chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding PREVNAR 13 was received from a consumer regarding a 4-year-old female patient who experienced lost a couple pounds and eating significantly less food. At 4 years of age, the patient received a dose on 07-Sep-2010. Additional suspect medication included KEPPRA. The patient experienced lost a couple pounds in Sep-2010 or Oct-2010 and eating significantly less food in Sep-2010. Outcome for both events was not recovered. Per the reporter, patient's epilepsy physician attributed the events to levetiracetam. No additional information was available at the time of this report. Following the integration of the legacy safety adverse event reporting databases, this case had been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. Follow-Up: 15Nov2010) This contactable physician reported that the patient had increased the dose of KEPPRA at the same time of the events, but is also currently weaning off levetiracetam. Patient is currently recovering from the events. Follow-up (02MAR2010): Follow-up information for this spontaneous case was received from a contactable physician. New information included the patient weight and height at the time of the event, lot number, new event - developmental milestones not within normal range, medical history, the explanation for the event, and outcome. The physician reported the developmental milestones (language/speech; emotional/social; fine/gross motor skills; and cognitive thinking) were not within normal range. The child's physical growth has been normal. The physician stated: Patient had increased dose of KEPPRA at the same time. Neurologist considered that this affected eating. At the time of this report, the physician reported the patient is improving. The physician also stated: the patient is currently weaning off levetiracetam.
Presents for L sided chest pain, worsening SOB, weakness, multiple recent falls x1wk PTA; COVID+ PTA . Admit for COVID pneumonia w/hypoxia, closed rib fxs, closed head injury. RRT called on day 3 due to increased lethargy. MRI shows small acute/subacute lacunar infarct L thalamus. Increased O2 demand on day 7, placed on NRB. Tx: dexamethasone, abx, regional nerve block for rib fxs, O2; remdesivir held due to unknown duration of sx.
Information has been received from a consumer and a school nurse concerning 41 child pts who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 pts were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated pts was an 8 year old pt who on 12JAN1996 was vaccinated with a dose of varicella virus vaccine live. On 11MAR2003, the pt developed chickenpox. The previously vaccinated pts included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other pts that developed chickenpox post vaccination with varicella virus vaccine live were also identified. Additional info is not expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA
This spontaneous report as received from a 66 year old female consumer refers to herself. Pertinent medical history included with allergies to sulfur and penicillin. On 16-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location and lot number was unknown). Concomitant therapies included atenolol and amlodipine. On an unknown date in 2015, the patient had a little itching at the injection site. On 22-FEB-2015, the patient experienced redness at the injection site. No treatment was given for the event. No lab studies were performed. Action taken with ZOSTAVAX was not reported. The outcome of itching at the injection site was unknown. The outcome of redness at the injection site was reported as not recovered/not resolved. The causal relationship between the events and ZOSTAVAX was unknown. No additional information was provided. Additional information has been requested.
Red and swollen in first 24-48 hr after injection.  This resolved.  On the evening  of 8/21 patient started to experience severe pain directly in the  left shoulder joint.  Patient also concurrently received Fluad in the right deltoid at the same time.  He has had no unusual reaction in his right arm. On 8/22 the patient experienced fever and chills.  He had difficulty toweling off after his shower and difficulty putting on his shirt.  He had to sleep with his arm over his head.  His pain level was reported at 10.  The patient used Ibuprofen 400 mg to manage pain.  The patient continues to have occasional flares of joint pain.  Patient massages the area to alleviate discomfort.   The patient currently describes his condition as having deep joint  pain in his left shoulder.
Over the course of 48 hours, I experienced flu or cold like symptoms including chills, flushing in the face, aches, fatigue, and sore throat. Extreme soreness at injection site also continues 48 hours after injection.
Patient presents to pharmacy with pain and swelling in left arm, and complains unable to lift arm nor get dressed.  I have advised patient to see her doctor for full evaluation.  Patient was unable to see her doctor today, Oct 21,2019 as a walk in patient.  She will return with results from her doctor.
ER 6/7/2021 Chest Pain, irregular heart beat/sinus arrhythmia. Labs showed, High, ALK Phosphatase,  Low Creatinine, High CRP.  Discharged.
Itchy Hives all over body lasting 2.5 days, took OTC Benadryl every 4-6 hours
tingling in arm & chest directly after vaccine given.  Tightness in throat and a little feeling of short of breath.    Went to emergency dept and received bendaryl & solumedrol - symptoms resolved except arm tingling.
