chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fast heart rate 145 BPM after Eight hours of first shot; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate 145 BPM after Eight hours of first shot) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Fast heart rate 145 BPM after Eight hours of first shot). At the time of the report, HEART RATE INCREASED (Fast heart rate 145 BPM after Eight hours of first shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, Heart rate: 145 (High) had a fast heart rate 145 BPM. On an unknown date, Laboratory test: normal (normal) All tests with cardiologist came back normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that patient had no medical history of heart conditions. No concomitant medications were reported.  She visited a cardiologist and wore heart monitor for a while. All tests with cardiologist came back normal. Also her diagnosis remained fast heart rate.  No treatment medications were reported.   This case was linked to MOD-2022-475635 (Patient Link).
7/22/2021: previously vaccinated with COVID-19 Pfizer vaccine on 5/25/2021 and 6/15/2021. Presents to ED with cough and shortness of breath, fevers. and tested positive for COVID-19. Diagnosed with acute hypoxic respiratory failure, COVID-19 positive, COVID pneumonia 7/28/21: discharged.
I am having cognitive problems (Anaphase, Brain Fog, and memory etc. and other health related issues as well) associated with my Moderna Vaccinations and after having covid and after my booster shot.  I am currently under medical doctor of Neurology and have had a second appion from another medical doctor of MD Neurology.   It is not in my best interest to keep getting boosters when each time I have more stroke- like problems as mentioned above.    Past tests.  I have lots of blood work done.  CAT Scan clear and normal.  Spinal Tap normal, EEG done.
Pain at armpit on the same injection site; This spontaneous case was reported by a consumer and describes the occurrence of APPLICATION SITE PAIN (Pain at armpit on the same injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Aug-2021, the patient experienced APPLICATION SITE PAIN (Pain at armpit on the same injection site). At the time of the report, APPLICATION SITE PAIN (Pain at armpit on the same injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided.   Treatment information was not  provided.   Reporter did not allow further contact
Vial of Moderna went past 30 day at 2-8 degree Celsius; Received past its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vial of Moderna went past 30 day at 2-8 degree Celsius) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 9:21 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 9:21 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial of Moderna went past 30 day at 2-8 degree Celsius). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vial of Moderna went past 30 day at 2-8 degree Celsius) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  A series of patients approximately 540 patients received lot 066H21A past its 30-day expiry date. Vaccines went into 2-8 c thaw state on or above 24-Dec-2021. This vaccine was administered up until its manufacturer expiry date of 04-Apr-2022.  No treatment medications were provided.
I started to experience diffuse joint pain and stiffness approximately a week to 10 days after vaccination.  I am experiencing pain with walking after being at rest for even short periods of time. These symptoms get a little better the more active I am throughout the day but worsen during the night while I am in bed. I also have intermittent tingling in my hands along with pain and stiffness in my fingers  and hands and knees especially throughout the day
This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On an unknown date the patient was vaccinated with MMR II (dose, route, lot# not reported). No concomitant medications were reported. It was reported that the MMR II was exposed to 20.5 degree Celsius for 2.5 hours and may have been administered to patients and no adverse effects reported. PQC was not involved. This is one of the 3 report reported by the same reporter (1405USA009701, 1405USA009072). Additional information has been requested.
higher glucose levels/glucose has gone up 15-30 points.; This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE INCREASED (higher glucose levels/glucose has gone up 15-30 points.) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Pre-diabetic.    On 16-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In May 2022, the patient experienced BLOOD GLUCOSE INCREASED (higher glucose levels/glucose has gone up 15-30 points.). At the time of the report, BLOOD GLUCOSE INCREASED (higher glucose levels/glucose has gone up 15-30 points.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Blood glucose: high (High) Glucose has gone up 15-30 points. On an unknown date, Blood glucose: 120 (Borderline) 120 (prediabetic).     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Patient received the first Moderna COVID-19 vaccination on Monday.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-570138 (Patient Link).   Reporter did not allow further contact
Initial case received from a health care professional on 15 November 2013. A 52 years old patient had medical history of reflux disease and had allergies to penicillin, sulfa drugs, peanuts, walnuts, pine nuts, shellfish, received a dose of FLUZONE ID intradermally in right deltoid on 11 November 2013 (Batch number UT4719BA). Patient had not reported concomitant medication. It was reported that on 11 November 2013 patient had experienced pain, redness and swelling at injected site. No corrective treatment was reported. At the time of report the outcome of event was not recovered.
