chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; improperly stored vaccine was administered to patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in July 2019 (reported as between 03-JUL-2019 and 29-JUL-2019), the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002393, expiration date 31-JAN-2021 and lot # R035225, expiration date 04-DEC-2020 (dose and route of administration were not reported) for prophylaxis and improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003178, expiration date reported as 31-JUL-2020, but upon internal validation established as 30-JUL-2020 and lot # S008577, expiration date reported as 30-SEP-2020, but upon internal validation established as 16-SEP-2020 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of total time in range -14 degrees Celsius to -10 degrees Celsius (-12.8 degrees Celsius) for 12 hours 3 minutes. There were no previous excursions reported. The data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA000192:
Child's physical reaction to injection was unlike any previous. She had been saying words and phrases, that stopped completely. She had been crawling, that stopped. She developed chronic diarrhea which lasted for over a year.  She did not speak again for 12 months. She developed chronic ear infections and respiratory illnesses. She also exhibits signs of ADHD.
Ongoing investigations for initial flu like symptoms leading to 3 months of shortness of breath, cough, haemoptysis, fluid retention, general malaise, fatigue etc
We were exposed to COVID-19 where I was attending a professional meeting. My husband contracted it first and then I tested positive 3 days later. My symptoms began on 07/20/2022 with just a runny nose. I tested positive with an at home COVID-19 test on 07/22/2022. After testing positive, I called my doctor's office but was unable to get in for a visit so my husband, who is a physician, was able to call in a prescription of PAXLOVID. I had a lot of congestion and a pretty bad cough, but the symptoms didn't last long. I was fine by the following Monday.
VITT: cerebral venous thrombosis and thrombocytopenia with positive PF4 antibody and no heparin exposure. Symptom onset on 6/4/21 which was 2 days after 2nd dose moderna vaccine (6/2/21) and diagnosed on 6/17/21. Started on bivalrudin. Clinically stable.
kidney failure/ going into renal failure; enlarged prostate; wearing a catheter on leg because he cant pee; High liver, kidney enzymes; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (kidney failure/ going into renal failure) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL FAILURE (kidney failure/ going into renal failure) (seriousness criterion medically significant), PROSTATOMEGALY (enlarged prostate), DYSURIA (wearing a catheter on leg because he cant pee) and HEPATIC ENZYME INCREASED (High liver, kidney enzymes). At the time of the report, RENAL FAILURE (kidney failure/ going into renal failure), PROSTATOMEGALY (enlarged prostate), DYSURIA (wearing a catheter on leg because he cant pee) and HEPATIC ENZYME INCREASED (High liver, kidney enzymes) outcome was unknown.            The Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  It was reported that the patient had high liver and kidney enzymes, and his health declined quickly following the covid-19 vaccine administration. No concomitant medications were reported. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information is not expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information is not expected.
Patient reported that she woke up on 02/17/2022 and noticed that her left upper arm was red, warm, itchy, swollen and painful. She reports the redness was spreading to her elbow but improved slightly since yesterday. She reports the redness has regressed back to her anterior, upper arm. She denies any fever, hives, chills or chest pain. No allergies to medication and angioedema. Patient also denies changes in laundry detergent, foods or body washes/lotions. She has not taken any medications to help the area. Patient reports she is not pregnant and is doing family planning and last period was 4 weeks ago. Pregnancy test was negative. Patient was diagnosed with cellulitis and given a medrol dospack 4 mg; bactrim 800-160 mg for 7 days and will follow up in my office to recheck site on 02/21/2022.
9 days from MMR patient developed a maculopapular rash abd, back, legs. Per dad rash lasted approximately 48 hours. No fever. Some area of rash coalescing to one red maculopapular area.
Fever; Headaches; Muscle Aches; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle Aches), FATIGUE (Fatigue) and CHILLS (Chills) 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 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle Aches), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle Aches), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Widespread Muscle pain, more so than with just fibromyalgia. lower back and hip pain making it hard to walk.   Still hurting pretty bad after over a week.  Either caused a fibromyalgia flare up or really affected my muscles.  Never had the hip pain like this.
