chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm hurt for about a day or so at the injection site.  I test positive for COVID-19 on 07/12/2022 with a home test. I went to a clinic but they did not let me in.  They contacted me  while I waited in the car. I was advised I was not eligible to take Plaxlovid due to  my current medication. I was referred to the hospital to receive the antibody infusion.  I started feeling better in two days.
Suspected Vaccination Failure; Had the shot.......got shingles.......; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she received the Shingles shot and got the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Beginning the evening I received the second Moderna vaccine, approximately 6 hours after receiving the shot, I started to feel flu-like symptoms--lethargy, headache, body aches. By about 11 I had a fever of 102. I went to sleep and woke up at 8am on the 19th with a fever of ~100.5 which lasted on and off all day, along with the same flu-like symptoms. On the 18th and 19th I took Tylenol for achiness and fever. By morning of 20th, I was still a little tired, but the fever was gone and I did not feel sick.  I have not had any additional issues since then.
Soreness, dull pain and weakness on left shoulder various days and weeks following the flu shot. Over time, has continually been bothersome and sore when doing chores such as lifting cups and glasses, crossing over body to wash, dress such as put on my bra and blouses. Cannot exercise well, sharp pain at times if lift overhead or try to do pushups.
Menstruation was extremely heavy for 8 days which is unusual (periods normally last 5-6 days), then I have continued light bleeding for the last 5 days.  This has never happened before where I bled for 13+ days straight.
sore arm; inappropriate schedule of drug administration; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of drug administration) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of drug administration). At the time of the report, MYALGIA (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of drug administration) outcome was unknown.            No concomitant medication  information was provided by the reporter.  No treatment information was provided by the reporter.  Patient took second dose on 14-JUL-2021 (039A21A) in his eft arm.   This case was linked to MOD-2021-281234 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Followup received on 09-Aug-2021. Patient DOB was added. First dose of vaccination date was updated and second dose details were added.New events (sore arm, inappropriate schedule of drug administration) added. Pre-existing event (missed dose) deleted. Corresponding fields and narrative were updated accordingly.
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age. On 2008 the patient was vaccinated with a pediatric dose of RECOMBIVAX HB 0.5 ml, intramuscular and then in January 2014, the patient received an adult dose of RECOMBIVAX HB 1 ml intramuscular. No adverse effects were reported. Additional information is not expected.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day as Moderna COVID-19 Vaccine to the patient. It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.     On 11-Feb-2022 at 1:38 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Feb-2022 at 1:38 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Ethnicity of the patient was reported. Patient received the booster dose of Moderna COVID-19 vaccine. No concomitant drug information was provided.  The 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg exp date of 04-Apr-2022  No treatment drug information was received.   This case was linked to MOD-2022-542869 (Patient Link).
A high temperature of 102 within 12 hours, extreme vomiting, aching in joints, and extreme redness in the right arm, and swelling from upper arm to elbow. I took Advil for swelling and Tylenol for fever. After 48 hours the fever is down, the right arm is still red and the swelling is down 30%.
Janssen CFOVID-19 Vaccine EUA I have had tinnitus for about 7 years.  It developed following an ear infection.  It's been at a manageable level for several years.  I started noticing that the noise in my ear was stronger/more noticeable/more annoying a couple of days after being vaccinated.  The noise actually woke me up out of my sleep.  I have to sleep with a sound machine and the sound machine is no longer masking the noise.  It has been about 10 days and the intensity level has not abated.
Red, raised rash on both fore arms extending from elbow to and around wrists.  On 29-Mar-2021 began the following treatment as prescribed by physician: Prednisone by mouth for 5 days  (5, 4, 3, 2, 1 daily) Steroid cream 2x daily Zyrtec 1x per day (AM) Benadryl every six hours / as needed  Rash responded well to treatment and diminished over a 1-week period.  No further issues.
The scheduling appointment system scheduled the patient to come back after 2 weeks to get the 2nd dose. After the dose was administered, a red flag popped up for the error. No known adverse reaction reported.
Redness, swelling of left lower extremity from mid thigh to knee. Fever at home not documented at office. Also had limping. Patient had received PCV13 4/17/2013.
