unsolicited valid non-serious case received from a patient via the agency through social media on 17-Oct-2020.  This case involves a patient (age, gender unknown) who experienced flu (Influenza), while being received vaccine Influenza Vaccine.  Medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient got flu (Influenza).   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
sick with flu like symptoms; sick with migraine headache; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced influenza-like symptoms and migraine headache. On an unknown date, the outcome of the influenza-like symptoms and migraine headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms and migraine headache to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient recently received  1st shot of Shingles vaccine and got sick the same night with flu like symptoms and a migraine headache and was in bed for 2 days.  He/she had another shot in September, really not looking forward to it but the patient did not want the shingles either.
6/17/2017 - ~ 12 days post receipt of vaccine, patient developed left sided Bell's Palsy; no cutaneous vesicular rash observed He called with above symptoms on 6/19/2017 and was evaluated in clinic on 6/20/2017 and started on prednisone and valacyclovir. Evaluated again on 6/30/2017 and significant improvement was noted. Further f/u pending.
Information has been received from a physician concerning a pt who was vaccinated with hep B vaccine recombinant. Subsequently the pt developed fever and leukopenia. Unspecified medical attention was sought. Additional info has been requested.
sweats; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), CHILLS (chills) and MYALGIA (muscle aches) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included BIMATOPROST (LUMIGAN), FLECAINIDE, BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]), ACETYLSALICYLIC ACID (BABY ASPIRIN), ACETAMINOPHEN and BENAZEPRIL HYDROCHLORIDE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HYPERHIDROSIS (sweats), CHILLS (chills) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Feb-2021, HYPERHIDROSIS (sweats), CHILLS (chills) and MYALGIA (muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
She made us aware of the adverse effect on 10/14/17. The shot was given on 10/4/17. She said she woke up the day after (10/5/17) with her arm hurting and it was turning red. She had pictures on her cell phone of it. The whole back of her upper arm was very red, swollen. She said it hurt so bad she couldn't even touch it. She said she did not go to the ER, but did go to her regular doctor 2 days later. She did receive both PNEUMOVAX 23 and flu shot at the same time in the same arm. It was the first pneumo shot she said she ever had. She gets the flu shot every year and has for a long time and said she never has had a reaction to it...which means it was most likely the PNEUMOVAX that made her arm hurt and swell. She showed me arm on 10/14/17 and it looked to be much better. There was a very slight redness in one area but it did not look swollen. She said it felt a lot better but could still feel a little soreness.
pt recvd vax & devel swelling of the lymph nodes & pain in the upper lt arm & neck; pt also had inject site swelling & redness; pt was treated w/ATB for a suspected inject site infect;
After 15 minutes checked on patient and mom (who got vaccine with him at same time and was sitting next to him) said he's experiencing some anxiety and felt funny. Asked him if he wanted to wait another 15 minutes he said no. Asked if they would like me to call 911 or emergency services they both said no. Both said they wanted to leave as sitting there was adding to his anxiety. I asked mom if she knew what to do if the situation escalated and she said yes and wanted to leave with her son and not wait an additional 15 minutes for observation.
Injection site redness; Injection site warmth; Rash; A spontaneous report was received from a nurse, concerning a 45 years of female patient who received Moderna's COVID-19 vaccine and experienced injection site (redness, warmth, rash). She received intramuscular injection on her left arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 27thDec2020, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (lot number 025J20A) via intramuscular route for COVID-19 infection prophylaxis.   On 27 Dec 2020 she received the first dose of vaccine. Two weeks later, she got antibiotics and steroid cream for her injection site reaction (redness that was spreading, warmth). Patient states that her reaction is now gone. Her primary care doctor wasn't sure if it was cellulitis or an allergic reaction, so on 05Jan2021 she took Keflex. On 09Jan2021, she used a steroid cream triamcinolone 0.1% since it hadn't gotten better and Benadryl on 09-11Jan2021 for treatment .She states that the rash was lower than where she remembers the injection being.  No treatment information provided. Action taken with mRNA-1273 in response to the events was not unknown.  The outcome of the events was injection site (redness, warmth, rash) was recovered and resolved at the time of this report.; 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.
raised erythematous warm area of skin at the injection site, began to developed approximately 1/13/2021, pt also had the following symptoms:  body aches, headache, flushed/hot face, chills, nasal discharge, joint pain, fatigue, weakness, tightness in back and arms, cough, diarrhea
Has been having problems with his sense of smell; Diarrhea is very very common/diarrhea just seems to be getting worse; Can't taste anything; Has a runny nose; Has slight chills; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Has been having problems with his sense of smell), DIARRHOEA (Diarrhea is very very common/diarrhea just seems to be getting worse), AGEUSIA (Can't taste anything), RHINORRHOEA (Has a runny nose) and CHILLS (Has slight chills) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L2CA) for COVID-19 vaccination.     Concurrent medical conditions included Spinal cord disorder (Cannot walk without a walker).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-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 PAROSMIA (Has been having problems with his sense of smell), DIARRHOEA (Diarrhea is very very common/diarrhea just seems to be getting worse), AGEUSIA (Can't taste anything), RHINORRHOEA (Has a runny nose) and CHILLS (Has slight chills). At the time of the report, PAROSMIA (Has been having problems with his sense of smell), DIARRHOEA (Diarrhea is very very common/diarrhea just seems to be getting worse), AGEUSIA (Can't taste anything), RHINORRHOEA (Has a runny nose) and CHILLS (Has slight chills) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not provided by the reporter.  The week before reporting patient started to experience the adverse events. Normally Patient  is a warm body person and experience loss of taste and worsening of diarrhea  and running nose in the last over 6 weeks.
