chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positive for COVID-19 on 13-Jul-2022.; Patient tested positive for COVID-19 on 13-Jul-2022.; fever; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 20Dec2021 as dose 3 (booster), single (Lot number: FL3197) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves Disease" (unspecified if ongoing); "Hyperthyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "not recovered" and all described as "Patient tested positive for COVID-19 on 13-Jul-2022."; PAIN (non-serious) with onset 13Jul2022, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 13Jul2022, outcome "not recovered"; PYREXIA (non-serious) with onset 13Jul2022, outcome "not recovered", described as "fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Flowflex COVID test Lab Notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19, pyrexia, chills, pain.  Clinical Information: Patient tested positive for COVID-19 on 13Jul2022. Symptoms include fever, chills, body aches. No other vaccine in four weeks. AE treatment: Tylenol. No covid prior vaccination and tested covid post vaccination. Other medical history: Graves Disease, Hyperthyroidism.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 hours after vaccination, about 1100 on 10/14/10, severe migraine began felt like face was on fire. Reports at 1600 had seizure, mom & grandmother present nosebleed that noc. Visit to ER about 2200. DC from ER at 0300. Fever of 100 degrees. ER reports unsure if vaccine related. At home nosebleed at times when blowing nose. Hx of past seizures x 3.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JAN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the excursion was 32, 33 and R. This is one of several reports received from the same source. Additional information has been requested.
Was currently w/hospice care. 5/25/2021 exhibited symptoms nausea/emesis. Seen by MD. Treated for symptoms. continued to decline consistent w/ dx. End of life care with nitro prn, oxygen continued and emotional support followed and he expired 5/27/2021 at facility.
Patient reports pain at injection site immediately post-injection at Lt deltoid. Pain progresses over next wk and at I saw patient on 12/7/10 with decreased ROM L) shoulder. Treatment OTC Ibuprofen or TYLENOL prn. Prednisone 5 dosepak x 5 d and sample.
vulvar pain and the presence of ulcers on the labia minora; arm pain at the site of injection; This is a literature report.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "post-menarchal female" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, single), for COVID-19 Immunisation. The following information was reported: VULVAL ULCERATION (medically significant), outcome "recovered", described as "vulvar pain and the presence of ulcers on the labia minora"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "arm pain at the site of injection". The patient underwent the following laboratory tests and procedures: Culture: Negative; Positive, notes: for Staphylococcus aureus; Cytomegalovirus test: unknown result, notes: were ordered but not obtained by the patient; Epstein bar virus: unknown result, notes: were ordered but not obtained by the patient; Polymerase chain reaction: Negative. Therapeutic measures were taken as a result of vulval ulceration, vaccination site pain. She was started on methylprednisolone for seven days and ibuprofen and later with amoxicillin.  Clinical course: The patient developed fevers and arm pain at the site of injection one day after receiving the second dose of the Pfizer-BioNTech COVID-19 Vaccine, followed by vulvar pain and the presence of ulcers on the labia minora. A genital culture was positive for Staphylococcus aureus and she subsequently started amoxicillin. A herpes simplex virus (HSV) polymerase chain reaction (PCR) test and fungal culture were negative. Cytomegalovirus (CMV) and epstein bar virus (EBV) titers were ordered but not obtained by the patient. Full resolution of the ulcers and symptoms were noted at follow-up on day 20.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event VULVAL ULCERATION and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201104494 Same Article/Drug/event and different patient;US-PFIZER INC-202201104493 Same Article/Drug/event and different patient;
Information ha been received from a physician concerning an unspecified patient (age and gender not provided), who was vaccinated with ZOSTAVAX (date of vaccination, dosage, and route of administration not provided). On an unspecified date, the patient developed shingles. The outcome of the shingles was not provided. No additional information currently available. This is one of two reports from this physician (see case # 1412USA000930). Additional information has been requested.
