chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    60 doses were received to several patient from Lot AS7148B. Concomitant medications were not reported.  No treatment information was provided   This case was linked (Patient Link).
Patient said it has been a couple years since she had the flu shot, never had any issues in the past, stated the day after the shot she started having a low grade temperature and whole body aches and thought this was unusual for her, she is going to go to dr office to verify nothing else is going on.
PATIENT HAD A SHINGLES LIKE OUTBREAK WITH A BLISTERY RASH ASSOCIATED WITH THE INJECTED ARM, IN WHICH AFTER 1 WEEK--SPREAD TO HER LEFT OUTER THIGH. PATIENT WAS GIVEN ACYCLOVIR. HER DR RECOMMENDED THE SHINGRIX DUE TO PAST SHINGLES OUTBREAKS.
expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
Initial report received from a health care professional on 20 August 2014. A 78-year-old male patient, had received an intramuscular dose of ADACEL vaccine (lot number: U4617AA, dose number was not reported) in right deltoid on unspecified date and had received an intramuscular dose of FLUZONE HD (lot number, dose number was not reported) in left deltoid on an unspecified date. The patient illness at the time of vaccination was not reported and the patient had no known allergies. It was reported that three day after vaccination on an unspecified date patient had experienced redness and itching around injection site of right arm and was becoming larger. Laboratory details and corrective treatments were not reported. At the time of this report, outcome of the event was not recovered. Documents held by sender: None. Follow-up information received from the healthcare professional on 20 Oct 2014. Received no additional information.
Give DTAP #5 on 01/12/2004 and MMR #2 on 01/13/2004.  Complained of arm "itchy and hurting" mom noticed redness around DTAP site. Seen in office today has 10x6.5cm area of redness with some swelling around injection site on left arm.
Pre-syncope patient light-headed, dizzy, sent to emergency room for IV hydration, recovered quickly and sent home.  Patient was on the way out of the hospital when dizzy.
About two hours after the vaccine, I started bleeding that appeared to be the onset of a period. I thought this was a one off case of spotting - albeit a substantial amount of blood - however I went on to have a period that was very heavy and lasted 7 days. This was alarming as I have not had a period since June 25, 2020 and was diagnosed as Perimenopausal in Dec 2020 with a FSH levels of 96.3 and TSH level of 2.27 and LH level of 74.8 I have not had any spotting or periods at all since June 25, 2020. The period that I had from 3/22/2021-3/28/21 was not painful (which is abnormal for me) and was extremely heavy ever day - which is also uncommon for me. Since then I have had my second shot on 4/12 and have not experienced any adverse effects nor another period.
SHOT GIVEN ON /  /19 - 2 hrs. later - congestion in throat, + bronchial area, sneezing. Approx 10.30 AM on /  /19 left arm + jaw numbness - Rushed to ER. Neurologist reviews MRI. Admitted to hospital. Brain scan. No STROke - Flu shot reaction
After I gave the patient the injection, patient said she felt warmth at injection site and had a little redness. I monitored the site every 5 minutes for 15 minutes and the red area lessened. She said it did not feel worse.  I told her that if her symptoms persisted or worsened to let me know. On 10/27/14 she returned and showed me she still had a little redness.  The area measured about the same as it had on 10/23/14, about 2 inches long and one-half inch wide.  She said it felt warm and she felt a slight burning sensation at times.  I contacted Merck and the rep said it could last 3.7-9.7 days.  I told her she could take an antihistamine, apply cool compresses or apply some Benadryl cream if needed. I asked her to contact me or come by the pharmacy again on 10/30/14 if her symptoms did not resolve.  I also advised her to seek medical treament if symtoms persisted, worsened or were bothersome.
The patient was in her normal (excellent) state of health with no significant past medical history upon entering service on 2 Feb 2010. She was vaccinated on 30 March 2011 with smallpox, typhoid and anthrax vaccines. She described feeling ill immediately after these vaccines to include symptoms of fever, chills, nausea and fatigue. Symptoms slowly progressed in nature to include GI symptoms, dysautonomia and frank anaphylactic episodes. Anaphylactic episodes were associated with elevated serum tryptase and urinary histamine levels. Patient eventually diagnosed with MCAS after mastocytosis and monoclonal disorders were ruled out. Patient failed treatment with imatinib but is currently being successfully managed with sutent (tyrosine kinase inhibitor). Patient has known somatic gene mutation of kit gene on exon 11 (F584C) causing gain of function mutation.
