chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old administered Moderna COVID-19 vaccine (1st dose in the series); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old administered Moderna COVID-19 vaccine (1st dose in the series)) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old administered Moderna COVID-19 vaccine (1st dose in the series)). On 09-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old administered Moderna COVID-19 vaccine (1st dose in the series)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided. The reporter reported that the patient was coming on Friday for the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 Jul 2021 and does not contain new information.
Patient developed urticaria over entire body, fever to 102, lethargy about 4 days following MMR vaccination. Lasted approximately 48 hours.
Patient developed an erythematous rash across lower abdomen that spread to back, arms and legs. Somewhat itchy and vesicular.
SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test (nucleic acid amplification test) performed on 7/25/21. Done at a pharmacy most likely. Came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
Fever, sever upset stomach, diarrhea, running nose, sore throat, lack of appetite, over all discomfort.
injection site pain left and right arms beginning two hours after injection and worsening over the next 24 hours before gradually decreasing.  Pain was worse in left arm versus right.  Headache and chills around 3 AM the following morning post injection resolved within 3 hours.  Significant right shoulder joint pain at 3 AM approximately 39 hours post injection.  Pain was not relieved with 600mg Ibuprofen, stretching or postural changes.  Pain eventually resolved spontaneously after about 2 hours.
NUMBNESS AND FLUSH FEELING ON ADMINISTRATION, THEN PAIN IN SHOULDER, LIMITED MOBILITY-CURRENTLY 3 WEEKS LATER, OFFICE APPT WITH MD TODAY 11/3/14 WHO STATED I HAVE A FROZEN SHOULDER, PRESCRIBED ANTIINFLAMMITORIES AND EXERCISES, IF NOT BETTER IN 3 WEEKS I HAVE TO HAVE AN X-RAY.
When pt's mother was contacted we found out pt had a rash reaction to the shot on chest and face and needed treatment.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 19th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There were 13, 11, and 6 different doses were given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:master case
Redness extending from the injection site in the left deltoid down to the elbow on lateral side of upper arm. Lump 68mm in diameter and warm to touch.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 07-NOV-2012 20:28, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
15min post vax pt lt deltoid pain down lt arm to hand x 1 1/2 day the aching intermittently diff lt arm until present;weakness lt arm;unable to raise lt arm above head w/o discomfort;seen by MD x2;
Right after adminstration, patient started feeling light headed and passed out and had a blank seizure which lasted for about a few seconds. He had 2 back to back within one minute.
ITCHING AND RASH ALL OVER BODY WITH RED UNDERTONES. SOME SHORTNESS OF BREATH. PT STATES, "I TOOK SOME BENADRYL ONCE THE SYMPTOMS STARTED." PT CAME BACK TO THE MEDICAL CENTER ON 2/29/2012 STATED SHE HAD THE ITCHING, RASH ALL OVER BODY AND SHORTNESS OF BREATH THE NIGHT BEFORE. SHE ALSO STATED, "I'M STILL HAVING ITCHING AT THE SITE. THE SITE HAS SOME LOCALIZE SWELLING. PT SAW PHYSICIAN ASSISTANT WHO ORDERED MEDICATION AND CONSULTED TO IMMUNOLOGY.
Several hours after receiving the vaccination, I became fatigued and sore with muscle aches in the arm of the vaccine site. That night I woke up with moderate body aches and chills and a dull headache, no fever. The next morning, I awoke feeling very fatigued, severe muscle/body aches, headache and chills, still no fever. I slept most of the day. Extra strength Tylenol helped tremendously with the body aches. I was symptom free the morning of 1/15/2021. I was scheduled to work the day after my vaccination and was unable to due to the symptoms described.  I had no adverse reactions with my first dose.  I am a nursing mother and for the first and second doses, I noticed no side effects or any concerns with my child or milk supply.
Has negative titers for MMR II; This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug allergy/reactions were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route, lot/ batch #, expiration date were not reported) for prophylaxis. It was also reported that no additional doses were administered.  On 30-AUG-2019, the patient had negative titers for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (hepatitis b surface antibody negative). No product quality complaint was involved. The outcome of hepatitis b surface antibody negative was unknown. The reporter's causality assessment was not reported.
Patient complained of itching; experienced fever of 102 degrees F; left arm swollen and hot; anxiousness.
Headache, Myalgia, Arthralgia, Fever, chills, fatigue Narrative: Employee reports feeling "feverish", experiencing chills, muscle aches, joint pain, headaches , and injection site pain/discomfort.
