chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SICK; NOT FEEL UP/NOT FEELING WELL; SORE ARM; BAD CHILLS OVERNIGHT; HEADACHE; FEVER; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sick. On MAR-2021, the subject experienced not feel up/not feeling well. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced bad chills overnight. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick, not feel up/not feeling well, headache, sore arm, bad chills overnight and fever was not reported. This report was non-serious.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Reporter did not allow further contact
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-abdominal) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-abdominal) was unknown.       No concomitant and treatment information was not provided.
When I got up in the morning to get ready for work, I turned on the lights.  The room appeared foggy or smokey.  It really frightened me.  The vision in my left eye was blurry even with my glasses.  As of today, October 17, my left eye is still blurry.
Pt reports localized red raised rash on Left hip and thigh. Very pronounced x 4 days. Referred to physician for further evaluation.
Grand-mal/tonic-clonic seizure.  First seizure of the kind ever. Caused shoulders to jerk in extreme robotic motions which caused RIGHT shoulder dislocation resulting in need for shoulder surgery. The shoulder dislocation was so severe that shoulder dislocated a second time within two hours requiring return visit to ER department and subsequent evaluation with orthopedic surgeon.
In a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Advil. The following information was reported: PAIN (non-serious), outcome "unknown", described as "In a lot of pain".  Additional information: Caller states she has not received the second shot yet and was given prednisone pack for arthritis. Caller states the prednisone is 5 mg tablets that she will be taking by the time she receives the vaccine. Caller states she will start at ta higher dose but it will be down to the 5 mg by the time she received the second dose. Caller states her physician prescribed her Advil to treat her rheumatoid arthritis and he prescribed 8 tablets per day. Caller concerned about starting a regiment of prednisone before second dose and would like to know the possible adverse effects, clarified has had first shot, clarified has not yet started taking 5 mg prednisone, but caller would like to because they are in a lot of pain  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe rash covering head, neck, chest, arms and upper legs. Impetigo. Began on October 10th and lasted for approximately 4 weeks. The symptoms resurfaced in late November and early December for two weeks.
I developed a ?bounding heartbeat? that I can still hear in both ears, especially at night when I?m sleeping. At times, it is so intense, it awakens me. I am also experiencing significantly higher than usual blood pressures which at time are listed as ?hypertensive crisis?.  I have seen several doctors including cardiologists, endocrinologists as well as my primary care physician in search of an explanation.  My blood work has been reported as normal, as well as my EKGs. I never experienced this pounding heart beat in my ear prior to my first vaccine. I have also been suffering from rapid heart rates with resting pulse at times being 100bpm or higher.  My doctors are at a loss- have described my symptoms as stress or anxiety related. I have been a practicing yogi and meditator for 28 years. None of this makes sense. The only thing I do know is that this began after my first vaccine. I have had three now-all Pfizer with the last (my booster) on 12/20/2021.  I hope this information is helpful. I know we are all learning about Covid, the vaccine and the side effects.
received Hep B vaccine in 4/2/2003, third dose that patient needs; drug dose interval too long; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 6-month-old patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 1st dose on 2nd April 2003).   On 4th August 2003, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, the patient did not receive the 3rd dose of Hepatitis B vaccine. On 4th August 2003, unknown after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comments: The patient received 2 doses of a Hepatitis B vaccine (brand name unknown). The pharmacist was looking for information about how to proceed with the third dose that the patient needs for the school. The did not consent to follow up. The permission for a follow-up was not asked to the pharmacist. Additional Supportive Information: The patient received 2nd dose later than recommended interval, which led to lengthening of vaccination schedule and till the time of reporting, the patient did not receive 3rd dose of Hepatitis B vaccine, which led to incomplete course of vaccination.
mom reports: fine red rash started approx 10 days following vax given 14FEB92; about 24FEB92 on pts chest & over 2 wks has spread up neck & on face; no fever reported, deneis pruritus or nay other problems;
PT with soreness to Rt arm to pneumonia vaccine. Also got a fever of 100.4. Pt called our office on 9/30 when symptoms resolved. Pt took MOTRIN and recovered.
