chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the pain has increased / chronic shoulder pain; the typical sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 27Mar2021 as a single dose for covid-19 immunization. Medical history included shoulder pain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced typical sore shoulder after the vaccine, but it seemed like within the past week, the pain had increased.  She had chronic shoulder pain and wanted to know if the shot caused the pain or if the pain was from her chronic shoulder pain. She had a history of shoulder pain so was not sure if it was the vaccine or if she had just overused it. She asked if she could get the second dose and how effective was it to just get one dose, 70 or 80 percent. Response: As noted in the fact sheet for recipients, you should not get the Pfizer-BioNTech covid-19 vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against covid-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. She was scheduled for second dose on Saturday (18Apr2021). Unaddressed medical questions were referred or forwarded to medical information. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On April 6, I donated blood, which is something I do routinely at my local blood bank. I was lightheaded for a prolonged period of time after the donation; by the time I got home around 11am, my blood pressure was very low and I could not stand up or I would get dizzy and off balance. I was unable to work. My blood pressure resumed to normal the next morning after a full night's sleep. On April 7, I had an appointment to receive trigger point injections and the nurse practitioner who administered them said I was bleeding at every injection site, which was highly unusual for me.
Information has been received from a registered nurse concerning a 65 year old female patient with hyperlipidemia and hypertension and a history of herpes zoster who on 14-SEP-2009 morning was vaccinated with the first dose of PNEUMOVAX (lot# 663486/0507Y). Concomitant vaccine administered on the same day included influenza virus vaccine (unspecified) (manufacturer unknown) in the other arm. By the evening of 14-SEP-2009 the patient could not move her arm. It was extremely swollen and painful. The patient was seen in the office and was given SOLUMEDRIL as it "looked like an anaphylactoid reaction". She was shaking and was taken to an unspecified hospital. The patient was hospitalized. The other arm administered the influenza virus vaccine (unspecified) had no reaction. The nurse stated that the patient developed "more of a reaction than you would expect". The office would like a lot check on lot# 663486/0507Y. Could not moving her arm, extremely swollen arm, extremely painful arm, anaphylactoid reaction and shaking were considered to be disabling. Additional information has been requested. This is one of several reports from the same source. A lot check has been initiated. 11/17/09:  Hospital Records received for dates of service 11/14/09 to 11/16/09. Dx: Allergic reaction.  Assessment:  Pt. states that immediately upon receiving the pneumonococcal vaccine she felt pain in her shoulder and then became SOB.  She also received the Influenza vaccine in the other arm. Pulse oxymetry was 83%.  Given Solumedrol in MD office.  Shoulder pain persisted and she presented to the ED and was admitted with shoulder pain bilaterally. Shoulder ROM limited due to discomfort.
Patient fainted 1 minute after administering the hpv vaccine and had a vasovagal reaction. She passed out and had a mild seizure. After she regained consciousness,  me and the doctor checked vitals. Her O2 and pulse were normal but her blood pressure was a little low. We gave her some juice and water and rechecked her vitals and they were all within normal limits.
Guillan Barre syndrome. Muscle pain, weakness and numbness in abdomen, legs, feet, arms and hands. Unstable gait. Intense physical therapy was necessary for recovery.  Treated with IVIG infusions and steroids.
Breakthrough case admission after 4 vaccines Pfizer 3/22/21 Lot# no recorded;  4/12/21 Pfizer lot # not recorded;  Pfizer 10/13/21 Lot# 30145BA;  Pfizer 5/13/22 Lot# FK9893
red, maculo-papular rash, starting on neck, spread to entire body overnoc;no fever, no resp sx;+blanching;negative pruritus;
Traumatic fracture of ribs of right side with pneumothorax - treated and discharged. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
1st dose 12Oct2020, late for 2nd; This 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 (received 1st dose on 12th October 2020, batch number YZ325, expiry date 9th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Vertigo, Dizzyness. This has been happening within 2 weeks of seocnd shot and continues too -Head Pressure and left ear discomfort about a week and a half/two weeks after second shot. -As weeks went on ringeing and loss of hearing at times. -Continued pressure in left ear with waves of pressure/ringng/loss of hearing/discomfort      Thought nothing of this at time figured it would go away.  No nasal issues or fluid from ear. -About 3/4 weeks from Second shot heasring loss started to become more aparent and could not clear ear pressure. -At that time (mid June) I began to notice loss of balance at times while standing in place.  -Severe case of vertigo, week of June 14th.  Lasted on off for 4-5 days.  Dizzyness cont
3 inch, round area of erythema developed over 2 days.  12 days after varicella vaccination.  Client states it is sore and itches and feels hot.  Client has been putting topical anti-itch cream on.  As of 10/31/2003, client developed some raised, hive-like lesions on chest.  Referred to medical center.