2 inch long X 3/4 inch wide red and swollen rash on the shot area, feeling hot and hurting. Onset on shot date (10/09/10), persisting till 10/13/10 for 4 days and gone. Pt. was told to apply ice packs and take OTC anti-inflammatories (TYLENOL/iburprofen) in the meanwhile.
full arrest @ home, CPR started, taken to hosp;full code gave, pronounced expired @ 2229;
Pt states 5-6 flat red spots, ~1/2" wide, with "microblisters" in the center of each one that have bruise-like soreness only upon depression of the area, slowly developed below the injection site starting about 18 hours after the injection. Pt states no similar reaction after 1st injection, and no other issues with this 2nd injection. Pt denies exposure to anything else (ex: poison ivy, etc) that could have caused a similar type of response.  Recommended a dose of Benadryl and watch for any resolution. If rash started to resolve, recommended a 2nd dose of Benadryl. If rash continued or worsened, advised ER or paging PCP.
None after the vaccine injection.  In late March, patient (myself) started having chest pains intermittently.  Tightening of chest, as if someone was squeezing my insides just in between my breasts.  Pain would last 4-5 minutes, then stop.  Would happen once a week or so.
Info has been received from a physician concerning a 5 year old female who, in approx. 2001, at 12 months of age, was vaccinated with a dose of varicella virus vaccine live. On 5/4/05 the pt had a mild case of breakthrough. This case was verified by the nurse, but she was not seen by a doctor. The mother used over the counter medications to make the child comfortable. Unspecified medical attention was sought and the child recovered. No product quality complaint was involved. Additional info has been requested.
Urticaria on both left and right sides of trunk (under arms) and along inner upper thighs.  Began along right side and progressively spread to left side, then to thighs. Treated with 25 mg oral diphenhydramine.
interstitial lung disease; 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. In or around 12-JAN-2012, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after zoster vaccine live (ZOSTAVAX) the patient suffered shortness of breath, dry and hacking cough in which symptoms did not resolve. The patient was diagnosed with interstitial lung disease. Symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition; sustained severe and permanent personal injuries suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter considered interstitial lung disease to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review interstitial lung disease was determined to be medically significant. Interstitial lung disease was considered to be disabling.
, I experienced very unpleasant and troubling side effects up through April 8.  Because the symptoms weren?t listed as side effects, it was only because a friend experienced the same thing after both her first and second Shingrex shot that I knew it was related.  The side effects come and go and were extreme at times.  I was confused, irritable, anxious, temperamental, and had sensations in my skin that were strange, but I cannot describe in words.  Although I do want to be protected against the Shingles, I am very hesitant about getting the 2nd shot.  Please provide your thoughts and guidance.
Information has been received from a physician concerning a female patient who on 5/12/03 was vaccinated on the left side with a dose of varicella virus vaccine live (lot # 641599/0204M). Concomitant vaccines that day included a dose of MMR and a dose of HIB conjugate vaccine. Subsequently, the patient developed shingles on the right side of the groin, lower hip and buttocks. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
GOT COVID-19 AFTER VACCINATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced got covid-19 after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid-19 after vaccination was not reported. This report was non-serious.
While administering the dose the syringe separated from the needle in mid injection and an undetermined amount of the vaccine escaped onto the patients arm.  Manufacturer was contacted  and they advised that we not repeat the dose.
C/O 3 DOTTED RASH(1 ON LIP, 1 ON EACH ARM). NO TRANSPORT
Lost of strength in left arm. Symptoms improve after a few days, however when working out the arm becomes extremely sore as if the vaccine was given again.
