chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse event; I was administered the second dose ofGARDASIL 9 around 3/21/2020 after the first dose ofGARDASIL 9 was administered around four years ago; This spontaneous report has been received from a healthcare professional who was also a 26 years old patient of unknown gender, referring to her/himself. The patient's current condition, history condition and concomitant medication were not provided.  In 2016 (reported as around four years ago (unspecified date)), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# and expiration date; dose, strength and route were unknown) for prophylaxis. On 21-MAR-2020 (reported as around 21-MAR-2020), the patient was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (intramuscular) (inappropriate schedule of product administration). No additional adverse event.
patient  symptoms: no strength, hard to breathe, notices blood clots a few inches from injection site
This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.   A 65-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jun2021 (Lot number: EW0191) (at the age of 65-year-old) as single dose for COVID-19 immunisation.  Medical history included glaucoma from an unknown date and unknown if ongoing. The patient's concomitant medication included brimonidine tartrate/brinzolamide (SIMBRINZA) taken for glaucoma, start and stop date were not reported. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 13May2021 (Lot number: ER8736) (at the age of 65-year-old) as single dose for COVID-19 immunisation and experienced bulging eyes, eye swelling and pain in eyes. The patient reported that:  she experienced swelling around and under her left eye which caused it to "bulge out".  The bulging was most notable in the mornings. The symptoms were worse after her second dose, that her "face is deformed a little bit". There was swelling in the tissue around her eye, the tissue around the outer part of her eye was swollen. It was not doing any of this before the vaccine. She stated that she was having sharp pain shooting through her eye. She said that it was from her eyebrow to the corner of her eye by her nose. The events required physician office visit. The patient outcome of the events was not recovered.
One day after getting vaccine, symptoms were sore arm, headache, very tired, of 101.  Two days after vaccine,  102 fever,, headache, flu like symptoms..  3rd day after 102 fever, headache, flu like symptoms.  4th day after vaccine, 101 fever during the day, and 100 in evening, headache...sore arm, 5th day after after 99 fever.  I always run a low temperature of 96.8 or close to it.
0 - 30 minutes: Dizzyness, mild bronchial tightening, aching at location, aching and cold sensation on dorsal 2-3 tarsal hand.   30min to 4 hours: increase in sourness.  No decrease in other symptoms.  4 - 6 hours: small rash at injection site developed, swelling, hardness, and inflammation developed at the injection site.  Increase in nerve ache at the hand, now including the wrist.  A decrease in dizziness.  No more bronchial tension.  6 - 12 hours:  Soreness at injection site increased.  Nerve pain with cold, ache, and numbness through the left anterior arm and left anterior and posterior forearm with weakness in the left hand.   Swelling on the lymph nodes in the Left arm pit.  12 - 22 hours:  Increased swelling of the left auxillary lymph nodes with associated pain.  Large node bulge is developing.  Inabiility to fully rest arm at side.  When anything less than 15 degrees (addcution or at rest) the nerve pain and lymph node pain increases to the point of mild nasea.
day p/vax pt began vomiting (x13) & diarrhea (x8) 31MAR99 diarrhea (x10) 2APR99 diarrhea (x4 by 11AM) c/o received from babysitter not from parent;c/o fever but did not have thermometer to use to verify;denies s/s dehydration;
COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4494422-00.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: 1162439), as dose 2, single (Lot number: 1162439) and as dose 3 (booster), single (Lot number: 1162439), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162439), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  Clinical course: The patient used Prescription drug from another patient. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Causality as per reporter (Drug/Vaccine) was not reported for HUMIRA for event COVID-19. Causality as per reporter (Drug/Vaccine) was reported as possible for Pfizer BioNTech Covid-19 Vaccine for event COVID-19.  The reporter considered "covid" related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be completely excluded.
