chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inflammation; Right ankle had swollen again; His right ankle and knee both were swollen; Inside arms right by the joint started swelling; Bridge of nose was swollen; Left eye was swollen up shut; Extreme facial swelling and was brought to the emergency room and was prescribed with medication to reduce the swelling; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: EW0175) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: EW0162) as dose 1, single for covid-19 immunization. On 02May2021 the patient experienced face swelling and went to the emergency room and prescribed with medication to reduce the swelling. Once it came down, on 11Jun2021, patient left eye was swollen up shut and patient returned to the medical facility and doctors gave him medications to reduce the swelling. On 18Jun2021, the patient's bridge of nose was swollen, 19Jun2021, inside arms right by the joint started swelling, 28Jun2021, patient right ankle and knee both were swollen, then went back to the emergency room and patient was again prescribed with medications for that. It went down for a couple of days, but patient right ankle had swollen again on 15Jul2021. On an unspecified date the patient had inflammation. The event swelling face was serious medically significant. The events facial swelling, joint swelling led the patient to emergency room visit and received treatment. The outcome the event swelling face was recovering, event his right ankle and knee both were swollen was recovered with sequelae on an unspecified date in 2021, and outcome of the other events was unknown.   Follow-up attempts are completed. No further information is expected.
1st and 2nd dose given 7 months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st and 2nd dose given 7 months apart) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast implant user.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st and 2nd dose given 7 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st and 2nd dose given 7 months apart) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not reported. Treatment information was not provided.   This case was linked to MOD-2022-546553 (Patient Link).
Diarrhea; Achy muscles; Achy muscles and joints; Low grade fever; Flu like symptoms; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 13:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and glucosamine (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. The patient previously took morphine and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 20:00, the patient experienced diarrhea, achy muscles and joints, low grade fever, flu like symptoms and nausea. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events diarrhea, achy muscles and joints, low grade fever, flu like symptoms and nausea were resolved on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient came in the pharmacy 4/19/17 at 8:30 PM to report an adverse reaction that he experienced the date after being vaccinated.  Patient stated that he experienced itchiness, redness, tender to touch and warm. He did not seek medication help.  He did not take any OTC medication to relief itchiness. He stated that the adverse reaction went away after about 2 week. All the symptoms went away after 2 weeks.
12/9/10 - Started having redness & swelling at injection site today - cellulitis - started on KEFLEX per Dr.
10-25-11 pt here & reports that after rec'ing 2 vaccines in the same arm (one day apart) that her upper arm (points out 1 1/2" strip across (L) deltoid that became red & tender & that a swollen "gland in her (L) armpit: (L) neck under chin" developed one day after second vaccine (PPV23) & worse by following Sunday & c/o "kidney pain in Sunday".
Muscle pain with shot resulted in progressed with shooting pain progressing down arm within 2 hours. 3 days of discomfort when moving arm behind body 1 hour. Advil 500 mg started yesterday mild pain still present.
itching; rash over her chest/ rash on her back site close the waist; 2 by 3 inches red (injection site); sore arm/ arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/ arm hurts), PRURITUS (itching), RASH (rash over her chest/ rash on her back site close the waist) and VACCINATION SITE ERYTHEMA (2 by 3 inches red (injection site)) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm/ arm hurts). On an unknown date, the patient experienced PRURITUS (itching), RASH (rash over her chest/ rash on her back site close the waist) and VACCINATION SITE ERYTHEMA (2 by 3 inches red (injection site)). At the time of the report, PAIN IN EXTREMITY (sore arm/ arm hurts), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (2 by 3 inches red (injection site)) outcome was unknown and RASH (rash over her chest/ rash on her back site close the waist) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.
PATIENT CALLED IN TODAY & STATED THAT HE HAD ISSUES WITH HIS HANDS & FEET BEING VERY SENSITIVE & IRRITATED & TENDER A WEEK AFTER THE PFIZER VACCINE WAS GIVEN, MARCH 5TH @ 8PM. THE NEXT MORNING HE AWOKE WITH A RASH ON ARMS & LEGS, WITH NO ITCHING, NOT RAISED, RED DOTS. NO OTHER SYMPTOMS NOTES, NO BREATHING ISSUES. CALLED THE DOTOR & HAD WAS GIVEN 5 DAYS OF PREDNIZONE & A LETTER ADVISING NOT TO GET 2ND VACCINE.
Swollen and sore arm persistent over the course of a week; red rash on arm and mainly around injection sight
Fever above 100F for five days, chills, weakness, dizziness, inability to walk without support, low appetite, some mental confusion, sleepiness, lethargy. After a week, very slow improvement. As of the time of this report, 10/03/2021, still very weak, easily fatigued, lost 12 lbs.
I became really itchy in different areas of my body and when I scratched those areas, my body broke out in hives. I took some Zyrtec to help which does relieve the itchy for the day but it comes back after not taking it.
