chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had the vaccine back in September, but on Feb 13th I started with slight cough, I took 2 COVID-19 Test and both were negative. Slowly getting better, no congestion, no fever, it just a gunk on my throat that made me cough, it lasted for a while; after 2-3 weeks I called the doctor and he prescribed medication, I take it at night, The doctor said that this is going around. It can last 3-6 weeks. It's not as bad as before, my voice is a little affected. I was only tired because I was not sleeping well. I am back to sleeping fine now.
1) AFTER THE FIRST SHOT, THE MIDDLE FINGER ON THE LEFT HAND, THE JOINT KEEPS POPING EVERY MORNING. AFTER THE SECOND SHOT, THE RING, THE MIDDLE AND INDEX FINGERS JOINTS ARE POPING. CAN NOT STRETCH FINGERS OUT WITHOUT HELP FROM RT HAND.   2) 2ND SHOT, PAIN AT THE INJECTION SITE, HEADACHE, CHILLS, TIREDNESS   3) AFTER THE 2ND SHOT, LUMP AND SWELLING UNDER ARMPIT AND LUMP AND SWELLING ON SHOULDER.   4) ENTIRE LEFT SIDE OF BODY IS FEELING SOME KIND OF WEIRD SHARP PAIN   5) WEEK OF 2/22/2021, THERE IS A LUMP AND SWELLING ON MY RIGHT SIDE NOW TOO. THERE IS SOME PAIN BUT NOT AS BAD AS LEFT SIDE.   6) 3/3/2021, RASH ON LOWER BACK   7) 3/4/2021, RASH ON LOWER BACK HAS SPREAD TO MY SIDES AND TO BOTH SIDES OF MY BREAST, SOME RASH ON MY NECK ALSO.  8) SINCE THE 2ND SHOT I HAVE ALSO HAD WARM FEELING, ANY TIME THE LEFT SIDE GETS IRRITATED.  9) WEEK OF 3/1/2021, NONE OF THE SYMPTOMS / ADVERSSE REACTIONS HAVE GONE AWAY
COVID Vaccine Breakthrough Case  Pfizer Dose 1 1/25/21 (lot NA) Pfizer Dose 2 2/15/21 (lot NA) Pfizer Dose 3 11/2/21 (301308A) COVID Positive 12/25/21  12/25/21: Patient is a 93-year-old female with past medical history of CAD, CVD, HFpEF, type 2 diabetes, atrial fibrillation, hypertension, hyperlipidemia, OSA,  GERD, and anxiety.  She presented on 12/25/2021.  There was concern at the nursing home that she had a seizure.  She was therefore transferred to the emergency department.  On arrival, the patient was febrile with temperature of 100.6° F, she was also requiring O2 at 4 liters/minute to maintain adequate saturations.  At baseline, the patient uses O2 at night, but was desatting while laying supine per nursing report.  She was mildly hypotensive as well with 1 blood pressure reading of 94/51, but this did improve with fluid administration.  Chest x-ray negative for acute findings. UA was unremarkable with the exception of microscopic hematuria.  Blood cultures pending.  Lab work notable for glucose 278, lactic acid of 3.2, WBC of 26, UA negative. Patient does have a chronic right lower extremity wound and her apparent sepsis is believed to be secondary to infection of this wound.  She was admitted for further management of this.  History is obtained from chart review and discussion with ED provider.  Patient is tired and slow to respond.  When I asked her how she was doing, she did say "Oh, pretty good."  I asked her if anything was bothering her and she responded "oh, I guess not."   She could not tell me where she was or why she was here.  She did not know what year it was.  I tried asking specific questions on review of systems, but she did not respond. This is reported to be her baseline mentation per nursing report.  Also, floor nurse informed me that she spoke with staff at nursing home who for pretty convinced that patient did in fact have a seizure.  She was reported to be shaking uncontrollably on the ground and not breathing at the nursing home.  12/29/21: Likely sepsis due to right lower extremity cellulitis.  Resolved. New diagnosis of COVID-19 pneumonia, present before current admission to hospital.  Acute hypoxia and O2 requirement down to 1 liter/minute. Baseline she is only on oxygen at night.  T2 dm, worse this morning because of steroid.  Steroid discontinued.  AFib history but not on oral anticoagulation likely because of advanced age.  HTN/HLD/OSA/GERD/anxiety  , stable.  Marked leukocytosis likely due to sepsis.  Improving.  Mild hyperkalemia, resolved.  She remains a DNR
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 64-year-old male patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. On 5th May 2018, several days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The concomitant drug included prostate medication. The patient received SHINGRIX on left arm. The patient's wife reported that the patient experienced a red arm and swelling at the injection site after receiving the SHINGRIX vaccine. The patient had denied permission to contact their physician.
