chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe progressive Tinnitus in the left ear only; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2020 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 19Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Severe progressive Tinnitus in the left ear only". The event "severe progressive tinnitus in the left ear only" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Hospital. Hospitalization Prolonged: No. Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The adverse event result in any of the following: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had received COVID 19 vaccine, brand=Pfizer, dose 3 (booster), single in left arm on 25Oct2021 for Covid-19 immunization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left deltoid swollen, warm to trunk. Warm compresses to site Tylenol. Suspension every 4 hours, discomfort.
Client received her COVID Pfizer Booster dose lot # FF8841 exp. 12.31.21 on her left arm on 12.09.21.  interpreter provided to client. At 1321, client reported to EMT that she was feeling a ?cold sensation on her face and hands? and dizzy (6/10 level) and he transported client to the anti-gravity chair in a semi-fowler position. PHN came to assist with the client. Client denied shortness of breath (SOB). EMT took client?s vitals: BP 110/66, HR 132, O2 Sat. 99%. At 1328, EMT took client?s vitals: BP 111/91, HR 123, O2 95% and she reported dizziness and ?coldness.? She denied SOB or any other anaphylactic signs and symptoms. She denied any history of allergy or taking any medications. She reported had tonsils infection and took ?Doxiciclina? for 10 days which she completed the antibiotic three days ago. She told she has a primary care doctor follow-up in three weeks for the tonsils infection. At 1331, she drank a juice and ate crackers provided without any issue. At 1336, client reported she still had dizziness, but she didn?t have the ?coldness.? At 1338, EMT took client?s vitals: BP 118/73, HR 111, O2 Sat. 99% and still had dizziness and feeling a ?chill in neck only.? At 1341, client reported she felt ?cold? on her face and throat and that she has a history of dizziness with blood drawn and vaccination. At 1343, client started ?shaking and scare.? At 1351, EMT took client?s vitals except BP: HR 100, O2 Sat. 99%, and client reported no more dizziness or coldness anywhere. At 1351, her ?shaking and scare? stopped. PHN educated client on adverse reactions and when to seek EMS. At 1358, client declined to have her last vitals taken and left the vaccination site with a steady gait with her parents.
Received 2month vaccines on 3/26/2007 @ 1:30pm. Site where HIB was given got reddened 4 hours later and child was crying inconsolably. Was seen by pediatrician at 5:30pm on 3/26/2007 and was given Benadryl liquid. Was followed up today and Local reaction resolved. I was notified by MD's nurse as to what transpired. Made telephone call to mother who states child now fine.
Patient is my brother; for 24 hours after his second vaccination shot, he had a fever and bad headache; Patient is my brother; for 24 hours after his second vaccination shot, he had a fever and bad headache; This is a spontaneous report from a contactable consumer. An adult male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number EN6206), via an unspecified route of administration on 08Mar2021 as a single dose for covid-19 immunization. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch number EL9267), via an unspecified route of administration on 18Feb2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. it was unknown whether the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Mar2021,24 hours after his second vaccination shot, he had a fever and bad headache. It was unknown if patient received any treatment for the events. The outcome of the events was recovered on an unknown date 2021   No Follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 7 year old male who, in 2000, at one year of age, was vaccinated with Varivax. In December of 2006 the patient experienced "breakthrough". The number of lesions was not specified. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Severe itching, pain, redness and inflammation similar to hives on the arms and legs. Especially prominent bruise like marking with swelling on the left arm that got the vaccine, not at the site of injection , but between the elbow and wrist. Several red inflamed areas. Pictures available.
AFTER PATIENT RECEIVED THE BOOSTER SHOT AND TOOK A SEAT, SHE STARTED TO EXPERIENCE NAUSEA AND ASKED FOR A PLASTIC BAG TO REGURGITATE AND SHE CONTINUED TO DO SO FOR NEXT 5 TO 10 MINUTES. WE THEN ASKED IF SHE NEEDED ANY MEDICAL ASSISTANCE WHICH AT THAT TIME WE DIALED 911. EMT TOOK OVER FROM THERE.
Rash/Hives on the from head to ankles. Very itchy.  Reaction was noticed within an hour of having the shot. Contacted the local ER and they asked me to come in to get looked at.  They gave me benadryl & prednisone.   Relieved symptoms fast.  The next morning just a little rash left.  I don't have all the information for the shot as they never gave me an after visit paper about flu shots or the information about the shot they gave me.
A report has been received from a health professional concerning a 11 year-old male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. During Sep-2012, the patient received a treatment with nasal FLUMIST. The dosage, frequency and indication for use of this medication were not provided. On 24-Sep-2012, the patient developed influenza A. The event of influenza A was ongoing. The report was considered to be non-serious by the reporter.
Patient presented for Pfizer booster. Did not have CDC card. Attested that it had been over 6 months. When I opened patient chart she had received primary series at the Clinic. Realized patient booster was given too early. Pfizer 2nd dose was on 06/24/21 and booster was given on 12/03/21. Patient notified that booster needs to be repeated per CDC guidelines.
Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was placed in refrigerator on 29 Oct 2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the QR code was scanned. The vials did not undergo temperature excursion.The patient did not experience any adverse event. No treatment medications were reported.
sore at vaccination site since 2/27/21 date of vaccination  redness - now larger - since 3/7/21
Pfizer-BioNTech COVID 19 Vaccine EUA  I am experiencing swollen lymph nodes under right arm.  Has subsided some, but there is still appreciable swelling.
Four days after shot developed horrific cough with green mucous, sore throat, muscle pain, brain fog, intense arm weakness, and hearing loss. It is 7/13/21 and the symptoms of muscle pain have warn off, but still have hearing loss in both ears as if they were plugged (like being on an airplane) but do not pop. Still have some minor brain fog, as well as coughing up mucous, but the cough is getting better. When the symptoms started, I went to urgent care as I read that these were not symptoms of the vaccine. A rapid COVID test was performed and was negative, and was prescribed an inhaler.
fainted/passed out; patient passed out; This is a spontaneous report from a contactable pharmacist reporting same events for suspect products for 4 patients. This report is for the 4th patient. Follow-up (06Apr2021) was received from same reporter and processed together with initial information. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8729; Expiration Date: 20Jul2021), via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included saline [sodium chloride] (SALINE [SODIUM CHLORIDE]). The patient reported that after administering the Covid 19 vaccine on 06Apr2021, within about 20 minutes there were 4 patients with reactions. The patient experienced fainted/passed out on an unspecified date and patient passed out on 06Apr2021. Three people fainted and one had seizure after receiving the first dose of the Pfizer-BioNTech Covid-19 Vaccine. These patients had just received the Covid 19 vaccine and were still being watched within the 15-minute post vaccination time. All 4 patients received the Covid 19 vaccine from the same lot number but not from the same vial.  Seriousness of events was medically significant. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Considering close temporal association, a possible contributory role of bnt162b2 to the events fainted and passed out cannot be completely excluded. Relevant medical history and details of clinical course are missing for further assessment.   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.
Red, swollen, painful rash displayed within a day after the 2nd Moderna vaccine dose. This also happened approx 7-8 days after the 1st dose. It didn't take as long to appear after the 2nd dose and is much more swollen and painful.
"felt like has cold"; increase in daily allergies; Fatigue; Headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS ("felt like has cold"), HYPERSENSITIVITY (increase in daily allergies), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Sore Arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergy (Daily allergies.). Concomitant products included IBUPROFEN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), FLUOXETINE HYDROCHLORIDE (PROZAC) and BENZONATATE (TESSALON) for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced MYALGIA (Sore Arm). On an unknown date, the patient experienced NASOPHARYNGITIS ("felt like has cold"), HYPERSENSITIVITY (increase in daily allergies), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, NASOPHARYNGITIS ("felt like has cold"), HYPERSENSITIVITY (increase in daily allergies), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.             Concomitant drug included high blood pressure pills. Treatment medication was not reported.  No adverse event was reported after dose 1.   This case was linked to MOD-2021-258007 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up was received patient email address was added, AE  sore arm was added after first shot
21 weeks pregnant, estimated date of delivery: 01/29/2022 The day after the shot: sore arm, headache, fatigue, general unwell feeling, nausea 3rd day after the shot: diarrhoea, nausea
Patient experienced numbness and tingling in both hands and feet 1 day post vaccination. Symptoms lasted one week. No treatment. Patient reports no longer having the numbness and tingling in hands and feet.
pt recv vax 28OCT98 pt exp swollen glands, h/a, fever & achiness;
Flushing/Sweating, dizziness; BP 157/93; HR 77 RR 17
reports frontal headache, leg aches, hot flashes w/o fever, nausea, dizziness all improved with rest and gone by the next day
Dizziness, trouble breathing, wheezing, chills, coughing, pain at injection site, nausea & vomiting
Information has been received from a female nurse in her early 20's who was vaccinated (date, site and route not reported) with Gardasil (lot # not reported).  There was no concomitant medication.  The nurse experienced bleeding, severe cramping and back pain.  She completed the series, but it was not specified if the experience was after each dose or if it was after a specific dose.  The nurse received unspecified medical attention.  At the time of this report, the patient was recovering.  Additional information has been requested.
Fever, chills, fatigue, headache developed on 1/28/21 after receiving 2nd Moderna vaccine.  1/29/21 began vomiting.  1/29/21 treated in the emergency department for dehydration and hypotension.
The patient received the vaccine on 11/15/2018. On 11/17/2018, he returned to the pharmacy to report that he had been seen at Urgent Care for redness in his right arm that started at the injection and extended all the way down his arm. Urgent Care diagnosed him with cellulitis and gave him antibiotics (pt did not know what antibiotic he was given).
