chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very tired; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Very tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 25-Mar-2021, the patient experienced FATIGUE (Very tired). On 25-Mar-2021, DIZZINESS (Dizziness) had resolved. On 27-Mar-2021, FATIGUE (Very tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included high blood pressure medication. Treatment for the event included none.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received, TCR added. It does not contain any new information.
BPPV VERTIGO, NO TREATMENT, BUT MANEUVERS.  IN GOOD HEALTH UNTIL I TOOK VACCINE. Last shot 4/24/2021 - BPPV VERTIGO - 5/11/2021
Patient got lightheaded and felt like her throat was closing up. Was lied down on the floor and lung sounds/pulse were checked. Patient stated that her coworkers stated that she looked pale. Patient's first vaccinated. 1:15 pm, Pt placed on back with pink color with complaints of difficulty breathing. AOCx3, no wheezes heard upon observation. Pulse was 110 BPM. 1:20, Pt continued to explain of difficulty breathing with now complaint of tongue feeling t0o big. When offered grape juice. Call placed to 911. Epi given R arm 1:1000, # 682492. 0.5 given by lead RN. 1:30pm, pt remained stable with complaints of heavy chest lessened. Paramedics arrived 1:35pm, pt walked with help to stretcher.
SKIN BECOME BLUEISH WHEN TOUCH TO SKIN; TIGHTNESS IN LEFT LEG; SHAKING LEG; HEART PALPITATIONS; NOT SLEEP AND WAKES UP AT NIGHT; CANNOT GO TO WORK; LEFT LEG PAIN; BOTHERING HEADACHES; PAIN IN LEFT EAR; DIZZINESS; VERY BAD FEVER; PAIN AT SITE OF INJECTION; HOT FLUSHES; BLURRED VISION/LOOSING VISION; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 29-DEC-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced pain in left ear. On 30-SEP-2021, the patient experienced dizziness. On 30-SEP-2021, the patient experienced hot flushes. On 30-SEP-2021, the patient experienced blurred vision/loosing vision. On 30-SEP-2021, the patient experienced very bad fever. On 30-SEP-2021, the patient experienced pain at site of injection. On an unspecified date, the patient experienced skin become blueish when touch to skin, tightness in left leg, shaking leg, heart palpitations, not sleep and wakes up at night, cannot go to work, left leg pain, and bothering headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bothering headaches, and pain in left ear, and the outcome of very bad fever, pain at site of injection, dizziness, skin become blueish when touch to skin, tightness in left leg, shaking leg, hot flushes, blurred vision/loosing vision, heart palpitations, left leg pain, not sleep and wakes up at night and cannot go to work was not reported. This report was non-serious.
could hardly walk and she is having problem walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "could hardly walk and she is having problem walking".  Additional information: Reporter stated, my wife had the COVID shot couple of days ago and she has got bad problems yesterday and today she could hardly walk and she is having problem walking but is, has less then listed so, I am just wondering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
AS LISTED IN #17 , I RECEIVED A TEXT AND EMAIL FROM THE COUNTY ON THE 20TH TO REPORT FOR THE 2ND SHOT ON THE 21ST, WHICH I DID, WHICH WAS A WEEK TO SOON AND NOT 1 OF THE 4 PEOPLE WHO LOOKED AT MY VACCINE CARD TOLD ME I WAS THERE TO SOON. AND THEY PROCEEDED TO GIVE ME THE SHOT. I WAS ALSO UNAWARE THAT I WAS THERE TO SOON UNTIL THE ADVERSE AFFECTS STARTED THE NEXT DAY. THAT'S WHEN I LOOKED AT MY CARD AND NOTICED THE MISTAKE. THE ADVERSE AFFECTS WERE AS FOLLOWS: FIRST CAME SHARP STABING PAINS MOVING TO VARIOUS PARTS OF MY BODY THEN CAME COMPLETE FATIGUE WITH INTERMITTENT FEVER AND CHILLS THEN CAME STOMACH ISSUES WITH DIARREA THEN CAME SEVERE SHORTNESS OF BREATH AND SOME CHEST PAIN I AM RECOVERING SLOWLY BUT STILL FATI
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 09-FEB-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Afternoon of 7/7/2017 patient started getting a fever. This quickly jumped to 102 F during her nap and resulted in a febrile seizure. She was admitted to the emergency department, where they found a mild UTI that they associated with the fever and she was dishcarged with an antibiotics prescription, but there were no other signs of a UTI (pain urinating, reluctance to urinate, etc) exhibited by Arielle. The next day she complained of a sore throat, and had canker-like sores all over her mouth/tonsils. Her fever continued three days until it resolved and the symptoms were treated with Tylenol along with her antibiotic. So mainly: Febrile seizure, sores in throat.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. Since 28-OCT-2016, on multiple unspecified dates, these patients' were vaccinated with improperly stored doses of VARIVAX (lot # M027342, expiry date 01-JUN-2018) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. On 13-OCT-2016, the vaccine was exposed to the temperature of minimum 9 degree Celsius and maximum 25.5 degree Celsius for 2 hours and 18 minutes. On 28-OCT-2016, the vaccine was exposed to the temperature of minimum 9 degree Celsius and maximum 25.5 degree Celsius for 2 hours and 57 minutes. There were no previous temperature excursions. The temperature excursions were recorded by a data logger. No product quality complaint was involved. This report is linked to case# 1611USA004361, due to same reporter source. Additional information has been requested.
