chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an adult patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 13-JUL-2017, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (lot# N002914, expiry date: 04-NOV-2019, dosing details were not provided) for prophylaxis. No adverse effects were reported. Additional information has been requested.
administered Havrix to a "4 days away from 3 months old pt"; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received HAV (Havrix) (batch number CN3G5, expiry date 19th November 2023) for prophylaxis.   On 20th October 2022, the patient received the 1st dose of Havrix. On 20th October 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: No other information was provided.  No additional adverse event or product quality complaint was reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The medical assistant was accidently administered Havrix on the day of reporting to a patient, which led to inappropriate age at vaccine administration.
Patient complained of feeling dizzy after receiving vaccine. Symptoms resolved spontaneously. Observed by provider on site for 30 minutes.
headache; muscle ache; fatigue; This spontaneous case was reported by a physician and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 18-Jan-2021.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, COVID-19 (positive-negative): positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
pt recvd vax & was crying (shrill) 6 hr after vax for 1 hr; had fever of 101 x 24 hrs, tx w/ apap;
stored Moderna vaccine in their refrigerator and administered past the BUD date; BUD was 01-Nov-2021 but the vaccine was administered on 27-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 27-Feb-2022) and PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 27-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 27-Feb-2022) and PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Myalgia, Fever, RespDepression, CoughWheeze, CHILLS Narrative:
PATIENT HAD A SYNCOPE EPISODE AROUND 5- 10 MINUTES AFTER GETTING THE INJECTION
Face numbed up on the left side; All her joints on the left side from her knee all the way to her neck bothered her; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (daughter) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 08Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the reporter was calling in regard for daughter, she had a reaction, reporter was just helping her out to try and find all these things to get the information. She had the Pfizer, and approximately on unknown date in Mar2021, she got a side effect of her like her face numbed up on the left side and then all her joints on the left side from her knee all the way to her neck bothered her. She was getting better now, they took the BENADRYL, and she took like Ibuprofen, but the problem they were having was they could not get any answers from doctors or anything, did she go for the second shot, or will this cause more of a serious condition with the face of numbing; asked by reporter. Reporter was trying to get information for daughter. Reporter stated, daughter will take care of herself. Reporter wanted to try and find out where she can call, as she wants to call that number and that was about it, because this was going to be frustrating for her. Outcome of both the events was recovering at the time of reporting.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Narrative:  64 YOM with a PMHx including T2DM, GERD, CKD3, tobacco use disorder, HTN, HLD, colonic polyps, OSA, COPD, Barrett's esophagus, and non-SCLC of LLL died at outside hospital on 6/12/21. Pt received COVID vaccines on 1/29/21 and 2/26/21. It appears death was unrelated to vaccines.
I have had a constant migraine headache and nausea since a few days after the first vaccination on March 18, 2021. Since I am being treated for migraines, I did not connect the symptom to the first vaccination. I took the second one on April 15, 2021. I am on three prescription medications to treat migraine headaches; however, none of them have relieved this constant migraine. One of my providers suggested that I report my symptoms.
Pain in left side of chest, increased with physical activity, shortness of breath, elevated heartrate - usually under 50, running over 80 without exertion
Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 15 years old female patient who was vaccinated with a dose of ADACEL (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on 27-Nov-2017. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included IPOL; MMR and MENACTRA for Immunization. It was a case of actual medication error due to extra dose administered. No adverse events had been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Developed fever, fatigue, shaking, and tachycardia.  Required admission to the hospital for observation due to persistent tachycardia and concern of myopericarditis.  He did not develop myopericarditis or end organ dysfunction of (Privacy).  He was discharge in approximately 48 hours and is continuing to improve.
Sxs started 2 hours post vax with flushing, palpitations, chest pressure.  Presented to ED. Sxs resolved after 2 hours of observation.
