chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) (batch number DN74H / 3G33K, expiry date 10th July 2023) for prophylaxis.   Previously administered products included shingrix (the patient received the series of Shingrix in 2019).   On 20th May 2022, the patient received the 3rd dose of Shingrix. On 20th May 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments: The reporter stated that, the patient received a 3rd dose of Shingrix. The reporter provided two different batch number as they were not sure which was the correct one, so they recorded both. The vaccine administration facility was the same as primary reporter. The reporter give consent to follow up. Additional Supportive Information: The patient received a 3rd dose of Shingrix, which led to extra dose administered.
Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA036951 and 2019SA036960 same reporter. This case involves a 16 months old patient who received 0.5 mL dose of vaccine ACT-HIB lot UI914AA, expiry date- 28-Nov-2019 via unknown route in the left thigh on 21-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that three patients received ACTHIB. One of these patients received it incorrectly, it was reconstituted with a Merck diluent. It is unknown which of these patients received it. It was unknown if any adverse event was occurred. 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 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. Documents held by sender: none.
07/07/2004 Grandmom states temp 99-101; 7/10/04 rash appeared on neck and shoulders; 7/12/04 temp 99 and diarrhea; 7/13/04 rash on entire body (face,arms, legs and back per grandmom; grandmom took child to Dr. Dx. given was reaction to MMR he ordered Tylenol, fluids and Aveeno baths during exam here child noted raised rash over entire body (face, arms, legs, back, abdomen) with rough texture, no itching noted by grandmom-if no improvement by Friday child is to be re-evaluated by Dr.
Patient returned to pharmacy 3 days after receiving FLUARIX vaccine with complaint of silver dollar sized reddened area at injection site that was slightly warm and painful to touch and very itchy according to patient.
Fever, ear pain, muscle spasms and pain in shoulders and neck, arm pain and muscle weakness, body aches and pain, sleeplessness, loss of reflexes in legs and ankles.
Pt was seen last week on 11/19/21 and received Tdap and flu vacc. Pt came in to clinic today and requested flu vacc. MA administered flu vacc. Pt received 2 doses of flu vaccine.
Swelling, redness, warm to touch on right arm from injection side down to elbow. Painful to touch. Started on Benadryl until swelling gone and Cephalexin 2x daily for 7 days.
Hospitalized;  COVID-19 positive;  fully vaccinated.  Discharge Provider: Doctor Primary Care Provider: Doctor Admission Date: 10/9/2021 Discharge Date: Oct 12, 2021 PRESENTING PROBLEM: Pneumonia due to COVID-19 virus COVID-19   HOSPITAL COURSE: Patient is a 84 y.o. female with a history of CAD, HTN, SVT, CVA, HLD, and GERD who presented with shortness of breath.  She was found a have COVID and hypoxia.  CT angiogram was mostly benign except for known large hiatal hernia.  She was treated with remdesivir and Decadron improved quickly.  She was discharged home to complete 4 more days of Decadron.  Told to follow up with surgery as needed for large hiatal hernia.
nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report from a non-contactable female consumer reported for herself (Non pregnant). A 46-year-old female patient received second dose BNT162B2 (Solution for injection, lot number was EL3246) via left arm on 24Feb2021, 10:30 AM, single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose BNT162B2 (lot number:EL3247) left arm on 03Feb2021, 10:30 AM at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. After second dose vaccination patient experienced headache, nausea, malaise, cold sweats, restlessness, unable to sleep on 24Feb2021 at 08:15 PM. The patient taking treatment 600mg ADVIL taken for all events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
I was having pain all over my arm. I was talking slow and acting like I had a stroke....nose bloods and headaches bad. I was embarrassed and scared ....people were noticing something was wrong.
On 10/24/13 Mom reports she had a knot that was red on her right leg, after injection. The area is decreasing in size and is about dime size. Denies rash.
a vial that has an expiration date of 8 Aug 2021 was given to 6 patients/Product removed from refrigerator on 07Sep2021 at 1p./08Sep2021: Correct expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a vial that has an expiration date of 8 Aug 2021 was given to 6 patients/Product removed from refrigerator on 07Sep2021 at 1p./08Sep2021: Correct expiration date.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a vial that has an expiration date of 8 Aug 2021 was given to 6 patients/Product removed from refrigerator on 07Sep2021 at 1p./08Sep2021: Correct expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a vial that has an expiration date of 8 Aug 2021 was given to 6 patients/Product removed from refrigerator on 07Sep2021 at 1p./08Sep2021: Correct expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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.    Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Significant Follow Up Appended: Patient Identifiers Added and lot number updated, correct expiration date updated. On 15-Sep-2021: Non Significant Follow up, patient contact details updated.
