chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-month-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. Patient developed a rash and returned to doctor 2 days later. Then 1 week later returned and it was diagnosed as an abscess. Patient had refused band aid after the dose was administered. Nurse reported patient had been picking at the scab bc there was no band aid. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: It cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role in triggering the occurrence of rash on the vaccination site later diagnosed as abscess. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
both leg pain. C/o of leg spasm x 5 days worsening this morning.Spasms began in Lower back radiating to posterior lower extremities towards calf with numbness.Tender to palpation and pain when walking.Denies numbness to feet.Denies trauma.1st shot of Monerna 9 Feb. 51-year-old male presents with 5 days of back pain radiating to both legs.  Patient reports acute onset of sharp, constant, moderate midline low back pain radiating to both lower legs.  Patient states she feels like she has leg cramps and spasms on the back of her legs.  She had the first dose Moderna COVID vaccine on the day her symptoms began.  Also reporting associated paresthesias in her legs, right greater than left.  Paresthesias are in lateral hip,
Patient presented with bilateral ptosis and weakness in the jaw while chewing that progressively gets worse as the day goes on. Patient was prescribed pyridostigmine bromide 60 mg with improvement of symptoms. Patient is following up with neurology.
Heart palpitations that  would come and go all day  and sometimes they were stronger than other times. The first time I felt them was early in the morning because they woke me up.  I had been exercising for a couple of week doing moderate or high intensity workouts and thought it could be that or maybe coffee but it was only one cup on occasions.  After a week I went to the doctor because they weren?t getting any better . Doctor said maybe it was stress and I got some blood work done. Everything was good  except my blood sugar was high, close to prediabetic. He said I could take some medicine for the stress if I needed but I didn?t because a few days later the palpitations were going away. I feel fine now and haven?t had any other problems but they did scare me because they were all day off and on and sometimes they were strong.
Severe chills Body aches Headache Joint pains Nausea Frequent urination Dehydration
Tingling in fingers on L hand, aching and soreness from shot site (L del IM) down to finger tips. Started immediately. Also complaining for dry mouth. Unable to do BP, Pulse on 80, nailbeds reactive, due to breast cancer.
This spontaneous report was received from a physician via a company representative and refers to a currently 11 months old female patient. There was no information about the patient's current conditions, concomitant medications and medical history provided. On an unknown date, the patient was administered with ROTATEQ orally (dose, lot# and expiration date were not reported) for rotavirus prevention. On an unknown date (reported as several days after the vaccination), the patient presented to an unspecified emergency room with blood stools. The physician reported the patient was transferred to hospital and received "enema-like procedure" (dates were not provided). On an unknown date, the patient was discharged home. The physician informed that at the moment of contact the patient was recovering and doing fine. The causality assessment was not provided by the reporter. The reporter considered the event of bloody stools to be medically significant.
Fever (101.5) for 18 hours. Light fever (99) until 36 hours after first symptom. Shakes and chills. Achey joints. Flu symptoms and weakness. Sluggish 24 hours. Cutaneous hyperesthesia for 48 hours. Chest pain and odd feeling when taking deep breaths until 04/23. Persistent headache until 04/24 evening. Headache persisted over front left eye and back of head.
Acute respiratory failure with hypoxia; COVID-19; NSTEMI, T2DM with hyperglycemia with long-term use of insulin
Patient reported feeling very hoarse and tingling around mouth approx 30 after vaccine administration. hx of bradycardia no erythema observed Pt transported via EMS to hospital for monitoring.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Covid-19 Test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID taken orally from 04Dec2022 to 09Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00122073) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (little sore arm). On 02-Mar-2021, PAIN IN EXTREMITY (little sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-054748 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up contained no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054748:wife Case
Fever of 102.5 for over 6 hours beginning 4/15/21, rash/hives appearing after 1 hour on left arm (not arm that received the vaccination), stomach, legs, hives still present as of 3:30pm 4/16/21 on arm, stomach, legs. Sore throat, headache.
Pt. had hives break out on her chest and didn't feel well. A blood pressure of 140/90 was observed and a resting pulse above 90 was also recorded. She said her chest was tight. We gave a 50mg Benadryl and that helped with the symptoms. After observation for over 1.5 hours, she felt better and her hives was looking better. She was taking home and rest. After speaking with her the next day, she is describing tightness in the chest and hurts to breath. I instructed to follow up with her PCP
Burning sensation in mouth. Tongue and lips swollen. Eyes feel like bulging. Ears ringing and burning. Face swollen. Numb face and dizziness. Lasted all night and into next day. On-going.
mom reported fever from 11AUG93, has swollen paratoid glands bilaterally greatly enlarged on rt side, redness in rt ear; fluid in both ear; c/o sore throat, throat edematous, sl red; dark circles under eyes; c/o sore eyes, pain in neck;
low neutrophils      45 on 4/20/2022 and 35 on 8/19/2022 high lymphocytes -44 on 4/20/2022 and 54 on 8/19/2022
10/29/02 Pt presented w/ herpes zoster (multiple clustered vesicular lesions) on L arm to L hand. Had been "out of sorts," fussy x 2 wks seen 10/23 for "fussiness" with URI sx. No fever, decreased sleep, decreased apet.
