chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced COVID-19 (Positive for COVID-19). At the time of the report, COVID-19 (Positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         In November 2021, the patient received Booster dose of Moderna COVID-19 Vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The causality between ADALIMUMAB (HUMIRA) and events COVID-19 (Positive for COVID-19) was reported as not related.  No treatment medication was provided.  Company Comment: This is a spontaneous case concerning a 54-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of COVID-19 (Positive for COVID-19), approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The event had resolved on unknown date. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of COVID-19 (Positive for COVID-19), approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The event had resolved on unknown date. The benefit-risk relationship of mRNA-1273 is not affected by this report.
She got her vaccine, she woke up at 3:00 AM the next morning with a fever of 101, very very lethargic, heart palpitations, chills. She was so tired that she slept on and off for hours in a very deep sleep. She was not waking up enough to even make it to the bathroom. She stayed in bed for 2 days, and started to feel better that evening by 5:00 PM and slept for 2 days basically. For 2 weeks afterwards she was very fatigued and then started feeling normal after that and has been fine since that time. She did have some swelling and redness at the vaccination site with some pain.  She called Teladoc and was advised to take Tylenol or Advil and she did which relieved the fever and felt better after that. She said with the first vaccine it felt like somebody had hit her in the arm with a board and hard to lift the arm. She works in a medical facility and a lot of them got really sick including the NP and the providers themselves and missed several days of work due to the reactions.  They are also younger than her.
72 hours after second vaccine injection, all ,my joints were on fire. Tremendous pain in joints and weakness in legs, hands and back.
Pt recvd PedvaxHIB on 25JUN91 & on 3JUL91 pt devel bacteremia & pneumonia; pt's exp was considered life-threatening; no further details were provided;
This spontaneous report was received from a healthcare student, regarding an unknown age and gender patient with no pertinent medical history reported. On 01-MAY-2013 the patient was vaccinated with the second dose of GARDASIL (lot number and expiration date not specified) (dose and route not specified). The first dose was administered in April 2012. No other suspect therapies or concomitant medications were reported. The reporter stated that the patient developed narcolepsy, slurred speech, abnormal movements and weakness after receiving second dose of GARDASIL. It was reported that the patient was hospitalized at an unspecified hospital on an unspecified date. The outcome for narcolepsy, slurred speech, abnormal movements and weakness was unknown at the time of the report. No treatment information was reported. The reporter did not assess the causality between GARDASIL and narcolepsy, slurred speech, abnormal movements and weakness. Additional information has been requested.
He tested positive for Covid; He tested positive for Covid; This is a spontaneous report from a contactable. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in mid Dec2020 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Saturday he developed a persistent cough. He tested positive for Covid. He was well enough to see his patients virtually but at home.  Event took place after use of product. The outcome of event was unknown.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for event "he tested positive for COVID".
Severe burning, itching, rash on both quads.  From back of knee cap, 8 inches up thigh, exact spot on each leg.  Experience was immediate on set after a work out, wearing work out wear.  First 48 hours increase swelling and itching., hard and hot to touch. Treated with Cortozone 10 and Advil. After 72 hours swelling decrease to just  itching .  Day 4  most erethymia  is gone.
Patient received Menveo & hepatitis a. Patient had syncopal episode. BP 101/63 HR 76. While supine. BP was 106/70 HR 86 while sitting up. Patient had x1 emesis Patient was give juice & was able to walk without complaint. BP 107/69 HR 67 when leaving
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Testosterone low, Lactose intolerant, Irritable bowel syndrome, High cholesterol and Sleep difficult (trouble sleeping). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), FINASTERIDE, LINACLOTIDE (LINZESS), TEMAZEPAM and CLOMIPHENE CITRATE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-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 Linzess, ,Crestor (5 mg daily), clomid citrate (25 mg every other day), finasteride (0.125 mg daily) and temazepam (30 mg twice a week).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up contains no new information.
APPROX ONE MONTH AFTER VACCINE, ALL THE SKIN PEELED OFF MY HANDS, FEET AND STOMACH.  SINCE THEN, IN A CYCLE OF APPROXIMATLY EVERY 4 WEEKS, I GET A RUNNY NOSE, SORE THROAT, AN OVERALL FEELING OF SICKNESS, ITCHY HANDS, FEET, NECK AND STOMACH, AND THEN THE SKIN PEELS OFF MY HANDS, FEET AND STOMACH AGAIN. THE SYMPTOMS LAST ABOUT 10 TO 14 DAYS, THEN CLEARS UP. THEN STARTS ALL OVER IN A FEW WEEKS.
Symptoms with my cycle. I started spotting well before I actually started my period, which is something that never happens to me. Additionally, my breasts have been swollen, tender, and painful on and off since I got my first dose. Some nausea intermittently throughout the last 3 weeks. I have been spotting the last few days and it's about 8 days before I should be starting my period and my breasts are swollen, tender, and painful again.
