chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SKIN SENSITIVITY OVER RUBBING OR TOUCHING CLOTHES; LOWER BACK PAIN; FEELS LETHARGIC; STIFF MUSCLES FEELS LIKE PUTTING EXTRA LABOR TO MOVE ARMS; LOW ENERGY; VERY BAD BODY ACHES; GENERAL FATIGUE (FEEL VERY TIRED); PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included myocarditis, and concurrent conditions included chronic migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 19:00 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced general fatigue (feel very tired). On 29-JUL-2021, the subject experienced pain at site of injection. On 30-JUL-2021, the subject experienced very bad body aches. On 02-AUG-2021, the subject experienced skin sensitivity over rubbing or touching clothes. On 02-AUG-2021, the subject experienced lower back pain. On 02-AUG-2021, the subject experienced feels lethargic. On 02-AUG-2021, the subject experienced stiff muscles feels like putting extra labor to move arms. On 02-AUG-2021, the subject experienced low energy. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from general fatigue (feel very tired), very bad body aches., skin sensitivity over rubbing or touching clothes, lower back pain, feels lethargic, stiff muscles feels like putting extra labor to move arms, pain at site of injection, and low energy. This report was non-serious.
pt recv vax 25JUL95&was pregnant in 1st trimester&had a spontaneous abortion;7APR96 pt was dx w/full blown case of varicella;lab eval revealed a lack of serconversion;no further details were provided;
Patient stated that when she woke up this morning she had a red, raised bump that was 2 inches below the vaccination site. The bump became flatter through the day, but the redness spread below the initial site. Patient also stated it was warm to the touch.
pt was given pfizer bivalent dose that expired 12.22.22 at 7:30pm by error.
This spontaneous report was received from a registered nurse, via company representative, regarding an approximately 21 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. In 2008, the patient was vaccinated with the first dose of GARDASIL injection (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On 23-MAR-2017, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis; as the second dose of Human Papillomavirus (interchange of vaccine products). The outcome of the event was unknown. The reporter did not provide a causality assessment between the event and the suspect vaccine. Additional information has been requested.
Pt unable to wake up and move.  Pt had total body weakness.  Had to have someone help her to take her to ER.
Information has been received from a registered pharmacist and a registered nurse concerning an approximately 66 year old female patient with no pertinent medical history and no drug reactions or allergies who on an unspecified date was vaccinated with PNEUMOVAX (lot # 662100/0742X) 0.5 mL IM. Concomitant therapy included FLUZONE which was given the same day but in the opposite arm. On an unspecified date, the patient developed headache and nausea. The injection site was red, warm and swollen to the size of a softball and was raised. 1cm. The patient sought medical attention in the office. On an unspecified date the patient underwent an electrocardiogram (EKG) and glucose and potassium levels were drawn. Results for labs and diagnostics were not reported. The reporters stated that the patient was told to take ibuprofen and TYLENOL. It is unknown if the patient recovered. No other details were available. A lot check was requested by the nurse. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
pt recv vax 7SEP95 & exp body aches, h/a, dizziness, t102, anorexia, fatigue, nasal congestion;sx lasted 3-4 days & pt recovered;
she experienced severe lymphedema in arms and second dose was not as bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Chemo drugs for unknown indication. The following information was reported: LYMPHOEDEMA (non-serious), outcome "unknown", described as "she experienced severe lymphedema in arms and second dose was not as bad". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very strong chills during the night, the next day weakness. Inappetence, excessive sleepiness, headache. place of the vaccine inflamed with pain and itching it is been five days and it's still swollen and painful, from day 4 throat swelling with pain, place of the vaccine inflamed and pain. I have taken antiallergy, ibuprofen, cortisone cream in the place of the vaccine, and cold and hot
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 13:00 as dose 1, single (Lot number: EN6205), in left arm, on 31Mar2021 at 13:00 as dose 2, single (Lot number: EN6199), in left arm and on 22Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Feb2022 at 13:00 as dose 4 (booster), single (Lot number: 007J21-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of Vaccine products" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (21Jul2022) Negative, notes: Tested negative 21Jul2022; (27Jul2022) Positive, notes: Tested positive again 27Jul2022 with a return of symptoms; (30Jul2022) Positive, notes: Still symptomatic and testing positive on 30Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: The patient tested negative on 21Jul2022 with cessation of all symptoms by 23Jul2022. The patient received treatment with Paxlovid from 15Jul2022 to 19Jul2022 for COVID-19.
Case number PHHY2011US33868 is a combined initial and follow-up spontaneous report received from a health care professional (HCP) on 19 Apr 2011. This report concerns an 18-year-old female patient. Her medical history was not reported. She was vaccinated with MENVEO (batch number: 100003, expiry date: Aug 2011) 0.5 ml dose, intramuscularly on 18 Apr 2011 which was stored incorrectly 55 F, one hour every night for one month. No adverse event was reported.