VACCINE SITE SWOLLEN AND PAINFUL 24HOURS AFTER INJECTION...ALSO FEELING WOOZY/HEADACHY. THEN ON SAT, NIGHT, THREE DAYS AFTER VACCINE, AT MIDNIGHT AWOKEN WITH HORRENDOUSLY PAINFUL AND SEVERE CRAMPING IN BOTH LEGS/THIGHS, FROM BIG TOE...TO INSIDE REAR THIGHS. UNABLE TO STRAIGHTEN LEGS. FOUR ATTACKS: MIDNIGHT 1HOUR30 MINS.USED SHIATSU MASSAGER THEN SECOND ATTACK TEN MINUTES LATER, 1 HOUR, EXCRUCIATINGLY PAINFUL, ON VERGE OF PASSING OUT, THIRD ATTACK 15 MINUTES LATER...TOOK HOT BATH FOR HOUR WITH MASSAGE...THEN FOUTH ATTACK IN RIGHT LEG ONLY...LIKE RIGOR MORTIS IN LEGS...UNABLE TO MOVE THEM AND SEVERE PAIN. I BENT OVER TO TRY AND STRETCH LEG MUSCLES AND IMMEDIATELY GOT SEVERE CRAMP IN LOWER RIB CAGE..INJECTION SITE STILL SWOLLEN AND PAINFUL TODAY TUESDAY, SIX DAYS AFTER INJECTION. HAVE NEVER EXPERIENCED SUCH EXCRUCIATING PAIN...UNREMITTING AND UNABLE TO BEND OR STRETCH LEGS. Follow-up Information 19-MAR-2009: Was unable to enter some data and in certain cases, eg #13 only UNKNOWN MANUFACTURER was the choice...and I had to choose it or not be allowed to submit the form at all. This second report is a follow up report to the first one filed in December 2007. It took me months to regain my health after this Sanofy Pasteur Td Vaccination...There is no warning on the package that this vaccine is EXTREMELY DANGEROUS TO PEOPLE WITH COMPROMISED IMMUNE SYSTEMS...LIKE ME. PLEASE ADDTHIS INFORMATION TO MY FIRST REPORT. Could you please provide me with copies of both reports or an integrated one? Thanking you for providing this valuable reporting system which may save someone elses life... Report submitted date: 12/18/2007 Temporary VAERS E-Report Number: E - 20159Report submitted date: 12/18/2007 This is a follow up report.Huge red papules on skin of chest and upper arms and feet...started early January 2008 and lasted for four months before easing...still appear on feet over a year later. Skin became terribly dry and scratchy as has still not returned to normal. Hair fell out and has still not grown back as thick as it was. Falling hair also lasted for months.
Headache, body ache, chills. Lasted from 7pm on Friday, 3-12 to 10am on Saturday, 3-13.  Symptoms faded away after I took a 500mg Tylenol at 9am on Saturday, 3-13.  This is the first time I have ever had an adverse reaction to a shot. I also do not get headaches, like ever, and haven't had body ache or chills since I had the flu in 2009.
flu like symptoms/ fever, body aches, headache, fatigue, loss of appetite, chest tighness  - began around midnight on 2/28 ( approxiamately 8 hours after vaccine) continued until around 9 am 3/1 -  chest tightness continued on
Rash on hands: deep blisters on palms and fingers and smaller dots on the backs of hands. Itchy and painful.  Rash on feet: deep blisters on the soles of feet  No other symptoms.
Breast changes; Remission since 2000 Medical Oncology needed Surgical Oncology needed Hospitalization Pharmaceuticals Transportation (medical) Other/ Radiology Oncology
Noticed the "covid arm" bulls-eye rash that morning, on day 12 after my first dose. It lasted about about 48 hours. There was no pain/itching/burning  at the reaction site. If I hadn't seen in in the mirror, I would not have known it was there.