MRN 1998862  - Occurrence Date: 03/11/2021. At 17:01, following Covid-19 vaccine administration at the vaccine POD, patient stated that he felt his heart racing. V/S taken at 17:05: BP: 140/103, HR: 105, 02 Sat: 100%, and RR: 18. Patient stated that he was diagnosed with high blood pressure 6 years ago in , but has not had a physical since then, and also stated that he is not taking any blood pressure medication. V/S retaken at 17:35: BP: 135/105, HR: 70, 02 sat: 99%, and RR: 16. Patient was advised to go to the ER, but declined.
Seizure like activity, uncontrollably crying, no response to verbal communication or when calling him to get his attention, loss of previous spoken words, no longer social or wanting to be held.
8PM lt leg sore warm red cried > 2 hrs w/o stopping used cool compresses given APAP did not take temp; p/applied cool compresses settled down & no further problems;
headache; tiredness and fatigue; soreness in his arm; pain injection site; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.   A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm, administration date 05Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation, reactions: "fatigue/ tiredness", "headache", "muscle pain", "pain at the injection site"; BNT162B2 (dose 2, Batch/Lot number: unknown), for COVID-19 immunisation, reactions: "fatigue/ tiredness", "headache", "muscle pain", "pain at the injection site". The following information was reported: HEADACHE (non-serious) with onset 06Oct2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 06Oct2021, outcome "unknown", described as "tiredness and fatigue"; PAIN IN EXTREMITY (non-serious) with onset 06Oct2021, outcome "unknown", described as "soreness in his arm"; VACCINATION SITE PAIN (non-serious) with onset 06Oct2021, outcome "unknown", described as "pain injection site".  Additional information: The reporter stated that he didn't even feel it when the provider gave him the shot (booster) and he felt like he didn't even get the shot. He didn't feel anything; his arm didn't even hurt. Then the morning after the 3rd dose, he noticed some of the same side effects as last time (previous vaccinations).   Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 11 hours after vaccine developed mild headache, severe chills, muscle aches, low grade temperature, extreme fatigue and slept about 20 hours out of 24.
This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on an unspecified patient was administered a dose of GARDASIL 9 on an unspecified date two years ago, when he/she was 11 years old. recently, on an unspecified date, the patient was administered a dose of  GARDASIL 9. No adverse effects reported.  Additional information has been requested.
Delayed onset ?Covid arm?  Injection site started itching about 7 days after first dose, at Day 8 a large (about 3-4 inches round) bright red rash appeared on arm, slightly away from injection site.  Intense red color and heat lasted 2 days, started diminishing on day 10.  It is still slightly visible 13 days out.
Wrong dose of Pfizer 0.3ml given of Pfizer Covid vaccine, instead 0.2ml.
Pt was nervous prior to vaccine.  Approximately 5 minutes after receiving vaccine he became nauseated and pale.   Pt was taken to a couch in a separate room to calm down and be assessed in private.  Pts vitals 106/64, HR 86, RR 18, Sats 100% on room air.   Pts symptoms resolved after approx 10 minutes.  He had no other complaints/sxs.   Mother declined further treatment and was told to follow up with pts PCP.
Body hot flashes; Low grade fever; Very sore arm; Feeling run down; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the left arm on 11Apr2021 at 13:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8730) via an unspecified route of administration in the left arm on 22Mar2021 at 18:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 05:00, the patient experienced low grade fever, very sore arm, body hot flashes and felt run down. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of the events low grade fever, very sore arm, body hot flashes and felt run down were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vaccine was administered after beyond use date and CDC expiry date; Vaccine administered to patient past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The vial was stored in standard freezer for the lot 068H21A with 2 degrees F high -1 degrees F low on 04-Jan-2022. The BUD date and CDC expiry date was reported as 02-Apr-2022.   No treatment medication was reported.  This case contains information for the eleventh of 45 patients described by the reporter.