Pt complained of chest pain, itching, rhinitis, and facial swelling. Given epinephrine. Developed wheezing and given Albuterol nebs and po steroids. By 1:40 pm the pt appeared well with decreased swelling, decreased wheezing, and no respiratory distress.
itching; got a rash on the arm of the injection and is spreading on her chest, neck and back; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (itching) and RASH (got a rash on the arm of the injection and is spreading on her chest, neck and back) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (allergic to, aluminum, latex, feathers, clorine, pine, lavender, peppermint, nuts (all kinds).), Drug allergy (allergic to, aluminum, latex, feathers, clorine, pine, lavender, peppermint, nuts (all kinds).) and Food allergy (allergic to, aluminum, latex, feathers, clorine, pine, lavender, peppermint, nuts (all kinds).). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (itching) and RASH (got a rash on the arm of the injection and is spreading on her chest, neck and back). At the time of the report, PRURITUS (itching) and RASH (got a rash on the arm of the injection and is spreading on her chest, neck and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug includes herbs. Treatment medication includes put Alevila on it.
MOM REPORTS REDNESS APPEARED -2 AFTER IMMUNIZATION . TODAY, & 3 DAYS  PT HAS REDNESS SURROUNDING PUNTURE MARKS ON R THIGH EXTENDING -3 X 4 INCHES INDUREATED, SLIGHTLY DARKENED AREAS, THINNING OF SUB Q TISSUE, + WARMTH
Fever, body aches, weakness, swelling, redness, and itchiness  at injection site and lower down the arm.
My arm was sore at the injection site for 3-4 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site for 3-4 weeks) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site for 3-4 weeks). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site for 3-4 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-377030, MOD-2021-377031 (Patient Link).
It all hit my son like a ton of bricks. Out of nowhere, he started screaming and crying like I had never heard. He was absolutely inconsolable for over 30 minutes straight (and he is not a fussy child). We gave him Tylenol after 30 minutes of this and it helped calm him down a little, but he still continued to whimpered in his sleep all night long. He was fine the next morning but then spiked a fever (over 100.4)  the Tylenol brought it down a little bit. The following day he was really crabby and really tired.
This was the 2nd dose of shingrix. Per patient no side effect with 1st dose. However, immediately after vaccination patient complained of lightheadedness and rapid heart rate. Gave patient an ice pack and water. Also checked patient's blood pressure which was normal 128/85, heart rate 90. Patient sat down and rested for about 20-25 minutes. She eventually felt better and was able to get up to leave.
Warmth, tender, red covers all lateral and posterior left arm, itchy and mildy tender.   Treated warm compress/anti-histamine
Caller heard a doctor state he had a fever for 24 hours after the covid vaccine (doesn't specify which one); This is a spontaneous report from a contactable other HCP. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced caller heard a doctor state he had a fever for 24 hours after the covid vaccine (doesn't specify which one) on an unspecified date. She has two questions. She is getting the second vaccine today. When they were there getting the first one, the nurse said she had reaction from the second shot. She advised caller to take Tylenol before the second. Since then caller has read that you are not supposed to take Tylenol, Advil, or pain medication because it will decrease the effectiveness of the vaccine. She doesn't want to do that. She wanted to know what Pfizer's protocol or recommendation would be. Her neighbor said she had heard not to take it, but then read that the county said you can't take it before but you can take it after. How long is the effectiveness. She read something two days ago that said it is only good for 3 months. It didn't say Pfizer specifically. Caller clarified product as COVID19 Vaccine. The doctor that put caller on the list, because she is over 65 and it is hard to get the vaccine, said he had a fever and it was the best fever he ever had because it was helping him. Caller is a 65 y/o female. She received her first dose of the Pfizer Covid vaccine and reports she had a sore arm and swollen neck glands the following day. She says it lasted for several days and also experienced fatigue. She is getting her second dose of the vaccine 12Feb2021 and wants to know if it's ok to take a pain reliever before or after the vaccine is given. Additional AE information: caller reports a nurse at the vaccination site is telling recipients to take tylenol before the vaccine because she had a fever after the Pfizer vaccine. Caller's aunt was freezing after receiving the Moderna vaccine. Caller heard a doctor state he had a fever for 24 hours after the covid vaccine (doesn't specify which one). Caller wants to know if Pfizer is creating a booster to address the new variants of the Covid virus. Outcome of the event was unknown.  Information about the Lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Pain, swelling, redness, bruising, tenderness, hot to touch, unable to sleep on left side due to pain
I had no adverse reactions to the vaccine except for a sore arm. When I had caught Covid, I had a headache, stuffy nose, chest cough, sinus pressure, and insomnia. On December 25th I tested positive for Covid.
