chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the time of vaccination, a burning sensation was felt immediately upon injection. The person who injected the vaccine proceeded to flick the plastic tubing of the syringe while it was still in my arm, escalating the burning sensation. I let the tech know about the burning and he claimed it could be a side effect of the medication and that I would be fine. I did not suffer any medication related side effects. Left arm stiffness began about two hours after vaccination and after nearly 3 hours, I was completely unable to move my arm. Loss of shoulder posture, complete arm/hand weakness and extreme arm soreness were reported for nearly 5 days. Numbness from the injection site down to the elbow is intermittent currently. Tingling down from the shoulder joint to the fingers is constant when arm is laterally raised or when overused. The left arm is still having trouble externally/internally rotating/raising above my head, and while lifting heavy objects. I'm in the process of starting physical therapy/occupational therapy to regain normal strength and functioning without the tingling or pain. An audible clicking noise is noted that was not there previously to the injection. I am unable to exercise normally and have been functioning at a decreased work and paperwork pace at my job as a nuclear stress technician. I have also been losing days of time at work due to various doctor's appointments and diagnostic tests needed to identify the problem.
Information has been received from a consumer concerning his daughter, an 8 week old female patient with no pertinent medical history and drug reaction / allergies who on 13-JUL-2009 was vaccinated with a dose of ROTATEQ orally.  There was no concomitant medication.  On 13-JUL-2009, soon after receiving vaccine, the patient vomited up the vaccine.  The patient had sought medical attention in the clinic.  No lab diagnostic study was performed.  Subsequently, the patient recovered on 13-JUL-2009.  This is one of several reports received from the same source.  No further information is available.
Myalgia, Arthralgia, UrticariaPruiritus, swelling, redness, throbbing, itching and hot to the touch - after 2nd dose Narrative: Sulfamethoxazole and Prednisone
Flush skin, tightness in throat. Client received vaccine at approximately 11:25 am after checkout, returned to front counter at approximately 11:45 am and reported to the Office Manager that she was experiencing tightness in her throat. Office Manager came to the back to inform this nurse. This nurse returned to the front and brought the client to the  back. The client was alert and oriented, reporting a tightness; upon swallowing. Upon assessment client throat appears normal; client was able to swallow actually asking for water. Skin was flush in appearance and very warm to touch. No respiratory distress noted. BP was 118/68 @ 11:50 am. RN was alerted to initiate protocol. Client received BENADRYL 50 mg IM at 12n, BP: 106/60. At 12:05 pm EMS was alerted due to client reporting no change in status. BP: 120/20. Client reports feeling "cold" and "very thirsty". At 12:10pm BP: 130/90 and client remains alert and oriented - attempting to call husband. Client in semi-fowler's position with cool cloth on neck cover with drapes for warmth. At 12:15 pm, BP: 120/94. At 12:20 pm EMS arrived and took over care of client. BP: 125/79, client reports no change in status since receiving BENADRYL 50 mg IM. Client departed on stretcher via ambulance to  hospital at 12:25 pm. This nurse called client at 4:45 pm. Client answered cell phone and reported that she was doing well and went home with no other problems, about twenty minutes after receiving IM Epinephrine in Emergency Room.
Severe fatigue and brain fog  which began the day after the shot and had consisted for the last two weeks. Persistent headache for first 7 - 10 days.  Occasional nausea and diarrhea.
This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient had no drug reactions/allergies. On 14-JUL-2014 the patient was vaccinated with ZOSTAVAX VIAL (lot # J014810, exp date 21-FEB-2015) 0.65 ml, subcutaneous (S.Q.) in the left arm. On 16-JUL-2014, the patient developed an injection site reaction of a red rash which became itchy, hard and warm to the touch. The patient also told the pharmacist she had pain on the left side of her neck on the same date. The patient visited the pharmacy on 17-JUL-2014 and the pharmacist suggested that she took BENADRYL. No lab diagnostics studies were performed. At the time of the report, the patient did not recover from the events. Additional information has been requested.