No adverse event; Past lot that had been expired, administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient) 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 (Past lot that had been expired, administered to patient).    NDCID number was reported as 80777027399. Patient age was reported as 79 years and 07 months. Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report was received from a female patient of unknown age, reporting on herself. The patient's concurrent condition included scoliosis. The patient had no concomitant medications nor drug reactions or allergies. On an unknown date in February 2014, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly (dose, anatomical location, lot# and expiry date were not reported) as pneumonia vaccine. On an unknown date in March 2014, (also reported as "a couple weeks after the vaccination"), the patient experienced extreme dizziness, trouble breathing, nerve pain, bronchitis, and "muscle twisting". Unspecified treatment was given for the events. The patient had many tests done (magnetic resonance imaging (MRI), X-ray, blood work - results unspecified) and the physician still could not diagnose it and treat it permanently. The patient visited a rheumatologist. At the time of the report, the patient was undergoing unspecified treatment to find why she was having sharp nerve pains, especially in her shoulders. The patient did not recover from the events. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 83-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 6th March 2019, the patient received SHINGRIX (intramuscular). On an unknown date, 7 days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX vaccine on left arm. The dose of SHINGRIX was given to a patient and almost 1 week later, she was experiencing ongoing redness at the injection site. The site was reportedly 2.5 to 3 inches in diameter and had gradually decreased in size since the redness first appeared. The patient denied any pain or swelling. The reporting pharmacist was not the immunizing pharmacist, however the vaccine was administered at the same facility.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. It was reported that on an unknown date, the patient may had received an improperly stored dose of GARDASIL 9 lot # M036059 for prophylaxis (expiration date: 03-JUN-2019; dose, dose number, frequency and route of administration were not reported).  Or may may had received an improperly stored dose of ROTATEQ orally, lot # M031807 for prophylaxis (expiration date: 02-APR-2018; dose, dose number and frequency were not reported). The medical assistant was not sure which of the vaccines the patient received. No adverse effect reported. The vaccines were exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 406 hours and 56 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. Additional information has been requested.
Very bad chest pain started on left side at 2am. Continues the entire day and still continues into the next Monday, less pain and more rare. Taking anti inflammatory as it said online this may be a side effect for men but I am a woman. Fever, chills, aches, headache.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 11-FEB-2015 the patient was vaccinated with an improperly stored dose od M-M-R II 0.5ml, lot # J014876, expiration date 21-NOV-2015, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 3156 hours with the lowest recorded temperature of 20 Fahrenheit degree. The total cumulative excursion of the second time was 1020 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Redness and pain at site. The area to her left upper arm was warm to touch with erythema. Area was marked to see if redness expands. No SOB or respiratory symptoms.
She fainted after the administration of the last of three vaccines administered that day.  The third was the HPV Vaccine.  She had on convulsion as she came to.  36 hours after the vaccine she started having intense itching which broke in to hives after about 48 hours.  She was very tired, dizzy, and had a bad headache and sore arms for the 24 hours following the vaccines.
This spontaneous report as received from a nurse refers to a 5 months 26 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K0116633, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Breakthrough Case of COVID-19; Started with a sore throat, I then had a sore throat the next day and then in the evening I was congested and started coughing a lot, I tested Positive, I started taking Tylenol for the headache on the next day, I had chills, fatigue, I lost my sense of taste and smell, I had bad muscle aches, my fever was up to 102, I took Zinc Cold Therapy, and Nyquil, And Cough Syrup. The next day the fever continued and I was really feeling bad. I got a prescription for Paxlovid on the next day, and I am still taking the Tylenol for the headache and fever, and the cough syrup.  I still have a headache, and a low grade fever, I am still coughing, I am feeling better but not as bad as before.
Patient with history of diabetes, heart disease, prostate cancer.   Patient brought to the ED by EMS on 10/26/22 for evaluation of stroke-like symptoms including slurred speech and left-sided weakness. Patient ultimately admitted from 10/26-11/2 for acute stroke. On admission on 10/26 patient tested positive for COVID-19 by PCR. Per chart review, neurology notes "Acute right MCA stroke with occlusion of the R M1 segment - mechanism is mostly likely cardioembolic and hypercoagulable state from cancer and COVID 10/26". He has been vaccinated with the COVID-19 primary series and two boosters.
Information has been received from a Registered Nurse concerning a 14 year old male patient with pertinent medical history reported as none and seasonal allergies who on 16-AUG-1996 was vaccinated with first dose of VARIVAX (Merck) (lot # 616867/0243D) subcutaneously. On 17-OCT-2006 he received second dose of VARIVAX (Merck) (lot # 654530/1046F) subcutaneously. Concomitant therapy included ZYRTEC. On approximately 13-AUG-2009 he was in contact with a friend who had chicken pox. On 25-AUG-2009 the patient broke out with a chicken pox rash to his back, stomach, body and shoulders. The lesions were patchy through these areas. The patient sought medical attention by phone. At the time of the report on 27-AUG-2009 the patient was recovering. There were no laboratories diagnostics studies performed. No further information is available.
No additional adverse effects reported; patient was administered an improperly stored dose of VARIVAX intramuscularly; patient was administered an improperly stored dose of VARIVAX intramuscularly; This spontaneous report was received from a physician and refers to a 28-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 31-MAR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S031494, expiration date 07-OCT-2021, intramuscularly (dose and dose# were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 15 Fahrenheit (F) degrees to 46 F degrees for 21 hours. There were no previous excursions reported. The digital data logger was not involved to capture the temperature excursion. No additional adverse effects were reported.