chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. A 49-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6199), at the age of 49, via an unspecified route of administration, left leg, on Mar 9, 2021, at 12:45, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included as lisinopril for unknown indication, from unknown date and unknown if ongoing. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, patient experienced headache, bloody nose and large lump on injection site. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache, bloody nose and large lump on injection site resolved on unknown date of 2021. The patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP7533), at the age of 49, via an unspecified route of administration, right arm, on Apr 6, 2021, single dose, for COVID-19 immunisation. No follow-up attempts needed. No further information expected.
This spontaneous case reported by a consumer, describes the occurrence of lymphadenopathy (swollen lymph node on left arm), myalgia (shoulder soreness and tenderness below the deltoid muscle), limb discomfort (felt like a rock was in my arm pit) and insomnia (couldn't sleep on that side) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007B21A) for COVID-19 immunization. No medical history reported. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 23, 2021, patient experienced lymphadenopathy (swollen lymph node on left arm) and myalgia (shoulder soreness and tenderness below the deltoid muscle). On Mar 30, 2021, patient experienced limb discomfort (felt like a rock was in my arm pit) and insomnia (couldn't sleep on that side). At the time of the report, lymphadenopathy (swollen lymph node on left arm), myalgia (shoulder soreness and tenderness below the deltoid muscle), limb discomfort (felt like a rock was in my arm pit) and insomnia (couldn't sleep on that side) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
On 10/14/1 5- severe body aches, unable to function, having chills, vomiting, severe headache migraine in nature.
pt recv vax 3SEP96 & 26SEP96 it was reported that pt devel a 1cm abscess that was incised & drained;cult showed no growth;4OCT96 site was well healed w/only a small nodular area where the incision & drainage was located;
Pain at injection site, referred pain on right side of neck and shoulder, injection sight redness, swelling, itching, itching/rash on left shoulder and chest
In early June I woke up with swelling below my right eye.  by the end of the month I had swelling under both eyes and was waking up with swelling above both eyes, trembling in my hands and legs, headaches and sweating profusely.  after 2seperate rounds of antibiotics and steroid shots from my regular Dr.  my systoms had not gotten any better.  In Sept of 2021 I went to a local Hospital of Urgent Care Center and was diagnoised with Hyperthyroidism.  Since that time I have been diagnosed wwith graves disease and Thyroid Eye Disease.
Breakthrough case admission after three vaccines Pfizer 8/25/21 Lot# Ew0179 ; Pfizer 9/2/21 Lot# Ew0179;  Pfizer 10/24/22 Pfizer GJ5342
Patient received Moderna COVID vaccine for dose 1 on 12/15/2021. Patient then received dose 2 Pfizer COVID vaccine on 1/5/2022 as indicated in this report.
Muscle cramps/a medical assistant having it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "Muscle cramps/a medical assistant having it". Therapeutic measures were taken as a result of muscle spasms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pt experienced transient hypotension immediately following vaccination. No urticaria was noted. Numbess/paresthesia on opposite side followed by emesis.
hand got numb; her voice is rough; every morning like something is wrong/it felt like someone has punched her in the arm or shoulder.; bruised line going across her arm; pain in arm; Can't hardly lift her left arm, it is weak; Can't hardly lift her left arm, it is weak.; Can't talk, something is wrong with her voice; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration at arm left on 02Aug2021 as a single, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was a 78-year-old female. She had the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 02Aug2021 and ever since, it felt like someone has punched her in the arm or shoulder. Her hand got numb and mentions she never got arthritis in the shoulder. She also reported that her voice was rough and gets like that every morning like something was wrong. There was also a bruised line going across her arm her son looked at it and it looked like it settled at the top. She also mentioned that a year ago she volunteered to give blood and was drawn on the same arm and her arm went numb. She was asking if she should get the second shot and should she get it in the right arm. She said that she doesn't want to get the second shot and she doesn't want both her arms to hurt. She also has 3 doctor appointments coming up. She had all the papers on it stating inflammation and bleeding and everything. Clarified this was what's listed on the paper. Reporter was not experiencing inflammation and bleeding. Now she can't talk. Something is wrong with her voice. It's rough and she can't hardly change that. Had three doctors, including a kidney and regular general doctor at (#). Her voice is rough this morning, it gets like that every morning. Wondering if she should get the second one because this hasn't gone away since she got the shot the first time. Had been in her house for two and a half years without leaving. Outcome of the events was unknown.
