chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme vertigo, nausea, fatigue and malaise. Epley Maeuver and Zofran, Advil.  Malaise and dizziness continue 5 days later
Asked to be given in back side due to patient fear of needles by provider. Given in Left hip area .Pain in area given
got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. They both got tested for COVID yesterday because she (the mother) ended up being sick, so her boss had asked her to go get tested. To be on the safe side she also had her daughter tested before they went to go get her vaccinated. They found out that the mother was positive, and the daughter was negative. She (mother) is hoping that the vaccine didn't trigger something completely crazy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "got covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 5 minutes I had sever asthma, coughing, chest pain, headache, dizzy, light headed,  over the next 4 hour all these symptoms increased as well as crushing chest pain, arm numbness in both arms . Passing out, muscle tremors.  Right king pain a d heart pain. Shaking. Coughing. I?m on my 2nd  round of prednisone and 1st round of antibiotic. It?s been 5 weeks . Still having chest/heart pain and arm numbness (not as severe as well as asthma is not under control. Also taking symbacort  two puffs twice daily. Still coughing and lethargic
This spontaneous report as received from a consumer refers her cousin, a 23 years old female with no medical history or allergies who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. No concomitant medications were reported. While on PNEUMOVAX 23 the patient's arm developed a bruise. No treatment was given. No lab studies were performed. The bruise was all gone now. Additional information is not expected.
Diarrhea, NauseaVomiting, stomach pain, fatigue Narrative:
After infant stopped crying, mother noticed redness and patches on scalp and face.  She walked right back to nurses for immediate assessment.  Assessment revealed hives on scalp, face, chest, arms bilat and legs bilat.  Respirations unlabored, infant content and calm.  MD notified at 4:55, advised parent to drive to MD office for Benadryl treatment 1/2 tsp every 6 hours was ordered.
The vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 07-Mar-2022 beyond 30-day use; We had given Moderna COVID-19 vaccine that was beyond the 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had given Moderna COVID-19 vaccine that was beyond the 30 days use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 07-Mar-2022 beyond 30-day use) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had given Moderna COVID-19 vaccine that was beyond the 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 07-Mar-2022 beyond 30-day use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had given Moderna COVID-19 vaccine that was beyond the 30 days use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 07-Mar-2022 beyond 30-day use) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had given Moderna COVID-19 vaccine that was beyond the 30 days use by date, The vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 07-Mar-2022 beyond 30 day use. It was reported that the vial had not undergone any temperature excursions. The patient had no event experienced and there was no product complaint associated. No treatment medications were reported.   This case was linked to MOD-2022-519582, MOD-2022-519593, MOD-2022-519602 (Patient Link).
Pt said have some rashes under the chin, right side of nose and forehead. Also, the rashes are itch and red. Pt called MD, per Pt MD made a recommend take BENADRYL.
No additional AE reported; Nurse called and reported that an expired dose of VARIVAX was administered to a 23 year old patient yesterday, 12/15/22. Patient has no reported side effects of adverse events. Nurse informed that the dose administered is supported per the post expir; This spontaneous report has been received from a nurse referring to a 23-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, and allergies were not reported. Concomitant therapies included sterile diluent(STERILE DILUENT).     On 15-DEC-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #T041505 has been verified to be a valid, expiration date not reported, but upon internal validation established as 09-DEC-2022) for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (expired product administered). No additional adverse event was reported.
Anthrax and typhoid vaccinations administered without incident, then approx. 3-4 minutes later smallpox vaccine administered; @ 13th scarification pt began to faint. Ammonia inhaler administered. Pt did not respond. His arms and legs were jerking and pt slumped to floor. After approx 30 seconds he became more alert and was oriented to person and place.  A office worker and one corpman were present @ time of reaction. He was already sitting in a chair when vaccine was administered. Several other corpmen responded immediately. Pt was assisted back in chair without incident. Vital signs stable. Pt monitored for 30 minutes then dismissed to return to his squadron.
pt recvd vax 25OCT94 & devel a systemic react described as anaphylaxis; pt was treated w/Epi & DPH 4-6 hrs p/inject; pt was hospitalized for 2-3 days & recovered;
56-year-old female presents via video visit today for symptoms that started after her second Covid vaccine on January 29.  Patient states that she started developing headache 1 week ago now with extreme fatigue, chills, body weakness and nausea.  Patient has no congestion, cough, fever, soreness, vomiting or diarrhea.  She was doing  fine the first few days after the vaccine but today symptoms worsen with new onset of nausea, weakness.  She has been drinking turmeric tea.  Has not been taking any NSAIDs.  She feels "winded" even doing a load of laundry.  She also reacted to the first dose of vaccine with a prolonged headache.