Patient received full body aches the day after the vaccine. The pain is more intense in her neck and her shoulders. The pain is all over her body. Patient is taking over the counter medication to ease pain but that did not help her. Pain in her neck and shoulder pain level is an 8. in the rest of the body is a low 6 high 7.
Patient received MENACTRA on 9-10-15 at around 12:45. Patient left office and Mom reported syncopal event in vehicle. Patient was brought in office - evaluated and let her go home.
SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from consumer on 30-Aug-2017. This case involves 16-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U4384AA, expiration date: 30 Nov 2014, dose and site of administration was not reported) via intramuscular route on 19 Oct 2012. The patient had a medical history of paralyzed vocal cord and prematurity. Illness at time of vaccination were reported as none. Patient had NKA (no known allergies). Concomitant medications was not reported. On 09 Aug 2017, 4 years 9 months 21 days (1755 days) following the vaccination, the patient experienced cough and was formally diagnosed with Whooping Cough on 23 Aug 2017 based on cultures. Patient was formally diagnosed and was continuing to cough and the parent had consulted with the Pediatrician over the phone and they advised that the cough will continue but to return if he has any concerning symptoms. It was reported that, the patient required emergency room visit. This was also a case of vaccination failure. Lab data were not reported. Patient received Z-PAK as corrective treatment. The patient had not recovered from events. Upon internal review, the company decided to consider the event serious because of important medical event whooping cough, cough and vaccination failure. List of documents held by sender: none. Sender's Comments: In this case Whooping Cough was reported approx. 4 years 10 month after vaccination with ADACEL vaccine. Whooping Cough was diagnosed based on culture however report was not provided. Considering that patient was fully vaccinated as a child he should be protected against pertussis, this case is therefore a suspected vaccination failure. More information regarding patient's medical history, immune status, vaccination schedule and PCR report (positive for pertussis) and investigation reports are needed for complete assessment of the case.
One week following the first dose, menstruation began two weeks early. Bleeding was heavy and last two days longer than normal.
PATIENT INDICATED HE NEEDED HIS 2ND MODERNA DOSE. VACCINATION CARD SHOWED 1 VACCINE GIVEN AT PHARMACY ON 12/30/21. HE SAID LAG TIME BETWEEN DOSES WAS DUE TO THE FACT THAT HE COVID. WHEN ENTERING INTO DATABASE IT SHOWED DOSES ON 3/21, 4/21, 10/02/21, 12/30/21 AND NOW ON 08/05/1922. PATIENT DOES TAKE TRUVADA AND IS OBESE BUT THE BOOSTER DOSE SHOULD HAVE BEEN 0.25ML NOT 0.5ML. MD WAS CONTACTED AND WILL DISCUSS WITH PATIENT AT HIS APPT IN 3 WEEKS.
Lymphadenopathy; arm very sore; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymphadenopathy), VACCINATION SITE PAIN (injection site soreness) and PAIN IN EXTREMITY (arm very sore) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for an unknown indication.     Concurrent medical conditions included Asthma (Asthma is controlled) and Arthritis. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), IBUPROFEN (MOTRIN IB), ALPRAZOLAM (ALPROZAM), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and MARIJUANA.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness). On 28-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymphadenopathy) and PAIN IN EXTREMITY (arm very sore). At the time of the report, LYMPHADENOPATHY (Lymphadenopathy), VACCINATION SITE PAIN (injection site soreness) and PAIN IN EXTREMITY (arm very sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood calcium: 1400 (High) high.         Patient was reported to  have skeletal muscular degenerative disease Patient is allergic to penicillin, Flagel, sulfa adhesive tape
11/7 bad headache and very thirsty. Wednesday morning noticed a rash on some areas of body. Some itching and feeling some what out of sorts. Thursday morning rash had moved to more areas of body. Thursday saw NP. NP gave me prescription for Triamconolone and suggested I take Allegra. Woke up this morning and rash is now on 85 percent or more of my body. Rash is inflamed, itchy, and very elevated hot and I look like I have a sunburn. Not running fever, but not feeling great.
