chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives all over the body after booster/Hives Unresponsive to medications after booster; Itching all over the body after booster/Hives & Itching Unresponsive to medications after booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body after booster/Hives Unresponsive to medications after booster) and PRURITUS (Itching all over the body after booster/Hives & Itching Unresponsive to medications after booster) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 002A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced URTICARIA (Hives all over the body after booster/Hives Unresponsive to medications after booster) and PRURITUS (Itching all over the body after booster/Hives & Itching Unresponsive to medications after booster). The patient was treated with PREDNISONE at a dose of 9 days; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 milligram, 4 tabs daily. At the time of the report, URTICARIA (Hives all over the body after booster/Hives Unresponsive to medications after booster) and PRURITUS (Itching all over the body after booster/Hives & Itching Unresponsive to medications after booster) outcome was unknown.            Concomitant medications was not provided by the reporter.  Patient experienced symptoms 13 days after the booster he had hives, and Itching all over the body. His Doctor prescribed 9 days of Prednisone which did not help. He took Benadryl on his own. The allergist prescribed Zyrtec 10mg 4 tablets daily.
Initial unsolicited report received from a consumer on 12 January 2016. This case involves a 70-year-old male patient who was vaccinated with a first dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left deltoid on 13 October 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy (NKA). Patient had no other vaccinations within 4 weeks of vaccinations. On 13 October 2015, same day following the vaccination patient developed all over body aches to his toes and generally feeling weak. On an unspecified date, "Within 4 days" following the vaccinations patient developed a cough and cold. On an unspecified date, following the vaccinations patient still had pain in his right (R) shoulder, arm and his low back into his bilateral thighs, left shoulder and testicular pain. Patient required emergency room (ER)/doctor visit. Laboratory investigation involved magnetic resonance imaging (MRI) of his right shoulder on 13 January 2016. Blood work involved Vitamin D deficiency noted elevated PSA level, Xrays of bilateral shoulders and pelvis, negative for arthritis. Corrective treatment was Nonsteroidal anti-inflammatory drugs (NSAIDs). The outcome of event was not recovered for event had all over body aches to his toes and generally feeling weak, pain is still in his (R) shoulder, left shoulder, pain in arm, low back into his bilateral thighs and outcome was recovered for the events cough/cold (lasted for months) and testicular pain. List of documents held by sender: none.
Client noted to have redness, minimal swelling, warmth to touch, and mild discomfort to injection site. Area noted to be oval in shape, redness the size of an egg surrounding injection site.
roughly one week after first Moderna dose my arm at shot site became very itchy and had a bump. A few days later I noticed a rash in the spot, roughly 3-4 inches in diameter.  It is now about one week later and rash has faded, but not completely.
Subject prior to receiving study medication: (Janssen ad26.CoV2. vaccine) subject during their clinical annual follow up post kidney transplant visit on 9/26/2022, subject complained of progressively worsening fatigue and weakness as well as worsening lower extremity edema. Subject was sent to the Emergency Department for work up. Subject had been recently diagnosed with a UTI and prescribed a 10-day course of ciprofloxacin. A chest x-ray was done 9/26/2022 in the Emergency department and showed signs of worsening pulmonary edema. He was administered 40 mg of IV Lasix and had a good urine output (-2.6 L during this admissions). Subject spent 1 night at the hospital when he did not have any acute events. Notably, no shortness of breath, chest pain, palpitations, fever or chills. He had a few episodes of hypertension that were controlled with his home antihypertensive regimen. We were concerned for prostate cancer recurrence because of his worsening back pain and hypercalcemia. An x-ray of the lumbar spine was done and did not show any signs of focal lesions. PSA was also measured. Subject was discharged on 9/27/2022 with diagnosis of Nonrheumatic Aortic Valve Stenosis Upon discharge, the patient was stable clinically and hemodynamically. He had no signs of dyspnea, chest pain, palpitations or other worrisome symptoms. Subject has history of aortic valve stenosis, fatigue and weakness, prostate cancer, diabetes mellitus type 2, hyperlipidemia, pulmonary edema, rheumatoid arthritis, dysphagia, spondylosis. Causality by P.I. is not related to study medication
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The patient self-reported the case. The patient received Shingles vaccine and was still getting the shingles. Additional Supportive Information: This case was reported via interactive digital media and described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Case number PHHY2011US51502 is an initial spontaneous report received from a health care professional on 09 Jun 2011. This report refers to an adult male patient. He was given only the MenA lyophilized component of MENVEO (batch number: A10047) intramuscularly on 28 May 2011. He did not receive the MenCYW liquid conjugate component of the vaccine. No other adverse reaction was reported.
