chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Moderna/ Dose 5: Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2023 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2023, outcome "unknown", described as "Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Moderna/ Dose 5: Pfizer."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measure such as Paxlovid from 11Aug2023 to 16Aug2023 was taken as a result of vaccination failure, covid-19. Additional information: The patient took other medication in 2weeks Levothyroxine and Gabapentin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
had one of moderna at (PII removed) market now they dont give out vaccine anymore. I need one more vaccines; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jun-2021 and was forwarded to the company on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had one of moderna at (PII removed) market now they dont give out vaccine anymore. I need one more vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had one of moderna at (PII removed) market now they dont give out vaccine anymore. I need one more vaccines). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had one of moderna at (PII removed) market now they dont give out vaccine anymore. I need one more vaccines) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were provided. No treatment medication were provided
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Mild, Additional Details: na
Twelve year old patient was given pediatric dose of Pfizer for 2nd dose in series. First dose given was age appropriate three weeks prior. Vaccinator was aware immediately after giving shot. Parents of patient were present and were told of the incident. Health Department  guidance was followed to align with CDC guidance. No repeat shot was given. Family was told to notify pediatrician of incident.
stated that had discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: DISCOMFORT (non-serious), outcome "recovered", described as "stated that had discomfort".  Additional information: The patient reported that the discomfort lasted a couple of days and was fine. She was about to be 50 years old. Wanted to know if this was something people had been saying about a side effect. she got the flu shot around second vaccine. Wanted to know there were anything that she should be taking it.  No follow-up attempts are possible; information about lot/batch number was not available despite the follow-up attempts made. No further information is expected.
I started to have shortness of breath and a high fever and body chills. Next day, I woke up and my blood pressure was high and my fever was worse, I thought I had COVID-19 so I went to see my PCP where my blood oxygen concentration level was 70% and I was admitted to the ER. They performed EKG, CT scans of my lungs, and ultrasound of my heart. I was hospitalized for 11 days where they monitored my INR levels.
April 16-18: Soreness (where shot was given). Very tender. Tired, first 3 days. One week after shot, April 22, 2021, I got what has been called COVID arm. Very red, itchy and swollen. The length of my left arm in an oval shape. Finally, the 4th day, the redness started to decrease. It is still present on the 5th day but does not hurt. Have been tired on and off. April 23-26, I experienced a dull headache, muscle aches, joint pain, chills and nausea. I had very low energy, which is extremely unusual for me. My symptoms increased one week after the vaccination. Currently, I am experiencing these symptoms.
Initial unsolicited report received from a Nurse on 25-Jun-2018. This case involves a 16-year-old male patient who was treated with 0.5 ml TUBERCULIN TEST [TUBERSOL] (lot number: C5474BA, expiry date: 29-oct-2018) via intramuscular in right deltoid instead of 0.1 ml dose of MENACTRA (Batch number, expiration date, dose and site of administration was not reported) on 25-Jun-2018. The patient's medical history was not reported. The patient's concomitant vaccines included TRUMENBA and MENACTRA injected intramuscularly in the left deltoid. It was an actual medication error due to wrong vaccine administered, vaccine administered at inappropriate site and overdose. No adverse effects had been noted. 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 and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient has had moderate to severe headaches and nausea ,as well neck and  upper back pain since her second injection.Patients father is a physician.He has checked for lymnes disease and patient has also been seen by another physician. She was also seen in the ER. She has a appointment with a neurologist next week.
This case was reported by a other health professional via call center representative and described the occurrence of chest pain in a 67-year-old male patient who received SHINGRIX. Concurrent medical conditions included aortic aneurysm repair (in 2014), coronary stent placement (in 2012 and 2014) and shoulder replacement (on 19th November 2016). Concomitant products included ADVAIR, Aspirin, PLAVIX, Magnesium, Probiotic, Calcium, TENORMIN, SINGULAIR, COMBIVENT, fish oil, isosorbide and SOLU-MEDROL. On 21st May 2018, the patient received the 2nd dose of SHINGRIX. On 23rd May 2018, 2 days after receiving SHINGRIX, the patient experienced chest pain (serious criteria hospitalization), choking sensation (serious criteria hospitalization), nausea (serious criteria hospitalization) and diaphoresis (serious criteria hospitalization). The patient was treated with Nitroglycerin and oxycodone. On 24th May 2018, the outcome of the chest pain, choking sensation, nausea and diaphoresis were recovered/resolved. The reporter considered the chest pain, choking sensation, nausea and diaphoresis to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the wife of the patient who was a Catheterization Technician. On Wednesday, in the morning, the patient experienced severe chest pain on the left side, diaphoresis, nausea, and choking sensation. The patient took up to 6 nitroglycerin tablets that did not resolve the pain and then went to the Emergency room at around 10 am that morning. The patient was then admitted to hospital for possible myocardial infarction and was given oxycodone for the pain. On 24th May 2018, the patient underwent cardiac Catheterization on which ruled out myocardial infarction and patient was discharged on the same day in the evening. The reporter was unable to provide full demographics for hospital where the patient received SHINGRIX or for the prescriber.
