chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    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, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. 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. No treatment medication was provided.  Company comment  This is a spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19, unknown days after  receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Patient previously received a dose of Pfizer vaccine and a dose of Janssen vaccines on unknown dates. Interchange of vaccine products was noted. Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of covid 19 was unknown. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19, unknown days after  receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Patient previously received a dose of Pfizer vaccine and a dose of Janssen vaccines on unknown dates. Interchange of vaccine products was noted. Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of covid 19 was unknown. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
PATIENT REPORTED THAT ABOUT ONE WEEK AFTER THE SHOT SHE DEVELOPED A "CHEMICAL BURN" ON TOP OF HER RIGHT HAND.  SHE DESCRIBES IT AS BEING PAINFUL AND RAISED.  SHE CANNOT ATTRIBUTE IT TO ANY OTHER CAUSE.  THE VACCINE WAS THE MOST PLAUSIBLE EXPLANATION.   THE "CHEMICAL BURN" PERSISTED FOR ABOUT A COUPLE WEEKS.  AT THE TIME OF HER 2ND COVID SHOT, IT HAS RESOLVED ITSELF BUT HYPERPIGMENTATION STILL VISIBLE ON HER HAND.
POST VACCINE WAS CONFIRMED THAT I HAVE NOW DEVELOPED ?TINNITUS? IN BOTH EARS.
hot to the touch; tiredness, tired; size of a tennis ball; got really red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (size of a tennis ball), ERYTHEMA (got really red), SKIN WARM (hot to the touch) and FATIGUE (tiredness, tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination.     The patient's past medical history included Pneumonia. Concomitant products included DULOXETINE and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PERIPHERAL SWELLING (size of a tennis ball), ERYTHEMA (got really red) and FATIGUE (tiredness, tired). On an unknown date, the patient experienced SKIN WARM (hot to the touch). At the time of the report, PERIPHERAL SWELLING (size of a tennis ball), ERYTHEMA (got really red), SKIN WARM (hot to the touch) and FATIGUE (tiredness, tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is taking concomitant medications :Blood pressure medication pill ,Thyroid pill patient had COVID in December Treatment information was not provided
Right axillary swelling and soreness; This report received from a business partner via clinical trial 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines, (subject number and site number were not reported). The subject's weight, height, and medical history were not reported. The subject initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 23-JUL-2021, the subject experienced right axillary swelling and soreness.  The dose of covid-19 vaccine ad26.cov2.s was not changed. The subject was recovering from right axillary swelling and soreness. The investigator assessed the severity of right axillary swelling and soreness as grade 1 mild adverse event. The investigator considered the causality between covid-19 vaccine ad26.cov2.s and right axillary swelling and soreness as possible.  This report was non-serious.
lump at injection site; This is a spontaneous report from a contactable consumer (Patients father reported for daughter). A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration in 2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lump at injection site on 22Jul2021. Reporter stated, His daughter received the shot about 5 weeks ago. They read the fact sheet which states that if there may be a lump when having the shot. He wanted to know Is it normal for it to appear 5 weeks later. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up.
Patient received 2 vaccines at the same time on 11/29/2021; prior to this patient received 5 vaccines on 10/28/2021 (Anthrax #10, Typhoid #6,  meningcoccal #3, JEV #1, Rabies #1) and 1 vaccine on 11/05/2021 (Rabies #2)  Patient reported 7 days post vaccination that he had left sided chest pain, pain under left side of ribs and into back, left quadricep pain, and pain with breathing and coughing.  Patient reports that symptoms started on 12/05/2021. Patient presented to ER on 12/06/2021.
I had a very low grade fever, muscle aches, fatigue, sore arm. About a week later I experienced a small fiber nerve tapping. Numbness and tingling and twitching around my eyes, nose, mouth and forehead. Also, have tingling in feet, legs, arms and hands. He prescribed Gabapentin for the nerve tapping. Still under doctors care.
This spontaneous report as received from a health care worker refers to a female patient of unknown age. The patients pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 31-MAR-2014 the patient was vaccinated with GARDASIL lot # J013324, expire date 12-FEB-2016, intramuscular. No concomitant medications were reported. On 31-MAR-2014, few minutes after the therapy the patient fainted. The sought medical attention was not reported. After few minutes (31-MAR-2014) the patient recovered from the adverse event fainted. It was reported that the lot check was requested. This is one of the two report received from the same reporter link (1404USA008325). Additional information has been requested.
Injected in L. Gluteus. Severe local reaction. 10 cm x 4 cm welting, redness, heat, itching. Lasting over 2 weeks.
I received my vaccine day 3 of my Menstrual Cycle. I have a history of heavy periods but it had gotten better after being on Birth Control. After receiving the Covid vaccine I had experienced a heavy hemorrhagic blood flow filling up an overnight pad and ultra tampon over the course of 90 minutes. I had bloodwork done about a week later. It was discovered that I was severely Anemic. I have started on Iron and will be getting Iron infusions.
