chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness of left arm after each injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 at 11:00 as dose 1, single (Lot number: EN6199) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021, outcome "recovering", described as "Soreness of left arm after each injection". Therapeutic measures were not taken as a result of pain in extremity.
Right jaw joint pain, very sensitive if I yarn,  noticed morning after 2nd covid vaccine shot on 4/22/21 and currently still painful 4/27/21
This child's right arm was swollen with redness and warm to touch at the injection site (deltoid area).
Trigeminal neuralgia diagnosed six months after receiving the vaccine, however I spent 6 months prior to diagnosis with severe headaches.
severe vomiting and diarrhea for 4 days, could only consume clear liquids in very small amounts all over body aches
This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE RASH (Rash (injection site)) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (Rash (injection site)). At the time of the report, INJECTION SITE RASH (Rash (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Client contacted clinic 12-7-09 to report ringing in ears. Started 6 hours after recieving H1N1 injectable. Continued x 2 days. Still experiencing. Client advised to see PMD.
Progress Notes  (Nurse Practitioner) ? ? Infusion Center Cosigned by:  MD at 3/4/2021  8:28 AM Expand AllCollapse All     COVID VACCINE CLINIC  3/2/2021        Subjective Patient is a 77 y.o. female who was seen at  COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience chest tightness and lightheadedness.  She denied rash, glossal tightness or increased work of breathing This provider was notified of patient reaction and I was then assessed in the emergency bay area.   PMH HTN, obesity and NIDDM. Cardiac cath 2 years ago: normal per report.   Pt has NIDDM, ate eggs/baco this AM with AM FBS: 150 mg/mL. Pt has re-applied her long sleeve sweater and heavy coat as she began her observation period. She was alert, mild pallor with normal VS on arrival.   Blood sugar: 80 mg/dL. Oxygen applied. BP138/62, HR76. Sat 100 % Granola bar/water provided with complete resolution of symptoms   Monitored patient for severe reaction symptoms, including but not limited to any need for additional diagnostics. Recommendation for 30" observation period at Dose #2 of 2 .  APRN-C     Previous Reactions: none    Objective Vitals There were no vitals filed for this visit.    Blood Sugar 82 collected at 0953     Arrives in wheelchair, awake, alert HEENT: No glossal issues, no stridor LS CTA S1S2 Skin pale. No rash Anxious    Assessment/Plan  Treatment included: oxygen, blood glucose, VS monitoring, snack Follow up response to treatment: complete resolution of symptoms Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: hypoglycemic event        APRN Electronically Signed 3/2/2021 9:52 AM
Started with bone aches at 9 pm on the 22nd and a blister developed at the injection site with swelling and redness on 23rd till the 25th when the blister disappeared but redness stayed and scabbed. It was still noticeable when I returned to work on Monday the 27th when I reported it to a nurse in PM and showed my employer. I was instructed to have this document completed.
21SEP97 pt exp approx 40 gen lesions p/being exposed to sister who also exp lesions (WAES97091711);PCR revealed wild type virus;
01/08/23 presents to ED for "diarrhea". PMHx of "breast cancer diabetes osteoarthritis hyperlipidemia, hypertension PE on Eliquis"
Patient stated has headache, chest congestion, weakness, aches all over, chills and fever that started the evening of the vaccination
Tingling in both hands and both feet. Persisted for 2 weeks. Symptoms have returned. No treatment. I was not asked if I wished to receive the high dose vaccine and it was administered without my knowledge.
Shingles diagnosis a few days after my first dose of Covid vaccine. Fatigue/ feverish/ flue like symptoms
Pt received pediatric dose (0.5 ml) of Hepatitis A vaccine instead of adult dose (1 ml) during program  no negative outcomes
Information has been received from a physician, for the pregnancy registry for GARDASIL concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (route and administrating site not reported).  In March 2008, the patient was vaccinated with a second dose of GARDASIL (route and administrating site not reported).  The patient became pregnant during the GARDASIL series.  On approximately 01-JUL-2008 the patient was attempting to get clearance from her physician for a sport physical.  The physician insisted on a pregnancy test which was positive.  On approximately 07-JUL-2008 the patient delivered and the infant was born at 32 weeks gestation.  The infant was placed on a respirator in the Neonatal Intensive Care Unit.  Additional information has been requested.
Initial report received on 22 February 2008 from a health care professional. A 17-year-old male patient, with no concurrent illnesses, or pre-existing medical history, had received a first, right deltoid dose of Menactra (lot number U2551AA); a second right forearm dose of Tubersol (lot number C2682AA); and a first, left deltoid dose of Hepatitis A (manufacturer Merck, lot number 0800U) on 21 February 2008 at 15:00 p.m. The route of administration was not reported for any of the vaccines, or the tuberculin test. Eighteen hours post-vaccination, and post tuberculin test, which was around 09:00 a.m. on 22 February 2008, the patient woke up with a stiff neck, generalized achiness, and dizziness. The patient was evaluated by his physician on the same day and was found to be afebrile. The patient was at the physician's office when this report was filed. Treatments received, and diagnostic tests performed were not provided. At the time of this report, the patient had not recovered.