Extreme fatigue (20 hours of sleep for five days)Extreme body ache, confusion, dizziness 4/20/09 Received PCP medical records of 4/13/2009. FINAL DX: none provided Records reveal pt seen for HPV #2 & breakthrough bleeding on BCP.  Reported no AE to HPV #1 other than pain at injection site.  t/c to office on 4/17 to c/o fatigue, achy muscles & fever since 4/14.  4/29/09 Received additional PCP medical records of 1/30/08-1/16/2009. FINAL DX: none provided. Records reveal patient experienced lower abdominal pain & diarrhea 7/08.  Colonoscopy done 8/22 abnormal w/congested mucosa left colon, redundant colon & internal hemorrhoids.  Tx w/diet & meds.  RTC 1/09 w/runny nose, achy, cough, fever & head congestion.  Dx w/sinusitis & URI & tx w/antibiotics.  RTC 5/08 w/weight gain, psych meds ineffective & pharyngitis.
Feeling soreness in the arm at the injection site.; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd February 2022, the patient received the 2nd dose of Shingrix. On 22nd February 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain 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 second shot on an unknown arm on the reporting day.  The patient was feeling soreness in the arm at the injection site.  The patient asked was it okay to take an Aleve. The follow-up would not possible as no contact details were available.
pediatric dose of Havrix was administered to an adult patient; pediatric dose of Havrix was administered to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 62-year-old male patient who received HAV (Havrix pediatric) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 27-JUN-2023, the patient received the 1st dose of Havrix pediatric. On 27-JUN-2023, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose of Havrix was administered to an adult patient) and underdose (Verbatim: pediatric dose of Havrix was administered to an adult patient). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK receipt date: 27 June 2023 Nurse called to report a pediatric dose of Havrix was administered to an adult patient. The reporter did not consent to follow-up. No follow up because reporter stated did not have email address. The adult patient received pediatric dose of Havrix  which led adult use of a child product and underdose.
Patient received 0.2 mL of vaccine from the adult (purple top) vial that was appropriately diluted.
ONE 18 YEAR OLD FEMALE THAT ONLY HAD A 15 MINUTE WAIT THAT STATED HAVING ISSUES. WITH CONTROLING HER BREATHING, HER MOTHER STATED SHE HAD BAD ANXIETY ATTACK, AFTER A FWE MOMENT THE YOUNG LADY SHE WAS NAUSEOUS. SHE WAS GIVEN A EMISES BAG AND TRIED TO DO BREATHING EXERCISE THEN SHE STATED SHE HAD TO THROW UP AND SHE DID.
pt c/o sore rt arm on 4OCT95; pt stated rt arm became swollen, red & very tender to touch by 6OCT95; pt came into clinic on 6OCT95 for tx; red area tender to touch & 2 1/2" wide x 2" long;area is swollen;sl red pin needle rash;
Case number PHEH2013US012428 is an initial spontaneous report received from a medical assistant on 05 JUN 2013, with a follow-up received on 09 JUL 2013: This report refers to a 17-year-old female patient. She was given only Men CYW liquid component of MENVEO (batch number: M12006/X12006) intramuscularly into right deltoid on 05 JUN 2013 (without being reconstituted with Men A powder component). Patient had no symptoms following this administration error (inappropriate preparation of medication). Patient asked whether revaccination required.   Follow-up was received on 09 JUL 2013: Patient demographics, vaccination site and information that patient had no symptoms were updated.
Extreme discomfort, not relieved through Tylenol, large swelling in the area that did not go away after 5 days.
a little tired hazy headache; intense burning in my chest; shaking jittery/ frightend; This a spontaneous report from a contactable consumer (patient).  An elderly non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN62020 and expiry date was not provided), via an unspecified route of administration, in the left arm on 24Feb2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history included skin cancer, kidney stones, HBP treated, arthritis and had skin cancer surgery removed 5 weeks ago center upper chest which involved injected anesthesia. Patient had allergies (unspecified). Concomitant medication included levothyroxine, liothyronine (NP THYROID); Olmesartan; citalopram and vitamins nos (MULTI-VITAMINS). She did not receive other vaccine in four weeks of vaccination. She did receive other medications in two weeks of vaccinations. She was not diagnosed with COVID, prior vaccination. She had not been tested for COVID, post vaccination. On an unknown date, patient experienced no problem for the first hours then a little tired hazy headache. Took paracetamol (TYLENOL) and went to bed early. Patient awoke in night by an intense burning in chest and was shaking jittery/ frightend. Patient had no serious fever and could breathe ok. She took 2 paracetamol (TYLENOL) and tried to go back to sleep. She felt better in the morning but still lingering burning sensation almost like underneath skin and was scalded or sunburn. She went to physician office and took diphenhydramine hydrochloride, paracetamol (TYLENOL PM) 2nd night. Better by 4th day but still did not feel normal. It was unknown if any treatment received. The outcome of events was recovered with lasting effects.  No follow up attempts are possible. No further information is expected.