pain, itch & lump @ site of inj;pt has cut nodular mass lt deltoid @ site of inj;no tx;
Vaccine was administered post use date. Patient's provider Dr. contacted the parents or guardian on 03/10/23 stating manufacturer's vaccine activity at the time of administration.   Manufacturer's Statement: Pfizer reviewed the stability of the vaccine you received and determined that it likely did not maintain the activity necessary to protect against COVID-19 at time of administration. Pfizer cannot guarantee the protection you may have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.
The symptoms started on Monday November 28th, 2022. I initially had upper respiratory congestion, fever that lasted for 4 to 5 days. It was around 101.5 along with fatigue and coughing. I eventually lost my taste and smell once the fever broke. I tested positive on Tuesday November 29, 2022. I was advised to get rest and fluid. I also took acetaminophen. The doctor prescribed PAXLOVID but I did not take it as I felt the illness was not severe enough. I still tested positive 7 days later, but most symptoms were gone. I feel fine but the taste and smell has still not returned.
diarrhea; she had a sore arm the first night; This is a spontaneous report from a contactable consumer (patient).  A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL3249) dose 1 intramuscularly, administered in upper right arm on 20Jan2021 at 13:00. Medical history included ulcer four year age, severe sepsis and kidney dialysis occurred four years ago. Concomitant medications included supplements and vitamins. Historical vaccination included flu shot on 04Oct2020. On 27Jan2021 the patient reported had diarrhea since a week after the first dose of the vaccine. It has been off and on since then, not continual. First it wasn't good and she crapped her pants a few times but it has been calming down. It was starting to look more normal yesterday, it was solid and was a better color. At first it was yellowish type stuff.  It was getting to be like runny in the morning, usually once or twice in the morning, but the rest of the day and evening it was fine. Today it was solid with a little bit of runniness, but not much. After lunch she ended up having to go to the bathroom again and she took Imodium. She has been taking Imodium off and on since she does not want to take too much. She had a stomach ache this morning twice and she did not have stomach aches prior to this morning. With the first dose she had a sore arm the first night on unspecified date Jan2021. States with the first dose it was nurses administering the vaccine. The outcome of event was Recovering for Diarrhea and Pain in arm was unknown.
pt recv vax AUG96 & early SEP96 4wk post vax pt devel one pox on abd;2 wk p/this pt roommate devel varicella;
Moderna COVID-19   Large red patch on arm where vaccine was given. Site is itchy often. Redness is present with heat on arm.
My husband had ringing in the ear after the Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (My husband had ringing in the ear after the Moderna booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (My husband had ringing in the ear after the Moderna booster). At the time of the report, TINNITUS (My husband had ringing in the ear after the Moderna booster) outcome was unknown.            No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Swelling, redness, and pain at the site in injection.  Low grade fevers up to 101.6 F.  Treated with oral prednisone and Zyrtec.
patient gets the flu shot every year, gets the flu every year too; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves female patient who experienced patient gets the flu shot every year, gets the flu every year too (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient gets the flu shot every year, gets the flu every year too (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Weakness to extremity. Affected ROM w/raising extremity to comb hair. Pain to extremity not improving. Occurred hours after injection and has persisted.
Rash over the body and itching; Rash over the body and itching; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced side effects rash over the body and itching. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The injection site became swollen and painful; The injection site became swollen and painful; This spontaneous case was received on 14-Sep-2020 from other health professional via agency (reference number: SEQW20-01606) and concerned a male patient of unknown age.  The patient's medical history and concomitant medication were not reported.  On 05-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid and route of administration: not reported) for influenza prophylaxis. The batch number reported was 283847 and expiry date was 20-Jun-2021.  On the same day, about an hour after receiving Flucelvax Quadrivalent, the injection site became swollen and painful. The treatment included ice packs to the injection site and this helped with the pain and swelling.  At the time of initial reporting on 14-Sep-2020, the patient was recovering from the events 'vaccination site pain' and 'vaccination site swelling'. The reporter stated, the patient was better, but still not resolved completely.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to case 202004442  due to the same reporter.  Company comment: The events of 'vaccination site pain' and 'vaccination site swelling' are assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events of vaccination site pain' and vaccination site swelling' are assessed as related to Flucelvax Quadrivalent.