Severe chills, then sweating, fever and chest pain in heart area for 24 hrs.  Body aches last about 72 hours.  Took tylenol  and drank lots of fluids
After the initial shot, I only experienced pain at the injection site. A month later, I noticed waves of pain from my upper arm all the way down to my wrist. It felt like arthritic pain, I could not lay on it or put weight on it. It hurt mostly at night. After two weeks, I went to the urgent care clinic where they did an x-ray. They did not find any breakage or fractures in the x-ray. They prescribed me medication for the pain, but when I ran out of the pain medication, the pain lasted for another 2 to 3 months before it subsided.
MUSCLE SORENESS WHICH WAS WORSE IN HIS SIDES AND BACK; FATIGUE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUL-2021, the subject experienced muscle soreness which was worse in his sides and back. On 15-JUL-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from muscle soreness which was worse in his sides and back. This report was non-serious.
fever more than 102.6  on and off every four five hours,  ough. sore throat.  body aches. fatigue (tiredness)  diarrhea,
the Pt received her vaccination around 3:10 pm she felt pain when administering the vaccine and immediately felt dizzy, whoozinc, thingling left side of arm site all thru Lf side of neck, the pt was taken to a room her vital signs were taken Bp 104/71 P: 76 the pt said she had taken 2 pill of ibufrone of 200 Mg at 2:00 pm. he was given 6 oz. of juice that the patient drank completely.   the dr checked her, took the vitals and checked she said she was fine, maybe they were just nerves, recommending that she rest for 10 to 15 minutes and she would check her again how she felt. The MA and the Lead of the site were left with pt. at 3:28 pm the pt say feel buzzy and dizzy. the Ma took the vital signs Bp: 131/79 P: 74 and SPO2 100%  The doctor returned to check her, she said that everything was normal that it had been a normal reaction of nerves but it was fine that if later she felt something more or worse she could come back and check her again, the pt said she felt fine when the doctor asked like this that at 3:38 she was ready to go home.
Client stated her lips felt tingly and her throat felt itchy. Airway clear, respirations even and unlabored, heart rate within normal limit. Patient in no acute distress. No angioedema noted. Patient was administed Benadryl 25mg PO X 1 dose.
~30min after the vaccine nausea/vomiting started, 4 bouts of vomiting then stopped, but the nausea continued for 24 hours then stopped then picked up at the 48-72hour mark, mild tingling at the injection site/soreness & got worse throughout the day with swelling of the arm to 24 hours in, at 48 hours the pain subsided to a tolerable throbbing, headache/migraine for 48 hours, double vision for 12 hours, sensitivity to light, fever + chills for 24-48 hours, malaise/lethargy/fatigue/flatulent for 72 hours, drank lots of fluids, lots of rest, couldn't get out of bed
Over 24 hours the site became very red and itched very badly; Over 24 hours the site became very red and itched very badly; tiredness; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jan2022 13:15 (Lot number: 33130BA) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose 2, Lot No: ER6727, Location of injection: Arm Right, Vaccine Administration Time: 14:00), administration date: 03Apr2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Lot No: EP7534, Location of injection: Arm Right, Vaccine Administration Time: 14:30), administration date: 13Mar2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 08Jan2022 13:30, outcome "recovering", described as "tiredness"; CHILLS (non-serious) with onset 08Jan2022 13:30, outcome "recovering", described as "chills"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 09Jan2022, outcome "recovering" and all described as "Over 24 hours the site became very red and itched very badly". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pruritus.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no fever. I also didn't really have site pain at first. Over 24 hours the site became very red and itched very badly. I called the pharmacy and was told to just take a Benadryl. I did and as soon as it wears off it's back to the itching. I feel ok otherwise. Not sure how long this will last. The patient received treatment with Benadryl. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No known allergies were reported.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 15 year old female patient who on an unspecified date was vaccinated with the first 0.5ml dose of GARDASIL (lot#, route and site of administration not reported). Subsequently, the patient experienced neck and leg pain and tingling. Unspecified medical attention was sought. At the time of this report, the patient had recovered. Additional information has been requested.