CHEST PAIN, POLYARTHRITIS, POLYARTHRALIA, UPPER AND LOWER EXTEMITY EDEMA. CONSITUTIONAL SYMPTOMS
On the morning of 12-14-2017, patient called to inform us of local site reaction (egg sized knot, severe pain, redness, itching of left arm). I advised patient I would call primary care provider for her and follow up with her. I spoke to pt with Dr. and she took the message. Dr. spoke to patient in the afternoon on 12-14-2017. Today, 12/15/2017, I spoke to the patient and she stated Dr. told her to take Benadryl tablets and use hydrocortisone cream and instructed her to call back on Monday, 12-18-17. Patient stated Dr. told her she is allergic to the ZOSTAVAX vaccine and not to take the new shingles vaccine, Shingrix, in the future. As of today, 12/15/2017 , patient stated her arm is much better (swelling, redness has decreased and doesn't hurt as much but is tender and doesn't itch).
1/7/21 arm soreness overnight, 10 AM 1/8/21  next morning pt noticed pulse was about 135 resting, pt went to work and felt out of it, overall unwell feeling, went to walk in clinic, blood pressure was high even after meds, EKG showed tachycardia but normal rhythm, pt went home went to bed at 2 PM slept until next morning, 1/9/21  fatigue, swollen lymph node under left arm, small lymph node in neck also swollen, headaches, flushed/grey looking, as of 2/16/21 pt is feeling much better
Myopericarditis following COVID-19 Booster Dose; This is a literature report for the following literature source(s)  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), outcome "unknown", described as "Myopericarditis following COVID-19 Booster Dose". The patient was hospitalized for myocarditis (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: electrocardiogram: st elevations; left ventricular end-diastolic pressure: 60 %; troponin: 10.4 ug/L.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information in the case, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be 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.,Linked Report(s) : US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient.;US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient
Patient stated that she received a lot of pain in shoulder and thigh. Heart complications. Rumbling in chest.
Dizziness, SkinRash, Rash & UrticariaPruritus Narrative:  received 1st covid vaccine 1/14/2021 and on 1/17/2021 developed rash over injection site "hive" and area puritic. Since 1/14/2021 injection rash has increased in size, continued to be puritic, and has experienced dizziness and feeling "clammy"
This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 05-FEB-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
injection site soreness; general body aches; upset stomach; This is a spontaneous report from a contactable consumer (patient's guardian). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 07Apr2021 at 16:15 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 17Mar2021 at 04:15 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient received other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 19:00, the patient experienced injection site soreness, general body, aches, upset stomach. No treatment was received for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Pt reported SOB and generalized pruritis.  SOB continued to worsen. Wheezes were noted BLL. Pt also began to produce stridorous sounds. 50mg Benadryl given IM at 1351. Pt also took 2 puffs of albuterol inhaler. Admitted to hospital recently for intubation for her seizures. Felt better after medication administration. Pt requested to go home, advised to go to ED if symptoms returned.
Lot of pressure in the brain; pain in head; R arm is in pain; A spontaneous report was received from a consumer (patient's son) concerning a 74-year-old elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "lot of pressure in the brain, pain in head and R arm is in pain.  The patient's medical history included Parkinson, diabetes type 2 and thyroid. Concomitant product use was provided by the reporter.  On 04 Mar 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 029A21A) via unknown route in right arm for COVID-19 infection prophylaxis.  On 04 Mar 2021, after first dose of vaccine, the patient had lot of pressure in the brain, pain in his head and all the R arm is in pain. Treatment medication included Acetylsalicylic acid.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events lot of pressure in the brain, pain in his head and R arm is in pain was unknown at the time of this report.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
the patient did not experience any other adverse event; patient received a dose of MMRII on 6/29/2023, after the product was involved in a temperature excursion.; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication included varicella virus vaccine live (oka/merck)(VARIVAX). The patient's pertinent medical history and drug reactions/allergies were not reported.   On 29-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) injection (therapy type: recombinant Human albumin [Rha], a dose, lot # W039699, expiration date 25-MAY-2024, strength and route not reported) for prophylaxis. Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was involved in a temperature excursion (Product storage error). The temperature excursion was 48.8 Fahrenheit for 7 hours and 45 minutes. It was unknown if there were previous temperature excursions. No additional adverse event (AE) was reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2307USA006147: US-009507513-2307USA006131: US-009507513-2307USA006253: US-009507513-2307USA006038: US-009507513-2307USA006117: US-009507513-2307USA006048: US-009507513-2307USA006043: US-009507513-2307USA005725:
Vaccine was given to patient 2 days after BUD.  Our vaccine BUD was 01/20/22, patient got vaccinated on 01/22/22. I contacted manufacturer to check what is the next step and they said that patient will be okay no need to get patient re-vaccinated since this date happened within the 2 days of stability of the vaccine. As per Pfizer they support the stability of the vaccine for 10 weeks +2 days. Which is just the time that patient got vaccinated. I contacted patient father and he is aware of this.
