chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achiness; Fever of 101 F, low grage fever next day; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), PYREXIA (Fever of 101 F, low grage fever next day) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, GLIPIZIDE, SAXAGLIPTIN, EMPAGLIFLOZIN, LEVOTHYROXINE, ATENOLOL, ALLOPURINOL and ROSUVASTATIN.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN (Achiness), PYREXIA (Fever of 101 F, low grage fever next day) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. On 25-Jan-2021, PAIN (Achiness) and CHILLS (chills) had resolved. At the time of the report, PYREXIA (Fever of 101 F, low grage fever next day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 101 (High) Degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-018803 (Patient Link).
INDIVIDUAL HAS NOT EXPERIENCED ANY ISSUES FROM HER VACCINATION.  COUNSELED MOTHER TO NOTIFY HER PRIMARY CARE PHYSICIAN THAT SHE RECEIVED THE VACCINE AND WAS UNDER THE AGE OF 16.  SHE WAS ALSO GIVEN A PHONE NUMBER TO CALL IF ANY EVENTS OR REACTIONS OCCUR FROM HER SECOND VACCINE.
Mom called at 1:31 pm today stating the patient's left arm was warm to the touch, painful and red at injection site. Mom says it started last night but looks worse today. Arm feels bumpy, hives-like at injection site. Nurse practitioner informed. Phone encounter charted in medical file. Advised to use BENADRYL as needed for allergic reaction. Keep skin clean and dry, ice pack, monitor for new and/or worsening symptoms. If symptoms persist and/or worsen patient needs to be seen in nearest emergency room or urgent care center. Call if no improvement to be seen in office. Second vaccine will not be administered per Nurse practitioner.
got so sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 11-Dec-2020.  This case involves a patient of unknown demographics who got so sick (illness), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  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 as prophylactic vaccination.  On an unknown date, the patient stated that he/she had one INFLUENZA VACCINE, 40 some plus years ago and got so sick (illness). The patient never got another one and haven't had the flu either  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
On 05/18/21at 6pm  I started hearing a loud hissing noise in both ears, tinnitus; left ear pain on and off; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8732), via an unspecified route of administration, administered in left arm on 11May2021 (age at the vaccination 59-year-old) as first dose single for covid-19 immunisation. Medical history included migraine and COVID-19. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date vaccine location left arm. On 18May2021 at 6pm patient started hearing a loud hissing noise in both ears, tinnitus, it subsided after about 15 minutes but returned at about 9 pm, it subsided after a few minutes, it has continued to come and go since. Also left ear pain on and off since vaccine. Patient did not received treatment for the adverse events. The outcome of the events was not recovered.
COUGHING UP BLOOD; DOWN FOR WEEKS; TERRIBLE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the patient experienced coughing up blood, down for weeks, and terrible headache. Laboratory data included: Laboratory test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the coughing up blood, terrible headache and down for weeks was not reported. This report was non-serious.
p/vax pt exp swelling & redness @ the inj site, gen malaise & a low grade fever;pt sought unspecified medical attention;f/u from MD indicated pt exp muscle soreness, general body aches, fever, fatigue @ the inj site;pt recovered;
Pt recvd HIBTITER in onle leg & inadvertantly recvd another dose in the other leg instead of DTP; Pt had a fever & flu-like sx for  2 days;
Nine days post vax the pt developed varicella like lesions. On 04/04/1998 the pt developed a few hive like lesions that crusted over.
Low grade fever 6/29/04, swollen arm 6/30/04, blisters around injection site 6/30/04 in PM. Rx given Cefzil, Zyrtec, Motrin, Cortisone cream.
22 x 17cm area of light redness and induration of left thigh. No fever. No pain with palpitation of area. No inguinal lymphadenopathy. Treated with topical ice only.
APPROXIMATELY 10 HOURS AFTER RECEIVING VARICELLA.  CHILD TOLD MOTHER THAT HER ARM HURT WHERE SHE GOT THE SHOT.  MOTHER GAVE HER OTC PAIN MEDICATION.  THE NEXT MORNING THE ARM WHERE VARICELLA WAS GIVEN WAS RED AND SWOLLEN 5CMX3.5CM  CLEARED UP BY 8/21/09
15MAY t102-104 AM; PM grand mal sz 3-4mins duration, vomiting; 16MAY 103T, 17MAY 101T;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine. On 15th March 2018, the patient received the 1st dose of SHINGRIX. On 15th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The pain lasted a couple of days and resolved. This case was linked with US2018111419 (2nd dose), reported by the same reporter for the same patient.
Child fainted for approximately < 10 seconds several minutes after receiving vaccine (she also received TB PPD skin test).
