chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has not gotten her menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (has not gotten her menstrual cycle) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No medical history.). Concomitant products included TAMOXIFEN.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-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 MENSTRUATION IRREGULAR (has not gotten her menstrual cycle). At the time of the report, MENSTRUATION IRREGULAR (has not gotten her menstrual cycle) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: negative NEGATIVE.         No treatment information was provided
About 11-12 days after administration of subcu. MMR, employee developed measles from rash, fever, and marked cervical lymphadenopathy bilaterally. Fever did not exceed 100.2 degrees. Symptoms resolved within a week. 3/9/10-No noted problems.
He does mention having shortness of breath along with cough. Admitted for COVID treatment including Remdesivir, dexamethasone, and supplemental oxygen
Believes she has Long COVID.  Started having a fever and an ear ache 3 months after vaccine. Was sent home from work and made to take the COVID-19 test. Tested negative. Still not feeling well though, when I saw my Dr, my oxygen levels were below 80. Immediately put my on oxygen. Was given labs and a CT scan, scan showed minor lung damage, believed to be from COVID-19 scarring. Ordered oxygen and have been on it ever since. Many lab tests taken, at one point it showed that I had a lot of acting white blood cells. Was given a lot of Smudge tests. Started feeling my heart fluttering and was given an EKG, and and Echocardiogram and they were normal. Given a Pulmonary Function test, negative;  Last CT scan said I have mild  Emphysema. Still have a low heart rate and am on oxygen. Had been on a CPAP already, then because of Insomnia I had 2 sleep studies done and was started on a CPAP with Oxygen. Oxygen needs keep increasing and up to taking 3 liters daily. Still have heart flutters at night and have started having Neuropathy Duloxetine, the dosages have been steadily increasing.  Have been having a lot of debilitating brain fog.
Information has been received from a 65 year old female with no medical history or allergies, who on 17-SEP-2007, was vaccinated with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included Effexor XR and vitamins (unspecified). "About a week after receiving zoster vaccine", on approximately 24-SEP-2007, the patient developed psoriasis in her scalp. Subsequently, she reported that she developed sores under her collar bone and swollen glands "several days" after receiving the vaccine. It was reported that she sought unspecified medical attention from her physician. The patient reported that at the time of the report she was recovering. A product quality complaint was not reported. No further information was available. The patient experienced pain in her arms following vaccination with "pneumococcal 23V polysaccharide vaccine" (manufacturer unknown) (WAES0170USA06172).
My arm has been hurting ever since I got my second dose of the vaccine. I had therapy for it, and it does not seem to be helping. I just started getting atrial fibrillation. I just seen the cardiologist. I had an EKG and TEE done to shock me back in rhythm for 3 times. It does not work. They have put me on blood thinner.
Administered to patients after possible temperature excursion; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021. The most recent information was received on 11-Aug-2021 and was forwarded to Moderna on 12-Aug-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Administered to patients after possible temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Administered to patients after possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Administered to patients after possible temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Significant FU: Reporter stated that no one has had any problems after the excursion.
This spontaneous report as received from a pharmacist refers to a patient (id# 925) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 14-AUG-2012. Lot# was reported as 0087AE, expiration date: 18-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes." This is one of several reported received from same source: 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
pt recv vax;red, hard x 24 hr;no T, on apap;rt upper arm bicep region cellulitis;claforan & augmentin x 10 days;
I was given the TDAP vaccine while pregnant and immediately felt sick to my stomach. That day I developed a low fever, chills, shaking, vomiting (once), body aches and pains, and nausea. This lasted for 72 hours. I missed work for 4 days and no medicated would sooth the symptoms. Doctor's told me it was "coincidence" despite my symptoms being labeled as possible side effects for about 1/100 people! I was not given informed consent.
Itchy Arm (Injection Site); Red Arm (Injection Site); Swollen Arm (Injection Site); Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)), VACCINATION SITE ERYTHEMA (Red Arm (Injection Site)), VACCINATION SITE SWELLING (Swollen Arm (Injection Site)) and MYALGIA (Body Aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)), VACCINATION SITE ERYTHEMA (Red Arm (Injection Site)), VACCINATION SITE SWELLING (Swollen Arm (Injection Site)) and MYALGIA (Body Aches). At the time of the report, VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)), VACCINATION SITE ERYTHEMA (Red Arm (Injection Site)), VACCINATION SITE SWELLING (Swollen Arm (Injection Site)) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
MIXED SERIES. PATIENT HAD PREVIOUSLY RECEIVED MODERNA VACCINE FOR FIRST DOSE.
Product temperature excursion issue; vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet). In September 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided. Frozen vaccine stored Minimum: -12  degree C, Maximum: -23 degree C. Multiple episodes of temperature fluctuation for 15-90 minutes each day from 01-Sep-2021 to 16-Sep-2021 due to freezer cycling and needing defrosted. Expired vaccine was used on 02-Sep2021 for 11 patients and on 16-Sep-2021 for 18 patients. This lot expires 24-Sep2021.
