chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Signs/Symptoms: Itching (to face, mouth and to a lesser degree the arms and legs).
It was a slow onset of me waking up. I started having fever that so I took ibuprofen (600mg) and Tylenol (1300mg). I had a headache for an entire month. The headache was in the front behind my eyes. The headaches flared up making the fever worse. The last two weeks my heart rate has increased I have a hard time walking around because of it. I also developed pneumonia and high d-dimeer levers the doctor talked to me about the concerns of blood clots Feb 24. They were also worried about my lungs and I have been having shortness of breath for the past two weeks.
headches; syncope episodes; fall; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 31-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 01, Lot: EK9231, Expiry Unknown, Route: Intramuscular), administration date: 29Dec2020, when the patient was 29-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 02, Lot: EL3249, Expiry Unknown, Route: Intramuscular), administration date: 19Jan2021, when the patient was 29-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 03, Lot: EW0176 , Expiry Unknown, Route: Intramuscular), administration date: 15Oct2021, when the patient was 30-year-old, for COVID-19 Immunization. The following information was reported: FALL (non-serious) with onset Sep2022, outcome "unknown"; SYNCOPE (medically significant) with onset 22Sep2022 at 06:30, outcome "unknown", described as "syncope episodes"; HEADACHE (non-serious) with onset 22Sep2022 at 13:30, outcome "not recovered", described as "headaches".  Clinical information: Caller states that, She received the Bivalent booster last week Thursday. This morning, after a good night sleep, she was getting ready for work and experienced a syncope episode. This is the first time this has happened. She basically has been resting throughout the day and is also having headaches. This is occurring 1 week out from the day that she got the booster. She doesn't have any stressors, she is not diabetic, she does not have low Blood pressure, she does not have low Blood sugar, she is well hydrated, she doesn't know why the syncope episode and headache happened. The Syncope episode happened today at 6:30AM. The headache also started today, after her fall, she rested and woke up, and since then she has had a headache, the headache has been since 1:30PM.   Causality: For syncope it is Unknown because she didn't have any precipitating factors, she doesn't know if there have been other cases that have been reported 1 week out of receiving the vaccine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal association of suspect drug BNT162b2, BNT162b2 omi ba.4-5  cannot be excluded for reported events -Syncope, Headache and Fall. 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
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, lot number and indication not provided). On an unknown date, the patient experienced inflammation and a rash around the injection site after receiving the PNEUMOVAX 23 vaccine. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient notified facility on 12/21/20 that he had residual injection site tenderness and muscle discomfort. He denied any significant adverse reactions and no inability to function.
Next morning woke up with small rash on upper back right side that burned especially with clothing, lasted all day but was gone by evening. Also I have postherpetic neuralgia from Shingles (diagnosed September 5, 2017). The pain is from the umbilicus to mid back spine on right side and somewhat controlled with Gabapentin and Nortriptyline. The burning pain was noticeably increased the next morning after the vaccine and lasted for about 48 hours.
over a month since first shot; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over a month since first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over a month since first shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over a month since first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Information has been received from a license practical nurse concerning two patients who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). the reporter stated that the patients had developed a severe local reaction, and redness and swelling elbow to shoulder. This was a revaccination for both patients. The reporter wanted an investigation into the lot number. In follow up information the nurse reported that one of these patients was a retired white 67 year old female patient with hyperlipidemia and hypokalemia who was vaccinated into the deltoid at 3:15 on Sept 207 2004 with second dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). The patient was not ill at the time of vaccination. On Sept 27 2004 at 8:00pm she developed an arm that was sore, red, feverish and swollen from the shoulder to the elbow. The patient had recovered from her experiences. the second patient that had an experience after vaccination with pneumococcal 23v polysaccharide vaccine was assigned WAES0410USA03658. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse also reported patient experiences following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0409USA01988, WAES0409USA00219, WAES0409USA02427, WAES0409USA00780).
4.5 cm x 7 cm Erythema/edema localized to Inactive FLU vaccine injection site.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 07-SEP-2013, the patient were vaccinated with a dose of ZOSTAVAX (lot# J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
her son was vaccinated at the same time and he has absolutely no side effects other than a sore arm for a couple of days; This is a spontaneous report from a contactable Nurse. This Nurse (Patient's mother) reported that a male patient of an unspecified age received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. The medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm for a couple of days. The outcome of the event was unknown.  Additional information about Batch no/ Lot no. has been requested.
