chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reports that by 11/11/2005 in the evening hours she had area patch that was warm to the touch about 7cm long a small orange size per pt. By Saturday 11/12/2005, pat reported redness had spread down her arm further, was very sensitive to the touch and had a darker center right around where shot was given. Pt is here on 11/14/2005 and arm is still red. Almost circumferential about 15-30cm in size. Given PRX of Keflex 500 mg QID x 7 days on 11/14/2005. The redness was around where pt was given Pneumovax vaccine.
Information has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), lot # L015047, expiration date 29-APR-2017 (dose and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax;to hosp w/ sx of encephalopathy;bacterial cultures neg;tx w/ acyclovir for viral encephalopathy;sx resolved other time;
rash on arm at injection site first noticed 2/9/21. Area is warm to touch and slightly itchy. Not painful. About 1 1/2 inch area. Still there this morning,2/10/21.
Initial misuse report received from a healthcare professional on 19 March 2014. A 05-month-old patient received 0.25 ml dose of FLUZONE inadvertently thinking that the patient was at 6-month of age. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Arm was itchy; deltoid area being warm; Welts in the back of the arm where she got her injection; allergic reaction; Arm got red; A spontaneous report (United States) was received from HCP  concerning an unknown years-old female patient who received the COVID-19 vaccine (mRNA-1273).  The patient's medical history is not reported. No relevant concomitant medications were reported.  On 4 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number:Unknown) via an unknown route for prophylaxis of COVID-19 infection.   On date 13 Jan 2021, the patient experienced the events itchy, red, warmth, rash and allergic reaction at the injection site.    No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events adverse reaction, arm was itchy,  arm got red,  band around her bicep, deltoid area being red, deltoid area being warm, felt like she had welts on the back of her arm and allergic reaction was resolved on 16 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
1st noticed redness Monday night 9/15/03, some swelling. On 9/16/03 swelling and redness increased, woke up at 4 AM crying and arm hurting.
The day following my vaccine I had a welt at the injection site. A day or two later it was gone. Approximately one week after the vaccine, I developed hives at injection site. Hives turned into another welt that continued to spread until I was given steroids to take. The steroids did cause the reaction to stop and go away.
Pt reported golf ball sized spot where she received the shot the day following shot. Sore over weekend & warm to touch. Pt took Benadryl, Tylenol, Advil & iced area.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 50 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 08-APR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient had 2 antibody tests done and both came back negative. The first test (Covid-19 antibody IgG/IgM rapid point of care test) was done on 18-MAY-2021 (coded as confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) Negative. The second test was Blood test done on 21-MAY-2021. Laboratory data included: Blood test (NR: not provided) Negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210551688-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Very slight muscle pain in area starting on 12th day (rcvd 1/12.  First symptom 1/24) Slight itching in area on 13th day.  That evening checked the area visually and noted slight reddening  (about 1.5 inches) and small swelling (approx 1.5 cm diameter) at the edge of the reddened area. Following morning the reddened area was somewhat more defined into a circular area approx 2.5 inches in diameter.   The small area was slightly puckered, but still present.   Pain and itching were very slight - less than 1 on a 1-10 scale.   Both are only present with some movements (pain) and cloth contact/movement (itching).
so sore my arm; body aches/  shouder pain; hardly lift them; Shouder pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th August 2021, the patient received the 2nd dose of Shingles vaccine. On 20th August 2021, 1 days after receiving Shingles vaccine, the patient experienced pain in arm, general body pain, mobility decreased and shoulder pain. On 21st August 2021, the outcome of the pain in arm, general body pain, mobility decreased and shoulder pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, general body pain, mobility decreased and shoulder pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient reported that got shingles vaccine last Thursday afternoon. On Friday the patient's arm felt so sore and hardly lift them and pain from shoulder to shoulder body aches all day long. The patient reported that on Saturday there was no more pain and it was good to be back to normal. The follow-up would not possible as no contact details were available.
1/6-cold chills began around 3pm with headache. Noticed a nickel size spot to the left of the injection site that was warm, itchy, hard and sensitive to the touch. Arm soreness but not in bearable. Cold chills turned into a fever accompanied by a throaty wet cough and went away around midnight.   1/7- spot on arm is roughly the size of a soda can rim. Very warm, itchy, hard and sensitive to touch. Arm is a bit more sore in lymph nodes under the arm and the left side of left breast. Slight headache since waking that went away around 10am. Tightness in upper chest back and shoulders.