Achy legs starting with tight prickly feeling behind knees and thighs and progressing to achiness in entire leg from below buttocks and into feet.  Finally contacted doctor on day 8 after feeling symptoms and heard back from him on day 11 (today).  Use of 2-3 tablets of  Advil twice a day with food for 3 - 4 days was recommended.  This will only be started later this evening since I had tried taking Motrin this morning which did not seem to help.
Patient developed swelling below left eye, then proceeded to take a mixture of vitamin C and aspirin. Patient was instructed to go to emergency room if symptoms get worse. Also gave 25mg PO.
About 20 minutes after the shot a tingling sensation , and then numbness went up the left side of my neck and into my jaw and lift cheek. The sensation lasted for about an hour or so.
Patient received a pediatric Pfizer vaccine that was not prepared with any diluent.  Patient has had no adverse events at this time.  Patient is being monitored closely for any signs of adverse events.
CHILD'S DATE OF BIRTH WRITTEN AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS FATHER. CHILD IDENTIFIED IN SYSTEM WITH DATE OF BIRTH.  CHILD IS TOO YOUNG FOR VACCINE ON 7/31/2021. VAERS TO BE COMPLETED FOR SECOND DOSE RECEIVED ON 8/25/2021.
I have a swollen lymph node under my right armpit, which is the same side as my injection. I also have a bruise on the inside of my right thigh, although I am unsure whether or not this is related. Is the bruising normal?
ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/28/2021 AORTIC VALVE REGURGITATION ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/28/2021 CANCER METASTATIC TO MEDIASTINUM
The patient received a COVID 19 booster dose that was later found to be involved in a temperature excursion of 34 hrs at max temp of 8.54 Celsius. The manufacturer was unable to provide additional stability information that applied to this excursion. The patient/parent was notified.
Sometime in July, I noticed a rash on my right arm (left arm was vaccinated). It then began to spread to other areas, both arms, shoulders, sides down to my bum. The rash is very itchy and causes me to wake up at 3 - 4 am scratching. I am not getting enough sleep. My PCP sent me to a dermatologist today. The dermatologist saw the rashes and said they are vaccine related. Note: my wife, has similar but worse rashes for 2 months and she had the J&J vaccine. Wife and I both have Rh neg, Group O blood. I have been prescribed Triamcinolone 0.5mg ointment.
SARS-COV 19 Infection.  Cough, congestion, runny nose, Diarrhea, Loss of taste, loss of smell, sore throat, fatigue, chills, muscle aches.
Redness, rash and hives all over the body. Very itchy. Presented several days after booster shot.   Went to the Clinic for treatment. Was prescribed Allegra and Benadryl.
Flu shot administered 1-13-15. A.M. of 1-14-15 C/O numbness/tingling in hands but quickly resolved. Participated in swim practice 1-14-15 and (L) arm "flapping" occurred. States would not stop unless she squeezed a stress ball. Did not occur during sleep. 1-15-15 Lifted weights and participated in swim practice. 1-16-15 ER. Told it was "stress" related.
Nausea, headache, stomachache, chest pains. Treatment = Tylenol
Itchy skin accompanied with small red bumps, mostly on hands and arms, bilateral, not near injection site. Minor discomfort, treatment not initiated.
the tv (tricuspid valve incompetence); This is a spontaneous report from a contactable physician. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 at 13:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included Stroke, and seizure. The patient's concomitant medications were not reported. On 12Apr2021 at 13:15, the patient experienced the tv (tricuspid valve incompetence). The patient did not received treatment for the event. The outcome of the event was unknown. The patient did not had COVID prior to vaccination and not tested for COVID post vaccination.  Information about lot/batch has been requested.; Sender's Comments: Based on the information currently available, the event is considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to the suspect drug.
Rash over whole body except face.  Worse on back and itchy on back.  Lasting over a week so far, but it is resolving significantly.