Approx 7 hours post vaccine, parent states 104 degree temp, "seizure" to ER. ER reports TX from OM - Rocephin - sent home with Amox RX. Poss febrile seizure.
I HAD MY BOOSTER 3RD SHOT ON 09/14/21 AND MY COLLAR BONE AREA AND CHEST IS SWOLLEN WITH A NODULE. I REPORTED THIS TO THE HEALTH NURSE HERE AND SHE TOLD ME TO REPORT IT HERE. TODAY IS 9/17/21 AND THE SWELLING IS STILL THERE.
FEVER -101.5 FALL MUSCLE WEAKNESS BODY ACHES  RHINITIS  POOR APPETITE
Client presented to receive Pfizer Booster. Client reported to RN that she experienced palpitations after Dose 2 of Pfizer. Client states that fours days after second dose she experienced migraines and a high heart rate up to 182bpm and nausea. She went to the ER twice due to the migraines and nausea. She saw a cardiologist which told her everything looked well with her heart. Client states all symptoms subsided after a month. Client reports dose 1 went well and had no issues. Medical Consult was submitted to Clinical Lead. Client was approved to receive Pfizer Booster by MD.  Client was vaccinated on RN and educated on side effects and Emergency precautions .
Redness,Swelling, Pain,Warmth,Itching to Left Deltoid.  No systemic symptoms.
This initial spontaneous case, was received from a Pharmacist on 18-Oct-2017, concerns a 14-year-old female patient. This report was 3rd out of 03 reports. The patient had no medical history and she did not receive any concomitant medications. On 16-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 1618701, and expiry date: Apr-2017). The patient received the expired product (explicitly coded as expired vaccine used) and did not experience any adverse event after the administration of the vaccine later. It was reported that, the patient was revaccinated. The reporter assessed the case as non-serious. Non-significant follow up received 30-Oct-2017: It was reported that, the patient did not experience any adverse event later and was revaccinated.
I had the shot in my right arm but my left arm got really really sore. The right arm did get sore eventually. In the middle of the night I could barely move my left arm at all from the soreness of it. It resolved after a day or 2.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 02-MAR-2015 the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Redness around injection site (left tricep), dizziness, lightheadedness, nausea, numbness in fingers and arm (left), heart palpatations.
Patient made an appointment via tool and filled out covid-19 vaccine informed consent form electronically which was automatically faxed to the pharmacy. Patient reported on the consent form that she had never received a previous dose of covid-19 vaccine. When patient came to the pharmacy, she told the technician that this was her first Covid-19 vaccine which was documented at the top of the electronically generated consent form. Additionally, when went into immunization room with the patient the rph verified verbally verified that this was her first covid-19 vaccine confirming what the patient noted on her consent form. Patient had second appointment schedule for 8/22/21 at 1:15pm. Upon checking Immpact(Maine immunization information system) on the morning of  8/22/21, it showed that the patient had received first Moderna dose on 1/7/21 & second dose on 2/6/21. immediately called the patient & left a voicemail asking the patient to call the pharmacy. The patient did not show up for her 1:15pm appointment, Rph called patient again leaving  a second voicemail to call the pharmacy. As of 4:20pm on 8/22/21, patient has not showed up at the pharmacy & has not called the rph back. At this point, given the information listed in Immpact and not being able to ask the patient questions about how many covid-19 vaccines she received & why she noted that she had never received a dose, I am filing a report. It is not known if the patient has had any adverse reaction.
trouble in the shoulder where they put the shot in; my back, my shoulder where they gave me the shot, it is like constantly pain like it is just like come and goes where in middle of the night I wake up; I have a bruise. Its been 4 week but I still have a bruise on my shoulder, my shoulder is hurting it. Its like my neck down my elbow; It is a rash or something itchy and its appear on me; It is a rash or something itchy and its appear on me; my back, my shoulder where they gave me the shot, it is like constantly pain like it is just like come and goes where in middle of the night I wake up; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number,  number, UPC number and Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. About month ago, patient took the first Pfizer shot (further clarification was unknown hence captured as unspecified vaccine) and patient never had COVID yet. Patient was having so much trouble in the shoulder, where they put the shot in. Patient must back up or something because it's like all sudden his track or patient should always dumb the elbow just like. Patient didn't even think that the shot might be the problem but the back and shoulder where they gave the shot was constantly in pain (like it came and went). In middle of the night, patient woke up and it was just like drubbing, like a pinch nerve which patient thought that might be back was out. Patient went to chiropractor and realized about having a bruise. It had been 4 weeks, but patient still had a bruise on the shoulder where the needle was put in. Patient realized the shoulder was hurting. It's like neck down my elbow. Outcome of the event bruise was not recovered while of other events was unknown.  Follow-up attempts are needed. Further information is expected.
