chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TINNITUS.  I actually began experiencing a pronounced ringing in my ears in August 2021, nearly 4 months after receiving my second dose of the initial Moderna vaccine series. The ringing in my ears continued for the next several months.  I received a first booster (3rd shot) on 11/27/21 and continued to notice tinnitus thereafter, sometimes louder, sometimes softer.  I decided to have my hearing tested in February 2022 -- and had an aural test on 2/21/22. The results were that my hearing is nearly perfect, even at my age. Still, the tinnitus persisted off and on. Perhaps it got a little better as time went on? Hard to say. I thought it was due to hypertension, which I have recently begun managing with drugs.   YESTERDAY, I got my 2nd booster (4th total shot). Today, my tinnitus is very, very strong. And my head feels tight, like someone is squeezing it with their hands.  I understand this is merely anecdotal evidence and that it's difficult to establish causality here, but I wanted my story to count toward the statistics -- as I see that there are multiple accounts worldwide of tinnitus occurring perhaps as a result of the vaccine.
Pain in upper left arm when raising above shoulder level. Pain when sleeping on left arm. Pain has not diminished over the course of 18 days. Unable to raise left arm to remove clothing without severe pain.
Fever Cold Chills Cold Sweats Heavy Head Headache Tired   Lasted 3 days. I Drank lots of fluid, Slept a lot and took Tylenol
PT ADMIN. HPV VACCINE 15 MIN. AFTER ADMIN. PT FAINTED WHILE STANDING IN CHECK OUT LINE WITH FATHER AND HIT HER HEAD.V/S TAKEN BY NURSING STAFF AND PT WAS ASSESSED BY PHYSICAN LACERATION FOUND ABOVE LEFT BROW.AREA CLEANED AND ICE PACK APPLIED FOR SWELLING.PT D/C @11:35 AM. FATHER ADVISRD IF EPISODE HAPPENS AGAIN TO TAKE PT TO E.R.
Patient received the vaccine at 1:41 pm the next morning when she woke up she had a headache, nausea, and flushing. These symptoms have continued and was evaluated in the clinic on 2/3/21 for continued symptoms.
Feeling really tired all day and as the day went on it got worse; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8732) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia; "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high.; "High cholesterol" (ongoing), notes: Verbatim: High cholesterol. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot Number-EN6205, Expiry Date-Unknown), administration date: 10Mar2021, for Covid-19 immunization, reaction(s): "my arm was really sore", "the person that gave me the first shot she pinched my arm you know to put the shot in and my muscle were really sore". The following information was reported: FATIGUE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Feeling really tired all day and as the day went on it got worse"; PAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "Body aches". Therapeutic measures were taken as a result of pain.  Additional information: She took medication for the blood pressure so that keeps it under control. The patient just wanted to report some side effects that she was having from the Pfizer this was the second injection that she had it did not have any side effects from the first one except for her arm was really sore for 2 or 3 days but this time her arm does not get sore at all and she thought it was because the person that gave her the first shot she pinched her arm, to put the shot in and her muscle were really sore, anyway this time she was feeling okay after she got the shot but yesterday, she got it on Wednesday and so the next day she was just feeling really tired all day and as the day went on it got worse and she had body aches and then today when she woke up she felt okay but the day was going on she was feeling really tired. When paraphrased the above concern, consumer stated, "Yeah more tired". She took regular medications that she takes. She used some Advil, it was a pain relief. No follow-up attempts are possible. No further information is expected.
BREAKTHROUGH COVID INFECTION, PATIENT TESTED POSITIVE ON 11/09/2021. PATIENT FULLY VACCINATED ON 10/12/2021
1:45 pm Post vaccination reports "feeling heart beating fast", denies any additional symptoms or complaints; medical monitoring x 30 min w/vital assessment: BP 126/88 HR 130-135 RR 14 O2 sat 99% RA; 2:15 pm rest w/po hydration and persistent tachycardia  noted w/monitoring; HR 133. Transported via ambulance due to unresolved elevated HR, for further evaluation / treatment.
2 inj. were given. 1st inj HPV (R) deltoid IM, pt was ok concerned about soreness. I then moved over to his left side to administer 2nd vaccine MCV4 on left deltoid. As I gave 2nd inj pt c/o feeling nauseous. After administering 2nd vaccine I stood in front of the patient who was sitting on edge of exam table and then he fainted. I caught him, supported his head and laid him back on the table. I called the other MA's to exam room and when we came in he was sitting up. We told him to lay back down and kept him in the exam room for 10 minutes. Pt stated he was ok and felt fine spoke to Dr. and she advised  to keep him a little longer and make sure is ok then ok to release patient. Pt was able to leave on his own with mom.
Dizziness; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). On 08-Jan-2021, DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  Nausea is consistent with the known safety profile of mRNA-1273.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  Nausea is consistent with the known safety profile of mRNA-1273.