On day of vaccine (9/22/22), patient called back at approximately 5:22pm stating that her arm was swollen and itchy.  She was advised to ice the area, and take some Tylenol and Benadryl.  She was also advised that if the reaction continued she should by seen by a physician.  Her husband informed us on 9/24/22 that she was admitted into the hospital. He said they marked the area with a marker and that swelling continued beyond the marked area.
another Nurse was administering VAQTA to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger; another Nurse was administering VAQTA to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger; This spontaneous report has been received from a registered nurse, referring to another female administering nurse of unreported age. The administering nurse's relevant medical history was not reported.  According to the reporting registered nurse, the other nurse was administering hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliter (ml) syringe formulation to a patient on 10-MAR-2022 (valid lot number U024504 and expiration date 15-OCT-2022) (case # 2203USA006289). While pushing the plunger to the barrel flange, a piece of the barrel flange broke (syringe issue), and a shard of glass broke through the administering nurse's glove and cut her finger (wound).  The administering nurse was seen by the facility's occupational health and was not hospitalized. The administering nurse's outcome from the wound was not provided.  The reporting registered nurse did not provide a causality assessment for the wound. ; Sender's Comments:  US-009507513-2203USA006289:
In the evening of 9/15/00, the pt experienced rigors, an oral temp of 104 and fatigue. He was seen in the ER on 9/15/00. The pt declined to stay in the hospital. Since that time, the pt has had a fever and rigors nightly associated with a minor headache. He has also experienced daily fatigue. He was treated with acetaminophen. On 9/17/00, the pt spiked a similar temp and the rigors returned. As of 9/22/00, the pt's temp spikes had ceased. although he  continued to have a slightly elevated temperature. As of 9/25/00, the outcome of the thrombocytopenia, rigors and fatigue is unknown. The fever is ongoing. Further work-up for the causes of fever and thrombocytopenia are in progress. Follow up on 02/02/2001: "The event of headache does not meet ICH serious criteria, but is being submitted as an expedited report by special request per 06/28/2000 letter."
Any little wind that hits him he feels it very cold; muscle pain; joint pain; some chills; did not even want to get up/ had no spirit to do anything; felt as if he was sick again; injection arm was in a lot of pain/ injection arm hurts; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt as if he was sick again), ASTHENIA (did not even want to get up/ had no spirit to do anything), FEELING COLD (Any little wind that hits him he feels it very cold), VACCINATION SITE PAIN (injection arm was in a lot of pain/ injection arm hurts) and FATIGUE (felt tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Diabetic.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced MALAISE (felt as if he was sick again), VACCINATION SITE PAIN (injection arm was in a lot of pain/ injection arm hurts) and FATIGUE (felt tired). On 25-Sep-2021, the patient experienced ASTHENIA (did not even want to get up/ had no spirit to do anything). On an unknown date, the patient experienced FEELING COLD (Any little wind that hits him he feels it very cold), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (some chills). At the time of the report, MALAISE (felt as if he was sick again), ASTHENIA (did not even want to get up/ had no spirit to do anything), FATIGUE (felt tired), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (some chills) outcome was unknown and FEELING COLD (Any little wind that hits him he feels it very cold) and VACCINATION SITE PAIN (injection arm was in a lot of pain/ injection arm hurts) had not resolved.        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 were reported. No treatment medications were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing), notes: Sleep Apnea - Treated. Concomitant medication(s) included: OLMESARTAN, start date: 05Jul2022, stop date: 07Jul2022; IBUPROFAN, start date: 05Jul2022, stop date: 07Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: 100 Fahrenheit; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 05Jul2022, Treatment stop date: 10Jul2022, Indication: Treatment of COVID-19. Adverse event: Rebound Covid approximately ten days after initial symptoms. Including positive at home test, slight fever (~100F), congestion, cough, and exhaustion. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient requested Hepatitis A vaccination; Hepatitis B vaccine was given. No adverse effects after vaccination while patient was still in clinic for 15 minutes. Patient had received full Hepatitis B vaccine series already, so this dose was not necessary.
I had my 2nd vaccine 2-26-21.  I woke up yesterday fairly tired.  I went to visit a friend, we both had our shots, and noted chills and not feeling well.  Thinking I hadn't eaten enough she gave me toast and a glass of milk.  I drove to another friends house feeling worse but needed to drop off some food.  I didn't know what was going on with my body.  The heat in the car was perfect.  45 minutes later I was home and on the couch fully clothed lightweight jacket and a down quilt still chilled.  My friend brought me soup and said he went through symptoms just 4 days ago and lasted three days.  We had gotten our 2nd shot a couple days apart...a 3 week later reaction.  Feeling better today.
Narrative:  symptoms were present prior to vaccination, but syncope occurred after vaccination. Low likelihood that vaccine was causative in our estimation.
Rash around injection site. Approx 6cm wide and 4.5cm long. Not raised, no bumps. Red ring, slightly itchy and warm to touch.
7FEB96 pt recvd vax given in rt arm area turned red,swollen & painful 8FEB96;mom to MD office 9FEB96 reported w/above sx not better area measured redness & swelling 1 1/2inches to inc rt;tx ibuprofen
On day two I noticed a golf ball sized lump at injection site. It was there until day 4 or 5 when it started to go away, but never went away completely. It was sore, but not very painful. On day 10, I noticed it was more sore and now there is a lot of redness over injection site. The lump is a little bigger, but not as big as it  was originally.
