chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 29 year old female patient with asthma. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, inj (lot# and expiration date not provided) (dose not reported) in the arm. Concomitantly on 20-OCT-2014 the patient received influenza virus vaccine (manufacturer unknown) (lot# and expiration date not provided) (dose not reported), in the same arm. On unspecified date (in approximately 2014) the patient developed pain at injection site that was then radiating to her neck and that she could not move her entire arm. It was reported that the patient was going to be seen by an unspecified physician in regard to this adverse event. The outcome of "pain at injection site that is now radiating to her neck that she could not move her entire arm" and was reported as not recovered/not resolved. The relatedness between the events and therapies was not reported. Additional information has been requested.
administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 041B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
3.) Call back from POA, notified of new skin condition and POC,  2.)  Call received from APRN- reported assessment to her, new order for Benadryl 25mg x one dose, medication given, called and left message with POA awaiting return call back      1.) Resident with raised red areas on left arm, did receive Covid-19 Vaccine on 01/05/21, no respiratory difficulties, call out to APRN- to report new skin issue
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 3/24/2021 METABOLIC ENCEPHALOPATHY
3-9-21 6:39PM HAS RASH TO BOTH ARMS X 10 MIN. 6:40PM BENADRYL 50MG GIVEN PO. NO SOB/DYSPNEA, NO DIFFICULTY SWALLOWING. A/O, PINK, W/D, RESP REG WITH EASE.  6:48PM DECREASED REDNESS NOTED. 6:55PM RASH IS BETTER NOW.  HUSBAND HERE TO DRIVE HER  HOME. 3-10-21 8AM TC:  PT STATES RASH ISGONE ALMOST COMPLETELY  NOW AND IS 'FEELING GOOD'.
1.  Muscle twitching at injection site 7 hours after injection.  My muscle twitching has not stopped and has spread to my legs and left hand and arms.   2.  Day 2  felt  soreness at injection site and weakness to my legs and arms that remains as of 3.14.21.   3.  Day 14 developed bad right sciatical pain that lasted 1 day and resolved on its own. 4.  Day 21 developed restless leg syndrome x 1 day and resolved on its own 5.   Day 25  developed severe body trembling  arms andl egs and severe anxiety at night, I could not sleep x 2 nights. 6.   Day 32 developed  a very faint inner tremor that I feel when I get out of bed.  I also found out I have poor balance when standing on one leg or trying to wak a straight line.  Also, my twitching muscles are more often and a little bit stronger.  My anxiety has increased greatly because I dont know why this is happening after getting the Moderna injection
Pain at injection site (84.1%) no ? Fatigue (62.9%) yes ? Headache (55.1%) yes ? Muscle pain (38.3%) some lower back ? Chills (31.9%)  no ? Joint pain (23.6%)  neck ? Fever (14.2%) no ? Injection site swelling (10.5%)  no ? Injection site redness (9.5%) no ? Nausea (1.1%)  no ? Malaise (0.5%) yes ? Lymphadenopathy (0.3%) no Blood pressure high on 4th day with accompanying eye pressure. 155/102
Patient was given first vaccine April 16th. Second shot was due May 14th. This was a med error as she was not due for her second shot.  Pt was told of the med error and agency guidelines were followed as I instructed patient not to get a second shot.
At 0930 1-21-2021 at the site of her injection on her left deltoid her arm began to itch.  Between 1100-1130 the left side of her jaw began to hurt.  She rates that pain 4-7/10.  Five minutes later the left side of her lips began to tingle and became numb.  She looked in the mirror and saw her face drooping.  The Occupational Health Call Center advised her to go the ED.  The ED physician told her she did not have Bell's Palsy due to the fact that her eyebrow and cheek were not involved.  She was give Toradol and later took Benadryl at home.  The ED physician reported to her she had a severe reaction and to monitor for symptoms.
"Felt dizzy at school".  Later in the evening while shopping with grandmother, "felt bad".  Grandmother stated child became pale and dizzy.  Temp 100.5 orally.  Grandmother phoned pediatrician hotline who instructed her to give Motrin for comfort and fever reduction.
Pt presented for pre-travel vaccinations prior to travel.  Vital signs at presentation were as follows; B/P 120/62, T 97.7, R 12 and HR 60.  Cursory physical exam was accomplshed, nml heart and lungs.  Past medical hx of febrile seizures.  Pt was to receive four vaccinations; however, after receiving 1.0ml HAVRIX #1 and 0.5ml Fluzone separately (separated by 7cm) patient had a vasovagal episode, was laid supine, then after approx. 15 seconds she had a 15 second tonic-clonic seizure episode.  She fully recovered, with HR 68 and B/P 120/70 after episode.  After resting for 20 minutes, waited for another 10 minutes and was sent by POV to emergency room and had a normal work-up.  Believed to be secondary to prior hx of seizure (none related to prior vaccinations).  Talked to mother of patient this morning and patient is feeling well.
Soreness in arm immediately.  13 hours after injection- sweats, chills, increased arm pain, body aches, extremity pain, palm sensitivity, nausea, trouble sleeping.  14 hours after injection- fever, shortness of breath, fatigue, redness in arm, swelling in injection site.  18 hours after injection- stiffness in injection site, extreme fatigue, increased nausea.