Fever 103 that would not common down with Tylenol or motrin (for 48 hours). Severe body aches - handle of coffee mug hurt hand too bad to hold to drink hot tea. Severe chills, severe headache, severe nausea, severe fatigue, dizziness .
Myalgia; overwhelming fatigue; injection site pain and swelling; injection site pain and swelling; This is a spontaneous report from a contactable physician, the patient.  A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek4176, via an unspecified route of administration on 08Jan2021 at 08:30 (at the age of 30 years old) as a single dose in the right arm for COVID-19 vaccination.  Medical history included attention deficit hyperactivity disorder, gastritis, and hiatal hernia all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included spironolactone, ethinylestradiol, norgestimate (SPRINTEC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), and 'dexylan', all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of  BNT162B2, lot number: Eh9899 on 18Dec2020 at 10:00 AM in the right arm. The vaccine was given at a Public Health Clinic. On 09Jan2021 at 12:00AM, the patient experienced myalgia, overwhelming fatigue, injection site pain and swelling. The patient did not receive treatment for the events. The clinical outcome of myalgia, overwhelming fatigue, injection site pain and swelling was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
C/O TROUBLE BREATHING/CHEST DISCOMFORT, PROVIDED WATER AND SNACK, SYMPTOMS RESOLVED, REFUSED TRANSPORT, AMA SIGNED.
24OCT97 devel rash p/exposure to chickenpox;rash typical of chickenpox;had recv vax 23JUL96;
4JAN97 pt w/jaundice, scaler icterus, fatigue, malaise & anorexia;neither liver no spleen was enlarged;total bilirubin was 8.1 4JAN97;MD felt poss EBV infect;dx havrix rxn though unlikely, status post EBV infect;Gilbert's synd;
This was my second vaccination: Fever 101.5 degrees for 36 hours, bad body aches, joint pains, felt like I had the flu. First vaccination 3 months before the same symptoms lasted for 3 full days.
4/17 Itchy abdomen  4/18 Nausea feeling 4/19 Abdominal pain  with more severe abdominal pain on the right side followed by itchy rash & blisters on the abdomen & back.  4/20 Severe rash in abdomen & back with severe abdominal pain & cramps. 4/22  Diagnosed with Shingles.
constant ear infection; This is a spontaneous report from a contactable consumer (Parent). A 12-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Right Arm on 16Jun2021 for COVID-19 immunization (The patient age at the vaccination is 12-years-old). The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccination included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not eported), dose 1 via an unspecified route of administration, at unknown anatomical location on unknown date for COVID-19 immunization.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient  did not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. The patient experienced constant ear infection on 21Jun2021. Antibiotics were taken as a result of constant ear infection. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
patient stated 15 minutes after covid 19 vaccine that her heart was racing. I brought her into the counseling room and took her blood pressure. Blood pressure was 185/122 at 4:00pm. Patient stated she felt anxious but had no other symptoms. I asked her to remain for observation and retook her blood pressure with an alternate unit at 4:30pm. blood pressure at 4:30pm was 190/101. patient stated her normal blood pressure is 130/80, Her doctor was contacted and stated he did not feel the her high blood pressure was a result of the vaccine. He asked he to monitor it every 2 hours over the evening and report back to him but she was ok to leave the pharmacy.
Patient came to the vaccination clinic and received her 2nd Moderna vaccine on 11/23/21.  The patient had self-scheduled the appointment online.  The patient had received her 1st Moderna vaccine on 11/2/21.  The timing of the 2nd dose given was only 21 days after her first Moderna vaccine and not the minimum 28-day interval.  Have called the patient three times, left 2 voicemails with contact information.  Emailed patient to contact Health Center regarding the interval error.  Pt called the Health Center back on 12/1/21.  Pt states she will be out of town at the 28 day window for the additional dose.  She states she will call the Health Center back when she arrives back in town to schedule her dose.