Patient received her flu shot and that evening on 10/10/19 felt light headed and dizzy and had heart palpitations. Stated she went to bed that evening and the next day she felt ok and then this morning 10/15/19 she woke up with the same symptoms as on 10/10/19. Patient is currently being seen in the emergency room to be evaluated for symptoms.
No known adverse effects - child was given 3rd ROTATEQ at 11 months of age - which is outside recommended age category.
I am a resident physician/ employee at the Hospital. I developed acute perforated appendicitis 56 hours after receiving the 2nd dose of Pfizer COVID vaccine. I received the vaccine on 1/12/21 and developed symptoms of epigastric pain and vomiting on 1/14/21. On 1/15/21, I developed fever and right lower quadrant pain that was sustained. I  presented to the Hospital Emergency Department on 1/17/21 and was diagnosed with acute perforated appendicitis by CT with contrast. I underwent emergency appendectomy at The Hospital on 1/17/21 and was hospitalized from 1/17/21-1/19/21.
Patient reports swollen arm and arm is hot to the touch. Patient received vaccine 01/31/22 and starting showing symptoms on 2/4/22. Patient reported adverse reaction on 2/5/22.
Fever 100.4, severe headache, diarrhea, nausea, lack of appetite...fever lasted 36 hours then dropped to 97.3...symptoms severe missed 5 days of work...brain felt like it was swollen, also felt dizzy...started feeling like able to do daily routine on Saturday 3/27...but still weak and tire easily.  Also, since this..my poop looks yellowish and floats every time. To be honest I am afraid of getting the 2nd vaccine.
Left arm noted increased swelling after 12-24 hours after shots, elbow to shoulder.  Hot and tender.  Now states itching.
Developed fever up to 102F, intermittently, from 11/10/00 to 11/13/00. Also, developed red, papular rash on the trunk and arms on 11/10/00 which is now resolving. Has nasal congestion but no cough and clear breath sounds.
On April 23, 2021 I noticed swelling in my left arm and then my arm got very very large in a progression of week. The swelling went down a little but my left arm was still bigger than my right and a few weeks in my whole left side started to swell from my left arm down to my left leg. I had a mammogram on April 29, 2021, and I noticed that my left breast was a little bit bigger than my right breast. I contacted my Dr. on May 19, 2021 on a video visit about the swelling. My Dr. stated that she didn't know why that would happened and just to monitor my swelling and if anything changes let her know. On July 10th I had a in-person Dr. Appointment. On July 10th, 2021, my Dr. was able to actually see and touch my arm. My Dr. said she had know idea how this would happened. I told her that I was having traveling pain all over my left side from the swelling. My Dr. thought it maybe was my arthritis causing the swelling. On July 15th I went back for a should x-ray, the x-ray results showed arthritis but it was not that significant. My next Dr. appointment is November 13, 2021.
developed myalgias post dose one of BNT162b2-V and had mild rhabdomyolysis; developed myalgias post dose one of BNT162b2-V and had mild rhabdomyolysis; This is a literature report.  A 14-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHABDOMYOLYSIS (medically significant), MYALGIA (medically significant), outcome "unknown" and all described as "developed myalgias post dose one of BNT162b2-V and had mild rhabdomyolysis". The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: 1600 U/L.; Sender's Comments: Considering the temporal relationship, a causal association between the suspect product bnt162b2 and the reported 'mild rhabdomyolysis' and 'myalgias' cannot be excluded. Case will be reassessed when additional information becomes 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200056097 Same article/drug/event and different patient;
The pt developed a low grade fever for two days, rash (five lesions), itching. The pt was exposed to chicken pox 15 days ago.
PT STATES HIS ARM IS SORE AND SWOLLEN WHERE VACCINATION WAS GIVEN.  SAYS THE PAIN IS UNBEARABLE.