Very sore arm 4 hours afterwards, 14 hours afterwards very sore arm, red rash around injection site, and aching joints, continuing now 30 hours later.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L000456 exp date 06-JAN-2017) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
got my second vaccination 2/4 and ever since have tingling in my vaccinated arm; itching in the affected arm without a rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (got my second vaccination 2/4 and ever since have tingling in my vaccinated arm) and VACCINATION SITE PRURITUS (itching in the affected arm without a rash) 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 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PARAESTHESIA (got my second vaccination 2/4 and ever since have tingling in my vaccinated arm) and VACCINATION SITE PRURITUS (itching in the affected arm without a rash). At the time of the report, PARAESTHESIA (got my second vaccination 2/4 and ever since have tingling in my vaccinated arm) and VACCINATION SITE PRURITUS (itching in the affected arm without a rash) outcome was unknown. Not Provided    Action taken with mRNA-1273 in response to the events was not applicable     No concomitant medications provided No treatment medications provided   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25th may 2021 contains no new information
This case was reported by a consumer via call center representative and described the occurrence of explosive diarrhea in a 80-year-old female patient who received SHINGRIX. Concurrent medical conditions included leukemia. Concomitant products included acyclovir, Albuterol, Losartan, EVISTA, IMBRUVICA, PULMICORT, Diphenoxylate HCL and Atropine Sulfate, IMODIUM, SOLU-CORTEF, terazosin, VAGIFEM and VITEYES. On 20th May 2018, the patient received the 1st dose of SHINGRIX. On 20th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced explosive diarrhea and injection site muscle pain. On an unknown date, the outcome of the explosive diarrhea was recovered/resolved and the outcome of the injection site muscle pain was not recovered/not resolved. The reporter considered the explosive diarrhea to be related to SHINGRIX. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient had a sudden onset of violent diarrhea about 3 hours after receiving SHINGRIX. Her stomach was emptied and the diarrhea resolved. Less than a day after receiving SHINGRIX, the patient also had some muscle pain at the injection site of the vaccine. The reporter denied permission to contact physician.
Swelling right arm (15x15cm) noted during 4-29-04 office visit. Right upper arm red and tender. Started on warm compresses and Keflex 250mg 3 times a day by mouth, and Motrin prn. Improved at 4/30/04 office visit.
On 10/17/2001, at 8:00 am the patient complained of body aches and abdominal pain. The patient felt warm to the touch, but her temperature was not taken. The patient vomited 6 times today, has had no food or liquid all day, and has been fatigued. On 10/18/2001 the patient ate soup and had no more vomiting.
Patient was admitted through ED, hypoxia, leukocytosis, acute chronic diastolic heart failure, A. fib with RVR. admitted initially on 5/22/2022 with pneumonia and shortness of Breath. Patient was placed on broad-spectrum antibiotics. ID was consulted, patient continued to worsen despite aggressive treatment. Patient also found to have 1 to 1-1/2-month of severe shoulder and back pain in upper back. MRI spine done and found to have likely tumor, possible metastasis versus primary malignancy. Patient  transitioned to hospice with overall worsening, patient and family in agreement. Patient passed away 6/02/2022.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2017, a healthcare provider at a medical group practice administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a physician at the medical group practice for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nurse administered an Adult Hepatitis B vaccine when a pediatric/adolescent dose should have been given.
Vaccine given 11/5/03. Generalized fatigue. Local arm aching. 2 1/2" diameter red swollen skin surrounding injection site. The follow up received on 12/31/03 states pt required doctor visit on 11/7/03.
Patient stated that the only thing wrong was a rash that was a little warm to touch. No other symptoms were reported. Patient stated that she has been taking benadryl and that it was only today that it seemed to get worst. Counseled patient that she needs to either reach out to her doctor  or she needs to go to the emergency room to have it looked at this weekend if doctor office is no longer open.
Pain in left arm; Passed out; Got dizzy; arm very swollen at the side of the injection; A spontaneous report was received from a consumer concerning her mother, a 52-year-old female patient, who experienced passed out (loss of consciousness), got dizzy (dizziness), arm very swollen at the side of the injection (vaccination site swelling), and pain in the left arm (vaccination site pain).  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  The patient received her first of two planned doses of mRNA-1273 (lot/batch number not provided) on an unknown date for prophylaxis of COVID-19 infection.  On 02 Feb 2021, approximately 1 day and 6 hours prior to the onset of symptoms, the patient received her second of two planned doses of mRNA-1273 (batch number: 012M20A) in the left arm for prophylaxis of COVID-19 infection.  On 03 Feb 2021, the patient got dizzy and passed out, her arm was very swollen at the side of the injection, and she had pain in her arm (at 6 to 7 in the morning).  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events, passed out, got dizzy, arm very swollen at the side of the injection, and pain in the left arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Pt called on 6/29/21. Pt received two doses of Pfizer vaccine at Clinic on 6/28/21 and 6/7/21. Pt complains of cough with phlegm, runny nose, sore throat,fatigue and headache onset 6/28/21 2 hours after received the vaccine.  Pt prefers in person consultation, advised pt to go to urgent care or express care and pt's daughter/pt verbalized understanding.
04/27/2021-Headache,Fever, Chills, N/V Diarrhea.  4/29/2021- Hospital ED: Witnessed seizure while in ED. Fever, Chills Headache.
