chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient experienced COVID; the patient experienced COVID; Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) till Dec2021 at 40 mg (citrate free, 40 mg (1 in 2 wk)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (hospitalization, medically significant) with onset 2021, outcome "unknown"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "the patient experienced COVID". The patient was hospitalized for drug ineffective, covid-19, pneumonia (start date: Dec2021, discharge date: Mar2022). The action taken for adalimumab was dosage permanently withdrawn in Dec2021.  The reporter's assessment of the causal relationship of "the patient experienced covid" and "pneumonia" 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.  Additional information: The patient was hospitalized from Dec2021 to Mar2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) The reporter's causality for the event(s) of COVID and PNEUMONIA was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of COVID and PNEUMONIA are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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.
Patient had nausea, vomiting, lightheartedness, dizziness, pain at the injection site, and fatigue. The symptoms resolved overnight, with the only residual symptom being fatigue and injection site pain the following day.
incorrect product storage; This spontaneous report has been received from an other healthcare professional referring to a patient of unknown age and unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 26-OCT-2020, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T007035 with expiration date 01-MAY-2022; route and dose details were unknown) was administered to the patient for prophylaxis, after a temperature excursion (product storage error). The vaccine was stored below 36 degrees Fahrenheit/ 2 degree Celsius (0.9 degree Celsius to 1.9 degree Celsius) for 10 hours and above 47 degrees Fahrenheit/ 9 degree Celsius (9.1 degree Celsius) for 30 minutes. There were no previous temperature excursions. There was no digital data logger was involved.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA011203: US-009507513-2010USA011367: US-009507513-2010USA011375:
I started noticing mild symptoms in the afternoon of May 20th which I thought were allergies. Saturday it got worse and was equivalent to a head cold. I emailed the doctor over the weekend and he replied on Monday. He asked me if I wanted to take Paxlovid and I agreed. I took it on a prophylactic basis. I also took a decongestant and cough. I was feeling better within 5 days. I currently feel I have fully recovered. My throat is a little sore and on Thursday I had a runny nose but I do feel that I am over it.
ovarian failure and type 1 diabetes, flare of HPV virus in cervix, lymphadenopathy draining breast  increased blood glucose and pre- diabetes, ovarian failure Medical tests and laboratory results related to the adverse event(s) Blood work showing hormone changes and pre-diabetes
With the first COVID vaccine, I had fatigue and chills for four days. I had no symptoms with the second vaccine on Feb. 9,2021. Then a few weeks later, I had chest pain when I exercised. This went on for weeks until I went to emergency on March 27th, 2021. I had a clot in a small diagnol heart vessel. The cardiologist stented the small vessel. All my major heart arteries had 50 percent and lower blockage. Although it can never be proved, I believe my clot was due to the Pfizer covid vaccines.
Severe RA flare.  Bilateral flare shoulders, elbow, wrists, hands, hips. Medrol Dosepack, without effect, then steroid infusion on 6/8/21 with a slow recovery.
28 hours after my 2nd vaccine I was very tired, with whole body muscle aches, and some chills.  I went to bed and slept for 12 hours.  The next day I was still tired and achy overall  and rested on the couch all day. Normally I am very active and a competitive athlete.
Information has been received from a 32 year old Caucasian female pt who on 3/12/99 was vaccinated with a 1st dose of varicella vaccine. On 3/15/99, the pt discovered she was pregnant. It was noted that the pt was 4 weeks pregnant at the time of the vaccination. On 11/14/99, the pt gave birth to a female. On 3/1/01, it was reported that the child is now 15 months old and is not talking or walking. She had no current medications or allergies. The child's hearing has been tested and seems fine. The mother reports that when the child is spoken to "she seems confused". The child responds to activity around her with "high-pitched screaming and low guttural sounds". The only word she says is "dada" and that is only when she is excited. A neurologist is conducting tests on her and will be performing on MRI. It was also reported that the child has a rotated sacrum on her right side. Upon internal review the pt's experiences were considered to be "Important Medical Events". Additional information has been requested. Pt has compulsive personality disorder, and lactose intolerance. The update was on thebabies condition. This report is part of the pregnancy registry.  Follow up on 06/29/2001: "Adverse event onset date/time and lot # for vaccine 1 is not provided."
