chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 hours after the dtap Booster) she is 19 and had received her TDap as an infant ) she started to itch ALL over her body. she thought it was something like her lotion but later on she took a shower to try and calm the itch down as it was getting worse, she managed to fall asleep but woke up to hives EVERYWHERE ON HER BODY , INCLUDING HER GROIN AND FACE AND SCALP, AND WELTED UP ON MOST OF HER SKIN, WITH INSESANT ITCHING. ALSO COMPLETELY RED WITH THE WELTS ON TOP OF HER REDNESS. its now 3 weeks later and she still has hives, she is taking ALEGRA and a prescription antihistamine aswell. we go back to the doctors on the 24th of February 2022
Localized Muscle pain on the day of vaccine administration, and on the days after (01/27/21 - 01/28/21)  Burning sensation on 01/27/21 which went away after 1 dose of regular Benadryl   A few days later during the first week of February I noticed a pretty noticeable large round lump on my left arm underneath my skin, and the area was red, warm and itchy to the touch. This lump went away after some time on its own.   Today, 02/06/21, the itchiness and pain returned, and what looked like a ?ridge? shape under my skin appeared on my arm at the site where the shot was administered.  It?s just bothersome but doesn?t impair my regular functionality. I intend to take a Benadryl and stay hydrated. Noticed I?ve been excessively thirsty today, much more than usual.
Transient Chest pain the following morning followed by weakness fatigue, body aches and sweating during sleep.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/28/2022 ABDOMINAL PAIN
Body aches all night; Chills; fever of 100.2 deg. Fahrenheit; A spontaneous report was received from a consumer concerning a 60-year-old patient who experienced fever/MedDRA PT: pyrexia, body aches all night/MedDRA PT: pain, and chills/MedDRA PT: chills.  The patient's medical history was not provided by the reporter.  Concomitant products including levothyroxine and Lexapro.  On 29-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30-Dec-2020 the patient experienced fever of 100.2 degrees, chills, and body aches.  The events were treated with Tylenol.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.   The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
swelling on neck, rt side, soreness in neck glands no SOB;node tenderness >4 days;tx w/APAP PRN;
pt called this am and states last night had chills and shivers, this am couldn't stand due to dizziness and muscle weakness and feeling of great fatigue.
1/14/2021. Around 1:00 a.m.  fever. (100.4), body aches, injection site soreness, weakness, aggravation of foot neuropathy causing shooting pain, fatigue, loss of appetite
Seconds after the administration of the Tdap vaccine, patient was dizzy, pale with involuntary movements, did not lose consciousness which lasted less than 1 minute.  Felt normal after breathing in some alcohol.  Laying down in a stretcher with elevated legs after being evaluated by doctor. BP 76/44.
Had slight swelling, rash & feeling of being flushed first three days after receiving the vaccine. On Thursday, January 21 found arm starting to ache with large lump, and a great deal of swelling. Friday, January 22 had large red rash 3 inches in diameter, which became larger hour by hour. Saw my primary physicia and she was unsure what was happening. We agreed to monitor the arm and call if it got worse or I had other symptoms. The following two days found the red rash becoming more of a bulls eye. The outer ring was red with the inner bulls eye brown, same coloring as a birthmark. The upper arm continues to ache, but swelling is down and today, Monday, January 25, it is still discolored, but brown rather than red.
Sore arm for three days after shot.  Cough increasingly more frequent w/ rib soreness at the intercostal anterior of primarily right side but occasionally left side as well. Increasing difficulty breathing on exertion, increase in altitudes over 8,000 feet, entering cold environments. Severity increased to point where entered ER on APR 26th.  Massive PEs found in both lungs. D-Dimer score of 10,000.0 ng/mL.  CTA Chest w/ contrast found multiple PEs. ALS transport transferred to Hospital for treatment. Released from the hospital APR 29.
Information has been received from a pharmacist referring to a newborn. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 24-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
I got the 1st dose of Covid-19 vaccine in left arm. I think I did experience a sore muscle and may have experience leg pain. Now this arm seems to be twitching like I have anxiety.
