chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I noticed on Friday (three days post-injection) that I had small bumps all over my arms, shoulders, chest, neck, and head. On Saturday, I noticed that the bumps had turned red and looked more like a rash. They aren't itching, and don't seem to be spreading, so I have not gone to see a doctor. I have have also had two migraines this week when in the past several months, I haven't had any migraines much at all. (Less than 1 per month.) I do not know if the migraines are at all related, but figured I would mention them because this is out of the norm for me. I have not changed my diet or my detergent, so I don't have anything new that could explain the rash.
Patient was inadvertently given the full dose (0.5 ml) for the Moderna booster instead of  standard 0.25 ml. Followed up with patient to see if immunocompromised in any way to qualify for full dose.  Spoke with patient's daughter on 1/24/2022 (after leaving 3 messages for the family).  Daughter confirmed mom was doing just fine with no adverse effects aside of a little fatigue like she had after first 2 doses.  I would like to note here that patient is morbidly obese as well.
shaky; chills; This spontaneous report was received from a nurse and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.   On an unknown date in 2019 (reported as last year), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, frequency, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis.     On an unknown date (reported as after the administration), the patient was shaky and had chills, she did not say she had a fever. The reporter inquired if the patient would have the same reaction after pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).     The outcome of the events was unknown.   The causality assessment was not provided.
22 y/o patient ref by Occ Hlth for eval of local rxn 48 hrs s/p receipt of Varicella #2 on 02DEC13 in LUE. "6"/10 pain on lifting Lt arm. No numbness or weakness in LUE. Also received Tdap in RUE on 02DEC13 w/o significant erythema, edema or warmth at Tdap injection site.
Approx 1 hour after receiving vaccine, patient states L arm and hand numbness, rash-small bumps.  Next day arm itchy, no rash, arm hurt at injection site.
Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Moderate use). Family history included Birt-Hogg-Dube syndrome (Family genetic disease: maternal side, including mother, grandmother), Breast cancer (From maternal side), Colon cancer (From maternal side), Leukemia (From maternal side) and Heart disease, unspecified (On paternal side). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 07-Dec-2020 and the estimated date of delivery was 13-Sep-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Pregnancy test: positive (Positive) Positive. On 25-Feb-2021, Prenatal screening test: normal (normal) Normal. On 08-Apr-2021, Alpha 1 foetoprotein amniotic fluid: normal (normal) Normal. On 28-Apr-2021, Amniocentesis: normal (normal) Normal, 20 week US.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event (Exposure during pregnancy) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information received on 10-May-2021, patients date of birth, gestation period (22 weeks), relevant medical history [Family genetic disease: Birt-Hogge Dube, cancers (breast, colon, leukemia), heart disease],  date of positive pregnancy test, diagnostic findings (Cell Free DNA, AFP, 20 week US), Alcohol use (moderate use).
Within 5 minutes of administering immunizations pt. reports tongue feeling swelling and numbness, heaviness in chest
Facility they doesn't swirl the vial after every withdrawal; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Facility they doesn't swirl the vial after every withdrawal) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Facility they doesn't swirl the vial after every withdrawal). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Facility they doesn't swirl the vial after every withdrawal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Follow-up received on 08-NOV-2021 contains no new information
Dizziness, nausea, vitals wnl. Initial chest pain, mild back pain.
This is an initial report of an AE, received on 01Nov2016, for Protein Sciences Flublok. A female received Flublok Intramuscular on 01Nov2016 at 10.30 am. The pharmacist observed the patient for 20 minutes with no recorded adverse signs or symptoms and the subject left the pharmacy. On, 01Nov2016, approximately 1.5 hours after receiving Flublok, the subject reported to her employer that she was on her way to the hospital. The subject had texted to her employer that she had symptoms of labored breathing (weight on her chest) and an itchy throat. The patients employer had called the pharmacy where the subject received Flublok to inquire additional information regarding anaphylactic reactions with Flublok, specifically the length of time between the injection and symptoms. The employer appeared to express doubt that this was a genuine medical event. At the time of the report, the outcomes of the events of labored breathing (weight on her chest) and an itchy throat were unknown. Medical or surgical history for the subject included an egg allergy (non descriptive adverse reaction to a previous flu shot from a few years prior). Concomitant medications were not reported. Additional information received on 08Nov2016, pharmacist who provided the Flublok vaccine and the infectious control officer at the hospital where the subject was seen were unable to provide any additional information at this time.
