chrisvoncsefalvay/vaers-outcomes huggingface dataset:
really sick; felt pressured; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female 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 sickness (Verbatim: really sick) and sensation of pressure (Verbatim: felt pressured).  The outcome of the sickness and sensation of pressure were not reported.   It was unknown if the reporter considered the sickness and sensation of pressure to be related to Shingles vaccine.     It was unknown if the company considered the sickness and sensation of pressure to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-SEP-2023 This case was reported the patient via interactive digital media. The reporter mother in law got the vaccine and got really sick and said she regretted getting the shot she felt pressured. The reporter mother got the Shingles they were painful and uncomfortable but did not last very long. Follow-up not possible as no contact details provided.
an expired dose of Ipol was inadvertently administered/No AE; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves female patient of an unknown age who inadvertently received expired dose of vaccine IPV (VERO) [IPOL].   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 05-May-2020, the patient received third 0.5 mL dose of suspect IPV (VERO) lot number not reported expiry date- 26-Apr-2020 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report there was no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There was no information available on the lot number.
Arm hot skin; Arm hard; Her arm got sore; Big red circle on arm; Nauseous; Dizzy; Had a hard time breathing/could not catch her breath; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DYSPNOEA (Had a hard time breathing/could not catch her breath), VACCINATION SITE WARMTH (Arm hot skin), VACCINATION SITE INDURATION (Arm hard) and VACCINATION SITE PAIN (Arm was sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 19-Mar-2021, the patient experienced DIZZINESS (Dizzy), DYSPNOEA (Had a hard time breathing/could not catch her breath) and NAUSEA (Nauseous). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm hot skin), VACCINATION SITE INDURATION (Arm hard), VACCINATION SITE PAIN (Her arm got sore) and VACCINATION SITE ERYTHEMA (Big red circle on arm). On 19-Mar-2021, DIZZINESS (Dizzy), DYSPNOEA (Had a hard time breathing/could not catch her breath) and NAUSEA (Nauseous) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm hot skin), VACCINATION SITE INDURATION (Arm hard), VACCINATION SITE PAIN (Arm was sore), VACCINATION SITE PAIN (Her arm got sore) and VACCINATION SITE ERYTHEMA (Big red circle on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included ice pack application.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant FU :Updated events outcome
My lungs hurt when I breathe in; 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 PULMONARY PAIN (My lungs hurt when I breathe in) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (My lungs hurt when I breathe in). At the time of the report, PULMONARY PAIN (My lungs hurt when I breathe in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient informed that," lungs hurt when the patient breathe in", and this happened after the shot   . no concomitant and treatment details reported.
3 months later, I was diagnosed with a benign tumor in my right arm. I don't think it has anything to do with the vaccine but the question asked if I had anything new and I did.
Left side face and eye paralysis. Diagnosed on Apr 15, 2021 with Bells Palsey at Emergency Room.  I cannot work due to this and now may have permanent damage due to this vaccination.
After recieving my last vaccine on 2/17/2021 - March into April my mentstral cycle was completely off - I had a lighter period, following by spotting on and off through the whole month of April - April - May I was on my period 23 days - with golf size blood clots. I have NEVER had a period that I have bleed so heavy on, or had blood clots, and cramping through my pelvic and legs.   Did blood work- all normal.  Papsmear- Normal   Had a ultra sound done and they found a polyp in my Uterus I will have it removed on 6/23/2021   And here we are in June and I have had two periods - 4 days apart   Im miserable - I have never had a heavy period like this - and blood clots
This is a spontaneous report from a contactable consumer. This 22-year-old female patient received the second dose of TRUMENBA via an unspecified route of administration on 15MAY2015. The patient medical history was not reported. Concomitant medication included APRI tablet as oral contraceptive. The patient had previously received the first dose of TRUMENBA in MAR2015. On 15MAY 2015 the patient had a lot of swelling in her arm, it was really red and really warm, it was sore like/was very painful. None investigation was reported. The outcome of the reported events was unknown. Follow-up (15JUL2015): Follow-up attempts completed. No further information expected.
Redness, itching, hives on the neck, under eyes, cheeks and forehead on the day following vaccination. Continued on the 2nd day following vaccination.