Pt woke up yesterday and has swollen glands under her armpits and both sides of her jaw. They are uncomfortable. Today they seem to be similar size. Patient is treating glands with anti-inflammatories (ADVIL) and monitoring. If it doesn't get better or gets worse, she will go be seen by MD.
After the vaccine was given, patient advised vaccinator that his first 2 doses were AstraZeneca.
Patient was accidentally given a half dose (0.25ml) of Moderna even though he should have had 0.5ml since it was his first COVID vaccine. We attempted to contact the patient the next day to recommend repeat vaccination with the full 0.5ml dose. We sent him text messages, called his phone (were unable to leave a voicemail) and went to his residence, but were unable to get in touch with him.
Initial report was received on 04 September 2014 from another manufacturer nation service center (service request number 1-12238167852), who received the report from a health care professional. An unidentified patient had received  a smallpox vaccine (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a severe reaction including severe swelling and fever. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Depression/anxiety, treated unsuccessfully with Lexapro, currently trying Wellbutrin 75 mg 1x daily, some improvement PS I wasn't sure if item 15 was about the place I got the vaccine or the place I got treatment for the adverse event, it was the latter, I got the vaccine in a vacant parking lot, no idea the address
Red, itchy 2.5 inch in diameter raised spot on my injection arm.  Tender to pressure and skin is hot in that area.  Appeared 8 days after injection.
Vials that were more than 30 days in refrigerator administered to patients; Out of specification product use; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vials that were more than 30 days in refrigerator administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Out of specification product use) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were more than 30 days in refrigerator administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Out of specification product use). At the time of the report, PRODUCT STORAGE ERROR (vials that were more than 30 days in refrigerator administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Out of specification product use) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment history was reported. HCP would like to know what to do with patients who received doses from vials that were more than 30 days in the refrigerator. They were stored from 2 to 8 °C.
Second dose earlier than the recommended dosing window; A spontaneous report was received from a registered nurse for a 35-year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and receieved the second dose earlier than the recommended dosing window.    The patient's medical history was not provided. No concomitant product use was reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Feb 2021, approximately 19 days apart, patient received second of the two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient received second dose a little early.  No AEs were reported and no treatment medications were reported.  The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, received dose earlier than recommended dosing window, was considered recovered/resolved on 03 Feb 2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # 013M20A  with no associated AEs.
Redness, indurated area approximately 8cm at IM site with associated shooting pain & transient numbness of (L) arm & hand.
EMPLOYEE DESCRIBES NUMBNESS TO BILATERAL LEGS ON 7-07-08. STARTED HAVING WALKING DIFFICULTY ON 7-8-08 - 7-09-08.  HOSPITALIZED ON 7-09-08 UNTIL PRESENT. 7/30/08-records received for DOS 7/9/08-admitted with back pain subsequent development of numbness in both legs, lower back, difficulty walking and urinary incontinence with no bowel movement for past 2 days. Presented on 7/8/08. Symptoms started 3 days before admission.  PE:Romberg positive, weakness left lower extremity, sensory exam reduced vibration up to both knees. 8/7/08-DC Summary received for DOS 7/9-7/23/08-DC DX: T6 sensory level neurologic deficit with neurogenic bladder and fever, rule out acute transverse myelitis, rule out Guillain-Barre. Obstructive sleep apnea on CPAP.  8/27/08-CDC's CISA staff reviewed this case and determined that it is Transverse Myelitis and not GBS.
Left upper arm, area of redness/swelling/warm to touch. Area is round and approx. 3.5 inches in size. Patient complains of sore arm and some itching at site of injection. Patient reports that symptoms began appearing on 04/03/2019 in the morning. Patient reported symptoms on 04/05/2019, stating symptoms have improved slightly. Recommended patient to take ibuprofen, oral Benadryl, and cold compress to affected area.
Red, indurated lesion at the injection site 3cm in diameter.  No evidence of cellulitis and it is not warm to touch.  Ice pack applied.
Child in exam room with mom. Injections given. Timer set 10 minutes. After 5 minutes, mom yells out, entered exam room to find child pale, slumped in chair. Put head between knees, applied cool cloth to neck and forehead. Talking to child entire time. Recovered approx 1 minute. Given H2O. Waited approx 7 minutes. Left office alert.
A non-serious report of administration of expired FLUMIST was received from a military non-commissioned officer and a health care professional an 18-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
nurse drew up covid vaccine with diluent, when giving vaccine to patient, nurse did not realize that the vaccine just given was 3 total doses of vaccine 0.9 ml instead of 0.3.  notified patients mother immediately and primary provider.  checked on patient multiple times that day afterward. denies any side effects or symptoms of anything.
nausea; vomiting; headache; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (not pregnant, occupation: pharmacist) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced nausea, vomiting and headache on an unspecified date. It was unknown if treatment received for the adverse events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Developed hives 48 hours after 2nd vaccine- persist, itching, low grade temp and headache.
