chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen joints; Pain; Hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen joints), PAIN (Pain) and HOT FLUSH (Hot flashes) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    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, dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced JOINT SWELLING (Swollen joints), PAIN (Pain) and HOT FLUSH (Hot flashes). At the time of the report, JOINT SWELLING (Swollen joints) and PAIN (Pain) outcome was unknown and HOT FLUSH (Hot flashes) had resolved.            No concomitant medication were provided  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  For Humira, causality as per reporter for events pain and swollen joints was not reported and for event hot flashes it was reported as no reasonable possibility.  For Janssen COVID-19 vaccine, causality as per reporter for events pain and swollen joints was not reported and for event hot flashes it was reported as possible.  No treatment details were provided
Received third dose , not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received third dose , not immunocompromised) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399243, 041L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received third dose , not immunocompromised). On 17-Sep-2021, EXTRA DOSE ADMINISTERED (Received third dose , not immunocompromised) had resolved.            No concomitant medications were reported. No treatment medications were reported.
severe headaches daily; This is a spontaneous report from a contactable physician who is the patient.   A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: unknown), via an unspecified route of administration on an unknown date in May2021 as a single dose for COVID-19 immunisation. Medical history included migraines. The patient's concomitant medications were not reported. The patient stated that since receiving the vaccine in May2021, he had severe headaches daily. The patient stated that he was a chronic migraine sufferer, but had it controlled with medicine. Since the vaccinations, the patient stated that he did not get relief from his migraines. The outcome of the event was unknown.  Information about batch/lot number has been requested.
patient given Tdap instead of Dtap during visit. Parent contacted; patient okay no reaction/symptoms.
Systemic: Joint Pain-Medium, Additional Details: finger swollen,red,hurting,cant move well
Vaccines administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyond use date after thaw process) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 31 years 1 month.  No concomitant medication was reported by reporter.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.  Patient was not involved with any adverse reaction.  No treatment medication was reported by reporter.
got Covid 1st time in Sep2021; got Covid 1st time in Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 82-year-old male patient received bnt162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 22Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2021, outcome "unknown" and all described as "got Covid 1st time in Sep2021". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 125/80, notes: blood pressure is in normal bounds, it was 125/80; SARS-CoV-2 test: Negative, notes: Negative now on Covid.  Clinical information: 84 years old great health. Over the last 3-4 years he had Covid 3 times. He has always had the Pfizer vaccine for Covid and has stayed up to date on the vaccines. 10-12 days ago, he had the third round of Covid. In the second round, he was advised to wait some period, either 2 months or 6 months, after ending the Covid to get the booster shot due to his body building an immune response. He is negative now on Covid. He was told he can take the new vaccine now instead of waiting. Why can he take it next week instead of waiting a certain period since his body has built immunity. There was no information stating there is a certain amount of time that must be observed after infection before a patient can get the vaccine.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300301887 same patient/drug/AE, different dose number/event onset date;US-PFIZER INC-202300301888 same patient/drug/AE, different dose number/event onset date;
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was asking how long side effects would last.
Received vaccine Tues am 5/31/16. Thursday felt muscle cramps neck and shoulders after driving 4 hours. Friday LBP with stiffness. Then fever, chills. Next tingling feet. Site: 1" red, mildly elevated, warm.
Swelling, soreness and stabbing pain in right shoulder.  Movement of the right arm results in persistent stabbing pain, radiating down to mid upper arm.  Pain ranges from a low of 4 out of 10 to a high of 10 out of 10, depending on direction of the motion for the arm.
The child was found rigid and frothing in her mouth in her crib at 5:00 am approximately 12 hours post vax. No fever.
got really sick; Bronchitis; rash around and under her arms; itching around the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), ILLNESS (got really sick), RASH (rash around and under her arms) and VACCINATION SITE PRURITUS (itching around the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced RASH (rash around and under her arms) and VACCINATION SITE PRURITUS (itching around the site of injection). On 27-Jan-2021, the patient experienced BRONCHITIS (Bronchitis). On an unknown date, the patient experienced ILLNESS (got really sick). At the time of the report, BRONCHITIS (Bronchitis), ILLNESS (got really sick), RASH (rash around and under her arms) and VACCINATION SITE PRURITUS (itching around the site of injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  Treatment information not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.   But for the event of Intentional Product Issue there  were no reported AE's noted.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, muscle pain and fever. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the muscle pain and fever were unknown. It was unknown if the reporter considered the influenza-like symptoms, muscle pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was patient's wife. The reporter stated that her husband experienced flu like symptoms after vaccination. She disconnected call abruptly and was not able to clarify if this was with SHINGRIX, but since the discussion of the call was around this product it was being captured. The reporter disconnected the call abruptly and was asked for name but declined. The reporter noted she would be calling back to see if any other reports in 2 months about numbness. The reporter disconnected before she could be told, GSK would not be able to provide that information. All questions were not asked before the reporter disconnected abruptly. This case was linked with US2018131398, reported by same reporter for the patient's wife.