Increased Crohn's flare; Horrible reaction with second covid vaccination; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4393868-00 (Abbvie).  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 38 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer: Pfizer), for Covid-19 Immunization. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Increased Crohn's flare"; IMMUNISATION REACTION (non-serious), outcome "not recovered", described as "Horrible reaction with second covid vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Unknown result.  The reporter's assessment of the causal relationship of "increased crohn's flare" and "horrible reaction with second covid vaccination" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.   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.
approx 5hr p/vax pt presented to nurses office @ school c/o weakness/wheezing/lightness in chest/diff breathing/hoarseness;went to PMD;racing pulse;rx decadron/clariton;
Miscarriage. I got the shot at 10:30am Monday 11/15 and early afternoon I started bleeding. 48 hrs HCG test confirmed miscarriage on Thursday afternoon.
Extreme elevated resting hear rate after 2nd shot. Normal resting heart rate is around 55-60, after shot stayed in mid 80's with a walk across the room easily putting it into the low 100's and any mild activity like sweeping or unloading dishwasher put it into mid 120's heart rate.  After two weeks resting heart rate has started to come down to mid 60's, still observing Second side effect is being mild/annoying itching all over body.
Missed second shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second 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 PRODUCT DOSE OMISSION ISSUE (Missed second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Almost a week later I started breaking out in a rash.  I went to a dermatologist and was dx with an allergic reaction to something I came in contact with.  I did a 3 week regimen of prednisone.  When completed the rash came right back.  I went back to my doctor and was told that people have had reactions to the shot with sun exposure and then was given a shot of prednisone that lasts for 3 months.
Erythema, warmth, edema with (Left upper arm) pruritis at site of injection approx 6 x 5 in. No systemic symptoms.
Havrix administration of an expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 32-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30-SEP-2022) for prophylaxis.   On 09-OCT-2023, the patient received Havrix. On 09-OCT-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix administration of an expired dose).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter called to asked for information about the administration of an expired dose of Havrix to a patient, which led to expired vaccine used. The reporter asked for guidance on this situation. The reporter consented to follow up.
3rd dose of MODERNA COVID VACCINE GIVEN 8/27/21, #052E21A; pt seen in ED on 8/7/22 and dx with COVID; given antitussives and sent home; 8/10/22 pt returned to ED with increasing SOB and Cough; hypoxic in ED; CXR showed multifocal pneumonia; O2 supplementation; dexamethasone, ABX, bronchodilators, Lovenox; ICU where intubation was required with mechanical ventilation; tracheostomy; fever; lost pulse; EKG showed ST MI; CPR done without success and pt passed away in the hospital
eye pain; lightheaded; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "clipped aneurysm", start date: 2010 (unspecified if ongoing), notes: I have a clipped aneurysm since 2010. The patient's concomitant medications were not reported. The following information was reported: EYE PAIN (non-serious) with onset Feb2022, outcome "not recovered", described as "eye pain"; DIZZINESS (non-serious) with onset Feb2022, outcome "not recovered", described as "lightheaded".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Days after receiving the 2nd vaccine, I experienced ringing in my right ear. Over the past several months, it has gotten worse, and both ears appear to be impacted.
My heart would flutter and tighten.  During the fluttering/palpitations my head would get light; if it happened while I was standing  I had to hold onto something or sit down.  It was happening often; say every 10 to 20 minutes.  This continued on with the same severity for about a week and has gradually subsided to just a few episodes per day as of this report.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 23-FEB-2015 the patient was vaccinated with expired ZOSTAVAX (0.65 ml, subcutaneous, lot # J014566, exp. date: 18-FEB-2015). No adverse event reported. The potency was supported. Additional information has been requested.
pt recvd vax 16JUN95 & exp thousands of canker sore;stomatitis lasted for a duration of 15 to 17 days;
Report Left sore arm, HA and fatigue started 12 hours post vaccination. Treatment: none. Outcome: Does not interfere.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or around June 2015, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or around September 2015, the patient was treated by a physician, for the onset of a rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
3/29/03 Left arm sore & itching. 4/1 left arm no longer sore. 4/1 Neck (left side) jaw, glands behind ear became sore. Headache - difficulty in opening mouth. 4/4 - presented to medical dept. Referred to an MD to see PT today 4/4/03 at 10:30 a.m.
I sat down for about 15 min and by the time I got back to my car, I noticed I was getting a light headache. I assumed I was just tired. About 30 mins later, my shoulders started to hurt. I woke up around 11:30 and I felt like a Mack truck had hit me. I had a fever, headache and chills. I remained this way for about 3 or 4 days, but improved. Then I started to become very lethargic. Just lifting my arm was a chore. On Monday, I went to see my doctor and he said that I was fine after checking everything, to include my thyroid and liver enzymes. Everything was fine, so my symptoms were attributed to the vaccine. Today, I have no pain, but I am very lethargic.
