chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 12-MAY-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
headache; neck pain; swollen lymph nodes under her neck, ears; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration dates were not reported), via an unspecified route of administration, on an 09Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Apr2021, patient experienced headache and neck pain. Two weeks later, after vaccine (in Apr2021), patient also experienced swollen lymph nodes under her neck, ears. Patient was scheduled to receive the 2nd dose on 30Apr2021. Patient wanted to know what would happen if she does not receive the 2nd dose and if this is a normal reaction to the vaccine, how long it would last, and if she should still receive the 2nd dose. Patient also wanted to know what medications are given for these reactions. Seriousness of the events was reported as non-serious. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No additional AE reported; Vaccine was administered after expiration; This spontaneous report has been received from a medical assistant and refers to a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. Concomitant therapies included sterile diluent.  On 10-JAN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 milliliter as prophylaxis (route and anatomical location of administration, and vaccine scheme were not provided; lot number T000892 has been verified to be valid lot number, expiration date reported and established as 08-JAN-2022) with the sterile diluent (concomitant therapy) 0.7 ml (lot number S016937 which has been determined to be an invalid lot number for sterile diluent, expiration date reported as 01-FEB-2022). No additional adverse events (AE) were reported.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 14-JUN-2013 the patient was vaccinated with M-M-R II (lot# H10135, expired date 17-MAY-2014), route, dose and frequency unspecified. The M-M-R II was improperly stored at 8.5 degrees C. -9.1 degrees C for 720 hours. There was no adverse effect reported. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Symptoms began on Sunday, April 3, 2022 during  tour. Originally thought of as allergy-related: head congestion, sneezing.  Mild symptoms of head congestion, fatigue continue
Moderna COVID-19 Vaccine   Vaccine on day 0 GI symptoms on days 1, 2, 3, and 4 including abdominal cramps, constipation, gas Uterine cramps (not related to menstruation) and light spotting on day 2 Soreness at injection site days 0, 1, 2, and 3
INJECTION SITE IS SORE DAILY AND THE PAIN WAKES ME UP AT NIGHT- HAPPENS ALMOST DAILY
pt rt thigh devel raised area approx 10mmx 10mm; area was below inj site;area around welt warm & red;pt kept in clinic for 20mins for observation;grandma encouraged to give DPH
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2014, the patient was inoculated with ZOSTAVAX, as administered by the physician (MD), as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, he was treated at the office of the physician (who administered the vaccine) for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
As soon as patient received the vaccine, she had a flushed look on her face and turned red.  She was feeling hot everywhere and had rapid heart rate. Paramedics came to check her out and her vitals very low.
Extreme fatigue all day 12/2 & 12/2 combines with dizziness.  12/2 body was very tender, felt like it had been beaten all over and weak, no energy.  Slept for sixteen hours on 12/2. Morning of 12/3 had a little more energy and was able to make it to work.  Was still a little fatigued and experiencing dizziness.  Around 3pm got very tired and had to lay down.  Body began aching and chills set in.  Slept for one hour and left home early from work.  Eyes were hurting and very sensitive. Found myself closing them any opportunity I had; if traffic would stop, at stop signs and red lights.  Was shivering uncontrollably and my fingers were very achy.  Once home slept for 3 more hours.  Woke up in a sweat.  Was able to eat and leave to get some Advil.  Was experiencing a horrible headache that 800mg of ibuprofen did not alleviate.  Went to sleep around 10pm and at 3:00 on 12/4 woke up in terrible sweats with extremely bad lower back pain the moved down into my legs as well as an aching headache.  Again took 800mg that did nothing.  An hour later took a Tylenol 3 and still no help. Fell back asleep around 6am to wake up at 8am in the worst pain I've ever felt in my lower back and legs.  Called student health services who brought me in that morning at 10:45AM.  I was given a shot for pain and observed for 30 min. The shot minimized the headache while not eliminating it and did nothing I help with the back pain.  Have been in bed with pain meds and a heating pad. Starting night of 12/5 stomach began to ache and there was pain on my left side when taking a deep breath.
