chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache,head hurting really bad, the patient said that has a blinging headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache,head hurting really bad, the patient said that has a blinging headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE (Primary series was Pfizer's with batch number EL9264 Second dose:Lot EN6200) on 04-Feb-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE. Concurrent medical conditions included Migraine (from before the vaccine).    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache,head hurting really bad, the patient said that has a blinging headache). At the time of the report, HEADACHE (headache,head hurting really bad, the patient said that has a blinging headache) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were reported.
A large bruise was evident when I removed bandaid night of receiving injection. 2 days later a large red ring- almost like a hive- was spread around the bruise and I could feel a hard knot in that area. There is also some itching at the site of the redness.
Right arm where shot was given is still severely sore where I can't raise it nor lay on it nor touch it.  It has been 4 days and I can hardly move my arm.  It is sore from the top of my arm to the middle of my elbow.  It is very severe.
Sore arm; Redness around the injection area; A little bit of swelling on his left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia (Start Date 15 years ago, no changes), Blood pressure high (Start Date 20 years ago, no changes) and Kidney stones (improvement or worsening is unknown). Concomitant products included LEVOTHYROXINE, AMLODIPINE, SIMVASTATIN, TAMSULOSIN and ALPRAZOLAM for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain in arm, at an unspecified dose and frequency. On 31-Mar-2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's height reported as 6'.  Patient had no allergy.  Patient experienced same symptoms after every vaccine for around 7 to 9 days.   This case was linked to MOD-2022-496528, MOD-2022-496529 (Patient Link).
Day after 2nd shot I developed extreme fatigue, almost feeling paralyzed,  On day 3 the fatigue has eased up but I have a rash from my neck to my bellybutton. It is not raised or itchy but red as an apple.  I took Benadryl and it was no help.  It is growing as I type.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies:Yes" (unspecified if ongoing), notes: Known allergies:Yes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Dec2021 at 12:00, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (29Jun2022) Positive, notes: Took a at home test and was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient no Other medication in 2weeks.The treatment medications Paxlovid on start date 16Jun2022 and stop date 20Jun2022.The Dose 3 Vaccine administration date 11Dec2021 12:00 PM and vaccine location left arm and Lot was unknown. The Adverse event were Woke up with stuffy nose and tired, just felt off. Took a at home test and was positive reported. The AE start date 29Jun2022 12:00AM patient recovered- Recovering. The Known allergies Other medical history- Asthma, anxiety were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt. developed itchy red bumps left hand, left wrist swelling & itching Lt. arm - numbness left forearm - scattered pustules left deltoid area & left hand.
Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ear ache, nausea for one day, headache, and shortness of breath with coughing and stairs. She had a telemedicine appointment with her MD office and they recommended her not to work and to use her inhaler and some cough medicine.
uninterrupted, unconsolable crying for 5 hrs, approx 8PM -1AM;
Extra dose administered (2nd dose); 18 year old administered 3rd dose 22/Jul/22; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 22nd July 2022, the patient received the 3rd dose of Menveo. On an unknown date, the patient received the 2nd dose of Menveo. On 22nd July 2022, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The clinic administrator reported that on the day of reporting the patient received 3rd dose of Menveo. The IT issues were present during and after call, call disconnected. The consented to follow-up was unable to obtain. Additional supportive information: The patient received 2nd and 3rd dose of Menveo, which led to extra dose administrated. As per local schedule, there is a single for Menveo and in narrative it was reported that patient received the 3rd dose, therefore in worst approach 2nd dose of Menveo was also captured along with extra dose administered event.
This spontaneous prospective pregnancy report was received from a 27 year old female patient regarding herself. Patient's concurrent conditions and relevant medical history was not reported. Approximately on an unknown date in December 2014, the patient was vaccinated with first dose M-M-R II (dose, frequency and route unspecified) and first dose of (Oka/Merck) VARIVAX (dose, frequency and route unspecified). Concomitant medications were not reported. On 07-FEB-2015, the patient was vaccinated with second dose of (Oka/Merck) VARIVAX (dose, frequency and route unspecified). The patient reported that now she was four weeks pregnant (exposure during pregnancy). No treatment was received by the patient for the adverse event. On an unknown date, blood work was done but results were not reported. The patient sought medical attention by contacting office. The outcome of the event was unknown. The causality of the event with M-M-R II and VARIVAX was not reported. Additional information has been requested.