This is a spontaneous report from a non-contactable nurse. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. About 6-7 hours later the patient experienced severe headache, muscle aches and pain on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
No other AE; patient that received PNEUMOV AX 23 in November 2018/ on 12/3/2020, but they administered PNEUMOVAX 23/ she has one non-functioning kidney/the patient is over 65 and is not immunocompromised; scheduled to receive a dose of PREVNAR 13 on 12/3/2020, but they administered PNEUMOVAX 23; scheduled to receive a dose of PREVNAR 13 on 12/3/2020, but they administered PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to an elderly female patient. The patient was not immunocompromised and had a single functional kidney. No information regarding the patient's medical history or concomitant mediations was provided. On an unknown date in November 2018, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial, (dose, route of administration, anatomical localization, lot # and expiration date were not reported) for prophylaxis. On 03-DEC-2020, the patient was scheduled to be vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVENAR), but she received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S028601 with expiration date on 02-JUN-2021 (dose, route of administration, anatomical localization, lot # and expiration date were unknown) for prophylaxis. No adverse event was reported.
Symptoms: Fever, Chills/Shivering, Body/Joint aches, Malaise, Headache, Rapid heart rate. Time course: Symptoms began about 12 hours after injection and continued for 30+ hours.  Completely resolved after about 40 hours. Treated with Ibuprofen.
Headache, lethargy, light headed, injection site pain, nausea, ocular migraine
Client received 1st dose vaccine and remained in post vaccine monitoring, at the 15 minute point (end of monitoring) before leaving client reported feeling very dizzy with blurred vision. On assessment client was sitting up in chair, alert and oriented, V/S HR 72, RR 20, BP 124/72 O2 sat 98%. Lungs CTA, no reported difficulty with breathing. Client reported additional symptoms of itching, no rash noted and no change in skin color or appearance; nausea was also reported at this time. Information obtained from client on medical history, vaccine history, allergies and current medications. During this time period the itching and nausea was relieved, but the dizziness and blurred vision remained; V/S HR 74, RR 20, BP 128/78 O2 sat 98% . Client reported he started on a new medication Hydroxizine approximately 2 weeks ago and did experience dizziness in the first 2-3 days of starting the medication, but has not had that occur since that time. Client was unable to stand initially for BP check while standing, at 0945 additional medical assistance available to assist: sitting BP 130/76 HR70, standing BP 124/70 HR 70. Client reported no change but states dizziness and blurred vision continued and now he is seeing with blurred vision in what he reported at "cool and warm colors - like a filter on a phone".  EMS was called at 0959, arrived at 1011 to evaluate and transport client to the hospital for evaluation. Client departed with EMS on a stretcher at 1014am.
Tightness in chest several times about 1 week and 2 weeks after 1st round. Difficulty sleeping on left side 20 and 21 days following 1st round. Severe pain with inhaling AM of 22 day. Diagnosed at ER Hospital, with DVT left calf and PE both lungs. On Heparin IV for 4 days inpatient. Now on Eloquis 10mg BID for a week, 5mg BID thereafter.
pt recvd vax on arm w/inject-swelling & hot & red from shoulder to elbow; swelling gone w/in 24 hrs; pt did not seek medical attention; used ice packs; f/u 24OCT94 all sx gone x/itching;
Hurting at injection site then arm swelling from shoulder to tips of fingers on entire right side of arm per dr 4 tsp liq Benadryl (12.5/5) given at 6:30 PM when pt returned to night clinic ice applied to area.
arm pain/soreness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EK9231), intramuscular at the left upper arm on 05Jan2021 10:20 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 05Jan2021, the patient experienced arm pain/soreness she took some Tylenol, not that she needed too much. She recovered from the arm pain/soreness within a day or two days. It was not a big deal.  The patient weight was 157-158lbs on an unspecified date. The outcome of the event was recovered on Jan2021.   No follow-up attempts are possible. No further information is expected.
I am atheletic and healthy, I do not take medicine nor have any physical conditions requiring me to do so.  I took the vaccine because I am the Director of Nursing at a Long Term Care facility and felt like I needed to encourage the staff.   First item was my knee became swollen like a bowling ball couldn't hardly walk, had to go to ER and was charged a significant amount due to my deductible, 2nd incident in March I had a knot come up on  my hip, could barely walk, 3 rd incident knot at my should blade, Pain with all the above and believe me I have never had pain or these kinda problems ever in my life.   Strange to me that these things have happened and continue only after I recevied the vaccine.  Just thought you should be aware.
The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent sentences.  Took Tyelenol before bed because my arm was very sore.  Next morning, my whole body ached and had a severe tension headache, my jaw was very tense also.  I was still very lethargic and my mind still "cloudy".  Took Tylenol again after dinner, that night I started to feel relief from aches, headache and my mind can think more clearly.
Case symptom onset 7/26/21 which included subjective fever, chills, runny  nose, sore throat, olfactory disorders, headache, fatigue and diarrhea. Case was Rapid Antigen tested for Covid 19 on 7/30/21 and was determined to be positive.
