chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events; patient was administered an improperly stored MMR II; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 11-JUN-2020, the patient was vaccinated with dose of improperly stored measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA)subcutaneous injection, lot# S020161, expiration date 30-JUN-2021 (strength, dose and route of administration were not reported) reconstituted in properly stored sterile diluent, for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion above 47 Fahrenheit degrees (F) (53 F) for 1 hour 30 minutes. There was no previous temperature excursion. The call was not due to digital data logger. No additional adverse events were reported.
Pt had co red, slightly swollen area that was warm to touch where the injection was given. Called pt's doctor and they wanted her to stop by. She stated she was going to go see Dr.
PANIC ATTACKS; LONG-TERM DIZZINESS; This spontaneous report received from a consumer concerned a female 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: Unknown) 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 panic attacks, and long-term dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the long-term dizziness and panic attacks was not reported. This report was non-serious. This case, from the same reporter is linked to 20210754977 and 20210759716.; Sender's Comments: V0 :  Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
No tender swelling of the left axilla and left chest wall started ~ 11 hours after immunization. Has increased to extend to the inferior border of the pectoralis muscle.
got the shot...still got shingles/Suspected Vaccination failure; got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient got the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. This case has been linked with the case US2021AMR138261, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138261:Same reporter
Development of blood clots in lower right leg causing swelling and pain. Pt. visited doctor who prescribed an ultrasound which revealed the clots.  Doctor has now put pt. on blood thinners indefinitely.
Afternoon on the day of vaccination patient felt a little weak and c/o mild pain at the injection site.  Next morning after around 11 am patient started to vomit almost a lot, her fever went up to around 38.5C auxiliary, she reported extreme weakness and shakiness, her blood pressure also increased to 160s/high 90s, she complained of extreme shortness of breath. Elevated BP could be related to the fact that she was vomiting so much, she had hard time taking her scheduled medications, included BP medications.   This lasted for 3 days. Patient was taking Ondasentron and that was only reliving nausea for 2 to 3 hours. She was taking Tylenol to bring her fever down. 650 mg Tylenol was only lowering temp to about 37.8.  For about 72 hours she was complaining of extreme generalized pain and weakness and had very hard time getting up to go the bathroom.  She started to fill a little better on March 27, 2021. Shortness of breath disappeared in the morning. Temperature fell to 37.1C. She stopped vomiting and was able to eat.  Generalized weakness and shakiness persisted till March 2, 2021. At the moment of submitting this report, patient is still reporting that she does not feel that she is "100% back to normal"
Freezing Fever Headaches All Body Aches No Energy     for 2 days
3-5 minutes after receiving Td and HBV #1 pt "felt funny". Pt had active seizure with eyes and upper extremities involved. No resp effort. Cyanotic. Seizure lasted about 1-2 minutes. Color improved with opening of airway. After about 3 minutes pt became responsive.
mother reports patient experienced hives 2 hrs post 2nd set of shots as well as trouble breathing described by mom as "gasping". Did not go to MD/ER. Reports hives lasted 48 hours and breathing returned to normal after dose of Tylenol.
Slight nausea/flu like symptoms  evening day 1, intermittent for 6 + days. Chills evening of day 2-3. soreness at injection site right arm day 1pm-day 3 redness at injection site (2-3" diameter) day 2-4
Persistant metallic taste, occurred with first dose and worse with second dose.  Lasted 5 days with the first dose and still continuing with second dose.
Bell's Palsy - developed on 1/2/2022 - droopy left mouth, lower strength of upper facial muscles.
had first dose of Shingrix in 2019. Never had second dose (Inappropriate schedule of vaccine).; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in the year 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Red Rash Near the Injection Site; Hot Rash Near the Injection Site; Fever; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Rash Near the Injection Site), VACCINATION SITE WARMTH (Hot Rash Near the Injection Site), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue). On 24-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash Near the Injection Site) and VACCINATION SITE WARMTH (Hot Rash Near the Injection Site). On 23-Jan-2021, PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. On 28-Jan-2021, RASH ERYTHEMATOUS (Red Rash Near the Injection Site) and VACCINATION SITE WARMTH (Hot Rash Near the Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products use was not provided by the reporter.  Patient reported taking Antihistamines, to try and help alleviate the symptoms.
24 hours after vaccine, extreme fatigue, sleepiness. Lasted 24 hours then cleared up. Slept most of the day on Monday
Pt recv vax in 7/98; 1 day post vax pt exp fever, muscle aches, coordination difficulty, difficulty walking, rash at vax site
This spontaneous report was received from a healthcare professional (who was also an office manager) via Poison and Drug Center (PDC) (ref# US17-008179) and refers to a 53 year old female patient. She did not have any relevant medical history. On 27-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II (expiration date 05-FEB-2017; lot #, site, exact dose and route of administration were not reported). Concomitant therapies included LIPITOR, aspirin (manufacturer unknown) and vitamins (unspecified). The outcome of the event was unknown. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 19-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State. The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. No adverse reactions were reported by the patient. No treatment information was provided by the reporter.
Covid arm; Warm; The size of her fist red; Lymph node on the opposite side of her arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), ERYTHEMA (The size of her fist red) and LYMPHADENOPATHY (Lymph node on the opposite side of her arm was swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (survivor as of 2017).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm), ERYTHEMA (The size of her fist red) and LYMPHADENOPATHY (Lymph node on the opposite side of her arm was swollen). At the time of the report, VACCINATION SITE WARMTH (Warm), ERYTHEMA (The size of her fist red) and LYMPHADENOPATHY (Lymph node on the opposite side of her arm was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Baby was fussy, vomited had temp. 1/2 dollar sized red hard raised area on right thigh warm to touch. Continue to give Tylenol for temp and discomfort call if site doesn't improve.
