chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Dose received: 3; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 16:00 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfates" (unspecified if ongoing), notes: known allergies: Sulfates. Concomitant medication(s) included: ZOLOFT. Vaccination history included: Bnt162b2 (Dose Number: 1, Dose 1, Single), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Dose 2, Single), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Aug2021 16:00, outcome "unknown", described as "Dose received: 3"; OFF LABEL USE (non-serious) with onset 20Aug2021 16:00, outcome "unknown", described as "Off label use"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 01Sep2021, outcome "unknown" and all described as "Pain in my right arm Elbow Shoulder Fingers Wrist Neck". The event "pain in my right arm elbow shoulder fingers wrist neck", "pain in my right arm elbow shoulder fingers wrist neck", "pain in my right arm elbow shoulder fingers wrist neck", "pain in my right arm elbow shoulder fingers wrist neck", "pain in my right arm elbow shoulder fingers wrist neck" and "pain in my right arm elbow shoulder fingers wrist neck" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia, arthralgia, pain in extremity, arthralgia, neck pain.  Additional information: Vaccine facility type was pharmacy or drug store. No other vaccines received in four weeks. Other medications in wo weeks included zoloft, pindenol. No covid prior vaccination. No covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever, body aches, stomach upset, GERD, patient called dr about symptoms but didnt mention vaccine so dr just told them it must be a virus and to take tylenol/advil.
skin looks swelled up; skin looks red; Rash on her face/rash on her cheeks/under her eyes; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (skin looks swelled up), ERYTHEMA (skin looks red) and RASH (Rash on her face/rash on her cheeks/under her eyes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007B21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced SKIN SWELLING (skin looks swelled up), ERYTHEMA (skin looks red) and RASH (Rash on her face/rash on her cheeks/under her eyes). At the time of the report, SKIN SWELLING (skin looks swelled up), ERYTHEMA (skin looks red) and RASH (Rash on her face/rash on her cheeks/under her eyes) outcome was unknown.            Concomitant medication included cholesterol pill but patient stopped taking it about one week ago.   No treatment medications were reported.  After the first dose she did not experience any side effect.   This case was linked to MOD-2021-388581 (Patient Link).
pt recv vax 13MAR79 & pt attorney stated pt suffered paralytic disease on 13APR79 & was classified by CDC as recipient of vaccine-assoc oral polio virus case;this event attributable to @ least part type 3 virus;
face puffy; face went numb; couldn't breathe through nose; ears felt pressurized; hives; throat scratchy; This spontaneous case was reported by a consumer and describes the occurrence of FACE OEDEMA (face puffy), HYPOAESTHESIA (face went numb), DYSPNOEA (couldn't breathe through nose), EAR DISCOMFORT (ears felt pressurized) and URTICARIA (hives) in a 29-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACE OEDEMA (face puffy), HYPOAESTHESIA (face went numb), DYSPNOEA (couldn't breathe through nose), EAR DISCOMFORT (ears felt pressurized), URTICARIA (hives) and OROPHARYNGEAL DISCOMFORT (throat scratchy). At the time of the report, FACE OEDEMA (face puffy), HYPOAESTHESIA (face went numb), DYSPNOEA (couldn't breathe through nose), EAR DISCOMFORT (ears felt pressurized), URTICARIA (hives) and OROPHARYNGEAL DISCOMFORT (throat scratchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Patient with history of and now active ulcerative colitis starting this morning and worsening after Vaccine. She was found bent over in bathroom in abdominal pain with c/o nausea and diarrhea. Brought to EMS-- water given. Patients husband drove her and will drive her home.
Per mom, after leaving the office and walking down to the car, she put child in her car seat. This is when child started coughing, c/o "burning feeling" in chest, face, mouth, throat felt tight and tongue felt like it was tingling. Mom said she monitored her closely but did not give her any medications. She monitored her for 20 minutes, which was when symptoms started to subside.
Coughing after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing after vaccination) 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 COUGH (Coughing after vaccination). At the time of the report, COUGH (Coughing after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Starting about 2-3 weeks after my 2nd dose of the Moderna COVID19 vaccine, I started experiencing daily joint/nerve pain and swelling.  It affects different parts of my body each day, but the usual targets are my fingers, wrists, knees, and ankles.  Sometimes, it is a pure nerve pain.  Other times, it is paired with swelling, especially in the knees and fingers.  I've experienced pain like this in the past, but very infrequently (once every few months at the most).  But the pain has been on a daily basis ever since late-March/early-April and still persists today.
Patient developed local reaction to vaccine (redness, pain) one day after immunization.  The next day developed full body hives.  Had virtual visit with another provider who prescribed prednisone.