Administered PNEUMOVAX 23 with an expiration date of 8-10-14. Contacted Merck and was told that vaccine is supported and we do not need to revaccinate.
RASH ON ARMS AND LEGS THAT WHEN AWAY WITH BENADRLY , RETURNED THE NEXT DAY AND PERSISTED., SEEN IN ed EMPLOYEE HAS PURRITIS IN THROAT, THRATED WITH BENADRLY.
mild upper arm soreness/Only hurt if you touched, bumped or slept on injection area; This is a spontaneous report from a contactable consumer. A 67-year-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Jan2021 13:00 (Batch/Lot Number: EL9262) at single dose for covid-19 immunisation administered at Pharmacy or drug store. Medical history included breast cancer female from 20May2018 to 2018 (Pertinent details: Lumpectomy, Radiation summer 2018; irritable bowel syndrome from 2000 and ongoing; breast conserving surgery from 2018 to an unknown date (Lumpectomy for breast cancer); radiotherapy from 2018 to an unknown date (Radiation for breast cancer). Historical vaccine included PNEUMOCOCCAL CONJUGATE VACCINE (PCV13-Pneumonia vaccine) (After 2 hours of the vaccine: fever, nausea, vomiting, diarrhea, nosebleed and dehydration). Concomitant medication(s) included anastrozole (ANASTRAZOLE DENK), oral from Sep2018 and ongoing for breast cancer female; amitriptyline, oral from Sep2019 and ongoing for irritable bowel syndrome; colecalciferol (VITAMIN D [COLECALCIFEROL]), oral; cyanocobalamin (B12 [CYANOCOBALAMIN]), oral; calcium, oral; melatonin, oral; famotidine (PEPCID [FAMOTIDINE]), oral. The patient reported, mild upper soreness for 2 days. Did not hurt to move arm. Only hurt if you touched, bumped or slept on injection area. The patient underwent lab tests and procedures which included influenza negative on an unspecified date. The outcome of event was unknown.  Additional information has been requested.
While pushing the moderna vaccine in left arm the medication leaked out of the syringe and dripped down patients arm.  Gave another dose in the right arm.
Ist shot on 7-28-21, 2nd on 8-25-21.  Rash from hell in my pubic area back to butt cheeks.  Don't recall whether it started between the two shots or shortly after the 2nd.  First sign was itching, then rash.  Have one small spot of psoriasis on ankle so thought it might be that so treated with MG217 that keeps my ankle psoriasis in check, no response.  Extremely itchy and if scratched, feels bumpy under skin, then oozes almost clear, somewhat sticky substance, like when one has a severe sunburn that blisters and there's watery substance under the blister.  Finally tried diluted vinegar wipe about the time I made appt with Clinic.  It relieved the itch.  Then applied A&D ointment or cream to area.  NP at Clinic tested for yeast/fungus, negative but gave me a script for Fluconazole and psoriasis tar treatment.  I got the Fluconazole and took it.  Rash may be improving, still using vinegar and A&D.