2 cm x 1 cm hard red area right leg. Reaction at site of Prevnar.
uncontrollable shaking & fever of 102, back pain, rash on back w/aches all over body; prev flu inject w/o problem; 2DEC93 No response to request for recovery status;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Aug2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Feb2022 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Serious: No. The patient did not receive any other medication within 2 weeks of vaccination. The patient received Paxlovid as COVID-19 treatment from 13Oct2022 to 17Oct2022. The patient was previously received a COVID-19 Vaccine. Reported Event: Fever, cough, no taste, no smell, headache and patient was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Significant localized redness and swelling at the injection site. No hives or anaphylaxis demonstrated.
6/9/2021 The night of the shot he had chills and did not sleep well. 6/10/2021 He had a headache, so I asked him to come to my home to be monitored. By 12:30pm, he had fever, temp of 101.1 and back and knees hurting. No issues at the site of injection. We are calling doctor now.
Member contacted MDS on 5Nov08 with C/O erythemia, edema, pain, and tenderness to Rt arm. Member received Anthrax #8 2Nov08. Member's S/S radiate from the top of his shoulder to his elbow. Member advised to seek Tx at nearest appropriate medical facility. Member received Dx of "sever local RXN" and was instructed to follow up with his PCP in 2 days.
12 hours after vaccine I experienced whole-body joint pain and headache lasting about 6 days. 12 hours after vaccine I experienced pain in my testicles and lower abdomen I would liken to being kicked between the legs. This pain has lessened in severity but has persisted for over 21 days and has been accompanied by swelling of the Vas deferens. Approximately 2 weeks after vaccine, most of my fingernails began to separate from the  nail bed at the base near the cuticle. Approximately 5 days after vaccine my gums became swollen, and my tongue red and painful.
Ten minutes after receiving immunizations, patient got up from sitting on exam table to standing. Fainted after taking 2 - 3 steps towards the door to leave. Pt. was conversing; denied any problems just prior to standing up. Alert, good color, etc. just prior.
Had an extremely sore arm the next day after the shot. Nine days after first shot, in the afternoon suddenly started feeling faint, dizzy/vertigo, fatigue, and heart palpitations strong enough to make me cough from the pressure drop.
Hives started during the night but I realize now it?s dermatographia because i have all the symptoms. I?ve never dealt with hives so when it occurred I figured it would go away with time but now realizing I have skin writing (goes away within 20-30 minutes) and itchy skin, it?s something else that happened within 6-10 hours of taking the vaccine
I had a rebound like breathing reaction where it was harder to breath.  I had the paramedics  check my oxygen levels which were normal.  It mostly went away in a couple of hours but I am still having to breath a little harder than usual.
Patient received 2 doses of moderna after receiving a dose of Johnson &Johnson vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2 doses of moderna after receiving a dose of Johnson &Johnson vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson & Johnson vaccine on 07-Apr-2021.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2 doses of moderna after receiving a dose of Johnson &Johnson vaccine). On 30-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2 doses of moderna after receiving a dose of Johnson &Johnson vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.
Arm extremely sore with the pain going into my shoulders. That night my muscles in my upper arm and armpit were a little swollen as well. 6/23 I started with a headache mid-morning. About 10:00 PM I had a welt come up on my upper arm around the shot area. It is approximately 4" X 8". I still have it. My shoulders, neck, and upper back are hurting like I have the flu. The area has a burning painful sensation and is hot to touch.
Pregnant client was seen in clinic for immunization updates. Client was assessed and health history was reviewed. Client was pregnant and therefore the second dose of Varicella was not given. Client was given HPV9, which is cautioned and not advised during pregnancy. This vaccine should have been withheld until after the duration of the pregnancy. No adverse symptoms or events at time of immunization. An alert added to clients record to advise to review event at clients next appointment.
Weeks of low appetite, nausea, diarrhea. No treatment prescribed. Digestive system is still fragile. Supplements, nuts, other(?) substances bring nausea and diarrhea back.
Within 3 hours after shot got chills and severe muscle pain throughout my body. May have had a fever but symptoms were so painful that I was not able to get out of bed to check.  This lasted all night and didn?t subside til around 5am the next morning.  I have been receiving flu shots annually since I was in my 50?s and have never had an adverse reaction.
