chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Donor states she woke up around 5am on 5/7/22 approximately over 12 hours after receiving her tetanus immunization. She describes her symptoms as being warm to the touch, redness, hardening, tenderness, pain, swelling, itching, and muscle pain. Donor denies any treatment while at home. She states symptoms subsided slowly on their own over the next couple of days. She states all symptoms have subsided except hardening still present. Donor came into plasma center and reported the adverse event. Donor denies seeking any outside medical treatment prior to presenting to plasma center today.
It was reported post vaccine pt had erythema of right anterior thigh with 5x8cm (medial aspect) no sign of infection.
Pt was administered the Menactra instead of MMR. When drawing up vaccine it was double checked by another MA in the office. Called and spoke with the patients mother, states that the patient is fine and there is no signs or symptoms.
1st dose 5 years ago, 2nd not yet; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose five years ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix.. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 15-Feb-2023. Reporter's Comment: The doctor wants to know if she should restart the series. The reporter consent to follow-up. Additional Supportive Information: Till the reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Injection site rxn (warm, redness from elbow to injection site), 24 hrs after injection developed chills, night sweats & nausea about system symptoms resolved within 48 hrs.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        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.   No concomitant medications were reported. No treatment medications were reported.
5 - 10 minutes after injection pt is face flushed c/o dizziness, chest tightness and shortness of breath / difficulty breathing
patient had syncope like less than a minute after the injection.  she passed out for 2 to 3 seconds and then she woke up all alert. she passed out again few times (4 to 5 times) for like 2 to 3 seconds. no sweating or cold extremities reported. all vitals are good. asked to move to supine and to elevate legs, mom said it is better for her to stay sitting on chair. she did not fall or hurt herself. she vomited a little after her 5th episode, and after that she felt so well. i observed her carefully for 30 minutes aside with her mom. after 45 minutes she left with her mother.
covid positive 1/7/22.  Completed 2 course covid vax 4 weeks prior to current presentation.    Had been asymptomatic. Slight nasal congestion.  Day of presentation sore ankles and legs.   Facial rash.  Some facial pruritis.   Now neck and arms and back.
Vaccine recipient received vaccine on 1/21/2021. Approximately 5 minutes after receiving the vaccination developed scratchy throat, hoarseness, and a rash over entire body. Patient self-medicated with diphenhydramine, cimetidine, and a steroid from her own emergency kit.  She was sent to the emergency department and she was given an additional diphenhydramine 25 mg and epinephrine 0.3 mg. She has a history of adverse reactions to vaccines in the past. In the ED when she was reexamined her condition improved and she was discharged to home.
Nurse drawing up Moderna doses drew up and administered wrong dosage. Patient was notified 10/06/21 and offered to received the additional mL to receive the full dose.
Expired vaccine that was administered to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered 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 (Expired vaccine that was administered to patients).    The patient's age was reported as 73 years and 2 months.  Number was reported as 80777027398.  Concomitant product use was not provided by the reporter.  It was reported that one list of patients received Moderna vaccine at the facility between 08-Apr-2022 and 15-Dec-2022. Additionally, there was second list where the reporter discovered a past lot that had also expired and was administered to the patients with batch number as 065F21A.  Treatment information was not provided.
Patient states that 45 minutes after vax there was a bad feeling in her back. Later on, patient had heart palpitations, patient stated that she usually has them but this time was different, had itching on right side o face and severe fatigue.
Local reaction, rash, swelling over 2 day period treated with Benadryl and cold compressors.
Knot on the back like the size of a golf ball; Headache; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), CYST (Knot on the back like the size of a golf ball) and HEADACHE (Headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 007B21A) for COVID-19 vaccination.     Concomitant products included ETANERCEPT (ENBREL MYCLIC) for Arthritis, CARVEDILOL for Blood pressure high, SEMAGLUTIDE (OZEMPIC) for Diabetes, TRAZODONE HCL for Sleeplessness, MELOXICAM, EMPAGLIFLOZIN (JARDIANCE), FUROSEMIDE, ACETAMINOPHEN, FOLIC ACID, AMLODIPINE BESYLATE, HYDROXYZINE HCL, VITAMIN D3, LISINOPRIL and METFORMIN for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VISION BLURRED (Blurry vision) and HEADACHE (Headache). On 23-Apr-2021, the patient experienced CYST (Knot on the back like the size of a golf ball). The patient was treated with IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurry vision), CYST (Knot on the back like the size of a golf ball) and HEADACHE (Headache) outcome was unknown. Not Provided
For 3 weeks after the vaccine, I had terrible memory loss. I could basically function, but could not remember simple things.  It was like my memory was a deep, empty pit.  My memory has slowly been coming back and is just about normal now.
