chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Customer has not received their second dose 3-4 months after getting first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Customer has not received their second dose 3-4 months after getting first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Customer has not received their second dose 3-4 months after getting first dose). In 2021, PRODUCT DOSE OMISSION ISSUE (Customer has not received their second dose 3-4 months after getting first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.   Reporter did not allow further contact
Patient is not 18 but was given the 1st dose of the vaccine.  She was observed for 1 hour with no apparent adverse effects.
This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (I got my first shot tuesday would it make me get my period earlier yhan usual) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (I got my first shot tuesday would it make me get my period earlier yhan usual). At the time of the report, MENSTRUATION IRREGULAR (I got my first shot tuesday would it make me get my period earlier yhan usual) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient treatment data was not provided. Reporter did not allow further contact
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies and concomitant medications were not reported. Between 23-AUG-2016 and 09-SEP-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L018351, expiry date 11-AUG-2017; dose and route were not reported). The doses were exposed to temperature of 33F for 20 minutes. There was also a previous excursion 2 days prior: temperature of 33F for 20 minutes. The data logger was involved. No adverse effects were reported. Additional information has been requested.
Resident at Rehabilitation facility was vaccinated by our team on 4/5/21 for what was presented as her second dose. Upon entry to department, it was determined that she had already had 2 doses (1/27/21 & 2/17/21). Spoke to Director of Nursing at the community and informed of the error and she stated patient has not experienced any adverse reaction.
Headache; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: 9269), via unspecified route of administration on 03Feb2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that later patient received the second dose of BNT162B2 (Lot number: EN6200) via unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization. On or around 18Feb2021, the patient experienced headache and tinnitus. It was reported that the headache came and went about a week and tinnitus has remained 24/7. Patient visited ENT specialist. Patient was recovered from headache on an unknown date and outcome of tinnitus was not recovered at the time of report.  Information about lot /Batch number is requested.
Patient called one day after receiving second SHINGRIX vaccine to report slight fever, chills, body aches, and injection site pain. Patient states that the adverse reactions are already improving. Advised patient to continue with pain reliever/fever reducer such as TYLENOL or ibuprofen and to apply ice to the injection site. Patient also reports feeling tingling in both feet that has improved to only slight tingling sensation in the left foot. Patient does report a history of peripheral neuropathy. Advised patient to contact physician if tingling does not continue to improve or if it worsens.
Describe the suspected adverse event. Such things as temperature, local and general signs and symptoms, time course, durations of symptoms diagnosis, treatment and recovery should be noted.  Approx 5 hours after administration the patient starting itching and then 2 hours later started breaking out in a rash & wheals. Rash/wheals are on her forearms, across top of chest, on her breast and abdomen. Few lesions on her back. Benadryl 25 mg eliminates itching for approx 4-6 hrs. She is not sure if the rash fades during that time.  No generalized sxs such as wheezing, dyspnea, dysphagia, tachycardia.  Has taken the Flu Shot annually without prior difficulty.
Pt's partner reported that she experienced pain running down her arm towards her wrist shortly after the immunization. She took ibuprofen & laid down. Later (about 2 hrs) she reported pain was worse, extending into neck and planned to seek medical attention.
Chills; headache; dizziness; pain in the arm; nausea; This is a spontaneous report from a contactable (patient, self-reported). A 57-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she experienced chills, headache, dizziness, pain in the arm, and nausea. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Day after shot (3/19/21) injection spot was red and hot to the touch, that lasted about 36 hrs.  Today, 3/26/21, injection spot now has a raised, bumpy, red rash that is very itchy. It is about 3 inches long and about 1 1/2 inches wide.
3-4 minutes post injection,  palpitations lasting 4-5 min, heart rate 150?s. chest tightness, all over body flushing, hot skin and flushing for 10 days. Palpitations every 3-5 days until sustained 40 minute episode with shortness of breath on March 19 went to Emergency room with heart racing, sinus tachycardia/ atrial tachycardia  150?s.. Having sporadic episodes since, getting better month by month. Episodes are 1 min to 20 minutes in length without any correlation to activity. Rates 110?s to 140?s with heart pounding.