Fatigue, muscular aches/pain in lower back extending to top of legs and groin area; weakness in walking.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 01/14/2021 and 02/09/2021. Pt presented to ED on 8/16/21 with c/o rectal bleeding, hematochezia, onset of the previous night. States she had 5-6 episodes last night of bright red rectal bleeding which has continued into today, including diarrhea. She had an episode of BRBPR in the ED. Patient was diagnosed with Covid on 8/13 but is largely asymptomatic. Patient was on 2L NC in the ED which is the same amount of O2 at home. Diagnostic colonoscopy was attempted twice, however, due to tortuous colon with acute angulations in the sigmoid, scope could not traverse area. IR was consulted, however cont., both CTA abdomen and angiogram were negative for any active bleeds. Surgery was consulted but determined that patient was too high risk for surgery. It was discussed with both IR and GI that if pt has significant bleed again, will consider potential repeat angiogram.  Patient's cough worsened throughout the course of hospitalization and CXR showed worsening opacities and dexamethasone and remdesivir were started. Patient also received vancomycin. Patient also began to display worsening mental status, became minimally responsive with agonal breathing, and difficulty swallowing. Pt status was changed to DNAR/COT and eventually patient's son decided to make patient comfort care. Patient expired on 8/24/21.
6/7/21- saw dr. for routine blood draw and reported onset of sore throat- stuffy head- drainage 6/12/21- saw dr. for low grade temp, head cold, massive drainage, horrible cough with sputum, fatigue, chest pain dr gave zithro pack 6/14/21 and steroid shot during office visit 6/12/21 took off work following dates due to illness: 6/7-21-6/8/21-6/10/21-6/14/21  sent home from work 6/23/21 due to covid test oxygen levels on days off were 80-92 or 96 fluxuating home check
nearly killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: nearly killed me) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.     It was unknown if the company considered the near death experience to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 02-Aug-2023 This case was reported by a patient via interactive digital media. The reporter reported that the Shingles vaccine dose nearly killed him or her. The follow up would not possible as no contact details were available.
pt recvd vax & had s syncopal or vasovagal episode; pt recovered w/o any residual effects; No further details were provided; MD reported 20 pts;
This case was reported by a nurse via call center representative and described the occurrence of hair loss in a 20-year-old female patient who received BEXSERO (batch number W149001A, expiry date 30th September 2016). On 12th April 2016, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced hair loss (serious criteria other: As per reporter), injection site erythema, injection site pain, stomach virus, diarrhea and nausea. On an unknown date, the outcome of the hair loss, injection site erythema and injection site pain were recovering/resolving and the outcome of the stomach virus, diarrhea and nausea were unknown. It was unknown if the reporter considered the hair loss, injection site erythema, injection site pain, stomach virus, diarrhea and nausea to be related to BEXSERO. Additional details were received as follows: The reporter stated that, the patient experienced hair loss, stomach virus-like symptoms, diarrhea, nausea and localized redness and pain at injection site. The patient was taken to the emergency room. No other vaccines were administered with BEXSERO. The dermatology testing was done for hair loss and colonoscopy was performed, which showed no abnormal findings. No further information was reported regarding the event.
IT DID A NUMBER ON FOR ABOUT 24 HRS; This spontaneous report received from a patient via a company representative concerned a 48 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced it did a number on for about 24 hrs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it did a number on for about 24 hrs was not reported. This report was non-serious.
Patient had initial numbness in Left arm that has progressed down to numbness and tingling in fingers as well
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent medical conditions included sjogren's syndrome. Concurrent vaccination included hepatitis A vaccine inactivated; manufacturer unspecified; unknown; unknown given on an unspecified date. On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown). At an unspecified time, after vaccination with Hepatitis B vaccine series, the subject experienced not responding to therapy. The healthcare professional reported the adult subject was diagnosed with Sjogren's disease by a previous providers office (unknown name and place) within the last five years (estimated) received a vaccine series of a hepatitis B vaccine (unknown if ENGERIX B) along with hepatitis A vaccine (unknown if HAVRIX). Titer testing at unknown interval after series showed seroconversion to Hepatitis A but no seroprotection to hepatitis B; lack of expected effect. The subject is going to travel and inquired if she should receive another dose of hepatitis B vaccine or series. Follow-up information was received on 15 October 2012 via healthcare professional who reported the subject "called the office for travel vaccines and has not been in". The subject has a history of Sjogren's syndrome and was not responding to therapy with Hepatitis b vaccine. At the time of the report, the event was unresolved, no other information was provided.
Pfizer Covid Vaccine was expired, vaccine was left out over 12 hours prior to patient receiving the vaccine.