Patient received the first dose of SHINGRIX on Friday, May 18. After several hours passed from the vaccine, patient complained of redness and soreness but the injection site became more and more swollen, raised and painful for the patient. Also, she started to develop severe headaches, nausea/vomitting, and severe diarrhea. The nausea/vomiting and diarrhea improved after 2 days but the injection site was still not decreasing in size, redness or pain. Patient tried some migraine medication like ADVIL and applied some hydrocortisone cream for now but will seek medical attention and question to her physician.
Presented to hospital in ED, per the advice of the on call nurse department of health after scratch on right leg and right and right thumb from a sick appearing cat which died on day 10 post scratch. The cat died naturally just prior to being euthanized at the vet. I asked for the PEP. I was given two injections of HRIG on the right gluteal area, and one injection of HRIG on the left. Ok, that's acceptable. I was given the rabies vaccine in the left gluteal area, which I learned later is not acceptable. I was also advised that the rabies vaccine and the HRIG should be injected into anatomically different body parts to be effective. My mother is a retired public health nurse and informed me of this the next day after learning of my experience. I googled this topic, and it was immediately apparent that I shouldn't have gotten the vaccine in the gluteal and I shouldn't have gotten GRIG and the vaccine in the same body part. I called back to the facility and explained I didn't think the dose was valid and an error was made. I was told to download my chart app and send a portal message to the provider who was not currently working. I explained this was time sensitive and regarding a post exposure to a fatal disease and was told "well he wouldn't have put it there for no reason." Actually, a nurse did the injection, but I had to return to the ED at the main hospital location and was advised to wait until my day 3 injection. I don't think that was correct either, as my limited research indicated I should've started over because the first was not valid due to location and proximity to the HRIG. Thankfully, the cat was negative for rabies, but that was a long four days.
Same day hives. Continued for 2 days.... The following 3 days unable to walk. Fever. No eating. Now has chicken pox.
1st vaccination (4/3/2021) - day 1 migraine, fever, chills, dizzy, body aches, neck a d bad very sore, sick to my stomach and sore arm. Day 2 I had a headache, hot than cold and sore arm.  2nd vaccination (5/2/2021) - day 1 migraine, dizzy, legs felt weighted down, fever, chills, upset stomach, throwing up all night, sore arm, every joint and muscle hurt, neck and back very sore
About 2 to 3 days after vaccination patient developed  red bumpy itchy rash . Rash was on both forearms , the calves on both legs and patients back. When  the rash areas opened up it was watery inside. Patient was given a Medrol Dose pack on 5/17 and the rash cleared up after 6 days. . Three days ago around June 20th  the patient developed another rash and he will be going to his physician for examination.  Patient says this new rash may be work related but he is not sure at this time.
5/21/04: Rash, fever 100.2. Complained of mild pain in legs and feet/hands. 5/23/04: Elbows and arms felt feverish (both arms above elbows). 5/25/04: Pain in legs and feet continued with rash that would come and go. Cheeks had the "slapped" red appearance. Saw doctor on 5/22/04 who feels symptoms are due to MMR. Blood work done. 5/27/04: Rash comes and goes. No fever. Reddened cheeks continued. Saw Dr. again- feels it is a reaction to the MMR, swollen lymph nodes in neck area.
Ringing in the ears, loud and high pitch sound, dizzy, when laying down or standing up. Injection area is bruised and painful. 5 hrs after injection had fever.
This spontaneous case, initially received on 07-Nov-2018 from other health professional (nurse), concerns a 58-year-old, adult, female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient experienced no adverse event after the vaccination. This case (201805344) was cross-linked to the source case 201805327 due to same reporter. The reporter assessed this case as non-serious. Follow-up received from the nurse on 28-Nov-2018: Age of the patient was added in the patient tab. Route of administration and anatomical location was added in the product tab. It was reported that the patient had not experienced any adverse event after the vaccination. Narrative and case comment were amended accordingly.
Patient reported adverse event in person at pharmacy on 10/13/2020. Per pt, patient received flu shot on 10/09/2020 and then starting from the next day, 10/10, she started feeling numbness on one side of her face. Pt denies previous history of reaction to flu vaccines besides minor flu-like symptoms. She opted for watchful waiting until 10/13 when she decided to present to urgent care for further evaluation when numbness had not resolved. Per pt report, urgent care provider diagnosed her with Bell's Palsy and was prescribed a course of prednisone 60mg daily for 7 days.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 06-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly store vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
I felt extremely dizzy & light-headed within minutes of receiving the vaccine & needed to remain seated so as not to pass out. My spouse & I spoke with the pharmacist & one of them came out to check on me. I asked if he could take my BP as it routinely runs low (92/52) as I thought it might be further depressed. He did take my BP & to my surprise it was elevated to 135/85 maybe to compensate for a previous drop in BP. I remained seated for several more minutes to allow the symptoms to subside before I left & felt safe enough to drive home. I was OK after that with the exception of a sore arm for a day.