Patient received his Pfizer COVID vaccines on 3/10/21 and 3/31/21 and was admitted to the hospital on 8/25/2021 with COVID-19. Due to   MD note #COVID19 PNA #Acute hypoxic respiratory failure  Continued on Dexamethasone (started 8/25 in ER), Ceftriaxone (started 8/30), Azithromycin (started 8/30).  5-day course of remdesivir was completed on 8/29. Now on BiPAP. Desaturating with any activity. Baricitinib was going to be started on 9/3 but just before giving Tocilizumab was delivered. He received 600 mg Tocilizumab. Baricitinib was not given. Duoneb q6h sch. I have concern of occult underlying infection such as fungal or other lung disease that is worsening with immunosuppression due to COVID treatment. It is odd to
suspected vaccination failure/got that in her eye; got that in her eye; blisters; couldn't stand light in my eye slept under covers; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), blister and photophobia. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, blister and photophobia were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, blister and photophobia to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient got shingles in her eye after vaccination. The had blisters and patient could not stand in light This case was considered as suspected vaccination failure as time to onset, number of doses and laboratory confirmation test were unknown at the time of reporting. This was 1 of 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR062659:same reporter US-GLAXOSMITHKLINE-US2021AMR069212:same reporter US-GLAXOSMITHKLINE-US2021AMR062659:same reporter
08:03- Vaccine administered at  Hospital in ED. Observation time increased to 30 minutes related to history of anaphylaxis. 08:18- Pt complains of difficulty swallowing and feeling as though throat swelling. Patient placed on monitor. O2 sat 98-100% on room air.  Epi 0.3mg administered in left outer thigh at this time. 09:21- Patient continued to be monitored in ED but not registered as an ED patient. Patient denies needing to be seen by provider. Symptoms resolved. Patient states "I'm fine. I'm better than fine, I'm great." 09:25-Patient discharged from observation. Instructed to return to ED or call 911 if symptoms return. Patient voiced understanding.
No additional AE's/PQC's reported; temperature excursion for VARlVAX / have been administered to patients; This spontaneous report was received from a registered nurse (also reported as a certified medical assistant) and refers to a 5-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 13-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) one dose, lot # U002394 was confirmed to be valid, expiration date 22-JAN-2023, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature from -10 degrees Celsius (C) to 8 C (4 C) for 20 minutes on 07-SEP-2021 and from -10 C to 8 C (4 C) for 20 minutes 09-SEP-2021 (both during transport). There was also previous temperature excursion reported as from -10 C to 8 C for 7 hours and 30 minutes. No additional adverse event was reported; Sender's Comments:  US-009507513-2109USA005628:
Expired dose administered to 7 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported.  No adverse events were observed in any of the patients. Date the vial was initially stored in the refrigerator on 19-Jan-2022. The vial undergone no temperature excursions.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was admitted to the hospital with COVID-19 symptoms 7/20/2022- 7/28/2022. Medications given included dexamethasone 6mg IV daily, ascorbic acid 500mg PO BID, cholecalciferol 50mcg PO daily, baricitinib 2mg PO daily.
SARS-CoV+SARS-CoV-2 (COVID-19) Ag [Presence] in Respiratory specimen by Rapid immunoassay~SARS-CoV+SARS-CoV-2 (COVID-19) Ag [Presence] in Respiratory specimen by Rapid immunoassay performed on 7/21/21. Test came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
Substantial increase in number of migraines and length of migraines. Unsure if the vaccine is at all related to this. I have been to my personal care physician since the vaccine was administered and we are working on trying to solve the migraine issues, but have not yet found a successful treatment.
The morning after, I woke up with severe aches in my bones and pain in my joints, head, and left arm. My nausea made it difficult to eat or drink. I was dizzy. I had a fever of 101 F, chills, and fatigue. I spent a lot of time sleeping and woke up with wet clothes and sheets. This lasted three days. Symptoms gradually lessened.  This was the first shot in the series.
Redness at injection site. Itching around injection site and on the arm. Headaches. Nausea
Hepatitis A vaccine given instead of Hepatitis B. Patient notified to return for Hepatitis B vaccine.
Information has been received from a licensed practical nurse concerning a 20 year old non-pregnant female patient. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient received a dose of RECOMBIVAX HB (lot numbers and expiration dates unspecified), intramuscularly, on 04-APR-1997, 05-MAY-1997, and 16-JAN-1998 as a vaccine. On 10-JUL-2017, the patient had a "blood draw" done where the surface antigen antibody quantitative was determined to be low. No treatment was provided. The outcome of the surface antigen antibody quantitative is unknown. No further details provided. Additional information has been requested.
Client called on 1/10/2023 to report swollen and painful lymph nodes in arm vaccinated (left delt) the PM followin her vaccination on 1/5/23. Through the night she developed a headach , fatigue and lethargy persisting for 3 days after vaccine administered. Her lymph nodes remained swollen and tender until 1/9/23.  Client reports not having any reaction to previous covid vaccinations (all Pfizer brand). She did report contracting covid in October of 2022.
Information has been received from a physician concerning a 36 year old female who was vaccinated with a first and second dose of varicella virus vaccine live on 6/23/04 and 8/4/04, respectively. It was reported that the patient's varicella zoster IgG titer came back negative. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Patient received vaccine in office on 11/03/20 around 8:30am. Patient contacted office later that evening (approx. 4:40pm) stating that the injection site was hard and had a football size knot across arm - warm to touch. Patient advised to Benadryl and cool compress. 11/04/20 - patient was contacted. He states arm is improving just hard lump at injection site. Area is not warm to touch or red.