Edema peripheral, Erythema. Injection site swelling, Injection site reaction. This case was reported by a nurse and described the occurrence of swelling of the arm in a 4-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, Glaxo SmithKline) for prophylaxis.  The subject had no pre-existing physician diagnoses allergies, birth defects, or medical conditions. The subject's concurrent medications were not reported. On 03 May 2005, the subject received the 5th dose of Infanrix in an unspecified arm (lot AC14A011AA). On 05 May 2005, two days after the administration of Infanrix, the nurse reported that the subject experienced, "extensive swelling from the injection site to the elbow lasting from one to five days." The subject also experienced erythema (11x8 cm area). The subject was treated with warm compress. The events resolved on an unspecified date in May 2005. The nurse considered the swelling and erythema related to vaccination with Infanrix.
Extreme pain and swelling in arm with fever from first shot in particular.  Heart issues and chest pain intermittently as well since the start and completion of my series of shots.  Any illness now causes heart rate to become dangerously fast since being both vaccinated and then sickened subsequently in August 2022.  I also have mild anemia as diagnosed by blood tests performed in Oct 2022 and other associated back and leg pain that is pretty much constant and nearly debiliating.  It takes a lot to keep pushing through the pain and symptoms.  Not clear to me if the vaccine alone, or vaccine followed by post-covid combo is more to blame, but did not have blood issues like this prior to covid vaccination. Pain in arm started almost immediately after the first shot.  Heart rate problems and fever started about 12 hours later and took a day or two to go away.  Did not seek out medical help until this fall due to being treated like a crazy person in Nov 2019 after getting hospitalized with covid-like symptoms and subsequently being instituationalized with what was called a "bipolar episode" due to the staff at med center, dissmissing claims as solely mental illness.  I have lost all trust of the medical establishment between these experiences and my own credentials as a PhD chemist with inside knowledge and contacts telling me what is really going on vs. the narrative with vaccine adverse effects.  I am still trying to figure out what is now going on with my body, but have not been able to get rid of the constant remaining lower body pain and issues caused by the blood  anomalies in recent tests.  I have a hard time believing with my education, contacts, and experiences your vaccine programs did not have a major role in my problems.
Patient experienced shortness of breath and nailbed cyanosis.  Symptoms were relieved at home with a nebulizer treatment.
Pre-vaccine, pt stated had broken out in a rash on Feb 12th, went to a walk-in clinic 02.13 and had been told to take Benadryl, 02.16 had Dr appt, continue Benadryl & added topical triamcinolone. Dr advised pt could get 2nd dose of vaccine. 15 minutes after second dose, pt presented with hives on both arms and back. Had not had Benadryl 02.18. Gave 1 dose of 25mg. No nausea, wheeze, thickening of tongue etc.  15 minutes later no change; at 30 minutes took 2nd Benadryl 25mg ( pt had been taking 2 per dose previously). Was given a rise home, lives with mother. Pt contacting Dr this afternoon for follow-up.
40 minutes after injection my tongue and throat began to swell and then close.  I had no saliva and could not swallow without sipping on water.  I stopped at a clinic to be near a facility in case I could not breath anymore.  They watched me for a bit (though I did not fully "check in".  The doctor suggested I get checked at an ER.  I went to ER and sat in the ER parking lot for two hours waiting to see if my symptoms got worse.  I did not want to use the ER unless I felt like I was in dire need.  After the couple of hours my symptoms weekend (but were still there).  I went to a friends place to not be alone in case the swelling increased again.  The next night I felt back to normal.  I have never had that reaction to anything, so I was a bit scared.
12Feb 10 - Onset of almost daily headaches, sometimes associated with shooting pains in hands and feet. No muscle weakness. History or chronic headaches since 1994.
Noted swelling and redness to upper right arm.  DTAP shot given in right deltoid.  Encouraged mother to apply a cold compress to area for 15 minutes at a time and give tylenol or ibuprofen as needed. Also recommended benadryl. Mother reports site improving gradually.  Encouraged mother to contact physician if site gets worse.
This spontaneous report as received from a physician assistant refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot# unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced throat cancer shortly after receiving ZOSTAVAX. No treatment information was reported. The outcome of throat cancer was unknown. Upon internal review throat cancer was determined to be medical significant event. Additional information is not expected.
Patient was diagnosed with  COVID-19 breakthrough infection on 8/27/2021 with positive PCR test
Pt was sitting in chair in the Observation area after waiting for approximately 30 minutes when she self reported tingling in face, arm, and tongue. Pt was moved to the gravity chair at the EMT station where she received water and 50mg of Diphenhydramine liquid oral solution. Pt self administered medication at 1310 and vital signs were taken every 5 minutes as patient was reassessed for any signs of respiratory distress. Vital signs 1505: BP 150/50 HR 72 RR 16 02 sat 99%. 1511: BP 145/75 HR 73 RR 16, 1515: BP 140/80 HR 64 02 97%, 1520: BP 140/70 HR 69 RR 16 02 98%, 1525 BP 132/75 HR 61 02 98%, 1532 BP 140/70 HR 66 RR 16 02 97%. Pt denied any SOB and reported relief from symptoms after taking oral medication. Pt vitals WNL throughout incident. Pt was able to communicate without any issues and make needs known throughout the incident. Emergency medical services (911) were offered to the patient; however, patient declined. Pt expressed wanting to go home and agreed to self administer allergy medication, Benadryl, for the remainder of the day. Informed the patient the need to go to the ER if symptoms worsened. Pt encouraged to sign up for VSafe upon leaving and to follow up with PCP.
