chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to 11 patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On 18-MAY-2015, in the afternoon, 6 of the patients were vaccinated with one of two improperly stored lots of LIQUID PEDVAXHIB lot # K011077, expiration date: 30-MAR-2017 and lot # K025006, expiration date: 22-JUL-2017 intramuscular which were improperly exposed to 19.2 Fahrenheit (F) for 17 minutes in the early morning of the same date. On 28-MAY-2015, in the afternoon, another 5 patients were vaccinated with one of the two improperly stored lots of LIQUID PEDVAXHIB lot # K011077, expiration date: 30-MAR-2017 and lot # K025006, expiration date: 22-JUL-2017 intramuscular which were improperly exposed to 31.5 F for 6 hours and 5 minutes in the early morning of the same date. No known adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Hepatitis B immunization was given on 6/20/08 1800.  Less than 24 hours later, he was hypothermic and a poor feeder.  Complete sepsis work-up done.  Results continue to be negative.
Passing out, generalized seizure, myoclonic seizures, nodule in thyroid, tiredness, memory loss, starring seizures
the morning following vaccination woke up with a hand tremor on the right,  that proceeded to then affect both hands.  has remained stable now for 2 weeks.
tired after the first vaccine; naueseous after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired after the first vaccine) and NAUSEA (naueseous after the first vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Oct-2021, the patient experienced FATIGUE (tired after the first vaccine) and NAUSEA (naueseous after the first vaccine). At the time of the report, FATIGUE (tired after the first vaccine) and NAUSEA (naueseous after the first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  Patient was tired and nauseous for a few hours after the first Moderna Covid-19 vaccine.
Nausea; Blood pressure elevated; Tachycardia; Vomiting; This is a spontaneous report from a contactable consumer. A 50-years-old female patient started to receive  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 23Dec2020 11:30 to 23Dec2020 11:30 and from 13Jan2021 13:30 to 13Jan2021 13:30 both intramuscular arm right at SINGLE DOSE for covid-19 immunisation.  Medical history included migraine from Feb2015 and ongoing. There were no concomitant medications. The patient stated that she has chronic migraines and takes medications to keep her at a level where she can function.  She was on them prior to taking this and did not think they were relevant.  She was diagnosed in Feb2015. On 23Dec2020 at 12:00, the patient experienced nausea, blood pressure elevated, tachycardia and vomiting. The patient also stated that she had the same symptoms of events on her second dose. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
C/O SORE ITCHY THROAT 5  MINUTES POST VACCINE.  BENADRYL 25MG PO GIVEN WITH LITTLE TO NO EFFECT.  40 MINUTES OBSERVATION PATIENT STARTED HAVING DIFFICULTY BREATHING, C/O UPPER TORSO STIFFENING.  VS SpO2 99  P 74  RR 20  BP 140/78.   PATIENT TRANSFERED VIA EMT TO LOCAL HOSPITAL FOR FURTHER EVALUATION.  PATIENT WAS ABLE TO AMBULATE BY HIMSELF TO THE AMBULANCE.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 75-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced redness and swelling that lasted over two weeks. It was resolved on it owns.
No adverse event; The patient was accidentally administered an expired dose of MMR II; This spontaneous report was received from physician and refers to a 12-month-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-DEC-2021, the patient was accidentally administered with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #S035356, recombinant human albumin (rHA), expiration date: 05-NOV-2021, strength, and route of administration were not provided), once follow vaccine schedule. The physician confirmed the patient had not had any symptoms after being administered the expired dose of the vaccine. The vaccine did not have any temperature excursions.
injection site swelling and pain; 1st 4 days fatigue and diziness. days 5-6 severe headache and cramps, fever, diziness, nausea. This report is made on day 7 and fatigue continues.  Events were reported to physcian via phone on 10/10/08.
pt recvd vax; lab tests done & revealed neg antigen, neg surface antibody & pos core antibody; repeat lab evaluation showed pos core antibody;
Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Wheezing. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WHEEZING (Wheezing). At the time of the report, WHEEZING (Wheezing) had resolved. Not Provided          No treatment information provided
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), on 25Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 31May2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing). Concomitant medication(s) included: RUKOBIA; SELZENTRY; TIVICAY. Past drug history included: Codeine, reaction(s): "Drug Allergy"; Azt, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE , COVID-19 outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Negative; (06Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: If vaccine received: Yes, Other medication in 2weeks: Yes. Anti-viral details: product; COVID 19 Treatment, brand; Paxlovid, treatment start date; 27Jun2022, treatment stop date; 01Jul2022, indication; Treatment of COVID-19. Other medication details: other medication in 2weeks product; Rukobia, other medication in 2weeks product; Selzentry, other medication in 2weeks product; Tivicay. Adverse event: On 05Jul tested negative, finally. Then thru the night developed typical Covid symptoms & tested positive again 06Jul AM. Adverse event start date: 06Jul2022. Adverse event start time: 02:00 AM. Known allergies: Codeine, AZT, Other medical history: HIV.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt was given flu mist yesterday then he broke out in hives that night the hives were not itchy and would move to different parts of body.