Gave a Moderna vaccine to a 17-year-old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave a Moderna vaccine to a 17-year-old) in a 17-year-old patient of an unknown 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, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave a Moderna vaccine to a 17-year-old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave a Moderna vaccine to a 17-year-old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications was not provided by the reporter.   Gave a Moderna vaccine to a 17-year-old on the 18th and parent wish to get a second dose for the patient.
Vasovagal bout 10 seconds and lied on exam bed. No injury and was oriented.
Information has been received from a 70 year old female with no medical history or allergies who in March 2007, was vaccinated with a dose of Zostavax. Concomitant therapy included PULMOCORT and montelukast sodium. In March 2007, two days after vaccination, the patient developed an orange colored rash on the back of her arm. Unspecified medical attention was sought and no diagnostic laboratory tests were performed. The patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Suspected Vaccination failure; came down with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and came down with shingles. The patient stated that it was three months of he/she never ever want to go through it again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Arm was AS sore this time. But several hours after receiving it, I started getting a headache,Took Tylenol and went to bed. Woke up a couple of hours later VERY FATIGUED AND ACHY, FEVER OF 100.8, HEADACHE.  All of this lasted about 18 to 20 hours. Approximately 24 hours after vaccination, I started feeling nauseous and light headed, which lasted an additional 24 hours. DID NOT seek or need medical care. Tylenol helped, except for the nausea
I received the PNEUMOVAX 23 inj 25mcg/0.5ml pf syr in left arm at 4:30pm. Around 8:00 pm I started to develop pain in my left arm. By 10:00 pm I was in extreme pain and could no move it. After 24 hours the pain started to lessen but still very painful. It has now been nearly 48 hours and 48 hours, and I cannot lift my arm higher than my chest.
After pt recv'd 5th dose of Anthrax, he exp local redness, pain, & stiffness; which moved to back and neck over course of next 3 days. No fever. 4 inch swelling.
PREVNAR administered to patient on 11/12/2018 by certified pharmacy intern. Patient had already received Flu shot in same arm. At time of administration, patient reported that she felt a lot of pain in her shoulder. Intern reported he administered the shot above Band-Aid where she received flu shot and was wondering if he administered the shot too high in deltoid area. Patient's husband reported to pharmacy on November 21st and said his wife was having so much pain in the area where the shot was administered that she could not lift any items and experienced a lot of pain to move her arm. She had reported to her physician on an unknown date after the shot for alternate problem and she described the pain in her arm and the approximate area that the shot was administered. The nurse confirmed that she thought the shot was administered above the area of the deltoid that the shot is usually given. The patient had her husband report this incident to our pharmacy, because she was too embarrassed. The husband said she was slowly improving, by using TYLENOL and heat to ease the pain. He just wanted to report the incident, so it did not happen again. I reassured him that I would discuss with staff and report incident to VAERS and our own reporting system. I listed as adverse drug reaction, however, I feel that the administration was more to blame than a reaction to the medication itself in this incidence.
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    It was reported as COVID19 Eligible. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.             No treatment information was provided by the reporter.
This spontaneous report has been received from a registered nurse referring to a female patient of unknown age. The patient's concomitant medication included sterile diluent (manufacturer unknown). The patient's pertinent medical history and drug reactions/allergies were not reported. On 17-JUL-2018 the patient was vaccinated with an expired dose of M-M-R II (route and strength unknown; lot # M028131, expiration date 02-JUN-2018; therapy type rHA) for prophylaxis. It was confirmed with nurse that dose of sterile diluent (manufacturer unknown) used for reconstitution of M-M-R II was properly stored which was already properly disposed. Confirmed with nurse that expired M-M-R II had no temperature excursions prior to being administered. No adverse effects reported.
-pt received 1st Shingrix shot 9-12-19. Injection site redness, hot, -> redness traveled to armpit area towards breast tissue x 3-5 day - chills, small rash left side, not pyretic. pt for second shot & wasn't told of reaction. MD aware.
Soreness at site, throat pain (felt lump when swallowing, but not like strep throat), itchy watery red eyes, headache, coughing, phlegm in throat
Patient became dizzy, lightheaded and shaky.  Epi Pen was given, patient felt much better after the dose of epinephrine.
Information has been received from a doctory of pharmacy concerning an 80 year old female who on 04-MAY-2007 was vaccinated with ZOSTAVAX (656859/0357U). There was no concomitant medication. On 15-JUN-2007 the patient developed lesions on her back and trunk. She was diagnosed with a mild case of herpes zoster. The lesions were no longer present as of 22-AUG-2007, but she did have postherpetic neuralgia. She was treated with NEURONTIN. Additional information has been requested.
Metallic/bitter taste in the mouth persists for more than one week from the onset(4th of April) to today (4/13). developed body aches 24 hours after the vaccine and disappeared after 2 days, 30 weeks pregnant( no other pregnancy-related complications) at the time of vaccination. Due date June/3/2021.