Extreme swollen lymph node; Hungry feel; Fatigued, Get tired; Nausea; Dizziness; Confusion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Jun-2021 and was forwarded to Moderna on 02-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), LYMPHADENOPATHY (Extreme swollen lymph node), HUNGER (Hungry feel) and FATIGUE (Fatigued, Get tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Drug allergy (Allergic to Iodine). Concomitant products included COLECALCIFEROL (VITAMIN D 3), UBIDECARENONE (COQ 10), GINKGO BILOBA and NATTOKINASE for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion) and NAUSEA (Nausea). On 01-Apr-2021, the patient experienced LYMPHADENOPATHY (Extreme swollen lymph node), HUNGER (Hungry feel) and FATIGUE (Fatigued, Get tired). At the time of the report, DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), HUNGER (Hungry feel), FATIGUE (Fatigued, Get tired) and NAUSEA (Nausea) outcome was unknown and LYMPHADENOPATHY (Extreme swollen lymph node) had not resolved. Not Provided          No treatment information was provided by reporter.   This case was linked to MOD-2021-219973, MOD-2021-041181 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Additional Information has ADR form with patient medical history,  conmed, 2nd dose ivaccine nformation,
Bruising on calf of left leg; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 14:15 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced bruising on calf of left leg on 08Mar2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received no treatment for the event. The outcome of the event was not recovered.    No follow-up attempts are needed. No further information is expected.
no immune response to the vaccine; Soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED IMMUNE RESPONSIVENESS (no immune response to the vaccine) and PAIN IN EXTREMITY (Soreness of the left arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Mantle cell lymphoma (for about 20 years on and off.). Concomitant products included BENAZEPRIL, AMLODIPINE and COLESEVELAM for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Soreness of the left arm). On 17-May-2021, the patient experienced DECREASED IMMUNE RESPONSIVENESS (no immune response to the vaccine). At the time of the report, DECREASED IMMUNE RESPONSIVENESS (no immune response to the vaccine) and PAIN IN EXTREMITY (Soreness of the left arm) outcome was unknown.            Concomitant products included blood pressure medication.  No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.
Fever - 101, hives - neck and trunk - BENADRYL 12.5 mg every 6 hours - TYLENOL.
Patient complained of feeling flushed and not "normal" which then followed up with complaint of feeling a flutter in her chest then numbness and tingling in the arm she received the shot.
20 minutes after shingles vaccine given severe diarrhea, body aches, headache, nausea - lasted approx 4 hrs. Arm injected swelled, red, bruising for 1 1/2 weeks.
background: 58 year old male with no active medical issues (based on medications received on record at pharmacy received a full vial of undiluted Pfizer vaccine as a booster dose on 12/18/2021 at 10:30am EST.the patient had no event or reaction during the 15 minute waiting period post vaccine. he had received Pffizer COVID 19 DOSES 1 AND 2 without issue. the administration error was discovered 3 hours following  the vaccination. Several attempts were made to try and reach the patient, but each time the phone number came back as inactive at that time. a message was left with dr's answering machine , because the patient has used Dr who worked at a walk in clinic supervised by PCP. no call back was received. each day since the patient has tried to be contacted , even searching the internet for a different phone number, but to no avail. continued efforts will be made to reach the patient as best as possible.
3/11/21 Pt. states onset of SOB, morning after vaccine was given. "Can't take a deep breath." Pt. admits to vaping yesterday. Sent to ER 3/12/21 Right arm is red with rash today, per patient. She is using an Albuterol MDI.
possible cellulitis; redness; swelling; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 85-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Aug2023 as dose 1, single (Lot number: GT0538) at the age of 85 years, in right deltoid for immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "HTN" (unspecified if ongoing); "BPH" (unspecified if ongoing); "CVA" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Patient had no known drug allergy. The patient's concomitant medications were not reported. The following information was reported: CELLULITIS (intervention required, medically significant) with onset 26Aug2023, outcome "recovering", described as "possible cellulitis"; ERYTHEMA (intervention required) with onset 26Aug2023, outcome "recovering", described as "redness"; SWELLING (intervention required) with onset 26Aug2023, outcome "recovering". Therapeutic measures were taken as a result of cellulitis, erythema, swelling included Antibiotics. Additional information: The vaccine was administered in Doctor's office/urgent care. Patient did not receive any other vaccines on the same date. The report was reported as non-serious by reporter.  Causality for "possible cellulitis", "redness" and "swelling" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of administration with PREVNAR 20 in triggering the onset of possible cellulitis with erythema, swelling might not be fully excluded, considering the temporal relationship.  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
One episode of dizziness approx 36 hours after influenza vaccine injection followed by slow onset of red fine macular rash over trunk. Presented to clinic 2 days afer vaccination, given loratadine, rash resolved on 10-30-08.
scheduled by her Physician for blood work on Friday; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced scheduled by her physician for blood work on Friday. The patient underwent lab tests and procedures which included blood count: abnormal on unspecified date. The outcome of the event blood count abnormal was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
I have a Very sore left upper arm since my vaccine. My doctor said I have SIRVA.