She became very irritable at 11:00 am on 11/21/14 just before vomiting.  She started a fever of 100.7.  She remained irritable all day, would barely eat, or sleep except for a couple hours after receiving Ibuprofen.  That night she was up crying all night, but seemed out of it at the same time, had 5 episodes of diarrhea, was congested and hoarse, and even after Ibuprofen would whimper like in pain and couldn't sleep.  Her fever broke around 11:00am on 11/23 (today). She remains very irritable, unable to sleep, hoarse/coughing/congested, doesn't want to eat much and seems to be in pain.  She is normally a very happy baby and barely gets fussy.
Low grade fever (onset 04/11; highest temp 100.4); Cough, coryza, conjunctivitis (onset 04/16; bilateral). Rash (onset 04/13; began on face-spread to chest, back and extremities) rash duration 10+ days.
my first two shots with no problems other than a sore arm; my first two shots with no problems other than a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 (Lot number: EN6207) at the age of 62 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; GABAPENTIN; LYRICA. Past drug history included: Codeine for Codeine based medication makes me nauseous., reaction(s): "Known allergies: Codeine", notes: Codeine based medication makes me nauseous. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Dose brand: Pfizer, Dose lot number: EN6202, Dose administration date: 06Feb2021), administration date: 06Feb2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Brand: Pfizer, Lot number: illegible, Administration date: 04Jan2022, Vaccine location: Left arm), administration date: 04Jan2022, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Jul2021, outcome "unknown" and all described as "my first two shots with no problems other than a sore arm".   Follow-Up: Follow-up attempts are completed. No further information is expected.
diverticulitis related to the colon and intestine; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (diverticulitis related to the colon and intestine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D 3), LEVOTHYROXINE SODIUM, CARVEDILOL, CLONIDINE HYDROCHLORIDE (CLONIDINE HCL), ALLOPURINOL, FAMOTIDINE, TELMISARTAN and SPIRONOLACTONE for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced DIVERTICULITIS (diverticulitis related to the colon and intestine) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 12 days due to DIVERTICULITIS. At the time of the report, DIVERTICULITIS (diverticulitis related to the colon and intestine) outcome was unknown.      As treatment the patient received antibiotic (not specified). Patient never had a flare up or anything like that in the past. Company Comment: An alternative explanation is that the serious unexpected event of Diverticulitis with the onset latency of 3 months 27 days following the mRNA-1273 vaccination was more consistent with the increased risk due to age, diet and lifestyle factors.; Sender's Comments: An alternative explanation is that the serious unexpected event of Diverticulitis with the onset latency of 3 months 27 days following the mRNA-1273 vaccination was more consistent with the increased risk due to age, diet and lifestyle factors.
Not feeling well after getting shots on 9/14/2023 for pneumonia, flu, tetanus, shingles and papilloma; had been sick after getting shots on 14 Sep 2023 for pneumonia, flu, tetanus, shingles and papilloma; Product origin unknown; labelled drug-drug interaction issue; This spontaneous report was received from a 50-year-old female patient referring to herself. Her concurrent conditions and medical past history was not reported. Concomitant therapies included sulfamethoxazole (+) trimethoprim (BACTRIM), furosemide, ondansetron hydrochloride (ONDANSETRON HCL), sulfamethoxazole (+) trimethoprim, spironolactone, salbutamol sulfate(PROAIR), oxygen, ambrisentan, sildenafil, fluconazole, paracetamol (TYLENOL), mycophenolate mofetil, diphenhydramine hydrochloride (BENADRYL N) and pantoprazole sodium monohydrate.     On 16-FEB-2023, the patient started therapy with treprostinil sodium (REMODULIN) 5mg/ml injection, subcutaneously (dose, frequency, lot number and expiration date were not provided) for pulmonary arterial hypertension. On 14-SEP-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) or pneumococcal 15v conj vaccine (crm197)(manufacturer unknown), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) (Product origin unknown), zoster vaccine live (manufacturer unknown) (Labelled drug-drug interaction issue), influenza vaccine (manufacturer unknown) and tetanus vaccine toxoid (manufacturer unknown) (doses, frequencies, anatomical locations, lot numbers and expiration dates were not reported) as prophylaxis. On the same date, the patient was not feeling well (Malaise) and had been sick (Illness). At the time of reporting, the outcome of malaise and sickness was unknown. The action taken with treprostinil sodium (REMODULIN) was not reported.  The reporter considered the events of malaise and sickness to be related to the suspect vaccines. The reporter did not provide causality between the events and treprostinil sodium (REMODULIN).
About 1 week, post vax, left wrist/hand was swollen and had numbness. The next day, right hand/wrist started swelling. The next day ankles and feet were sore and swollen. This lasted 3 weeks. Dx' by personal MD