chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she is jerking; her leg was jumping out of control; whiteness in her eyes; shaking; she had fatigue; teeth chattering/body chills; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LOSS OF CONTROL OF LEGS (her leg was jumping out of control) and DYSKINESIA (she is jerking) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VITAMIN 15 for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONTROL OF LEGS (her leg was jumping out of control) (seriousness criterion medically significant), DYSKINESIA (she is jerking) (seriousness criterion medically significant), EYE COLOUR CHANGE (whiteness in her eyes), TREMOR (shaking), CHILLS (teeth chattering) and FATIGUE (she had fatigue). At the time of the report, LOSS OF CONTROL OF LEGS (her leg was jumping out of control), DYSKINESIA (she is jerking), EYE COLOUR CHANGE (whiteness in her eyes), TREMOR (shaking), CHILLS (teeth chattering) and FATIGUE (she had fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to emergency room and doctor did not tell her anything. The patient was treated with Tylenol (acetaminophen) and ibuprofen.; Sender'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.
performed a molecular COVID test. The result was Positive.; performed a molecular COVID test. The result was Positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "performed a molecular COVID test. The result was Positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient just completed (PRIVACY) training and then experienced an event that patient thought was supposed to report. Patient received the new Pfizer monovalent booster on 30Sep2023, at a [pharmacy name withheld] (Mailing address withheld). This morning patient woke up with a mild sore throat and performed a molecular COVID test. The result was Positive. Patient's symptoms remain mild and patient had started treatment with an oral antiviral. Patient was traveling right now but could provide the lot number for patient's vaccine dose if needed. Thanks.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
pt recv vax 17OCT97 & 2wk later exp sudden onset of severe (debilitating) muscle aches & pains in hands, knees & legs;there was no rxn @ the inj site @ the time of inj;no dx has been made;x-ray has shown mild osteoarthritis;
Patient reported having difficulty swallowing at approximately 1600, approximately 2-3 min after vaccine administered. MD notified, patient brought into exam room. Benadryl 25 mg administered PO at 1605 with little effect. Patient continued to report difficulty swallowing, diaphoresis visible, pale, reported nausea. Epinephrine administered 1616 by Dr. Paramedics called. Vital signs: 118/78 Left arm laying down, Temp 98.1, Pulse 94 BPM, RR 20, O2 99%. Patient taken via ambulance to hospital at approximately 1640.
Uterine shedding the morning following first dose of vaccine (~24 hours later). Was not menstruating or expecting menstruation for another 2 weeks
11/5/03 arm got hot and feverish and continued until 12/21/03. Got black and blue. Saw doctor 2 weeks ago.
Altered sense of smell and taste; Altered sense of smell and taste; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ewo181), via an unspecified route of administration, administered in left arm on 12Jun2021 09:30 (at the age of 13 years old) as dose 2, single for COVID-19 immunization. Medical history included Hashimoto's disease, allergies to cherry, watermelon, pumpkin and tree pollen in spring. The patient was diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ewo177) via an unspecified route of administration, administered in the left arm on 22May2021 at 09:30 (at the age of 13 years old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced altered sense of smell and taste on 14Jun2021. It was reported that the patient has not regained a proper sense of taste since the second vaccine was administered. The patient's mother thought it would resolve on its own but she still is gravely hampered by this side effect. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered. The reporter assessed the events as serious (disability and permanent damage).
As mother was leaving office after shots she noticed a red raised rash on right leg. This was immediately after MMR and Varicella were given in that leg. Area was about 2 inches in diameter, red raised rash. No other areas on body. No wheezing, bandage removed. Ice applied.
After I got the vaccine about 18 days later I started having symptoms of scratchy throat congestion headache minimal coughing and fever of 101. The next day I was diagnosed with COVID-19. I was prescribed Paxlovid an antiviral to treat COVID-19. Symptoms still ongoing sense of smell has been gone. Still fatigue and having to use inhaler more frequent. Joint pain has increased.
