chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed  fever ,hypoxemia, and hypertension  day after the injection which was on the 9th.   I saw him March 12 2021.  He had fever, and hypoxemia. Cat Scan imaging of abdomen and chest did not suggest pneumonia or pulmonary embolus.  . He was admitted for hypoxemia. On my review ot the records, it is not clear why  was  hypoxemic.  He was discarded on March 17, and no symptoms today  on March 19 th when I speak with his wife by phone.
SWOLLEN, RASH, AND SKIN PEELING ON LEFT BICEP - SHE STATED IT HAS GOTTEN BETTER AS DAYS PROGRESS.
As soon as I pulled the needle out of her arm, the Inject-safe Barrier Bandage filled with blood. I removed it, and blood dripped to the floor. Placed cotton ball on site and pulled off a few seconds later with no blood flowing from spot. Wiped arm off with cool rag. Next the area raised a little and patient began to fill nausea and light-headed. She passed out for less than 10 seconds. Was very groggy, nauseous, light-headed and broke out in a cold sweat. We put her feet up and rested for greater than20 minutes. She finally did feel better and left with her family.
No symptoms or additional adverse effects reported; second dose in ROTATEQ immunization series was inadvertently administered past its expiry; Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication was not provided.      On 22-JUN-2020, the second dose in rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral, lot # R025731, expiration date 14-JUN-2020; strength and dose were unknown) immunization series was inadvertently administered past its expiry (expired product administered). No symptoms or additional adverse effects was reported (no adverse event). The outcome of the events was unknown.
Have heat in my back like there was an electric heating pad turned on high; This is a spontaneous report from a contactable consumer. An elderly female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EM9810) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Pre-diabetes and asthma. The patient's concomitant medications were not reported. The patient previously took sulfur and experienced allergies. The patient received first dose of  bnt162b2 for covid-19 immunization on an unspecified date (Batch/lot number not reported). The patient started to have heat in my back like there was an electric heating pad turned on high on 23Feb2021. It was reported as; Two days after second dose, started to have heat in my back like there was an electric heating pad turned on high. Now it's five months later and still experience this every day all day long. The event was reported as serious-medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08May2021. Outcome of the event was not recovered.
muscle pain over lower back and was going up to shoulder and neck; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain over lower back and was going up to shoulder and neck) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced MYALGIA (muscle pain over lower back and was going up to shoulder and neck). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (muscle pain over lower back and was going up to shoulder and neck) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
After a few days the patients arm starting swelling. The swelling never went down. Patient went to her Primary care DR, her ENT DR, and urgent care. Patient also went to her Cardiology Dr. There is a knot on her left arm. It is very tender to touch. The pain goes into her elbow and her fingers are beginning to become stiff. The knot and the arm is very painful.
Case number PHEH2014US022748 is an initial spontaneous report received from a consumer on 10 Nov 2014. This report refers to a 76 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413101) intramuscularly in the left arm on 06 Nov 2014. She reported that it was just a little sore from the shot on the day of vaccine. She experienced pain in left shoulder of the arm that was injected on 08 Nov 2014 and it hurts her whole shoulder. The event outcome was unknown. The seriousness and causality were not reported.
This spontaneous report was received from a physician and registered nurse via a company representative to a 17 year old female patient. On 25-JUL-2007, report was vaccinated with dose 1 GARDASIL (lot #, expiration date and route not reported). On 19-OCT-2007 the patient was vaccinated with dose 2 GARDASIL (lot #, expiration date and route not reported) in the arm. Other suspect therapies included MENACTRA given in the same arm where GARDASIL was administered and TDAP on the other arm on 19-OCT-2007. On an unknown date the patient developed face swelling, pain in the arm, arm swelling and high fever of 104-105 degrees Farenheit. Treatment information was unspecified by the reporter. The events resolved on an unknown date. It was unspecified whether patient sought medical attention. Laboratory diagnostic tests performed were unspecified by the reporter. Additional information has been requested.