expired Adacel was administered to a patient, no adverse event; Initial information received on 16-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse..  This case involves a 13 years old female patient who received an expired booster dose of 0.5 ml of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] via intramuscular route in left deltoid (lot U5477CA, expiry date: 29-Oct-2018) as prophylactic vaccination on 16-MAR-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given.   This was actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Generalized weakness,and muscle/bone aches , slightly dizziness, loss of appetite for 3-4 days
Mild systemic symptoms; cutaneous lymphoid hyperplasia; This is a literature report.  A female patient in her 70's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Surgical excision" (unspecified if ongoing), notes: Done for CLH. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PSEUDOLYMPHOMA (medically significant), 22 days after the suspect product(s) administration, outcome "recovered", described as "cutaneous lymphoid hyperplasia"; GENERAL SYMPTOM (non-serious), outcome "recovered", described as "Mild systemic symptoms". The patient underwent the following laboratory tests and procedures: CD30 expression: Positive; CD4/CD8 ratio: 2:1; Histology: revealed T-cell-predominant lymphoid infiltrates, notes: revealed T-cell-predominant lymphoid infiltrates: consistent with pityriasis lichenoides et varioliformis acuta (n = 2), cutaneous T-cell lymphoid hyperplasia (CLH) (n = 2), and lymphomatoid papulosis type A (n = 2); T-cell receptor gene rearrangement test: Positive. Therapeutic measures were taken as a result of pseudolymphoma, general symptom.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event pseudolymphoma and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Since getting Moderna Vaccine the first week of April, I have suffered a significant loss in mobility, tinnitus in right ear, rapid inflammation response, especially in both legs and pain in left hip to spreading to left foot.
7:30 PM whole body muscle aches started on day of shot. By the morning of 5/9 I had the chills and shaking, I was extremely dizzy. A headache on a scale of 9/10.  I was also having odd shooting pains near the chest and stomach. I slept roughly 22 to 23 hours and the little bit I was up I was nauseated.  By the morning of 5/10 I was sweaty and I had diarrhea x1. unexpectedly no pain at that point. By noon of 5/10 I was starting to feel better.  By 5 PM 5/10 I felt about 93% back to normal. I called my doctors office at 4 PM 5/9.  The  nurse who I was told would probably be remote didn't return my call until 10:30 that evening.
Injection site hurt every now and then; I have not had a period,; my breast hurt; My sleep is disturbed. I only sleep a total of about 3 hours a night; Vision in my right eye is blurry; im having back & joint pain; im having back & joint pain; The patient administered first and second doses on same date 29Mar2021; This is a spontaneous report from a contactable consumer(patient). A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 15:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EP6955 ) via an unspecified route of administration in the right arm on 29Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient reported the Facility type Vaccine was Doctor's office/urgent care. Medical history was not reported. The patient reported past drug event of known allergies was Naloxone. Concomitant medication within two weeks of vaccination included Subutex, xanax, vitamins, prebiotic taken for unspecified indication and start dates and stop dates were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 02:30 the patient experienced not had a period, breast hurt, both injection site hurt every now and then, sleep is disturbed, and I only sleep a total of about 3 hours a night, Vision in my right eye is blurry and having back & joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Same day: excessive swelling, redness/rash, itching at site of injection. mild fever, chills, headache.  72 hours later: rash on both ears (bright right visibly, feel hot/burning sensation, itchy). Rash on both arms (dotted rash all over arms, itchy)
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 10:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 10:58 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 72.51 years.  No concomitant medications were reported.  On 19-Apr-2021, vaccines were moved to the fridge. On 29-Apr-2021, 05 vials were sent to the clinic, On the same date, at 10 AM, vials underwent temperature excursion with temperature of 33 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 19-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medications were reported.
COVID breathrough. First vax 2/41/2021  69-year-old male who had a syncopal episode and was involved in a car accident without any significant lesion from the car accident.  Was also found to be COVID positive.  He has a history of diabetes mellitus, relatively well controlled
Starting with onset of symptoms (pressure in left ear) on evening of 7 December, the day following booster vaccine, and developing through 8/9 December,  developed partial facial paralysis (Bell's Palsy) on left side of face.  Was prescribed a course of  steroids (prednisone) and anti-virals (valacyclovir) which had no effect in alleviating symptoms.  Paralysis continues 4 weeks later, with about 20-30 % of muscle movement regained on affected side of face.
Information has been received from a physician concerning a 14 month old male who on 09/04/03 was vaccinated with a dose of varicella virus vaccine live (Lot # 644719/0016N).  On 10/03/03 the pt presented to the physician's with about 50 vesicular lesions. No other symptoms were reported. There was no product quality complaint involved. Additional information has been requested.