Arm felt feverish; Pain at the injection site; Arm felt feverish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 immunization, reaction(s): "flu symptoms", "arm felt feverish", "sore arm on the injection arm". The following information was reported: PYREXIA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Arm felt feverish"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at the injection site".  Additional Information: He had a caller on the line who shared some adverse events after the COVID vaccine. After the first shot she had flu symptoms for a week, and a sore arm on the injection arm. For the second dose she pain at the injection site.  The details were confirmed provided by the transferring agent. She had the sore arm and pain at the injection site. Her arm felt feverish after both vaccines. She doesn't want to report it because she feels like it is normal. Her and daughter in law had the same side effects. She felt like she had the flu for 5-7 days. She doesn't really care to report it.  Follow up (31Aug2021): This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. The response included that: After reviewing the call recording, there were a total of 3 patients that were reported, the reporter, her son, and her daughter in law.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Localized erythema, edema and tenderness lasting 3-4 days, relieved by warm compresses and ibuprofen. Saw doctor and return visit on 12/22/00.
Pt has a history of recurrent lung cancer, CAD, COPD, and CKD.  Pt came to ER due to weakness and altered mental status.  She started with cold like symptoms one week prior.  Pt admitted for acute hypoxic respiratory failure due to COVID and sepsis.
Upon walking back from the clinic, I asked my Supervisor who was walking with me if he heard "that siren". He said he didn't, at which point I thought something was off. Throughout the day, the siren was reduced to a ringing in my left ear and in both ears that night. This has continued up until today with the pitch and frequency varying. I do not notice the ringing when I sleep, however, sometimes it is quite pronounced upon waking.
Case number PHEH2106US028838, is an initial spontaneous report received from a pharmacist on 01 Nov 2016. This report refers to a 63 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 165803) at a dose of 0.5 ml intramuscularly on 22 Sep 2016. On 24 Sep 2016, the patient experienced ringing in the ears and tinnitus two days after being administered with FLUAD (reported as on or about 24 Sep 2016). The patient has seen a few physicians for the issue, but was insure of the cause. The patient called into the pharmacy on 28 Oct 2016 to see if FLUAD could be the cause and the pharmacist in turn called the Med Info center. Tinnitus was ongoing and had not resolved. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the event was not reported.
PT C/O DIZZINESS AND ANXIETY FROM RECEIVING THE VACCINATION. 1ST  BP 192/89 SpO2 99% 2ND  BP 166/87 HR 66
Redness, swelling, pain at injection site approximately 4 inch in diameter on day one of reaction. Redness and warmth continued to spread to just above the elbow. Rash consistent with evolving cellulitis, emanating from injection site. Patient also with generalized symptoms including itching all over, fatigue, decreased appetitie , loose stool, urge incontinence, fever/chills Tmax 103.6. Patient treated with doxycycline 100 mg BID for 10 days. Patient will return next week for follow up.
I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot,  I went into anaphylactic shock,  I broke out in hives, and my throat was closing
Narrative: Patient received J&J vaccine on 6/2/2021@1251, went to ER later  that day with hypotension, dizziness, nausea. may have been related to J&J  vaccination as no other cause could be determined. Pt was checked by cardiology  due to hx of Afib but was not found to be having any acute episode.
Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported .  No treatment information was provided by the reporter.  The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as we used.
Dry Cough, upper respiratory congestion, sub-normal temp (97.1F), Weakness in limbs.
Reported throat feeling "funny" and "hoarse" approximately five to six minutes post vac.  Observed pt x 51 minutes.  No SOB, tachycardia, tachypnea, wheezing, hives, cyanosis observed.  Vitals WNL x 2.  BP 118/80, Resp 16-18, Pulse 80-88.  A/O x3.  Over the 51 minutes feeling in throat improved w/o intervention.  Left w/o assistance and under no duress.