headaches, nose bleed, congestion nasal drip, muscle pain chills, fever, the severe joint pain has stayed with me and i never had joint pain including neck, arms, elbows , wrist, fingers, lower back, knees ankles toes, it is getting worst every day medicine does not help sleeping is a change
On 11/18/2021 Left arm, injection site was very sore immediately after shot.  11/19/2021 6:30am, I woke up with knot under left arm pit. As the day went on, the knot got bigger and was very tender. I had a fever, a headache and my whole body ached. The symptoms started fading that night after work, with fever reducing medication. 11/20/2021 under my left arm pit was a knot as big as a baseball, and my stomach on the right side around my belly button was sore like I had pulled a muscle. I continued to take fever/pain reducer. 11/21/2021 I woke up and the pain was gone from my stomach, but under my left arm the knot was still there but not bad. 12/7/2021 the knot is almost completely gone, with mild pain.
Gastro symptoms started the Monday following the vaccine. Acid reflux was continually getting worse and causing difficulty eating, and sleeping. Thursday I went to the ER and was diagnosed with pneumonia and given a gastro cocktail and recommended follow up with gastrointestinal physician. On Friday I felt worse and had a fever of 101 I took Tylenol and Motrin and continually felt worse. Went to ER with 103.4 fever and racing heart rate. BP was normal. Was discharged and told to continue medication. The next day (Saturday) I woke with a swollen penis and went back to the ER where I was given a steroid shot and told to ice and watch for any additional swelling. Fever has stayed down but have had aches and pains throughout the day
Started getting chicken pox lesions 10/20/2004, 1 on arm lesion on rt arm. 10/21/2004 lesions on her neck (5-6), 20 on her stomach, too many to count on her back. Fever started 10/18/2004- temp not taken but she was hot.
Infant was quite irritable the night of vaccine and swallowing air and vomiting, woke with swollen left thigh (where Pentacel was administered), petechiae on the site, measured 22cm vs 21cm on unaffected leg (where hep B and prevnar were administered), less irritable today.
After first - had increasing fevers after 3-4 weeks, then states they seemed to get worse, and continued.  Was diagnosed with rare H. Influenza endocarditis - with injury to Aortic and Mitral Valve, with vegetations (see below).
Pt reported redness swelling and warmth at injection site that lasted 3 days. 5 day after injection developed weakness, nausea, fatigue - had f/u office visits 11/12/ & 11/16 - still symptomatic at time of completing report.
Patient started experiencing intermittent chest pain the day after receiving second dose of Moderna vaccine.  No cardiac history, non-smoker.
Slurred speech right after receiving the 2nd dose. Headaches that still continue to this current time. Brain fog and difficulty concentrating. Sensitivity to site of 2nd dose of the vaccine still to this current time and difficulty sleeping. Low vitamin d and b requiring weekly b12 shots. All of these symptoms started after the vaccine.
Initial unsolicited report received from a non-healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016590759) on 05-Jan-2017. This case involves adult female patient (age unknown) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient experienced fever and headache. Laboratory investigations and corrective treatment were not reported. The outcome of the events were not reported. List of documents held by sender: none.
Minimal side effects, one day; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Minimal side effects, one day) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 023M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included RITUXIMAB (RITUXAN) for Rheumatoid arthritis.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Minimal side effects, one day). In 2021, IMMUNISATION REACTION (Minimal side effects, one day) had resolved.            No treatment details were provided   This case was linked to MOD-2022-627444, MOD-2022-611803 (Patient Link).
Patient stated feeling nausea and cold. clammy skin.  Fast heart rate and elevated blood pressure. Then also chest tightness.
