chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received an expired HAVRIX; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAV (Havrix 1440 adult) (batch number EK59B, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th March 2022, the patient received Havrix 1440 adult (intramuscular) and Havrix Pre-Filled Syringe Device. On 4th March 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, a patient received an expired Havrix vaccine in right arm, which led to expired vaccine used. The reporter wanted to know what to do about this situation. The reporter also stated that, the patient had not been informed that they have received an expired vaccine. Spoke from content and warm transferred call to Medical Information. Provided phone number for future reference. The reporter consented to follow up.
Pain in right arm from day shot was given through till three separate doctor's visits, including 2 rounds of antibiotics and 6 day steroids. Flu shot required by employer. Slight fever 11/19/13.
Left arm pain that moved to shoulder and neck by the end of day two.   Tylenol every four hours and cold packs for treatment. No relief from either. Tightness in neck getting worse.
Large fever blisters on both upper and lower lips started one week after vax.  Pt was prescribed Valtrex to help with blisters.  Pt stated she had the influenza and Shingrex vax at the same time. Pt had 2nd dose of the Shingrix vax on 12/31/2020 and 3 days later had a major episode w/ more fever blisters.  Pt was prescribed more Valtrex and was told to take it 2 X daily.  Pt states she still has the blisters and has to take the Valtrex daily to control it.
4 days after vaccination I developed a rash that looks like eczema at these locations: - right neck and ear - right hand over thumb between pinky fingers - back of upper left leg - genital
After does 1 Moderna vaccine mild sore arm for 1 day. 10 D after Moderna 1st dose he developed total body pruritus. no other sx. 14 days after vaccine he developed total body hives without other sx for 1 day. No hives for next 3 days. Then recurrent hives on upper limbs. 2nd vaccine dose was postponed. 4 week after 1st vaccine he developed hives UE and bilateral sides of trunk.  He has had hives about 6 days/week and 30% of time it is total body. He takes 4 claritin and 4 zyrtec daily without much effect. 4/29 he had second moderna vaccine and that night had T102 and was in bed for 12 hours. FEver broke at 6am this morning 4/30 and he has not had hives today.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: 6H9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3246), on 09Feb2021 as dose 2, single (Lot number: EL9262), on 24Sep2021 as dose 3 (booster), single (Lot number: FF3587) and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4489) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Erosive osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Allergy"; Morphine, reaction(s): "headaches". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Mar2023) negative; (26Mar2023) negative; (29Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included Paxlovid from 20Mar2023 to 24Mar2023, lot number 2707493.
Observation 9/15/22-9/17/22 N/V/D, abd pain, weak, fatigue, dysuria,
103 fever, body aches, chills beginning 02/26 11am. These symptoms continued on 02/27 and 2/28. Went to urgent care on 03/1 for continuing symptoms. No diagnosis. Symptoms continued and a mild cough developed. Returned to urgent care on 3/2. Diagnosed with bacterial pneumonia on 3/2 after chest X-ray. Started doxycycline. 103 fever, chills, and body aches continued on 3/3 with O2 levels dipping to 92, referred to the ER by urgent care on 3/3. Augmentin added to treatment by ER. Fever, chills, and body aches abated on 3/5.
Patient was given a lower than authorized dose of Moderna bivalent vaccine; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was given a lower than authorized dose of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient was uncompromised.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was given a lower than authorized dose of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was given a lower than authorized dose of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was given a lower than authorized dose of Moderna bivalent vaccine).    No concomitant medications were reported.  It was reported that the patient was administered an invalid dose of Moderna COVID-19 vaccine bivalent booster dose. The nurse had no standing order other than what they had while administering the second booster dose, during administration of bivalent booster doses, so they assumed the dosing to be same dose as second booster doses and hence administered 0.25mL to uncompromised adult patient.  It was reported that CDC had recommended to re-vaccinate the patient with a full dose of 0.5 ml.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case, same reporter
Tingling lips, left arm and hand, welts/hives at site of injection (left arm). Patient took Benadryl.
Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax. The patient developed an upper respiratory infection after vaccination. At the time of report the patient was recovered. Additional information has been requested.
Patient called office today and stated yesterday afternoon, he developed a few small blisters on the dorsal aspects of both hands. Blisters are not itchy or painful. He stated he did a lot of yardwork yesterday. No signs of anaphylaxis present. Otherwise feeling fine. No chest pain, dyspnea, syncope, swelling.
I am having uncomfortable cramping on the right side of my ovaries.  This has happened about two hours after my second shot (11/8/21). The right side of my ovaries is having a cramp and pulsing feeling, it is extremely uncomfortable that I need to be sitting at work.  I am a healthy, 33-year-old with regular periods.  It is 2:00 pm on  11/9/21 and the pain is still happening.  I am planning on calling the doctor if continuing for 24 hours.