4 foci of avidity (SUVmax, 3.2) in the left axilla localizing to mildly enlarged; This is a literature report for the following literature source(s).  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "surgery for prostate cancer" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (medically significant), outcome "unknown", described as "4 foci of avidity (SUVmax, 3.2) in the left axilla localizing to mildly enlarged". The patient underwent the following laboratory tests and procedures: Computerised tomogram: images show avidity localizing 4 mildly enlarged, notes: but morphologically normal lymph nodes (arrows). Remaining images (not shown) confirmed no other sites of potentially pathologic radiotracer avidity; SUV mean: 3.2; 3.5; Negative; Pathology test: revealed a Gleason score of 7 (3 1 4) with, notes: evidence of perineural invasion and 1 of 5 local lymph nodes positive for spread; Positron emission tomogram: it is to be expected that, as with 18F-FDG,, notes: low-grade avidity by axillary nodes will be a potential finding, after COVID-19 vaccination; examination revealed 4 foci of avidity (SUVmax,, notes: 3.2) in the left axilla localizing to mildly enlarged but morphologically normal lymph nodes; Prostatic specific antigen: 1.0 ng/ml; undetectable, notes: at 6 mo, confirming the benign nature of the uptake and the absence of residual malignancy; undetectable, notes: at 9 mo, confirming the benign nature of the uptake and the absence of residual malignancy.; Sender's Comments: Based on the temporal relation, the association between the event of lymphadenopathy and the suspect product cannot be completely ruled out. 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.
The pt received vax's on 8/27/01. On 9/5/01 the child's mother called on symptoms child was experiencing. The child experienced a fever and rash on trunk characterized pox-like eruptions. Upon follow up the pox began to scab over and dry up. Pox were on trunk only.
Was not feeling well on 11/10/22 low grade fever, clogged ear and dry cough and went to walk in clinic and tested positive. Took OTC meds to dry up sinus and ear. Symptoms began improving instantly and seemed mostly resolved by 11/14.
patient noted soreness in the arm the day off (11/10) during the evening, swelling to the size of a baseball.  But by saturday morning (11/11) the swelling had moved moved down her arm towards her elbow (residing just above the elbow crease under the bicept) and had brusing (approxamately 3x5 inches) and was warm and tender to the touch. Patient came into the pharmacy Sunday 11/12 and stated brusing was slightly lightening and this reporter observed the brusing, no obvious inflamation. Patient reported during the day her arm (above the brusing) has started lightly itching. Patient stated she obtained her vaccination in the standing position
I tested positive for covid on April 14th; I tested positive for covid on April 14th; shakiness; brain fog; I've been unable to work, drive, or generally function normally for 2 weeks now and feel worse than ever; sinus congestion and pain; sneezing; coughing; sinus congestion and pain; headache; Fatigue; low fevers in the afternoons (99.7-100.8).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Shellfish" (unspecified if ongoing); "most fruits" (unspecified if ongoing); "pollen" (unspecified if ongoing); "ragweed" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY; FLONASE ALLERGY RELIEF; SUDAFED 12 HOUR; LEXAPRO. Past drug history included: Vegetables pollen, reaction(s): "Allergy", notes: Shellfish most fruits some vegetables pollen ragweed pet dander. The following information was reported: FATIGUE (non-serious) with onset 25Apr2022 at 13:00, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Apr2022 at 13:00, outcome "not recovered" and all described as "I tested positive for covid on April 14th"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 25Apr2022 at 13:00, outcome "not recovered", described as "I've been unable to work, drive, or generally function normally for 2 weeks now and feel worse than ever"; FEELING ABNORMAL (non-serious) with onset 25Apr2022 at 13:00, outcome "not recovered", described as "brain fog"; COUGH (non-serious) with onset 25Apr2022 at 13:00, outcome "not recovered", described as "coughing"; HEADACHE (non-serious) with onset 25Apr2022 at 13:00, outcome "not recovered"; PYREXIA (non-serious) with onset 25Apr2022 at 13:00, outcome "not recovered", described as "low fevers in the afternoons (99.7-100.8)."; TREMOR (non-serious) with onset 25Apr2022 at 13:00, outcome "not recovered", described as "shakiness"; SINUS PAIN (non-serious), SINUS CONGESTION (non-serious) all with onset 25Apr2022 at 13:00, outcome "not recovered" and all described as "sinus congestion and pain"; SNEEZING (non-serious) with onset 25Apr2022 at 13:00, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Apr2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: On April 25th, for ongoing fatigue and brain fog patient recommended continuing rest, vitamins, fluids. COVID 19 Treatment started on 14Apr2022 and stopped on 19Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever increased 103 on 8/10/11. Immunizations administered 8/8/11.
Redness, swelling at injection site 24hrs after vaccination. Five days later, non tender, dime size lump at injection site noticed.