Phizer-BioNTech Covid-19 Vaccine EUA  Nausea and fatigue beginning about four hours after administration. Diarrhea beginning about six hours after administration. Vomiting and chills beginning about eight hours after administration.
Cellulitis of left arm - 2 inches from top of shoulder down to elbow MD placed child on antibiotic for tx.
I received Moderna on 02/16/21.  Ten days later, a lump under my left arm of shot appeared.  Over the next 2-3 weeks, the swelling in my lymph nodes spread into my breast and then to the right side.  I rotated between ice and epsom salt baths.  It was very swollen, red, and painful.  I could not sleep well at night.  Because the swelling was so bad, I did not get the second shot. I was given lab work, a mammogram, and an ultrasound.  All came back normal. Called the Dr of the health board and they said not to give steroids as my "body was fighting it off."   After some reading, I decided to take the J & J vaccine on 11/26/21, as it has different ingredients.   I was worried as the numbers are so high.  Similar to before, 10 days after the vaccine, my lymph nodes swelled up.  A bit different was that instead of a slow spread, I awoke to both armpits with lymph nodes swollen. and lymph nodes in my breast swollen.  There are hard lumps.  I have rotated epsom salt baths and ice.  They are still swollen.  I have not seen anyone because I honestly don't know if they can do anything.  It's very frustrating as a proper contact would be helpful.
sonic issues and feels like burning; sonic issues and feels like burning; chest does not feel right in which she stated "her heart does not feel right".; diarrhea; lost of appetite; her joints hurt; her face is swollen around her chin.; arm hurts; chest and stomach does not feel right; Experiencing stomach issues, it feels like it is burning; the nurse did not dilute the vial and was given multiple doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101275650 (Pfizer).  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunization.  The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "the nurse did not dilute the vial and was given multiple doses"; HYPOACUSIS (non-serious), EAR DISCOMFORT (non-serious), outcome "unknown" and all described as "sonic issues and feels like burning"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest does not feel right in which she stated "her heart does not feel right"."; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; DECREASED APPETITE (non-serious), outcome "unknown", described as "lost of appetite"; ARTHRALGIA (non-serious), outcome "unknown", described as "her joints hurt"; SWELLING FACE (non-serious), outcome "unknown", described as "her face is swollen around her chin."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurts"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "chest and stomach does not feel right"; DYSPEPSIA (non-serious), outcome "unknown", described as "Experiencing stomach issues, it feels like it is burning".  Additional information- Reporter asks, if this could be damaging to her daughter, since she received too much vaccine and asks what is the recommendation in this situation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2014US024320 is an initial spontaneous report from a nurse received on 02 Dec 2014 and a follow up report from the nurse received on 19 Jan 2015. This report refers to a 64 years old male patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included flu vaccine (manufacturer and batch number: not reported) and it was well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in the left deltoid at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow up report from the nurse received on 19 Jan 2015: Vaccination history and site of FLUVIRIN vaccination were updated.
Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2019SA082208, 2019SA082211, 2019SA082210 and 2019SA082209 (same reporter). This case involves a 6 months old male patient who experienced 102 Fahrenheit fever (38.8 C), while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13; and ROTATEQ. On 13-Mar-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ095AA via unknown route in the thigh NOS. On an unknown date in 2019, the patient developed a non-serious 102 Fahrenheit fever (38.8 C) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Relevant laboratory test results included: Body temperature - On an unknown date: 38.8 Cel [38.8]. Final diagnosis was 102 F fever (38.8 C). It was not reported if the patient received a corrective treatment. The patient's event outcome was not reported.
This spontaneous report was received from a nurse and refers to a patient of unknown and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 29-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L037924, expiration date 22-JUN-2017, orally; exact dose were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 48 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effects were reported. This is one the several reports received from the same source. Additional information has been requested.
very sore arm, extreme swelling and redness  in hand; patient says it "looks like a lobster"; advised patient to contact physician
Immediately after receiving first dose of vaccine, pt felt lightheaded and started sweating profusely. Pt also became pale. Immediately had patient lay down on the bed and elevated bilateral legs. Pt reports feeling better shortly after.
A nurse reported that a 71 year old female received an injection of Pnu-Imune 23 on 10/2/00 and subsequently, developed an injection site reaction characterized by redness, swelling and itching. The pt's husband insists that his wife received Pnu-Imune 23, 1 year ago; however, the pt does not remember this. She recovered.