Patient called into our office on 2/19/2018 in regards to arm pain -- patient was seen in office by PA. Patient voiced to PA that right arm hurt immediately after injection, was swollen, red, and hot to the touch immediately. Nurse that had given the injection stated the patients injection site looked normal after injection. Did not even bleed. Patient did not voice to any office staff that her arm was in pain or swollen before leaving. Patient did not call into our office to inform us of this until 02/19/2018. PA discussed with her in office the side effects of this vaccination and sent her in prednisone 20 mg. Take one tablet PO daily for 5 days. Patient called back in after that please see documentation attached. I spoke with both the patient and her daughter in regards to your recommendations. Patient is not able to afford an ultrasound at this time due to finances being tight and being on a fixed income. Patient declined to schedule us at this time, but is aware that the order is pending and may be scheduled at a later date if she so desires. Both patient and her daughter expressed continued frustration with this matter. Patient asked what treatment would consist of it ultrasound findings were abnormal? I advised the patient that would depend on the results and explained to her that imaging was important in order to give a clearer picture to what's going on with her right arm. Patient still declined to schedule ultrasound. Patient is planning on calling to report adverse reaction. Ok for her to call to report adverse reaction/side effect to injection. We can get ultrasound of soft tissue to rule out abscess IR fluid collection in that area due to shot. Order placed. Patient called in, states she continues to have excruciating pain in right arm. Patient believes this pain to be related to PREVNAR that was administered on 2/8/18. Patient reports that the right arm pain is centralized to the upper arm and will radiate into the right side of her neck at times. Patient notes small amount of swelling, but states she is much more concerned with the pain than the swelling. Patient states since being seen in office on 2/19/18 she has taken all prescribed medications without any benefit. Patient admits to taking NORCO QID for back pain. But the NORCO is not helping to alleviate the right arm pain at all. Patient states she was reviewing the VIS and is highly considering calling to report an injury related to PREVNAR. Please advise.
rash at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax & next day noticed redness @ inj site;resulted in 1" circumference;
Complete body numbness. Unability to walk. Felt something was very wrong. Its almost impossible to describe here.
interchange of vaccine; Moderna first dose and Pfizer second dose; Second dose given on day 23; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine), OFF LABEL USE (Moderna first dose and Pfizer second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 23) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 23). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) and OFF LABEL USE (Moderna first dose and Pfizer second dose). On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 23) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) and OFF LABEL USE (Moderna first dose and Pfizer second dose) outcome was unknown.        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.   A patient had received the first COVID-19 vaccination from Moderna on 09Aug2021 on  unknown deltoid muscle  Concomitant product use was not provided by the reporter.   No treatment information was provided.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 17-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1164 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type of were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
blood clots; urinating blood; arm pain; fatigue; he started bleeding from the second one; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206) on 17Mar2021 (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization and experienced urinating blood and blood clots profusely, UTI, bleeding, arm pain, and fatigue. The patient received his second shot on 17Mar2021 and almost to the date three weeks later, had the same incident with urinating blood and passing blood clots. He waited an extra day because he could not go to the bathroom and then he went to the ER that same day so that they could flush him out. He also had an appointment on that same day with his urologist. A CT scan was done at the ER and then in the afternoon he went to the doctor. The doctor did a catheter flush. The patient was unclogged but he was passing blood. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. He has no other adverse reactions at this time. The patient reported 11Apr2021 or 12Apr2021 was when he started bleeding from the second one (shot). He went to the hospital on 14Apr2021. The patient confirmed he was not admitted. The patient reported he is going to the doctor today (21Apr2021) to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of the events urinating blood, blood clots, bleeding, arm pain, and fatigue was unknown. The patient stated he does not know if this is an issue, however, it coincided with both of his shots. The patient was calling to see if this is something that has been seen or if it is in his head.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470922 same  patient/reporter, different AE/first dose
I am on kyleena for birth control. I have had it for a few years. My periods have almost completely stopped since having this IUD. I experience slight spotting every now and then but haven?t seen actual blood in about half a year or longer.  I got the Covid shot on November 2, 2021 and on November 4, 2021 I started a full heavy bleeding cycle. During this cycle I have experienced severe cramping. One cramp sent me to the floor it was so bad. It is now November 11, 2021 and I am still bleeding. The bleeding has slowed down but still there and I am still experiencing mild cramping today. I have been taking ibuprofen for pain and using a heating pad. I will be scheduling an appointment with my OBGYN in the morning.  I have also experienced more frequent headaches since receiving the shot.
Pain, redness, and a swollen hard lump in the injection site that has lasted 8 days and persists. Chills and body aches for 3 days.