chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from social media regarding a male patient of unknown age. No information about medical history, concurrent conditions was reported. On an unknown date the patient was vaccinated with GARDASIL (batch #, lot #, dose, frequency, route, indication not reported). No concomitant medications were reported. On an unknown date the patient experienced seizures (medically significant). The outcome of seizures was unknown. The causality of the event was not specified by the reporter. This is one of the two reports received from the same reporter (sibling case 1406USA005357). Additional information has been requested.
6 months later fighting a horrible reaction around my eyes, red swollen, eczema/dermatitis
Subsequent to receiving varicella virus vaccine live the pt failed to seroconvert after completion of vaccination series.
A MMRV WAS ADMINISTERED INSTEAD OF A MMR WHICH RESULTED IN THE PT RECEIVING TWO VARIVAX DOSES
bad headache; have a lot of soreness in my arm; This is a spontaneous report from a contactable other HCP (patient). A 32-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at 14:30 at single dose for covid-19 immunization. Medical history included joint pain, thyroidic of the bladder, allergies: penicillin. There were no concomitant medications. The patient previously took codeine and experienced allergies: codeine. The patient experienced bad headache, and had a lot of soreness in her arm on 14Jan2021 at 17:30. Event details: 3 hours after getting the vaccine have a lot of soreness in her arm and bad headache that wouldn't leave even after 24 hours and taking paracetamol (TYLENOL) for treatment. The patient did not receive treatment for soreness in her arm. The outcome of the events was resolving.   Information on the Lot/Batch number has been requested.
Information was received on 17AUG2020 and 24AUG2020 from an Investigator.   A 55-year-old male developed satellite lesions after the administration of the open study drug (ACAM2000).  On 03AUG2020, the subject received the dose of the study drug. The subject reported that the scab from the inoculation site came off on 14AUG2020, and two other blisters also appeared later in the day. The site formed a new scab which appeared to have been removed. The two new blisters also appeared to have been popped up and their tops removed. The new blister ½ inch to the left of the initial site formed a scab. The blister 1/8 inch to the right of the initial site was slightly wet. No other information was provided at the time of the initial report.  Outcome: The outcome of the event was ongoing at the time of report.   The action taken with study drug was none.   The Investigator assessed the event satellite lesions as grade 1 (mild) and related to therapy with study drug.  Company Comment. In agreement with the investigator's assessment. Satellite lesion are considered when the lesions are located within 2.5  cm (1 in) of the vaccination site.  Despite it is not described in the label, this kind of complication are very common and considered listed. Satellite lesions are not required submission to the FDA.  Case will be kept in the database although it is from clinical trial and is not serious  Follow-up information was received on 08SEP2020: The follow-up information included update in outcome and SAE end date as described in the above narrative.  Outcome: The outcome of the event was reported as resolved on 30AUG2020.  Company Comment (18SEP2020): After review of the f/u information, the Company's assessment is unchanged with the event considered related to the study drug.; Sender's Comments: In agreement with the investigator's assessment. Satellite lesion are considered when the lesions are located within 2.5  cm (1 in) of the vaccination site.  Despite it is not described in the label, this kind of complication are very common and considered listed. Satellite lesions do not require submission to the FDA.  Case will be kept in the database although it is from clinical trial and is not serious  Company Comment (18SEP2020): After review of the f/u information, the Company's assessment is unchanged with the event considered related to the study drug.
This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 02-DEC-2015, the patient was vaccinated with improperly stored dose of M-M-R-II therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L001336 with expiration date: 13-JAN-2017). Concomitant medications were not reported. No adverse events were reported. The administered dose was stored in 47 F for 8 hours.There was no previous temperature excursions. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient stated that immediately after the shot was administered he felt numbness in his right arm that was vaccinated from elbow to the shoulder. His sensitivity to touch has been decreased but he feels a burning sensation when touched or moving the arm. He has not tried anything to treat it except moving his arms through exercise and work. It has been 16 days before he mentioned it to me.