Trouble breathing; stomach problems; Exhaustion; over all feeling of sick; headache; This is a spontaneous report from a contactable consumer who reported for patient (son-in- law). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number/ NDC number/ Expiry date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced trouble breathing, stomach problems, exhaustion, over all feeling of sick and headache. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021527264 same reporter/drug/event, different patient
Patient contracted covid after being fully vaccinated. Exposure to a positive caregiver.  Cough, fever, congestion
trouble breathing; She had bad pain in her chest; Her oxygen saturation dropped to 92 and it is usually 98 or 100; not been feeling well; A fast heartbeat 5-10 minutes after initial dose; This is a spontaneous report from a contactable healthcare professional (dental assistant) reporting for self. This female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously had reactions with the flu shot in the past for immunisation and she only was able to take the vegan version of the flu shot due to the egg content in the regular version of the flu shot. She also stated not being able to take the flu shot in the arm, leg, hip etc. Patient stated she was scheduled to take her second dose of vaccine tomorrow. She received the first dose on 22Dec2020. She stated she was in the ER on Monday for 5 hours because she was unable to see her primary care physician because his office was filled with patients with Covid and they could not provide her with guidance. She stated after receiving the first dose of vaccine she had not been feeling well ever since. Stated she had had trouble breathing and this took her by surprise. She had bad pain in her chest and a fast heartbeat 5-10 minutes after initial dose (on 22Dec2020). Her oxygen saturation dropped to 92 and it was usually 98 or 100. She stated something inhibited her ability to breathe and this scared her because she was healthy prior to the vaccine and never been in hospital and wasn't born in the hospital. She stated the condition she was diagnosed with will take 6-12 months for her to recover from and go back to normal. She stated during her ER room visit there were a lot of tests done. She would like to know if she should receive the second dose of the vaccine. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dyspnea, chest pain, oxygen saturation decreased and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, arterial blood gas and pulmonary function tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Received the injection at 17:20 on 12/22/20 and had no immediate symptoms. At 23:00 hives and itching on chest, arms, back, and legs. Arm soreness at injection site. Soreness improved with oral tylenol. Hives did not resolve. Asymptomatic after taking oral benadryl at approximately 7:00 on 12/23/20
around midnight on 04Mar2021, she started throwing up; she got very, very nauseous with the second COVID-19 Vaccine shot; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 15:00 (Lot number: EN6198) at the age of 87 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cerebral palsy" (unspecified if ongoing), notes: Reported she has had cerebral palsy for almost 88 years. No further details provided. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Administration Time: about 10:30 AM, Route: Intramuscular, Anatomical Location: Arm Right, Lot Number: EN5318), administration date: 09Feb2021, when the patient was 87 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 03Mar2021 22:00, outcome "recovered" (04Mar2021), described as "she got very, very nauseous with the second COVID-19 Vaccine shot"; VOMITING (non-serious) with onset 04Mar2021, outcome "recovered" (04Mar2021 06:00), described as "around midnight on 04Mar2021, she started throwing up". Additional Information: The patient reported she didn't want to take the COVID-19 Vaccine, but her three daughters wanted her to take the COVID-19 vaccine. She said she was concerned something may occur down the road from taking the COVID-19 Vaccine, and that was why she didn't want to take the COVID-19 Vaccine. The patient avoided eating while she was nauseous and throwing up. There was no additional vaccines administered on the same day of vaccination of BNT162b2. The events did not require emergency room or physician office visit. There was no vaccine administered within 4 weeks prior COVID-19 Vaccination. Vaccination facility type: hospital, vaccine was not administered at military facility. No relevant rests/investigations performed.  No follow-up attempts are possible. No further information is expected.
Painful joint in recently operated on right hip. Surgery was extensive full hip revision. Soreness started around 7 hours after dose was received and I?m still experiencing it after 24 hours. Additionally, I also have normal side effects reported (soreness at injection site, fatigue).
Syncope- Roughly 5-7 minutes after administration of the covid vaccine, patient was standing next to her father near drop-off at the pharmacy and passed out , falling backwards, hitting her head off the floor.
Our friend received the Pfizervaccine and was feeling tiredafterwards.; This is a spontaneous report from a contactable consumer. A female patient of unknown age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. On an unknown date, the reporter was speaking to a friend and she said their friend, the patient, received the Pfizer vaccine and experienced feeling tired afterwards. The clinical outcome of the event feeling tired afterwards was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No adverse effects reported; Inappropriate administration schedule; This spontaneous report was received from a pharmacist refers to a 13-year-old male patient. No information regarding the patient pertinent medical history, concomitant medications, drug reactions or allergies was provided.   On 21-JUL-2018, when the patient was 12-year-old, he was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported). On 17-NOV-2018, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported). No additional doses administered. No adverse effect was reported.
Tested positive for COVID-19 on June 25th, 2022. Sore throat, chest congestion, body aches.  Urgent care visit on July 7th due to no improvement/worsening symptoms.  Was diagnosed with Bronchitis and Sinus Infection. Was prescribed steroids and antibiotic.  As of today, 7/11, symptoms are improving but still battling extreme fatigue, tightness in chest and cough.
Patient was given the moderna booster at the age of 13 which is not approved for his age group.