Patient had lymphoma after primary vaccination with Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Patient had lymphoma after primary vaccination with Moderna COVID-19 Vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, 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 experienced LYMPHOMA (Patient had lymphoma after primary vaccination with Moderna COVID-19 Vaccine) (seriousness criterion life threatening). At the time of the report, LYMPHOMA (Patient had lymphoma after primary vaccination with Moderna COVID-19 Vaccine) outcome was unknown.            Concomitant medications were not provided. Treatment information included chemo.  Company Comment - This case concerns a 77 year old female patient with no relevant medical history, who experienced the serious (life threatening) unexpected event of lymphoma. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 77 year old female patient with no relevant medical history, who experienced the serious (life threatening) unexpected event of lymphoma. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Pt.'s Wife states that after receiving the 3rd Booster Phizer 11/04/2021, started experiencing symptoms that evening of fever (103.3), fatigue, excessive sweating, and nausea. No noted Primary visit/communications. (Covid + Mid-April) 2nd Dose of Phizer 04/2021 similar reaction to above (Emergency Room visit, treated with IV Fluids for dehydration and nausea).
Rash and inflamation of (L) arm that progressed to rash over upper trunk, face and swelling of eyes. By 8/2/21 pt was not having eye swelling, still upper trunk rash and induration with hyperpigmentation and erythema on upper (L) arm.
Never felt better; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics)who experienced never felt better (feeling abnormal), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date (January), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious never felt better (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-APR-2015, the patient was vaccinated with a dose of GARDASIL lot # K006960 (expiration date, dose, route and site of administrations were not provided) that was exposed to temperatures outside the recommended range for 24 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
sore arm; little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRALAX. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization, reaction(s): "Sore arm", "Little fever"; Bnt162b2 (Dose: 02), for COVID-19 Immunization, reaction(s): "Sore arm", "Little fever"; Bnt162b2 (Dose: 03), for COVID-19 Immunization, reaction(s): "Sore arm", "Little fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever".  Additional information: My wife and I took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. We also had one bivalent booster. We experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. We are eligible for the second bivalent booster however, my wife started taking Miralax for digestive problems one or two 17gram capsules a day and it is pure polyethylene glycol. She might have developed a rash with itching with it, because it started when she started taking it and went away after she quit taking it. We think there is a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine, does it contain Polyethylene glycol?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180008 same reporter/patient/product/AE, different dose;
Swelling, redness and resultant pain of both  ankles, and lower legs  worse at the end of the day, improved in the morning.  Awakening with swelling of hands (moderate) and face (mild) resolving as the day goes on.
First day I had fever, chills , cold sweats three days  headaches, body aches
got ALS after the vaccine; damaged immune system; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant), outcome "unknown", described as "got ALS after the vaccine"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "damaged immune system ". It was reported that the patient got the same (ALS and damaged immune system) after the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201341349 Same reporter, drug and event; different patient.;US-PFIZER INC-PV202200114181 Same reporter, drug and event; different patient.;
Severe runny nose and sneezing. Hives on top of left ribs and on top of right ribs.
Systemic: Fever-Severe, Systemic: LOCK JAW-Severe, Additional Details: PATIENT REPORTED HIGH GRADE FEVER FOR SEVERAL DAYS (NON SPEECIFIC) STARTED A DAY OR SO AFTER VACCINE. REPORTED HAVING LOCK JAW THAT CONTINUES TO IMPROVE. PT ALSO STATED SE DID VISIT HER DR IN THIS TIME FRAME BUT LITTLE WAS DONE.
pt recv vax 4NOV96 & was inadvertently vaccinated w/2nd dose of vax;pt exp redness, swelling, & pain @ inj site;the reporter was unsure @ which inj site the rxn had occurred;in addition pt seemed tired & had cold sx;
I woke up and found I couldn't stand up to get out of bed. I felt dizzy and unsteady. I sat on the bed for about five minutes. I've never had that experience. It lasted for about 20-30 minutes. It was scary. I took my blood pressure reading. It was fine. It was about 117/78. I checked it three times. My wife took me to the emergency room. They did an EKG. It was normal. They took my blood pressure reading. It was normal. They did lab work. It was all normal. They performed an MRI to see if I had a stroke. The MRI did not show signs of stroke. I also was not dehydrated. They couldn't figure out what was wrong with me, so they sent me home. I haven't had that problem since.