Information has been received from a health professional referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, these patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # reported as 1025738, expiration date: 14-AUG-2017, strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
then died within 24 hours afterwards; This is a spontaneous report from a contactable consumer.  This consumer reported that a 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration an unspecified date at single dose for COVID-19 immunization. Concomitant medications were not reported.  The patient with a host of health issues (heart issues/had a pace maker, diabetes, among others) was in a rehabilitation center following a hospital stay and was given the second dose of vaccine. It was reported that the patient died within 24 hours afterwards. It was not reported if an autopsy was performed.   Information on batch/lot number was requested.; Reported Cause(s) of Death: then died within 24 hours afterwards
Flu-like symptoms including malaise, sore throat, mild headache and appearance of flat red lesions over the upper torso. Large area of localized redness at innoculation site X 24-48 hours. Also unilateral axillary adenopathy. Symptomatic treatment with fluid and tylenol.
MISSED TO TAKE THIRD CAPSULE ON TIME; This spontaneous case report was received from a consumer (PVX2019-327) on 05-Feb-2019. The report describes a male consumer who "missed to take third capsule on time". The consumer was receiving Vivotif capsule for an unknown indication.  It was reported that the consumer missed to take the third capsule according to schedule and took it a day later. The doses were taken on 28-Jan-2019, 30-Jan-2019, and 02-Feb-2019 respectively.  The action taken with Vivotif with respect to the event "missed to take third capsule on time" was not applicable.  The clinical outcome of the event "missed to take third capsule on time" was unknown.  Company's Comment: The causality of the event "missed to take third capsule on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third capsule on time" was considered as not applicable.
Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.            The patient was asking if the patient could take pain relivers with the second dose of Moderna. The patient was having some body aches.
Suspect rash on chin on the day of the vaccination. No temperature. On Thanksgiving, she had a rash around the site and then on her stomach and back. She had a temperature last night, inside ear and around mouth.
15JUL92 leg swelling; 15JUL92 fever 101.7; 15JUL92-21JUL92 periods of crying & unusual temperment; MD involved in care of pt maintained problem due to vax;
lymph nodes started swelling in a few hours. Woke up in middle of night with 100.3 degree fever, aches, chills, congestion, and congestion related headache
ACCORDING TO MOTHER, CHILD DEVELOPED CELLULITIS IN THE LEFT ARM WITH A TEMPERATURE OF 104.8 AND NEEDED IV ANTIBIOTICS FOR 2 DAYS. 2/6/09 MR received doe DOS 1/25-26/2009 with D/C Dx:  L Upper Arm Cellulitis. Pt presented with several day hx of fever and edema, erythema and warmth of the L upper arm 1 day after vax.  Seen twice in ER and tx with abx. Now with emesis and T=104'F. Started on IV abx.  Hives 2' to Unasyn. Responded well to Clindamycin.
Shingles in throat. Vertigo, dizziness, half of head numb. Disoriented, Throat and ear pain, eye pressure on face and in eye, tinnitus, tired. Most symptoms since April 12th. Took two doses of antiviral because I got sores in my throat twice three to four weeks apart. Vertigo, dizziness, disoriented persists.
Woke up 6/20/06 with chills, weakness - especially in arms. Total body weakness.
About 5 minutes following injection of all 6 vaccines, pt was sitting in chair and upper body fell forward. RN rushed to sit her up, eyes were open, arms out and rigid, possible seizure, lasted about 5 seconds.  Pt then began blinking and looking around, not responding. Pt was able to squeeze both hands on command.  About 2 minutes after pt was able to nod responding that she was okay, shook her head saying no pain.  About 2 minutes later pt asked to lay down on exam table. Juice and snacks provided, pt only wanted juice. Pt was now able to respond verbally.
Dizziness  started 1 pm lasted 24 hours Migraine with insomnia  started 4/27/2021 8 pm ended 4/28/2021 10 am
SOB began 5/4/22. Required O2 via NC at 3LPM on admission. Treatment includes, monitoring, labs, O2, and Corticosteroids.