7 days post vaccine: Pt. had 101.3 fever, and developed abdomenal LLQ 2-3mm papule, very tender to touch.  Also very tender rt inguinal node(about 2-3cm), left cervical and left axillary node.   8 days post vaccine: LLQ (abdomen) definite vesicle.  Nodes show no change.  Patient feels better.
2nd Dose of Moderna Vaccine administered on 9/6/21 from Lot #011A21A expired 8/16/21.  *Site leadership consulted with the Safety Department and received the below confirmation: * If the dose given in error is the first dose, a second dose should be administered 28 days later. If this dose is the second dose, the series is complete and no additional doses are needed.
Patient developed severe local reaction involving left arm  extending below elbow; slowly resolving over 4 weeks
sick; like having the flu; nausea; diarrhea; vomiting; couldn't eat, could only drink very little; dry heaves; dizzy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm, administration date 07Mar2021 13:00 (Lot number: EN6205) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney cancer" (not ongoing), notes: Had cryosurgery; cancer free for about 6 years.; "cryosurgery for kidney cancer" (not ongoing); "Breast cancer" (ongoing); "high blood pressure" (ongoing); "hip surgery", start date: 04Jan2021, stop date: 04Jan2021, notes: hip surgery on 04Jan2021 but didn't work so another one on 11Feb2021. Concomitant medication(s) included: FASLODEX taken for breast cancer female (ongoing); HERCEPTIN taken for breast cancer female, start date: 2011 (ongoing); IBRANCE taken for breast cancer female (ongoing); DOXAZOSIN taken for hypertension (ongoing). The following information was reported: MALAISE (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "sick"; INFLUENZA LIKE ILLNESS (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "like having the flu"; NAUSEA (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "nausea"; DIARRHOEA (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "diarrhea"; VOMITING (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "vomiting"; DYSPHAGIA (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "couldn't eat, could only drink very little"; RETCHING (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "dry heaves"; DIZZINESS (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "dizzy".  No follow-up attempts are needed. No further information is expected.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 62 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-JUL-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event shingles to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
I experienced an increase of my gout. I now have chronic gout since I got my vaccine. This is why I saw my doctor. The medication I was originally taking for my gout is no longer working. My doctor doesn't think that it is related to the vaccine, but he doesn't know what is causing this chronic level of gout. I also experienced a severe odor from all over my body. It lasted a few days after my vaccine. My right foot was quite swollen. They referred me to a specialist so that I could be fitted for something for my feet. The medication I am taking for my feet now is allopurinol (Zyloprim). There has been a lot of confusion about getting a booster. Given my pre-existing condition, my doctor has encouraged me to get the booster. It has been extremely difficult to filter through all of the available information.
Headache, Vertigo, and nausea for one day 7am-3pm, sore arm all day for one day, I used Ibuprofen for the headache and slept off all the symptoms
Localized swelling, redness, and warmth at injection site. Greater than normal reaction. No sickness or breathing difficulty. Treated with antihistamine.
lump on injection site, hot, redness size of hand, fever 100.0 for 2 days on and off, swelling of arm, fatigue, hangover feeling
Dose 1: slight fever (99.4), achy upper back, slight headache  Dose 2: slight fever (99.7), achy neck and upper back, slight headache, chills, fatigue
face was kind of swollen/swelling in her cheek and her face on the left side; swelling in her eye; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1284, via an unspecified route of administration from 31Dec2020 to 31Dec2020 as single dose for COVID-19 immunization.  The patient has no medical history.  The patient's concomitant medications were not reported.  On 01Jan2021, the patient experienced face was kind of swollen, have some swelling in her eye and her cheek and her face on the left side. The outcome of the event was unknown.
The patient had an apparent allergic reaction along the lower lip - in line with the location of dermal filler injected in March 2020. The reaction was minor and localized. This is known with Moderna but to my knowledge hadn't yet been reported with the Pfizer vaccine.