A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient received expired FLUMIST QUADRIVALENT on 14-Jan-2014 as expiry of vaccine was on 13-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by reporting health professional. Follow-up of insignificant information received by AstraZeneca/MedImmune on 13-May-2013 from Health Professional: Initial AZ date corrected. Corrected report 04-Apr-2014: Formulation corrected.
5 days post vax pt fussy, gassy, urticaria, + hives;
Patient received DPT shot and had high fever following administration. Approx 1 hour after administration pt suffered grand mal seizure. Taken to hospital.  11/25/08 Reviewed hospital medical records from 10/1995-12/1996. FINAL DX: recurrent respiratory tract infections; reactive airways disese; failure to thrive; hx of pertussis; RML pneumonia Records reveal patient initial hosp admit 11/20-11/25/1995 w/congestion, fever, reduced oral intake.  RSV (+) bronchiolitis.  Had bilateral inguinal hernia & left hydrocele repair 12/21/95.  Admitted 12/30-1/2/96 for viral gastroenteritis.  ENT clinic notes reveal prolonged OM despite antibiotic coverage.  Recurred OM 7/96. Had PE tube placement  & found left TM severely retracted.  Seen in ER multiple times for URI.  Admitted 11/26-11/28/1996 for status asthmaticus, presumptive pneumonia.  Admitted 12/4-12/11/1996 w/pertussis, posttussive vomiting & dehydration.  Pulmonary consult done & suggested immune w/u.  No further records available.  10/7/08 Reviewed PCP medical records. FINAL DX: migraine HAs; major depression; oppositional defiant disorder. Records reveal patient experienced hospitalization 10/20-10/30/1995 but no birth records attached (other records state hx of RDS).  8/21/06 neuro eval for migraine w/auras being tx w/depakote.  Hospitalized 9/20-9/29/2006 w/intermittent explosive disorder; major depression w/homicidal & suicidal features.  Seen in neuro clinic 11/23/2006 w/weight gain on current meds.  Most recent psych dx 2/2007 of oppositional defiant disorder.
Pt recvd vax & returned to nurse p/30 mins w/c/o dizziness & sl nausea, lt deltoid area erythematous w/papular rash approx 4x4; Ice applied to site area & pt laid down;
After receiving the initial dose, patient checked with observation staff. Patient had a syncopal episode after walking 12-15 feet away from the check in desk. Patient reported "blacking out." Patient stated that he does not like needles. Patient was assessed by paramedic. Patient A/Ox4 with CMS present in all extremities. Airway patent, pulse regular, no bleeding noted. Patient's skin pale, cool, and diaphoretic. Patient was assisted to a chair. Patient reported "feeling better." Patient observed for 10 minutes past the 15 minute observation time. Staff offered to call EMS, patient declined.
Pt states heR thRoAt Feels LIke It Is constRIctINg. Pt stAtes pRevIous EpI-PeN use due to spIcy FooDs. Pt states she Feels LIke she CAN't SwAllow.   *DIpenhyDRAmINe ADMINIsteReD IM 50 mg. (6) ShouLDER. 1345. ReFuSAL oF MeDIcAL tRANspORt. 1400 pt stAtes she Feels betteR But sleepy. Pt motheR ARRIveD @ 1450 to tAke pt Home.
