chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a 2 year-old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 23-JUN-2017, the patient was vaccinated with improperly stored second dose of VARIVAX, one unspecified dose in the left thigh (lot # M047662 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with a dose of hepatitis a vaccine, inactivated (manufacturer: Merck Sharp & Dohme). The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
Within 24 hours of injection patient reported severe redness, pain and swelling from shoulder to elbow . Patient stated that she could barely move her arm. After 3 days, all symptoms resolved.
pt recv vax 15JUL96 & reported that restaurant in which worked for closed down 1JUL96 d/t hepatitis outbreak;nurse performed blood work to see if pt had become infected;results showed inc IGM & sl inc bilirubin;other liver function test nl;
temp elevation starting on 20APR variable as high @ times as 104;parents giving baths & med to reduce fever;still elevated today 24APR;MD could not determine any cause;pt taken to MD who stated pt had ear infect 27APR98;mom uncertain of dx
Three weeks after first shot, the shingles appeared; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Three weeks after first shot, the shingles appeared) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: VARICELLA ZOSTER VACCINE (when patient was 60 (15 years ago)).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Three weeks after first shot, the shingles appeared). At the time of the report, HERPES ZOSTER (Three weeks after first shot, the shingles appeared) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Pale, hypotonic, shaking, poorly responsive, listless for 4hrs slowly improving;
I was sick roughly one week before the vaccine and was sick while receiving the shot. I tested negative for Covid when I first got sick as well as when I went to the ED. After the shot my malaise increased similar to my second dose of the vaccine. I continued with mild symptoms of the illness until 01-22-2022 and 01-23-2022 where I had 2-3 runs of vtach, each lasting a few seconds. These runs were accompanied by shortness of breath and dizziness. On 01-24-2022 I had 2 runs of vtach each lasting 5-10 minutes. I went into Afib with RVR on 01-24-2022 did not stop until Adenosine was administered in the ambulance and a Cardizem drip was start in the ED. The total time was roughly four hours from the onset of symptoms that day. Diagnostic tests showed I had myocarditis, but no indication as to the etiology. I have been on metoprolol 25mg BID since as well as colchicine BID for 8 inconsecutive months. I started taking MagOx 200mg Daily in October 2022. Some changes in medication have been made due to ongoing symptoms such as frequent PVC's, PAC's,  moments of rapidly changing heart rate at rest.
PT RECEIVED PEDIARIX, HIB, AND PREVNAR ON 02/06/15. NO ADVERSE EVENT REPORTED DURING THAT DAY. NO SYMPTOMS. PT WAS FOUND UNRESPONSIVE AROUND 8AM ON 02/07/15. CAUSE OF DEATH HAS YET TO BE DETERMINED.
Severe local reaction. Immediate redness, large 8x6" redness, itchy. Then 5d later developed 10-12 papular pink bumps, not vesicles, intensely itchy. Client felt faint shortly after getting injection.
Received immunizations on 9/13/12. Woke up next morning RT arm was red and itching.  9/15/12 RT arm was swollen to twice the normal size from shoulder to elbow with dimpling.  Pimple like lesion at injection site.  Went to ER, diagnosed with cellulitis and started on antibiotics.
Spinal synovial cyst; Lower extremity dysfunction; Pain; Ankle swelling; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL SYNOVIAL CYST (Spinal synovial cyst), MUSCULOSKELETAL DISORDER (Lower extremity dysfunction), JOINT SWELLING (Ankle swelling) and PAIN (Pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB for RA.    Patient had no known allergies.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (unknown route) Citrate Free. In October 2021, the patient experienced JOINT SWELLING (Ankle swelling). On an unknown date, the patient experienced SPINAL SYNOVIAL CYST (Spinal synovial cyst), MUSCULOSKELETAL DISORDER (Lower extremity dysfunction) and PAIN (Pain). The patient was treated with DICLOFENAC SODIUM ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SPINAL SYNOVIAL CYST (Spinal synovial cyst) and PAIN (Pain) was resolving, MUSCULOSKELETAL DISORDER (Lower extremity dysfunction) outcome was unknown and JOINT SWELLING (Ankle swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient had not enrolled in a COVID-19 Vaccine trial.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2022: Follow-up: Patient demographics (age), event information, reporter opinion ofcausality,treatment drug information, narrative description and medical history. The event of "PAIN" was added.
I probably had it too COVID; I probably had it too COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 (Lot number: EW0217, Expiration Date: 30Sep2021) at the age of 54 years as dose 2, single and administered in arm left, administration date 10Jun2021 (Lot number: EW0179, Expiration Date: 31Aug2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "muscle relaxer" (unspecified if ongoing), notes: Additional Information for Concomitant Products Tizanidine: Consumer stated, "At the time the only medication that I was taking is the muscle relaxer, it's called Tizanidine.". Concomitant medication(s) included: TIZANIDINE taken for muscle relaxant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I probably had it too COVID". The patient underwent the following laboratory tests and procedures: investigation: unknown results. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are needed. No further information is expected.