Patient has not had an adverse reaction to the vaccines. I contacted Agency and was advised to report the incident through VAERS reporting system. Pateint had previous received the Tdap and MENACTRA at his last check up.
patient received an extra dose of Fluarix by accident; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 24-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 7Z423, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 27-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season. On 27-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: patient received an extra dose of Fluarix by accident). The outcome of the extra dose administered 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 Information: GSK receipt date: 27-OCT-2023 The medical assistant stated that a patient received an extra dose of Fluarix by accident (October 18 and today), which led to extra dose administered. The reporter did not consent to follow-up.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001853 is a spontaneous case report initially received from a nurse via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (fourth out of nine).  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided) intramuscularly (IM), at an unknown dose or site of administration, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').  At the time of this report, it was unknown whether the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Aug-2022 included the country of occurrence.  Additional information received from Bavarian Nordic on 12-Aug-2022 included the local case ID.  This case is linked with cases no.  US-BN-2022-001839, US-BN-2022-001851, US-BN-2022-001852, US-BN-2022-001854, US-BN-2022-001855, US-BN-2022-001856, US-BN-2022-001857 and US-BN-2022-001858, concerning the same reporter.; Reporter's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
lethargic, sleepy, soreness of lt arm, dizziness, lt shoulder & neck, head & ear sore;cont x2 more days;
This spontaneous report a 64 year old female consumer refers to herself who was allergic to Sulfa and erythromycin with no pertinent medical history. The patient was vaccinated intramuscularly with ZOSTAVAX (lot number not reported) in fall 2011. No other co-suspects were reported. Concomitant medications included "LABOXOL" and lisinopril. The pharmacy near her home gave her the ZOSTAVAX intramuscularly (or IM) instead of subcutaneous. Her arm started bleeding right away and the pain began right away and it did something to her arm muscles. The patient had sought unspecified medical attention. No treatment or any laboratory diagnostics study was given. The outcome of bleeding, it did something to her arm muscles and pain was reported as recovered/resolved in September 2012. Additional information has been requested.
I immediately had swollen lymph nodes under my armpits for about 4-5 days and then about a week later, I began noticing chest pains. I am still having them a few times per day. I would have reported sooner but I wasn't aware that the pains were a possible side effect.
severe joint pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported having severe joint pain and she was questioning if she should get the second dose of the vaccine. The second dose is scheduled for 28Jan2021. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
04OCT89 pt vax 2nd hepta B; devel stomach cramps, queasiness, n/ & vomited 3x.  Tx w/pres. drug.
pt says she started loosing hair the day after taking the vax.  (she had Covid in January 2021) pt says she has lost more than half of her hair.  she says most of it comes out when shampooing.  Pt contacted a PCP.  They ordered her to have a thyroid test which she is currently waiting on the orders to come in the mail.
Patient had 2 doses of Moderna Covid vaccine from another facility.  Patient came in for a booster shot and Pfizer was given.  Patient says he had fever and dizziness for 2 days after the shot.
Had elevated heart rate shortly after receiving booster with no prior experiences.  BPM of 160 when walking from sleep.  Multiple trips to ER. Doctor follow ups.  Have not had anything to help.   Had two prior vaccinations with minimal side effects.  2 years later,  and I still experience periodic elevated heart rate.
start time 03:00 am 12/29/2020:  headache, neck pain, fatigue, injection site pain  - treating with over the counter ibuprofen and rest
Vials were dropped; 3-6-2021 expiration on vial; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT PHYSICAL ISSUE (Vials were dropped) and PRODUCT EXPIRATION DATE ISSUE (3-6-2021 expiration on vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0028218) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Mar-2021, the patient experienced PRODUCT PHYSICAL ISSUE (Vials were dropped) and PRODUCT EXPIRATION DATE ISSUE (3-6-2021 expiration on vial). At the time of the report, PRODUCT PHYSICAL ISSUE (Vials were dropped) and PRODUCT EXPIRATION DATE ISSUE (3-6-2021 expiration on vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Director of Nursing stated they held Covid Clinic on 2-6-2021 and administered 300 vaccines. Director stated that during preparation one of the vials were dropped and 75% frozen. Director stated that they returned vial to refrigerator. Director wants to know can they still use vial. Consent to email and call.
Negative Hepatitis B Antibodies; Hepatitis B Antigen of 41; Initial Report Received on 10-May-2023  A registered nurse reported that a 28-year-old female patient (race and ethnicity unknown) had a needle stick, then received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization per protocol, and had a positive hepatitis B antigen titer the next day.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had an allergy to amoxicillin (throat swelling and vomiting).  On 06-May-2023, the patient had a needlestick. Per protocol, on 07-May-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 941584; expiration date 31-Jan-2025, NDC # unknown) intramuscularly in the left deltoid. On 08-May-2023, the patient had a hepatitis B titer that showed a hepatitis B antigen of 41, and negative for Hepatitis B antibodies. No adverse effects were reported by the patient.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Severe localized reaction Red, erythemic entire upper arm, deltoid to elbow No c/o arthralgia
Patient states red rash developed 24 hrs. after vaccine given. Rash 4 1/2 long X 6 1/2 wide. Sick feeling, fever; joint pain, nausea, starting 36 hours after immunization. Motrin 600 mg every 8 hrs. taken by patient to treat symptoms, along with ZYRTEC. Ice to site.  All but rash subsided in 24 hrs. with some lagging symptoms.
