chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received the Moderna COVID vaccine booster dose (lot 069H21A, expiration 01/07/2021) to her left arm and Fluarix Quadrivalent (Lot 7557A, Expiration 6/30/2022) to her right arm at approximately 1320. Patient reported to EMT at 1345 that she was experiencing mild dizziness. EMT notified Co-Lead RN. RN assisted client to anti-gravity chair. At this time, client stated that dizziness started approximately 15 minutes after receiving both vaccinations.  Vital signs at 1346 were as follows: O2 98%, pulse 75, blood pressure 172/82, respirations 17. Client also reported a mild headache in back of her head and neck. Upon assessment, client is alert and oriented to person and place. Client could not recall year, month or president. The client's husband agrees that client's orientation is typical for her and that client  " has been having recent issues with her memory". Clients skin is appropriate for ethnicity, dry and warm to touch. Pupils are equal and reactive. Client denies shortness of breath, chest pain, itchiness, palpitations, swelling of throat or tongue and any other symptoms of concern. Medical conditions include: history of breast cancer. Client's husband reports she does not have a history of high blood pressure, but reports her systolic blood pressure has been reported in the 150-160s during her last few visits at her doctor's office and reports that the client normally complains of a tension headache in her neck and back of her head. Client denies allergies and reports that she last ate a cookie and cup of coffee at 0800. Vital signs at 1355 are as follows: O2 99%, pulse 82, blood pressure 160/82, respirations 18. Client reports that dizziness and headache have improved, but reports symptoms are still present. At 1410 vital signs at are as follows: O2 99%, pulse 83, blood pressure 172/80, respirations 18. Client offered EMS due to continued symptoms of dizziness and high blood pressure. Client and husband declined EMS. Co-Lead RN advised client and husband to follow up with physician immediately. Lead RN educated client and husband on ER precautions. Client and husband verbalized understanding.  Client's husband stated he would drive client home and reported " I will call her doctor right away". At 1430, Co-lead RN and Lead  monitored client while she ambulated to her car with a steady gait. No further nursing interventions required at this time.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 20-MAR-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild-moderate asthma, supraventricular tachycardia (SVT), thoracic outlet syndrome, and mango allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 12-MAR-2021 at right arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient additionally received non-company suspect vaccine included: Moderna (elasomeran) (dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 29-DEC-2021 at right arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 2). Concomitant medications included Atrantil (aesculus hippocastanum/mentha canadensis/schinopsis lorentzii heartwood) for drug used for unknown indication.  On an unspecified date in FEB-2023, the patient experienced sickness (covid 19 infection) for which patient received non-company suspect drugs included: Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 25-FEB-2023 to 01-MAR-2023 for covid-19 treatment.  On 02-MAR-2023, the patient tested negative, day 6 of sickness (started paxlovid day 1). On 03-MAR-2023, the patient tested positive, day 7 of sickness (had confirmed covid 19 infection) (dose number in series 2) which resulted into confirmed clinical vaccination failure (dose number in series 1). At the time of reporting, the patient had headache, some shortness of breath, nose felt like breathed water. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000275617.; Sender's Comments: V0: 20230349388-confirmed clinical vaccination failure . The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
I had hives for 2 weeks straight. I had a lot of swelling in my face and injection sight area for 2 weeks.  was very tired and very itchy. I had to take benadryl twice a day for 2 weeks. before I saw any changes.
Miss Communication between Dr. and myself. Pt was given PEDIARIX which contains polio and Polio.
Administration Comments: Patient observed for 15 minutes then notified RN that she was starting to feel a tingling sensation on her tongue at 1717. Called provider and had MA bring vitals cart to conference room. PA presented to room. MA Sup brought vitals cart. BP at 1717 was 201/78 with a pulse of 58 and an O2 of 97. Patient states only her tongue is tingling. Denies SOB, chest pain, nausea/vomiting, trouble swallowing, vision changes or dizziness at this time. Had patient take her mask off and gave patient water. Patient denies feeling anxious but did run over to vaccine clinic for extra available dose of vaccine from across the street to receive vaccine. Patient appears flushed. States it is the end of tax season and she has been a little more stressed. Hx of COVID infection on 10/31/2020. Repeat BP at 1724, BP was 194/95, O2 99%, pulse 55. States it is only the sides of her tongue that feels tingly at this time. Denies hx of HTN, hx of anxiety. At 1726, states she is starting to feel tightness in her chest. States her tongue is getting better, is still oriented and talking. PA assessing patient. PA left at 1729 and requested that patient be observed for 30 more minutes. RN continues to stay with patient. Rechecked BP at that time and switched to R side for BP cuff, BP 203/83, pulse 58. Had MA get stethoscope. Assessed lungs and heart. Lungs sound clear bilaterally. Heart rate is regular. Radial pulses are present and regular. At 1735, patient states less chest tightness but now feels shaky. States she gets shaky when she goes through a high stress time. RN sat and talked with patient. Patient states she does feel like she was feeling a little anxious and worried of the unknown. Feels less tingling on her tongue now, just near the back near her molars. Denies dizziness, nausea/vomiting, numbness/tingling, vision changes, HA, chest pain, SOB, trouble swallowing. Pulse 54 per radial pulse. At 1750, BP 194/80, tightness gone, tingling improved. Denies any other symptoms at this time. Patient had been observed for 55 minutes after initial injection, provider back into room and assessed again. Plan for patient to follow up with her primary care provider within the next week. Reviewed signs and symptoms of when to seek ER care. Patient states her husband has a BP cuff at home and will check her BP daily. If she continues to have high BP, will go in to be seen sooner. If experiencing sypmtoms, will go to ER. Walked with patient to front door. Patient states she is still feeling good. Patient left building at 1800.
