chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Pyrexia: 104 (Inconclusive) 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
FEEL QUEASY; AWFUL HEADACHE; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received 1st dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number/Batch Number: UNKNOWN), solution for injection via an unspecified route of administration in the left arm on 14March2021 at 10.30 am as a single dose for COVID-19 immunisation. The patient was allergic to gluten (celiac), Zithromax and Augmentin. The patient concomitant medications include Zoloft (Manufacturer unknown) , Junel birth control (Manufacturer unknown) and Claritin (Manufacturer unknown). On 14March2021, the patient experienced awful headache and queasy. The patient has recovering from the event headache and queasy at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.
Got my period a week early after receiving vaccine.; This is a spontaneous report from a contactable other hcp. A 38-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported.     The patient's concomitant medications were not reported.  On 10Mar2021 13:15, the patient got her period a week early after receiving vaccine. The patient underwent lab tests and procedures on 15Mar2021 which included COVID test (sars-cov-2 test) via nasal swab with pending result. The outcome of event was unknown. Patient did not receive treatment for the event.  Follow-up attempts are completed. The following information on the batch number has been requested.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 19:00 (Lot number: 3203080) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; B12 [CYANOCOBALAMIN]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 2021, outcome "unknown", described as "Diagnosed with Covid after first dose"; CARDIAC DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "feeling like heart is being squeezed"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "chest discomfort"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "numbness in face"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "pricking sensation all over body including face"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Therapeutic measures were not taken as a result of cardiac discomfort, chest discomfort, hypoaesthesia, paraesthesia, headache.  Additional information included: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient received Vitamin D, B12, multivitamin within 2 weeks of vaccination. The feeling like heart is being squeezed happened twice after first dose.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
covid test date=28Dec2022; covid test result=Positive; covid test date=28Dec2022; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 at 12:30 as dose 1, single (Lot number: 330268D), in left arm and on 14Jul2022 at 14:00 as dose 2, single (Lot number: FN2903) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "prediabetes" (unspecified if ongoing); "right bundle block of heart" (unspecified if ongoing), notes: right bundle block of heart; "mild hypertension" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "known allergies: Black Pepper" (unspecified if ongoing); "known allergies: shrimp" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; ASPIRIN (E.C.); BISOPROLOL. Past drug history included: Cortisone, reaction(s): "known allergies Cortisone", notes: known allergies Cortisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Dec2022, outcome "unknown" and all described as "covid test date=28Dec2022; covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300042104 same patient/drug, different dose/event;
Received muscle pain, redness, swelling, and heat at site of injection that started within a couple hours after the vaccine was given.  This continued and got bigger and worse by the next morning and became itchy.  Ice pack was applied by me which helped the pain but the swelling, redness, and itching continued for the next 5 days.  On day 3 I did start to apply Diphenhydramine Hcl 2% topical gel every 6 hours with some relief.
Case number PHEH2017US001864, is an initial spontaneous report received from a consumer on 12 Jan 2017. This report refers to a years old male patient. Past medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUAD (batch number: 166102, expiry date: Apr 2017) into left deltoid, at a dose of 0.5 ml, intramuscularly on 18 Nov 2016 at 14:40 PM. On 31 Dec 2016, the patient experienced sharp stabbing pain at injection site. It was reported that, patient had tender in upper arm/ deltoid area. Patient stabbing pain seems to have stopped as on 31 Jan 2017 unless he moves his arm in a certain way but patient still had tender at the site of injection. No treatment or evaluation by physician at the time of report. Outcome of the event as condition unchanged and seriousness and causality was not reported. Follow up report received from a healthcare professional on 01 Feb 2017: Added patient demographic (patient height), suspect drug information (vaccination site and time of vaccination), updated event (tender at the site of injection), event onset date (changed from 30 Dec 2016 to 31 Dec 2016) and reporter comment.
Information has been received from a 21 year old female who on 08-FEB-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included allergenic extract and corticosteroids (unspecified) for the treatment of acne. On 08-FEB--2008 the patient felt bad and came down with the flu. No further information was provided. Additional information has been requested.
Pfizer 2nd dose was given @ 1540 , Dose expired @ 1500.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210557803.
