chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a retired physician of unknown age via a company representative, referring to himself. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were unknown to the reporter. On an unknown date, approximately in 2009 (reported as 8 years ago) the patient was vaccinated with ZOSTAVAX (dose, frequency, anatomical location, route, lot/batch # and expiration date were not reported) to prevent shingles. On an unknown date, approximately in 2015 (reported as about a year or two ago) the patient experienced "prodrome" of shingles "without rash". The symptoms included pain and numbness. On an unknown date (reported as presently), the patient experienced "prodome" of shingles without "rash". The symptoms included pain and numbness. The patient treated himself with VALTREX (dosing details unspecified). It was unknown if laboratory diagnostics were performed. It was unknown if the patient sought any medical attention. The outcome of the events (first occurrence) was unknown and the outcome of events on second occurrence was not recovered (reported as presently experiencing). The causality assessment was not provided by the reporting physician. There was no product quality complained involved. Additional information has been requested.
Acute myopericarditis c pleuritic chest pain occurring 8 days p vaccination; On exam, afebrile, VSS; Heart and lungs wnl; no pericardial friction rub. + 8 mm Jennerian scab c ~ 7 cm rim of erythema, CPK elevated to 512, Troponin I level 36.40 ng/mL  (nl 0.3-2.0) ESR 6, CBC, chemistries otherwise wnl. CXR wnl; EKG: diffuse 1mm ST elevations.  Echocardiogram c sl global hypokinesis, LVEF 50-55%.  Complete clinical recovery, resolution of echocardiographic abnormalities c rest, ibuprofen.  Nurse follow up on 07/27/04 states: "Short of breath, epicarditis, pericarditis, decreased stamina, decreased strength."
Phone call received from clients mother informing that client has a red, raised bump on the outside of her left leg. Mom states that it does not bother the client and she has not complained about it.
Day after 2nd injection extremely sore right shoulder.  Extreme headache.  Very fatiqued for two days.
Not getting my period like normal once I stop my pill for the time stated. Will come on almost 2 weeks after stopping pill for only 1 day - very light
STATUS EPILEPTICUS 9/28/2021 LACTIC ACIDOSIS, UNSPECIFIED STATUS EPILEPTICUS 9/28/2021 STATUS EPILEPTICUS
One day post vax, this pt experienced swollen lymph nodes of the right arm and pain at the injection site. As of 09/15/99, the pain and swelling had not resolved. Additional information received from the physician indicated that the pt developed lymphadenopathy of the neck and axilla, fever within 48 hours and an injection site reaction characterized by swelling. The pt recovered.
mom states pt has had fever 102-103 since 10PM 9SEP93 & vomited 9SEP93;
Developed dizziness, lightheadedness, warmth, sweaty and had a syncopal episode at 8:45pm.  All symptoms resolved then within 15 minutes of laying down in bed and having a cold compress on forehead
Information has been received from a Registered Nurse referring to an 8 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 26-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided)). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
no adverse event; patient received a dose of Moderna Bivalent from a vial tat was punctured 26 hrs prior.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna Bivalent from a vial tat was punctured 26 hrs prior.) and NO ADVERSE EVENT (no adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna Bivalent from a vial tat was punctured 26 hrs prior.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna Bivalent from a vial tat was punctured 26 hrs prior.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna Bivalent from a vial tat was punctured 26 hrs prior.).    Concomitant medications were not reported.   Treatment medications were not reported.
TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient was previously treated with estradiol. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
No additional adverse events reported; VARIVAX had been administered today,21OCT2021, to a patient via the intramuscular route versus the recommended subcutaneous route of administration; This spontaneous report was received from a pharmacist referring to a 53-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 21-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T024283, expiration date 15-JUL-2022, intramuscular (instead of subcutaneous) for prophylaxis (incorrect route of product administration). No adverse event was reported.
hot, flush, dizzy, and briefly fainted roughly 5 min after shot was administered,  gave ice pack and pt felt better after 10 minutes
I started having difficulty breathing, even more that before the vaccine. There are times now that it feels like I cannot get enough air in me. I've even tried to take more of my inhalers but that doesn't seem to help. I really am concerned that I will get to the point that I cannot breathe any longer..
Patient reporting reaction to PCP office. Influenza vaccine received at his place of work. Within 2 hr. of administration he began to experience "the exact same symptoms as when I had COVID: Cough, Rash to abdomen and chest, bilateral flank pain, fatigue" now resolved. Note: Board of Health did not respond to our outreach requesting details on Vax info listed above.