Was tested on 07/10/2021 at medical clinic. Rode in private car. Ended up getting admitted to Hospital on 07/12/2021
Pt developed a high fever ranging from 100F to 103F; fussy and tired and lacking in appetite.
When pt. awoke, he noticed swelling of his left axilla lymph node and left anterior cervical lymph node. Pt. took Tylenol for some relief of swelling. No fever or malaise. Swelling gone at 6 days.
The first 3 days got sore arm,  slight fever in the 2nd day.  In the 7th day the area got very swelled and  redness with fever on the area and very itching.
Total body shaking, trembling, tachycardia. Of note, patient took 1 week course of Septra. NP thought reaction could have been attributed to the antibiotic. Vitals wnl. Benadryl 50 mg IM given.
Information has been received from a physician concerning a female patient who on 20-SEP-2010 was vaccinated with the first dose of GARDASIL (lot # and route no reported). On 20-SEP-2010 the patient had fainted when given the GARDASIL. The physician stated the patient had no eaten or had anything to drink prior the injection. The physician reported that the patient was also very petite and the patient stated that she would continue with the injection series. At the time of the report, the patient had recovered. It was unknown if the patient sought medical attention. Additional information has been requested.
Had the vaccine, have shingles on hand/ suspected vaccination failure; Shingles on hand; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the vaccine, have shingles on hand/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on hand). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by patient via interactive digital media. The patient had the vaccine and had shingles on his/her hand. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Heavy, irregular period in timeframe after vaccine spotting bleeding for about a month, then heavier than usual flow; Heavy, irregular period in timeframe after vaccine spotting bleeding for about a month, then heavier than usual flow; Heavy, irregular period in timeframe after vaccine spotting bleeding for about a month, then heavier than usual flow; More painful than usual cramps at expected period date.; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 28-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for unknown indication on unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 the patient experienced heavy, irregular period in timeframe after vaccine. There was spotting bleeding for about a month, then heavier than usual flow and more painful than usual cramps at expected period date. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced heavy, irregular period in timeframe after vaccine; spotting bleeding for about a month, then heavier than usual flow and more painful than usual cramps at expected period date was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Suspected vaccination failure/I had the 2 shots, still get them; Still get them; So much pain; I burst out crying; It's so frustrating; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, crying and frustration. On an unknown date, the outcome of the vaccination failure, shingles, pain, crying and frustration were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, crying and frustration to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine and experienced shingles and pain. The patient really felt for the one that gets it. The patient burst out crying when nobody was watching, and it was so frustrating. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Tinnitus and severe hearing loss in right ear. Scheduled for an MRI by ENT doctor to rule out anything else. Audiologist checked hearing. Normal on left ear , severe hearing loss and tinnitus right ear. Scheduled for 2nd dose on April 6, 2021. Probably going to at least delay second dose as I am now terrified hearing loss will get worse! Just to note, I have NEVER had anything wrong with my hearing ever until I got this shot!
8 days after vaccine developed large baseball diameter swelling and inflamed arm.    Skin noticeably raised, hot to touch, hard.  Gradually spreading in diameter as swelling reduces.  Now(13 days from vaccine) a grapefruit sized rash with slight itching and warmth at edges.
Case number PHEH2014US020253 is an initial spontaneous report received from a Medical Assistant on 06 Oct 2014 and a follow up report from the medical assistant received on 18 Nov 2014. This report refers to a 09 month old female infant. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A13059) at a dose of 0.5 ml intramuscularly on 19 Sep 2014 (at 09:10 am). On the same date, she also received HIB vaccine (batch number: UH966AB) at a dose of 0.5 ml intramuscularly. It was reported that the MENVEO vaccination was inadvertent as she was not at high risk for meningococcal disease. On 22 Sep 2014, she developed a rash on her buttocks and groin area, felt fuzzy, had fever and diarrhea. Treatment was rendered with nystatin. The outcome of the events reported as recovered on 06 Oct 2014. The seriousness and causality of the events were not reported. Follow up report from the medical assistant received on 18 Nov 2014: Updated MENVEO dose and vaccination time. Added co-suspect HIB vaccine, events (fever, diarrhea and fuzzy) and recovery date of the events. Changed event onset date from 26 Sept 2014 to 22 Sept 2014.
pregnant consumer; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant consumer) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (prior use). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 30-Sep-2021. On 18-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant consumer). On 18-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant consumer) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided  No concomitant information was provided   Previous pregnancy had outcome of live full-term birth with gestational diabetes as a complication on 28-Dec-2019.
severe migraine, panic attack, sweats, chills, nausea, ocular aura most side effects lasted about 14 hours, completely miserable.
