chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and swelling at vaccine site right deltoid, then became more swollen with bulleye appearance.  Approx. 6cm in diameter with induration especially in center of area.
The day after receiving the booster I started my period which lasted for a little over a month (which has never happened to me before). It started decreasing towards the end and, after about 2 days of no bleeding, I restarted my period and tested positive for COVID on 12/24/2021. This episode lasted for 3 weeks until I went to see my OBGYN who had me start progesterone pills to stop the bleeding. I was informed by the OBGYN that this was happening a lot to women who got the booster. Also, I started an iron supplement per the recommendation of my doctor at the end of November. Once I stopped the progesterone pills, my period returned like normal and I haven't had an issue since.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 02-DEC-2014 the patient was vaccinated with an expired dose of ZOSTAVAX vial (lot # J008436, expiration date 11-OCT-2014 subcutaneously. Strength, indication and dose not provided). There was no concomitant medication. No known adverse effects. Additional information has been requested.
Received dose #1 Covid vaccine... Feb. 11, 2021 ...location at lot...Moderna ... Developed a minor reddish rash at injection site ... Itchy ... No blistering or pain ... Appeared maybe 5 days after injection ... Still noticeable today ... Rash is oval shaped maybe 3 inches by 2 inches ... Took a photo ...
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. This report refers to a 8 weeks old infant patient of unknown gender. On 17-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Patient came in today to ask if leg weakness and a red swelled bump was normal from a recent vaccine she had received from us on Saturday. I saw she got a shingrix on Saturday. She had a round red, hard spot approx 3 in x 3 in, marked in black marker, but the spot was lower than the anticipated IM vaccine administration site. She said it is painful and was very hot to the touch. She said she feels that her legs are sore, where she could not stay standing for the full church service as she usually can. She said she has been icing it at work for some relief. I instructed her to keep icing it and keep watching the outlined boarder to notice if the redness changes. If gets worse, I instructed her to go and get seen.
pt recvd flu vax & devel flu-like sx; the following morning pt collapsed & was adm to the hosp; pt is on a respirator & is critically ill;
This spontaneous report was received from a Certified Medical Assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concurrent conditions was reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot number # M037770, expiration date 01-JUN-2019, dose and route of administration were not provided) reconstituted with properly stored sterile diluent. The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 42 minutes. There was unspecified previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA002252: US-009507513-1706USA002251.
On Sept 29 I started having a scratchy throat some congestion runny nose, and some nausea and lots of fatigue. I tested on Oct 1st and I was positive I called my doctor but she was out so I waited until shew got back thinking she would prescribe the Paxlovid but she did not. Today Oct 13 was the first time I was able to test negative.
Narrative: COVID infection following COVID vaccine series 07/09 Janssen, dose #1 10/06 CRP 7.899 10/06 DDIMER: 1.20 10/06 SARS-COV-2 TOTAL AB, SPIKE: 958.5 10/06 COVID swab, result: detected 10/06 SARS-COV-2 IgG: 6.40 10/06 CXR IMPRESSION: New heterogeneous opacities in the right mid and lower lung which may be related to viral pneumonia. 10/07 DDIMER 0.91 10/07 CRP 7.269
Red Bull?s eye erythemic area ~ 8cm x 4cm; initial warmth & swelling, noted on day 9.  Erythema & warmth continues with mild itching.