Received shot. Sat down for mandatory 25 to 20 mins. Got up. Felt ?off?, I.e. unlike myself. Nurse came and helped me to front to have BO checked. I was red faced. Heart was skipping beats. Never ever had this symptom before. Never. Nurse asked if I were on heart meds. I said no, never. She suggested f/u with PCP. A week or two later, PCP did EKG. Abnormal, so saw a cardiologist. Wore heart monitor for week.  Follow up June 30. I am convinced this was from second does.
about 5 minutes after administration pt. experienced strange hearing,dizziness; stated she was worked up and feeling her nerves taking over.  i sat with her and she started feeling better. i gave her water and that seemed to help, too. she was soon on her way to going home attributing the incidence to anxiety. called her later and she was fine
CHEST TIGHTNESS; FEVER OF 101.1 F; This spontaneous report received from a consumer concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 3580333, and expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 F. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 28-MAR-2021, the subject experienced chest tightness. On 28-MAR-2021, the subject experienced fever of 101.1 F. The action taken with covid-19 vaccine was not applicable. The outcome of the fever of 101.1 f and chest tightness was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
got the vaccine, still got shingles/Suspected Vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the vaccine, still got shingles/Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-JUN-2023 This case was reported by a patient via interactive digital media. The reporter reported that his/her mom got the Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Swelling of the lateral side of the R femur around injection site and fever up to 105.0F.
Dizziness, seen by EMS onsite. Translate in Spanish via phone translation. Pt. stated that she had been dx. with HTN, anxiety, depression, Her PMD advised her that she did not display those s/s. Pt. further stated that she was prescribed meds for medical conditions. Pt. v/s presented with hypertension between 11:35-12:00, while in the provider's care. The final set of v/s obtained .B/P=164/110; Pulse:106; SPO2=97%, RA; NSR 3-Lead Found to have increase B/P which didn't resolve. Pt. agreed to be Transported via ambulance to hospital ER for evaluation and treatment as indicated at 12:00 noon. See Elite for further pt. info.
Involuntary shaking/convulsions/shivering across entire body.  Was able to walk, but very difficult going up/down stairs.  No fever nor did I feel cold.  Shaking subsided after about 15 minutes.
Appx 6 hrs after pneumonia injection (R deltoid) patient noticed pain and erythema around site. Next morning had considerable erythema, pain, warmth on entire upper arm. Rash is slowly traveling upward toward neck. Pt also shows some redness on eyes. Pt incorrectly marked that she had not yet received PNEUMOVAX, but received previous dose 10/25/10.
I took 1st dose of Pfizer 3/23/21, next day at night around 10pm i felt heavy chest, i couldn't make a deep breath, it was hard to talk - if i pronounced a word i had a sharp pain in my chest, my heart was beating very fast, i had an unpleasant sensation around my neck, felt short on oxygen . Rapid heart beat lasted for few hours then i fell asleep. Next  3-5 days i had constant 24/7 burning sensation in the chest near heart, my chest was tight, i could not make a deep breath,  i was tired i couldn't stand on my feet because it gave  pressure on my heart and my heart hurt even more, i couldn't talk because it was painful. Symptoms lessen a little bit day by day but in total i had burning and aching sensation in my heart for 30 days non stop 24/7. I went to see a cardiologist, he told me that was a coincident. By eye he diagnosed me with scoliosis and told me that was a pinched nerve  that gives me me pain in the chest area.
Tunnel vision & entire body became hot prior to <10 second tonic clonic seizure.
Post vaccination the pt experienced redness, warmth, baseball size area and generalized flu-like pain.
c/o Rash.  Red swelling down arm to wrist.  site hot.  did have tightness in throat.  made her feel "gooqy"
Second Shot was in my right arm. About 25 hours after. My entire right side from my neck to my knee felt like I ran a marathon without training. I could barely sit on toilet, walk, bare weight on only my right side. Consumed 13 aleve during the next 36 hours yrs
one week after the vaccine I developed an approximately 6 cm x 6 cm red, warm, itchy local skin reaction at the injection site
At 3 AM on 12/19/15 I woke up with numb/tingling and cold feet, a temperature of 102.9, generalized body aches and chills, chest and back pain, and nausea. I was brought into the emergency department by my husband. Lab work and chest xray came back normal and I was informed the cause for symptoms was unknown but they may be related to receiving the flu vaccine and instructed to come back if my symptoms, especially if my neurological symptoms, increased or if I developed new symptoms and I was discharged home. I continued to run a low grade fever, and continued with numb/tingling feet, and generalized feeling of not feeling well. I woke up 12/20/19 at 8:00 am feeling numbness and tingling on the left side of my face and noticed I was drooling from the left side of my mouth. My family noted the left side of my face was drooping. Again my family brought me into Emergency department. The doctors there worked me up for stroke which was negative and it was determined I had recurrent Bells Palsy. I was given a prescription for Prednisone and Valacyclovir and discharged home. I later found out in people with a history of certain Bell's palsy the flu vaccine is not recommended and discovered cases of Bells Palsy after receiving the vaccine have been reported. I was never asked in the screening questions prior to receiving the flu vaccine if I had Bell's Palsy.