Worsened Rheumatoid Arthritis Flareups; Runny Nose; Dry Scalp/ Dry Skin; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4364310-00.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 04Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 28Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 27 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "Worsened Rheumatoid Arthritis Flareups"; RHINORRHOEA (non-serious), outcome "recovering", described as "Runny Nose"; DRY SKIN (non-serious), outcome "recovering", described as "Dry Scalp/ Dry Skin". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a Covid-19 vaccine Trail. The primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's assessment of the causal relationship of the events Rheumatoid arthritis, Rhinorrhoea, Dry skin. with the suspect product was provided Possible at the time of this report. Since determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Rheumatoid arthritis, Rhinorrhea, dry skin and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Early sing of anaphylactic reaction; Face was bright orange; A spontaneous report was received from a consumer concerning a 71 years old, male patient who experienced early sign of anaphylactic reaction (anaphylactic reaction), and face was bright orange (erythema).   The patient's medical history included anaphylactic reaction since an unknown date, high blood pressure since an unknown date, anxiety since an unknown date and pain since an unknown date. Products known to have been used by the patient, within two weeks prior to the event, included High blood pressure medication, Pain medication, Anxiety medication and Vitamins all since an unknown date at unknown dose, frequency, route and formulation.   On 10-Feb-2021, approximately 20 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.   The patient experienced anaphylactic reaction and face was bright orange on 10-Feb-2021 after receiving the vaccine. Patient was treated in the ER and stayed there for four hours while the symptoms slowly resolved. Patient indicated face was 75% back to normal while in ER. Treatment for the event included steroid injection, Zicam and steroid tablets.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event(s), early sign of anaphylactic reaction, and face was bright orange were considered resolved or recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (within 20 minutes after receiving the vaccine), a causal relationship cannot be excluded. Further information is requested.
The patient did not have an adverse reaction. I am reporting that she completed her 2 dose series of Pfizer vaccine in March while living alone. She was admitted to a LTC facility in April and failed to report to staff that she had her Covid vaccine, so they brought her to our pharmacy for the Moderna series. She subsequently completed the Moderna series here. We discussed with staff at her facility, and they stated that neither she nor her POA let them know she had previously been vaccinated. The patient has suffered no adverse reactions at this time.
Side effects to the COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects to the COVID vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION COMPLICATION (Side effects to the COVID vaccine). At the time of the report, VACCINATION COMPLICATION (Side effects to the COVID vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
steady pain in rt upper arm;pain assoc w/movement of arm since vax;no pain noticed in lt arm where 2nd dose given;
Right arm where DTaP given, largely swollen form above shoulder to elbow. Not painful when child moves arm.
Pt developed heat sensation in left buttock immediately following administration of vaccine, followed by constant tingling in left gluteus muscle with associated soreness in left gluteus. Symptoms lasted for about 3 hours and resolved with no treatment.
Redness, warmth and knot in arm at injection site lasting longer than 48 hours.
pt recv vax 23FEB94 & was irritable then weakness, appetite dec, failure to thrive, diarrhea, neuropathy;GBS;
108 days passed since first dose given; Covid Infection; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid Infection) and PRODUCT DOSE OMISSION ISSUE (108 days passed since first dose given) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced COVID-19 (Covid Infection). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (108 days passed since first dose given). At the time of the report, COVID-19 (Covid Infection) and PRODUCT DOSE OMISSION ISSUE (108 days passed since first dose given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Breakthrough case admission after 2 vaccines Moderna 4/7/21 Lot# 017B21A;  Moderna 5/5/21 Lot# 040b21A
Patient reports side effects of being achy, but it is manageable.; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (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. The following information was reported: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Patient reports side effects of being achy, but it is manageable.". The lot number for bnt162b2 was not provided and will be requested during follow up.
The next day after the vaccine, I woke up with extreme headaches and checked my BP that was 170/120. I have never had a blood pressure reading that high and my blood pressure has always been normal. I went to my doctor and was prescribed a medication. It did not work so called my doctor again and was put on another medication. After the 4th or 5th attempt at contacting my doctor and changing meds, I finally have a medication that works and controlled my blood pressure. To this day, I am still on blood pressure medications.
Approx. 1 hour - 1.5 hours after immunizations, while shopping--the child got very stiff all over, then began shaking, and then limp per report from mother.  This occurred in approximately 2 minutes.  911 was contacted and child was transferred to the hospital in an ambulance --.
3 day after 2nd injection, Extreme nausea, day 4 pink rash on abdomen,  day 6 extremely intense sore throat, tired, slight cough, no fever.  Day 7 continued intense sore throat, congestion, fluid buildup in throat, cough, no fever.  Day 8-9 extreme runny nose, congestion, deeper cough, no fever.