chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up on the morning of the 06/15/2022 with a really bad headache and sinus pressure. So I had a over the counter test that I administered and it tested positive. I quarantined on a ship for 5 days that I was on. When I got off the ship I stayed in a hotel and then went to a urgent care who recommended I go to the hospital to get PAXLOVID. I got it filled at the hospital and took the PAXLOVID for 5 days. After 11 days I finally tested negative. After the first 3 days my symptoms went away. I haven't had any problems since.
Pt recvd 2 doses of Engerix-B 6MAY91, 4JUN91 & 11NOV91 exp burning while inject was given which cont for a few hrs; Reporter indicated that 3 doses of Engerix-B were given 12NOV91 (?11NOV91);
Brief episode syncope. Patient felt nauseated, knelt to floor from chair and passed out; no injury noted, stable BP after rest.
Information has been received from a registered nurse concerning a female with an allergy to PCN who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live as a child.  It was noted that a titer done this summer was negative.  No further information was available regarding the adverse event.  It was reported that the adverse event did not improve and the patient is not recovered.  There was no  product quality complaint reported.  The patient sought unspecified medical attention.  Additional information has been requested.
Pt came in to receive 12 y/o immunizations (TDAP and Meningococcal) and HPV vaccines. Pt then received HPV, TDAP, and Pentacel.  Pt came back on 8/6/21 to receive meningococcal.
Post-injection patient complained of feeling hot, ill, & that tongue was tingling & tarty.  Lying supine.  Patient is diabetic.  She had not administered her insulin dose prior to eating lunch, but she ate a normal meal.  Checked her heart rate & it was rapid at 120 bpm. Called 911 since patient kept stating feeling ill & that her tongue was tingling.  Patient then mentioned that she feels like this whenever her blood sugars are high.  Instructed patient to check blood sugar & her level was 329.  Advised her to give insulin & she did.  Her heart rate almost went down immediately to 96 bpm.  She began to feel better when emergency personnel arrived.  Her blood sugar decreased & her heart rate dropped to 80 bpm.  Patient refused emergency treatment & signed a waiver of release & did not go to hospital.  Bouts occurred around 3pm on 11-13-07.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 78-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history included: "Shortness of breath when walking" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid Treatment from 05Sep2023 to 09Sep2023.   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.; Sender's Comments: Based on the information provided in the narrative and known drug safety profile, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300305506 same patient, same product, different dose/events;
9:00 PM - Extreme fatigue 10:00 PM -  Weakness and headache, Body aches 10:05 PM - Took Ibuprofen and drank water 11:30 PM - Chills with Tremors 11:35 PM - Covered self with many layers of blankets, chills and tremors persisted 04:00 AM - Fever 8:00 AM - Deviation between Chills and Fever
chills; fever; 7 patients received Pfizer Covid vaccine, out of temperature range; 7 patients received Pfizer Covid vaccine, out of temperature range; This is a spontaneous report from a contactable pharmacist. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207; Expiration Date: Jul2021), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patients received vaccine, that was out of temperature range, where, pharmacist miscalculated the time for temperature storage. It was determined through the control log and the excursion information, where for first time: at 18:27 PM - 46.9 (47 )Degrees Farheneit, at 18:57PM -  47.5 F, at 20:00- 49.4 F, at 20:57-  50.5 (51 F), at 12:42- 51.8 (52 F), at 2:12 - 52.9 (53F), at 3:12 -  49.6 (50 F), at 5:42- 47.3 F, at 8:42- 48.3, at 9:57- 46.7, at 10:12- 46.3 F (16 hours out of range) and at 10:27- 45.8 F. The patient also experienced chills and fever. It was reported that patient believed that the vaccine worked for her. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021305630 Different patient, same drug, same event (split)
Pt recv vax on 2/12/99; on 2/13/99 pt exp diarrhea w/ cramping; dx=intestinal flu; tx=Pepto Bismol w/ no relief, special diet
Patient collapsed onto floor from standing about 5 minutes after his injection.   Was unresponsive for about 1 minute then came to.  Head laceration with light bleeding to the back of his head.  911 was called immediately and patient was transported to a hospital ED.
Hive like rash on arm, hard around injection site, itchy, soreness came back
From 1/6/2022 to 1/9/2022, I have experienced moderate vertigo, dizziness, nausea, and headache to the point that I have been in able to get out of bed and perform daily activities.
She has a rash on both hands that is  itchy and warm.  Looks dry as well.