after first shot, hives on thighs. Progressed to upper legs, backside and stomach from day ten until second shot slight decrease in hives a few days before second shot. Within 12 hours of second shot, hives from head to ankles all over body.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 23Apr2021 at 13:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 14May2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any other medical history and known allergies to medications, food, or other products. Concomitant medication taken within two weeks of vaccination included over the counter sleeping pill doxylamine succinate (UNISOM) from an unknown date. 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. Five days after first shot, on 28Apr2021, the patient noticed appearance of hives on thighs. Progressed to upper legs, backside and stomach from day ten until second shot. There was slight decrease in hives a few days before second shot. No medications were taken (upon advise of family physician). Within 12 hours of second shot, hives appeared from head to ankles all over body (down to elbows on arms). Seventy-two hours after first shot, the patient started taking antihistamines and took one prednisone pill at 72 hours as a therapeutic measures for the event hives. Stopped prednisone after one pill and continued with antihistamine. One week, post-shot if antihistamine was stopped, hives reappeared within 32 hours. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event hives was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected
Redness, flushed, SOB occurred instantly after receiving injection to L arm. Benadryl was given immediately. L shoulder area above injection site remained reddened throughout the night. Upon rising 3/10/21, noted painful rash/whelped/raised areas (approximately 6 different blotched areas of blister like rashes to L shoulder/Lneck/Lshoulder blade area). Went to urgent care clinic approx 2 days after injection  r/t pain/irritation/burning in L shoulder/neck area. PO steroids were administered and cream for site.  After 5 days of PO steroids, rash did not burn/sting anymore but Blisters/raised areas never went away after this. Area is currently still there and flares up at times causing irritation and itching.
Fever began on 4/5/10 with associated dizziness and decreased appetite. Tmax=103.6 degrees vaccine administered 4/1/10.
MAJOR BRAIN FOG, ANXIETY, HEART BEAT HAS BEEN RACING, WEIRD DREAMS, AND NOT BEING ABLE TO SLEEP MOST NIGHTS NOW.
This spontaneous report as received from a pharmacist refers to a 51 year old female patient with allergic to penicillin VK. On 22-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot # J000433 expiry date on 10-APR-2014) subcutaneous. Co-suspect product included Influenza Virus Vaccine (manufacturer unknown) received on 21-JAN-2013. Lot# was unspecified. There were no relevant concomitant medications. On an unspecified date in March 2013 the patient experienced bumps and a red flare around the injection site. Exact site was unspecified. As of 23-MAR-2013, patient was still experiencing bumps and a red flare around the injection site. Additional information has been requested.
I continue to have pain in my arm that radiates from my shoulder down. I also feel sharp pain in my left scapula area.
15mins p/vax pt exp feeling of warmth & was flushed; BP 260/160 tx Nifedipine SL & DPH; pt c/o h/a; pt adm to hosp,pt hyper, then hypotensive, discharge dx hypertensive urgency w/poss rt sided weakness; feochromocytoma
Adverse reaction to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction to vaccine) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction to vaccine). At the time of the report, ADVERSE REACTION (Adverse reaction to vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's current conditions and medical history were not reported. On 12-JUN-2015, the patient was inadvertently vaccinated with PROQUAD (Merck) (Lot # L006388 and expiry date of 25-AUG-2016) (unknown strength, route and dose) instead of prescribed M-M-R II. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. There was no product quality complaint involved. Additional information has been requested.
I woke up on the morning on April 15th with pain in the testicles, mainly the left. I called my primary care doctor who referred me to the emergency room for an ultrasound, which resulted in a diagnosis of Thrombo Phrombo Phebitis of Varicocele. My urologist believed that it was likely the vaccine that may have caused it and urged me to report it.
experienced occasional headaches and still have them.; This case was reported by a pharmacist via call center representative and described the occurrence of intermittent headache in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In March 2020, the patient received the 2nd dose of Shingrix. In March 2020, immediately after receiving Shingrix, the patient experienced intermittent headache. On an unknown date, the outcome of the intermittent headache was not recovered/not resolved.   It was unknown if the reporter considered the intermittent headache to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient received the second dose of Shingrix and immediately started to experienced occasional headaches. The reporter consented to follow up.
Information has been received from a physician concerning two patients in their 50 who on approximately 09-DEC-2008 ( " last week") were vaccinated with a dose of PNEUMOVAX (lot # 663012/1163X). The physician reported that the two patients experienced a severe local reaction and a fever of 102 degrees within 24 hours of being vaccinated with PNEUMOVAX. The physician contacted the center for disease control and was told to discontinue using lot # 663012/1163X however a specific explanation for this was not available at the time of the call. The two patients sought unspecific medical attention. At the time of the report the two patients were recovered. Attempts are being mad to obtain additional identifying information to distinguish the individual patients. Follow up information received from an office manager indicated that one patient was 67 year old female. The patient received a dose of PNEUMOVAX (lot # 663012/1163X) on 09-DEC-2008. The patient went to urgent care but was not hospitalized. Additional information was received from an office manager concerning a 67-year-old female with a codeine allergy who on 09-DEC-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (lot # 663012/1163X) intramuscularly. The patient experienced upper respiratory infection after receiving PNEUMOVAX. The patient developed a 102 degree fever and felt weak. The patient also developed 15 cm of redness and swelling at the injection site. The patient went to an emergency room and was released. Laboratory/diagnostic studies were performed and included a complete blood count. This is one of two reports from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Left leg pain and localized swelling, headache, stomach ache and fever 101 degrees 4 hours after receiving vaccines. Patient referred to orthopedics and lab work done.