General tiredness; cold like symptoms; Dose Number: 4; Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 24Mar2022 02:00 (Batch/Lot number: unknown) at the age of 49 years as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 24Mar2022 02:00, outcome "unknown" and all described as "Dose Number: 4"; FATIGUE (non-serious) with onset 25Mar2022 07:00, outcome "not recovered", described as "General tiredness"; NASOPHARYNGITIS (non-serious) with onset 25Mar2022 07:00, outcome "not recovered", described as "cold like symptoms". Therapeutic measures were not taken as a result of fatigue, nasopharyngitis.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt came back after 45 minutes and complained of numbness in two fingers. She didn't complain of shortness of breath. After about 15 minutes I went to check on her and was told she was taken to ER because she started complaining of SOB she had an EPIPEN & BENADRYL.
Vaccine series given at other provider with conclusion on 7/10/2021.  Patient given vaccine booster too early.  No patient adverse event.
Localized dermatitis at site of varicella vaccine - most likely due to vigorous cutaneous immune response to live vaccine. Has been ongoing x1 year. Onset delayed by one week after vaccine administered. Decided against therapy at this time, anticipate it will fully resolve.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 27-JUL-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (route oral, lot # L048854, expiry date 31-AUG-2017) (strength, dosing details, anatomical location were unknown). No adverse effect was reported. The vaccine was exposed to the temperature of 34 degree Fahrenheit for 53 hours. No digital data logger was involved. No product quality complaint was filed. This is one of the several reports from the same reporter. Additional information has been requested.
pt recvd vax & devel swelling at inject site ? infect, eventually had excision of area; pt had high grade malignancy arising from site (merckel's cell tumor of skin);
Dizziness, Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, HYPERtension, fatigue, injection site pain/itching, chills Narrative:  Employee reports feeling dizzy and "foggy" about 3 hours after receiving vaccine. Also reports nausea, diarrhea, headaches, fever/chills, fatigue, muscle aches, and injection site pain/itching. No medications taken for symptoms relief per report.
BLOOD CLOTS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 212 pounds, and height was 65 inches. The patient's concurrent conditions included: high blood pressure, nerve problems, asthma, herpes, anxiety, penicillin allergy, pain, non alcohol user, and non smoker. The patient had no drug abuse or illicit drug usage. The patient was previously treated with acetylsalicylic acid (Aspirin) for drug used for unknown indication and experienced allergy.  The patient previously received covid-19 vaccine ad26. cov2. s (Janssen, Dose number series in 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administrated on an unspecified date in JUN-2021 (6 months before booster dose) for prophylactic vaccination. It was unknown if patient had adverse event for covid-19 vaccine ad26. cov2. s. (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 16-DEC-2021 into left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included montelukast for allergy, budesonide/formoterol fumarate for asthma, salbutamol for asthma, hydrochlorothiazide/lisinopril for drug used for unknown indication, potassium for drug used for unknown indication, valaciclovir for herpes, sertraline for nerve problems, and anxiety, and meloxicam for pain. On 25-DEC-2021, the patient noticed her legs were swollen from groin down to her ankle. On 27-DEC-2021, the patient went to doctor and was sent to hospital and had done ultrasound and found blood clot and was sent to emergency room at same hospital for treatment and was discharged on same day from emergency room, and was put on Eliquis (apixaban) twice daily and was advised that it may take 3 months for her blood clots to recover, and she was advised to elevate her legs, patient stated she started to feel better. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clots. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0:20220100209-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a physician concerning a 2 year old male who in approximately 2006 "about a year ago" was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced chickenpox (broke into lesions). Medical attention was not sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Pt had reported to us that she once fainted in her doctor's office when she was pregnant and receiving the Tdap vaccine.  We watched her closely, encouraged her sit in pharmacy waiting area and eat and drink.  Pt reported that she felt dizzy even after eating a sandwich and drinking some.  I gave her an ice pack to put on her head.  When I came back to check on her, her brother who came with her, had laid her down on the floor. She had fainted but did not fall or injure herself.   We called 911 and for management.  EMTs arrived on scene and took vitals, offered to take her to the hospital but she declined.  EMTs walked with her to her car.  I called the patient this evening before the closed but she didn't answer so I wasn't able to confirm how she was doing.
Pain for injection site up arm to neck started appr 1 hr after injection. In am 4/17 severe headache not responding to Tylenol.
