chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site was warm a few days after receiving the vaccine; warm to touch on arm at site of injection; Some redness has developed in the arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Site was warm a few days after receiving the vaccine; warm to touch on arm at site of injection) and VACCINATION SITE ERYTHEMA (Some redness has developed in the arm at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Latex allergy. Concomitant products included GLIPIZIDE, LEVOTHYROXINE SODIUM (SYNTHROID), FENOFIBRATE and LOSARTAN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (Site was warm a few days after receiving the vaccine; warm to touch on arm at site of injection) and VACCINATION SITE ERYTHEMA (Some redness has developed in the arm at the injection site). On 27-Jan-2021, VACCINATION SITE WARMTH (Site was warm a few days after receiving the vaccine; warm to touch on arm at site of injection) and VACCINATION SITE ERYTHEMA (Some redness has developed in the arm at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information included antihistamine and ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up received on 13-Apr-2021 included no new information. On 14-Jun-2021: New information included concomitant products.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Soreness from injection left arm subsided after a day Bad Migraine next day - Migraines / headaches are chronic condition already prescribed meds helped Mouth sores - still experiencing Mild sore throat - still experiencing
Late 2nd dose/ went to receive the 2nd dose of Shingrix, but it had passed at least one year after 1st dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received at least one year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose/ went to receive the 2nd dose of Shingrix, but it had passed at least one year after 1st dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-MAY-2023 The reporter called and reported that the patient went to receive 2nd dose of Shingrix, but it had passed at least one year after the 1st dose of the Shingrix. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Symptom onset was 7/16/21; symptoms included cough, shortness of breath, congestion, wheezing, headache, fatigue, myalgia. Case was treated with prescription inhaler, Z-pak and Mucinex. Admitted to Hospital from 7/19/21 to 7/25/21. (Covid vaccination dates were 2/23/21 and 3/20/21),
MILD RINGING SOUND IN LEFT EAR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 13:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced mild ringing sound in left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild ringing sound in left ear was not reported. This report was non-serious.
Patient received Pneumovax 23 vaccine IM to right deltoid on 03/24/09.  On 03/25/09 he presented with progressive painful swelling and erythema at the site of vaccination that he stated developed approximately one hour after vaccine administration.  At the time of the 03/25/09 office visit he had a 19 inch x 14 inch area of induration and swelling that was warm to touch, tender and erythematous consistent with cellulitis.  The patient was already on day 2 of 7 of Avelox 400 mg Qday for an unrelated respiratory infection (AECB), and line of erythema was drawn with instructions to seek urgent medical attention of the line of erythema advanced.  He presented to the ER on 03/26/09 and was admitted.  During hospitalization he was placed on IV Vancomycin.  He was discharged on 03/27/09 with Rx for PO TMP-SMX DS.4/13/09-records received-DC DX: right upper extremity erythema with swelling, possible cellulitis verus reaction from Pneumovax vaccine. Recent cough and some mild shortness of breath. Bronchitis
Around Oct 17th 2009 started feeling weakness, tiredness, short of breath, sleepless nights; thought it was just cold related symptoms - took NYQUIL-DAYQUIL-TYLENOL.
Discussed usual side effect to Shingrix Ice to area Keep an eye on effected area.
adverse event that occurred 8-10 days after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse event that occurred 8-10 days after receiving vaccine) in a female patient of an unknown age 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) at an unspecified dose. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ADVERSE EVENT (adverse event that occurred 8-10 days after receiving vaccine). At the time of the report, ADVERSE EVENT (adverse event that occurred 8-10 days after receiving vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: NNI , patient wants to cooperate but not comfortable releasing her medical health records to unknown third party, seeking advice from Moderna; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
No actual adverse event - patient received his first dose of moderna at a clinic when he shouldn't have because he was underage.  We completed series because no one would give him Pfizer since he had Moderna already and no where else would give him his Moderna 2nd dose because he was underage.  His primary care provider is aware and we decided it was the best course of action to take for the patient so he could complete his COVID vaccine series.