Dizziness, Headache, fatigue, sweats, sore arm Narrative:
pt recv vax & devel deep pain @ the inj site;pt also devel striations of infect radiating from he inj site to the neck & elbow;
rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) (batch number NB9D3, expiry date 16th April 2022) for prophylaxis.   On 1st September 2020, the patient received Shingrix. On 2nd September 2020, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The batc number was updated from NB903 to NB9D3, as per sales data sheet. The patient experienced rash after receiving Shingrix the following day. The reporter did not consent to follow up. The HCP was in a hurry and provided a few details of the case. This case linked with US2020182653, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020182653:same reporter
felt terribly sick/ really sick; ached all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt terribly sick/ really sick"; PAIN (non-serious), outcome "unknown", described as "ached all over". Additional information: The patient's age was "85" (unit not reported). The patient has been in bed the whole time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient claims presenting red spots on his back. No fever, itching or pain. (9/11/2020)
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient said she felt dizzy, hot, weak, lightheaded about 5-10 mins post vaccination. Her hands were shaking and she looked sweaty. This lasted about 5 minutes. She remainded seated a while longer, then said she felt better and left.
Had seizures and ended up in emergency room; Had seizures and ended up in emergency room; scar in left arm/scar in his left arm before he had a seizure; 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble; This is a spontaneous report from a contactable consumer (parent). A 40-year-old male patient received the second dose of BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 (at the age of 40-year-old) as single dose indicated to prevent from Corona virus (Covid-19 Immunization). Medical history included seizures and gout. The patient's concomitant medications included unspecified medication for seizures. The patient previously received the first dose of BNT162B2 (lot number: ER8730) on 24Mar2021 for Covid-19 Immunization. The patient got the second Pfizer shot later this month, left the office, 45 minutes later (on 14Apr2021) he had seizures and ended up in emergency room. He has had small seizures but they are not back to back, of and on throughout the years and now we are saying that maybe COVID Vaccine shot is what provoked him to, what made him had seizures. Reporter stated, even though he has had seizures in the past like it could be 2, 3 years apart for one. But the shot it caused him to have another seizure, but he is not going to continue to have seizures, as he is on medication (unspecified medication) right now. But the medication is on, if they take him off it, he could have multiple seizures constantly (name of medication not clarified further). Also on 14Apr2021, the patient also had a scar in left arm, it is another symptom he had. He had the scar in his left arm before he had a seizure, he said over here between his heart and his arm felt like a (incomplete sentence), now they don't know if he had a one scar or what it says but he says that 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble' (not clarified further).  The patient underwent laboratory test which included: blood work, a urine sample and they did a CAT scan to see knowing the problem in his brain, all on 14Apr2021 with unknown result. The day of the test was on the 14th, it would have been on a Wednesday. It was the same day that he got the second shot. So, he had these test done on 14Apr (14Apr2021). Reporter confirmed of getting the test results on Thursday, so did not have the details. Therapeutic measures were taken as a result of seizures which included Levetiracetam 500 mg tablet, he takes one tablet twice a day, so he takes two tablets a day. This was ordered by his doctor in emergency room. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Bursitis; Skin disorder, skin problem; Upper extremity dysfunction, hand problem; Blisters; Infection; Foot infection; Blood pressure high; Psoriasis flare-up/ breaking out with psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis), SKIN DISORDER (Skin disorder, skin problem), MUSCULOSKELETAL DISORDER (Upper extremity dysfunction, hand problem), BLISTER (Blisters) and INFECTION (Infection) in an 86-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.    Co-suspect product included non-company product  (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2022, the patient experienced PSORIASIS (Psoriasis flare-up/ breaking out with psoriasis). On an unknown date, the patient experienced BURSITIS (Bursitis), SKIN DISORDER (Skin disorder, skin problem), MUSCULOSKELETAL DISORDER (Upper extremity dysfunction, hand problem), BLISTER (Blisters), INFECTION (Infection), LOCALISED INFECTION (Foot infection) and HYPERTENSION (Blood pressure high). At the time of the report, BURSITIS (Bursitis), SKIN DISORDER (Skin disorder, skin problem), MUSCULOSKELETAL DISORDER (Upper extremity dysfunction, hand problem), BLISTER (Blisters), INFECTION (Infection), PSORIASIS (Psoriasis flare-up/ breaking out with psoriasis), LOCALISED INFECTION (Foot infection) and HYPERTENSION (Blood pressure high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High.         No concomitant medications were reported.      No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2022: Follow-up received wherein event psoriasis updated to psoriasis flare-up as well as reporter's causality and newevent (blood pressure high) added. Lab test added. Dose description of co suspect and narrative description updated.