Within 10 minutes of vaccination, client began having a metallic taste in her mouth, then states she "wasn't feeling right."  Client advanced to dizziness and acute onset of fatigue to the point of almost lethargic, started to complain of pain in back, radiating to from of chest and "feeling cold" with shaking all over.
12/23/21-Sore throat, nasal congestion, body aches, and cough since last night, worse today with aching eyes. Has not taken anything for his symptoms. No chronic health problem. Positive exposure to 2 persons with Covid. Had Covid Pfizer vaccines in April 2021, no booster as yet, no flu shot this year. Review of Systems  Constitutional: Negative for chills, fatigue and fever.  HENT: Positive for congestion and sore throat.   Respiratory: Positive for cough.   Musculoskeletal: Positive for myalgias.  Neurological: Negative for headaches.
Myocarditis with ventricular tachycardia, second degree heart block with chest pain.  Spent 8 days in Memorial Hospital on monitor and had a heart cath that showed no atherosclerosis.  Symptoms subsided with steroids.  CRP was an unheard of 190!
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 18-OCT-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
sick for 2 & 1/2 days after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 2 & 1/2 days after receiving the vaccine) in a 50-year-old female patient 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 13-Apr-2021, the patient experienced ILLNESS (sick for 2 & 1/2 days after receiving the vaccine). At the time of the report, ILLNESS (sick for 2 & 1/2 days after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 78-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed alopecia (hair loss), with outcome of unknown. Additional information: Reportedly, patient thinks it started in October or the first of October. Patient continued to explain she is losing her hair and she can't figure it out. She takes Biotin which helps for hair. She and her daughter both received the COVID-19 vaccine and both are experiencing hair loss. The lot number for batch/lot number not provided and will be requested during follow up. Sender's comments: Linked report: US-PFIZER INC-202200427816 (same reporter/drug/event, different patient).
prone to SVT and the A-Fib reaction; prone to SVT and the A-Fib reaction; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-MAY-2023, the patient received the 1st dose of Shingrix. On 30-MAY-2023, 21 days after receiving Shingrix, the patient experienced atrial fibrillation (Verbatim: prone to SVT and the A-Fib reaction) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). On an unknown date, the patient experienced supraventricular tachycardia (Verbatim: prone to SVT and the A-Fib reaction) (serious criteria hospitalization). The outcome of the atrial fibrillation was not resolved and the outcome of the supraventricular tachycardia was not reported.   It was unknown if the reporter considered the atrial fibrillation and supraventricular tachycardia to be related to Shingrix.     It was unknown if the company considered the atrial fibrillation and supraventricular tachycardia to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-AUG-2023 The patient self-reported this case. The patient was prone to supraventricular tachycardia and the atrial fibrillation. She had these reactions for first time. She was very reluctant to get the second dose of Shingrix due to the fear of atrial fibrillation. Reporter consented to follow up.
Per the patient's spouse and Hospital: The patient received a rapid COVID test at clinic prior to vaccination, which read negative.  The patient received vaccination on 2/23/21 and the following day (2/24/21) began to experience breathing difficulties.  The patient was admitted to the emergency room at Hospital on 2/26/21 and diagnosed with hypoxic respiratory failure d/t COVID-19 (oxygen saturation < 50%).  Patient was intubated on 3/2/21.  Per Hospital pharmacist, patient expired on 3/12/21 at 6:40pm.
has stuffy nose, without sinus congestion and no post nasal drip  symptoms associated with : severe fatigue, loss of appetite ( drinking good, eating fair) , severe headache upper posterior headache , severe nausea with out vomiting, mild generalize muscle pain with weakness or joint stiffness  1. mild dizziness with out passing out, worst with movement, use walker
Anaphylaxis - instant hives - lip swelling, itching, throat closing, nasal congestion within 5-10 minutes of administration. Treatment: BENADRYL, Epinephrine injection, Zyxal suspension.
Injection site (Left Deltoid) sore for a couple days, then developed redness at injection site, area warm to touch. Seen in office 10/06/14 and Dx: Cellulitis and given cephalexin and desloratadine as pt also had itchy throat which Dr felt was a reaction to the vaccine also. As of today 10/8/14 deltoid area is still red and warm but not as "bright" red as was before.