Unconsolable crying for several hours, post vax. Pt had a low-grade temperature. Pt admitted to the hospital for 24 hours observation. Diagnosed with intussusception
One of our ambulatory clinics reported that the lot number on the box differs from the lot number on the vial. This has created some issues with decrementing inventory and confusion about which lot number to record in patient chart. The clinic said that this has been an issue for a while, at least a year and a half. Unclear why some vaccines have the lot number on vial matching the box but this one does not match.
After 4 hrs. I developed severe shaking and felt extremely cold. An hour later I was fine but tired.
Reportedly on 11/3/00, the pt presented to the hospital ER with lethargy, fever and skin the color of purple. He was transferred to a university hospital on 11/4/00. The pt went into organ failure and disseminated intravascular coagulation. The pt died on 11/5/00, the pt's wife refused an autopsy.
Patient is a 81 y.o. female who came in with the chief complaint of confusion, cough, tiredness, decreased appetite, secondary to covid 19, her symptoms improved with symptomatic management but was debilitated from hospital stay. Pt/ot was consulted and they recommended SNF , she will be discharged to SNF.
Left arm red 3 x 4 inch area, pt taking XYZAL and TYLENOL.
The initial arm pain was gone by day 2-3. Today (day 7) I woke up with pain all down my left arm and swelling around my shoulder/collar bone area.
Soreness at injection, down the arm to hand; Soreness at injection, down the arm to hand; minor headache; chills; tired; This is a spontaneous report from a contactable reporter, patient. A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via unspecified route of administration in the right arm on 15Mar2021at 10:45 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via unspecified route of administration in the left arm on 22Feb2021 at 10:45 (at the age of 58-years-old), as a single dose for Covid-19 immunisation. The patient Medical history was not reported. Concomitant medication included ibuprofen and claritin from for unknown indication an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19 and the Patient has not tested positive for COVID-19, since having the vaccine. The facility where the most recent COVID-19 vaccine administered was at a Workplace clinic. The patient experienced soreness at injection, down the arm to hand, minor headache, some chills, tired and arm soreness on 15Mar2021 at 11:00. No treatment was receive for reported events. The clinical outcome of the vaccination site pain, tired, headache, pain in arm, chills was recovering. No follow-up attempts are needed. No further information is expected
Patient reports an adverse reaction of fever and chills the day following vaccination 1/17/23 and also reports another reaction approximately on 2/11/2023. The reaction occurring on 2/11/2023 was described as a maculopapular rash covering his back, arms, and abdomen for which he was treated with a Medrol dose pack. During the course of the Medrol dose pack he reports improvement in his rash but states that it returned the day after completion. He reports going to the hospital on 2/19/23 for treatment in which they administer Solu-Medrol 125mg intramuscularly and prescribe him another Medrol dose pack at discharge. He also began taking Allegra, Prilosec and Xyzal on 2/19/23. He states that the rash is now primarily located on his abdomen and back, and has a similar pattern/dermatome to shingles, but without vesicles. He has also began using topical OTC hydrocortisone 1% cream on 2/26/23.
Rash on shoulders, chest and sides. Rash reminds me of poison oak. This vaccine is purified rabies vaccine (Vero cell) SPEEDA.
Patient stated blurry vision and dizziness at 11 am so I had her sit down and I took her blood pressure 173/98 pulse 51 using an automatic upper arm machine.  We gave her a glass of water and just rest for 18 minutes.  She stated she was feeling better so I took her blood pressure again and it read 115/56 pulse 48.
Lose of consciousness and jerking, Stethoscopes was used to check breathing, happened right after injection. Was told symptoms were normal and was told we were okay to leave.
toothache; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient started with a toothache on 01Apr2021. The patient wanted to know if she can get a tooth extraction before getting her second dose which is due 08Apr2021. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient first experienced a fever on day 1, which was then followed by swelling of her arm. The arm continued to swell and was red in color. Patient claimed that it also itched, and took Benadryl for the itching.