Report 2001024387-1 describes a lump at the injection site of a 5 month old male who inadvertently received the fourth injection of Infanrix five weeks, rather than six months, following receipt of the third injection. This report was received from the infant's mother and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the infant received his fourth injection of Infanrix, this injection was administered five weeks, rather than six months, following the administration of the third injection of Infanrix. On 09/25/2001, an unspecified time post-imunization, the infant developed a lump at the injection site. He had not experienced a lump at the injection site following receipt of any other vaccines. The lump persisted as of 10/01/2001.
had fevers and chills up to 104.7 degrees Fahrenheit for a 36-hour period; lethargy; This is a spontaneous report from a contactable Physician. A 40-year-old non-pregnant female first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899) intramuscular at arm Left on 19Dec2020 11:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included COVID-19 in Mar2020 with 10 days of fevers and chills and bilateral interstitial pneumonia. The patient had no other medical history and no known allergies. Concomitant medication included silicon dioxide (VIVISCAL), ascorbic acid (VITAMIN C), calcium, colecalciferol (VITAMIN D) and Gummy vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was administered at 11am on 19Dec2020, fevers and chills up to 103 Fahrenheit, and lethargy were started around 11pm. It was reported that the patient have had fevers and chills for 36 hrs after getting the first shot of the vaccine. She had fevers and chills up to 104.7 degrees Fahrenheit for a 36-hour period. The patient wanted to know if this response of fevers and chills was related to her being positive last march with accompanying Pneumonia and that if it still safe for her to take the 2nd dose, if it was due to a second time being exposed to Covid which was through the vaccine, could this be a robust immune response. COVID was not tested post vaccination. Outcome of the events was not recovered.
Patient looked very pale and felt neasous  and lightheaded. she was out of conscience for 20 seconds then came back. Called 911 ,paramedics arrived at the scene in like 3 minutes and put her in the ambulance after an examination. Patient was able to talk to paramedics and answering their questions. They diagnosed her problem being low blood pressure.
My entire face was swollen.  I lost my appetite for 3 days.   My blood sugar  is still elevated by 400 points and I didn't eat anything but water.   I had pain in my lower back up until yesterday.  I'm petrified of taking the final dose next week.  I went to the e r and het gave me Benadryl and prednisone.   What's happening with my blood sugar?
Information has been received from a physician concerning a newborn male (less than 24 hours old) with a normal newborn heart murmur who on 10/12/06 was vaccinated IM with 0.5ml first and second dose of Hep B vaccine at 18:00 and 20:00 respectively. No fever was reported and no other symptoms were noted. It was reported that the pt was hospitalized, pt is newborn. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Local reaction to injection site (cellulitis) treated with cephalexin. Resolved within 5 days.
/15/2022   Chief Complaint:  Shortness of breath, cough   Source of Information:  Patient   History of Present Illness:  This is a 81y.o. male Afib on Eliquis, HTN, HLD, diabetes mellitus, OSA on CPAP, BPH who presented to ED on 1/15/21 for shortness of breath and cough.  Patient reports he has been experiencing a cough associated with shortness of breath for several weeks, and it has progressively worsening.  He reports he starts coughing, and can not catch his breath, and becomes short of breath.  Patient reports experiences increased shortness of breath with laying flat, and has not been able to wear his CPAP machine the past few nights. Today prior to presentation, patient reports experiencing a coughing fit, and stating his whole body stiffened up, and extremities started shaking.  He reports he remembers the event.  Denies urinary incontinence or fecal incontinence associated with the episode.  He reports total compliance with all medications, and denies any missed doses.  He states he currently takes Lasix every other day.  Cough is nonproductive in nature.  He denies ever feeling like this before in the past. He also admits to intermittent right sided chest pain, that improved with nitroglycerin. Denies history of MI, PCI, or CVA. Denies fevers, chills, palpitations, abdominal pain, nausea, vomiting, constipation, diarrhea, dysyuria, hematuria.    He follows with doctor outpatient, who ordered a chest xray but what unable to get it due to his coughing, and came to the ED instead.  Upon my exam, patient sitting upright in bed, breathing on room air, unlabored, without accessory muscle use.   Upon presentation to the ED, patient afebrile 97.5, BP 115/70, HR 80, RR 20, SPO2 96%. COVID positive. CBC?WBC 4.6, Hb 13.5, platelets 139. Sodium 143, potassium 3.8, chloride 105, bicarbonate 27, BUN 16, creatinine 0.88, glucose 100. Magnesium 1.6. Lactic acid 2.6, 1.8.  EKG afib, rate 77 bpm. Troponin 0.01, 0.02.  BNP 264. CK 69. D-dimer 372.  CXR showed left basilar airspace consolidation. In the ED, patient started on azithromycin and rocephin.
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. ON 07-AUG-2012, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported) and on 02-JAN-2013 was vaccinated with the second dose of GARDASIL (dose, route and lot not reported). No adverse effect reported. The outcome of the event was unknown. The reporter considered the event to be not related to GARDASIL. Additional information has been requested.
Two days after her vaccine, she started itching, then a few days after that, the rash appeared. She has been taking Benadryl for itching. She will make an appt. with her dr. today to hopefully get a prescription for the rash and itching.