w/in 24 hr of vax devel rash confined to neck & chin area, no lymphadenopathy, no facial swelling noted;rash was itchy;last 1-2 days & dissipated by itself
Drug ineffective; SARS-CoV-2 infection; Symptoms returned and we tested Pos; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "SARS-CoV-2 infection"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Symptoms returned and we tested Pos". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again for covid despite receiving the BNT162B2 vaccines; Negative, notes: tested Neg; Positive, notes: tested Pos. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter stated that, the same for my brother who lives with us. We all wake up with scratchy throats, had fever and headaches during the night. Took the test and were all pos, called our Drs. Took the Paxlovid for 5 days, tested Neg. Then 3 and 4 days later symptoms returned and we tested Pos.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201022236 Same reporter/vaccine/event, different patient;US-PFIZER INC-PV202200053462 Same reporter/vaccine/event, different patient;
Pt describes onset of high fever, chills, and tightness in chest, 4 hours after receiving vaccination. Also had body aches and fever that continued for 36 hours.
7 Days after receiving the vaccine the injection site developed a palm sized rash around the site. It is mildly itchy but otherwise painless. It is red, raised skin around the site.
Information has been received from a registered nurse concerning a 3 year old white male who on 31-JAN-2005 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot# 649847/0768P) in the left thigh. There was no illness at the time of vaccination. on 22-MAY-2007 the patient was diagnosed with varicella for "breakthrough chickenpox characterized by 50 to 75 lesions." No labs or diagnostic studies were performed. Subsequently the patient recovered. No further information was available. No further information is available.
Fever (101.5 F), body aches, headaches, rash, lethargy. Fever lasted 3 days, headaches and lethargy are  continuing.
received by error a 4th dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 19-year-old female patient who received HBV (Engerix B) (batch number CM294, expiry date 19th April 2024) for prophylaxis.   On 1st August 2022, the patient received the 4th dose of Engerix B. On 1st August 2022, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-Aug-2022 Reporter's Comments: HCP had patient that, on 1st August 2022, received by error a 4th dose of Engerix-B. The reporter did not want the information stored in their database but agreed to follow up by safety. the reporter consented to follow up. Additional Supportive Information: The patient was administered with 4th dose of Engerix B vaccine, which led to extra dose administered.
infection in her arm below the injection site; soreness at injection site/pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection in her arm below the injection site) and VACCINATION SITE PAIN (soreness at injection site/pain at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site/pain at the injection site). On 24-Apr-2021, the patient experienced INFECTION (infection in her arm below the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 30-Apr-2021, INFECTION (infection in her arm below the injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness at injection site/pain at the injection site) outcome was unknown.            Concomitant medications were not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-293234 (Patient Link).
Locallized site infection to Left Deltoid area where immunization was given. Excessive pain, swelling redness was reported. Pt went to dr office and was given 5 day supply of augmentin.
I tested positive with covid last august 2020 with no residual issues.  January 5 2021 I received 1 moderna vaccine.  Approximately 2-3 weeks later I experienced sudden onset fasciculations in both feet with concurrent bilateral thenar eminence fatigue-pain and questionable weakness, incoordination of bilateral thenar eminences.  Fasciculations resolved over a few days and thenar symptoms improved.  I was evaluated by neurology, which was unremarkable (however I did not receive any labs, imaging or testing).   Neurologist called it an apparent "peripheral polyneuropathy, possibly related to vaccine". I opted not to receive the second vaccine dose Since onset I have experienced intermittent thenar symptoms that seem to last ~1-2 weeks every month.  I have not been able to identify a pattern or trigger. Severity of symptoms overall seem to be improving
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 07-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
I had body aches, low grade fever, very bad sore throat and very bad sore ears for two days. Loss of taste and smell, fatigue, cough. Treatment was OTC Advil, Flonase and Sudafed. Used Cepacol for the throat. After 10 days, I went back and I did test Negative.