injection site was red and itchy; injection site was red and itchy/she still has redness in the injection site; headache/she still has some headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site was red and itchy), VACCINATION SITE ERYTHEMA (injection site was red and itchy/she still has redness in the injection site) and HEADACHE (headache/she still has some headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure fluctuation. Concomitant products included DICLOFENAC and MISOPROSTOL for an unknown indication.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was red and itchy), VACCINATION SITE ERYTHEMA (injection site was red and itchy/she still has redness in the injection site) and HEADACHE (headache/she still has some headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 20-Jun-2021, VACCINATION SITE PRURITUS (injection site was red and itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site was red and itchy/she still has redness in the injection site) and HEADACHE (headache/she still has some headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included diabetes medication and blood pressure medication(unspecified). Treatment included ice on the injection site.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-Jun-2021 and contain significant information. The events vaccination site erythema and headache became serious with criteria other medically important condition. Added vaccine batch number. Changed the outcome of the event vaccination site erythema from recovered to not recovered. Changed the outcome of the event headache from unknown to not recovered.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pfizer Bio-Tech Covid 19 Vaccine EUA. About 3 to 5 minutes after vaccination, began to feel light headed and dizzy. She has a history of fainting after some vaccines but does not faint after every vaccine. She was fine after her 1st Pfizer vaccine and did not feel faint. We had her move to the ground and elevate her feet while applying ice under her neck and on her wrist to help with light headedness. Her blood pressure was 134/85 5 minutes after laying down, and 136/85 5 minutes later. She felt better after laying down for 15 minutes and then sat for 10 minutes and felt comfortable to leave. All symptoms were resolved when left the clinic.
That evening after my 2nd injection of the vaccine I became extremely weak and achy.  I went to bed and had chills, fever, and night sweats.  I woke up with a bad headache that lasted 24 hours and the weak, achy feeling was still present for a couple more days.  Those feelings eventually went away but I still felt very tired and drained for the next several days.
FELT SHITTY; JOINT PAINS; FEVERISH WITHOUT A FEVER; INJECTION SITE ACHES; This spontaneous report received from a patient via a company representative concerned a male 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 not reported, batch number: 212C21A expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the subject experienced felt shitty. On JUL-2021, the subject experienced joint pains. On JUL-2021, the subject experienced feverish without a fever. On JUL-2021, the subject experienced injection site aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt shitty, feverish without a fever, joint pains and injection site aches was not reported. This report was non-serious.
No symptoms were reported by the HBP; HBP called to report that a dose of PROQUAD and an inadvertently given additional dose of VARIVAX were given today, 9/25/2023, to a 15-month-old patient. HBP reports that the medications were pulled for the Medical Assistant, by a brand-new employee,; PROQUAD and an inadvertently given additional dose of VARIVAX were given today, 9/25/2023, to a 15-month-old patient. HBP reports that the medications were pulled for the Medical Assistant, by a brand-new employee,; This spontaneous report was received from a nurse practitioner and refers to a 14 (also reported as 15) month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 25-SEP-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W039688, expiration date not provided but upon internal review established as 13-DEC-2024), and inadvertently on the same date, with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # X007355, expiration date not provided but upon internal review established as 08-SEP-2024, therapy type rHA) (inappropriate schedule of product administration, overdose), as the vaccines were pulled to the medical assistant by a brand new employee, but the medical assistant did not check the doses prior administration. No symptoms were reported, but it was informed to the patient's family to be on the lookout for fever and febrile seizures.
Patient received this shot one month too early.  She did not mention she had any side effects from this
No adverse event; patient received a dose of Moderna COVID-19 Vaccine on 6MAR2023 but the vaccine expired on 26FEB2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna COVID-19 Vaccine on 6MAR2023 but the vaccine expired on 26FEB2023) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 06-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .05 milliliter. On 06-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna COVID-19 Vaccine on 6MAR2023 but the vaccine expired on 26FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna COVID-19 Vaccine on 6MAR2023 but the vaccine expired on 26FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna COVID-19 Vaccine on 6MAR2023 but the vaccine expired on 26FEB2023).    No concomitant medication were reported. Patient has not advised of any adverse effects. No treatment information was provided by the reporter.
"Knots the size of marbles where the shots were given" shots given 4/14.  Reported by mother 4/22/08.
Pt reports two days after vaccination eyes became "itchy, irritated, and glazed" and at times "painful".  Symptoms would "come and go".   Received second dose of Moderna COVID-19  vaccine on 1/21/21 with same symptoms 2-3 days after that dose that have continued off and on since then.
Flu-like symptoms for about 3 days as well as very sore arm at injection site.  On day 5 a rash appeared that was very itchy md warm to touch about 4-5 inches long and 2 inches across at injection site.  Arm still very tender as of day 5.
Welts on her face; Dark spots on her face where her skin has turned totally darker than what it was; Face is itching; Can hardly sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "not recovered", described as "Welts on her face"; SKIN DISCOLOURATION (non-serious), outcome "not recovered", described as "Dark spots on her face where her skin has turned totally darker than what it was"; PRURITUS (non-serious), outcome "not recovered", described as "Face is itching"; INSOMNIA (non-serious), outcome "not recovered", described as "Can hardly sleep".  Additional information: Patient had 2 of the Pfizer Covid Shots and she called for medical advisement on what to do about her current ongoing symptoms. She states that her face has broken out, including welts and dark spots on her face where her skin has turned totally darker than what it was, and her face was itching. Patient was advised to seek medical help if she was experiencing swelling and numbness of the face. Patient clarified that she was not having numbness but dark patches of itchiness. She also adds that she can hardly sleep. The reporter was advised to contact HCP or initiate emergency services due to ongoing potentially emergent events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Local reaction pt. waited 30 min due to pt.  having a local reaction to Varicella vaccine on right thigh.