This spontaneous report is received from a health care worker refers to two unspecified patients of unknown age. On 27-MAY-2014 the two unspecified patients were vaccinated with expired MMR II (lot# H010134, expiration date 17-MAY-2014, dose, frequency and route were unknown). No adverse effect was reported. Additional information is expected.
it was rpt by MD concerning a pt recv vax 7/22/98 & on 7/28/98 the mom devel 30 lesions on trunk, scalp, legs, & face. pt given acyclovir.
patient who is 17 years old and in a similar boat; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient who is 17 years old and in a similar boat) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient who is 17 years old and in a similar boat). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient who is 17 years old and in a similar boat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information were not reported. Treatment information were not reported.   This case was linked to MOD-2021-114524 (E2B Linked Report).; Sender's Comments:  MOD-2021-114524:
On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.
Patient states that on 3/18/15 evening his left arm started throbbing-came in today 3/19-left arm edematous, red, warm-Cephalexin 500mg 1 tab BID x 10 days.
Swelling immediately (with out hives) at injection site. Now 4cm indurated swelling and discomfort.
Information has been received from a nurse practitioner concerning a 2-year-old patient who on approximately 13-AUG-2007 (18 days after the adverse experience) was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). This was the first set of immunizations the child had ever received, the child is from out of the country. On 31-AUG-2007 the patient developed injection site rash. At the time of the report it was unknown if the injection site rash had resolved. Additional information has been requested.
This is a 92 y.o., male a 92 year  old male with past medical history of hypothyroidism, HTN, HLD, IBC, vitamin D deficiency, and anemia who presented with a complaint of progressive weakness in all four extremities x 2 days prior to presentation. Given concurrent absence of reflexes and progressive extremity weakness S/P recent immunization (flu shot), a 5 day course of IVIG was started and completed for a presumptive diagnosis of AIDP. As part of his evaluation, EMG/NC was remarkable for sensorimotor peripheral neuropathy with axonal an demyelinating features. No temporal dispersion or conduction block at this time, per report. A Lumbar puncture was obtained. CSF studies was not consistent with an infection so far, his HSV was also negative. The lumbar puncture was a difficult and traumatic tap with limited CSF fluid collected. We monitored his respiratory parameters with PVC/NIF Q2hrs. On 8/18/16, his respiratory status declined requiring HFNC 100% FIO2. Given that the family had requested he be intubated if needed on a temporary basis on admission despite a Postform stating otherwise, he was transferred to the ICU. However family eventually decided that the patient would not want to be intubated/trached or PEG placed. Supportive Care was consulted to facilitate the family discussion. Following a family meeting, "they agree with the option of weaning from HFNC while keeping pt comfortable with morphine." Early morning, on 10/20/16, the on call neurology resident was paged that the "patient does not have any spontaneous respirations." He was subsequently pronounced dead at 0250 on 10/20/2016.
Redness at injection site Raised, semi-swollen, red patch of skin at injection site; approximately 3? diameter.  Sore, felt like a bruise.  Hot to the touch.  Lasted two days, then subsided.
Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest upper left side. when i would shift to laying flat, pain would go away.
Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was a little sore). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore) outcome was unknown.            No concomitant medications were provided.  The patient had nothing after the first two shots of Moderna; his arm was a little sore.  No treatment medication were provided.   This case was linked to MOD-2021-363693, MOD-2021-363679 (Patient Link).
This is a spontaneous report from a Pfizer-sponsored program comScore Quant Concept Testing. A contactable consumer reported for a female patient (his/her mother) of an unspecified age and race who received PREVNAR 13 at single dose on unknown date for immunization via unspecified route. Relevant medical history and concomitant medication were unknown. The patient died of pneumonia. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected. Reported Cause(s) of Death: Died of pneumonia.
no additional adverse event; a patient was less than a full recommended dose because of needle leakage; a patient was less than a full recommended dose because of needle leakage; This spontaneous report was received from a customer referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 09-MAR-2021, a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin (rHA)) (strength and route were not provided; lot# was S039312 and expiration date was 04-DEC-2021) 1 dose with sterile diluent (strength and route were not provided; lot# was T005076 and expiration date was 04-OCT-2022) 1 dose was given to a patient, which was less than a full recommended dose for prophylaxis because of needle leakage (needle issue and underdose). No additional adverse event was reported (no adverse event).
diarrhea; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 03Feb2021 13:30 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID-19 vaccine yesterday at 13:30. She was experiencing diarrhea all day today (04Feb2021). The outcome of diarrhea was not recovered.     Follow-up attempts are completed; information about lot number cannot be obtained.