Even right now I have no energy; joints are hurting; was not able to lift my arm; started getting sharp pain in the back; started feeling cold; temp went above 99degF; started feeling tired; little heaviness in hand in the evening; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (little heaviness in hand in the evening), PAIN IN EXTREMITY (was not able to lift my arm), BACK PAIN (started getting sharp pain in the back), FEELING COLD (started feeling cold) and BODY TEMPERATURE INCREASED (temp went above 99degF) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LIMB DISCOMFORT (little heaviness in hand in the evening). On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (was not able to lift my arm), BACK PAIN (started getting sharp pain in the back), FEELING COLD (started feeling cold), BODY TEMPERATURE INCREASED (temp went above 99degF) and FATIGUE (started feeling tired). On 31-Mar-2021, the patient experienced ASTHENIA (Even right now I have no energy) and ARTHRALGIA (joints are hurting). At the time of the report, LIMB DISCOMFORT (little heaviness in hand in the evening), PAIN IN EXTREMITY (was not able to lift my arm), BACK PAIN (started getting sharp pain in the back), FEELING COLD (started feeling cold), BODY TEMPERATURE INCREASED (temp went above 99degF), FATIGUE (started feeling tired), ASTHENIA (Even right now I have no energy) and ARTHRALGIA (joints are hurting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment with Ibuprofen associated with events, was provided by the patient   Reporter did not allow further contact
This spontaneous report as received from a nurse refers to a patient of unknown age. The nurse reported that ROTATEQ (lot ws not reported) which expired 09-JUL-2014 ws given to a patient on 07-AUG-2014. No adverse effects reported. Additional information has been requested.
Pain in left shoulder blade; Tightness in left shoulder blade; Burning sensation on skin; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) on 12Mar2021 at 12:45 PM (at the age of 42-year-old) on left arm as a first dose for COVID-19 Immunisation. Medical history includes body mass index high from an unknown date. The patient was allergic to latex and penicillin from an unknown date. Concomitant drugs include Cyclobenzaprine (MANUFACTURER UNKNOWN) and Pepcid (MANUFACTURER UNKNOWN) for unknown indication. Patient was not diagnosed with COVID-19 prior to the vaccination. The patient was not receive any vaccination 4 weeks prior to COVID-19 vaccination. The patient experienced pain and tightness in left shoulder blade and burning sensation on skin on 12Mar2021 at 5:00PM. The clinical outcome of the pain, burning sensation on skin and tightness in left shoulder blade were not recovered/not resolved. No follow-up attempts are needed. No further information is expected.
chills for 2hrs; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills for 2hrs) and PYREXIA (fever) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (chills for 2hrs) and PYREXIA (fever). On 20-Feb-2021, CHILLS (chills for 2hrs) had resolved. On 21-Feb-2021, PYREXIA (fever) had resolved.            Concomitant medication includes chemotherapy.  No Treatment informations were reported.
Pc from pt started Saut 05/01/04 (left) upper arm red, swollen, flu-like symptoms, achiness, joint pain, malaise, did not work Mon and Tues. Working today, much better exept still having joint pain.  05/07/04: Pt back to normal self.
Father states that some hours after vaccines were administered ( 2 in L deltoid, 2 in R deltoid), pt began to have fevers and L deltoid was red, hot, swollen and painful. Gave pt Tylenol throughout weekend and pt was seen in our office on 5/5/03 w/all of above complaints unresolved. Rrc'd Motrin and cool compresses.
pt recvd vax 26MAY94 & on 29MAY94 broke out in rash on lt deltoid area & abdo- 12-15 papaules scabs had been scratched off-no fever, bilateral; tonsilar nodes papable-enlarged tonsils;
Redness and warmth of entire deltoid ice and antihistamine started about 4 hrs after injection. First seen 3pm next day.
HYPOXIA 4/12/2023 CONGENITAL URETEROPELVIC JUNCTION OBSTRUCTION
A report was received from a health care professional on 3OCT2003 concerning 9 vaccinees of unknown demography who inadvertently received expired Fluvarin vaccine on an unknown date. On an unknown date, 9 vaccinees inadvertently received expired Fluvirin vaccine. No adverse events wee reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
pt recv vax 14Jan99 & w/in 24 hr itching tx=benadryl;18Jan99 jaundice;bloodwork/tests done; saw specialist on 25Jan99 to sched scope; 31Jan99 had pain-went to ER, adm to hosp & had gall bladder removed