Mother reports that after vaccines pt awoke from a nap & lips were blue, pt shaking. Reports symptoms resolved quickly. Reported to provider on 2/28/2012.
Narrative: COVID infection following COVID vaccine series 01/26, Pfizer, dose #1 02/19 Pfizer, dose #2 12/23 Pfizer, dose #3 12/27 COVID swab, result: detected 12/27 pt cc: chills cough, fatigue, fever, headache, rhinorrhea, dyspnea, sore throat exposure: unknown
chills.fever very soar and very achy it all lasted a littlr over 24 hours
Patient received dosage that had not been reconstituted.  No negative outcomes reported to the provider.  Provider monitoring for additional symptoms
PT'S MOM CALLED ON 07/28 AND EXPLAINED PT HAS BEEN HAVING VERTIGO RIGHT AFTER GETTING VACCINE AND IT WORSENS AFTER LYING DOWN. SHE ALSO MENTIONED PT IS GETTING FATIGUE AND BODY ACHES
11th - I started having chest pains - classic symptoms - difficulty breathing;  radiating down the left arm; hot and cold at the same time. Call -9-1-1 and they took me to the hospital. I went into Ventricular afibulation and they transferred me to another hospital and I went into Cardiac arrest.  Angioplasty - implanted three stents in the main vessels of the heart itself- as far as I understand. I was in the hospital until the 16th.
I am unsure which vaccines were given. Whatever is normal for her age at the time. The next day, it was noticed that patient was having a seizure in her sleep. This was witnessed for 25 minutes by the paramedics, despite the use of rectal VALIUM. Since then patient has continued to have more seizures.
no adverse event; incorrect product storage; This spontaneous report as received from a medical assistant and refers to a currently 4 year old patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose, frequency, route of administration were not provided (lot # T029099 has been verified to be a valid lot number, expiration date 23-FEB-2022) for prophylaxis.        The reporter stated that the vaccine was administered following a temperature excursion on 12-APR-2021; temperature range was -58°F/5°F: 6.3F for 6 hours 0 minutes 30 seconds, 10.9F for 0 hours 7 minutes 30 seconds, previous excursions were reported. The call was due to a data logger.       No adverse effects were reported, no Product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA008219: US-009507513-2104USA008134:
PATIENT RECEIVED MORE THAN THE RECOMMENDED DOSES OF COVID-19 VACCINE. THE PFIZER SERIES WAS ADMINISTERED ON 12/29/2020 AND 1/18/2021, THEN THE MODERNA SERIES WAS ADMINISTERED ON 4/25/2021 AND 5/23/2021. TREATMENT, OUTCOME, AND SYMPTOMS UNKNOWN.
15 minutes after receiving the vaccine in the left arm, patient stated that the left side of her face, around her cheek, under her eye was starting to feel numb.  I asked about her throat and mouth and said it was fine. i observed her face for any swelling and no swelling was noticable.   I watched her for about 1-2 min and asked her again and she said face still and numb. i asked about mouth and throat and this time she stated her mouth/throat were dry and starting to tingle.  i asked if she was having trouble breathing and she said no.  pt was not wheezing . pt was talking and laughing without problems.  i checked her pulse.  she had a normal pulse at ~70 bpm.  i asked pt if she had someone to drive her if i gave benadryl. she stated that her mom was on her way to pick her up. at that time, 12:32, i gave her a 25mg dose of liquid benadryl.  I continued to monitor her and ask how she was feeling.  she continued to say the face was numb in same areas and mouth dry and tingles.  she continued to talk and laugh without distress, breathing was normal.  no labored breathing was evident.  her mom and sister arrived at 12:45. with her permission, i reported to her mom the events that transpired. her mom said she would take her straight to dr office but did not tell me which doctor they were going to. pt left walking on her own with no help needed still talking and laughing without any noticeable distress
My children came home sick, my oldest child woke up sick on 3/9 and then the youngest started coughing the next day. On the evening of 3/10 I started to develop a cough and that night I was up helping the kids and felt a sore throat developing. The next day 3/12, I developed a fever. Over the next week I had a fever that ranged from low grade up to 102 and had a very bad sore throat and cough. I went to urgent care on 3/15 because my PCP didn't have any appointments available. At the urgent care I tested negative for COVID19 and Strep but positive for Influenza A. I was outside the window for TAMIFLU. By 3/19 the fever had abated but I still had a pretty bad cough. Yesterday 3/23 I contacted my PCP about my cough and they prescribed TESSALON PERLES for the cough and an inhaled steroid. I want to mention that a few weeks before all of this I had a TDap vaccination at urgent care because I cut my finger and had to get stitches, and my Flu vaccine was in the fall.
amenorrhea for 8 weeks, heavy cycle with severe cramping and clot passage. NOT pregnant
Itchy skin and hives three days straight now. Have to keep taking Benadryl for relief.
states had  covid vaccine yesterday, approx 24 hrs later has developed itchy rash on forehead and back (has been there for about 1 hr) , forehead is sl less itchy now, used Zyrtec with improvement of sx