SORENESS FROM NECK TO ELBOW ON LEFT ARM. STINGING AND ITCHING OVER MUCH OF BODY. PATCH OF REDNESS AT INJECTION SITE WITH A SMALL LUMP UNDER THAT AREA. AREA IS HOT.  SHE DOES SAY SHE HAD MUCH WORSE FROM THE ZOSTAVAX AND HAS A HISTORY OF SHINGLES.
Period started suddenly 10 days before regular cycle, which had been regulated by birth control and has been the same for nearly 5 years. Amount of blood seems to be more then normal.
Shaking/her whole body shook; Legs would not work/ hard to get her legs to work; Mild arm ache; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking/her whole body shook), MUSCULAR WEAKNESS (Legs would not work/ hard to get her legs to work), PAIN IN EXTREMITY (Mild arm ache) and CHILLS (Shivers) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking/her whole body shook), MUSCULAR WEAKNESS (Legs would not work/ hard to get her legs to work), PAIN IN EXTREMITY (Mild arm ache) and CHILLS (Shivers). At the time of the report, TREMOR (Shaking/her whole body shook), MUSCULAR WEAKNESS (Legs would not work/ hard to get her legs to work), PAIN IN EXTREMITY (Mild arm ache) and CHILLS (Shivers) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.    This case was linked to MOD-2021-010360, MOD-2021-245521 (Patient Link).
Patient called complaining of fever, severe chills and several bouts of diarrhea. He also complains of lethargy and loss of appetite.
I had a sharp pain in my left leg while walking. I went to E.R. and they sent me for imaging and they found a blood clot in my left leg. I ended up staying in the hospital for 2 nights. In December, I was diagnosed with Deep Vein Thrombosis.
pt recvd vax; high pitched crying after vax;to er & hosp next night;MD gave apap & alcohol pads for leg;got better saturday;took bottle at 2am sunday;was found not breathing at 6am sunday;to er & pronounced dead;
Patient was inadvertently given extra dose  ( 2 doses) of Pfizer Biontech Bivalent Booster (Dose #4) today. Patient was informed immediately and educated on outcome (ie side effects). Patient was monitored for 15 to 20 minutes and did not experience a reaction. Patient was given written documentation of the incident as patient wanted written documentation prior to leaving. Patient safe and ok after vaccine.
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Oct-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 31-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-676622 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-676622:Same reporter
mild case of pneumonia; no appetite; body temperature was 4-5F above baseline; lost 10 pounds in 10 days; xray were similar to someone to had covid; Vomiting; Forgetfulness; uncoherent and unresponsive episode; body tremors; weakness; A spontaneous report  was received from a consumer concerning a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced memory impairment, pneumonia, asthenia, decreased appetite, body temperature increased, incoherent, vomiting tremors and weight decreased.   The patient's medical history included leukemia/AML since an unknown date in SEP-2017 and Stem cell transplant since an unknown date in JAN-2018.  No relevant concomitant medications were reported.   On 18-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On the same day, the patient experienced the events weakness, no energy, no appetite, body temperature were 4-5F above baseline. On 21-JAN-2021, the patient started experiencing body tremors and incontrollable shaking, both are worse at night. On 24-JAN-2021, he had an episode being uncoherent and unresponsive. On 25-JAN-2021, his resting heart rate was increased at 93BPM and his respiratory rate was also increased at 21 RPM. On 26-JAN-2021, he started vomiting and was forgetful. On an unknown date during a follow-up visit with PCP he was prescribed with antibiotics due to a mild case of pneumonia and suspected COVID-19.   Laboratory details included a negative COVID test performed on 22JAN2021 and some blood tests showing elevated WBC on 26JAN2021. He also had done a neuroscan and chest X-rays with unknown results.    Treatment information included antibiotics for the indication pneumonia.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events , memory impairment, pneumonia, asthenia, decreased appetite, body temperature increased, incoherent, vomiting tremors and weight decreased was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Patient's advanced age along with underlying conditions may have been contributory for the occurrence of the events. Further information has been requested.
elevated heart rate/highest was 210; This is a spontaneous report from a contactable consumer (patient).  A 15-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm Right on 12Jun2021 09:00 at the age of 15-years-old as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination.  Medical history included Covid-19. Concomitant medications included ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP) taken for an unspecified indication, start and stop date were not reported; tazarotene (FABIOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced elevated heart rate/highest was 210 on 02Jul2021 with outcome of recovering. The patient underwent lab tests post vaccination which included sars-cov-2 antibody test: negative and sars-cov-2 nasal swab test: negative on unknown date. Therapeutic measures were taken because of the event: cardiology work-up/testing.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101197640 Same reporter/, same patient, different dose of vaccine.