Patient came to hospital on April 23, 2021 with shortness of breath and a productive cough, very weak and debilitated. Patient was diagnosed with pneumonia and required 2 liters of oxygen. Patient also has mild tremors and family states that this is new.  Patient received the first dose of the COVID vaccine 10 days prior to admission on April 13, 2021.
Dizziness; Fatigue; Swelling arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Diabetes. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and VITAMIN D3 for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
pt recvd vax & exp limp, pale, diaphoretic, poss sz activity-head jerked 3x, groaned x 3 mins; pt felt weak;
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 32-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 at 15:00 as dose 1, single (Lot number: ER8734), in left arm, on 28Apr2021 at 15:00 as dose 2, single (Lot number: EW0171), in left arm and on 01Dec2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 18MAY98 & o AM of 19MAY98 awoke w/hives & itching;saw MD 20MAY & had large erythematous swelling on face & elgs;saw MD 19MAY & rx antihistamine;returned MD 20MAY for worsening angioedema & rx steroids
extremely sore arm to start.  Full body/muscle/joint aches.  Fever 101' . Headache.  fever lasted ~20 hrs.  Headache lasted ~ 40 hrs.  I have not felt this sore and achey even with the real flu,  worse than the flu.  Will not get 2nd dose , as this was pretty debilitating.  I have had many vaccines  This was by far the worst.  Feel better for the most part, still a bit of a dull headache.
Initial unsolicited report received from a nurse on 21 May 2018. This was an invalid case as no patient identifiers were reported. This case involves two dose of IPOL (batch number, expiry date, route and site of administration were not reported) vaccinated on an unspecified date. It was a actual medication error due to incorrect product storage, as two doses of product were inadvertently given after excursion. No adverse event was 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. Documents held by sender: none.
Headache; Metallic taste; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received bnt162b2 (BNT162B2; reported as Pfizer-BioNTech COVID vaccine; lot number: EL0140; expiration date: unknown), intramuscular left arm on 19Dec2020 06:45 AM at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the COVID vaccine in a hospital. The patient did not have other vaccine in the last four weeks. The patient reported that she had headache and metallic taste on 19Dec2020. The events were non-serious and did not result in hospitalization or prolonged hospitalization. The patient received naproxen (ALEVE) as treatment. The patient was not diagnosed with COVID-19 prior vaccination and the patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Dec2020.  The following information on the batch/lot number has been requested
Headache; Joint pain; Pain in armpit of left arm; Lymphadenopathy left; Mild nausea; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 54-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 01Dec2021 (Lot number: PH8030) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation Relevant medical history included: "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish. The patient received unspecified concomitant medications. Past drug history included: Thimerosal, reaction(s): "Drug allergy", notes: Known allergy: Thimerasol; Minocycline, reaction(s): "Drug allergy", notes: Known allergy: minocycline and Calamine lotion, reaction(s): "Drug allergy", notes: Known allergy: calamine lotion. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8737, Anatomical site: Left arm), administration date: 05Apr2021, when the patient was 53 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot number: EW0171, Anatomical site: Left arm), administration date: 27Apr2021, when the patient was 53 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 02Dec2021, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 02Dec2021, outcome "recovering", described as "Joint pain"; AXILLARY PAIN (non-serious) with onset 02Dec2021, outcome "recovering", described as "Pain in armpit of left arm"; LYMPHADENOPATHY (non-serious) with onset 02Dec2021, outcome "recovering", described as "Lymphadenopathy left"; NAUSEA (non-serious) with onset 02Dec2021, outcome "recovering", described as "Mild nausea". Therapeutic measures were taken as a result of headache, arthralgia, axillary pain, lymphadenopathy and nausea.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache, arthralgia, axillary pain, lymphadenopathy and nausea and included treatment with ACETAMINOPHEN.
Patient noted redness, pruritus and pain at injection site (L) deltoid at site of injection. Sought care 2/13 Rx: Ibuprofen, diphenhydramine PO PM 1% hydrocortisone topical cream, f/u prn.
Rash in the arm 11 days after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in the arm 11 days after the vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced RASH (Rash in the arm 11 days after the vaccination). At the time of the report, RASH (Rash in the arm 11 days after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.
fever, chills, muscle pain, joint pain: starting approx. 7hrs. after injection, continued through the night (9hrs). The following morning, all symptoms were gone and continued normal daily routine.
Pt presented 01/10/07 with L arm red and slightly swollen. Per mom, L arm was red, swollen, hot to touch am of 1/9 child was awake night of 1/8 with fever. Swelling was receding. Amoxicillin was prescribed.