2/27/21 First few minutes:  Throat tightness Nausea Dizziness  15+ minutes/day of:  Hives on arms Itching Flushing face Facial swelling Low blood pressure 96/46) Headache Chills  Next day 2/28/21:  Bilateral Kidney pain  Muscle aches/joint pain Facial swelling low-grade fever  (99-100) Chills  2 Days 3/1/21: Worsened kidney pain Chills Nausea Swelling around eyes Facial flushing Abdominal Pain Headache
Probable myoclonic jerks; Fever 102F ax; 2cm area erythema;
This case was reported by a consumer, who was also a GSK sales representative, that described that occurrence of irritability in an adult male subject who was vaccinated with HEPATITIS B vaccine, (manufacturer unspecified).  A physician or other health care professional has not verified this report.  Previous vaccination included the 1st dose of TWINRIX, (GlaxoSmithKline); unknown; unknown given on 07 July 2008.  On 16 July 2008, the subject inadvertently received an unspecified dose of Hepatitis B vaccine (unknown, right arm), instead of the intended 2nd dose of TWINRIX.  The subject received the 1th dose of TWINRIX on 07 July 2008 on an accelerated dosing schedule.  The subject was scheduled for the 2nd dose of the TWINRIX series on 14 July 2008, but stated that he came back late to receive the dose on 16 July 2008, when he inadvertently received a monovalent hepatitis B vaccine instead.  On the evening of 06 August 2008, 21 days after vaccination with the Hepatitis B vaccine, the subject experienced diarrhea, stomach cramps and stomach pain, which made him irritable.  The subject stated that he initially thought that the events were just due to an unspecified illness and did not relate the events to the vaccine.  However, upon learning that the physician's office inadvertently gave him the wrong vaccine for the 2nd dose in the TWINRIX series, he began to question if the monovalent hepatitis B dose may have caused the events.  At the time of this report, the subject had not required treatment for these events, but stated that he was scheduled to return to the physician's office on 12 August 2008 for further evaluation.  It was unknown at the time of this report how the TWINRIX vaccination series will be completed.  At the time of reporting, the events were unresolved.
After receiving her 1st dose of the Pfizer vaccine , and being observed for 15 minutes, participant stated that she though that maybe her throat was swelling, this was 2:05, pm.    EMS was on site and immediately took her to their EMS truck for evaluation.  Her vital signs were BP : 120/80 Pulse:  76, and Sats:  98%, and she expressed that she is a mouth breather.  She was given 25mg of Benadryl and a bottle of water to sip on.  At 2:20pm participate stated that she felt fine and was checked out to go home.  She was instructed to call 911 for difficulty breathing, swelling in the face or throat, dizziness, weakness, increased heart rate, and an all over body rash.  She verbalized understanding.
Covid arm on left arm rash near where injection was given. Started on feb 9 and is still there on feb 19 . I he?s on occasion some warm to touch. No swelling of my arm rash is 2 inches in circumference when it started is was about 1.5 inches. So it has not gone away and have had it fir 11 days.my primary , when I showed it to him stated he wasn?t sure . It is mild, my only concern is that it has not gone away ,and slightly grew in size. All my readings indicate that it usually goes away in 24-48 hours.
This spontaneous report has been received from a registered pharmacist refers to a 64 years old female patient with no drug allergy and pertinent medical history who was vaccinated with a dose of ZOSTAVAX on 14-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. On 25-JUL-2012 the patient experienced unspecified condition and brought in a prescription for prednisone (manufacture unknown) 4 week therapy to treat an unspecified condition. There was no lab diagnostics studies performed. At the time of report, the patient was not recovered. Additional information is not expected.
Flu-like symptoms; Redness; Swelling; Tired; body ache; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2019, the patient received Shingrix. On 19th May 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, injection site erythema, injection site swelling, fatigue and generalized aching. On an unknown date, the outcome of the influenza-like symptoms, injection site erythema, injection site swelling, fatigue and generalized aching were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site erythema, injection site swelling, fatigue and generalized aching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced flu like symptoms, redness and swelling in the injection site, fatigue and body ache. No further information was received. This case has been linked with case US2019093477, reported by the same reporter. There was a discrepancy with respect to the patient's initials. In initial source document it was given as one set of initials however in follow up source document it was given as different initials.  As no information available of which is the correct one, worst approch we have retain both cases.
This spontaneous report was received from a 69 years old female patient; Historical condition included varicella. The patient's concurrent conditions and concomitant therapies were not reported. The patient reported that on an unspecified date, she was vaccinated with ZOSTAVAX "1 time vaccine" for prevent shingles (route of administration was reported as "vaccine", strength, dose, lot number and expiration date were not provided); but in OCT-2012, got the shingle. Three years later, in approximately 2015, the patient experienced another case of shingles. The patient sought unspecified medical attention. At the time of this report, the outcome of the events was unknown. The causality between the aforementioned events and ZOSTAVAX was unknown. No product quality complaint (PQC) was involved. Additional information is not expected, as there was no consent to contact the physician.
I had a sore throat, cough, body aches, malaise, fatigue, loss of appetite. I took an at-home COVID-19 on 06/18/2022 which came back positive. I called my doctor and was prescribed PAXLOVID and began the prescription a couple of days after. Once the prescription almost finished, I began feeling better. Currently, I'm doing fine and better than before.