Patient complained about feeling weak. Turned pale however recovered upon fluid uptake and reassessment. Blood pressure check attempted, no result due to machine malfunction. Called 911 while patient pale. Patient provided with bottle of water and orange juice. Upon interview, patient has not had any breakfast.
Information regarding Prevnar (pnemococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received form a pharmacist regarding a  male pt who experienced erythema nosodum. The pt received the first dose on an unspecified date. Event Details: The reportere stated that the pt developed erythema nodosum , after receiving his first dose of Prevnar. The child is now 2 years old and received Prevnar "sometime within the first year" The adverse event was treated and resolved" No additonal information was available at the time of this report.
Initial report was received on 02 February 2010 from a health care professional. A five-year-old male patient who had a past history of verbal receptive and expressive delays, had received a first dose intramuscular left deltoid injection of H1N1, lot number UP031AA on 11 December 2009, and an unspecified amount of time later, he became a little less communicative. The patient subsequently received a second dose intramuscular injection of H1N1, lot number UP038AA on 16 January 2010 and three days after receiving the second dose, the patient experienced a behavior change; he stopped talking and communicating, and he had bursts of laughing and jumping up and down. The event required a doctor's visit (date not reported). The patient's past medical history included a VSD which closed on it's own, late in mental milestones, receptive speech effected, and speech delayed receptive and expressive. At the time of vaccination, the patient had no concurrent illness and he had not been taking any concomitant medications. The reporter stated that in the last few days, the patient began to speak again and the laughing and jumping had slowed a little. Outcome was not recovered. Documents held by sender: None.
Myalgia, Arthralgia & Fever Narrative: dose 1: sore arm day 1 and 2 dose 2: day 1-3-sore arm;day 2: achy muscle and joint; fever chills
high pitched crying x 1 1/2hr-14hr p/vax;nl physical exam w/fever (tactile);
ACCORDING TO PARENT'S STATEMENT: WAS A PAINFUL RED LUMP. AFTER 2 DAYS THE LUMP GREW IN SIZE. BIGGER THAN A SILVER DOLLAR. STILL PAINFUL AND HAS FEVER WAITING. ACCORDING TO DOCTOR'S VISIT REPORT STATING:3 yo male was here in Peds clinic 2 days ago and received DTaP#4 and Varicella #1 vaccines, DTaP was given in L thigh. Mom reports that when that vaccine was given, child reached down and grabbed the syringe and does not know if it pulled out or moved while the vaccine was still being given. Child developed a small knot in his left thigh that night, the following day child with redness, firmness and warmth at injection site. TTP but not affecting pt's activity, normal gait. No fevers. No problems with righ thigh (varicella) injection site. Child had no previous problems with prior DTaP vaccines.
Information has been received from a medical assistant concerning a patient who on 26-AUG-2010, was inadvertently vaccinated with VARIVAX (Merck) (Lot# not reported). The patient was intended to receive ZOSTAVAX (Merck). No adverse symptoms were reported. No further information is available.
No adverse event; she gave the wrong vaccine to two patients today 22Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (she gave the wrong vaccine to two patients today 22Feb2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu shot on 22Feb2023 (Dose 1) on 22-Feb-2023; for COVID-19 prophylaxis: Spikevax (Dose 2). Past adverse reactions to the above products included No adverse event with Spikevax and flu shot on 22Feb2023.    On 22-Feb-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (she gave the wrong vaccine to two patients today 22Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (she gave the wrong vaccine to two patients today 22Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (she gave the wrong vaccine to two patients today 22Feb2023).    No concomitant medications were reported.  It was reported that the medical assistant gave the wrong vaccine to two patients on 22-Feb-2023, they were supposed to get the adult bivalent vaccine but accidentally administered with 6-11 year old Monovalent vaccine.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712429 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712429:2nd patient case
Rash on my stomach and my left thigh; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on my stomach and my left thigh) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on my stomach and my left thigh). At the time of the report, RASH (Rash on my stomach and my left thigh) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.
got the shots, shingles / suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, between 4 and 5 months after receiving Shingles vaccine and between 6 and 7 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shots this past spring. The patient came down with shingles a week and a half ago. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation were unknown at the time of reporting. The follow up was not required.