chrisvoncsefalvay/vaers-outcomes huggingface dataset:
punctured more than 12 hours ago.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (punctured more than 12 hours ago.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (punctured more than 12 hours ago.). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (punctured more than 12 hours ago.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications were not reported. treatment medications were not reported.
Flu like symptoms; Fatigue; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No relevant past medical history was provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE, DOCUSATE SODIUM (STOOL SOFTENER), VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), SPIRONOLACTONE, WARFARIN SODIUM (COUMADIN), ATORVASTATIN CALCIUM (LIPITOR), VITAMIN D [VITAMIN D NOS], CALCIUM CITRATE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue) and HEADACHE (Headache) was resolving.            No treatment information was reported.
Information has been received from a health professional concerning a pt who, on 11/1/05, was vaccinated with a first IM dose in the right deltoid of Pneumococcal 23v polysaccharide vaccine (lot 650457/0937P). It was reported that the pt had a pretty significant allergic reaction and would be coming into the physicians office the week of 11/7/05. Follow up information from a woman working in a physicians office indicated that on 11/3/05 the pt called reporting a a local reaction to Pneumococcal 23v polysaccharide vaccine, described as a reddened, 6in circular area. The physician ordered Ibuprofen. On 11/4/05 the pt came to the office with localized cellulitis of the right upper arm. The pt was treated with Ibuprofen, Fexofenadine hydrochloride Allergra, heat to the area, and antibiotics. The pt was to return if there was no improvement. Additional information has been requested.
Headache; Chills; Body aches; Nausea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration at left arm on 19Jan2021 08:28 at 0.3 mL, single for COVID-19 immunization. Medical history included Open heart surgery in Jan2003 and in Jan2018 (he had two open heart surgeries, the first one in Jan2003, and the last one in Jan2018);Stent placement (he has had 14 stents placed over a period of time, the last stents were done when open heart surgery was done, they put in 3 that time, in Jan2018); and Gallbladder removal on 16Jun2020. The patient's concomitant medications were not reported. The patient previously took influenza vaccine (flu vaccine) in Sep2020. The patient had a reaction to the COVID-19 vaccine two days (on 21Jan2021) after getting it. He had a really bad headache, chills, body aches and nausea, a whole series of things went wrong. He woke up at 04:00 21Jan2021 with an intense headache. The reaction happened all together, his headache, body aches, chills, and very bad nausea started about the same time, he contacted his doctor that day. At time of report was the first day he was starting to feel better. It was the first day he didn't have a headache, he was feeling better now, he was basically in bed from Thursday on. He got up a little bit yesterday, and at the time of report he was feeling much better, it lasted 4 to 5 days (as reported). He took Tylenol 500mg, two of them, and kept taking it 6 hours apart, it was all he had to take, and it barely touched it (UPC: 30043739 LOT SMA115, EXP Sep2022). The outcome of the event headache recovered on 26Jan2021; and recovering outcome for the other events.
Redness and soreness next day, lump in  deltoid about 2-3 inches away from injection site. Lump is about 3 inches in diameter. Experiences similar  adverse effect after 1st dose and each year after flu shot but the size of lump , itchiness, and redness a lot more . Reaction lasted for more than 2 weeks and got better without treatment. Itching still on as at today
Rash after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (Rash after vaccination). At the time of the report, INJECTION SITE RASH (Rash after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. No laboratory provided by reporter Treatment information was not provided.   This case was linked to MOD21-080818 (E2B Linked Report).; Sender's Comments:  MOD21-080818:cross linked case
Vaccine given at 10 weeks and 1 day after being moved from freezer to refrigerator storage. No adverse reaction noted to patient.
MMRV and Varicella given at same visit rather than MMR and Varicella.
ON 6/27/2009 CLIENT NOTICED THAT LEFT ARM WAS SORE AND WARM TO TOUCH ALSO RED AND SWOLLEN, INSTRUCTED TO TAKE BENADRYL AT BEDTIME AND APPLY COLD PACK TO SITE FOR COMFORT. PATIENT STATES THAT ARM WAS BETTER TODAY
She was admitted with new onett hypoxia from her COPD exacerbation. She was treated with nebs, steroids wih marked improvement, earlier than expected. With findings of aneurysms, she was also started on metoprolol. Discharged home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
This initial spontaneous report was received from a 60 year old male patient referring to himself. Concurrent conditions included high blood pressure and pityriasis rosea. Medical history included measles and a fungal infection. He had no drug reactions/allergies. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) and hydrochlorothiazide (+) triamterene (DIAZIDE). On 06-JAN-2016, the patient received ZOSTAVAX subcutaneously for the prevention of shingles (lot # not reported). On 11-JAN-2016, the patient experienced a rash all over with the exception of the neck, face and genitals. He went to see a physician on 11-JAN-2016 who prescribed three courses of tapering dose of steroidal ointment clobetasol. The patient began noticing the rash clearing up by April 2016 but by November 2016, the rach returned. He was still experiencing discomfort from the rash and only felt some relief when using the ointment. The outcome of the event was not recovered. Causality was not provided. Additional information has been requested.