Sudden onset redness, itching and swelling of left upper arm at injection site and distally extending to elbow, prescribed cephalexin for favored developing cellulitis. Symptoms resolved within 24 hours.
Shingles type reaction; lips got tingly; This case was reported by a consumer via interactive digital media and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced vesicular rash and tingling lips. The patient was treated with prednisone. On an unknown date, the outcome of the vesicular rash and tingling lips were recovered/resolved.   It was unknown if the reporter considered the vesicular rash and tingling lips to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient had Shingrix dose, 2 months ago and had a reaction the following day. On chest the patient had a Shingles type reaction and also lips got tingly. The doctor treated patient with Prednisone and it went away. The patient reported he/she was due to get the second dose and wanted to know if should take Benadryl.
pt brought to ED via EMS after being so weak she couldn't get up off of the floor; SOB, cough and weakness started 4-5 dys earlier; EMS found pt hypoxic, O2 70% on RA; placed on NRB with O2 sats 83%; admitted and placed on high flow NC and NRB with O2 sats 94%; ICU; on BiPAP; DNI; given remdesivir and baricitinib; respiratory status declined and pt passed away in the hospital
muscle pains since 2 days after receiving the vaccine and is currently still presen; This is a spontaneous report from a contactable consumer (wife) reporting on behalf of her husband.  A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 19Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient has experienced muscle pains since 2 days after receiving the vaccine (myalgia) and which currently still present on 21Jun2021. Caller wanted to know is this a side effect that has been reported before and how long will the side effect supposed to last. The outcome of the myalgia was not recovered.  Information about lot/batch number has been requested.
LOW GRADE FEVER, BODY ACHES, HEADACHE, RESTLESSNESS, TIREDNESS. TOOK TYLENOL EVERY 6 HRS AND REST.
This spontaneous report was received from a registered nurse and refers to a currently 16 months old child patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ, lot # L033549, expiration date 05-JUN-2017 ,for prophylaxis (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0.8 degrees Fahrenheit for 24 hours and 30 minutes. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1802USA003852: US-009507513-1802USA003853:
fits of high pitch screaming for hours, glazed eyes, self harm, severe mental regression, night terrors that would last for hours, spitting of mouth, banging head, stomach cramps when eating,
This spontaneous report received from a health care professional (Nurse) concerned a 59 year old white and unknown ethnicity of male. The patient's weight was 290 pounds, and height was 75 inches. The patient's concurrent conditions included: non alcohol user, non smoker, and blood pressure, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included allopurinol 300 mg, enalapril 20mg, hydrochlorothiazide 25mg, and levothyroxine100mcg once a day. On 26-AUG-2021, the patient's blood sample was collected. 30-AUG-2021, the laboratory test results received for SARS-CoV-2 IgG antibody test (SARs Covid - IgG spike test (does not give numerical results) -semi QN test) was found to be negative (units unspecified) which was concluded as confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191666.; Sender's Comments: V0:20210900292-COVID-19 VACCINE AD26.COV2.S- Confirmed immunological vaccine failure- This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Patient stated the injection site started to get red the same day. When she went to the Dr on 7/24/18 it told her it was infected/cellulitis.
Information has been received from a physician concerning a nurse who was vaccinated with a dose of Gardasil. Subsequently, the patient was inadvertently vaccinated with a another dose of Gardasil instead of Vaqta (manufacturer unknown). The patient developed  a bump and pain in her arm. There were no laboratory or diagnostic tests performed. The patient sought medical attention from the physician. At the time of the report the patients outcome was unknown. Additional information has been requested.
Mother reports child was covered in hives from evening of 11/17/09. Thighs to knees swollen. Hives on arms, shoulder, back, chest. One (lemon size on face). Benadryl .25mg po give 10pm and again 11/18/09 am. Child recovered and went to school.
Patient stated she had stomach pain x 3 weeks after 1st Gardasil Imm.