3-28-08 10 x 8 cm erythema - increased warmth - edema started on Augmentin 875mg BID 10 days.  3-29-08 - Cellulitis improving.
hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) 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) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details was not reported .
difficulty breathing; awoke around 1230AM; was up to about 5AM; has happened in the past but takes Theodur & it ususally resolves; lasted longer than usual; As of 15OCT93 PM resolved just very tired from being up all noc;
he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away
Movement disorder; Myoclonic jerks 10/29/07-records received for DOS 10/23/07-Impression. acute onset of movement disorder. Not improving. Tic-like movements involving head and neck and right upper extremity. The question of streptococcus induced movement disorder is raised. Symptoms should slowly improve. Medical management of her streptococcal infection. C/O neck and back pain from twitiching movements. PE: intermittent head and neck tic-like movements particularly of the right side, rare movements noted in right upper extremity and few abnormal movements in her trunk. The intensity of movements tended to vary during course of examination, she did have some momentary control over them.
vaccine administered 8 days after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 8 days after first puncture) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 8 days after first puncture). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 8 days after first puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-333898.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: follow up contains No new information
pityriasis rosea; This spontaneous case was reported by a patient and describes the occurrence of PITYRIASIS ROSEA (pityriasis rosea) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Patient had no COID-19 diagnosis.  The patient's past medical history included Central serous retinopathy (Central series retinopathy, diagnosed before any of the COVID-19 vaccine.), Arrhythmia (diagnosed before any of the COVID-19 vaccine.) and Ischemia retinal (Retinal transient ischaemic attack, diagnosed after March 2022). Concurrent medical conditions included Cystitis interstitial (diagnosed before any of the COVID-19 vaccine.) and Irritable bowel (diagnosed before any of the COVID-19 vaccine.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PITYRIASIS ROSEA (pityriasis rosea). At the time of the report, PITYRIASIS ROSEA (pityriasis rosea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had rash at the very beginning after the second dose. Patient did not have information on previous doses, but all were Moderna vaccines. And patient mentioned that on 26-Apr-2023, received Moderna Bivalent dose. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743176 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743176:6th dose (SPIKEVAX 2023-2024)
Patient began feeling warm, dizzy and vertigo. Patient also reports feeling anxious from receiving the vaccine. Vitals signs monitored and remained stable.  Patient sat and drank water. Patient felt better and discharged to home.
Early morning less than 48 hours after the booster shot I rolled over in bed and experienced spinning sensation in my head. I later woke and got out of bed and had coffee. Soon after I vomited and was unable to hold down food or water for 2 days. I had fever and felt extremely sea sick.  After five days I felt well enough to go out but I had to be careful not to move my neck in order to avoid vertigo. The vertigo was especially sever when I would lay down or get up. The vertigo began to improve gradually, and finally, on December 1, I finally felt normal again with no vertigo in any position.
Pt recvd 1st dose of Heb P vax 28MAR91 & on 31MAR91 pt devel generalized rash; ER MD dx allergic rxn to vax; MD suggested that pt received no further vax; pt recovered;
Pt reported pimple-like bumps on hand and arm opposite arm receiving shot about one week after receiving vaccine. She stated the bumps itched and then scabbed over in about a week. No pain with bumps.
feeling cold; Weakness; Tired out; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), ASTHENIA (Weakness), PYREXIA (Fever ), CHILLS ( Chills) and FATIGUE (Tired out) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever ) and CHILLS ( Chills). On 19-Feb-2021, the patient experienced FEELING COLD (feeling cold), ASTHENIA (Weakness) and FATIGUE (Tired out). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (feeling cold), ASTHENIA (Weakness) and FATIGUE (Tired out) outcome was unknown and PYREXIA (Fever ) and CHILLS ( Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 102 (Inconclusive) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fever chills and fatigue are consistent with the product safety profile.
Chest pressure, Headache, Fatigue.  Lingering minor headache and fatigue every day for more than one week after the vaccine second shot.
This spontaneous report as received from a healthcare worker (also reported as office manager) refers to a 14 year old female patient. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 24-MAY-2016 the patient was vaccinated with first dose GARDASIL 9 (dosing details were not reported) (lot # L026602 with expiry date of 19-OCT-2017), intramuscularly. On 24-MAY-2016, 15 minutes after the patient received the GARDASIL 9, the patient collapsed in the waiting room of the physician's office and began shaking, the physician thought the patient was having a seizure. On 24-MAY-2016, after 45 minutes of receiving the GARDASIL 9 an ambulance was called and the patient was taken to an unspecified hospital due to the reaction that occurred (the patient sought medical attention). It was not stated if the patient was admitted to the hospital. The outcome of the events was unknown. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Upon internal review, seizure was determined to be medically significant. Additional information has been requested.