Swollen in the face. Red in the face, ears, stomach, and diaper area. Gave some lemonade and Motrin. Within 2 hours the allergic reaction went down. Went back to the Dr. to document later that afternoon.
tachycardia; shortness of breath; elevated blood pressure 165/90; tired; stomach upset; felt unwell; This is a spontaneous report from a contactable other health professional (patient).  A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced on 04Jan2021 felt unwell, tired, stomach upset (it continued all week) and on 07Jan2021 tachycardia and shortness of breath. Clinical course: she was feeling very like short of breath and her heart racing, had elevated blood pressure 165/90, usually it was normal. The patient was sent to the emergency room (ER) and got worked up, she had a complete blood panel, everything came back normal; she had a chest X-Ray and 2 bags of fluid, then the patient was discharged. The patient outcome of the events was recovered.   The information on the batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Meningitis Bacteremia; pt recvd vax @ 2y/o & 4yr later devel sx;
Patient reports bruising, rash and edema @ site. Patient seen by MD for office eval.
shot area has developed 2 holes where shots were given and there is a rash and some discomfort.
My wife was positive for COVID-19 and symptomatic and I presented with sore throat and body aches with malaise and headache.  I tested positive with COVID-19 with a home test.  I contacted my provider thru health system and was giving Paxlovid and I started that on 7/18/22 and that kind of helped the progression of my symptoms. I did not have any congestion or shortness of breath but I did have a cough that lasted a couple weeks.
Approximately 7 days after first COVID vaccination patient had raised, red rash, warm to touch and tender at injection site. Lasted a few days. No other symptoms reported. Received her second vaccination 02/26/2021.
PATIENT WAS GIVEN  VACCINE BELOW THE AGE OF 18. PATIENT HAS HAD NO ADVERSE SIGNS SO FAR DUETO THIS EVENT. MOTHER WAS NOTIFIED.
she was loosing her taste and smell; she was loosing her taste and smell; nose constipation; feeling tiredness; generalized body pain; This is a spontaneous report received from a contactable consumer (reporting on herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 27Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of  BNT162B2 for COVID-19 immunization. Patient mentions that she got the second dose of the BNT162B2 on 27Apr2021 and that same night she started feeling tiredness and generalized body pain. Next day on 28Apr2021 she continue with the same symptoms but she also noted that she was loosing her taste and smell as well as having nose constipation. She wanted to know if this was normal. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Left arm red, hot to touch, swollen, 1 degree temp (97.7 her normal) 98.7, fatigue, achy all over.
(+) Covid-19 infection 10/08/21. Cough, sore throat, headache, nasal congestion, loss of taste/smell, SOB, elevated heart rate, and fatigue. Out of work 6 wks.
Vial was first punctured on 06-JUN-2022, post punctured stored at fridge and administered on 24-JUN-2022; Dose administered >12(hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12(hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 06-JUN-2022, post punctured stored at fridge and administered on 24-JUN-2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022 at 7:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022 at 7:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12(US hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 06-JUN-2022, post punctured stored at fridge and administered on 24-JUN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12(hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 06-JUN-2022, post punctured stored at fridge and administered on 24-JUN-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received second booster dose of Moderna COVID-19 vaccine. No concomitant information was reported by the reporter. On 01-JUN-2022 vial was initially stored in refrigerator, on 06-JUN-2022 at 10:00AM  vial was first punctured and on 24-JUN-2022 at 7:00 A vial was administered to patient .It is also reported that vial after punctured stored in fridge and the vial doesn't go under temperature excursions. No treatment information was provided by the reporter.   This case was linked to MOD-2022-594660.
I tested positive for Covid-19 on October 22, 2022 my symptoms were a runny nose only.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form, dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
MOM NOTICED RIGHT UPPER ARM WAS SWOLLEN FROM SHOULDER DOWN TO ELBOW. SWOLLEN AREA 5½ X 4CM. WARM TO TOUCH.  NO FEVER.