This spontaneous report as received from a consumer refers to a 4 years old female patient. The patient was vaccinated with a dose of VARIVAX (lot #, dose and route not reported) in 2010. No other co-suspects were reported. No concomitant medications were reported. The patient's mother reported that after recent testing on an unknown date, she learned that her daughter had no immunity to chicken pox virus. No treatment information was reported. The outcome of the event was unknown. The relatedness for the event was no provided for VARIVAX. It was unspecified if the patient sought medical attention. The twin brother's event is reported in Case # 1210USA008465. Additional information is not expected.
PT CAME IN WITH NO VACCINE CARD AND ASKED TO GET PFIZER BOOSTER DOSE AND TECH TOOK A WARD FROM PT AND WE ADMINISTERED PFIZER SINCE PT WAS UNDER IMPRESSION THAT SHE HAD RECEIVED PFIZER IN THE PAST FROM DIFFERENT PLACE. IN FACT, WE DISCOVERED LATER ON THAT PT HAD RECEIVED MODERNA IN THE PAST FROM THE local HEALTH DEPARTMENT. SO SHE HAD 2 DOSES OF MODERNA BACK IN MARCH AND APRIL AND TODAY SHE GOT PFIZER FROM THE PHARMACY SO WE ARE REPORTING THIS AS AN ERROR TO VAERS.
12-13 hours post second COVID vaccine shot (~2100) started to feel full body pains, lightheadedness and nausea. Then throughout the night symptoms worsened with significant body chills despite multiple layers, severe body pain and migraine trigger. In the morning felt like full-blown flu with fever of > 100 F, sensitive skin painful to the touch, cold sweats, full body pains, heart palpitations (pounding heart beats and ave 100-120 bpm), and migraine level 8/10. Medication required to try to treat symptoms (metoclopramide, claritin, excedrin). Symptoms continued and did not start to lessen until approximately 30 hours post vaccine dose (18 hours post severe symptom initiation) and two doses of medication regimens. Arm around injection site also showed raised, red irritation local to the site, however, was not exacerbated throughout the symptom course. COVID call center recommended for me to see emergency care facility due to symptoms which I waited to see if symptoms worsened before deciding to not go to the urgent care center.
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS Co-2 virus at time of administration". Patient reported no adverse reactions.
This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 31-AUG-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011133.
improper storage error/ no patient involvement.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product storage error (Verbatim: improper storage error/ no patient involvement.). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2023 The HCP (health care professional) requested stability data for Arexvy vials after cap removal, unknown length of time for cap removal or if vials have been punctured.  Arexvy refrigerator and in original box. No patient involvement, which led to intercepted product storage error. Did not get permission from reporter for safety follow-up.
Got really nauseous the first night and headache along with aches and pains. By the end of evening on 29th, I was running a fever. Fever on 30th - nauseous; aches; and pains. On 31st, the fever broke. I still had aches, pains, fatigue. Had chest tightness - harder to breathe. Each day a couple of symptoms would go away or get better. By Monday, I was mostly just tired. Tuesday I was  back at work.
82 year old lady with hx of CAD, valve surgery, post op PAF, PPM, paced, on coumadin, PCI, HTN, HLD, Pulmonary HTN, heart failure, VHD DM on janumet, presents to ED for evaluation of AMS due to hypoglycemia, blood glucose was 50s at home, was treated and here it was 32, was treated with Dextrose and improved after po diet intake up to 124. She had a rapid SARS and it was positive for COVID 19. She is asymptomatic for COVID, no cough, fever or any other symptoms, no sob, has not been out of her home but does have aides come to her home several time a week and PT personnel as well visiting her in her home . She does not speak language, information from daughter obtained . Patient is vaccinated with J/J vaccine last year.
On the 8th day I was not able to get out of bed, I had a lot of paint all over my body but the worse was on my both knees and joints. My husband had to carry me to the rest room to the living room. I when to the hospital where they told me I had to blood cloth on my both knees.
Moderna COVID?19 Vaccine: Immediate onset of left cervical tightness with headache noted later that day. Headache has been present off and on daily since (2 weeks later); with intermittent nausea
shortness of breath now evaluated as asthma, light headed, brain fog----first booster, next day and continuing, light headness off and on, brain fog off and on- hard to concentrate, find words
Headache started within 2wk of #2 vaccine for covid and has never stopped.