No additional AE reported; patient was accidently administered an expired dose of MMR II on Apr 17, 2023.; This spontaneous report was received from Pharmacist and refers to a patient of an unknown age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  17-APR-2023, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II)  once, lot #U011149, expiration date: 08-APR-2023, administered for prophylaxis (strength, and route of administration were not provided (Expired vaccine used). No additional adverse event was reported.
18AUG92 pt states had high fever (didn't take temp) & was delirious during evening from 3AUG92 through 7AUG92; pain up to shoulder area & hot flash sensation across back; hurt all over; seen by MD 7AUG92;
Possible breakthrough infection after receiving Moderna COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BREAKTHROUGH COVID-19 (Possible breakthrough infection after receiving Moderna COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 BREAKTHROUGH COVID-19 (Possible breakthrough infection after receiving Moderna COVID-19 vaccine). At the time of the report, BREAKTHROUGH COVID-19 (Possible breakthrough infection after receiving Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug information was provided.  It was reported that patient had either received all Pfizer doses or Moderna doses previously, and had contracted COVID recently. However, reporter was not sure if the vaccine administered was Pfizer or Moderna.  No treatment drug information was provided.  Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history. The patient experienced the unexpected non-serious AESI event of breakthrough Covid-19 (possible breakthrough infection after receiving Moderna Covid-19 vaccine). It was reported that the patient either received all Pfizer doses or Moderna doses previously, and had contracted Covid-19 recently. No further clinical information was available for medical review. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-644263 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history. The patient experienced the unexpected non-serious AESI event of breakthrough Covid-19 (possible breakthrough infection after receiving Moderna Covid-19 vaccine). It was reported that the patient either received all Pfizer doses or Moderna doses previously, and had contracted Covid-19 recently. No further clinical information was available for medical review. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-644263:same reporter
This spontaneous report was received from a medical assistant regarding a 4 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 23-FEB-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L019128, expiration date 27-MAY-2017, (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 8F, Time frame- 3 hours and was back in range. There was no previous temperature excursion before and yes call was because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax c/o body ache, h/a, chills;states had T exactly does not know F;c/o lt deltoid red, warm;T taken on 5//19/99=99 on AD & swollen, no energy;
Weeks after noted muscle tenderness.  Have sore/tender places to touch all over my body.  No better and no worse since noting these.  No joint involvement.   I don't feel the pain until the spot is touched and then the pain is much more than the touch that triggered it and it will slowly resolve over time.  Tried scheduled Tylenol without help.  Can't take consistent NSAIDS due to causing stomach pains.  Have had steroid shots, due to other issue, in my shoulder and the steroid didn't help.
Chills, progressed to fever of 100 F, muscle aches, swelling and discomfort in left armpit
Sore arm at site of injection; balance problems (from a couple hours after injection continuing and worsening somewhat morning after.
Patient reported geographic tongue with increasing pain / inflammation and difficulty eating 3 days after second dose of Pfizer vaccine
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 12:00 as dose 1, single (Lot number: EN6205), in left arm, on 06Apr2021 at 12:00 as dose 2, single (Lot number: EN8727), in left arm and on 02Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PTSD" (unspecified if ongoing); "Liver disease" (unspecified if ongoing); "Gall bladder disease" (unspecified if ongoing); "Sensitivity to Flagyl" (unspecified if ongoing); "Sensitivity to Cipro" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; XANAX; BUSPAR. The following information was reported: COVID-19 (medically significant) with onset 13Jul2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 13Jul2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148415 same patient/SD (dose 3), different AE.;
1406: Pt received COVID19 vaccination and proceeded to observation area 1430: Pt reported feeling lightheaded, shortness of breath, bilateral wheezing. O2 sat = 93% on room air 1438: 911 called 1443: 2 puffs albuterol MDI given, placed on 2L O2 via nasal canula. Heart Rate: 104, BP: 140/100 1445: BP 130/90, O2 sat = 96% on 2L O2, wheezing improved 1446: Rapid response vehicle arrived. Continued with 2L O2, sat = 96%, wheezing improved 1454: Ambulance arrived 1502: O2 sat = 96% on room air, seated BP: 110/70 1504: Standing BP: 114/82. Client declined ambulance transportation to local hospital.  1511: Client left site with co-worker driving her vehicle. Client reported going to local ED for follow up.
extreme aches, whole body hurt, bad headache and fever. blacked out twice in the middle of the night trying to go to the bathroom and came crashing down on hardwood floor and was unable to know where I was for a few seconds. Upon getting helped up and led back to bed I blacked out again and the same thing happened.