Moderna COVID-19 Vaccine and experienced a side effect.; lymph nodes were swollen and enlarged under arm; pain on left side of the neck; Arm felt weak; Trouble sleeping; had pain at injection site; Had fatigue later that evening; Had joint pain later that evening,; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain on left side of the neck), VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.), MUSCULAR WEAKNESS (Arm felt weak), INSOMNIA (Trouble sleeping) and VACCINATION SITE PAIN (had pain at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (pain on left side of the neck), MUSCULAR WEAKNESS (Arm felt weak), INSOMNIA (Trouble sleeping), VACCINATION SITE PAIN (had pain at injection site), FATIGUE (Had fatigue later that evening) and ARTHRALGIA (Had joint pain later that evening,). On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.) and LYMPHADENOPATHY (lymph nodes were swollen and enlarged under arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, NECK PAIN (pain on left side of the neck), VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.), MUSCULAR WEAKNESS (Arm felt weak), INSOMNIA (Trouble sleeping), VACCINATION SITE PAIN (had pain at injection site), FATIGUE (Had fatigue later that evening) and LYMPHADENOPATHY (lymph nodes were swollen and enlarged under arm) outcome was unknown and ARTHRALGIA (Had joint pain later that evening,) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Birth control tablets was also included in the treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up appended
Dizziness, headache, leg pain & numbness, confusion, tingling all worsening over time with extreme fatigue
A mild fever, headache, nausea and diarrhea -> Few hours after shot. Severe joint pain -> (1) an inflammation of the right knee (2) pain of the lower back and the left hip (3) muscle weakness in the both legs (4) anal fissure as a result of diarrhea.
Information has been received from a health professional concerning a 9 week old male, with no allergies and a history of premature birth, who on 20-FEB-2007 was vaccinated with a 2ml oral dose of Rotateq (lot #656105/1232F). Concomitant vaccines administered on the same day included a dose of Dtap,  Prevnar, and a dose of Ipol. Concomitant medication including SYNAGIS. The patient was seen in the office on 26-FEB-2007 with vomiting and a fever and was hospitalized. The patient was admitted for observation only and was discharged within 24 hours. It was reported that the patient was now feeding well, and had recovered. The patient experienced poor feeding and was hospitalized. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be immediately life-threatening and other important medical events by the reporter. A lot check has been requested. Additional information has been requested.
Pregnant patient given 2nd booster per physician recommendation - not immunocompromised or >50 years
Injection site and area around tricep to elbow red, warm wheal, no induration, swelling, painful started ibuprofen 200mg 2 tab Q 6 hours prn, BENADRYL 25mg 1 tab Q 4 to 6 hours prn. Follow up as needed.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: she felt numb in her left side of face, face was hot red itchy felt some swelling in lips, itching on face and body dizzy and nauseaous-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tachycardia-Mild
mom states pt recvd vax 845AM & 1 hrs later started high-pitched, shrill cry couldn't be comforted x 24 hrs, vomited everything ate during that 24 hrs; mom gave APAP;t101-102; called family MD who said was a pertussis react;
PT RECEIVED COVID VACCINATION THAT WAS PAST THE BEYOND USE DATE. NO ADVERSE REACTIONS NOTED.
heartburn; shortness of breath,Labored breathing; a lot of muscle pain; weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DYSPEPSIA (heartburn), DYSPNOEA (shortness of breath,Labored breathing) and MYALGIA (a lot of muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: influenza vaccine on 27-Oct-2021. Past adverse reactions to the above products included No adverse event with influenza vaccine.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced ASTHENIA (weakness) and MYALGIA (a lot of muscle pain). On 01-Nov-2021, the patient experienced DYSPEPSIA (heartburn) and DYSPNOEA (shortness of breath,Labored breathing). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 01-Nov-2021 for Heartburn, at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), DYSPEPSIA (heartburn), DYSPNOEA (shortness of breath,Labored breathing) and MYALGIA (a lot of muscle pain) was resolving.            No concomitant medication was provided.  Patient experienced shortness of breath, requiring labored breathing. Patient didn't visit the doctor as the shortness of breath has improved.
This spontaneous report was received from a pharmacist referring to a 63 year old male patient with no medical history, concurrent conditions and concomitant therapy. On 15-DEC-2016, the patient was vaccinated with ZOSTAVAX Injection for prophylaxis (strength, route, dose, lot number and expiration date were not provided). On 15-DEC-2016 (reported as since receipt of the vaccine), the patient had complained of irritation at the injection site, "almost like a bee sting". However, this was not described as a rash in any way. None lab diagnostic test were performed. The outcome of injection site irritation was reported as not recovered/not resolved. The causal relationship between the event and therapy with ZOSTAVAX was not assessed. Additional information has been requested.