No additional AEs; The patient received MMR II by the intramuscular route instead of the recommended subcutaneous route; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 19-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, 0.5 milliliter (lot# S028913 has been verified to be a valid lot number and expiration date was 16-SEP-2021) by the intramuscular route instead of the recommended subcutaneous rout for prophylaxis (incorrect route of product administration). The nurse reported the needle size used was a 25 Gauge, 1 inch length needle. No additional adverse events were reported. The outcome of the event was unknown.
Moderna COVID-19 vaccine.  Severe Vertigo and Nausea - started at ~ 5am 4/17/21 - at the time of this report - continuous uncontrolled vertigo and nausea for over 5 hours.
pt became nauseous & vomited @ 3AM on 10JUL92; there was no local reaction from either vax; MD dx flu;
Patient complained of feeling of overall malaise. He felt weak and did not sleep well the night after the vaccine. He felt much better in the morning and is regaining his strength back.  Patient was advised to increase fluids.
Swollen lymph node in the sub clavicular area; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node in the sub clavicular area) in a 28-year-old patient of an unknown 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph node in the sub clavicular area). At the time of the report, LYMPHADENOPATHY (Swollen lymph node in the sub clavicular area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.
Pt became pale, faint <5min p/receiving vax; Did not LOC, BP 60/40, P 80 & thready; no tremor or sz activity noted; p/5min BP 70/52, P 76 & reg, inc volume;
Fever-101.6; headache, body aches; all over body tremors; weakness; vomiting. Tremors ended by 4:00 AM, fever gone by 6:00 AM headache, body aches and fatigue persisted until 09/23/2010.
Minutes after the dose was administrated I started to experience chest pressure and numbness in both hands. I returned to employee health for evaluation as was transferred to the ED.
she had no appetite; weakness; fatigue; breathless; anxiety; she was very sleepy; 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 DYSPNOEA (breathless), ANXIETY (anxiety), DECREASED APPETITE (she had no appetite), SOMNOLENCE (she was very sleepy) and ASTHENIA (weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD. Concurrent medical conditions included Emphysema.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SOMNOLENCE (she was very sleepy). On 03-Mar-2021, the patient experienced DYSPNOEA (breathless) and ANXIETY (anxiety). On 04-Mar-2021, the patient experienced DECREASED APPETITE (she had no appetite), ASTHENIA (weakness) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (breathless), ANXIETY (anxiety), DECREASED APPETITE (she had no appetite), SOMNOLENCE (she was very sleepy), ASTHENIA (weakness) and FATIGUE (fatigue) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.
Chills started first at 3am. No fever at that time. By 6a I was dizzy and had a fever of 101F. I was nauseated, weak, tired, and had muscles aches and a horrible headache. I had taken ibuprofen at 4a with no relief. At 7a I took Tylenol and did get some relief from all but the headache until the Tylenol wore off about 12p. At 1p I took more Tylenol and this time the relief wasn?t as much. I wound up bed with chills, fatigue, body aches, nausea, and headache for the next 8 hours. I took more Tylenol (1000mg), ibuprofen (400mg), and a Benadryl (25mg) at 9p in hopes of getting some sleep. At 10p I woke up overly hot from the 3 blankets on me. My temp was 101.5 at that time. I was able to go back to sleep and woke up with only some weakness and muscle aches in the morning.
On the evening of June 4, 2022 extremely runny nose like a faucet had been turned on. I got up the next morning and had a bad headache that lasted for two days. I was extremely fatigued on June 5, 2022 and was running a fever. I could not wait to get to bed. By June 6, 2022, I could hardly sleep because of the fever and was nauseated. By Tuesday morning I asked to be taken to get a COVID-19 Test that came back positive. I also have developed a hoarse scratchy throat. I was not given any medication but I did take some Tylenol for the headache and a pseudoephedrine to help dry up the sinuses.
Received 2nd dose 7 days after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 7 days after 1st dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 7 days after 1st dose). On 30-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 7 days after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Additional Information received included no new significant information. On 26-Jul-2021: Additional Information received included no new significant information. Race and ethnic group updated.
Developed ascending bilateral symmetric weakness ~under one week after receiving second Moderna shot.  MRI negative, LP with elevated protein, low cell count.  Guillain-Barre suspected, neurology consulted likewise agrees, has been started on IVIG and is hospitalized presently
Numbness of legs, unable to sleep, out of breath, feels as though she would pass out, dizzy and nauseau
Nausea, diarrhea, vomiting, headache, sudden feeling of faintness, extreme fatigue, body ache, chills, fever, dry heaving, loss of appetite,  brain fog, restlessness, stomach bloating, memory loss - symptoms began 12 hrs after second dose and are still occurring 5 days later. Missed two days of teaching my in-person and online students thus far.
Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number f73dc7, expiry date 03-JUL-2023) for prophylaxis.   On 19-JUL-2023, the patient received Engerix B. On 19-JUL-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter did not have additional adverse event details. The patient received an Engerix B which was already expired, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On unspecified dates (reported as after temperature excursion on 21-SEP-2015), the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L006545, expiry date 16-NOV-2017 (dose and route of administration were not reported). Administered doses of the vaccine experienced the temperature excursion of 48.7 Fahrenheit degrees for 55 hours. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Fever, chills, tenderness that grew by the hour. This lasted until 8/16/15 PM.
Onset of Left Shoulder pain immediately after Flu vaccination. Pain continues at site of injection. Continuation of pain reported to Employee Health Nurse on 11-9-2018. Denied need for Provider evaluation and he is doing Self stretches.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 51-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EE3594), at the age of 51, in left arm, on Dec 8, 2021, single dose, for COVID-19 immunization. No medical history or concomitant medications reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0150), at the age of 50, in left arm, on Apr 12, 2021, for COVID-19 immunization; reaction(s): pressure in ears, felt like she couldn't hear as well. She also received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot#  EW0164), at the age of 50, in the right arm, on May 3, 2021, for COVID-19 immunization; reaction: ringing in ears. The patient experienced tinnitus, with outcome of not recovered; and aggravated condition (ringing in her ears/it has gotten a little worse), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: Reporter stated she received all three of the Pfizer COVID-19 vaccines, the first two and a booster. Reporter reported she has had issues with her ears since having the first one. After the second one, she stated she has more ringing in her ears. Reporter clarified after first shot she had pressure in her ears, felt like she couldn't hear as well. Reporter stated it faded a little but after second shot she has been having ringing in her ears that has gotten worse. The pressure started either day after or even the same day like they were clogged a little bit after the first vaccine. It subsided a little bit and she didn't notice it as much. She would open her jaw to clear out her ears. The ringing has been really bothersome, and started almost immediately after the second shot, on the same day. It is more bothersome now, and has gotten a little worse. At first, she could hear it when it is quiet but now she can hear it during a conversation. She had an auditory test done. It was a little off. Exact readings or details unknown. Her husband told her to go get tested. Follow-up attempts completed. No further information expected.
Swollen arm, constant urination, fever, no taste in food, no digestion, aches joints all over body, skin peels. Lasted for 10 days.
DIZZINESS, AND ITCHING IN THE INJECTION SITE, ABOUT 10 MIN AFTER GETTING THE FLU VACCINE. AROUND 4:30 PM WHICH WAS 2 HOURS LATER I STARTED GETTING SEVERE PAIN IN THE ARM FOLLOWED BY ITCHING BURNING ALL OVER THE BODY, SORE THROAT AND ITCHING AND SWELLING IN THE ARM. BY 6 PM I WAS UNCOMFORTABLE WITH STABBING PAIN IN THE ARM. AND 7:45 I BEGAN TO VOMIT WITH SWEATING AND DIZZINESS. TOOK 800MG MOTRIN AND WENT TO BED. SYMPTOMS WERE PRESENT THOUGHOUT THE NIGHT.
had a heart attack and died; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A male patient of unknown age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was fully vaccinated with the Pfizer Covid 19 vaccine, had a heart attack after both vaccine. The patient died due to heart attack. It was unknown if autopsy was done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: had a heart attack and died.
Patient calls in and reports severe pain in her arm and that she can barely move her arm. Denies any redness at vaccine site. She received her vaccine earlier today. I advised to take Tylenol or Ibuprofen and use a cold compress on her arm. If it does not improve with nursing recommendations she should call her doctor.
Fever, chills, severe body aches and migraine lasting into 10/6/2010.  Severe enough to require sick day off of work.
Approximately 8 minutes after vaccine administration, the recipient reported feeling nauseous and dizzy.  The patient threw up.  After, she reported still feeling dizzy and experiencing some blurred vision.  Within a 45 minute time span, the recipient threw up 2 additional times and reported persistent dizziness and weakness upon standing.  The recipient did report resolution of blurred vision.
On Sat afternoon started with fever (T-102-104.1) and vomited x1 and loose stool x1, lethargic, also teething.