1 week after 2nd dose, on 1/24/21, woke up with stiff neck (left rear cervical area) which proceeded with nerve pain down left shoulder and arm.  After 2 weeks with no relief OTC remedies, saw PCP on 2/8/21, who ordered PT.  Saw chiropracter for neck pain on 2/8/21.  Weekly PT appts x 5 weeks, no relief.  Saw PCP again on 3/5/21 for extreme nerve pain in arm.  Prescribed Tramadol for pain, put on 11-day course of Prednisone.  Some pain relief, but not resolved.  MRI ordered and completed on 3/19/21 with no findings except arthritis.  Now being referred to Spine Clinic for further diagnosis.
Caller states her doctor has COVID-19 and she knows he "had all the vaccine"; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller states her doctor has COVID-19 and she knows he "had all the vaccine") in a male 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) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller states her doctor has COVID-19 and she knows he "had all the vaccine"). At the time of the report, COVID-19 (Caller states her doctor has COVID-19 and she knows he "had all the vaccine") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided. Patient received all the vaccine.  Company Comment: This case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Received Moderna spikevax 12+ on Saturday On Monday morning, Right eye, same side as injection arm, has subconjunctnal  hemorrhage
This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of vaccination site erythema (big red circle around the injection site) and vaccination site pruritus (itchy around the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history reported. On Dec 30, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 12, 2021, patient experienced vaccination site erythema (big red circle around the injection site) and vaccination site erythema (big red circle around the injection site) and vaccination site pruritus (itchy around the injection site). The patient  treated with Benadryl (diphenhydramine hydrochloride) for adverse event, unknown dosage form. At the time of the report, vaccination site erythema (big red circle around the injection site) and vaccination site pruritus (itchy around the injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medication not reported. Treatment medication included topical steroids. 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.
Arm tenderness; Induration at the injection site; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2022, the patient received the 1st dose of Shingrix. On 6th May 2022, less than a day after receiving Shingrix, the patient experienced pain in arm and injection site induration. On an unknown date, the outcome of the pain in arm and injection site induration were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site induration to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-AUG-2022 Reporter's Comment: The patient received Shingrix vaccine. The patient had arm tenderness and the induration at the injection site. The reporter consented to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR116654.; Sender's Comments:  US-GSK-US2022AMR116654:Same reporter.
refusal to eat foods once enjoyed, refusal to nurse which ended breastfeeding, lack of eye contact, fussy, behavior continued until autism diagnosis was given.
Case number PHEH2016US023418 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 53 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the right arm on 31 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experienced any adverse events following vaccination.
69 year old male stated that he notices a small red mark on his left forearm approximately 15 minutes after receiving his second Pfizer vaccine.  The mark was approximately 3 x 1inches.  Patient denied any other complaint and stated that he didn't know if the mark was there before he came in for the vaccine today.  He stated that it was possibly an abrasion.  Vital signs stable.  Patients chest, abdomen, back, neck, head, and extremities were examined with no other signs of rash, allergic reaction or anaphylaxis.  Patient denied any other complaint.  Negative chest pain, SOB, weakness, dizziness, and no signs of stroke or anaphylaxis.  Patient has a history of hypertension, type II diabetes, high cholesterol, gout and a left total knee arthroplasty.  Patient states that he is compliant with all medications and has no allergies.  Patient stated that he did not want further treatment or evaluation and did not want EMS activated.  All risks and consequences explained and patient was advised to contact his primary care provider or seek treatment for emergency symptoms if they arise.  Patient stated that he will be with his room mate for the rest of the day and left via private vehicle.
Patient had significant bleeding at injection site. After bleeding stopped, a dime sized welt was observed at the injection site. On 11/14/15, the patient reported that she has a 3" bruise at the injection site and pain that radiates the length of her arm.
tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 2nd of 4 patient.   A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient has tested positive for covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076785 same reporter/drug/event, different patient
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The follow-up includes non-significant information.