rash that went up the front of her neck to her chin; soreness at the injection; her left eye became very red; both the left and right eye were itchy; developed itching on her neck, both arms, and face (primarily centered around the chin, nose area, and cheeks).; facial flushing; Tingling; Headache; Dizziness; Chills; feel like she had the flu; Body aches; This case was reported by a consumer via call center representative and described the occurrence of facial flushing in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On 30th October 2019, the patient received Boostrix (intramuscular). On 30th October 2019, less than an hour after receiving Boostrix, the patient experienced facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms and general body pain. On 31st October 2019, the patient experienced eye red, eye pruritus and pruritus. On an unknown date, the patient experienced rash and injection site pain. On an unknown date, the outcome of the facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms, general body pain and eye pruritus were unknown and the outcome of the eye red, rash and pruritus were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms, general body pain, eye red, rash, eye pruritus, pruritus and injection site pain to be related to Boostrix.  Additional details were provided as follows: At 10:00 am, the patient received Boostrix on left deltoid. It was reported that,within 45 minutes after receiving Boostrix, the patient experienced facial flushing, tingling, headache, dizziness, and chills. By the afternoon after receiving Boostrix, she experienced body aches which made her feel like she had the flu.  The next day, after receiving Boostrix, her left eye became very red and both the left and right eye were itchy. The left eye stayed red and itchy for a week while the right was intermittently itchy throughout the week. It was reported that, as the eye symptoms began to resolve, she started to develop a rash that went up the front of her neck to her chin and developed itching on her neck, both arms, and face (primarily centered around the chin, nose area, and cheeks). The patient also experienced soreness at the injection that lasted for a couple of days after receiving the Boostrix. The reporter did not consent to follow-up.  The reporter was unable to obtain additional information.
Cold sore on my lip; This case was reported by a consumer via interactive digital media and described the occurrence of cold sores lip in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown.   It was unknown if the reporter considered the cold sores lip to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient asked if having Shingrix shot could cause a cold sore on lip. The follow-up would not possible as no contact details were available.
She was given her first Pfizer COVID-19 vaccination and within 20 minutes she experienced a tight and swollen throat.; She was given her first Pfizer COVID-19 vaccination and within 20 minutes she experienced a tight and swollen throat; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 23Jul2021 (age at vaccination: 58-years) as dose 1, single for covid-19 immunisation. Patients medical history included anaphylaxis reactions from an unspecified date and un-known if ongoing (has a history of anaphylaxis reactions). Concomitant medications were not reported. On 23Jul2021, within 20 minutes of vaccination, she experienced a tight and swollen throat. She stated the symptoms were mild and that she had experienced anaphylaxis many times in the past and carries an EpiPen. She was observed in the clinic for worsening and she declined steroids. She never used her EpiPen and was sent home. The clinic advised her not to get the second vaccine. No treatment was given for the adverse events. The outcome of the events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
MOTHER OF PATIENT STATES SHE NOTICED RAISED BUMPS ON CHILDS TORSO AND EXTREMITIES APPROX. 2 HOURS POST VACCINATION. PATIENT WAS ACCOMPANIED BY FATHER AND TAKEN TO THE CLINIC TREATMENT AREA WHERE SHE WAS EXAMINED BY THE PEDIATRIC NURSE PRACTITIONER. AT THAT TIME THE FATHER TOLD THE RN ON DUTY THAT THE CHILD HAD AN APPOINTMENT WITH THE PROVIDER THAT MORNING FOR ONGOING COLD SYMPTOMS AND WEIGHT LOSS.  HOWEVER THEY MISSED THE APPOINTMENT AND WERE NOT SEEN. THE MOTHER THEN BROUGHT THE CHILD TO IMMUNIZATIONS TO SEE IF SHE NEEDED ANY SHOTS. I (IMMUNIZATION TECHNICIAN) TOLD MOP THAT THE CHILD WAS DUE FOR HER HEPATITIS B BOOSTER.  MOP FILLED OUT THE SAFETY QUESTIONNAIRE STATING THE CHILD WAS NOT SICK TODAY.  I THEN ADMNISTERED THE VACCINE.  WHEN THE PATIENT RETURNED TO THE CLINIC WITH HER FATHER SHE WAS PRESCRIBED BENADRYL AS A PRECAUTION AND SENT HOME.
While working in garden, notice two purple dot. No puncture, no itching,  no swelling,. Dot had lasted 3l lasted 3 weeks. Then four days after the shot, itching, oozing, blisters, rash, burning,  grew to 6in  by 2in  purple "road rash."  Went to  demetologist, Urgent care, ER within 4 days.  Follow up with with dermetologist.
outside recommended schedule; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number abxb2888, expiry date 20th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 19th July 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 19th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient  received a second dose of Bexsero outside recommended schedule the first dose was administrated on 12th July2021 and the second dose administrated on 19th July 2021,which led to shortening of vaccine schedule. The reporter reported that the side effect was not known. The reporter consent to follow up.