Body aches started day 3 with pounding headache. Missed 4 days of work.
This spontaneous report as received from a registered nurse referring to multiple patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug allergies were reported. On an unknown date the patient was vaccinated with improperly stored doses of GARDASIL 9 lot # M005714, expiry date : 03-OCT-2017 (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported and no additional information was provided. There was no product quality complaint reported. Temperature of 30.2F for 56.47 hours. There was no previous excursions. Data logger was reported as yes. This is 1 of 3 reports from the same reporter source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA003747: US-009507513-1701USA003863: US-009507513-1701USA003747:
Tenderness at the site of injection with ongoing, intermittent, mild aching and weakness in affected limb.
Headache, fatigue, nausea, pain at injection site, muscle/joint pain, fever and sweats experienced Thursday/Friday after vaccination on Wednesday. Heavy menstrual period triggered on Saturday after very light spotting on Thursday/Friday (which stopped on Friday for a time). Period should not have occurred and was about 10-12 days early. Heavy bleeding with little tissue. Still on-going as of Sunday after vaccination on Wednesday. Also experiencing twitching/pain in calf muscles as of Sunday after Wednesday vaccination.
Pt has food allergies, mild reaction to milk and egg. Approximately 1 hour after received flu vaccine developed hives with severe itching. Spoke with provider who advised Benadryl & ER. 2:00 Mom did not take to ER (Spoke with Nurse) hives gone breathing fine, playing. Discussed never to receive flu vax in future.  10-21-08 spoke with mom. Continues to be doing fine, no hives, no breathing problems.
R arm sore-hot to touch and swollen Friday, fan fever of 103 on Saturday, area swollen and puffy. Went to urgent care on Sun. Arm getting worse, saw MD was put on Zithromax and Paulor with codeine. Pt reported to nurse Monday feeling a little better. 10/8/02 pc to pt pt stable arm is still swollen and now itching.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included GLIPIZIDE and LISINOPRIL for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include supplements ,statins for cholesterol. No treatment medication details was reported.
Within 24 hrs redness and swelling seen near but not at injection site ((L) deltoid). Then swelling to (L) axilla with pain and "fluid" felt in (L) axilla.
On 11/11/2021 hives started on back and stomach. Went to PCP who did a steroid injection and a pred-pack. By 11/22/2022 hives were worse, with shortness of breath with short distance. Called PCP back with no response. On 11/23/2022 went to Urgent Care who transported me to  Emergency Room by ambulance for overnight admission to control heart rate and respiratory symptoms and control hives reaction. IV doses of steroids, Benadryl, fluids given. Lab work and EKGs performed.
I noticed my lymph node - there was a lump/bump there. My whole left side was sore - around the clavicle left side.. I consulted the health practitioner at work and she told me to go to my practitioner. My practitioner sent me to get a sonogram and a CT.  By then I got the second dose, 1/21/2021.  In time they all went back to normal (shrunk). It took about a month after the second vaccine for everything to subside and get back to normal. No treatment.
The patient does not recall any adverse effects at the time from any of the vaccines given; Patient received three doses of pneumococcal vaccines (PREVNAR 13 & PNEUMOVAX 23) in a one month period; Patient received three doses of pneumococcal vaccines (PREVNAR 13 & PNEUMOVAX 23) in a one month period; This spontaneous report was received from a pharmacist refers to a 66 year old male patient. The patient's current condition included type 2 diabetes mellitus. The patient's historical conditions, drug reactions/allergies and concomitant medications were not reported. The patient received three doses of different pneumococcal vaccines. On 15-SEP-2014, the patient received the first dose with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) as prophylaxis. On 17-SEP-2014, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) as prophylaxis (dosing details, route, lot # and expiration date not reported). On 15-OCT-2014, the patient received the third dose with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) at an unspecified clinic. Patient received three doses of pneumococcal vaccines (pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23)) in a one month period (inappropriate schedule of product administration, interchange of vaccine products). The patient did not recall any adverse effects at the time from any of the vaccines given.  Product quality complaint not involved.
Right side starting hurting within a few days after the vaccine. Went to the hospital on 09/20/2021 and was diagnosed with Appendicitis. Appendix was removed on 09/21/2021.
vaccines given today from a vial that had been held past the published expiration date.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines given today from a vial that had been held past the published expiration date.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines given today from a vial that had been held past the published expiration date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines given today from a vial that had been held past the published expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines given today from a vial that had been held past the published expiration date.).    No concomitant medications were reported. No treatment medications were reported.