had little pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had little pain at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Back pain.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PAIN (had little pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-May-2021, VACCINATION SITE PAIN (had little pain at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   This case was linked to MOD-2021-290939 (Patient Link).
I had the shot and still got shingles/Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced shingles. The reporter stated it cannot be prevented and was told it was not as bad as if not had the shot. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
severe pain in shoulders; could not raise hands above elbows; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia and chronic lyme disease; both from an unknown date and unknown if ongoing. Patient's concomitant medications were not reported.  After the 1st dose in Apr2021, patient had severe pain in shoulders and could not raise hands above elbows. Outcome of the events was not recovered.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Patient was given the COVID vaccine dose she tolerated procedure well. On her way to observation she had a vasovagal syncopal episode.  Pt immediately woke up and was able to ambulate. She was unaware of what happened, She was escorted to a chair and given juice. Her 02 sat was %100 and her pulse was 47. She was escorted to observation by two nurses to lay down. She ambulated well and her pulse was at 57 and patients 02 remained at %100. After laying down in Observation for 30  minutes  her pulse was at 67 and her 02 remained at %100.
I had a sharp pain in my back and pressure in my chest. The ER doctor said that I had a small case of pneumonia. I'm not sure if it had anything to do with the vaccine.
Trouble breathing feels like crack ribs; Fever above 102; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing feels like crack ribs) and PYREXIA (Fever above 102) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (Fever above 102). On an unknown date, the patient experienced DYSPNOEA (Trouble breathing feels like crack ribs). The patient was treated with PARACETAMOL (TYNELOL) ongoing from 09-Feb-2021 at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Trouble breathing feels like crack ribs) and PYREXIA (Fever above 102) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.   Reporter did not allow further contact
Patient received 2nd dose of Pfizer vaccine on the 14th day after the first dose. 1st dose given on May 13th 2021 2nd dose given on May 27th 2021  reported having the following symptoms after the 2nd vaccine; soreness of arm, fatigue, slight shortness of breath per patient yesterday.
flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: ER8732) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (ongoing), notes: Onset date: 8 or more years ago, Patient Details: fine with blood glucose and on low carb keto diet. The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "flu like symptoms".  Additional information: After the first dose patient was fine after 3 days of flu like symptoms. after the second dose, patient was waiting to recover from it but arms did not recover from pain. Patient can not move left arm upward and its now pain full to raise left arm or reach back patient can not tie hair and became so difficult to remove clothes or put them on  patient can not lean on it when patient sleeping and it wakes me up when accidentally turn to the left. its un comfortable even if not leaning on it that patient need extra pillow under it.  No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In January 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2010, the patient was treated by a physician for symptoms of a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Dizziness with-in one minute of injection that lasted approximately two hours. Neck and chest broke out in hives approximately 15 minutes of injection lasting one hour.
88 y/o male, PMHx of quadruple bypass and CKD, admitted for chest pain and afib with RVR on 9/24/21. Pt was previously hospitalized for possible non-STEMI and heart problems. Pt had slightly elevated troponin of 0.217 and chest x-ray showed fluid overload. Pt was found to be COVID positive, but was asymptomatic. Pt was discharged back to skilled nursing facility on 9/25/21.
Pt reports approx 20 hours after injection experiencing aching and chilling for 2 days and then a dull headache on 3rd day. Arm hurt with movement and had welts in circular pattern on upper arm below injection site area warm to touch on day 5. Welts are also resolving.
Patient reported severe muscle pain  the day after injection. They were treated by their primary care physician who referred the patient to physical therapy to treat the pain associated with vaccination. Patient is still reporting pain with movement in the affected arm.