Temp 100 degrees on 4/17. (L) deltoid area redness, warmth and induration at site of injection - approx 10 x 10 cm2.
Extra dose of MMR administer. Child tolerated vaccine well. No adverse reactions immediately following vaccine.
(R) sided Bells Palsy - Lyme (-) tx eye drops. Pt seen 9 am - 7/13/12 eve same day family noted (R) side facial weakness.
Bell's Palsy on Right side. Treatment prednisone 80 mg, valacyclovir 1000 mg TID, and REFRESH drops.
Patient received: Pfizer Covid 19 Bivalent 5-11 10mcg/0.20 ml  Patient should have received: Pfizer Covid 19 Bivalent 30mcg/0.3ml
Initial and follow-up information has been received from a registered nurse concerning a 60 yr old caucasian female pt with hypertension, no known allergies and no past medical history who on 12/19/2001 was vaccinated IM in the left deltoid with the second 0.5ml dose (lot number 64115/1159L) of pneumococcal vaccine 23 polyvalent. There was no concomitant medication or illness at the time of vaccination. That same evening, the pt developed localized redness, swelling, and heat at the injection site. The pt was seen in the physician's office on 12/21/2001 and treated with diphenhydramine hydrochloride (Benadryl), ibuprofen (Advil), fexofenadine (Allegra) (180 mg QD), celecoxid (Celebrax) (200g, up to BID) and warm compresses. The pt never returned for a follow-up visit, but it was reported that the event lasted for three days and the pt recovered. No further information is available.
Took a dose of Vivotif which was not refrigerated for 2 days; This spontaneous case was received on 28FEB2020.  A pharmacist reported that a consumer "took a dose of Vivotif which was not refrigerated for 2 days" (PT: Product storage error). She was receiving Vivotif capsule for immunisation. The consumer took the first dose of Vivotif immediately after it was picked up three days ago. Then, the consumer never refrigerated Vivotif and took the second dose on 27FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the event was unknown.  Company Comment: A consumer took a dose of Vivotif which was not refrigerated for 2 days (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took a dose of Vivotif which was not refrigerated for 2 days (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Patient's neighbor called pharmacy sunday 5/2 at 4:30 pm stating he is experiencing fever, chills, nausea/vomiting. Advised for him to drink fluids to keep hydrated when able, take Tylenol. Patient does not have a regular doctor, advised to go to ER if symptoms continue to worsen.
This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FLUMIST while vaccinating military personnel. The reporter determined the events to be unrelated to FLUMIST administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FLUMIST administration. Investigation into  these events resulted in no definitive reason why the FLUMIST was responsible for these symptoms. The reporter determined the events to be unrelated to FLUMIST vaccination. Further information has been requested. Additional information receved on 05JAN05 and 19JAN05 incorporated into above narrative. Additional information received on 04MAY05: patient name, gender and DOB , vaccine lot number.
no adverse event; HCP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. The vaccine expired on 08/07/2023 and was administered on 09/21/2023. Limited patient demographics provided. No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 21-SEP-2023, the patient received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (valid lot #U026216 with reported expiration date: 07-AUG-2023), administered for prophylaxis (strength, dose description and route of administration were not provided) (Expired product administered). There was no additional adverse event (No adverse event).
Fatigue; Myalgias; Chills; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 22Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medication(s) included: OCREVUS. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 24Mar2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 23Aug2021, outcome "recovered"; FATIGUE (non-serious) with onset 23Aug2021, outcome "recovered"; MYALGIA (non-serious) with onset 23Aug2021, outcome "recovered", described as "Myalgias".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The pt presented erythema and induration extending to approximately 2 inches circle around the injection site. Treated with po Benadryl Q8. Reaction started within minutes of vaccine administration.
Pt. reported that around 5:00 pm she began having trouble swallowing & as condition worsened at 5:30 she called ER & was told to contact Dr. She arrived at ER at 6:00pm & was given albuterol treatment 2.5 & observed for four hrs. & then released.
A patient was received an expired dose of vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from other Health Care Professional via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00817294) and transmitted to Sanofi on 18-Oct-2021.  This case is linked to case 2021SA347320 (same reporter).  This case involves a 72-year-old female patient who was received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 27-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ540AA, expiry: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported "Clinical supervisor states they gave FLUZONE high dose (HD) QUADRIVALENT to a patient in September and it was expired. Do they give another dose or what does she do? The caller reported that a husband and wife received expired doses on the same day."  No other event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a health professional concerning a 15 month old female with a penicillin allergy who on 31-JAN-2008 was vaccinated with a "single dose" of MMR II subcutaneously (SC) (Lot # 654893/1029F). Secondary suspect therapy included VARIVAX. On 11-FEB-2009 the patient developed a red macular/papular rash on her trunk and extremities. The patient was seen in the doctor's office on 12-Feb-2008. The red macular/papular rash lasted for 48 hours and then resolved. Additional information was received from the health professional who reported that the patient received a fourth dose of TRIPEDIA (Lot number U2291BA), intramuscularly, on 31-JAN-2008. It was reported that the patient had a viral illness on 24-JAN-2008 prior to exam. It was reported that the patient was allergic to amoxicillin which caused hives. It was reported that at the time of the rash, the patient was cranky, but she did not have a fever. It was reported that the patient's birth weight was 20 lbs., 2 oz, and that she had one sibling.