Arm swollen and turned red 3 inches above and below injection site; Arm swollen and turned red 3 inches above and below injection site; arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (lot number: EN5318), intramuscular on 25Jan2021 08:30 at single dose in the right arm for Prevention. Medical history included diabetes diagnosed 10 years ago, acid reflux and cholesterol, all on unknown dates. Concomitant medication included esomeprazole sodium (NEXIUM) taking for 10 years for Acid Reflux, ongoing metformin for diabetes, "Sarxigo" taking for about 3 years for diabetes and unspecified cholesterol medication. On 26Jan2021 09:30, the patient experienced arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy. The flu shot did that to her too, but not as bad. Flu shot turned her arm red this year also. She got it in Oct2020. She also got in the right arm in the muscle. She would like to know if she will she be safe to take second dose of BNT162B2. The patient did not receive any other vaccines within four weeks prior to the vaccination. The outcome of the events was not recovered.
1st dose was given on 1/6/21. The side effect was injection site pain and muscle pains in all over the body. 2 nd dose was given on2/1/21. Severe side effect happened. Fever with 102.2, tachycardia, palpitations, abdominal pain, chills, muscle and joint pain all over the body(of course, injection site pain).
injection site reaction appeared.; Round, raised, red and warm to touch; Round, raised, red and warm to touch; Patient diagnosed with uti on 6/6 and prescribed Bactrim.; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown), via an unspecified route of administration on 03Jun2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient diagnosed with uti (Urinary tract infection) on 06Jun2021 and prescribed Bactrim. On 10Jun2021 patient experienced injection site reaction appeared. Round, raised, red and warm to touch. The outcome of events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
12 days after vaccine, red, hot swollen area on arm where shot administered. Area continues to spread downward towards elbow area.  Started out about size of 50 cent piece, now @ 6 inches long and@ 3 inches wide
Low grade temp on Friday with spots. Taken to doctor. chicken pox activated temp. 103 deg. F by Saturday. Spots turned to pox and now scabbed over. Had approx. 30 pox. Chicken pox virus circulating at child's day care.
blood pressure went up to 150/101; feeling like fainting; feeling really tired; Weakness; irregular heart beat; sob; feeling like flushing in the body; chills; This is a spontaneous report from a contactable healthcare professional.  A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 30Dec2020 07:15 at single dose for COVID-19 immunisation.  Medical history included hypothyroidism, depression, cardiac murmur and pvc. The patient hadno known drug allergies and had not tested for COVID-19 prior and after vaccination.  Concomitant medication included levothyroxine sodium (SYNTHROID), ergocalciferol (VITAMIN D), tocopherol (VITAMIN E) and sertraline hydrochloride (ZOLOFT).  The patient experienced weakness, irregular heart beat, feeling like fainting, sob, blood pressure went up to 150/101, feeling like flushing in the body, chills, feeling really tired, all on 30Dec2020 07:15. The patient received treatment. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "blood pressure went up to 150/101" with BNT162b2 can not fully 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.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-OCT-2014, the patient was inoculated with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot number were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-JAN-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and would continue suffering significant medical expenses, pain, suffering and other damages on unspecified dates. The final outcome of the events was not specified and they were considered to be related to ZOSTAVAX.
Patient was given her 10 year booster update for Tdap on day of her physical exam.  Later that night she began to have severe bilateral leg pain that woke her up from sleep.  She continued to have this pain mainly at night when she lied down for the next few days and her itraconazole and statin medications were stopped to see if they were contributing.  As of 3/7/23 she continues to have bilateral severe leg pain at night despite stopping these medications and with no other  symptoms.  Her creatinine kinase and ESR are both normal.  She was just started on gabapentin last night with some relief.  Lumbar spine x-rays are pending.  Due the acute onset of the pain on the night of her exam with no other precipitating events or injuries, and the severity of symptoms I thought it should be reported.
Day 4 post vaccination (pt also gave vaccinations) she developed 3 lesions on the right upper eyelid with crusting and trace conjunctive infection. Lesions resolved in 3 days with Bacitracin. Few lesions were vaccinia related. Eyelid swelling on right began day after vaccination.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N017700, expiration date: 09-JUN-2019 (concentration and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes.  The patient did not experience any adverse effects. Data logger was involved. This is one of several reports received from the same report.; Sender's Comments:  US-009507513-1711USA002012:
sore injection site arm for 2 or 3 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm for 2 or 3 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 047A21A, 058P21A and 038A22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Prenatal vitamins. Past adverse reactions to the above products included No adverse reaction with Prenatal vitamins. Concurrent medical conditions included Asthma and Allergy (Patient takes over the counter allergy medication).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arm for 2 or 3 days). At the time of the report, VACCINATION SITE PAIN (sore injection site arm for 2 or 3 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient received first Moderna Covid-19. Patient had a sore injection site arm for 2 or 3 days.  The patient received second Moderna Covid-19 vaccine. Patient had a sore left arm.  The patient received next Moderna Covid-19 vaccine. Patient had a sore injection site arm.  The patient received her next Moderna Covid-19 vaccine. Patient had a sore left injection site arm.   This case was linked to US-MODERNATX, INC.-MOD-2023-743819, US-MODERNATX, INC.-MOD-2023-743825 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743819:Same patient, PFS moderna vaccine Breast feeding case US-MODERNATX, INC.-MOD-2023-743825:Same patient, Bivalent moderna vaccine Pregnancy case
The next day after the vaccine, I had lymph node swelling, fever, and chills all within 12 hours. The swelling was under my arm. The swelling lasted 3 days. I had my second dose of Pfizer lot number EN5318 and I had the exact same symptoms as the first dose. I also had Moderna 3rd dose lot number 012H21B with the exact same symptoms.