Pt presented to the ER with c/o of fever and worsening 12 x 5 cm area of faint erythema over the right deltoid x 2 days, just inferior to a small echymosis from  vaccine site. The vaccine site and the anterior half of the red patch is markedly tender, but there no induration or fluctuance. No extremity edema noted. Pt diagnosed with cellulitis and admitted to hospital for IV vancomycin and IV UNASYN. Cellulitis improved over the course of the 6 day hospitalization, without developing an abscess. Anticipated DC to home on 11.07.17.
This case was reported by a physician and described the occurrence of total body rigidity in a male subject of unspecified age who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ENGERIX B pediatric (unknown injection site and batch number). At an unspecified time after vaccination with ENGERIX B pediatric, the subject experienced total body rigidity and high fever. At the time of reporting, the outcome of the events were unspecified.
Arm swelled down to elbow, redness went around arm and down to elbow, started next morning. Mother giving Benadryl, still has redness and some swelling on 1/2/07. On Prednisone per Emergency Room doctor.
Loss of taste of anything sweet; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via unspecified route of administration in the left arm at 15:45 on 27Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Patient was allergic to penicillin. The concomitant medications included iron (MANUFACTURER UNKNOWN) and b12 (MANUFACTURER UNKNOWN). The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6198) at 15:00 left arm on 06Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021 at 20:00, patient felt loss of taste of anything sweet. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of the event loss of taste of anything sweet was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, Palpitations, HYPERtension, Tachycardia, flushed Narrative:
PATIENT HAS RAISED RED BUMP THAT IS HOT TO TOUCH AND GETTING LARGER, SHE IS MARKING WITH A PEN
A few bruises on my arms 2-3 days later. Blood test showed my platelets were fine.  10 days after the vaccine, hard lumps started developing on my joints (knees, wrists, hands, ankles and feet). They are still growing and now in my shoulders and elbows too. Not painful, just uncomfortable at times. Feeling restrictions in my knees and wrists.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with the first and second doses of GARDASIL (lot number, expiry date, route and site not reported) on 16-FEB-2011 and 14-mAR-2013 respectively. No adverse symptoms reported. The outcome was unknown. The same event of the twin of the patient was captured in MARRS # 1303USA007957. Additional information has been requested.
After over 5 years without periods (nexplanon user), I had a heavy period with cramping 2 weeks after the injection. My nexplanon is fresh (April 2021) so based on my personal history with the nexplanon it should be completely suppressing my periods at this time.
it was like having a brain hemorrhage; headache; fever; couldn't focus on anything; Random thoughts were coming and the patient couldn't stop; It didn't feel good at all; This is a spontaneous report received from non-contactable reporter (consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single, Manufacturer unknown, Batch/Lot number: unknown), for COVID-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown," described as "it was like having a brain hemorrhage;" HEADACHE (non-serious) with onset 2021, outcome "unknown," described as "headache;" PYREXIA (non-serious) with onset 2021, outcome "unknown," described as "fever;" DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "unknown," described as "couldn't focus on anything;" INTRUSIVE THOUGHTS (non-serious) with onset 2021, outcome "unknown," described as "Random thoughts were coming and the patient couldn't stop;" and MALAISE (non-serious) with onset 2021, outcome "unknown," described as "It didn't feel good at all." It was further reported that the patient took 2nd dose of the Pfizer-BioNTech vaccine. There was a severe headache with fever for more than 24 hours (hr). It was like having a brain haemorrhage and the patient couldn't even focus on anything; random thoughts were coming and the patient couldn't stop. It didn't feel good at all.  The batch/lot number for BNT162B2 was not provided and will be requested during follow up.
Hives and heart palpitations after third dose of rabies vaccine.  Hives started after third dose and palpitations began off and on for 1 week following first dose.  Treated with Tagamet, Methylpred, Atixan.
No adverse reaction reported. Patient received a booster dose of primary series formulation when he should have received the updated bivalent booster
A non-serious spontaneous report of gave H1N1 LAIV to person >49 years old was received from a registered nurse/healthcare professional concerning a 60-year-old female. No relevant medical history was reported for this patient. On 23-Nov-2009 the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Received the first vaccine 3/31/21 but never got the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the first vaccine 3/31/21 but never got the second) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first vaccine 3/31/21 but never got the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the first vaccine 3/31/21 but never got the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details provided.   Reporter did not allow further contact
Within 2 days pt, previously well, developed 5x8 cm red, warm rash at injection site, (L) deltoid. Also, viral syndrome with F to 102, chills, weak, vomited x one & poor appetite.
Patient given COVID J&J vaccine and within a minute complained of being dizzy/faint. While seated, patient fainted, eyes rolled, arms and hands clonic/tonic activity which caused him to fall from chair. Doctor was able to hold on to upper back of patient as both fell to the floor. Patient hit head on carpet with not traumatic injury. 911 was called and by time of paramedic arrival the patient was alert and oriented. Patient was assited to wheelchair and taken to ED for evaluation.