chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 week from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (10 week from first dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT DOSE OMISSION ISSUE (10 week from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (10 week from first dose) had resolved.            No concomitant medications were reported.     Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FM0698), 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: "Gastrooesophageal reflux disease" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
DIFFUSE ERYTHMATOUS PAPULES AND PLAQUES CONCENTRATED OVER THE CHEST WITH CONFLUENT ERYTHEMA AND BACK BUT INVOLVEMENT OF NECK AND LESS SO THE EXTREMITIES; FEW SCATTER PINPOINT PUSTULES BUT NO LESION HAVE THE APPEARANCE OF HIS PRIMARY SMALLPOX VACCINATION SITE (CURRENTLY SCABBED). STARTED ON DAY #9 POST-VAX, SEEN ON DAY #11 WITH ABOVE EXAM AND RE-EXAM TODAY WITH FADING OF ABOVE FINDINGS.  DIAGNOSIS CONSISTENT WITH ERYTHEMA MULTIFORME AND TREATED WITH ZYRTEC 10 MG QD-BID.  NO MUCOSAL INVOLVEMENT
Tumor removed from tricep. A tumor developed over the tricep area, in same arm as the immunization was given. The pathology report identified the tumor as benign.
Pt's husband reports that pt. flinched as the needle was injected into her right arm and she stated the injection hurt. Pt is experiencing left shoulder pain (pain level 8/10). This past Sunday 5/16/2021 and this morning pt. stated her pain has increased, and there's a lot of pain when she moves her arms forward and out. Pt reports that when she bend her arms and keep her arm at chest level there is less pain. Pt husband's states that bc of pt.'s Ehlers-Danlos Syndrome sometimes her shoulders would sit lower and this could be the possibility that the pharmacy technician could have given the injection too high up on her right arm.  Pt husbands reports that pt. had tried Tylenol, Oxycodone and medical marijuana none provided her with any relief. When she took Cyclobenzaprine that seems to help a little. Pt had also tried massaging it, and this made the pain a lot worse. She also tried ice and heat, the iced helped a little but not much.
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 4/8/2021 SYNCOPE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 5/11/2021 SYNCOPE
Arm soreness, chills, sweats, and severe body aches day of vaccine 1/5/21.
began vomiting 1/2 hr p/vax; became lifeless; turned blue, called ambulance 02 was administered w/heart monitor on way to hosp-CXR-blood work done;
pt called and said feeling sick had fever 101 and chest tightness, Recommended calling dr and seek medical help
Have had hives/rash since my 1st vaccine that never went away.  2nd shot caused more hives to develop (head, face, neck, shoulders, chest, both arms).  Since 2nd shot, the site has been swollen (like a goose egg), red, itchy, sore....gets worse each day (on day 5 now).  Been taking Hydroxyzine & alternating Zyrtec & Benadryl.  Used hydrocortisone & Calamine.  Applied ice to site.  Have also had a horrendous headache that will not ease.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2021 as dose 3 (booster), single (Lot number: 301358) at the age of 67 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment,. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: There was no other medication in 2weeks. Antiviral details: Product: Paxlovid, Treatment start date: 10Sep2022, stop date: 14Sep2022, Indication: Treatment of COVID-19. Rebound 5 days after finishing paxlovid course. Adverse event start date: 18Sep2022. If patient recovered: Recovering. If treatment ae: No. Known allergies: No.
Muscle pain, joint pain, because of muscle pain it hurts to breathe in lower back. Have to take shallow breathes. Can?t sleep the pain is so bad. Still probably better than getting COVID... but darn this sucks.
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 was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 30-SEP-2016, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, on or about 30-SEP-2016, the patient presented to a medical group with complaints of a painful, itchy rash, along with other symptoms (unspecified). The patient was evaluated and diagnosed as suffering from shingles. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of ROTATEQ (strength, lot# and dose were unknown) orally, which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
3 welts the size of 1/2 dollar developed on the neck behind the ear 3 days after vacccination.  They were red, swollen and tender but getting better.
Cough and diarrhea the day after receiving vaccine.  The next day, had difficulty breathing and collapsed.
Half of my face (left side, same as shot side) went slightly numb, and had increased any of saliva.