HA; brain fog; short term memory issues; This is a spontaneous report from a non-contactable nurse (patient). A 28-year-old male patient received BNT162B2, via an unspecified route of administration, administered in deltoid left on 18Sep2021 (Batch/Lot number was not reported) at the age of 28 years old, as dose 1, single for COVID-19 immunisation. There were no other medical history nor concomitant medications. No known allergies. No other vaccine in four weeks nor other medications in two weeks. No covid prior vaccination; not covid tested post vaccination. Got shot 2 weeks ago. The patient experienced headache (HA), brain fog and short term memory issues on 18Sep2021, every day since including the day of the injection. The reporter assessed adverse events as serious, resulted in disability or permanent damage. No treatment was provided. Outcome of events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Headache, Feeling abnormal, Memory impairment and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Red erythematous area 3 1/2 diameter around injection site. Tender, no fever. Cool compresses, observe.
On the afternoon of 9/7/16 patient develop itchy welts to both arms, chest, back and both legs.  They continued through 9/8 and resolved with no intervention.
Vaccine #1:  Only the sore arm as described on the Fact Sheet. Vaccine #2:  Stabbing anterior, posterior, and lateral left thorax chest pain at approx. 3 hours post injection lasting 2-5 seconds. Cardiac arrhythmias at 10 hours post injection:  I could feel the arrhythmias as they were about to start with fullness in my throat. Unable to detect radial pulse during episodes and no cardiac beats heard on auscultation.   Complete compensatory pause noted per palpation and auscultation.   Frequency of about two (2) episodes every 30-45 minutes for approximately three (3) hours, with gradual decrease in frequency over 24 hours.  By 24 hours post to present  none noted.  During all of these episodes I was supine. At 72 hours post the axillary swelling and chest pain (not the same size as the stabbing pain)  noted at 36 hours post had decreased from a full football in size to approx 1/2 a football.  Captured a picture of that (the half-size football), but not the full-size event. Considerable abdominal pain to LLQ at approx 90-100 hours post vaccine #2 that persisted for 24+ hours.
over 50 varicella pox started 26SEP cough started 19SEP;fatigue
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 8th February 2023, the patient received Havrix. On 8th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The pharmacist reported that the patient received the dose of Havrix which was already expired. The reporter consented to follow up by email. Additional Supportive Information: The use of Havrix, which was already expired on 16th December 2022, which led to expired vaccine used.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 28-AUG-2017, the patient was inadvertently vaccinated with expired dose of VARIVAX lot # L031066, expiration date: 18-AUG-2017, 0.5 ml, subcutaneous, for prophylaxis. No adverse effects reported. No product quality complaint involved.
Rash about 2? in diameter at injection site 10 days after injection.  Injection site is warm to touch.
Occupational exposure to product via eye; Occupational exposure to product via eye; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while administering product in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA689A, expiry date 31st October 2022) for prophylaxis.   On 17th February 2022, the patient received Menveo. On 17th February 2022, unknown after receiving Menveo, the patient experienced occupational exposure while administering product and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while administering product and exposure via eye contact were unknown.  Additional details were provided as follows: Medical assistant reporting an occupational exposure to Menveo to the patient, which led to occupational exposure while administering product.  The vaccine splashed into the patient's eye, which led to exposure via eye contact. Healthcare professional gave permission for safety team to follow up.
booster; cold symptoms; cough; stuffy nose; headache; scratchy throat; Breakthrough case of Covid; Breakthrough case of Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 (Lot number: EW0217) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLONAZEPAM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 55 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "not recovered" and all described as "Breakthrough case of Covid"; IMMUNISATION (medically significant), outcome "unknown", described as "booster"; NASOPHARYNGITIS (non-serious) with onset 05Jan2022, outcome "not recovered", described as "cold symptoms"; COUGH (non-serious) with onset 05Jan2022, outcome "not recovered", described as "cough"; NASAL CONGESTION (non-serious) with onset 05Jan2022, outcome "not recovered", described as "stuffy nose"; HEADACHE (non-serious) with onset 05Jan2022, outcome "not recovered", described as "headache"; THROAT IRRITATION (non-serious) with onset 05Jan2022, outcome "not recovered", described as "scratchy throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) negative, notes: Nasal Swab; (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasopharyngitis, cough, nasal congestion, headache, throat irritation. No any other vaccine in four weeks. No covid prior vaccination and no Known allergies. The patient had covid tested post vaccination.