Fever; body aches; fatigue; This is a spontaneous report from a contactable nurse. A 48-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 22Dec2020 11:30 to 22Dec2020 11:30 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin, erythromycin, vancomycin and cipro; all experienced allergies. The patient had fever, body aches and fatigue on 01Jan2021. The outcome of the events was recovered in Jan2021.  Information on the lot/batch number has been requested.
We had one adverse event after administering the Pneumovax23. The patient went to sit in front of the pharmacy and her son came to say her face was turning red and she wasn't feeling well. We called code white and went out to her and gave her 2 ice packs and water and offered to call 911. She said she felt like it was a little hard to breathe and I got the Epien ready but she was still doing ok and started feeling better. The store manager brought her a soda she requested for something sweet. I told her not to get the Prevnar13 or any other Pneumovax23 without speaking to her Dr. or getting it administered in the Dr. office. She was ok and store management got her an electric cart when she was feeling better just to be safe.
Local soreness, fever, chills (uncontrollable chills x 2 hours), malaise, lymph node swelling in armpit, striations toward armpit, large, local (size of golf ball) knot in elbow joint.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot # reported as N011867, expiration date 08-NOV-2018 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. The administered doses of PNEUMOVAX 23 were stored in the temperature between 9 degrees Celsius and 25 degrees Celsius for 1 hour and 45 minutes. There were no previous temperature excursions reported. Data logger was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006295: US-009507513-1707USA002309: US-009507513-1707USA006296: US-009507513-1707USA006293.
Patient presented to the clinic two days post vaccination. Redness at injection equivalent to the size of the Patient's palm. Not tender to the touch, no fever, so swelling, or any other symptoms. Pt. advised to take diphenhydramine or cetirizine and monitor. If swelling continues to return to the clinic.
Vaccination given 3/10/21.... On March 17, 2021 early evening injection site area became red, itchy, swollen and sore. Still the same today 24 hours later.
Within 25 minutes of 2nd Moderna dose, the left side of my neck and back center of neck started to feel like it was being constricted.  Began taking Aleve 2/day (rather than just 1 Aleve per week or less for lumbar arthrosis).  Next few days, didn't feel great.  The worst part was my neck.  I couldn't understand why I now had constant stiff and achy neck. By week 4, started waking up with occasional right side of body being numb (arm, hand, leg).  This had never before happened in my lifetime. By week 13, severe left leg cramping and pain from thigh to knee to shin to calf.  Out of nowhere, my left top of foot looked swollen.  In addition, my right hand middle finger ached.  Was getting 2 hrs of sleep for 10 d
after receiving the vaccine 4/20 and three weeks later I couldn't breath and called 911 and went to hospital and diagnosed with pericarditis. But the day before I felt like I had a fractured rib and it intensified that evening and I took pain medication, then the pain in the left side intensified and I could not breath it felt like a knife piercing and had to breath with very shallow breath into my upper chest and the pain was so intense.  I called 911 and they did an EKG, my heart rate went down to 30. One doctor gave me morphine to help me, they did test to check for blood clots and EKG's and blood test. I was also given Oxycodone.  Test showed that there was a virus that got into it that caused pericarditis.  I'm taking Ibuprofen and anti-inflammatories to help. I'm very active and never had health issues and believe this was a response to the vaccine.  First dose was given on 3/23/2021 Lot 047A21A and experienced Molluscum contagion a few days later, and this is a virus. I was prescribe a topical cream, Imiquimod a topical cream to put on it to break down the virus. Triamcinolone Acetonide cream was prescribed later and I'm still taking it now and the site was oozing puss and bleeding.
Approx 4 days after immunization developed painful round scab like sore at site of injection (R upper arm)
Area of induration and questionable muscle atrophy appeared 2 weeks after vaccine was administered.  Increased to 1 inch diameter over 7-10 day period.
approx 20 mins following vax pt devel localized reaction (42mmx 35mm) @ the inject site-lt deltoid; no systemic reaction occurred in the subsequent 1 hr; pt taken to ER 6 hrs later because of hyperventilation;