Itchy rash all over body; Developed rash on her right arm then to her both arms and legs. On Sunday, the rash spread from her arms and legs to her stomach and back; This is a spontaneous report from a contactable consumer(patient). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0198, Pfizer NTEC), via an unspecified route of administration in left arm on 25Jun2021 16:45 as dose 1, single for COVID-19 immunization (at the age of 36-years-old). The most recent COVID-19 vaccine was administered in pharmacy. Medical history and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient stated that she had her 1st dose of the COVID-19 vaccine on Friday 25Jun2021 on her left upper arm and the next morning, she developed rash on her right arm then to her both arms and legs. On Sunday, the rash spread from her arms and legs to her stomach and back then come Monday the rash were on her neck and face and today, the rash spread to the palm of her hands. It was further stated that when she woke up Saturday morning (5 or 6 am), she had a rash on the opposite arm that she got the shot in. By 24 hours later, on Saturday night the rash was on both of her arms and both of her legs. The condition was reported to be worsened. Sunday (7 am), rash had spread from arms and legs to stomach and back. On Monday (6 am), rash was on her neck and face. Today, Tuesday, (29June2021), Tuesday (5 am) it was on the palms of her hands. She states she did go to the doctor (11:15 am) and she was given a steroid shot. The events lead to physician office visit for itchy rash all over body. The clinical outcome of Developed rash on her right arm then to her both arms and legs was not recovered except for event, itchy rash all over body which was unknown.
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 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 11Mar2022 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 06Sep2023 to 11Sep2023.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Experienced parosmia immediately after receiving the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAROSMIA (Experienced parosmia immediately after receiving the vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (Experienced parosmia immediately after receiving the vaccine). At the time of the report, PAROSMIA (Experienced parosmia immediately after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided.  Patient also mentioned that he was recording the call to send it to media.  No treatment medication was provided.   Reporter did not allow further contact
Information was received on 05-JUL-2017 from a pharmacist via a company representative who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. The pharmacist reported that the patient received a dose of ZOSTAVAX (lot and expiration not reported) on an unknown date "about a month ago" and developed a rash "from the injection site down the length of the arm". The patient was advised by the pharmacist to see their primary care physician. The patient has not provided any follow-up information to the pharmacist on the status of the event. No other information is available. Additional information is not expected. No further information to report.
Pain in left eye and tearing and under left eye, into cheek!  Pain in ear and in left side of throught fatigue and chills
started in july 2021 with severe hot flashes, daily headaches, severe depression, fear, rapid heart beat, dry eyes, dry nose, weight loss, dehydration, insomnia, stomachaches,
Within a few days was experiencing extreme pain in left leg, and difficulty walking. Pain ranged from lower left abdomen into leg down to calf. The pain , sharp, pins and needles, numbness got increasingly worse and began to experience atrophy in the left Quadriceps and Psoas. By the 15th I was unable to lift my leg off the floor in a lying down position and  was thought to be nerve  impingement /dysfunction.  For 2weeks following I was bed ridden not able to sit up , stand, move without bouts of excruciating pain. I could only lay on my right side. From Feb. 15th-Feb24th I had a CATScan,  Lumbar MRI, Pelvic MRI , 3 evaluations, and A dozen xrays with absolutely no findings or abnormalities in the spine, no tumors or hernias present, no issues with vertebrae or slip discs. Doctors were at a loss for diagnosis. I began to improve the 25th/26th of February gaining mobility and function back in my left leg. I have made almost a almost a complete recovery as of today , March 3 (yesterday March 2, I received my 2nd dose of Moderna. )
Patient reports arm pain and difficulty moving arm since the vaccination, patient reported during second vaccine appointment and was advised that his arm would need evaluated, due to NP feeling uncomfortable administering vaccine with patient symptoms, at which time patient left clinic with father.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, NauseaVomiting, Loss of taste and smell Narrative: Still have loss of taste and smell and continue to struggle with fatigue. Missed a week of work
Atrial fibrillation with rapid ventricular response, hospitalization, converted to NSR with flecainaide, 2 days hospitalization
All I had was a fever that started a few hours after. I was drinking fluid. But, after a walk I  had shortness of breath, and felt weak. I never had chills. But, when I got into my air-conditioned room, I felt better. Just had a fever. After, over a week the fever wasn't as bad. Just felt dehydrated, ringing in ears, and when I walk in sun my eyes see sparkeles. Plus, after the first week, my left nostril dried and felt uncomfortable. I can't afford a doctor, and I thought after 4 weeks things would be fine. But, still feel dehydrated, although I drink a lot. Still have ringing in my ears. Sight is better though, and my nostril is better.
TEMPERATURE EXCURSION FOR AN HOUR AND ADMINISTERED VIALS TO 5 PATIENTS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced temperature excursion for an hour and administered vials to 5 subjects, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion for an hour and administered vials to 5 patients and incorrect product storage was not reported. This report was non-serious.
Provider documented - Annular swollen areas where vaccination was given, around 6 cm in diameter, no warmth, no drainage.