Breakthrough case admission after 2 vaccines Pfizer 4/6/21 lot# EW0153;  Pfizer 5/4/21 lot# Ew0182
Day after administration, tenderness and redness at site noted. Symptoms increased by end of day to include edema, warmth, and soreness at site.  Also, body aches, weakness and headache.  Slight elevation of temperature.
Severe hives, itching and burning over whole body 4 hrs after flu shot. Took Benadryl 50mg every 6 hrs continued to get worse. Big red splotches all over. On 4th day, went to urgent care center, got injection of Kenilog and Keflex 80mg. Rx for prednisone and Keflex.
Approximately one week after second vaccine and then booster, I I started menstruating. This was out of my birth control cycle, way more blood flow, and extremely painful cramping! It lasted well over two weeks and remained fir a second month with one more extreme 2 week period and less significant but uncomfortable, unpredictable, and lingering period throughout.
This case was reported by a nurse via call center representative and described the occurrence of local swelling in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown.   The reporter considered the local swelling to be unlikely related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and another vaccine in the same arm on the same day and experienced localized swelling which did not think was related directly to the vaccinations, but more related to patient receiving them in the same arm.  The reporter did not had any patient details available at the time of this call and was not the one who administered the vaccines and did not take the patient's follow up phone call to the office.  However, stated if safety wanted to follow up would likely be able to gather the patient details if needed. The reporter consented to follow up. This case linked with US2020AMR203680, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR203680:same reporter
About 10 days after the Injection my right thigh started to itch where I have some small lipomas internally the itch started.   I kept wondering why and ignoring it.  Then about 2 weeks later I got shingles.    Was given  Valacylovir 1 gram 2 times a day.
She got the vaccine, did have pain at the site and thinks it was the first day at the end of the day.  When she laid down she could feel it and also on the 2nd day at night.  On day #2 she felt like she was coming down the flu.  She had skin sensitivity, chills and a fever, extreme fatigue and her nose was running.  These symptoms lasted all day long and into the evening.  By the third day she woke up and was fine.  She was a little tired,  which lasted for about 3  more days, but minimal.  She cleaned an area in her kitchen and came across a detox that she had taken (herbal formula), and she thinks when she first found it she took it, and the next day she took it as well.
a pretty significant edema on the upper arm; paresthesia on her left hand and fingers; redness from the shoulder to the elbow; injection site redness; injection site swelling; injection site tender to the touch; a few hives; Did not fell well; chills; fatigue; arm soreness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm soreness), OEDEMA PERIPHERAL (a pretty significant edema on the upper arm), PARAESTHESIA (paresthesia on her left hand and fingers), MALAISE (Did not fell well) and CHILLS (chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), OMEPRAZOLE and PROGESTERONE.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), CHILLS (chills) and FATIGUE (fatigue). On 17-Jan-2021, the patient experienced MALAISE (Did not fell well). On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (injection site tender to the touch) and VACCINATION SITE URTICARIA (a few hives). On 21-Jan-2021, the patient experienced OEDEMA PERIPHERAL (a pretty significant edema on the upper arm), PARAESTHESIA (paresthesia on her left hand and fingers) and VACCINATION SITE ERYTHEMA (redness from the shoulder to the elbow). On 09-Jan-2021, PAIN IN EXTREMITY (arm soreness), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. On 18-Jan-2021, MALAISE (Did not fell well) outcome was unknown. On 25-Jan-2021, OEDEMA PERIPHERAL (a pretty significant edema on the upper arm), PARAESTHESIA (paresthesia on her left hand and fingers), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (injection site tender to the touch), VACCINATION SITE URTICARIA (a few hives) and VACCINATION SITE ERYTHEMA (redness from the shoulder to the elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl, elevation of the arm and ice for the hives. Prednisolone and Keflex.
I have developed redness, swelling, and itching at the injection site that I noticed eight days post injection. The swelling is a hard knot.