Blood clot removed 10/12/2021, started as a small lump.  Initial doctor appointment 8/30/2021. Mass left side of leg.
felt very foggy, almost cloudy; my skin turned bright red and very hot to the touch; my skin turned bright red and very hot to the touch; heart started to race; blood pressure was very high; throat was itchy as well as my whole body from like the inside out; throat was itchy as well as my whole body from like the inside out; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 42-year-old administered in Arm Right on 01Apr2021 13:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included svt (supraventricular tachycardia), mvp (mitral valve prolapse), high blood pressure, anxiety, known allergies: yes. Concomitant reported as the patient received unspecified drug within 2 weeks of vaccination. On 01Apr2021 13:00, within 20 seconds of receiving the vaccine, the patient felt very foggy, almost cloudy, her skin turned bright red and very hot to the touch, her heart started to race, they called an ambulance her blood pressure was very high but her o2 was at 98 despite the fact that her throat was itchy as well as her whole body from like the inside out. Events caused patient visit emergency room/department or urgent care. Events were treated with monitoring and allergy medication. The outcome of the events was recovered. The patient is not pregnant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, the causal association between the events feeling abnormal, erythema, feeling hot, palpitation, hypertension, pruritus, throat irritation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
2 hour infection right thigh of breast feeding mom, who's husband was immunized on 5/7/03 with vaccinia vaccine.
Patient had a fall at home and CT of her lumbar spine noting hydronephrosis, hydroureter and perinephric fat stranding.  Subsequently admitted 4/8/2021 for pyelonephritis two days after left renal lithotripsy with basket extraction and left stent. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
- numbness in elbow and through to the fingers - short term memory loss - slight slurring of words - slightly incoherent....trouble putting all words of sentence together/forgetting words to use in a sentence - trouble recalling relevant information - briefly forgot sons name - disoriented for several days - muscle fatigue and low energy
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 30Oct2021 as dose 2 (booster), single (Lot number: EW0173), in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 05Apr2021 as dose 1, single (Lot number: 041A21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Multiple days of negative RAT; (22May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Patient received second shot of COVID vaccine on 12/9/2021.  Patient experienced COVID-like illness on 11/25/2021.  Patient experienced onset of MIS-C on 12/25/2021.  Patient experienced shock, hypotension, elevated troponin, elevated NT-proBNP, cough, elevated d-dimers, thrombocytopenia, abdominal pain, elevated liver enzymes, rash, altered mental state, myalgia, and periorbital edema.
Arm aches for the first 4-5 days after the shot. I also have had body aches ever since I got my vaccine on 12/6/21. It feels like I constantly need to stretch, and it seems to get worse as I try and fall asleep. It often takes me hours to fall asleep.
Debilitating fatigue for 4 days, which occurred beginning at a progressively later hour of the day each day. Runny nose for one week. Low-grade fever 100.1 that lasted for several days.
Noticable rash and discomfort after first innoculation and severe reaction after second innoculation.  Minimizing allergic reaction required multiple visits to the clinic and multiple persciptions.  (Note of interest:  this patients child almost died after second Hep B innoculation and was granted a school waiver for the third shot in the series).
Psoriasis flare - scalp  Psoriasis flare - white spots on lower legs
Patient complained of headache and nausea. Nausea resolved on 10/09/10 and headache resolved on 10/11/10. Patient then states a few days later small bumps (hives?) appeared on wrist and have subsequently spread to other parts of her body. Patient saw CNP on 10/29/10 and was prescribed antihistimines. CNP prescribed steroid dose pak on 11/1/10.
Isolated redness, itching, swelling and radiating heat from injection site 7 days post injection
SOB, Chest tightness. Facial tingling, light-headedness. Narrative:  Seen in ER for SOB and chest tightness will follow up with PCP 1/26/21. Given Ventolin inhaler- use every 6 hours. Rapid COVID test on 1/13/21 negative. Reports facial tingling and light-headedness that is intermittent
headache (not migraine) and ear ringing began about 20 hours after my second shot, had extreme arm pain as well with both shots. The ear ringing is constant and loud and hasn't stopped since the day after shot 2. The headache seems to come and go.
destroyed my immune system / near killed me; This case was reported by a consumer via interactive digital media and described the occurrence of immune system disorder in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced immune system disorder. On an unknown date, the outcome of the immune system disorder was unknown.   It was unknown if the reporter considered the immune system disorder to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Influenza vaccine, the patient experienced immune system disorder.
pt got hives so bad could not go to school; eyes swelled shut lips swelled so bad could not talk; hands swelled;
Bottom lip swelling, 1 hour after injection was given. Dad gave child Benadryl, no trouble breathing. Was ok after dose of Benadryl was not seen in ER.