Received vaccination on 1/9/21 left arm at my place of employment as a Registered Nurse at Medical Center Woke up this morning 1/15/21 with painful swollen axillary lymph node left arm Reported to Occupational Health Nurse at work, who suggested I report this adverse affect to CDC Will monitor for a couple days and report back to Occupational Health
20 yo WF c/o dizziness and nausea 20 minutes after receiving her 2nd dose of Pfizer vaccine.  Patient stated she attempted to stand and got light headed. Staff member notified EMS and NP of the incident. Patient  was evaluated by on-site EMS and NP.  VS, BS initiated. Both were WNL. Patient has no PMH.  Patient stated she started her Period and bleeds heavy on the first day which could have trigger her dizziness. After about 15 minutes patient was reevaluated by NP and EMS. Patient stated she was  feeling and agreed to call family member to drive her home.
5-10 sec. seizure with loc eyes rolling back, drooling and extension of lower extremities. Tiredness followed x-4 hr-stat glucose W 20 81 EKG 1st degree A-V block. No tx given. Sent to ER where electrolytes + CBC were normal. BP 118/67 HR 77. RR 22. T=97.7 No evidence of infection process.
Varicella Vaccine given was expired for 3 days. Expiration date 04/16/04 and vaccination administered 04/19/04.  No adverse events noted.
This spontaneous report as received from a Licensed Practical Nurse refers to 2 unspecified patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On 10-MAR-2015, the patients were vaccinated with a dose of M-M-R II (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting nurse stated that the vaccines were reconstituted using an expired diluent (lot number: H015687 and expiration date: October 2014). The nurse also confirmed that the vaccines were not expired. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Dehydration, vomiting, headache, severe muscle pain, sneezing, coughing, bloating, nausea, fever, chills, increased asthma attacks. Onset of symptoms began 9 hours after vaccination, majority of symptoms lasted 3 days. Could not keep any food or water down the first day. Vomiting ceased after 24 hours. Muscle pain and bloating 4 days later. It felt like all illnesses combined into one.
cannot go to work or focus properly; covid-19 positive; insomnia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INSOMNIA (insomnia), DISTURBANCE IN ATTENTION (cannot go to work or focus properly) and SARS-COV-2 TEST POSITIVE (covid-19 positive) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 10-Jan-2021. Concurrent medical conditions included Hypertension since 03-Mar-1997 and Hyperlipidemia since 03-Mar-1997. Concomitant products included METOPROLOL from 03-Jan-2000 to an unknown date and FENOFIBRATE from 03-Jan-2000 to an unknown date for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced INSOMNIA (insomnia) and SARS-COV-2 TEST POSITIVE (covid-19 positive). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (cannot go to work or focus properly). At the time of the report, INSOMNIA (insomnia) and DISTURBANCE IN ATTENTION (cannot go to work or focus properly) had not resolved and SARS-COV-2 TEST POSITIVE (covid-19 positive) outcome was unknown.            More information during hospital admission included, Vipassana meditation for 15 minutes, Art of living meditation for 15 minutes, Walking 2 miles for 45 minutes, sit ups, arms swinging for 15 minutes. Treatment information not provided.  Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 positive and the product use is assessed as unlikely.  Event was most-likely pre-existing. The remaining events show temporal association with the use of mRNA-1273 and a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-077717 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow Up information received on 17-MAY-2021, Medical history added, concomitant medication added, Hospitalization details added.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 positive and the product use is assessed as unlikely.  Event was most-likely pre-existing. The remaining events show temporal association with the use of mRNA-1273 and a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-077717:First dose case
CLIENT STATES 3 HOURS AFTER RECIEVING VACCINE HE HAD A SEIZURE, WIFE IN ATTENDANCE AND LASTED ABOUT 30 MINUTES, HAS O2 SAT FINGER PROBE AT HOME AND SAT WAS 96 % BUT HEART RATE VIA MACHINE WAS IN 30 RANGE. HAD CHEST PAIN NON RADIATING. DID NOT SEEK MEDICAL ATTENTION UNTIL MONDAY, 3 DAYS AFTER VACCINE,THIS IS WHEN HE SAW HIS CARDIOLOGIST AND HAS ECHO ORDERED FOR 1 WEEK. HE ALSO HAS A MD APPOINTMENT WITH UROLOGIST FOR KIDNEY STONES. PULSE RATE WAS BACK TO 60 RANGE WITHIN 1 HOUR.