Information has been received from physician concerning a 47 year old male with codeine allergy and a history of pneumonia who on 10-MAY-2007 was vaccinated intramuscularly with Pneumovax 23, (Lot # 654977/0888F). There was no concomitant medication at the time of vaccination. On Approximately 10-MAY-2007, around 3 hours post vaccination the patient reported pain in his upper arm. He was seen again two days later by another physician in the same practice and reported that the pain had not resolved. He was treated with "nambumetone" and PERCOCET. The pain continued and the patient was seen again six days post vaccination. He was then referred to an orthopedist who ordered and magnetic resonance imaging (MRI) that was positive for shoulder joint effusion. The orthopedist changed the patient's treatment to indomethacin. The patient had reported some pain relief and increased mobility since the medication was changed. Subsequently the patient was recovering. The reported considered shoulder joint effusion to be disabling. Additional information has been requested.
Patient complains of shaky hands and wrists when writing after getting her second dose. Advised to follow up with Primary Care Provider.
After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; This is a spontaneous report from a contactable consumer (patient).   A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Right on 01Feb2021 12:00 (at the age of 78-year-old) as 1st dose, single for COVID-19 immunisation. Medical history was none and no known allergies. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive any other vaccines within four weeks. Post vaccination, the patient had not been tested for COVID. After the first vaccination in Feb2021, the patient was down for 4 days with achy body, tiredness, fever and chills. The outcome of the events was unknown.  Follow-up attempts possible. No further information expected.
Patient received the vaccine in the vaccination room and was instructed to wait 15 minutes to monitor for a reaction. The pharmacist returned to the pharmacy and shortly after was notified by another customer that someone had fallen down. The pharmacist arrived at the aisle to find the person laying on floor  unconscious. The patient quickly regained consciousness and had no breathing or swelling. He was assisted to a chair and was responsive to questions. A few minutes later, he lost consciousness again and emergency services were contacted. He was taken to the hospital.
Patient inadvertently received the BIVALENT Pfizer product instead of the intended MONOVALENT Pfizer product for dose 1 of her COVID-19 series.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patient were vaccinated with doses of PNEUMOVAX 23 (dose and lot # not reported) after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
just felt like having the flu; Cold; Throbbing headache; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA, NASOPHARYNGITIS, HEADACHE, and NAUSEA in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced INFLUENZA, NASOPHARYNGITIS, HEADACHE, and NAUSEA. The patient was treated with TYLENOL at an unspecified dose and frequency. On 10-Nov-2021, INFLUENZA, NASOPHARYNGITIS, HEADACHE, and NAUSEA had resolved.            No concomitant medications were reported.
Patient reports pain in the arm of the shot and in that same shoulder. She states the pain goes from the shoulder to the front of her body and it hurts to move her arm. She says that she did not have any side effects from the first 2 Moderna shots she received. She states having no other symptoms from this booster shot (no fever, chills, etc). She had not tried to take anything yet, so I told her to try some ibuprofen and keep me updated if that doesn't work or if she starts having any other side effects.
Mother states client woke up from a nap around 4pm the same day of vaccination and his legs were stiff and he was screaming in pain.  Mom states she took him to the ER and the dr stated it was related to the pain of the injection.  His pain was more in his right leg than his left.  The ER dr told mom to continue motrin or tylenol for pain as needed.
Extremely painful period.  Never had painful periods before, now my back hurts so bad. My stomach. Worst period I?ve had. And came early. In April and now  happening again in May
This spontaneous case, initially received from the other non-health care professional on 06-Dec-2017 and concerns a 29-year-old adult female patient. On unspecified date in 2013, the patient was administered with FLUVIRIN, dose: 0.5ml, route of administration: intramuscular, anatomical location: arm, batch number: 13444P (as reported), expiry date: not reported). On unspecified date in 2013 after vaccination, the patient's whole side of the face was became puffy. It was unknown to the reporter, how soon the symptom began after the vaccine. Subsequently on an unspecified date in 2013, the patient recovered from the event. The reporter assessed this case as non-serious. Follow-up for this case is not being sought as reporter information is not available. Hence the case was lost to follow-up.