On 12-16-21, patient experience extreme dizziness, a headache, and numbness across the face immediately after receiving her first dose of the COVID 19 Vaccine(Age12+). Patient was offered room temperature water and drank it. Patient declined 911 services. patient sat down in the lobby until she was able to walk. Patient was with her husband and he helped her walk outside the store to their car. Patient was followed up with on the morning of 12-17-2021 and she is felling significantly better. The headache and dizziness was subsided. She has ilk numbness across the face.
Patient received PPV vaccine 8/14/07 2pm patient called to report left arm pain - swelling - warmth. Appointment 8-16-07 with PA - extensive erythema, swelling extending from left elbow to shoulder, tenderness to palpation.
This case was reported by a consumer via out of hour services and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. On 24th September 2018 15:00, the patient received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced sickness, sore throat, mobility decreased and fever. On an unknown date, the outcome of the sickness, sore throat, mobility decreased and fever were unknown. It was unknown if the reporter considered the sickness, sore throat, mobility decreased and fever to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient stated almost immediately after having the vaccination, she felt sick. One side of her throat was sore and she couldn't physically move.
Heart Palpitations( daily especially upon exertion), shortness of breath (daily upon exertion, e.g climbing stairs, walking for exercise, bike riding for exercise - need to stop and rest),  joint pain (knees especially  -required anti-inflammatory doses of naproxin for 10 days but still a problem), fatigue (lack of desire to do even mundane tasks), confusion (making simple mental errors at work and in daily life).
patient reported that when she got home around 12:30 pm she started feeling discomfort, wobbly, and a headache
Swollen throat; Severe headache; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swollen throat), HEADACHE (Severe headache) and VOMITING (Vomiting) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat), HEADACHE (Severe headache) and VOMITING (Vomiting). At the time of the report, PHARYNGEAL SWELLING (Swollen throat), HEADACHE (Severe headache) and VOMITING (Vomiting) outcome was unknown.            No concomitant information was reported. Treatment information was not reported.
pt recv vax;mom noticed swelling & applied ice;Low grade T;Lt arm from deltoid to elbow swollen,tender & hot to touch; redness noted below deltoid area;to see MD;
Post vax, the pt developed localized erythema and swelling over right anterior thigh where DTAP was given.
Expired vaccine was given to 10 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to 10 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to 10 patients). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to 10 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  No concomitant medication was reported.  Initially, other Health Care professional reported AE patients who received second dose, and Consent for Safety to follow up: Provided   Further, query was updated from Safety in follow-up, regarding the incident which was occurred in a jail, where all patients are male, and where they administered expired vaccine in three different instances to 10 patients each time: 2 of these instances were first doses, while the third instance (described in case MOD21-146004) were second doses.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up was received on 22-Sep-2021 which  included no new information
48yr old female presents to the ED via the ambulance.  On 12/4 she started getting abdominal pain in the late afternoon and it has gradually gotten worse.She is rating her pain at a 9/10 middle abdominal to the left and to mid back.  Patient states that it is constant, sharp.  She took Tylenol at 0045 today and ibuprofen Saturday afternoon.  Has not tried anything else for the pain.  diagnosis:  diverticulitis (no previous history)
A lump at injection site roughly the same diameter as a baseball appeared the day after injection. Extremely tender. Red circular coloration about 2.5-3 inches in diameter.
71 year old vaccinated and boosted male was admitted for Covid-19 pneumonia and type 2 MI. He also had a fib with RVR which was controlled with CCB. He was on heparin drip due to elevated troponin and d dimer. VQ scan and BLE venous US both (-) for thrombus. He was given Remdesivir. He has improved sooner than expected after 3 doses of Remdesivir has been given. He had paracentesis yesterday with removal of 6 L. He will be discharged home today in stable condition
Localized edema to area directly below injection site, right arm with edema also noted to right forearm. No other S/SYS.
Urticaria.  Rx BENADRYL 25 mg P.O.
Large painful lump under armpit on the side the vaccine was given.  Started with pain 12 hours after vaccine, progressed to a lump the size around of a baseball.  After 3 days, slowly started getting smaller and a little less painful-taking ibuprofen still
Severe gastrointestinal cramping and diarrhea for more than 24 hours. Malaise.
Pt developed dyspnea and decompensated  due to underlying metastatic adenocarcinoma of lung and large pericardial effusion which caused cardiac tamponade ultimately causing him to succumb.
Physician ordered IPV. Pt given .5cc pneumovax (adult) in error. Spoke with pt's mother and she stated that the pt has no problems.