Pt. develped redness at site and low grade fever lethargy next am, edema of left arm and red blotchy rash kind of like hives but not raised in the left upper deltoid.  Dr. prescribed alternating tylenol and motrin, also benadryl until improved.
pt recv vax 21DEC95 & 22DEC95 pt devel a very sore arm @ the inj site & advised to treat w/cool compresses & elevation;29DEC95 pt devel watery eyes, sore throat & ear pain;tx w/cool compresses
Patient received vaccine and had shoulder pain that evening into the night. She went to her prescriber and was diagnosed with SIRVA. Patient just reported the event on 9/17/22 when she came in for another vaccine. She is still experiencing pain and stiffness in the mornings due to the injury.
Started with very large knot under left arm and ended up in the er with stroke like symptoms Was taken from ER to hospital had an MRI and sent home lost speach as in starting to find the right words to say and a very weak left side  my left side is my dominant side currently using a cane for support
Patient received that vaccination around 11:30am. He went to lunch after and started to feel unwell around 12:15. Patient was experiencing the symptoms of cold sweats, shaking and weakness related to the sensation of passing out.  Patient experienced these symptoms for roughly two hours only to be relieved by sleeping
Condition aggravated; Flare up of RLS; This case was reported by a consumer via call center representative and described the occurrence of restless legs syndrome in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 42CM4, expiry date 11th June 2023) for prophylaxis.   Concurrent medical conditions included restless legs syndrome. Concomitant products included ropinirole hydrochloride (Requip), methadone and trazodone.   On 22nd March 2022, the patient received the 1st dose of Shingrix. On 22nd March 2022, less than a day after receiving Shingrix, the patient experienced restless legs syndrome. On an unknown date, the patient experienced condition aggravated. On an unknown date, the outcome of the restless legs syndrome was unknown and the outcome of the condition aggravated was recovering/resolving.   It was unknown if the reporter considered the restless legs syndrome and condition aggravated to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-Jul-2022 Reporter's comment: The patient received first dose of Shingrix vaccine in left deltoid.  After beginning the first dose of Shingrix, at night, patient experienced a flare up of restless legs syndrome, which did not calm down for 1 week.  More medicine was added to her medication protocol for restless legs syndrome when the flare up began.   Patient symptoms had improved. The consent to follow up was given. Patient gave consent to follow up with HCP.
recurring dizziness. After the virus inflammation that cause my hearing loss, I had several days with strong dizziness that eventually went down to almost zero. After I took the second shot, the dizziness returned when making sudden moves with my head.
Complaint of diaphoretic, passed out, heard to arouse, appear drowsy, and lethargic.  Obey command(directions)
This spontaneous report was received from a registered pharmacist via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not provided), for prophylaxis. On an unknown date, after receiving GARDASIL 9) the patient's Papanicolaou smear (PAP) test was positive (smear cervix abnormal). It was unknown if the patient received any treatment. At the time of reporting, the outcome of smear cervix abnormal was unknown. The causal relationship between the event and the GARDASIL 9 was not reported.
Mom states t106 R; pt given APAP & t102 R p/5 minutes; p/24 hrs temp never >102; also mom was administering only 1/2 the recommended dose for weight of pt; temp remained in control w/proper dose of APAP;
Rash around injection site; Chills; headache; Body ache; fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body ache), FATIGUE (fatigue), VACCINATION SITE RASH (Rash around injection site), CHILLS (Chills) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No specified medical history has been reported.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (Body ache), FATIGUE (fatigue), CHILLS (Chills) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE RASH (Rash around injection site). On 25-Jan-2021, PAIN (Body ache), CHILLS (Chills) and HEADACHE (headache) had resolved. At the time of the report, FATIGUE (fatigue) and VACCINATION SITE RASH (Rash around injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-023601 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR received on 14 Jul 2021 contain adverse events ,patient detail information
Patient had fever and URI 7 days after vaccine. A day later, she had multiple seizures, rapid deterioration of mental status and died within 4 days of illness. Nurse follow up on 10/15/04 states: "Family reported infant "not breathing" prior to arrival at ER, and that PCP diagnosed a viral syndrome the day prior to arrival at ER." Medical Record received on 12/15/2004 states pt experienced status epilepticus, global anoxic brain injury, edema brain, brain hemorrhage, retinal hemorrhage, and diabetes insipidus.  Nurse follow up on 10/19/04 states: No new information. 1/6/05 Received autopsy report which states COD as complications of seizures of undetermined etiology & manner of death as natural.  Neuropathology report provides diagnoiss of global hypoxic/ischemic encephalopathy (respirator brain).
About a day after receiving the Tdap vaccine, the patient developed soreness in his right arm, at the site of the injection, followed by 3 or 4 days of fever. During this time, he developed body aches. The aches will vary, it feels as though it is deep in his bones and forearms, hands, and lower extremities. He has not had any rashes and has not noted any redness or swelling in his joints. Pain has been so severe at times, he has had a hard time gripping his pen. The patient is taking ibuprofen for symptoms.
11-16-09-2 episodes of projectile vomiting and high-pitched screaming. Advised to go to a Peds ER. A XR showed OBSTRUCTION. Intussusception diagnosed by ultrasound.