So, just got my 2nd MODERNA vaccine yesterday at 4 pm. This morning I have a splitting migraine, I'm so tired, all of my bones hurt, especially when I take a step and my throat is swollen and my armpits are swollen like a grapefruit! I have intense chills and my fever is 100 degrees Fahrenheit.
pt recv vax 23OCT96 & on 2AUG97 pt devel a rash across the lower rt chest;pt was seen by MD on 6AUG97 pt had approx 4 days w/o shingles;
Low grade fevers; This is a spontaneous report from a contactable consumer (patient husband), from a Pfizer sponsored program.  A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 05May2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 13Apr2021 as dose 1, single for covid-19 immunization. The reporter states that he is 62 y/o and wife is 65 y/o. They both received their second Pfizer Covid vaccines on 05May2021 and on 06May2021 he reports they have low grade fevers. The reporter together with his wife, got their first dose of the vaccine 3 weeks ago (13Apr2021). The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Low grade fever (99.5-100.2 F), has been occurring every day starting around 5pm and continues into the night. Has not stopped since beginning about 3 weeks ago. Whole body feels hot when temperature runs high. No other symptoms. Negative COVID test.
pt died 2 1/2 days p/vax; mom went to feed pt & found pt dead;
itchy rash on arms; This is a spontaneous report from a non-contactable other-HCP (patient). A 34-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 22Dec2020 10:30 at a single dose for COVID-19 immunization at the hospital. The patient has no medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced itchy rash on arms on 25Dec2020 12:00. Outcome of the event was recovering. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received antihistamine for the event. The event was assessed as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Achiness; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), PYREXIA (Fever) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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, the patient experienced PAIN (Achiness), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, PAIN (Achiness), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.9 Inconclusive.         The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.    Reporter did not allow further contact
Rash, annoying; This case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu unspecified (Flu vaccine) and covid-19 vaccine (Covid 19 Booster).   On 9th September 2022, the patient received the 1st dose of Shingrix. In October 2022, between 1 and 2 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   The reporter considered the rash to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 19-Oct-2022 Reporter's comment: The patient self-reported this case. The patient received the Flu shot, Covid booster and then first dose of Shingrix from August to end of September. The patient thought he/she had a rash from the Shingrix vaccination. The patient in the past few days experiencing a rash, unusual for him/her and wonder that if it was possible side effect. The patient was asking that it means the Shingrix did not work for him/her. The patient reported that it was just annoying and not terrible. Additional Supportive Information: The follow up would not possible as no contact details were available.
pain in her arm after receiving the covid vaccine; This is a spontaneous report received from Pfizer sponsored program COVAX US Support. An unspecified age of non-contactable female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 23Mar2021 at single dose for covid-19 immunization. On 23Mar2021, the patient had experienced pain in her arm after receiving the covid vaccine. The patient wanted to know if she can take Tylenol to the event and wanted to know if she may have a glass of wine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I got the J&J vaccine around noon on Wednesday, April 17. Shortly after noon on Thursday, April 18, I started having very severe abdominal pain that lasted well into the night.  The only thing I can remotely compare it to is extremely severe gas pain.  I did take simethicone in case it was gas -- but that did nothing & the pain lasted 10 hrs or so.  The pain subsided by the following day but my abdomen was sore internally.  This was NOT listed in the FACT SHEET that I was given after vaccination.  The deep pink sheet listed:  Injection site reactions, General side effects, Difficult breathing, Swelling of face & throat, etc.
This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2021 15:00 (Lot number: EL3302) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: DROSPIRENONE;ETHINYLESTRADIOL taken for contraception (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Jan2021, outcome "recovered" (16Jan2021), described as "sore arm"; FATIGUE (non-serious) with onset 14Jan2021, outcome "recovered" (16Jan2021), described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional Vaccines Administered on Same Date of the Pfizer Suspect and Prior Vaccinations (within 4 weeks) was reported as none. Patient's Medical History (including any illness at time of vaccination), Family History, Relevant test was reported as none. Patient History: No. Investigation Assessment: Yes. On same day of vaccination she experienced fatigue; had a sore arm and then went to bed early. All of these effects cleared up in a day or so.   No follow-up attempts are possible. No further information is expected.
Induration 4 1/4 x 3 1/2 with fever 99 to 103 degrees and chills.
02/16/23 presents to ED for "fatigue, shortness of breath and chest pain". PMHx of ", HLD, heart murmur, atrial flutter"
pt recv vax 01MAR94 & exp itching @ inj site which resolved p/a few hr; No further details were provided;
pt recv vax & became lethargic;pt was taken to local hosp, dx of HIB meningitis was made following LP;pt was transferred to ped ICU of tertiary care ctr where pt died 3 days later;
PT WAS GIVEN MODERNA BIV BOOSTER FROM VIAL THAT WAS LEFT OF FRIDGE FOR 27 HOURS. SPOKE TO PATIENT ON 1/12/23 SHE IS FEELING OKAY A LITTLE TIRED NO FEVER.