Feeling pain on left side below the nipples; Sometimes would feel a bit dizzy; Feel uncomfortable on left side; Left arm would give pain mixed with a lot of discomfort; Left arm would give pain mixed with a lot of discomfort; Feeling weak in legs; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Jun2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or any other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Jun2021, the patient started feeling pain on left side below the nipples, felt uncomfortable on his left side and sometimes would feel a bit dizzy. The patient's left arm would give him pain mixed with a lot of discomfort and this would prevent him from focusing on what he was doing. Patient did not know what to do about this, and went to the gym to see if that would help and it helped for a day and came back the next day. Most of the time, this issue happened when patient woke up and was getting ready for work. He started feeling weak in his legs and started having pain on his left side. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events feeling pain on left side below the nipples, feel uncomfortable on left side, left arm would give pain mixed with a lot of discomfort and feeling weak in legs which included treatment with ibuprofen (MANUFACTURER UNKNOWN) and it seemed to help the patient so far. It was unknown whether any therapeutic measures were taken as a result of the event sometimes would feel a bit dizzy. The clinical outcome of the events feeling pain on left side below the nipples, feel uncomfortable on left side, sometimes would feel a bit dizzy, left arm would give pain mixed with a lot of discomfort and feeling weak in legs were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
seemed to almost fall asleep and become unconscious like; hypoglycemia; some fatigue; sore arm at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (seemed to almost fall asleep and become unconscious like) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported.).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). On 04-Apr-2021, the patient experienced FATIGUE (some fatigue). On 07-Apr-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (seemed to almost fall asleep and become unconscious like) (seriousness criterion medically significant) and HYPOGLYCAEMIA (hypoglycemia). At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (seemed to almost fall asleep and become unconscious like) and HYPOGLYCAEMIA (hypoglycemia) had resolved and VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (some fatigue) 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. On 03-Apr-2021, patient took Tylenol for the sore arm. On 09-Apr-2021, patient went to his doctor. He got some blood work done. His A1c was fine, his fasting glucose level was fine. Doctor doesn't think it's diabetes but had an episode of hypoglycemia. He also did not rule out possible side effect of the vaccine. He has not had another episode since then. Caller is asking if there have been any other reports of hypoglycemic episodes and also asking if Moderna would recommend getting the second dose given the reaction he had with the first dose.   This case was linked  ( Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Client states feeling "a little loopy" after receiving the vaccine.  Fire Rescue at the scene to assess client.  All vitals + glucose stable.  Symptoms resolved.  Client cleared to leave at 11:52 am, per Fire Rescue no further evaluation needed.
Red rash from vaccine site extending to popliteal fossa. No warmth, no tenderness.
FIRST HOSPITALIZATION:  On 12/14/2022, patient presented to the emergency department after a fall because he hit his head and is on anticoagulants. His CT scan of the brain was negative for intracranial bleed or other acute finding. He was antigen tested for COVID-19 and had a positive result; his chest x-ray was clear and showed no evidence of pneumonia. Patient was diagnosed with COVID-19, Shortness of breath, COPD exacerbation, Fall, Contusion of scalp, Dehydration, and Acute chest pain. He was treated with IV fluids, DuoNeb nebulizer, and Decadron. Patient initially was going to be discharged home but then developed chest pain in the emergency department. His chest pain was evaluated with 3 EKGs, none of which showed myocardial infarction; he was given nitroglycerin and fentanyl which resolved his chest pain. However due to patient?s past medical history of myocardial infarction and coronary artery disease, he was admitted to the hospital for further evaluation and treatment.   Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital.    SECOND HOSPITALIZATION:  On 2/8/2023, patient presented to the emergency department due to shortness of breath. He was assessed to be in moderate respiratory distress with decreased lung sounds and wheezing. Treatment included BiPAP, an albuterol treatment, and Solu-Medrol. Patient was NAA tested for COVID-19 and had a positive result; His chest x-ray was suspicious for pneumonia and showed mild patchy bibasilar airspace consolidation. Patient was diagnosed with Respiratory Failure secondary to COVID-19 viral infection with pneumonia and COPD exacerbation. He was admitted to the hospital for further evaluation and treatment.   Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a elderly female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, muscle pain, injection site and nausea. On an unknown date, the outcome of the fever, chills, muscle pain, injection site pain and nausea were recovered/resolved. The reporter considered the fever, chills, muscle pain, injection site pain and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 70 years or 71 years. The patient received SHINGRIX in the right deltoid. Fever, chills, nausea, muscle aches and injection site soreness were lasted up to 4 days after administration of SHINGRIX. The symptoms resolved completely with no complications. No medical visit was required.
Severe Pain, no ability of movement in the right arm, blood pressure is very high (156 / 87), severe shaking and chills, the pain has traveled into the neck and collarbone - chest area.
Severe hives 4 days after. Seem to be getting worse by the hour. Managing with OTC antihistamine oral and it h relief topical skincare.
The mom states the baby cried non-stop for 2 hours from 7:00 pm - 9:00 pm on the day of vaccine.
hard red spot size of a silver dollar; hard spot; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (hard red spot size of a silver dollar), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE INDURATION (hard spot) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (hard red spot size of a silver dollar) and VACCINATION SITE INDURATION (hard spot). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching). On 21-Jan-2021, VACCINATION SITE INDURATION (hard spot) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (hard red spot size of a silver dollar) was resolving and VACCINATION SITE PRURITUS (itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were nor provided by reporter.