first vaccine- my period came more a week early; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: POLYMENORRHOEA (non-serious), outcome "not recovered", described as "first vaccine- my period came more a week early". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of polymenorrhoea  Patient did not receive other vaccine in four weeks. Other medications in two weeks were none. Patient had not received covid vaccine prior to vaccination. The patient had not received any other vaccines ,The patient had covid test date: 29Apr2021, The patient had Nasal Swab test with result Negative. Patient sates period came more a week early, 2nd vaccine patient still waiting to start period over 2 weeks  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Given Pediarix instead of TDAP-IPV-HEP-B; inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number IN259, expiry date 5th October 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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, the 14 years old patient received dose of Pediarix instead of the combo TDAP-IPV-HEP-B, which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Sporadic itching for about a week throughout body. No redness, hives or rash
A few minutes after receiving the vaccine, the patient said he though he was having a reaction.  He said that he was dizzy and that is vision was blurred.  He started sweating profusely and said he felt like he was going to pass out.  His blood pressure was 78/67 which is stated was very unusual.  His blood sugar was 136.  He continued to sweat profusely and said that his hands and fingers were tingling.  We called for an EMT to come check him out.  When the EMT arrived his blood pressure was back up within normal range and he was filling much better.  The patient stayed at the pharmacy until he felt fully recovered.
patient had a vaso-vagel episode /vital signs checked/ po fluids given/patient discharged to home  after approx 30 minutes
Headache, brain fog, forgetfulness, fever, fatigue, nausea, weakness, neck and back pain, not seeing clear, ringing in ears, dehydration, high blood pressure, dizzy, hard to catch my breath, sweating through clothes at night, body ache.
Feels bad; Diagnosed with Covid-19; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 1st dose of Shingrix. On 02-MAR-2023, between 1 and 3 months after receiving Shingrix, the patient experienced covid-19 (Verbatim: Diagnosed with Covid-19). On an unknown date, the patient experienced feeling bad (Verbatim: Feels bad). The outcome of the feeling bad and covid-19 were unknown.   It was unknown if the reporter considered the feeling bad and covid-19 to be related to Shingrix.     It was unknown if the company considered the feeling bad and covid-19 to be related to Shingrix.   Linked case(s) involving the same patient:  US2023046077   Additional Information: GSK Receipt date: 27-MAR-2023 The patient felt really bad with 1st shot of Shingrix. The patient did not provide any details about adverse reactions after the 1st dose of Shingrix, and reported that she received the dose of Shingrix in January 2023 (she did not have an exact date). The patient also reported that she was diagnosed with COVID. The reporter did not consent to follow-up. The patient said safety could follow up with her pharmacy if necessary. For tolerance to the 2nd dose refer case US2023AMR046548.; Sender's Comments:  US-GSK-US2023046077:Same reporter
Case number PHEH2015US022365, is an initial spontaneous report received from nurse on 29 Oct 2015. This report refers to a 29 year old female patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUVIRIN (batch number: 1515101) at a dose of 0.5ml subcutaneously on 21 Oct 2015. On the same day after vaccination patient had an injection site reaction. Outcome of the events was reported as unknown. Events were reported to be non-serious and causality of the events was not reported.
lethargy; felt tired; This is a spontaneous report from a non-contactable consumer for herself. A 45-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 09Jan2021 via an unspecified route of administration at SINGLE DOSE for COVID-19 Immunization in the hospital. The patient's medical history and concomitant medications were not reporter. The allergies to medications, food, or other products were unknown. The patient was not pregnant at the time of vaccination. It was unknown if the patient has been tested positive for COVID-19 and if the patient was tested positive since vaccination. On 09Jan2021 the patient felt tired, lethargic all weekend. The events assessed as non-serious by the reporter. The patient did not receive any treatment. The outcome of the events was recovered on an unspecified date of Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
LARGE ASYMMETRICAL MARK AROUND INJECTION SITE DEVELOPED DAYS 5-6 AFTER INJECTION.  NOT PAINFUL--LASTED 4 DAYS
Vaccine administered past published expiration date. Contacted Moderna, received this communication:The vaccine administered on November 10, 2021 and November 15, 2021 from lot number 046C21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration,? therefore there is no need for revaccination.