Minor arm swelling & hardness day after vaccine, which resolved. Sx returned and progressively worsened on 1/13/21. Was admitted to hospital on 1/15/21 and remains under treatment.
Information has been received from a RN concerning a 7 yr old white female with no known medical history or allergies who on 07May99 was vaccinated in the left thigh with a 0.5mL first dose of varicella virus vaccine live (lot629254/1849H). It was noted that on 03Jan06 the mother called the physician stating that on 02Jan06 the pt came down with a rash. On 03Jan06 she was seen by the physician in the office. The pt complained of multiple varicella lesions on the chest, back, head, mouth and vaginal area. The pt was diagnosed with breakthrough chickenpox. The physician ordered diphenhydramine hydrochloride (Benadryl) and avena (Aveeno bath). At the time of the report the pt was recovering. There was no product quality complaint involved. Breakthrough chickenpox was considered to be an other important medical event (OMIC). Additional information is not expected.
Localized allergic response on her arm; Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite; Injection site hard; Arm was sore right away; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Localized allergic response on her arm), ERYTHEMA (Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite), VACCINATION SITE INDURATION (Injection site hard) and VACCINATION SITE PAIN (Arm was sore right away) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA), SERTRALINE HYDROCHLORIDE (ZOLOFT), ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Injection site hard) and VACCINATION SITE PAIN (Arm was sore right away). On an unknown date, the patient experienced HYPERSENSITIVITY (Localized allergic response on her arm) and ERYTHEMA (Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site induration and Redness, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Localized allergic response on her arm), ERYTHEMA (Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite), VACCINATION SITE INDURATION (Injection site hard) and VACCINATION SITE PAIN (Arm was sore right away) had resolved.            Concomitant products included unspecified statin.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received: contains updated event outcome.
THe wrong amount of diluent was used when drawing up this vaccine. 0.8ml was used rather than 1.8ml resulting in a more concentrated dose administered to this child.   Vaccine protocols were in place but the nurse who was drawing up the vaccine did not use the correct diluent amount.
ACHING & SWELLING IN JOINTS (HANDS/ELBOWS/KNEES) WITHOUT RASH, REDNESS OR FEVER LASTING APPROX 7 DAYS. TOOK ONLY OTC MEDS FOR SYMPTOMS.
Pt reported swelling, redness on 1/30/13 on the area ((R) SQ upper arm) where she received a shingles vaccine on 1/29/13. Pt was given per PA 500mg of ceftriaxone IM. Pt tolerated well and is scheduled for a f/up on 1/31/13 for an additional injection & re-evaluation.
PT developed a fever of around 102 as expected about a day and a half after his second dose. After four days I called the nurse at his pediatrician and she said kids his age can have fevers longer than adults did, and not to worry if it lasted a week. He ultimately had a fever for nine days, slowly lowering to 99-ish the last few days. He felt relatively fine throughout, only a little tired the first couple of days. I do not consider this a serious reaction (especially as the nurse said not uncommon). He did not see his pediatrician in person. I'm only reporting it bc the VSafe person I talked to said to.
Client became light-headed, dizzy, and pale after vaccination. Client lost consciousness for a few seconds and jerked but came too and knew where he was. Crackers and water given. Talked to father on the phone. Color returned and he stated he felt much better. Father came to health dept and client left with father.
Dx. Cellulitis. Tx: Hydroxyzine; NAPROSYN x 10 days
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient's husband stopped by the pharmacy on 10/2/2015 to report that his wife described the site around her Zostavax injection as red and swollen. He said that his wife did not report any itching. He also said that she was currently out of town so he had not seen the rash in person. He inquired about what he could tell his wife to do for her symptoms and I told him to have his wife apply ice to the area and take some diphenhydramine in case of allergic reaction. I plan on following-up with the patient in a couple days and also told him to call if the symptoms do not improve.