Intermittent episodes of left-sided chest pain; leading to symptoms of fatigue, pre-syncope; eventually diagnosed with pericarditis.
Itchy, well-defined (2.5" x 3"), circular redness at site of injection.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by RA for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Moderna COVID-19 Vaccine EUA  Fever, sweats/chills, severe headache, dizziness, brain fog, extreme fatigue, muscle and joint pain Treated with ibuprofen, hydration and rest. Symptoms mostly resolved 48 hours later, severe headache remains.
Acute Zoster. T 10 left.  (seen 12/8/08). Note: vaccine given at husband's physician office.
Swelling; This is a spontaneous report based on the information received by Pfizer from a contactable Other-HCP via GALDERMA Laboratories LP. (Galderma Reference Number: GL-020821-3448). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2, via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Past drug included Restylane-L, injected in tear troughs, since 14Sep2021, unknown if ongoing, for unspecified indication. Patient experienced swelling occurred to tears troughs 24 hours following 2nd vaccine, on an unspecified date. The outcome of event was unknown.   Follow-up attempts completed. No further information expected.
Patient admitted for pneumonia on 9/19 and became hypoxic on 9/21.  Patient positive for COVID.
first dose on 02Feb2021 and second dose on 20Feb2021 (18 days apart); developed a rash all over my body/rash got worse/ rash was drug related; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the left arm on 02Feb2021 (at the age of 72-years-old; lot number: EN5318, expiration date not reported) as first dose, single dose and via an unspecified route of administration, administered on the left arm on 20Feb2021 09:30 (at the age of 72-years-old; lot number: el3246, expiration date not reported) as second dose, single dose both for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included amlodipine and simvastatin; both taken for an unspecified indication, start and stop dates were not reported. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 10Feb2021, about a week after the first vaccine, the patient experienced rash all over her body and after the second shot, on an unspecified date after about a week, the rash got worse. The patient also experienced inappropriate schedule of vaccine administered on 20Feb2021 as the first dose was given on 02Feb2021 and second dose on 20Feb2021 (18 days apart). The patient underwent lab tests and procedures which included biopsy: the rash was drug related on an unspecified date in Feb2021. Treatment with topical steroidal cream was taken as a result of the event rash all over her body/ rash got worse/ rash was drug related. The event rash all over her body/ rash got worse/ rash was drug related resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event rash all over her body/ rash got worse/ rash was drug related was not recovered and the patient still have it.  No follow up attempts are possible. No further information is expected.
Fever, headache, dizziness. Started about 8 hour after shot.  Symptoms not resolved yet
This spontaneous report as received from a pharmacist refers to an unknown number patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patients were vaccinated with improperly stored (Merck) VARIVAX (lot#, dose, route and frequency were not provided).  No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
5 min after injection I began feeling extremely hot. Tongue began tingling. This spread across my face then up to my nose and to the top of my throat- tingling and numbness. Felt hard to breathe.   Given Benadryl 15 minutes later. It began subsiding but would come back few minutes later. Sent home to continue benadryl. Took Benadryl for 12 hours. Heart rate stayed over 100 for hours after. The tingling and numbness continued slowly getting milder until stopping after 12 hours.
Severe bone pain lasting approximately 16 hours, beginning at around 01:00am the day following the vaccine (2nd dose). It felt like when you hit your elbow too hard and get both a deep, dull, aching pain, and a burning, shooting nerve pain. I experienced it down both arms and both legs, with the leg pain lasting longer and feeling more severe than the arm pain. I also experienced muscle spasms in my arms, legs, and lower back, with nerve pain shooting from my lower back into my legs, almost like sciatica. The pain was between a 7 or 8/10 at most times and was some of the worst pain I?ve continuously felt in my life. The pain subsided around 16 hours after starting, however I?m still experiencing occasional shooting pain or sudden aching in my bones or muscle spasms, although it?s usually only one area at a time and very brief/manageable. During the 16 hours, I also had joint stiffness that was severe enough to limit my ability to move and I had difficulty walking to the bathroom or shifting positions in bed. It also mostly subsided after the 16 hours, however I am still experiencing minor joint stiffness still.
Pericarditis - resulting in symptoms: dry cough, muscle weakness, extreme fatigue, shortness of breath, pain (chest, back, shoulder), joint aches, tingling arms/hands, restless legs, confusion/lack of concentration, dizziness, nausea, anxiety, low heart rate (36 - 70 bpm).
Phantom pain in heel of left amputated leg - has been amputated for 15 years with no phantom pain .  The phantom paid resolved by morning.
Evening of vaccine admin. pt noted (R) arm swelling ache and flu like symptoms. Pt states was in bed x2 days with fever 102 body aches swollen (R) arm.
Intense shoulder pain. Shoulder blade/Scapula is inflamed and radiates heat/pain. Limited mobility and shortness of breath due to pain in upper back.