Lg red raised area, warm to touch 3 1/2" x 3 1/2" at injection site
Pain at the site of the injection after administration and for the remaining monitoring time: hot, red, infammed, raised area approx 3 cm in diameter : given 25 mg oral benadryl, ice to area with instructions to continue the benadryl , add oral pepcid and call MD for eval: to call 911 for any SOB or severe anaphylactic reaction; family notified and accompanied pt home
Johnson and Johnson vaccine use for COVID-19 under Emergency Use Authorization (EUA): Patient received the J&J vaccine approximately two weeks prior to medical event. He had a right middle cerebral artery acute ischemic stroke. He received proper treatment revascularization of thrombus. Extensive work up showed no explanation for his stroke. No evidence of underlying malignancy. No obvious hypercoagulable state. No patent foramen ovale. Final conclusion was cryptogenic stroke in 20yo that occurred two weeks after receiving the J&J vaccine.
Sore arm with moderate pain Shivering, headache, muscle and joint pain, tiredness, stomach pain and nausea. Couldn?t do regular activities for two days.
Pt reports that she developed dry, scaly, scalp, lips, and hands, peeling.
29OCT90 Seen in ER rx Rondec then Wed had sz- ear infection - temp 105 had sz admitted started antibiotic- CT scan sz 28JAN91 had a one side weakness then OK-seen by Neurologist OK.
SkinRash, Rash, UrticariaPruritus, rash near site of injection,tingly, numbness between shoulder blades intermittently continues 1/4/2021
On July 6th 2018 at 9:00pm fever began and lasted until July 8th. Fever spiked as high as 103.9 degrees. Vomited at 1am on July 7th. On July 9th, a red, bumpy rash developed at the injection site - upper right thigh.  Rash lasted a few days, and then bruised over. Called Dr. on July 9th to explain symptoms. Emailed a photo of the rash. Doctor called back and said is was a reaction to Varicella shot and said there was no need to come into the office for a visit.
24 hours after receiving vaccine, the patient became extremely weak. He could not eat or get out of bed. Localized injection site reaction lasted for a week and was severe. He experienced an extremely large shot and was very swollen for a week post injection.
flu like symptoms; Nausea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (Nausea) and FATIGUE (Tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (Nausea) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (Nausea) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant treatment medication were used   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Non-significant follow up appended.
I may have received a vaccination similar to this before; I may have received a vaccination similar to this before; No adverse effect reported; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history, concurrent conditions, concomitant medications and drug allergies/reactions were not provided. On an unknown date in July 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and on 02-OCT-2019, the patient vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient stated that "she might had received a vaccination similar to that before" (circumstance or information capable of leading to medication error and inappropriate schedule of product administration). No adverse effects reported. No product quality complaints (PQC) were involved.
Severe pain/ pressure in temples,eyes,back of the head. Blood pressure spike,red on chest, heaviness in chest and bile in throat, coughing, shallow breathing. Pain in temples tarted 5min after shot chest issues 25 mins later. Paramedics, ekg, iv, shot to bring down pressure, Benadryl in iv. Hospital 60mg of Prednisone and 20 mg Benadryl and kept me for observation.
She received her Shingrix vaccine on 5/6 at an outside facility.  On 5/7 she reported body aches, night sweats, and headaches.  On 5/8 she reported blisters and discrete lesions on her body.  She was taking Valtrex 1 g daily.  She states that she has 10-15 lesions throughout her body: back, legs, and arms.  She reports pruritis of her rash.  She also endorsed a nerve pain associated with these lesions.