No adverse reaction; patient received 2 bivalent booster doses before approval; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received 2 bivalent booster doses before approval) and NO ADVERSE EVENT (No adverse reaction) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 1, route: intramuscular, Location of site: left deltoid, batch/lot number: 028L20A, expiration date: 09-Jul-2021) on 23-Jan-2021, Moderna (Dose 2, route: intramuscular, Location of site: left deltoid, batch/lot number: 013M20A, expiration date: 31-Jul-2021) on 23-Feb-2021, Moderna (Dose 3, route: intramuscular, Location of site: left deltoid, batch/lot number: 939904, expiration date: 24-Mar-2022) on 29-Oct-2021, Moderna (Dose 4, route: intramuscular, Location of site: right deltoid, batch/lot number: 002M21A and expiration date: 11-Sep-2022) on 13-Apr-2022; for Product used for unknown indication: Pfizer bivalent (Dose 5, Booster route: intramuscular, Location of site: left deltoid, batch/lot number: GJ5342 and expiration date: 30-Jun-2023) on 16-Sep-2022. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna, Moderna and Pfizer bivalent.    On 22-Nov-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Nov-2022, the patient experienced EXTRA DOSE ADMINISTERED (patient received 2 bivalent booster doses before approval). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXTRA DOSE ADMINISTERED (patient received 2 bivalent booster doses before approval) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (patient received 2 bivalent booster doses before approval).    No concomitant medications were reported. It was reported that patient didn't experienced any adverse event.It was noticed that when patient come in for bivalent booster after cdc approval of 2 nd dose that he had already received 2 bivalent boosters. It was reported that patient history was not reviewed before entering or administering the vaccine No relevant lab tests or prior vaccinations with in 4 weeks were reported.  No treatment medications were reported.
Pt received Varivax, Comvax, and IPV.  Within 5 minutes of receiving Varivax, pt developed an urticaric wheal with an erythematous base that was warm to touch.  Pt had no respiratory distress and was given Benadryl 12.5 mg/5cc po immediately and cool compresses were applied to leg. Pt waited for 20 minutes, wheal disappeared but erythematous base of 1" x 1/2" remained.  Pt was active, alert, and in no distress.  Mom instructed on what to observe for and to give Benadryl in 4 hours.
Site of injection: left deltoid Patient c/o "mild muscle ache for two days, injection site sore/painful/ uncomfortable' tight and heavy; left side of neck down to left arm also tight and heavy". No treatment.
Admit for COVID pna. Fully vaccinated. Rocephin, Zithromax, steroids, vit-c, vit-d, zinc, singulair, O2. Weaned to RA. Discharged home.
4 days after first shot extreme chills body aches fever 101.6.  Fatigue. 24 hours later much better. 7 days later *today extreme body aches pain and chills. Has had fatigue most of week.
Information has been received from a licensed practical nurse concerning a 11 year old female patient with no drug/reactions allergies, who on 17-DEC-2008 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot # 660555/0279X).  Concomitant therapy included HAVRIX and MENACTRA.  The patient fainted and fell about 5 minutes after receiving GARDASIL vaccine causing a laceration on her chin.  The patient came to immediately.  It was not known what the patient hit when she fainted.  The patient's blood pressure was low.  It took about 30-45 minutes until her blood pressure and color returned to normal.  The patient received stitches for the laceration in an emergency room.  At the time of reporting, the patient was recovering.  Additional information has been requested. Follow up information was received from the nurse via medical record which reported that the patient had asthma. It was reported that the patient was vaccinated with the first dose of GARDASIL (LOT # 660555/0279X) IM, in her left deltoid at 16:10 PM. Concomitant therapy included the second dose of HAVRIX (lot no. AHAVB147AA) given at 4:12 PM in her left deltoid, MENACTRA (lot no. U2632AA) given IM at 4:11 PM in her right deltoid and albuterol (unspecified) taken occasionally. It  was reported that patient fainted at 16:30 and revealed a chin laceration that was cleaned and bandaged. Blood pressure was 78/58 and 102/68 and the patient was give juice and snacks and was under observaction for 40 minutes. The patient was sent to Emergency room for stiches. A physical examination was performed in the ER which was normal. THe patient did not remember the fainting spell. THere was no headache, no  head injury, no sore throat, no cough, and no urinary symptoms. The patient had no illness at the time of vaccination. On 24-DEC-2008, the stiches were removed and the patient subsequently recovered. Additional information is not expected.
maybe with all the doses of the Covid I've got these muscle aches; maybe it's caused me more acid; joint pain at the top of my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "gastritis" (unspecified if ongoing); "esophagitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "maybe with all the doses of the Covid I've got these muscle aches"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "maybe it's caused me more acid"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain at the top of my legs". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:   Experience lists "Gastrointestinal Disorders: fundic gland polyps".  No mention of 'muscle pain' but patient medication guide does discuss "Low magnesium and other mineral levels in your body can happen in people who have taken PROTONIX for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice."   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced having a liver function test done. No treatment information was reported. The outcome of having a liver function test done is unknown. The relatedness for having a liver function test done is unknown for ZOSTAVAX. The pharmacist did not have any patient specific information. No further information is available.
Dehydrated; felt very weak; Acute diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Acute diarrhea), DEHYDRATION (Dehydrated) and ASTHENIA (felt very weak) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included Diarrhea. Concurrent medical conditions included Irritable bowel syndrome.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced DIARRHEA (Acute diarrhea). On an unknown date, the patient experienced DEHYDRATION (Dehydrated) and ASTHENIA (felt very weak). At the time of the report, DIARRHEA (Acute diarrhea), DEHYDRATION (Dehydrated) and ASTHENIA (felt very weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the Concomitant medications were not provided.  Treatments drug included Fluids, Anti Diarrheal.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR updated medical history. Irritable bowl syndrome and diarrhea.