Patient got both shots in her left arm and now she can no longer lift her left arm. She went to the doctor and the doctor told her that she has muscle damage from the shot.patient is still in pain from the shot.
Patient blacked out, eyes dilated, started sweating, was unresponsive for about 2 minutes, with shallow breathing. He had a pulse the whole time. EMS was called. He started to be responsive, blood pressure was ok and he felt better so he refused to go to hospital.
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with seventh report out of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 15-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 19-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (number 1022277) received from quality assurance department on 29-Jul-2017: QA investigation result was updated. Narrative amended accordingly. Non significant case correction received on 10-Aug-2017: Narrative was corrected.
Chills, severe myalgias,  headache, multiple shingle eruptions within 7 days(R abdomen and Left waist), right occipital neuralgia/allodynia, costochondritis, flank discomfort, and sensation of weakness in legs associated with myalgias.
c/o arm hurting w/in couple hr p/vax;redness @ inj site x 4 days;next AM c/o joint pain, muscles aching, becoming extremely tired, x 3 days;states felt like bad case of flu;took APAP did not see a MD mom states eyes yellow;
tooth abscess; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient is scheduled to get the second dose of the Pfizer covid vaccine on Monday, but on an unspecified date she experienced a tooth abscess. Patient wanted to know if its ok to take the second dose. The outcome of event was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
This spontaneous report as received from a nurse practitioner refers to a 19 years old female patient with penicillin allergy and no pertinent medical history. On 26-NOV-2012 the patient was vaccinated with dose 2 of 0.5 ml VARIVAX (Merck) subcutaneously. No other co-suspects were reported. Concomitant medications included: oral hormonal contraceptive (unspecified). At time of vaccination, the patient experienced a scratchy throat. In the night she experienced increased throat pain. The next day, on 27-NOV-2012, the patient came back to the health department and was examined by the nurse practitioner. A monospot test was positive and the patient was diagnosed with mononucleosis. At time of this report the patient did not receive treatment medication. The outcome was reported as not recovered/not resolved. No causality assessment was provided. Additional information has been requested.
Pt recvd vax 4DEC91 @ 11AM temp went up to 103 ax later in afternoon nose started running; slept all day;
Information has been received on 03-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In 2012, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated at a physician's office for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is unknown. The causality of the events is related. Upon internal review, severe varicella pneumonia was determined to be medically significant. Additional information has been requested.
Patient Recieved vaccines on 10/18/08 at a store flu clinic. On Monday the patient reported that her arm was red and sore to a pharmacy technician. I called her today to see get all of the details and see how she was doing. she said that her right arm from shoulder to elbow was red, sore, warm the touch, and swollen. she said that she has limited range of motion of her arm and that she can't put weight on it. I asked her if she had been to a physician yet and she said NO. She has taken tylenol for the pain but is unable to take an antihistamine because she is allergic to the class. I urged patient to see  physician because she said that it is progressively getting "worse". Patient said she did not want to go to the ER because to expensive and I told her about the  urgent care across the street and they only charge an office visit copay. She said she will try to go there tomorrow.
pt called 2 days p/vax states rt upper arm reddened, very painful, warm to touch ordered amoxicillin;aldo DPH;pt is pregnant;
DAPTACEL vaccine may have been administered to an adult, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Medical Information (Reference number- 00643980).  This case involves adult and unknown gender patient who may have been administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was case actual medication error due to product administered to patient of inappropriate age [Latency: on the same day].   It was reported that, Health care professional states that she had found a discrepancy in their vaccine count- she was not sure yet, but a DAPTACEL vaccine may have been administered to an adult.  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.