THE PATIENT INFORMED THAT SHE GOT HER FIRST VACCINE IN JANUARY. WE ADMINISTERED THE VACCINE ON 3/20. THE PATIENT CALLED BACK AN INFORMED US THAT SHE ACTUALLY GOT IT IN FEBRUARY. WE CALLED GSK AND THEY INFORMED US THAT AS LONG AS THE PATIENT GOT HER FIRST VACCINE 4 WEEKS AFTER THE FIRST DOSE THAT EVERYTHING WAS OKAY AND THERE WAS NO NEED TO REPEAT ANY DOSES IN THE SERIES. THE PATIENT HAD NO SYMPTOMS OR ADVERSE REACTIONS THAT SHE EXPERIENCED.
Hives/rash and severe itchiness started 9 days after my booster shot. The first two Moderna vaccines did not cause this response. The hives come and go during the day and travel throughout the body. Itching can be severe. I'm taking Zyrtec and that seems to help but am worried that I'll have to be on Zyrtec forever.
On the following day, hives developed and patient's mom called the on-call provider and was instructed to take Benadryl and a Prednisone taper with good effect
Bruising at injection site of the Adacel vaccine, and reduced mobility in the left shoulder due to pain
Ten minutes after receiving  vaccine, mother noticed blotchy rash on bilateral sides of neck. Pt denied pain or itching. Cetirizine 10mg (2 5mg chewable tablets) given. After 30 minutes rash almost 100% resolved.
pt recvd vax in AM & by the evening & the following 2 days exp chills & warmth off & on; devel 10" red streak which was warm in rt arm; streak went from inj site down to elbow lasted 1 wk;
Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 53-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration in left arm on 10Apr2021 at 14:15 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes, high cholesterol. There were no known allergies. Concomitant medication included metformin 100 mg, atorvastatin 20 mg and lisinopril for unknown indication. The patient not had COVID prior vaccination. The patient had not taken any other vaccines four weeks prior vaccination.  On 10Apr2021 at 14:30 (15-minutes after vaccination), patient experienced severe headaches, swelling, heavy dizziness, heart palpitations, heavy body aches and pain, dry mouth. The patient visited emergency room/ department or urgent care and was hospitalized for the events for one day on unspecified date. The patient was not tested for COVID post vaccination. Therapeutic measures taken as a result of events included intravenous drip, Prednisone. The outcome of all the events was recovering.  Information about Lot/Batch number is requested.
Per pt's 11/15/18 follow-up e-mail: 10/05/2018 @ 2pm the pt states her left arm hurt & worsened into the evening. By 11/09/2018 discomfort limited ROM & she began icing left deltoid area & taking 800mg ibuprofen every 4 hours which reduced the pain so that she could manage her office setting work obligations. The brief exam performed 11/13/18 outside of clinic (while pt remained at her work station where we unexpectedly met) exhibited no palpable left deltoid abscess nor change in color of injection site or surrounding area. Lymph: LUE lymph neg. by palpation & inspection. MSK: AROM LUE possible but performed with statement of discomfort & admits that she could not perform left shoulder motion without ibuprofen 800mg on-board. PV: Neg LUE peripheral edema. Integumentary: warm, dry with tanning bed color variations but without local redness nor swelling at site or near site. Neuro: Denies LUE sx of neuropathy.
couldn't really eat anything; sweating; weakness; fatigue; headache; chills; nausea; fever; arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting), DECREASED APPETITE (couldn't really eat anything), HYPERHIDROSIS (sweating), ASTHENIA (weakness) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm started hurting) and PYREXIA (fever). On 05-Feb-2021, the patient experienced NAUSEA (nausea). On an unknown date, the patient experienced DECREASED APPETITE (couldn't really eat anything), HYPERHIDROSIS (sweating), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVEL) at an unspecified dose and frequency. On 06-Feb-2021, NAUSEA (nausea) had resolved. On 07-Feb-2021, PAIN IN EXTREMITY (arm started hurting) had resolved. At the time of the report, DECREASED APPETITE (couldn't really eat anything), HYPERHIDROSIS (sweating), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.
Chest pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Starting in May, my menstrual period has progressively gotten lighter and lighter and it did not present in November or December at all.
Vomiting, chills, fever, body aches, not able to keep anything down, headache.   Tried OTC antinausea meds did not work, went to ER and was given antisemitic and iv fluids, and sent home with oral antisemitic. Called primary doctor today and they said if not better by tomorrow 3/30 then getting emitted to hospital for IV fluids.
Expired Moderna Covid-19 vaccine was administered to a patient; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered to a patient) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered to a patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Normal initial injection soreness had been gone for several days, then began having problems lifting arm, deep pain at injection site, that has continued, and is gradually worsening, and spreading down arm, and into shoulder joint.
Reported fever (100.9), chills, aches, cough, hives on right arm and upper abdomen. Symptoms over period of approximately 36 hours. Treatment consisted of bed rest, anacin, fluids. Vaccine information not available as the vaccine was not administered by reporter.
pt recv vax 3FEB97 & 13FEB97 pt exp rash;
Axillary lymphadenopathy amd pain starting day 3 after vaccine. Continue to have chronic axillary and breast pain for past 10 months.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product.
Generalized itching/rash, red bumps to arms and neck, scratchy throat.
Patient reported to her doctor complaining of red, hot arm at site of injection and the redness was going down her arm.
Patient states that they immediately had shoulder and neck pain. This has lasted for 3 months now.