CARDIAC PROBLEMS; LEG NUMBNESS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced cardiac problems, and leg numbness. The action taken with covid-19 vaccine was not applicable. The outcome of the leg numbness and cardiac problems was not reported. This report was non-serious. This case, from the same reporter is linked to 20210937614, 20210920683 and 20210936884.
Morning after injection joints started to ache and felt feverish w/chills. He then noticed his arm where the injection was given became stiff, swollen, red and warm to the touch.
1 week later: (1) right arm rash, 3 in wide around arm - looks like arm band (2) developed ear infection, took ZPAK from urgent care (3) right ear feels blocked + pain - ENT wants further testing I haven't had ear infection in probably 60 years. (1) Hearing is normal for age in fact above normal. Checked 12/5/19 otolaryngology. 6 week followup for further testing if symptoms persist. (2) rash is still there faintly new, still itches (3) 11/20/19 woke up with blocked ear & pain. Went to urgent care. I was told ear was infected. I took Z-PAK. No change
Sore left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix. On 9th January 2020, the dose was an unknown dose. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a sore arm and it has lasted for months and yet not recovered. The reporter consented to follow up.  For tolerances of 2nd dose, refer case US2020AMR079295, reported by same reporter for the same patient. This case linked with US2020078683, reported by same reporter.
Patient's mom states patient had a temperature, severe nausea, headaches, dizziness, and fatigue - starting 06/19/2008 - 2 days after injection  of GARDASIL  #1
This case was reported by a healthcare professional (also the subject) via sales representative and described the occurrence of headache in an adult female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On 27 September 2013 the subject received a dose of FLUARIX quadrivalent (.5 ml, unknown, left arm). In September 2013, within 24 hours of vaccination with FLUARIX quadrivalent, the subject experienced headache, body aches and pain, injection site soreness and raised area injection site. Within 24 hours of receiving FLUARIX quadrivalent, a nurse reported experiencing a headache that was between three and four on a pain scale, body aches and pains, and a local injection site reaction, clarified as sore and raised at the site. All the events lasted for about 48 hours before completely subsiding. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX quadrivalent.
COMMON COLD; body aches; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (chest congestion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition reported.).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-1021, the patient experienced PULMONARY CONGESTION (chest congestion) (seriousness criterion medically significant). On 15-Apr-2021, the patient experienced NASOPHARYNGITIS (COMMON COLD) and MYALGIA (body aches). At the time of the report, PULMONARY CONGESTION (chest congestion), NASOPHARYNGITIS (COMMON COLD) and MYALGIA (body aches) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Reporter did not allow further contact
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning an adult female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 13-Mar-2012, the patient received expired FLUMIST for flu prevention. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 17-Apr-2012 and incorporated into the narrative: Suspect drug information, patient demographics and no late occurring adverse event.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-SEP-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 13-JUN-2016, the patient was treated at a healthcare facility/office (by an unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a pharmacist refers to a female patient of unknown age. No medical history was reported. It was reported that the patient was currently pregnant, but no further details were provided. On 24-JAN-2014 the patient was vaccinated with M-M-R II (albumin status: rHA), subcutaneous for vaccination. Lot number was reported as 0664AA with an expiration date of 04-MAY-2013. Therefore, this concerned an expired dose of M-M-R II. No adverse effects or any details regarding the patient's pregnancy were reported. No further information was provided. Additional information has been requested.
Roughly 36 hours after injection my son woke up with his left thigh swollen, itchy, tender, and hot to the touch. Went to the ER where they diagnosed cellulitis. Swelling has continued throughout the day and is still spreading. ER doctor prescribed 10 days of antibiotics.
Patient received Moderna bivalent dose BUD; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna bivalent dose BUD) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna bivalent dose BUD) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna bivalent dose BUD) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna bivalent dose BUD).    No concomitant medications were reported.  No treatment medications were reported.
he received GARDASIL and it did not work for him; he is seemingly unhappy; This spontaneous report was received from a pharmacist via company representative, who is also a male patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the company unidentified human papillomavirus (HPV) vaccine (strength, exact dose, dose #, lot #, expiry date, anatomical location and route of administration were not provided) (not verify whether the reporter was talking about GARDASIL or GARDASIL 9) for prophylaxis. He stated that it did not work for him (vaccination failure). The patient was seemingly unhappy with this experience.  At the time of reporting, the outcome of the events was unknown.   The causal relationship between the events and the suspect therapy was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA002125:
Redness around injection site of the right arm and tenderness in this area.  Redness 2 days later measures 23cm x 23cm in size.
Patient began to feel what she describes as "tightness and pressure" on bilateral sides of neck near lymph nodes. Pt became flushed red in the face and face became warm. A minute thereafter breathing became difficulty and she began to feel some abdominal pain. After deep inhalation and exhalation, pt was administered a Benadryl 25mg and 8 ounces of water patient's color began to return and her breathing improved and her abdominal pain resolved. Patient was monitored for 30 minutes and assessed before departure.