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced flu. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
2 hours after injection, I became tired, dehydrated. I went to bed early just to wake up feeling extremely cold shaking as if I was in a snow storm on the brink of hypothermia. A couldn't say how long but I fell asleep and woke in a pool of my own sweat. I felt extremely sore at the injection site along with the rest of my body being sore. This lasted through out the night and into the morning. I felt these effects for another 2 days, but it diminished with everyday.
pt recv vax;c/o dizziness & then had episode of syncope;pt assisted to floor;alert immed;no oth side effects;unable to walk back to exam room;rested approx 15 min; then taken home by family mbr;
The patient was diagnosed with pancreatic cancer with mets to the liver on 8/25/2021.  She also had a breakthrough case of covid on 12/30/21.  She had her covid vaccines on 2/11/21 and 3/11/21.  No booster.  I do not have the lot numbers or location where the vaccines were given.
lump at injection site; got 3 shot; 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 MASS (lump at injection site) and EXTRA DOSE ADMINISTERED (got 3 shot) 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 VACCINATION SITE MASS (lump at injection site) and EXTRA DOSE ADMINISTERED (got 3 shot). At the time of the report, VACCINATION SITE MASS (lump at injection site) outcome was unknown and EXTRA DOSE ADMINISTERED (got 3 shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
1630 PT HAVING ITCHING AND FEELING HOT AND DIAPHORETIC POST VACCINATION. 1645 HYPERTENSIVE 169/115, HR 88. RAPID RESPONSE TEAM CALLED. PT WITH ICE PACK TO NECK AND GIVEN WATER TO DRINK. CONTINUES TO FEEL ITCHY AND HOT. 1657 178/115 BP REMAINS HYPERTENSIVE AND CONTINUES WITH ITCHING AND FEELING HOT AND ANXIOUS. 1710 REMAINS HYPERTENSIVE AND ITCHING. PT RELAXING TAKING WATER. 1730 PT REMAINS HYPERTENSIVE BUT REFUSES FURTHER TREATMENT BP 175/112. WANTING TO GO HOME. NO FURTHER TREATMENT GIVEN. INSTRUCTED TO GO TO ER OR NOTIFY MEDICAL PERSONEL IF CONDITION PERSISTS/WORSENS
Started about 3 hours, post vax, with inconsolable crying X 12 hours. Afebrile, no swelling at injection sites. Treated with Tylenol every 4 hours.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an elderly patient who was vaccinated with a dose of FLUZONE HIGH DOSE lot UI994AA; expiry date: 09-Apr-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of syringe leak since few drops has been leaked while administering the vaccine from the tip where the needle connects. It was not reported whether the patient has been affected following the vaccination. This is reported to 13th complain of this type for this product for a year. List of documents held by sender: none.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   The vials were stored in the freezer and taken out of the freezer and placed on the date of administration.   The vials did not undergo any temperature excursions.  No treatment medications were provided.
I went to a wedding out of town and was texted that several guests had tested positive for COVID-19. I started to feel sick like I had a bad cold. I was very congested, had coughing, runny nose and I felt like I had a head cold. I then took at home COVID-19 test and it was negative. I took another at home COVID-19 test 24 hours later and it was positive. I then went to my primary care doctor, and she prescribed PAXLOVID. Then when I got home, I isolated for 5 days and 5 additional days. On the 9th or 10th of July I tested again, and the results were negative and then 24 hours later I tested again and it was negative as well.
Shortness of breath; Rapid heartbeat; Rash; Itching; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot/batch number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for an unspecified indication. The patient's medical history included she was allergic to silicone and sulfur. The patient's concomitant medications were not reported. The patient received the COVID vaccine on an unspecified date (reported as Friday) and two hours later, she experienced shortness of breath, rapid heartbeat, rash, and itching. The outcome of the events was unknown.  Information about lot/batch number has been requested.
This patient had acute pain to neck, wrists, and knees. She has had prior surgery to her knees. Also experienced joint pain and swelling.
This spontaneous report as received from a nurse refers to a 17 year old patient of an unknown gender. On 03-MAR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
The day of injection, within a few hours, pt became very irritable and had rapid jerking motions of her extremities.
but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Over anterior (L) thigh - 2 circular bands of erythema surrounding injection site. Min. raised, tender. No violaceous discoloration. No deep hematoma.
Redness at injection site; Itchiness at injection site; Warm to touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE WARMTH (Warm to touch at injection site) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251202A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) and ATORVASTATIN for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE WARMTH (Warm to touch at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE WARMTH (Warm to touch at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Patient was administered expired vaccine. Patient was shortly contacted and informed same day, and came back in to receive correct vaccine that was not expired. He received the same lot number in the right arm.
Presents at ER 3d. post vaccines with redness and swelling present "today". Had mild fever "yesterday". Exam: 10 cm area of erythema and induration L. thigh.
Pt completed the COVID-19 Moderna vaccine series on 5/15/21. Pt was admitted to the reporting hospital on 8/30/21 with complaint of abdominal pain. Pt in the ER was noted to have fever, abdominal pain, and fatigue. Admission test for COVID was positive per PCR on 8/30/21. Pt was discharged 8/31/21.
My mother has the Moderna rash.  It started on 2/11, a week after her 1st dose.  The  site is rash is about 4 inches in the vicinity of the injection site.