On 09/28/2000 the pt received one dose of Lymerix. On 10/12/2000 the pt had a positive pregnancy test. The pts last menstrual period was 09/07/2000; the estimated delivery date is 06/14/2001. Follow up states that the vaccinee had four previous pregnancies resulting in normal births. On 06/20/2001, at 40 weeks gestational age, the vaccinee delivered a male infant by spontaneous vaginal delivery. Birth weight was eight pounds and nine ounces. Neonatal status was recorded as "normal." His apgar scores were 8/10at one minute and 9/10 at five minutes. Mother and infant experienced "no complications" and "no problems."
This spontaneous report was received from a physician via two company representative and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit (8.222222222 degrees Celsius), the second lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit (8.444444444 degree Celsius), the third lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit (8.611111111 degrees Celsius) and the fourth lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit (15.5 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
I administered the vaccine and patient sat in the lobby for a few minutes while I was filling out her paperwork. Patient become clammy and dizzy. Patient begin having seizure. I was going to stick her with the EPIPEN if she stopped breathing but patient became response. She was transported to the emergency room.
Information has been received from a Registered Nurse referring to a 14 year old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 20-JUL-2015 the patient was inadvertently vaccinated with ZOSTAVAX (lot#, dose, route not reported) instead of VARIVAX. Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
After Receiving the Moderna vaccine. I did not get my period. I've only skipped my period twice in my life. This is a serious side effect and more women should know about this symptom. I thought I was pregnant ( I was not), however when I took a test and it was negative. This was even more concerning for me. Can the Vaccine interrupt fertility for woman.  My period finally came 58 days later from the END of my last menstrual cycle in June. This was my first dose and I am due for my second on 28 August. Periods Missed: 1st Time: When I was pregnant with my son. 2nd Time: After I was vaccinated - I was 58 days late.
metallic taste ,  arm  swelling, itchy arm, 50cent size raised swelling, red, painful hot to touch.  24 hours later 3x2 inch swelling raised area, hot to touch arm swelling
Patient was going to pass out when receive the Trumenba and also given Menactra at the same time; Patient got very dizzy; This is a spontaneous report from a contactable physician via Pfizer sales representative.  An 18-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose, and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration at unknown dose, both on an unspecified date for immunisation.  The two vaccines were administered at the same time. The patient medical history and concomitant medications were not reported.  The patient was going to pass out when received the two vaccines at the same time and the patient got very dizzy on an unspecified date. The outcome of the events was unknown.  The information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 (TRUMENBA) contributed to the development of the reported events passing out and dizzy.
Temperature of 99.8 degrees and muscle pain all over the body like the flu. Took Tylenol, low heat pack on where I got the shot in my arm and tool epsom salt bath a few times. Fully recovered within 48 hours.
Fever 100.4, chills, soreness at site of Shingrix vaccine,  flu like symptoms
My entire upper arm has ached continually since I had the shot and I have sharp pains in the muscles in much of my upper arm when I move it. I can barely lift the arm on its own. The pain keeps me awake at night and makes it difficult to even change positions in bed due to the sharp pains the movement causes. I spoke to my doctor's office last week and they instructed me to take Advil every 4 hours and use moist heat on a regular basis. I've been doing that since but it has not helped. They were referring to the injection site, so I am not sure they understood how bad the symptoms are. I was going to give it until the end of this week and make an appointment to get checked if still not improved by then. Just a follow-up to my e-mail of yesterday. Today is really bad. I now have swelling in my upper arm along with the pain (I'm talking shoulder to elbow upper arm) and feeling a strange sensation. King of a tingling with cold or hot, I can't figure out which. One thing that seems to be a common denominator from those I've compared notes-Where she gave the shot and where she put the band-aid were not the same. The shot was higher than the band-aid. I'm beginning to wonder if she simply missed where she was supposed to inject and that is why we are having problems.
Erythema and induration at vaccine sith with bruising. Began 04/12/2003 worse 04/13/2003. Slight improvement 04/14/2003. Follow up scheduled 04/21/2003
Severe pain at shoulder when vaccine was injected. Tingling in arm. Some of pain went away but still soreness of arm. Mother suffered the same reaction. Took mother 3 days for her arm to recover. Most painful inoculation patient got.