Had a seizure in the waiting room 15 minutes after being given the shot. Started immediately having memory loss, dizziness, headaches, weakness, stomach issues/pain, numbness/tingling in extremities, seizures, breathing difficulties, chest pain, back pain, brain fog, extreme fatigue, shortness of breath.  (Probably has more symptoms). These symptoms have not stopped at all just gradually getting worse.
Left ear is 100% deaf after vaccination; Very unhappy with the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Left ear is 100% deaf after vaccination) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DEAFNESS UNILATERAL (Left ear is 100% deaf after vaccination) (seriousness criterion medically significant) and FEELING ABNORMAL (Very unhappy with the Moderna vaccine). At the time of the report, DEAFNESS UNILATERAL (Left ear is 100% deaf after vaccination) and FEELING ABNORMAL (Very unhappy with the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided. No treatment information was provided. The patient reported that, she was very unhappy with the Moderna vaccine that she received. Per ENT her left ear was 100% deaf after vaccination. She stated that, she did not have a medical history of hearing issues. Company Comment: This spontaneous case concerns a 47-year-old female patient with no relevant medical history reported, experienced serious unexpected AESI event of Deafness unilateral after receiving the first dose of mRNA-1373. The event occurred on an unknown date but within the same month of vaccination in August 2021. Patient did not have any medical history of hearing issues. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Sender's Comments: This spontaneous case concerns a 47-year-old female patient with no relevant medical history reported, experienced serious unexpected AESI event of Deafness unilateral after receiving the first dose of mRNA-1373. The event occurred on an unknown date but within the same month of vaccination in August 2021. Patient did not have any medical history of hearing issues. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
Pt reports localized rash with mild swelling and itching progressing from injection site halfway to elbow. Began appx 1-2 hours after injection and has continued to contact by phone today. Pt reports a mild cough which she believes is unrelated as she has had for several days previous. No other sequelae noted. Advise pt to use cold compress and perhaps an antihistamine. She is to see her PCP today on an unrelated issue but will ask that provider to also take a look.
Hospitalized 3 days on blood thiners, oxygen 4 liters until released then sent home on Eliquis and oxygen 3 liters.
This spontaneous report was received from a physician refers to a 16 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. The physician informed that on an unknown date the patient was inadvertently administered a dose of PROQUAD (strength, dosage, lot# and expiration date were not reported) instead of a dose of VARIVAX. No adverse events were reported. Additional information has been requested.
AE: Seizure upon admission to hospital, was sent to ER because of slurred speech and inappropriate responses to questions, had seizure after arriving at hospital, TX: KEPPRA at hospital, 1500mg/day, ATIVAN IV. In hosp for 12/24 to 12/28th. Sent home with KEPPRA & Buspirone.
Sore arm for the rest of the day after receiving the shot.  On 2/27 fatigue.  On 3/4 possible low grade temperature with periods of feeling very warm and sweating. Lasted approximately an hour. On 3/6 again periods of feeling warm and sweating. Rotating achiness in muscles.  Brief feelings of discomfort in axillary region but unable to palpate lymph node.  Lasted half the day. On 3/14 headache across the front of my face above my eyes with left side neck discomfort. On 3/15 again experienced periods of warmth and sweating throughout the day. In between headache, Not as severe as headache on 3/14.                        Contacted doctor by email.
6 cm hard, swollen, red area on left thigh (painful). Tx: CEPHALEXIN 250mg/5ml - 4 ml po BID x 10 Naproxen susp 125mg/5ml - 1/2 tsp po Q12H x 20 days ORAPRED susp 15mg/5ml - 3/4 tsp BID x 5 days.
This spontaneous report was received from a certified medical assistant and refers to an unknown number of unspecified patients of unknown demographics. No information regarding any of the patients' medical history, concomitant medications and concurrent conditions was provided. On unknown dates in 2017, between 01-FEB-2017 and 04-MAY-2017, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # N002720, expiration date: 12-MAY-2019). The vaccine was stored in a temperature between 47 and 77 degrees Fahrenheit for 2256 hours. No previous temperature excursions were reported, the Digital Data Logger was not involved. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004568: US-009507513-1705USA004567: US-009507513-1705USA004569:
Blotchy slain rash developed approx 10 days after receiving vax, over chest and both shoulders. No itching or other complaints.