On September 5 the patient started showing signs of a heavy chest cold.  She was sick for the next week with heavy cough, on and off fever, extreme fatigue, shortness of breath.  She kept insisting she just had a strong chest cold.  On September 12 I found her barely conscious, foaming at the mouth, with extreme labored breathing.  Emergency medical services took her to the ER.  She was in ICU intubated for one week, then died on September 19.
Skin rash all over the body with hives, itching that appeared two days after vaccination.
When I entered the Bivalent 5-11yr vaccine in database, it showed "Not Valid" therefore the Pfizer 5-11yr Monovalent dose was given. Database accepted it as a 2nd Booster.
Supraclavicular lymphadenopathy on the right side, slight red rash at injection site
Two days post vaccination patient experienced swelling, slight reddening, and warmth at injection site. Size of swelling described as " baseball-size" lump.  Afebrile, or any other adverse effects.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, in May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), (SARS-COV-2 TEST POSITIVE) COVID-19.(medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, (sars-cov-2 test positive). COVID-19. Clinical course: The patient received treatment anti-viral product brand Paxlovid, treatment start date 06may2022, treatment stop date 10may2022. The patient experienced rebound symptoms after five-day course of Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling/small lump in the right lymph nodein the armpit; Soreness in my right lymph node in her armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling/small lump in the right lymph nodein the armpit) and AXILLARY PAIN (Soreness in my right lymph node in her armpit) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE (NATURE'S BOUNTY CALCIUM) from 01-Jan-2020 to an unknown date for Bone disorder (NOS).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling/small lump in the right lymph nodein the armpit) and AXILLARY PAIN (Soreness in my right lymph node in her armpit). On 06-Jan-2021, LYMPHADENOPATHY (Swelling/small lump in the right lymph nodein the armpit) and AXILLARY PAIN (Soreness in my right lymph node in her armpit) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow up received on- 01-APR-2021, Reporter details updated, Patient demographic updated, Outcome of the events updated from unknown to recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache, Myalgia, SkinRash, NauseaVomiting, ITCHING BEHIND KNEES WITH RASH Narrative:
8/23/22 pt had a positive COVID test at Center; was give Azithromycin and Medrol Pak; 8/27/22 pt brought to ED with fever, body aches, O2 saturation in 80s; O2 supplementation; CTA chest shows multifocal pneumonia; pt's condition worsened; transitioned to DNR, comfort measures; family requested BiPAP to be removed and patient passed away in the hospital
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. Initial information was received along with additional information received on 04-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total administered to right arm on an unspecified date in APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The drug start period was 15 months. The patient received booster dose of non-company suspect Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered to right arm on an unspecified date in NOV-2021 for covid-19 prophylaxis.  The patient received non company suspect unspecified Pfizer drug (form of administration and route of administration were not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered from 14-JUL-2022 and last dose of administration was 19-JUL-2022 for covid-19 treatment. On 20-JUL-2022, at 12:00 the patient experience fatigue, cough, headache, elevated heart rate (confirmed Covid-19 infection) (Dose number in series 2) which led to confirmed clinical vaccination failure (Dose number in series 1). Laboratory data included: COVID-19 virus test Positive.  The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported.. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000245099.; Sender's Comments: V0:20220806664-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX dose, route, indication and lot # not reported. On an unknown date the patient got shingles. The outcome of adverse event was unknown. The relatedness between adverse event and therapy with ZOSTAVAX was unknown. This case is linked to same reporter's report # 1306USA007892. Additional information has been requested.
On 04/14/2921, Client received second dose of Covid 19 vaccine five days prior to due date  04/19/2021 04/16/21 TC to client to follow-up after vaccine. No answer. Voicemail not set up. 02:15pm TC to client. Client informed that vaccine was given five days prior to due date. After reviewing agency recommendations, it is not recommended to repeat dose. Client stated he did experience mild flu-like symptoms on 04/15/2021. Client reports feeling better today. No swelling or redness reported at injection site.
When she caught COVID-19 she started with a cough and a sore throat on April 18, 2022. She had a sore throat, mild cough, myalgia, arthralgia, and a headache. She had sinus drainage and sneezing that became worse than the day before. She saw a doctor and got a Z-PAK prescribed. She finished that medication on April 25th. She was feeling well on April 28th.