Patient hospitalized twice after receiving COVID vaccination. Admitted on 2/15/21 and 3/29/21
Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C; This spontaneous safety report, with Case Number: 2023SA191135 (Inquiry Number: 01662682, Parent Inquiry: 01662646), was received by a partner on 19-JUN-2023 and forwarded on 22-JUN-2023, from a HCP.   This case was considered non-valid due to no patient identifiers were provided (temperature excursion only).  Due to the nature of the event, the causality between the event "Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C 1600: 10.7C" and Vaxelis was not applicable.  Further information is expected.  NON-SIGNIFICANT follow-up information was received on 21-JUN-2023 by the partner and forwarded on 22-JUN-2023, from a HCP. The case is maintained as non-serious and non-valid.  Due to the nature of the event, the causality between the reported event "Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C 1600: 10.7C" and Vaxelis was not applicable.  SIGNIFICANT FOLLOW-UP INFORMATION was received on 22-JUN-2023 from the physician.  The case is maintained as non-serious and valid as patient identifiers were provided and no adverse event following vaccination was reported.  Due to the nature of the event, the causality between the reported event "Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C 1600: 10.7C" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004930 and MCM-004931.  Further information is not expected.
Diffuse red, raised rash/ hives mainly to bilateral legs, some to arms and torso, intensely itchy,  worsening by the day. Started 4 days post Moderna booster.
feverish sensation with chills; calf muscle pains and tenderness; spider angiomas on anterior chest and neck and upper back antipyretics were given
Narrative:  63 year-old male with a history of HTN, asthma, Stage 3a CKD, GERD, BPH, OSA, glaucoma, and AR, who presented to the MC emergency department on 10/11/21 with complaint of 5 days of body aches, fever, chills, malaise, cough, and shortness of breath. He reported having gone to a large gathering, and developing his symptoms subsequent to that event. He received both doses of Moderna vaccination (on 03/04/21 & 04/01/21). In the ED, the patient tested positive for COVID-19 virus. A CT angiogram of chest showed multifocal groundglass opacities within the left greater than right lower lobes, consistent with viral pneumonia, but was negative for nay large acute pulmonary embolism. On arterial blood gas, pO2 was 52. HOSPITAL COURSE: PATIENT was admitted to the general medical floor on 10/11/21 for treatment of acute hypoxic respiratory failure and COVID-19 pneumonia. He was placed on 2 liters supplemental oxygen. He was also treated with 3 days of IV remdesivir, dexamethasone, and his home inhalers. He showed good clinical improvement, and supplemental oxygen was successfully weaned by the morning of 10/13. PATIENT was medically stable for discharge home on 10/14/21.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23, lot number: N024717 (expiration date: 06-APR-2019) for prophylaxis (strength, route and dosage schedule were not provided). There was digital data logger involved. The storage characteristics were the following:  Temperature: 9 degrees C to 25 degrees C (9.7C) for 2 hours.  Previous temperature excursion: No. No adverse effects were reported.
I've been home since May 2nd , I had some type of congestion and cough. So we were on vacation for 3 weeks, we did try to mask up the whole time because we were seeing my parents. The last week we didn't wear it on the train because of the heat wave. We did test before we went home on the 23rd that was negative. We went to a graduation. And I think I still had my cough. I was feeling tired and had a small fever and I took a test May 28th and did it twice and it was positive. I called telehealth and they gave me medications.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
This spontaneous prospective pregnancy report as received from a 29 years old female patient refers to herself, for GARDASIL, a pregnancy registry product. The patient had allergy to penicillin. The patient's history of previous pregnancies and live births is not known. The patient went to her doctor for two shots. She was given GARDASIL (route, dose and lot # were unknown) instead of a shot for whooping cough accidentally on 22-OCT-2012. No other co-suspects were reported. Concomitant medications included: prenatal vitamins. The Pregnant Gestation was 24 weeks. The patient was exposed to GARDASIL during trimester 2. The patient had performed lab diagnosis studies blood work a few months ago. Additional information has been requested.
pt recv vax 3APR(7 @ 1700-devel t100.5, gen aches & pains, malaise, h/a, severe chils on 4APR97 2PM;
RASH STARTING FROM INJECTION SITE ACROSS CHEST AND DOWN BOTH ARMS RESOLVED IN 48 HOURS Narrative:
Elevateed temp. of 102 F Hives that were present for 12 hrs.
Same day post vax, the pt developed a more than usual soreness at the injection site. Additionally, two pts had inflamed shoulders and could not lift their arms. This is one of two reports from this facility of adverse event following receipt of vax.