Pain in left arm around injection site; radiated into chest/underarm area and down arm a bit. Patient reports she couldn't lay on it for 4 days and each day it felt a little bit better. She said the pain was much more severe than previous immunizations and had no trouble with the PNEUMOVAX shot in right arm.
Patient got bad 4.5 inch bruise in arm that he got a fluzone HD in. He could move his arm, but the pain made it hard to sleep. Pain is improving now. He ran a low grade fever for about a week which is gone now.
1st Dose 2/5/21- hives appeared on arms, legs and stomach -02/11/21. Hives lasted for seven days 2nd Dose 3/5/21-initial sore arm. Next day whole body sore and hard to move. Felt better by 3/7/21 Menstrual cycle did not arrive. doctor appointment on 3/23/21. Blood test showing that my thyroid is not producing properly.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (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) Unknown results, notes: COVID 19 Treatment; (08Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid treatment started from 23May2022 to 28May2022.  Causality: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE. Clinical information: Patient got COVID back test positive 10 days after taking paxlovid. No known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Vaccination site rash; Vaccination site swelling; Vaccination site pain; Vaccination site erythema; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 023M20A) for COVID-19 vaccination.     Concomitant products included NAPROXEN SODIUM (ALEVE), MIRABEGRON, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). The patient was treated with HYDRALAZINE HYDROCHLORIDE (APREZIN) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-031995 (Patient Link).
Information has been received from a registered nurse concerning her 6 year old daughter who on 09, Mar 2007 was vaccinated IM with a 0.5 ml dose of zoster vaccine live (Oka/Merck) (lot# 652947/1411F) instead of varicella virus vaccine live (Oka/Merck) (MSD). Additional information from another registered nurse and certified medial assistant indicated that  the patient developed a rash and swelling at the injection site. The patient had redness the size of a half dollar at the injection site. the nurse reported that the staff reached for the bottle of varicella virus vaccine live (Oka/Merck) (MSD) but picked up zoster vaccine live (Oka/Merck) instead. The viala are stored near each other in the freezer. This was not product confusion, it was an error. It was reported that the patient received her first dose of varicella virus vaccine live (Oka/Merck) (MSD) on 03, Dec 2002. No product quality complaint involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Additional information from a registered nurse from the physician's office indicated that the patient had a local minor reaction only, slight redness at injection site for twenty-four hours. No work-up or follow-up was performed. No further information is expected.
Pt reports migraine type h/a and fever of unk elevation. Seen in ER for head pain.
Site of injection feels worm; Site of injection has red mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Site of injection feels worm) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Site of injection feels worm) and VACCINATION SITE ERYTHEMA (Site of injection has red mark). At the time of the report, VACCINATION SITE WARMTH (Site of injection feels worm) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI
Started March 6 about 4:00 Headache Very tired muscle aches Upset stomach
It was reported that a female pt received a TD Adult vaccination on 11/07/2000. Reportedly on 11/10/2000, the pt developed a local reaction of redness and soreness at the injection site. A physician evaluated the pt; no prescribed medication was given.
I received the shot at about 11 a.m. on  11/20/07 at the office of my son's pediatrician; my 20-month son received it too.  Hours after the shot I started to fell dizziness, weak, like vomiting and this continued until the next day (today). Today, around mid day I vomited my hands shaked for most of the day as if I had drank a high dosage of caffine. I feel very weak and spacey/disoriented. My son seems to be okay. My ex, my son's father also received the shot at the same time that my son and I did. He says that he has felt fine. Today, I had to rest for part of the day because I did not feel well.  If this feeling continues tomorrow morning, I will go in to see a doctor. I have had the shot before but have not had this reaction. I don't know why I am feeling this way this time, I was not ill before I received it.
patient received a dose of PENTACEL on 22Oct2020 that had expired on 11Oct2020, no AE; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional..  This case involves patient who received a 0.5 ml expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number of one part was U6469AB and other was UJ134AA with the expiration date of 11-Oct-2020) via intramuscular route in unknown administration site for prophylactic vaccination on 22-Oct-2020 (expired product administered).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used (same day latency).  No adverse event reported at the time of reporting.  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 in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Left upper arm was red, swollen, hot to touch. Injection site measured 8.5x4.5. No other symptoms.
Narrative: The patient received their 4th dose of Moderna COVID 19 Vaccine on 19 October 2022 and experienced rash and thrombocytopenia drop in his platelet counts to 75. The patient was treated with prednisone and ibuprofen. The patient returned to the clinic on 2 November 2022 with residual arthritic pain and rash, but platelets returned to normal.
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 45 years old male patient who received vaccine TYPHIM VI. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 17-Oct-2018, the patient received injection of suspect Typhoid VI Polysaccharide Vaccine, lot N1K811M, expiry date 29-Oct-2019 via unknown route in the left deltoid. It was an actual medication error due to vaccine underdose and syringe issue. It was reported that TYPHIM VI prefilled syringe was leaking from tip when administering the dose, uncertain if patient received any amount of vaccine, pharmacist observed leakage on the patient. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender- none.