Stinging sensation, needle, burning on right side of head. Cannot see out of right eye when bright of lights shine eye.
Body temp - up 101.4. Body cold shake. No food. No sleep. Talking to self. Low oxy. in blood.
very tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 (Lot number: EN620) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot number: EL9262, Site and route of Injection: Left arm), administration date: 01Feb2021, when the patient was 85 years old, for covid-19 immunisation, reaction(s): "had no reaction at all not even a sore arm". The following information was reported: FATIGUE (non-serious) with onset 25Feb2021, outcome "unknown", described as "very tired". Additional information: It was reported that the second shot was uneventful. The 2nd day after the shot, in the late afternoon, the patient felt very tired and not sure if it had anything to do with the shot. The patient has had no problem since then.   No follow-up attempts are possible. No further information is expected.
Patient: Felt tired 5 minutes post vaccine administration. Treatment: no medication was given. patient was under observation.  Water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
UNSPECIFIED ADVERSE REACTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse reaction was not reported. This report was non-serious.
Patient complains of joint pain and fatigue.  Obvious swelling to joints of fingers.  Complains of general body aches.
Stress/anxiety; Stress/anxiety; heart issues; get the 2nd dose so late after the first one,  I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (Stress/anxiety), ANXIETY (Stress/anxiety), CARDIAC DISORDER (heart issues) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (get the 2nd dose so late after the first one,  I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STRESS (Stress/anxiety), ANXIETY (Stress/anxiety), CARDIAC DISORDER (heart issues) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (get the 2nd dose so late after the first one,  I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later). At the time of the report, STRESS (Stress/anxiety), ANXIETY (Stress/anxiety) and CARDIAC DISORDER (heart issues) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (get the 2nd dose so late after the first one,  I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient went to the cardiologist for tests. No concomitant medications were reported. No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Significant follow up appended: event addition On 30-Aug-2021: Non-Significant Follow up document received contains no new information. On 30-Aug-2021: Non-Significant Follow up document received contains no new information.
Pt. went to hospital. Injection site was red, hot and painful. According to MD. pt. might have had serum reaction which develop into infection and to cellulitis. Pt. given clindamycin and MEDROL pack.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare professional via Medical Information (Reference number- 00718286) and transmitted to Sanofi on 10-Aug-2021.  This case involves a 11-year-old male patient who received an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received an expired dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5660AA and expiry date: 06-Aug-2021) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "Office manager called to confirm guidance because a consumer received an expired dose of Adacel. The office manager she does not have the patient information at the time of the call so limited information was obtained."  This was a case of actual medication error due to expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt became lightheaded, nauseated, pale, coloring BP 110/70, P64;2:45 BP 108/60, P80 given sucker to munch on;2:50 BP 108/70, P 80;given H20 to drink;pt left 3PM advised to eat upon arrival @ home;
PATIENT STARTED HAVING FLU LIKE SYMPTOMS (BODY ACHES, FEVER, CHILLS, FATIGUE) THE EVENING HE RECEIVED THE FIRST AND SECOND DOSES OF THE SHINGRIX VACCINE. HE ALERTED THE PHARMACY OF THE INITIAL REACTION THE DAY HE RECEIVED THE SECOND DOSE. HE SAID THAT HE TOOK SOME IBUPROFEN AND IT HELPED WITH THE PAIN.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients. The patients' medical history, concomitant medications, concurrent conditions, drug and allergy history were not provided. It was reported that on unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot number M006708, expiration date 02-JUN-2018 (dose and administration route were not reported) for prophylaxis. Temperatures and time frames registered in the data logger, were: 0°Centigrades (C) to 1°C (0.8°C) for 34 hours; 9°C to 25°C (8.7°C) for 27 hours and 26°C or warmer (26.2°C) for 27 hours. No adverse effects were reported. This is one of of several reports from the same reporter.; Sender's Comments:  US-009507513-1707USA004510: US-009507513-1707USA005547: US-009507513-1707USA005548: US-009507513-1707USA005549: US-009507513-1707USA005551:
R deltoid area is slightly swollen with mod. erythema 6cm x 6cm patch, mildly tender, warmth, full ROM of right UE. Mom states increased redness over 2 days. Advised pt to use Motrin and ice PRN.
Patient reports he started having a headache since 3hrs after vaccine, he had 24hours of chills and myalgias but the headache has persisted. Patient tried tylenol and migraine tylenol. Headache is nagging persistent since second injection   Counseled patient to schedule NSAID (take with food), stay hydrated, rest.
Large red swelling the size of a silver dollar.  Hot to touch, became very itchy.  Applied benadryl to the site and then took one antihistamine pill after the second or third day.  That helped and while it is still red it doesn't itch anymore.  It is now about the 10th day after injection.  The swelling and redness is abating.