I got Guillain Barre Syndrome a short time after I had the Meningococcal vaccination at the new. 4/30/08 MR received for DOS 7/18-30/2007 with DX:  Guillain-Barre Disease which has resulted in significant motor weakness.  Significant improvement noted after tx with IVIG.  S/P Respiratory Failure 2' to above.  Pneumonia which was improving.   Pt presented with numbness, tingling of the hands and feet and weakness of the legs. Unable to ambulate, having SOB and difficulty clearing secretions.  PE (+) for facial weakness, decreased motor stregth, absent DTRs of the lower extremities bilat and trace in upper extremities bilat. Pt's condition continued to worsen and developed respiratory failure, intubated and placed on vent. Developed fever on 7/19/07-atelectasis with pneumonia. Treated with IVIG and abx.  Extubated 7/23/07. Ambulatory with walker by 7/29/07. D/C to family's home.
10/23/2013, injection site on left shoulder swells to about 4" across, then spreads down to inside of elbow area, turns red and hot and begins to itch. Antihistamines and ranitidine taken to combat symptoms.  10/24/2013, 10:30 AM, same symptoms but more intense. Same medications taken along with Tylenol for the pain of swelling. 1:30 inflamed area spreads to inside of elbow to armpit. Same medications administered. Medications are at 4 hour intervals.  10/25/2013 through 10/27/2013 symptoms now include both lips swollen, right foot and bottom of left foot swollen, same medications taken. 10/28/2013, symptoms are now subsiding. Same medications except for Tylenol are taken. 10/30/2013 all symptoms are gone. NO OTHER REACTIONS TO FLU VACCINES EVER TOOK PLACE IN PRIOR 50 YEARS.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the unspecified patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L004006, expiry date 05-AUG-2016) (dosage, strength and route were not reported). There were totally 10 patients administered with 2 incorrectly stored vaccine and the exact number of patients on PROQUAD (Merck) was unknown. At the time of the report, no adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer booster given instead of Pfizer Bivalent booster.  Pt aware
Dtap, IPV & MMRV given on 3-20-07 in AM. Patient began breaking out with hives in PM. Benadryl given. Hives improved. No other complications.
Sudden appearance of urticaria lesion on left arm below injection site.  Not painful or cellulitis.  Not itchy.  Not raised.  Lesion was visable and spanned approximately 3x5 inches.  Resolved in 48 hours without medication.
minor sore arm; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  It was unknown if there are other vaccine administered in four weeks. There was no COVID prior vaccination, and patient was also not COVID tested post vaccination. The patient experienced minor sore arm on 10Mar2021 with outcome of unknown. It was unknown if there was any treatment for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The pt developed pain and redness at DTaP injection site 24 hrs post vaccination. No antibiotics given.
My injection was at 4:08 pm on 1/13/21.  I woke up from a dead sleep at 2:30am on 1/14/21 and started vomiting for about 20-25 minutes. Also muscle pain at injection site.
Severe headache the night after vaccine, worst headache ever - not known to have migraines.  It resolved over 6 hours - vomited once.
Additional info was received on 7/10/02 from a healthcare provider regarding concomitant vaccines, an adverse event and event outcome. A nurse reported that a 2 month old male inadvertently received a dose of Hib-TITER and ACT-HIB vaccines at the same visit (date not specified). Concomitant vaccines of DTaP and IPV vaccines were also administered. The infant developed a fever of 101.4 degrees C. He was examined by the physician the following day and "was fine." The original report was received from manufacturer.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Mar2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer history" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Patient was healthy overall. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) Negative, notes: COVID rebound tested positive 2 days (today) after negative test; (06Aug2022) Positive, notes: COVID rebound tested positive 2 days (today) after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid (Lot number: GC2132) from 29Jul2022, to 02Aug2022 for the treatment of COVID-19. It was unknown if the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient took 8 doses of Paxlovid and discontinued due to severe headache and terrible metallic taste. COVID rebound tested positive 2 days (today) after negative test, rebound symptoms different and milder than initially.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Herpes simplex virus reactivation with every dose.Reactivation with in hours and up to 3 days following each dose. Upper lip; 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), on 06Aug2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FE3592; Anatomical location: Arm Left; Vaccine Administration Time: 15:30), administration date: 30Nov2021, when the patient was 58-year-old, for COVID-19 Immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip"; BNT162b2 (DOSE 2, SINGLE, Lot number: EP6955), administration date: 07Apr2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip"; BNT162b2 (DOSE 1, SINGLE, Lot number: EP6955), administration date: 17Mar2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip". The following information was reported: ORAL HERPES (non-serious) with onset 06Aug2022, outcome "recovered" (08Aug2022), described as "Herpes simplex virus reactivation with every dose.Reactivation with in hours and up to 3 days following each dose. Upper lip". Therapeutic measures were not taken as a result of oral herpes.  Additional information: The patient had no known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medication in two weeks. Prior to vaccination the patient was not diagnosed with COVID. Post vaccination, the patient had not tested for COVID.