She has some swelling, near her clavicle bone,some swelling in that area. It's on the left side. Shereceived her Covid 19 vaccine in her left arm; Swelling in the clavicle bone area on the left side of my neck; . This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021432418 (Pfizer), US-PFIZER INC-2021432671 (Pfizer).  A 68-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 09:30 (Lot number: EW0169) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 16Apr2021 12:00, outcome "unknown", described as "She has some swelling, near her clavicle bone,some swelling in that area. It's on the left side. Shereceived her Covid 19 vaccine in her left arm"; SWELLING (non-serious) with onset 16Apr2021 12:00, outcome "not recovered", described as "Swelling in the clavicle bone area on the left side of my neck". Therapeutic measures were not taken as a result of swelling.  Additional information: She was not calling to report new events. She was asking if swelling near her clavicle bone was a common side effect. There was no product complaint to report. No other vaccine was received in four weeks. Patient had COVID prior vaccination and was not tested COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
I am not sure if my event was caused by the vaccine I received on  April 8, but I have a very strong feeling it is, as never in my life have I experienced anything like it.  My day began normally, and I just had returned home from an appointment.  I had some lunch, and a few minutes later as I was standing in my kitchen,  I began sweating terribly,  heart was racing, and I felt like I was going to pass out.  I  managed to make it to a large living room chair, and once I say down and put my head back, I passed out.   My daughter witnessed everything and said when I passed out, my arms were trembling and my eyes rolled back.  This lasted for about 30 seconds.  She was unable to arouse me for a bit, but when I came to my speech was slurred.   I did not know what had happened.  My daughter called 911.  By the time medics arrived, I was feeling much better and aware of everything happening.  The checked for signs of stroke, vital signs, blood sugar, and everything was normal.   I was transported to the ER, and my work up there was normal, including EKG and blood work.  The physician that I saw diagnosed me with  vasovagal syncope and did not feel the event was related to the vaccine.  I  completely recovered, and like I said  I?m not sure if it was related to the vaccine I received or not.  I just feel that it may be worth noting since I?ve never had an experience like this and  I?m pretty healthy with really no medical history.
Fainted, lost consciousness for a few minutes.  Hit head on floor. Nauseous. Extremely ill feeling.
Quadracel vaccine was inadvertently administered to a person who was 16 years of age with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received fvia Medical assistant on 20-Sep-2022. number: 01286642.  This case involves a 16-year-old female patient to whom Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Immunization.  On 23-Aug-2022, the 16-year patient was inadvertently administered suspect Quadracel vaccine at dose 0.5ml once via intramuscular route in the left deltoid (lot: C5916AA, expiry date: 06-Jul-2023) for Immunization with no reported adverse event (product administered to patient of inappropriate age) at same day latency.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    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 of the Good Pharmacovigilance Practices. 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.
Two days post vax the patient experienced an increase in blood glucose, received a mildly increased insulin dose. The next day the patient had a seizure associated with the blood glucose in the 50's. The seizure was generalized and brief. On arrival to the ER the patient's blood glucose was 88. No further problems or treatment.
Breakthrough COVID case. Development of symptoms 9/10/21. Tested positive for COVID on 9/12/21.
24 hours later i developed ringing in my left ear and after being tested slight hearing loss in left ear.
Client received dose of bivalent vaccine too early per new CDC interim guidelines. Second dose (bivalent) will need to be repeated at the correct interval.
The first sign I noticed was severe and ?brain fog?.  After that my joints and tendons became red, swollen, inflamed and it had become too painful for me to perform my jobs at work. I took a 6 day round of prednisone and once I finished taking the steroids the inflammation returned and it has spread to my elbows. My elbows are in pain and they are dark red. I also see some inflammation in my knees and few and there is some redness.
I had a torn ligament in my hip that was taken care of, and after the vaccine it flared up again for no reason.
Had my first Moderna shot on 1/19/2021 around 5 p.m.  Around 3 in the morning on 1/20/2021 I woke up with pain radiating down my left arm.  My left hand was aching and I wasn?t able to straighten out my left thumb.
Thigh was reported by mom to be red, swollen with a hard knot under skin, intense itching but no fever. Affected area was 4 fingers wide, 3/4 way around leg and hip to knees. Taken to physician's office and treated with Benadryl and antibiotics.
Red, swollen, given MOTRIN in office Aug 18 2006, advised to apply ice when needed.
Numbness on side of face absent of rash. The following day the numbness had extended to the opposite side of her face covering cheeks and chin and had developed a red rash on her chin. At this point she visited her PCP and was prescribed Valacyclovir to take 1 tablet three times daily for 7 days. She admitted she only took 3 to 4 tablets whenever she though of it and did not finish the prescription.
The patient received a dose of covid booster that was from a vial that had been opened the previous day. The patient was called and informed the same day and no adverse reaction was reported by the patient.