. Adverse effect of vaccine, initial encounter  T50.Z95A E949.9   2. Exacerbation of asthma, unspecified asthma severity, unspecified whether persistent  J45.901 493.92   3. Allergic rhinitis due to animal hair and dander  J30.81 477.2 montelukast (SINGULAIR) 10 mg tablet
Site: Pain at Injection Site-Medium, Additional Details: Patient states that her local site injection reaction of a sore arm is still lingering (11/27/21). Proper landmarks of immunization administration were performed and patient had zero complications upon administration of the vaccine. There is no ecchymosis, red streaking, welt or swelling of the extremity. Denies systemic effects.
COVID Positive Testing - Patient has received full vaccination but had a positive COVID screen on admission.  However subsequent testing demonstrated negative.  The patient is being treated as COVID positive but this diagnosis is somewhat suspect.  She is completely asymptomatic at this time and has had no symptoms to suggest active COVID infection
My daughter was given Kinrix, Flu, and ProQuad.  ProQuad was given subcutaneous on her right arm.  At the injection site her arm became swollen and turned reddish/purple and mottled the next day 10/12/12.  She complained that her arm hurt and wouldn't let anyone touch it.  On 10/14/12 on her left arm in the bend of her elbow she developed a petechial type rash, some spots darker than others.  The right arm remained swollen and mottled for 5 days and the petechial rash started to go away on 10/16/12 (2 days).  She had no other symptoms, no fever, or nausea, or loss of appetite. The majority of her discomfort was over the weekend and it didn't seem like an emergency because there were no other symptoms.  She didn't take any medication.  I called the physician's office on Tuesday 10/16/12.
Moderna COVID-19 Vaccine EUA  Twitching bottom lip, from approx 3:40pm - current (3:56pm)
At 12:30AM on the following day, my left arm woke me up due to pain and stiffness. It was not hot or swollen but when I tried to move I had the same kind of pain in all of my joints. By Friday, I could barely move to even go into the kitchen to get food. The lymph node under the left arms were swollen. The glands in my right breast were swollen. I also had a mild headache. By that Saturday, I could move better but everything was very achy and felt inflamed. The injection spot became sore a little bit and felt bruised if I bumped into anything. By that's Sunday, it was the kind of achy where it felt like I was getting over the flu but by Sunday I was fine. The swollen glands remained for about a week. I took liquid children's Tylenol throughout the day to treat my symptoms. I have completely recovered from this.
She received FLUARIX vaccine on 9/15/15 and by mistake another FLUARIX vaccine on 10/23/15. She has no symptoms - reporting for misadministration.
everything was all red; joints aching and his knees were aching; he had muscle pain and muscle soreness; headaches; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 09Feb2021, as DOSE 2,SINGLE for covid-19 immunization and  leflunomide via an unspecified route of administration, on an unspecified date, at an unspecified dose and frequency, for an unspecified indication. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. Historical vaccine included (PFIZER-BIONTECH COVID-19  VACCINE), on 20Jan2021, as DOSE 1,SINGLE for covid-19 immunization  and hand started swelling up , had aches and pains and stuff like that, hand got red, knuckles turned red and everything else, including his joints. On an unspecified date after second vaccination, the patient experienced everything was all red, joints aching, his knees were aching, and patient had muscle pain, headaches, and muscle soreness. The patient would like to know if the medication he is taking did anything to his immune system. The patient further reported that he had never had a real flare up as far as his rheumatoid arthritis. The outcome of the events headaches and muscle pain and muscle soreness was not recovered at time of report, while outcome of all other events were unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced tremor and back pain about 45 minutes after injection of pneumovax 23. Injection was given on 07/17/2019 and when patient report the event to the pharmacist at 07/24/19, all his adverse reaction had been resolved.
Tiredness, weakness, body aches, diarrhea, pain that moves through out the body.