MODERNA COVID-19 Vaccine: My dad has never had any sort of odor in his life and 3 days after getting the first vaccine shot, he has an incredibly foul odor (that he cannot smell) and it has not yet gone away. He showers frequently and I wash all his clothing and pajamas but this odor is strong and relentless. It's not a typical body odor smell though...it's like a "medical odor," or something else very strange that is quite hard to describe.  I cannot seem to attribute this new odor to anything other than a negative side-effect to his first shot of the Moderna vaccine as nothing else has changed in his day-to-day life.  He also began experiencing cold symptoms about 4-5 hours after receiving his first dose of the vaccine. He was stuffed up, very congested, and extremely tired. He slept a LOT more than usual. I believe it is quite possible he actually just ended up with a cold because his immune system was so busy responding to the vaccine. (Is this possible/likely?)  Please let us know if others are experiencing this too, or if something can be done about it. Is his body not metabolizing an ingredient to this vaccine or something?
Patient received a Monovalent Booster Dose instead of the Bivalent Booster Dose.   Patient was contacted on 11/9/22 at 12:40pm with no adverse reactions to the vaccine administered.
Approximately 40 minutes post vax, pt reports feeling lump in throat and nose plugging up. Pt then developed hives on face and trunk, and puffiness below eyes, and became lightheaded. Physician noted tachycardia. Pt treated with albuterol and diphenydramine. Pt had a jittery and sleepy feeling. Hives began to clear.
I've had 3 Moderna vaccines (1st on 1/19/21, 2nd on 2/17/21, booster on 10/7/21). On 1/19/21, my left arm had a red, hot lump at the injection site for 2 weeks.  It was less for the 2nd and booster shot. On 9/24/21, I noticed a bump that came up on my scalp over my left ear (yellow looking on skin).  I don't think it had been there long or I would have noticed before. On 10/7/21,  (dermatologist) removed the bump.    sent the specimen to 2 different labs.
8/20/07 - very lethargic this continues even now.  9/13/07 - headaches treated with Motrin.  9/23/07 - ER visit, got steroids for pseudo tumor behind right eye, pain was so severe that Motrin couldn't control them.  At this point she was incapacitated.
Strange flushing of rear & top of head, proceeding to neck, shoulders & down to back of waist.  This made walking painful & very difficult. After resting for 15 minutes the symptoms minimized, and I was able to go home.  I rested there for several hours, but then felt very cold & shivery/shaky.  I was taken to the Emergency Room at 5 pm. and was there 3 hours.  No treatment was give, no drugs & minimal advice - my wife states that my answers to the doctor were sometimes incoherent.  I was left alone much of the time and, then, felling somewhat better, requested discharge.
From around midnight the day of the shot until 6 pm the following day: Gallbladder spasms  Heartburn  Headache Fatigue
Patient presented to ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Presented to ED on 3/15, was admitted 3/15-3/19, then transferred and admitted to another Hospital 3/19/21 for another 10 days.
Vaccine were drawn up in the manor that they are always done.  The vaccines have  stickers that can be taken off instead of writing down the lot number and expiration date.  Stickers were taken off and put on the sheet. It was not noticed that the Bexsero vaccine was out dated by 4 days. The vaccines were not checked a second time before given. The Bexsero was give by RN . The patient was also given the Menveo vaccine at the same time by CMA. It was not noticed that the Bexsero was out dated until it was being  charted.  The doctor and clinic lead were both notified of the incident.
At noon today, patient came in for the second dose of pneumonia. After giving the patient the shot, a few minutes later she told me, "I think I am having a reaction to the shot." I quickly went other there and started talking to her. She described her reaction as a pressure on her chest making breathing a bit difficult and then the pain started moving to different areas of her body such as lower back, behind, back of neck, behind the ears, and head.  She then told me she was nauseous but not enough to vomit. A couple minutes of sitting with her she asked me if I could call the paramedics. I asked her again to confirm that she would like me to call 911. Within 10 minutes the paramedics arrived and all her symptoms were gone. When the paramedics left, she came to the counter and said she is feeling better but feels tired and wants to go home and rest.  I later called her a few hours later to check on her (around 3pm I think it was) and she said she is doing better after resting but has a headache.