Pt started having inc fever on 21FEB91 around 7PM; Also has vomiting, shake, fever of 104F; Fever lasted for 3 days; Saw PMD & he thought inc fever was due to DTP;
Within 2 months, patient began to experience severe panic attacks, and noted substantial depression, without any active or acute cause.  Was back in with doctor by 5/29/12 and did note this to the attending physician.  The primary purpose of this follow-up visit was for a skin inflammation/infection.
A 60-year-old patient received flu zone high-dose no AE; A 60-year-old patient received flu zone high-dose no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via a consumer/non-health care professional via (Reference number- 00824766) and transmitted on 22-OCT-2021. This case is linked to cases 2021SA356392 and 2021SA355376 (same reporter). This case involves a 60-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). At the time of the event, the patient had ongoing medical history of Chronic obstructive pulmonary disease (COPD) and Neoplasm malignant (unspecified cancer). The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no other concomitant vaccine. On 22-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ769AA, expiry: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination. It was a case of an actual medication error due to inappropriate age at vaccine administration and overdose (latency same day).  It was reported "Pharmacist states that during a flu-shot clinic, three of the patients who received FLUZONE QUADRIVALENT HIGH-DOSE, after attesting to be less than 65 years of age, were found to be younger. Two of the women were 60 and one was 45 years old. Caller asking what should be done." No other adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Straight line bruise vertically down arm from injection site extending down about 3 inches. Still visible now.
This spontaneous report was received from a medical assistant, concerning a 15 year old female patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Approximately in March 2018 (reported as 6 months ago), the patient received her first GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On 28-SEP-2018, the patient was at the office to receive her second dose of GARDASIL 9 for prophylaxis, lot #R009614 and expiration date 30-NOV-2018 (strength, dose, frequency and route of administration were not reported) (inappropriate schedule of drug administration). No adverse effects were reported.
Information has been received from a 74 year old female with pain from two previous back surgeries, unspecified heart problems, and a sulfa allergy who on 19-DEC-2006 was vaccinated with a dose of Zostavax. Concomitant therapy included valsartan (DIOVAN), atorvastatin calcium (LIPITOR), duloxetine hydrochloride (CYMBALTA), tramadol HCl (TRAMADOLOR), acetaminophen (TYLENOL ARTHRITIS PAIN), and prednisolone. Within a week of vaccination, on approximately 26-DEC-2006, the patient's typical back pain was intensified. The patient also mentioned experiencing headaches. Unspecified medical attention was sought and blood work was performed (results not provided). At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Pt recvd 3 doses of Engerix-B 5APR91, 6MAY91, & 5JUN91 & 17JUN91 titer level was 3.6, borderlline; 4OCT91 recvd another dose of Engerix-B & 9DEC91 titer was again checked & found to be 2.9, borderline; vax was considered to a non-responder;
Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm; Fatigue; Mild swelling, itching, and redness of left upper arm; mild swelling, itching, and redness of left upper arm; Nightsweats; Bilateral ankle sweling; Edema ,unspecified; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Nightsweats), JOINT SWELLING (Bilateral ankle sweling), OEDEMA (Edema ,unspecified), VACCINATION SITE SWELLING (Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included High cholesterol, Migraine, Shortness of breath, Heart rate abnormal in 2016, Chronic back pain and Depression. Concurrent medical conditions included Hypertension, Fibromyalgia, Neuropathy, Bipolar disorder, Drug allergy (Ultram (tramadol)), Drug allergy (Sulfonamides allergy), Drug allergy (Savella) and Drug allergy (metoproplol). Concomitant products included ARIPIPRAZOLE (ABILIFY), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FAMOTIDINE, SIMVASTATIN, PROPRANOLOL HYDROCHLORIDE (PROPANOLOL HYDROCHLORIDE), OMEPRAZOLE, PROMETHAZINE and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced NIGHT SWEATS (Nightsweats), JOINT SWELLING (Bilateral ankle sweling), VACCINATION SITE SWELLING (Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Mild swelling, itching, and redness of left upper arm) and VACCINATION SITE ERYTHEMA (mild swelling, itching, and redness of left upper arm). In 2021, the patient experienced OEDEMA (Edema ,unspecified). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at an unspecified dose and frequency and TRIAMCINOLONE at a dose of topical, one application two times a week for 10 days. At the time of the report, NIGHT SWEATS (Nightsweats), JOINT SWELLING (Bilateral ankle sweling), VACCINATION SITE SWELLING (Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Mild swelling, itching, and redness of left upper arm) and VACCINATION SITE ERYTHEMA (mild swelling, itching, and redness of left upper arm) outcome was unknown and OEDEMA (Edema ,unspecified) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Pt recv vax on 11/17/98; on 11/19/98 pt exp tremors/ pain of RA