This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (I felt my throat start swelling), VACCINATION SITE INDURATION (forming a knot), VACCINATION SITE PRURITUS (then began itching), VACCINATION SITE SWELLING (had swelling at the injection site) and VACCINATION SITE ERYTHEMA (red all around the injection site/the center is dark) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PHARYNGEAL SWELLING (I felt my throat start swelling) and VACCINATION SITE SWELLING (had swelling at the injection site). On 12-Mar-2021, the patient experienced VACCINATION SITE INDURATION (forming a knot) and VACCINATION SITE PRURITUS (then began itching). On 23-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red all around the injection site/the center is dark). On 11-Mar-2021, PHARYNGEAL SWELLING (I felt my throat start swelling) had resolved. At the time of the report, VACCINATION SITE INDURATION (forming a knot), VACCINATION SITE PRURITUS (then began itching) and VACCINATION SITE SWELLING (had swelling at the injection site) had resolved and VACCINATION SITE ERYTHEMA (red all around the injection site/the center is dark) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient was advised by her doctor to take Benadryl before getting her second dose. No treatment information was provided by the reporter.
Information has been received from a nurse practitioner referring to one unspecified patient of unknown age and gender. The patient's medical history, concomitant therapy and drug reactions were not reported. On an unspecified date, the patient was vaccinated with improperly stored doses of PNEUMOVAX23 (lot # L014458, expiration date 11-FEB-2018, dose, dose number and route were not provided) for prophylaxis, which were exposed to 48.4 Fahrenheit (F) for 24 hours. There was no previous temperature excursion. No adverse symptoms were reported. The data logger issue was involved. Additional information has been requested.
Started with chest pain because I work out a lot. Had to stop running. Been to ER 4 times. Cartilage inflammation. Had 24/7 headache. Everything came back normal. But headache has not gone away.
Had vaccination but I have still had shingles since/Suspected vaccination failure; Nerve endings are still healing on my neck and shoulder; I have still had shingles since; Try to destress but too much going on; 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.   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), neuropathy (serious criteria GSK medically significant), shingles and stress. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the neuropathy was recovering/resolving and the outcome of the stress was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and stress to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporters comment: The patient self-reported the case viainteractive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles several times. The patient stated that, when he/she got super stressed it came out. The nerve endings were still healing on his/her neck and shoulder. The patient tried to destress but too much was going on at the time of reporting. The patient also stated that, shingles was horrendous. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Developed elevated temperature with muscle aches and pains Day 7 after vaccination.  Swollen, painful lymph notes, unable to sleep x 24 hours.  Missed one day of work
Tinnitus in my right ear; pressure in right ear; migraine headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 15:00 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 09Apr2021 23:00, outcome "recovering", described as "Tinnitus in my right ear"; EAR DISCOMFORT (non-serious) with onset 09Apr2021 23:00, outcome "not recovered", described as "pressure in right ear"; MIGRAINE (non-serious) with onset 09Apr2021 23:00, outcome "not recovered", described as "migraine headache". The events "tinnitus in my right ear", "pressure in right ear" and "migraine headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, ear discomfort, migraine.  Additional information: Patient reported that, Immediately in the next day the tinnitus spread to his left ear and it was a continuous high-pitched ringing. The patient never had tinnitus before. The tinnitus began to subside after two weeks. Therapeutic measures were taken as a result of the reported events included antibiotics (unspecified). The patient did not receive any other medications within 2 weeks of vaccination. The patient did not have a history of any past drug therapy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
eyes became red & child started sneezing, then eyes started swelling periorbital edema;DPH & Pred given;
Information has been received from a pharmacist referring to a 64 year old patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 11-NOV-2015 the patient was inadvertently vaccinated with ZOSTAVAX (lot # K011003, expiration date 07-NOV-2015, strength, dose and route were unknown), after the vaccine had expired. The patient's concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Administered Novartis H1N1 (4 yrs and older) vaccine 0.25mL IM right deltoid. Should have given Sanofi Pasteur H1N1 (6 mo and older) 0.5mL IM. No signs or symptoms of distress noted.