Received Hep B #1 on 5-2-06.  Within 4 hours of the injection  had nausea, diarrhea, dizziness.  On 5-4-06 the employee was still feeling tired and drained since taking the vaccine.
I had went to a family gathering with all vaccinated people. I had symptoms of cough and muscle aches. I had 3 negative home tests, 1 positive COVID-19, and then I tested positive for COVID-19 at a testing site. I had flu like symptoms with cough, fatigue, confusion, headache, nasal congestion, and loss of smell which lasted approximately 3 weeks. Nasal congestion and headaches persisted for 3 months which my doctor said was inflamed sinuses from COVID-19. I still to this day have brain fog.
LITTLE ARM SORENESS; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included little arm soreness, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: 09-JUL-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 17-MAR-2021, the subject experienced little arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little arm soreness on 18-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210726161.
Itchy hands progresses to itchy skin and 03/03/2010 development of erythema multiforme
Approximately 12 hours after receiving eah dose, he experienced some soreness and achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Approximately 12 hours after receiving eah dose, he experienced some soreness and achiness) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CITALOPRAM for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Approximately 12 hours after receiving eah dose, he experienced some soreness and achiness). On 25-Jan-2021, PAIN (Approximately 12 hours after receiving eah dose, he experienced some soreness and achiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported   This case was linked to MOD-2021-418822, MOD-2021-418848 (Patient Link).
Lightheadedness Fatigue Dizziness Sore arm Nausea Malaise
Client states that he developed a "rash" on his neck on the morning of 3/19. The client described the rash as "red and puffy looking." Per client, the rash is a uniform red area with "no dots." States the rash has defined borders, is on both sides of neck and extends down to his collarbone. Client states he first thought it was "bad sunburn." Client denies any other symptoms. Since its development, client states the rash has gotten worse. He applied some hydrocortisone today. Client took first typhoid pill on the night of 3/16 and has taken 2 pills so far.
Around 24hrs after the Pfizer booster shot in my LEFT shoulder, I started to experience neck pain mostly on the RIGHT side of my neck, and slightly to the back.  The pain increases in intensity greatly when I tilt my head to the left.  It becomes TOO painful when I tilt it to the left and back.  I cannot go very far when I do this.  Also, when I open my mouth wide to yawn it also causes pain the area.  This pain can radiate slightly up behind my ear on the right side of my skull and above my ear on the right side of my skull.    My doctor recommended alleve and lidocaine patch to rule out a stiff neck.  I tried that 48hrs after symptom onset, it did not help.    6 days later my symptoms have NOT improved.  The pain is still there and maybe on a scale of 1-10 it is perhaps one number higher.  I can tell that there's an issue when my head is in a neutral position.  It feels like a slight stiffness, but no pain in that neutral position.  However, when I tilt my head to the left, my pain it is about a 5 on the pain scale and if I tilt it to the left and back I would say it gets into 7-8 territory, which I have not tested beyond that.    My internet sleuthing found that the closest description fitting my symptoms appeared to be "acute thyroiditis," although it is unclear if this diagnosis is correct.  I have an appointment to see a general physician on the Monday, 27th of December, 2021.    I received my initial of Moderna on March 18th, 2021... received a 2nd dose April 15th, 2021.  I had a breakthrough infection of COVID end of July/beginning of August 2021.  The adverse event was after my Pfizer booster on December 17th, 2021.    After the Moderna vaccine I did NOT have similar symptoms.  I had side effects in line with flu like symptoms after the first shot (but I don't completely recall exactly how severe).  24hrs after After my 2nd Moderna shot I had 24hrs of flu symptoms, fever 101-2F, chills, muscle pain and weakness.  After this 3rd dose Pfizer booster shot, I have had NO flu like symptoms.  The only symptoms have been the been the neck and head pain described above and a very mild swelling under the left armpit.    The severe neck pain is what concerns me and how long these symptoms have lasted.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications have not been reported.  Treatment has not been specified.