Low grade fever; itchy throat and face/slight hives, cold compress; few hours Tues: fatigue; Wed: okay; Thurs: all day diarrhea; Fri: morning diarrhea; Sat. okay; Sun and Monday; Sneezing and runny nose; Tues: runny nose
Have a dry hacking cough. Have had it for almost two weeks. it is slowly tapering off.
Chills, adenopathy. Substernal chest pain radiating down both arms. ST depression. Inferior wall hypokinesis on echo.
Felt woozy like; felt like she's drunk.  Pt denies tightness in chest, jaw pain or heaviness in chest.  Treatment: Rest and water also referred to primary care clinic as she refused to go to the emergency room for further care.   The pt was able to walk without assistance and stated she was fine.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with the first dose and the second dose of GARDASIL, INJ 120 Y, (lot #, expiration date, dose and route unspecified) on 02-NOV-2012 and in January 2013 respectively. The patient would like to receive the third dose on 08-NOV-2013 (at the reporting time). No adverse symptoms reported. Additional information has been requested.
17 year old client seen in COVID clinic on 12/27/2021 for COVID booster (Pfizer #1 rec'd 4/2/2021; Pfizer #2 rec'd 4/22/2021). Moderna booster inadvertently administered in clinic on 12/27/2021 per documentation. Client stayed for 15 minute observation period post vaccination and experienced no adverse events while in clinic. Client's father accompanied him to clinic. Administration error on 1/27/2022.  Per directions and confirmation of error per clinic paperwork, Medication Error Report and VAERS submitted.
Fever, sore arm, body aches, joint paint, chills, headache, and fatigue
Information has been received from a consumer concerning her approximately 24 month old son with no medical history or drug allergies who in January 2006, was vaccinated with a dose of MMR II. The patient received total of 4 vaccines (the names of the other vaccines was unknown) during the same visit. It was reported that the patient was a changed child after getting vaccinations in January 2006 (within 24 hours of vaccination). The son started to give blank stares, didn't look or address anybody with his eyes, and acted like a 4 month old baby instead of a 2 year old because he did not acknowledge anyone. He had sensory issues like problems picking up things. The patient was seen by a physician, autistic testing was performed. Within 6 months of the vaccination, he was diagnosed with autistic spectrum. He was recovering but has not received any vaccinations for 25 months. The reporter considered autistic spectrum to be disabling. No further information is available.
diagnosed with COVID 19 with symptoms; diagnosed with COVID 19 with symptoms; This is a spontaneous report from a contactable physician. A 28-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 05Jan2021 as a single dose for COVID-19 immunisation. Medical history included seronegative rheumatoid and CPPD arthritis (Calcium pyrophosphate dihydrate deposition). Concomitant medication included prednisone for arthritis 10 mg daily and again restated with 5-10 mg. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in mid Dec2020 as a single dose for COVID-19 immunisation. Patient previously received etanercept (ENBREL) and tocilizumab (ACTEMRA) both for arthritis and had failed prior to immunization. On an unspecified date in 2021 (reported as 2 weeks ago), patient developed a fever and sore throat and was diagnosed with COVID 19. Patient was now feeling better and outcome for the events were recovering. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection, specific dates for onset of covid symptoms are needed for meaningful medical assessment.
Received Td in L deltoid on 11-14-05.  On 11-21 arm became itchy, red, warm and swollen and began losing feeling in fingers.  Saw MD on 11-21-05.  Was treated with antibiotics and steroids.
Patient stated that the reaction started as injection site redness and itching approximately 3 hours after receiving vaccine. The reaction then progressed to muscle spasms of the jaw, feet, and hands -- followed by shortness of breath and throat swelling -- followed by swelling of and pain in the legs, hands, and feet. The patient then went to the local clinic for evaluation and treatment of symptoms. The treating physician wanted to admit patient to the hospital but she was not willing. She was then sent home after symptoms had resolved.
Three days after getting the vaccine, client woke up with pain in his arm hurting to the point of difficulty lifting his arm . Took Tylenol and muscle cream.  8/2 started ibuporfen.
(11-2) Hives the next morning after shot; increased (more and itching) on 11/30-took Benadryl tablets to relieve-3rd day(11/4) hives decreased.
This case was reported in a literature article and described the occurrence of bilateral optic neuritis in a 15-year-old female subject who was vaccinated with DTPa (with small D and P), manufacturer unspecified) and Hepatitis A. On an unspecified date, the subject received an unspecified dose of DTPa (with small D and P) (administration site and route unknown) and an unspecified dose of Hepatitis A (administration site and route unknown). 18 days after vaccination with DTPa (with small D and P) and Hepatitis A, the subject experienced bilateral optic neuritis. This case was assessed as medically serious by GSK. The fundoscopy revealed bilateral disk edema with blurring of disk margins. At the time of reporting, the outcome of the event was unspecified. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed Tdap vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ration was about 2 to 1. The majority of reports distributed. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's Palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
Patient was given Moderna vaccine at 16 years and 6 months instate of 18 years. No side effect We miss understand age requirement