Anaphylactic reaction (flushing, erythema of skin on arms, chest, and neck, tachycardia, diaphoresis, AMS, weakness); received 0.3mcg epi (Epi-pen) in right thigh after being placed on a litter.  EMS contacted.  Patient improved prior to EMS arrival and was evacuated for further eval and treatment.
child received too many vaccines. The infant was scheduled to receive VAXELIS, PREVNAR 13, and ROTARIX. However, the infant also received MMR, VARICELLA, and a Flu shot which were not scheduled with no reported adverse event; Initial information on 13-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 2 months old female patient who was administered too many vaccines. the infant was scheduled to receive Diphtheria/Tetanus/5 AC PERT/IPV/HIB(OMPC)/HEP B vaccine (Vaxelis), PREVNAR 13, and ROTARIX. however, the infant also received MMR, VARICELLA vaccine, live and Influenza vaccine which were not scheduled with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 AC PERT/IPV/HIB(OMPC)/HEP B (VAXELIS) vaccine (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient received a dose of suspect Rotarix, MMR, Prevnar 13 and Varicella vaccine, live not produced by Sanofi Pasteur (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On 12-Dec-2022, the patient received too many vaccines. the infant was scheduled to receive Diphtheria/Tetanus/5 AC PERT/IPV/HIB(OMPC)/HEP B vaccine (Vaxelis), PREVNAR 13, and ROTARIX. However, the infant also received MMR, VARICELLA vaccine, live and Influenza vaccine which were not scheduled with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Woke up approx 12 hours after the shot with extreme body and joint aches and a fever of 100.8.  Took Tylenol regularly, rested and plenty of fluids.  Fever did not break and only lowered to 100.7 even with Tylenol/motrin in my system.   Extreme fatigue and body aches until fever broke almost 36 hours later.   Felt good almost immediately afterward, however, I now have a rash on  both legs which I assume is from this vaccine.  Rash is blotchy but does not itch.  Shot was on Friday and today is Monday and the rash  is still there.
Patient received an additional Pfizer Bivalent booster on 12/22/2022. She originally received the bivalent booster on 9/22/2022.  Patient has no adverse effects so far.
found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m20a) for COVID-19 vaccination.     Concurrent medical conditions included Traumatic brain injury, Movement disorder, Seizures (since she was a baby at 11 months old) and Speech loss. Concomitant products included CLONAZEPAM, OXCARBAZEPINE (TRILEPTAL) and GABAPENTIN for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 04-Apr-2021 The patient died on 04-Apr-2021. The cause of death was not reported. An autopsy was not performed.            Reporter stated that death certificate said the cause of death was natural causes. She did have her yearly physical exam after her first dose with her physician prior to her death and no other health issues were noted at the time of the exam.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Natural causes
Hives all over my face and ears, onset 7 days post-vaccination, on and off for four days so far, on different parts of the face
Pt presented to the hospital with abdominal pain and shortness of breath  May 28, 2021 Noted to be thrombocytopenic - had normal platelet 20 days prior Had bruising, melena
pt recv vax 20MAR96 & ran fever 104 & had sz-EMS called & transported to ER;advised to see PMD;pt started on phenobarb
didn't get my 2nd dose when suppose to; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received almost 2 years ago from the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The patient self-reported this case. The patient asked he/she did not get his/her 2nd dose of Shingrix when he/she was supposed to. Should he/she start all over or just get 2nd. The reporter asked what a patient should do if their second dose of Shingrix was later than six months after receiving the first dose. The patient read suggestion, but it had been almost two years since first dose. So, he/she thought he/she should asked. The patient also stated that his/her healthcare provider did not know because it had been so long and asked him/her to contact GlaxoSmithKline. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to Incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Following the initial Moderna shot, Red spot began to appear on my torso. Following the second shot, the red sore continued to appear, and following the third(booster shot)  more red spots.
First dose (Moderna) received 12/30/2020 - reaction 12/31 - 1/1.  " Flu like sx: severe fatigue, chills, SOB, felt like hear racing" : was tested for COVID on 1/6 , reportedly negative & for Flu B .  F/u with PCP, who dx'd with 'atypical flu' - sx su,bsequChills,Fatigue
Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked to reporter, if a patient had first dose of shingrix however developed shingles prior to the second dose what was the recommendation regarding second dose. HCP did not have vaccine details (lot number or expiry date of administration).  He or she also stopped responding when asked if they could be contacted regarding the report. The reporter did not consent to follow up.
On 12/7/99, the pt developed flu-like symptoms including muscle weakness, scratchy sore throat, slight temperature, and green mucous. On 12/8/99, his throat was so sore that he reportedly could not speak.
Fever, significant swelling and induration bilateral thighs left more than right 4 days after vacc. and redness left only