Redness; Tenderness; Itching; 2 small blisters at the site of injection; This spontaneous case was received on 21-Oct-2020 from other health professional via agency (reference number: SEQW20-04014) and concerned a 51-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283852 and expiration date: 30-Jun-2021.  On an unspecified day in Oct-2020, an unknown amount of time after receiving Flucelvax QIV, the patient experienced itching, redness, tenderness and developed two small blisters at the site of injection. The patient used the band aid after vaccination and blisters were noted after she removed band aid. After that, the blisters got better.  At the time of initial reporting on 21-Oct-2020, the patient was recovering from blisters at the site of injection.  The outcome of itching, redness and tenderness was not reported.  The reporter assessed blisters at the site of injection as not related to Flucelvax QIV and related to bend aid and did not provide causality assessment for other events.  The reporter assessed this case as non-serious.  Company comment: A 51-year-old patient was administered Flucelvax QIV vaccine. An unknown amount of time after receiving vaccine, the patient developed tenderness, erythema, pruritus and vaccination site vesicles. The patient used the band aid after vaccination and blisters were noted after she removed band aid. However, causality is assessed as possibly related for all events.; Reporter's Comments: The reporter thought that the blisters were a reaction to the Band Aid and not the vaccine.; Sender's Comments: A 51-year-old patient was administered Flucelvax QIV vaccine. An unknown amount of time after receiving vaccine, the patient developed tenderness, erythema, pruritus and vaccination site vesicles. The patient used the band aid after vaccination and blisters were noted after she removed band aid. However, causality is assessed as possibly related for all events.
Hot to Touch Sensation - Near Injection Site; Arm Pain; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced INJECTION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). At the time of the report, INJECTION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
"Effects my fertility". "I must start progesterone one day after ovulation to avoid spotting in luteal phase"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2021 11:00 (Lot number: EL9267, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Luteal Phase defect", start date: Aug2019 (ongoing), notes: Monthly Since August 2019. There were no concomitant medications. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset Feb2021, outcome "not recovered", described as ""Effects my fertility". "I must start progesterone one day after ovulation to avoid spotting in luteal phase"". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of intermenstrual bleeding.  Additional Information: It was reported that the vaccination facility type was at school/student health clinic. Prior vaccination was reported as none. From Aug2019 to Feb2021 patient had started spotting. One week after ovulation so she takes progesterone to allow her body to successfully conceive a baby starting. Starting from Feb2021 to present, patient started spotting the day after ovulation making it impossible to Conceive w/o progesterone. There was a positive co-ordination to her vaccine dates and needing to start progesterone much sooner than before to avoid mid-cycle Spotting during entire Luteal Phase. It appears the vaccine further imbalanced my hormone levels. Progesterone test was conducted 6 days after ovulation. Seriousness criteria was reported as effects my fertility.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101005236 same patient and drug, different dose
Child fever 102 degrees F, sleepy, lethargic, diarrhea X 3 da.  MOTRIN alternating with TYLENOL 9 4 - 6 9m.
Within an hr after vaccination I had pain at injection site, fever, chills, headache for 2 days and tested positive for covid-19.
Passed out (taken to ER); Swelling at the injection site (while in ER); Pain at the injection site (while in ER); Fever (while in ER); Tightness in his jaw (while in ER); This case was reported by a consumer via call center representative and described the occurrence of passed out in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ethanol (Ethyl Alcohol) for product used for unknown indication.   On 23rd November 2022, the patient received the 1st dose of Shingrix. On 24th November 2022, the patient started Ethyl Alcohol at an unknown dose and frequency. On 24th November 2022, 1 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), injection site swelling, injection site pain, fever and tightness of jaw muscles. The action taken with Ethyl Alcohol was unknown. On an unknown date, the outcome of the passed out, injection site swelling, fever and tightness of jaw muscles were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix and reported that on 24th November 2022 he had been consuming some ETOH (ethanol) for most of the day and then that evening he passed out at the dinner table. The patient reported that an ambulance was called the paramedics were able to get him to begin responding to stimulation and was taken to the emergency room. The reporter reported that while in the ER experienced swelling and pain at the injections site, fever and tightness in jaw. These symptoms had resolved.  The reporter consented to follow up. The patient received ETOH (ethyl alcohol) and less than a day experienced passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles. It was unknown if the reporter considered the passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles to be related to Ethyl alcohol.  Additional supportive information: Vaccination date captured as 23rd November 2022 as per narrative and same had been asked in query.
Pt given Covid Bivalent for 12 yo  she was given 0.2 cc instead of Covid Bivalent for 5-11 yo Reported the event.  On call nurse with the state advised no specific treatment and to monitor for increased local reaction.
Pain at injection site. Could not lift (injected) arm higher than 8/10 inches, certainly not above my shoulder for 3/4 days. Chills (never had chills when I had Covid in Dec 2020. Fingers in either hand loosing feeling then numbness for 2 days. Fatigue mid-mornings stll happening, No incentive to exercise, tired etc. even now.
Haemophilus influenzae type B septicemia, periorbital cellulitis. No other dx at time of onset. Hit in eye, became infected, then septicemia. Blood culture for H influenzae, type b.