Described Lyme disease in 36 year old male who reportedly received the complete immunization series of Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccine and has been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee work outdoors. The vaccinee stated that he received three injections of LYMErix, with the last dose in 05/2000. After 14 months of completing the LYMErix immunization series, the pt underwent a complete physical. he reported fatigue, headaches, and severe joint pain, especially in his feet and hands. The vaccinee requested to be tested for Lyme disease. He was notified by his physician that an unspecified test for Lyme disease was positive.
Very painful that he cannot sleep comfortably; Fever; Chills; Headache; Pain on the left arm,After that, he will still have intermittent moderate to severe arm pain. the arm pain started to be severe; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the left arm,After that, he will still have intermittent moderate to severe arm pain. the arm pain started to be severe), INSOMNIA (Very painful that he cannot sleep comfortably), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0056021A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain on the left arm,After that, he will still have intermittent moderate to severe arm pain. the arm pain started to be severe), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 03-Sep-2021, the patient experienced INSOMNIA (Very painful that he cannot sleep comfortably). At the time of the report, PAIN IN EXTREMITY (Pain on the left arm,After that, he will still have intermittent moderate to severe arm pain. the arm pain started to be severe), INSOMNIA (Very painful that he cannot sleep comfortably), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was reported by reporter.
Patient fully vaccinated (pfizer): 12/28/21, 1/29/21
INFANT PRESENTED FOR FIRST DOSE IN COVID SERIES. CLIENT GIVEN MODERNA BIVALENT 6M-5Y (0.2ML DOSE) FOR FIRST DOSE. DID NOT KNOW MISTAKE WAS MADE IN GIVING THE MODERNA BIV 6M-5Y FORMULATION UNTIL CLIENT CAME IN FOR 2ND PRIMARY DOSE AND NOTED WRONG FORMULATION GIVEN. CLIENT'S MOTHER WAS MADE AWARE OF FORMULATION ERROR AND REPORTED NO ADVERSE EVENTS AFTER FIRST DOSE.   INFANT GIVEN 2ND DOSE WITH CORRECT FORMULATION (MODERNA 6M+ 0.25ML DOSE).
The patient developed  significant axillary swelling 2 days post booster in the right arm which is the same arm as the booster administered in. No erythema. No lymphadenopathy. No fluctuance. No fevers
About 5 minutes after patient received FLUZONE HD, she felt shooting pain down her spine. The ambulance took patient to ER, where nothing significant was found.
Pfizer-BioNTech COVID-19 Vaccine EUA Patient indicated that this was his first dose of any COVID-19 vaccine. Therefore, we gave him the vaccine we were dispensing at this clinic. However after further investigation after administration, it was discovered that  he received the Moderna vaccine at another facility on 03/30/21. Confirmed with other facility and reached out to patient.
Rash after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had rash after vaccine. The follow-up could not be possible as no contact details were available.
Pt was activated on 10/23/2001. After activation he received multiple vaccinations. January 7, 2002 he started his Hepatitis B series. August 13 and 20 he received his Meningococcal and his second Hepatitis B respectfully. He was deployed on September 2, 2002. Prior to deployment he had a physical exam and was reportedly normal.  On October 14, 2002 he received his first anthrax vaccination and on October 15 he received typhoid vaccine. His second and third anthrax vaccinations were on October 28, 2002 and November 11, 2002. This patient reports that he began experiencing numbness in his right lateral thigh approximately ¾ of the way up and into his hip area on November 20,2002. He has been diagnosed with multiple sclerosis.
Child was taken to emergency room in pm of 6/7/05 with elevated temperature, was admitted to hospital.  Had testing done by Dr. which Dr. states revealed no evidence of infection.  No sign or symptom of local reaction was noted.   Child's temp was up & down with max. temp of 102.7 F, was discharged from hospital AM of 6/9/05 and still had fluctuating temp. 7/18/05 Review of 16-page medical record confirms fever & rash. Additional symptoms were vomiting & diarrhea. 9/15/05 Review of 6-page medical record confirms fever. 9/15/05 Review of 1-page d/c summary confirms scattered rash & fever. 1/25/06 Review of 7-page d/c summary confirms viral illness & fever. Follow-up: Child Dx with Kawasaki disease on 8/19/05, and heart problems with poor circulation.