48 hr of vaccine had rash @ site of inject-then developed overall rash? Erytheos multiforms discussed over telephone /w MD 31Mar91-Pt seen in ofc 1Apr91
have been suffering with some form of warts on the cuticles of both of my thumbnails for 12 to 15 years/Now, 6 months after your vaccine they are GONE; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Warts on the cuticles of both of my thumbnails" (unspecified if ongoing), notes: warts on the cuticles of both of my thumbnails for 12 to 15 years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "have been suffering with some form of warts on the cuticles of both of my thumbnails for 12 to 15 years/Now, 6 months after your vaccine they are GONE".  Additional information: Patient had visited many dermatologist with injections, freezings and medications to no avail. These warts were very painful with drying, cracking and bleeding. Now, 6 months after your vaccine they are gone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
While administering, some of the liquid came out of syringe (between the syringe and needle attachment). Unknown volume lost during administration.
Felt heaviness/weight on chest, difficulty breathing around midnight on 10/30/21 - had been having "palpitations" for a couple weeks prior; felt same symptoms around 3:30am on same day. Contacted PCP who referred for a stress test and holter monitor. Failed both tests, so referred to a cardiologist. Had appointment on 11/18/21, and cardiologist performed heart catheterization on 12/14/21. Final impression: 1. Nonobstructive CAD with 30% proximal LAD plaquing, otherwise patent coronary arteries 2. Mildly elevated LV filling pressures, with LVEDP of 20 mmHg 3. Normal LV systolic function, with LVEF of 55% by LV gram  Increased atorvastatin from 10mg/day to 40mg/day. Also had carotid doppler ultrasound on 1/14/22 - final impression: right carotid vasculature - fibrous plaque at the proximal ICA results in a less than 50% stenosis; left carotid vasculature - fibrous plaque at the proximal ICA results in a less than 50% stenosis; vertebral arteries - antegrade flow is seen at the bilateral vertebral arteries.
Pt recv vax on 12/28/98; on 1/7/99 pt exp nausea, light headedness, chills, diarrhea, hyperventilation, numb hands/face/ legs; stiff neck, headache; tx=Ibuprofen; pt imp 1/12/99
I lost my sense of taste and was very fatigued, a month later I contacted my doctor. I took a COVID-19 test and it was negative. I was put on medication for Thrush and have an upcoming appt with an EMT to do a culture. As far as we know it didn't have anything to do with COVID-19.
Pt was well w/no s/s illness when recvd vax; no fever p/vax on the 3rd day post vax pt devel pneumonia & was hospitalized for 3 days; mom said MD thought pt reacted to HIB vax;
This case was reported by a healthcare professional and described the occurrence of acute renal failure in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 18 September 2008 the subject received 3rd dose of ENGERIX B at 0.5 ml in the left arm. On 02 October 2008, the subject began to complain of lower abdominal pain and was diagnosed with a hernia at a walk in clinic. On 06 October 2008, the subject continued to feel ill and was sent to the emergency room. From that day on, the subject has been hospitalized. The reporter also considered the events disabling, life threatening and clinically significant (or requiring intervention). Additional symptoms experienced by the subject included acute renal failure, stomach pain, platelets decreased, joint pain, lower abdominal pain, hernia, feeling unwell, headache, insomnia, diarrhea, vomiting, loss of appetite, weakness, chills, nausea, stomach cramps and petechiae. The subject was treated with blood transfusion. At the time of reporting the outcome of the events was unspecified.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 30-JUL-2014 the patient inadvertently received a dose of (Oka/Merck) VARIVAX (lot # unknown, 0.5 ml, subcutaneous) and a dose of (Oka/Merck) PROQUAD (lot #, strength, dosage and route). No symptoms reported. The outcome of the event was unknown. Additional information has been requested.
Bell's palsy 4/08 and 12/08 (Not certain vaccine related - Pt concerned and asked for it to be reported