On day 12: Nasal congestion, painful lymphadenopathy in neck, jaw and pre-auricular area (palpable and tender), mild sore throat, mild fever (except for lymphadenopathy, the rest of the symptoms have almost subsided); in addition: arthritis and arthralgia (left wrist, and interphalangeal joints of right 3rd and 4th fingers) on day 17, which are still ongoing. Treatment: TYLENOL, cetirizine.
This spontaneous report as received from a pharmacist and hospital safety officer (nurse) refers to a 68 year old male patient. The patient's current conditions included hyperglycemia, hypercholesterolemia, GERD (gastroesophageal reflux disease) and sleep apnea. Patient had no known drug reactions/allergies. On 19-DEC-2013 the patient was vaccinated with PNEUMOVAX23 (lot number reported as J005071, expiry date 19-JAN-2015, intramuscular). No other concomitant medications were reported. In December 2013 (approximately) after receipt of the vaccination, the patient experienced red, hot, swollen, tautness of skin which was painful and sore. Patient also experienced fever and chills. Patient sought medical attention-he visited an unspecified emergency room in which he was treated with unspecified intravenous antibiotics for cellulitis (disability and hospitalization). Laboratory tests included an unspecified blood test that showed elevated neutrophils. Hospital physician requested patient to come back to the hospital the following day to receive additional intravenous antibiotics, but patient denied due to lack of transportation. Hospital physician wrote patient script for unspecified oral antibiotics. The event caused temporary disability to the patient. The event was not life-threatening and no intervention was required to prevent any other serious criteria. The outcome of cellulitis was reported as not recovered. The causality for the cellulitis was not reported. Reporters have requested a lot check to be conducted on this lot (J005071). Additional information has been requested.
Patient called 4/28/21 to report that she woke up 4/27/2021 with a warm red rash that is slightly painful and approximately 4 x 4 inches. Patient also stated that her throat started tingling/itching so she took diphenhydramine.  This patient had a full allergic reaction to the vaccine and needed to use an epi pen after taking benadryl after her first dose. This has already been reported to VEARS previously.
Pt received Pneumovax at 0945 2/2/2007, left office  without any problems or complaints of pain. Patient in office @ 1630 with complaint of pain in right arm from fingers to shoulder, he was unable to drive his truck, patient in tears with the pain, ice applied, site is free from any redness, swelling at this time, 800mg of Ibuprofen given p.o.  @ 1642.
Myalgia, Arthralgia, Pain/Discomfort at injection site, fatigue Narrative:
Left shoulder-size of baseball at injection site, very hot, red to purple and some swelling and down towards elbow.  Sore and painful.
Fever, chills, sweats, body aches, left arm red, swelling & pain.
sneezing; general malaise; cannot smell; cannot get rid of her nasal problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Jul2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (flu vaccine for over 65-years-old; had a reaction); Pneumonia shots (not Prevnar; never had a problem). The following information was reported: NASAL DISCOMFORT (non-serious) with onset Jul2022, outcome "unknown", described as "cannot get rid of her nasal problems"; ANOSMIA (non-serious) with onset Jul2022, outcome "unknown", described as "cannot smell"; MALAISE (non-serious) with onset Jul2022, outcome "unknown", described as "general malaise"; SNEEZING (non-serious) with onset Jul2022, outcome "unknown".  Additional information: patient was over 65-years of age. She reported that when she came home from the shot, she immediately started sneezing then went on for 3 days in a row. She added she had general malaise, cannot smell, and cannot get rid of her nasal problems. She never had a problem with her previous pneumonia shots (not Prevnar) but had a reaction years ago to the flu vaccine for over 65-years-old. She wanted to know how long it will last and what is in the vaccine that caused it.  Follow-up attempts are completed. No further information is expected.
Patient had developed a rash on her chest and slight rash on her injection site after 10 minutes.  She felt slightly short of breath.  Patient was given diphenhydramine 25 mg and monitored for 35-40 minutes.  Blood pressure was taken and patient felt fine.
This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On the same day, the patient was administered with this improperly stored GARDASIL (route of administration unknown). Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Case number PHEH2015US022884 is an initial spontaneous report received from a consumer on 03 Nov 2015. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 174087A) intramuscularly on 03 Nov 2015. It was reported that she was breast feeding. No adverse events were reported following the vaccination.
This spontaneous report was received from registered nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2015 01:00 PM, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K004205, expiry: 12-JAN-2017) dose 1, intramuscularly in the right arm (right deltoid). No concurrent medications were reported. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.