2 days after vaccination, patient presented with acute onset of swelling and redness of bilateral hands and feet.  In addition, patient had a macular red rash on his chest.   The day after vaccination, patient had a fever of 100.9 degrees.
Pfizer-BioNTech COVID-19 Vaccine: Patient noted to have hives on hands five minutes after receiving immunization. Administered two doses of oral diphenhydramine with symptom resolution. Patient monitored in clinic: Vital signs stable throughout. No other symptoms noted. Discharged to home stable.
Next day had a headache that radiant around the back of my head and ear.  By Friday, my left eye was drooping as the day went on I was having trouble chewing on the left side and numbness.  Saturday morning woke up and my entire left side of my face was drooping.  Looked like I had a stroke during my sleep.  Drooping eye, slurred speech, unable to drink from a cup, can articulate correctly with my mouth.
Initial report received from consumer on 11 November 2013. A female patient (age unknown) whose medical history and concomitant medications were not reported received fourth dose of intramuscular FLUZONE intramuscularly (batch number unknown) (frequency, dose and site of administration not reported). The patient received FLUZONE during pregnancy. The patient had no adverse event. Her estimated date of delivery 15 December 2013. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Syncope, 88/52, O2-99%, pale - happened less then one minute after vaccines. Given crackers, sprite O2 @ 1L per nasal canula, Patient layed down, wash cloth placed on forehead. Dr requested call 911. Patient C/O dizziness, blurred vision. Within 5 minutes BP 122/68, P-70, & O2 99%. EMS arrived - Patient in their care.
Developed few discrete hives arms, legs around 9-10 pm: 6/24/11. Advised BENADRYL 25mg every 4-6 hours. Mom called approximately 10-10:30 AM following morning with "sunburn rash, sl. puffiness hands/feet - urticaria spreading to face/torso -> advised ER. Rx prednisone x4 days.
My leg muscles and joints hurt all the time; My leg muscles and joints hurt all the time; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (My leg muscles and joints hurt all the time) and ARTHRALGIA (My leg muscles and joints hurt all the time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (My leg muscles and joints hurt all the time) and ARTHRALGIA (My leg muscles and joints hurt all the time). At the time of the report, MYALGIA (My leg muscles and joints hurt all the time) and ARTHRALGIA (My leg muscles and joints hurt all the time) had not resolved.            No Concomitant medication was reported. No Treatment medication was reported.   This case was linked to MOD-2022-598674 (Patient Link).
This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The patient's concurrent conditions included an allergy to SEPTRA. Her medical history and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with the dose of ZOSTAVAX (lot # M011665, expiration date 17-MAY-2017, 0.65 ml, once, subcutaneously). On 20-SEP-2016, the patient developed redness and pain at the injection site that was the size of a dime. The pharmacist reported that when the patient came back to the pharmacy on 21-SEP-2016, the redness at the injection site had increased to the size of a quarter and a hard lump developed under the skin at the injection site. No treatment was given for the adverse events. The outcome of the adverse events was reported as not recovered at the time of this report. The relatedness between the adverse events and ZOSTAVAX was not provided. Additional information has been requested.
On the 18th (evening after shot) developed fatigue, chills, aches. The next day developed diarrhea and then started with chest pain during the night. Pain responded to nitrogylcerin x3  and tylenol. The chest pain increased over the next several days, including exertional chest pains and then became acutely severe on Sunday evening. Called 911 and admitted to the hospital for acute MI. During hospitalization was found to have persistent dyspnea and interstitial pneumonitis (not characteristic of MI) despite active treatment for CHF. Responded to IV prednisolone.
At 10:00pm on 1/22/21 at the site of injection I began to feel a dull ache. Around 1:00am on 1/23/21 I felt a stabbing pain at the site of injection as well as an aching numbness from my left shoulder down to my left pinky finger.  The morning of 1/23/21 I was weak and could barely walk, and I had a fever of 100.9. I got chills and would feel inexplicable cold and have goosebumps despite my fever. I had no appetite and was extremely fatigued. When sleeping on and off throughout the day I had extreme sweats and soaked my bedsheets. My muscles ached and touch was painful, even the spray of a shower felt painful.These symptoms continued until the early morning of Monday 1/25/21 which was the last time I experienced chills.
No adverse event; Nurse called to report a 26-year-old patient who received 3 doses of VARIVAX; the third dose being administered in the buttocks; This spontaneous report was received from a nurse refers to a 26-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2002, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On 05-JUL-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On 02-AUG-2023, the patient was vaccinated with the third dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, exact dose, route of administration were not reported), anatomical location was reported as in the buttocks for prophylaxis (extra dose administered, product administered at inappropriate site). No additional adverse event (no adverse event).
Painful shoulder, shoulder frozen for about 12 hours, then continued to be sore for a couple days before full function returned.