This spontaneous report as received from a Licensed Practical Nurse refers to a male patient of unknown age. On 15-FEB-2013 the patient was vaccinated with a dose of CERVARIX instead of a dose of GARDASIL (dose, route, lot number not provided). No product confusion discovered, just medication error. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
Information Has been received from a nurse concerning a 19-20 year old female patient who around the end of 2007, was vaccinated with the first doe of GARDASIL. The patient had no medication history. The nurse reported that the patient experienced irregular menses after receiving GARDASIL. The patient sought unspecified medical attention.
mom called 20AUG98 & reported child becoming flushed approx 2hr p/vax given;next morning rash on face devel;mom reports rash itchy but now almost resolved;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-FEB-2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed ZOVIRAX and NORCO for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The pt received a TD for facial abrasions on 3/12/01. On 3/15/01 she returned for a follow-up of injury and mentioned her right are was painful. She was placed on antibiotics.
two allergic reactions; This is a spontaneous report from a contactable pharmacist via a program. A contactable Pharmacist reported similar event for 2 patients. This is 1st of two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER Covid-19 Vaccine, formulation: solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced two allergic reactions. Outcome of the event was unknown.   No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021323766 same reporter/drug/event, different patient
Less than 24 hours of vaccine administration, left leg became quite swollen and red from thigh down to knee.  Warm to touch.  No pain on palpation.  Able to walk.
Pt got a drop of vax on her skin; area became red w/ irregular shaped area, erythema & pruritus
Child had Dtap and Hib vaccines the morning of 06/14 at 0956. mother reports that child broke out with hives at about noon that day. Mother further reports that child had hives until Saturday, 06/16. Reports would give Benedryl and hives would go away, but would return after medication wore off. All hives were on his chest and belly.
Speech was very slurred. Very dry mouth, slept 20 hours straight thru. All of these symptoms started about 2 hours after the vaccination. Still sluggish at 09/18/2010. Fever.
PATIENT REPORTS REDNESS, TINGLING DOWN ARM, PAIN THAT CONTINUES 8 DAYS LATER
Felt head was about to explode. Settled in chest. Muscle aches. Worst flu ever.
I went to the ER for what I believed to be kidney stones based on past experience a CT scan was done as well and gall stones were discovered. The Kidney stone past and at a follow up appointment with my PCP I was referred to a General Surgeon for the gall stones and the General Surgeon removed the gallbladder on 27FEB2023.
Chills, sporadic fever, shivering, body aches, low appetite, slight dizziness, lasting so far 3 days,
Mother stated her child woke up with hives on arms and legs. Child has history of rashes after all shots, however never hives and never this extensive.
Employee noted swelling and slight warmer to touch at injection site a couple hours after administration.  No other symptoms. Site was observed by  myself and PA who instructed employee to apply ice and take Motrin if needed.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13 single dose and FLU VACCINE VII, both in the same arm via an unspecified route of administration, on an unspecified date for immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced extreme redness and swelling on an unspecified date with outcome of unknown. It was noted that it was more prevalent when injecting the influenza vaccine and pneumococcal 13-val conj vac (dipht crm197 protein) in the same arm.
Admitted for COVID. symptoms started about 1 week prior to admission, received Regeneron day of admission at a different facility.  after admission pt started on supplemental O2 and decadron but refused remdesivir.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:22 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.07 years.  Concomitant products were not provided.  Batch number 031A21A administered on 20-Mar-2021 underwent temperature excursion with temperature range 34 degrees Fahrenheit at 09:00 am and 37 degrees Fahrenheit at 10:00 am. Vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Initial case was received from a health care professional on 15 October 2013. A female patient (age unknown) had no medical history reported, received a dose FLUZONE HD vaccine intradermally on an unspecified date in 2013 (site, batch number not reported). Patient had not reported concomitant medication. It was reported that on an unspecified date on 2013 patient experience 3.5 cm red and swollen at injection site. No corrective treatment was reported. At the time of report the outcome of event was not recovered.