COVID arm; Injection site hard; Injection site  area was red.; INJECTION SITE RASH; Injection site  inflamed / area was red.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Injection site  inflamed / area was red.), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE ERYTHEMA (Injection site  area was red.) and VACCINATION SITE RASH (INJECTION SITE RASH) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21 and 031B21) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (Injection site  inflamed / area was red.), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE ERYTHEMA (Injection site  area was red.) and VACCINATION SITE RASH (INJECTION SITE RASH). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). On 21-Mar-2021, VACCINATION SITE INFLAMMATION (Injection site  inflamed / area was red.) and VACCINATION SITE INDURATION (Injection site hard) had resolved, VACCINATION SITE ERYTHEMA (Injection site  area was red.) outcome was unknown. On 23-Mar-2021, VACCINATION SITE RASH (INJECTION SITE RASH) had resolved. At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown. Not Provided          Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-068732 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: A new event rash was added. All event outcomes were changed to Resolved. The Batch number of doses was updated. On 16-Jul-2021: Event Covid Arm  added having outcome unknown
pt c/o fever high,numbness on inj site (lt deltoid) w/bruise colored,all over body ache w/soreness on inj site,rashes all over body-pinpoint sized x/face since 29APR96;h/a,fever up&down;
MA did not dilute pfizer bivalent booster for 6mo-<5 year patient in our clinic today.  This resulted in about 9-10 doses administered in a single event.  The patient was also let go prior to the 15 minute observation period.  MA informed the parent of child of the vaccine administration error.  The parent will be contacted by clinic physicians this afternoon July 10th 2023 to discuss concerns.  MA discussed the following: Parent of child agreed to plan to monitor for local, acute, and systemic vaccine reactions including  but not limited to fever. Parents will return to clinic tomorrow for a more comprehensive evaluation by a physician.
Dizziness occurred when standing after a 15 minute wait time.  She sat back down and we gave her an ice pack and took blood pressure/pulse (159/98 + 66bpm) She waited about 10 more minutes and was not dizzy so she left with family.  We checked back in at the end of the night and she was  not feeling her best but wasn't dizzy any more.
erythemic rash, small vesicular sites seen, no temp, no other s/s-rash lasted approx 3 days;
pt had elevated temp p/last vax; hospitalized x 5 days; mom states temp went as high as 114; MD said hospitalization could be related to vax reaction;
A Bad rash all over the body. Started on 3/6/21, one week and a day after the first dose was administer. Started treatment prescribed by Dr on 3/8 consists of   hydrOXYzine 50 MG tablet Take 0.5 tablets by mouth every 8 (eight) hours as needed for itching or anxiety for up to 30 days.  As well as   Methylprednisolone Tablets, USP Dosepak 4mg 6 day treatment
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
lightheaded; hitting her face against the wall; passed out; losing vision; was not able to sit up without losing vision, hearing; Could not stand up; sweats; nausea; This is a spontaneous report from a contactable physician (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 07Apr2021 (at the age of 47 years) (Batch/Lot Number: EW0158) as a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included systemic lupus erythematosus and allergies: sulfa. Concomitant medications (other medications in two weeks) included unspecified birth control pills, allergy pills, and joint pills. The patient previously took codeine and experienced allergies. On 08Apr2021 23:00, thirty hours after the vaccination, patient got up to get something from the bathroom. She felt lightheaded - like when standing up too fast. On the way out of the bathroom, she passed out, hitting her face against the wall. When she came around, she could not stand up, had cold sweats and nausea. Symptoms lasted for several hours. She was not able to sit up without losing vision, hearing and feeling lightheaded. Patient is recovering from the events. No treatment was received. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events passed out, temporary vision loss, deafness transitory . The case will be reassessed once new 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
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of SHINGRIX. On 20th July 2018, not applicable after receiving SHINGRIX and immediately after receiving SHINGRIX, the patient experienced pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The caller stated that the patient received the SHINGRIX adjuvant in left deltoid without being reconstituted with the antigen which, led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The caller stated that once this was discovered, the patient received a dose of the reconstituted vaccine and the patient reported that she felt soreness in her arm immediately following the injection of the reconstituted vaccine. The patient experienced soreness in the left arm for 2 days before the symptoms resolved. The caller stated that one of his fellow colleagues reported this event; however, an agent was not able to locate this report.
Pt devel erythema, warmth, & swelling of the entire upper arm @ site of inject p/receiving Td; rxn was accompained by numbness & tingling extending into the hand & fingers; sx resolved in 1wk;
pt had localized react to a MMR vax; lt upper arm had sl redness & swelling;
I began having painful- heavy clot like periods every other week about 3 days after i received my first injection. The injection site also became magnetic.  I could put a refrigerator magnet on my arm and it would connect.
No additional AE; expired vaccine, MMR II, was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 29-JAN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 1 dosage form, expiration date reported as 01-NOV-2020 (route of administration and lot number were not reported) for prophylaxis. No additional adverse events reported.