Vaccine administered IM in right arm. Bandaid applied and immediately patient fell backwards onto exam table, eyes rolled back, and she had body twitching for a couple seconds. Medical assistant was supporting patient's head and patient's father was supporting her arms. 3 seconds later she regained consciousness and complained of headache. Patient reclined on table, given water and juice. Patient examined - normal and back to baseline. Able to sit up and stand up normally. No unsteadiness.
Patient was DOA at local hospital 3 days after immunes were given.  2/27/09 Autopsy report states COD as sudden unexplained death of infant & manner of death as undetermined.  Autopsy report also states patient's caregiver was smoker; patient co-sleeping w/2 adults who had used alcohol & marijuana.    04/29/08 Reviewed ER medical records of 4/06/08. FINAL DX: full cardiopulmonary arrest & prehospital death of uncertain cause. Records reveal patient arrived in ER asystolic w/pupils fixed & dilated, rigor mortis already present, cyanotic, mottled, early livido w/CPR in progress.
Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Medium
3RD DOSE OF PFIZER COVID VACCINE GIVEN 1/14/22, LOT #FG2537. pt had a positive COVID test on 8/7/22; pt in hospice facility at unknown residence for metastatic lung CA, GIP dyspnea; non-verbal; unable to make needs known; pt passed away in the facility 6 days later after positive test.
Within 45 minutes of receiving vaccine #2 on April 15, 2021 at approximately 11:45 a.m., my head started feeling full and my ears started ringing - Tinitus. As of this morning, April 16, 10:45, my ears are still rining. The Tinitus has not gone away. I took 1,000 mg of Tylenol twice on April 15 for the headache and "weird" full-head feeling, and I've taken 1,000 mg of Tylenol this morning at 8:20 for headache, body aches and the weird full-head feeling. My ears are still ringing. I placed a call this morning to my regular doctor and am waiting for a reply.
16 YEAR OLD PATIENT WAS ADMINISTERED MODERNA 0.5ML. PATIENT DID NOT HAVE ANY SIDE EFFECTS OR REACTION TO THE VACCINE.
Patient received two doses of Janssen vaccine. No adverse event has been noticed at the time of reporting.  Patient is an inmate at the time of administration of the second vaccine on 07/21/2021. When asked if the individual had received a COVID-19 vaccine, he stated he had not. First dose was administered on 06/03/2021..
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Epilepsy. Concomitant products included LAMOTRIGINE (LAMICTAL) and CLONAZEPAM for Epilepsy.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.     This case was linked to MOD-2021-099239 (Patient Link).
Focal seizures of R arm with some generalization started several hours after immunizations received. The infant was seen that evening and the following day, seizures stopped after 15mg/hg single IV dose of phenobarbital.
Contracted Covid on 16Aug2021; Contracted Covid on 16Aug2021; administration date=28Dec2020/other vaccine same date vaccine date=28Dec2020; This is a spontaneous report from a contactable Nurse(reporter). A 51-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration on 28Dec2021in right arm as DOSE 1, SINGLE and also received second dose (COMIRNATY, Solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration on 28Dec2021 in right arm as DOSE 2, SINGLE for covid-19 immunization (at the age of 51 years)at Workplace clinic. The patient medical history and concomitant medications were not reported. The patient had not any known history of allergies. The patient had not diagnosed with COVID-19 prior to vaccination. It was reported that patient did not take any vaccine within 4 weeks prior to Covid vaccine. On 16Aug2021 the patient had experienced Contracted Covid-19. The patient underwent lab tests and procedures, which included Nasal Swab and was diagnosed as having covid test Positive after vaccination on 16Aug2021. Therapeutic measures were taken as a result of adverse events. The outcome of the events were recovering; Sender's Comments: As there is limited information in the case provided, the causal association between the event drug ineffective and Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Within 2 hours, she was vomiting and had a low-grade fever of 99.8F. She was irritable, loss of appetite and constant crying. This lasted for 2 days. She also had horrible gas during this time. We gave her Tylenol and held her all through the night.
Infection at lower than normal injection site (cellulitis). Prescribed antibiotics (Keflex).