pain from neck to shoulder area; both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,; both real stiff; cough; Runny nose; could not leep last night; had a slight headache; body is achy; Received pfizer as the first dose and Moderna as the second; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain from neck to shoulder area), PAIN IN EXTREMITY (both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,), MUSCULOSKELETAL STIFFNESS (both real stiff), COUGH (cough) and RHINORRHOEA (Runny nose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concomitant products included LAMOTRIGINE and IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.   On 03-Aug-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain from neck to shoulder area), PAIN IN EXTREMITY (both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,), MUSCULOSKELETAL STIFFNESS (both real stiff), COUGH (cough), RHINORRHOEA (Runny nose), INSOMNIA (could not leep last night), HEADACHE (had a slight headache), MYALGIA (body is achy) and INTERCHANGE OF VACCINE PRODUCTS (Received pfizer as the first dose and Moderna as the second). At the time of the report, NECK PAIN (pain from neck to shoulder area), PAIN IN EXTREMITY (both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,), MUSCULOSKELETAL STIFFNESS (both real stiff), COUGH (cough), RHINORRHOEA (Runny nose), INSOMNIA (could not leep last night), HEADACHE (had a slight headache) and MYALGIA (body is achy) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Received pfizer as the first dose and Moderna as the second) had resolved.            Reportedly, Patient was planning to visit Emergency room if she did not feel better.  No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: significant Follow up appended.Suspect product information : Start date and Dose number was updated, Events added
This spontaneous report was received from a registered nurse refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified patient's were vaccinated with improperly stored doses of GARDASIL 9 (lot, expiry date and dosage regimen was unknown) for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is a 79 y.o. female patient of MD with history of CKD stage 4, CAD, T2DM, HTN, HLD, GERD, OSA requiring CPAP, and rheumatoid arthritis  presented to Hospital with worsening SOB.   Assessment and Plan   Acute hypoxic respiratory failure, improved COVID-19 pneumonia P/w worsening SOB; had returned home from SNFon 2L NC QHS Troponin negative x2, ntBNP 3528 (204 on 11/28/22) CXR: cardiomegaly and interstitial markings.  EKG: NSR, Qtc 457 Echo in June 2022 showed normal EF of 60 to 65%, no pulm HTN Continue Decadron 6mg daily for 10 days  Albuterol, robitussin-DM, tylenol PRN S/p Levaquin for potential superimposed bacterial pneumonia PT/OT/SW O2 weaned to 2L NC 12/18.  Continue Mucinex, Robitussin-DM, IS/PEP  Plan to discharge home   AKI on CKD-III Initial Cr 1.21, peaked at 2.99. Now 1.98 Prerenal from overdiuresis.  Continue to hold Lasix for another 2 days Follow-up with nephrology clinic in 1 month for longitudinal care   NSTEMI Chronic HFpEF Likely type 2 MI in setting of AHRF and COVID-19 pneumonia Denies chest pain, troponin down trending Echo in June 2022 showed normal EF of 60 to 65%, no pulm HTN Cardiology rec outpatient nuclear stress test   Type 2 DM with hyperglycemia requiring long-term current use of insulin Last A1c 6.1 on 11/28/22  Continue home regimen   Rheumatoid arthritis Chronic presentations without joint swelling or acute deformity Continue home plaquenil   Chronic back pain Multilevel diffuse disc bulging and degenerative disc disease on CT L-spine and mild disease on CT C-spine Known hx of impaired gait in context of RA and plantar fascitis with regular wheeled walker use  PT/OT Lyrica bid Pain control with PRN oxycodone
Symptoms of rash and flushing and aches and vomiting. Pt went to emergency departmnet.
The dose for the Moderna vaccine is .5 mL. The patient inadvertently received an overage of 0.01 to 0.02 mL. The manufacturer instructed us to inform the patient that the increased dosage could potentially lead to side effects that could be local or systemic. No serious adverse effects were reported by the patient.
I started with cold-like symptoms on Wednesday, April 7, 2021. Coughing, sore throat, low grade fever 99.7to 100.9, stuffy nose. Fever was off and on for about 4 days. Sore throat didn't last too long. Also very tired and just feeling blah.  Coughing and stuffy and now runny nose are still with me today. Also coughing up phlegm. Everytime I think, I am feeling better, I start coughing. A horsey cough. I tried calling the doctor last week, but there was a long wait time and I work at an elementary school, so it was not convenient for me to wait. I think this is lasting extremely long and wonder if it is from the Moderna shot? My husband also had similar symptoms. Let me know if you need any other info.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had first flare upto 2.5 yeas ago, from the day of reporting and had 1 to 2 bumps, was down for the week could not drive or move the arm at all), shingles (few months later after the 1st flare up, had a second flare up and had 1 to 2 bumps, was down for the week could not drive or move the arm at all), nerve pain (experienced nerve pain in right shoulder down the right arm) and pain (worst pain ever). On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.  It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient got both the shots as soon as he/she could and stated that, now the flare ups were not as bad as earlier. The reporter suggested to get the shot before actually getting shingles and might be that would never cause a flare up. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This case was reported by a pharmacist and described the occurrence of fever in a male subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown route, unknown arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced fever and injection site warmth. The subject's wife described to the pharmacist "a 4 inch band around his arm that was warm to touch." The pharmacist stated that the vaccination was administered at a different location from her pharmacy. Relevant test results included body temperature of 101 degrees Fahrenheit. At the time of reporting the outcome of the events was unspecified. The pharmacist reported another adverse event with BOOSTRIX for the subject's wife. The subject's wife had contacted the pharmacist. See case A0997904A for details.