pt recvd vax & approx 4 wks later pt began exp muscle pain & cramps in rt leg & pain in the rt upper arm (pneumococcal site); pt exp no weakness or atrophy; pain is still persisting for more than 6 months;
11DEC95 pt noticed rashes when awoke in AM;described rash as bright red, raised pinpoint to rice sized, non-blanching when pressed & mildly itchy;rash first appeared on rt forearm near wrist & 3hrs later similar type rash appeared lt wrist
aching in arm, pain in neck & rt side of face red, tender & swollen;eye also swollen, forehead appears bruised;referred to PMD for eval;no other details available;
My son woke up on thursday 01Jul2021 the day after he received the 2nd dose of the covid 19 vaccine with partial facial paralysis and was diagnosed with bells palsy; My son woke up on thursday 01Jul2021 the day after he received the 2nd dose of the covid 19 vaccine with partial facial paralysis and was diagnosed with bells palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 14-year-old male patient received second dose of BNT162b2 (CONMINTARY, Solution for injection, Lot No: EW0196), via an unspecified route of administration, administered in Arm Left on 30Jun2021 17:45 (at the age of 14-year-old), as 2nd dose single for COVID-19 immunization (Administered at Pharmacy or Drug Store). The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2(CONMINTARY, Solution for injection, Lot No: EW0191), via Left arm on 23May2021, 01:00 PM (at the age of 14-year-old), for 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. No other medical history was reported. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The reporter stated that their son woke up on Thursday 01Jul2021 the day after he received the 2nd dose of the covid 19 vaccine with partial facial paralysis and was diagnosed with bell's palsy. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of facial paralysis and bell's palsy. Treatment received included prednisolone. No seriousness criteria was reported. Outcome of the events was not recovered at the time of reporting.  Device Date was 09Jul2021.  No follow-up attempts needed. No further information expected.
01/14/23 presents to ED for "chest pain". PMHx of "paroxysmal A. fib not on anticoagulation, lower back pain, DVTs and other comorbidities"
About 15-20 minutes after injection. Upper body and arms felt numb. The  numbness feeling like arm and leg are asleep are currently on the right side of the body from right shoulder to right foot. It?s hard to describe it feels heavy of like I was laying on my right side. It?s an annoying pain that has t gone away.
I felt horrible for about 10 weeks; Initial information regarding an unsolicited valid non-serious case received on 15-Nov-2020 from a consumer (Patient).  This case involved a patient of unknown demographics who felt horrible for about 10 weeks (Feeling abnormal), while patient received vaccine INFLUENZA VACCINE.  Patient had a past vaccination with Influenza vaccine.  The patient's medical history, medical treatment, other vaccination details, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination.  Patient tried for 2yrs. Patient felt horrible for about 10 weeks (feeling abnormal) (Unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory tests reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for reported event.  There will be no information available on batch number for this case.
Joint aches; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint aches) and MYALGIA (muscle aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Muscle injury.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ARTHRALGIA (Joint aches) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Joint aches) and MYALGIA (muscle aches) outcome was unknown. Not Provided          No concomitant medications were provided. Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-082921 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082921:1st dose of vaccine
4-5 hours post vaccine patient began experiencing nausea. Nausea has lasted 13 day. Vomited times one.
Started around 2:00 am severe chills, sweats, fever, nausea, body aches continues with symptoms at time of documenting this.
A 38 year old male pt reported that he received a dose of Flumist on 12/5/03. On 12/8/03, a 38 year old male pt developed dry, hacking cough, sinus congestion, slight headache, sore throat, muscle aches, chills, and burning eyes, tiredness and weakness following receipt of Flumist. As of 12/10/03, the pt's symptoms persisted. As of the date of this report, the prescribing physician has not been contacted. No additional info was available at the time of this report.
Approx 8 hours after dose received, chills, fever up to 102, severe body aches, severe headache,  lasting about 44 hours
Painless red rashes appeared first on inner left thigh after first dose, then began to fade. After the second dose, the original rash became bright red and more rashes appeared on my left leg, one appeared above my pubic area, and light rashes appeared on my stomach, back, and inside my buttcheek.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX  for prophylaxis, lot # N014630 with expiration date of 11-MAY-2019 (strength, dose, route and frequency were not reported). The sterile diluent (manufacturer unknown) that was used to reconstitute the VARIVAX was not improperly stored.  No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6°F (degrees Fahrenheit) to 14°F for 48 minutes; previous temperature excursion was done, 6°F to 14°F (34.68) for 54 minutes (worse case). The call was because of a "data logger".
Pt recvd #1 vax on 22OCT90 @ 1030AM according to mom pt had severe screaming & falling to sleep for 1/2 hrs & awake w/severe screaming for 1.5hrs; erythematous rash on forehead;
COAGULATION DEFECT, UNSPECIFIED TYPE, IN PREGNANCY, UNSPECIFIED TRIMESTER 5/12/2021 HEPATIC ENCEPHALOPATHY
On 5/15/22 started feeling a sharp pain in the abdomen.  By evening time the pain was unbearable and patient went to the hospital (ER).  Was treated with pain meds and saline.  Had an untra-sound conducted and presiding doctor determined it to be gallstones.
About 12 hours following the High Dose Flu Shot she experiences severe chills, sweating, dizziness, diarrhea, vomiting, unable to walk....Patient crawled to the phone and dialed 911 and was taken to Emergency Room.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient passed out within 10 minutes of receiving vaccine. He was very nervous about receiving the shot to begin with. After passing out, he was pale skinned, disoriented and sweating.
Seen in the ER on 7-20-22 for altered mental status and hyponatremia.  Pateint was tested for covid upon arrival and found to be positive.  She was admitted the same day for further evaluation and treatment.