Received Pfizer vaccines on 6/3, 6/25/21; tested positive for COVID by PCR on 11/3/21; admitted to hospital on 11/3/21 d/t respiratory distress.
Pt stated his eyes began itching and became red.  He stated he felt his throat was dry and his nose was running.  He stated he did not feel his throat was swelling and denied shortness of breath.  Pt stated this lasted "a few hours".  He stated he went to bed and slept all night without difficulty and the symptoms were gone the next morning.
Patient had a headache shortly after receiving vaccine 3/10/09.  He also experience throbbing of the head and near his left eye thereafter.  On 04/12/09 patient called to say that he could not read out of left eye.  He had his vision checked 4/18/09 vision is fine.  Headache is gone.
Initially thought I was having a stroke. Went to ER.  Not having stroke. A few weeks lates started having: Loss of balance including falling, speech difficulty, memory impaired, cognitive functions diminished, vision irregularities. Went to see Dr. who prescribed Steroid IV infusion for 5 days. Trazadone for sleep, and has ordered IVIG infusions ( awaiting on someone to administer.
I was home after getting my influenza vaccine that morning. I had increased joint pain throughout my body with low grade temp. 100.8-101. I have continued to have joint pain ever since. Severity varies day to day but never gone. Referred to Occupational Medicine Provider and was referred to Primary Care Provider.
This case was reported by a pharmacist and described the occurrence of elevated liver enzymes in a 38 year old male patient who received hepatitis B vaccine recombinant (Engerix B). On July 27 2004, the patient received the third dose of Engerix B (lot ENG5589A4). The pharmacist reported that at an unspecified time following the third administration of Engerix B, on or before 2/09/2005, routine laboratory testing showed slightly elevated liver enzymes. The event was on going at the time of initial reporting, 2/09/2005. Elevated liver enzymes was assessed as medically serious by manufacturer (OMIC).
Within 5-6 hours after vaccine, he was having tongue swelling, legs went weak and numb. Patient started having hallucinations. Took to ER, given IV fluids and ZOFRAN, and DILAUDID. About 24 hrs. after vaccine he also developed vomiting and diarrhea.
Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan2021; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received second single dose of BNT162B2 (Pfizer, solution for injection, batch/lot number and exp date not reported), intramuscular (left arm) on 09Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included migraines. The patient was not pregnant. There were no concomitant medications. No other vaccine was received in four weeks. No other medication within two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) wherein patient had known allergies and anaphylaxis. The patient received the first single dose of BNT162B2 on 22Dec2020 15:00, Intramuscular (left arm). The patient received second dose of BNT162B2 on 09Jan2021 11:00. The patient experienced body aches, chills, nausea, headache, arm pain, and fatigue on 09Jan2021 21:00 (09:00 pm). The patient did not have COVID prior vaccination. Patient was not Covid tested post vaccination. Treatment for AE included paracetamol (TYLENOL) OTC every 4 hours x 24 hours. The patient recovered from the events body aches, chills, nausea, headache, arm pain, and fatigue on an unspecified date in Jan2021.  Information about lot/batch number has been requested.
pt given vax 18DEC92 w/in 1-2 hrs noted lips, hands, legs, shivering like was cold lasted 1 min; become sleepy;
The next morning I had a raging case of Tinnitus in both ears. Swooshing/hisssing.  Like a compressor in a Refrigerator. I still have it as of today's day of 4/6/2021
Patient was 4 years 11 months on date vaccine administered.  He was given COVID vaccine for 5 - 11 year olds.  No adverse medical reaction.
17 year old patient received Moderna vaccine; A spontaneous report was received from a nurse concerning a 17 years-old patient (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant product use was not provided by reporter.    On 16 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot #: 013M20A) (site of administration not specified), intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the 17 years-old patient was administered Moderna vaccine. The nurse was inquiring what to do next. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.  On 16 Feb 2021, the event 17 year old patient received Moderna vaccine was considered resolved.; Reporter's Comments: This report refers to a case of 17- year-old patient who received for mRNA-1273, lot # 013M20A (Inappropriate age at vaccine administration) . There were no reported AEs associated with this case of Inappropriate age at vaccine administration.
Headache, Myalgia, Arthralgia & Fever  Narrative:  Other Relevant History:
The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date; No adverse event; Bivalent Moderna vaccine was administered after 30-day Use by Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after 30-day Use by Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after 30-day Use by Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  No treatment medication was provided.  This case contains information for the 15th out of 19 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)