This spontaneous report was received from a pharmacist refers to a 72 year old female patient. On an unknown ate, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously for prevention of shingles. No concomitant medications were reported. Approximately on 29-AUG-2013 (reported as about one and half weeks ago), the patient developed cellulitis after being administered ZOSTAVAX. The patient sought medical attention-visited an unspecified emergency room, on an unspecified date and was treated with antibiotics (unspecified names, dosages/frequencies, and manufacturers). It was confirmed that it was unknown whether the patient was admitted to the hospital for cellulitis. There were no demographics provided for the emergency room. The outcome of cellulitis was reports as recovering. Additional information has been requested.
35mmx25mm induration at injection site 24 hrs within given cool compress, Benadryl, Tylenol
8/24/09 around 1:30pm after I gave pt GARDASIL injection, noticed that she wasn't feeling well. I asked if she had had lunch and she said no. I went to get juice & crackers and asked staff to watch her. When I came back she had no BP, pulse was difficult to obtain, eyes dilated, sweating, clammy. We called Dr to come and check her out. Lasted about 15-20 minutes.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date in August 2014 (also reported "5 months ago"), the patient was vaccinated with ZOSTAVAX, subcutaneous injection, (strength, dose, anatomical location, lot number and expiration date were not reported), on 20-NOV-2014 was inadvertently administered another ZOSTAVAX, subcutaneous injection, (strength, dose, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. No adverse effects were reported. No further information was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine 6/4/07. States she began having sweelling, redness and pain the morning of 6/5/07. On 6/5/07, left deltoid area with 65 mm x 55 mm erythema and edema. No increased skin temperature.
Chills fever diarrhea in the evening, short of breath next day with exertions, continued decreased activity tolerance until unable to go up one flight of stairs without fatigue and SOB, after 1 week slight foot swelling, 2 weeks, swelling of left foot and leg (pitting). Increased weight gain on 5 pounds, abdominal bloating.  Had cardiac blood test come back abnormal showing heart failure, DVT ruled out, echo showed LA enlargement mitral tricuspid prolapse, increase RA pressure.  While scheduling abdominal scan swelling went away. Repeated bloodwork and it came back normal.  Stress test 3 weeks later normal. Plan to repeat echo in 6 months
brief episode (15-20 seconds) of pt being blue, pale in color, lethargic & non-responsive;
Body aches, excessively swollen, red, warm to touch area about 3 inches by 6 inches that has progressively gotten worse throughout the day
patient received dose from a vial that had been punctured for 48 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that had been punctured for 48 hours) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that had been punctured for 48 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that had been punctured for 48 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    Reporter did not allow further contact
Patient, with no past medical history seen today for report of tingling in her upper and lower lips blurred vision and feeling lightheaded 10 minutes post vaccination. Patient reports that she has allergy to yogurt. Patient also reports that she takes xazyl daily for allergy, however she didn?t take it today.  Patient states that this is her first dose in the series. Patient denies being pregnant. NP and Paramedics at patient side. Patient blood pressure is elevated 156/95. Patient denies any history of HTN. All other vials within normal limits (99% RA, 98 HR, 18 Resp, bs 108). Benadryl 25 mg given to patient with a bottle of water and legs were elevated on a chair. Patient BP decreased to 130/90. Patient reports that she feels better after taking the Benadryl. Patient educated on the side effects of Benadryl. Patient instructed not to drive home. She verbalizes understanding and states that her mother will drive her home.
Sinus tachycardia, dizziness, left hand numb and knees, legs very weak, chest pain, swollen lymph nodes hard time swallowing, and diarrhea
Lt deltoid-15cm diameter erythema, increased warmth surrounding puncture site. Suspect local reaction. Placed on antibiotics 8/12/02.
Lower half of body (waist down) aches, like one would expect with all over body aches with the flu or like I had with the 2nd dose.  Upper body was fine. This started to occur late at night about 10-12 hours after shot on Friday May 20th, 2022.  Next morning, symptoms worsened but I carried on. Left home and when returning around 11:30am, had much difficulty ascending stairs as the pain in back and legs were quite noticeable.   Laid down and rested. Symptoms continued to get worse and I had to lay in bed with alternating ice and heat packs to get relief. Took Tylenol. Already was on Meloxicam so did not take any more NSAIDS.  Ultimately had to start taking Vicodin (I have Rx leftover from a surgery) and only got out of bed to go to the bathroom. By Wednesday, May 25th, the pain was so severe I had to be taken to the ER.   X-rays, CT and MRI completed.  Finding of Turkic cysts on either side of spine at S1-2.  These were considered incidental findings but I was given two steroid injections that helped. While in the hospital, my acid reflux became severe.