Sudden onset of a very painful and tender scalp; mostly located on the right side of the head.  The scalp, neck, and chest became bright red.  The scalp was extremely painful.  For treatment, I took Tylenol with diphenhydramine (Tylenol PM). Upon waking in the morning, the redness has subsided and the scalp is only mildly tender.  It is currently 11:30 AM and the scalp is still mildly tender.
Generalized itchy rash in entire body the night after MMR injection on 2/25/08.
Information has been received from Sanofi Pasteur MSD (MFR # DE-1577272925-E2015-05044) on 13-MAY-2015. Case was received from a physician on 12-MAY-2015. Case is medically confirmed. A male patient received the complete immunisations series with three doses of ROTATEQ orally starting at the age of seven weeks on 09-APR-2013 (D1, lot#. J000051, expiry: 30-SEP-2014), on 10-MAY-2013 (D2, lot # J000051, expiry: 30-SEP-2014) and on 14-JUN-2013 (D3, lot #. J000554, expiry: 30-SEP-2014). One and a half year later at the age of 2 years, on 01-MAY-2015, the patient developed diarrhea. On 03-MAY-2015 during the night he additionally developed recurrent vomiting. On the next day, on 04-MAY-2015, he was presented to emergency room due to vomiting and reduced general condition. He was hospitalised on that day. On admission physical investigation revealed slightly reduced turgor, dry mucous membranes and slightly reddened pharynx. Laboratory test results: 04-MAY-2015: pH: 7.32, Carbon dioxide partial pressure (pCO2): 3.59 Hydrogencarbonate (HCO3): 16.1, Base excess: 11.2, CRP: 32.4. Urine- acetone: +++ (positive) (check up showed normal results), blood gases analysis: pH: 7.38, Base excess: -8.6, potassium: 2.7, potassium (serum): 2.68. Check up on 05-MAY-2015: pH: 7.38, Base excess: -5.9, potassium: 3.21. Check up on 05-MAY-2015, 06:00 pm: potassium: normal. The patient was treated with infusion therapy consisting of sodium chloride 0.9% and glucose-electrolytes mixture with potassium supplementary. Stool test was positive for rotavirus. Following diagnoses were established: rotavirus gastroenteritis, hypokalaemia, food refusal, vomiting and acetonuria. On 07-MAY-2015 the patient was discharged in good general condition.
MENVEO inj given: 7/20/2011 later redness, fainted 7/21; MENVEO IM in Right arm Lot # 10053 Novartis VIS: 1/28/08. Red, hot, tender 7 3/4 cm x 5 cm (R) arm, no pruritus.
Numb; Tingly; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb) and PARAESTHESIA (Tingly) 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, the patient experienced HYPOAESTHESIA (Numb) and PARAESTHESIA (Tingly). At the time of the report, HYPOAESTHESIA (Numb) and PARAESTHESIA (Tingly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. No concomitant medication were provided.
Patient presented to hematology clinic to discuss surveillance labs.  He was found to have creatinine of 4.27, up from 1.06 just 4 days prior.  Other pertinent labs include calcium of 8.6, BUN 54, uric acid 9.2.  CBC relatively stable from priors.  LDH 201. Liver labs unremarkable.  He could not remember the last time he urinated.  He felt lightheaded with 5 falls yesterday.  He was transferred to inpatient care for further evaluation of his kidneys.  Patient found to be COVID positive upon admission.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 15:30 as dose 1, single (Lot number: EP7534), in right arm and on 06Apr2021 as dose 2, single (Lot number: ER8737) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 939905), in right arm and on 16Jun2022 at 16:00 as dose 4 (booster), single (Lot number: 048L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "no smoking" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jul2022, outcome "recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (04Aug2022) Negative, notes: I've tested Negative for covid today. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID-19 treatment with Antiviral Paxlovid (Lot: 1918528A) from 29Jul2022 to 03Aug2022. Patient had just turned 65 and was very healthy and active. No smoking, drinking or drugs. No known allergies. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201038139 Same patient, different product and event;
12/30/13 Rash, redness, soreness, at injection site 24 hrs after receiving shingles shot on left arm. Arm still sore after 1 month of shot. Hoarseness of voice also. 1/31/14 Rash, redness, warmth, soreness at injection site after pneumonia shot. Arm slightly sore from shingles.