made us feel very ill!; This case was reported by a consumer via interactive digital media and described the occurrence of illness in an unspecified number of patients 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 illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients received the shingles shot that made them feel very ill. The reporter stated that it was better than getting shingles. This case was linked with US2021AMR196890, reporter by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196879:same reporter (reporter case)
Received shot on Thursday, 10/6/05.  Awoke on Sat with generalized muscle and joint aches, sinus congestion, sore throat, ear ache.  Did not have a fever. Stayed in bed all day and took acetaminophen.  Felt somewhat better on Sunday and recovered on Monday.
menstrual cycle every month and was supposed to start on 27Dec and still has not had her menstrual cycle as of 01Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Dec2021, outcome "not recovered", described as "menstrual cycle every month and was supposed to start on 27Dec and still has not had her menstrual cycle as of 01Jan2022".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt says he developed a rash on both legs that looks like chicken pox.  The rash is on the front and back of both legs below the knees.  Pt says it is not spreading and has not seen a health care provider yet.
Loss of taste; This is a spontaneous report from a non-contactable consumer reporting for herself. A 36-year-old female patient received the 1st  dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EL3247), via an unspecified route of administration in the right arm, on 21Jan2021 at 08:00, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced loss of taste on 21Jan2021 at 18:15 with outcome of recovered in Jan2021. No therapeutic measures were taken as a result of the event. Patient did not have COVID-19 prior to vaccination, and was not tested for COVID-19 after vaccination.  No follow-up attempts are possible. No further information is expected.
Within 24 hours of injection erythema was noted. Area of erythema spread became irregular in shape and warm to touch.
This case was reported by a consumer and described the occurrence of arthritis in a 62 year old male pt who received Lyme disease vaccine recombinant (Lymerix). A physician or other health care professional has not verified this report. The pt's past medical history included hay fever. Concurrent medications included Advil. On an unspecified date in Jul2002, the pt received the third dose of Lymerix. At an unspecified time following the third administration of Lymerix, the pt experienced arthritis. The pt also developed Lyme disease and did not respond to the vaccination series with Lymerix. The pt seen by a physician. The events were unresolved.
As with each dose of the Moderna, my arm became sore within minutes of receiving it. With the Booster, by 9:00 p.m. my arm became very, very sore/painful, the entire outside area of my arm, from the injection site to almost my elbow area, became swollen, red and blotchy, and very warm to the touch. It is now approximately 45 hours after receiving the Booster and there has not been any improvement.  As far as the Lot # of the Booster given to me at the Pharmacy, you may need to contact them for the correct number.  On my Covid vaccination card the number is illegible so the Lot # I have listed is only what it looked like to me.
Headache, Myalgia, Fever, NauseaVomiting,  injection site pain, low grade fever
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. ON 17-MAR-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Induration & erythema at injection sites. Plan: KEFLEX 250mg QID x 5 days, warm compresses.
Patient was hospitalized with COVID-19 infection following first vaccination.  Patient had a positive COVID test on 3/1 (10 days after 1st COVID vaccination) and presented to ED on 3/2 with fever, chills, weakness, dyspnea.  In ED, patient was noted to be afebrile, non-tachycardic, tachypneic, hypoxic at 88% on room air,  and hypotensive.  Diagnosed with acute hypoxic respiratory failure.   Influenza A&B were negative.  Patient did receive convalescent plasma on 3/3/21 and 3/8/21.  Patient also received 5 days of Remdesivir therapy (started on 3/8/21).  Pulmonary embolism was ruled out during hospital stay.  Patient was discharged on 3/16/21 to rehab hospital.
I started to experience symptoms of a sore throat. I didn't think much of it because I was doing a lot of running around. I started to develop a runny nose and a cough a day later. I tested for COVID-19 and the test came back positive. I also started to experience lower back pain and a headache that went from the base of my neck to the top of my head. I went to an urgent care because of the back pain and headache that I was experiencing. I felt that there was more than the virus that was causing this pain. They found an unspecified acute sinusitis and hypertension. I was given amoxicillin and cough medicine with codeine for the sinusitis. I also experienced two spells of fainting and vomiting following dizziness.
Local site reaction, headache, feeling bad. Lasted 2 day. Resolved now.
Patient was administered 0.25ml of the adult Pfizer Bivalent. Patient was not given the appropriate dose of 0.2ml of Pediatric Pfizer. There was not any side effects or issues of concern with medication error. Patient was notified when error occurred and followed up on 5 days later. No issues to report, or any addition med/follow up required.
12JUL95 was @ beach 15mins when pt had sz; taken to ER fever 104, swollen glands, ears red, throat red, cutting 4 molars; had f/u visit w/MD to have EEG