chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Nurse refers to a 4 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX (Merck) Lot # H014074 (dose, route and frequency were not reported). The nurse reported that on 24-OCT-2013, VARIVAX (Merck) was stored for -13.9 C for 8 hours. On 29-OCT-2013, the VARIVAX (Merck) was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX (Merck) was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX (Merck) was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX (Merck) was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX (Merck) was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling, felt faint and pain. On an unknown date, the outcome of the swelling, felt faint and pain were unknown. It was unknown if the reporter considered the swelling, felt faint and pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional stated that, he had a lots of patients, who experienced swelling (more than usual), pain and feeling of pain, after vaccinating with SHINGRIX. The reporter did not spoke to the healthcare professional himself. The adverse events were reported to the reporter by the inside sales department. The reports were send to the Regulatory Authority by the reporter.
Started with scratchy throat, proceed to runny nose, congestion and coughing, fever, weakness and some headache. 4 days later seeing recovery but still signs. NOT: in very good health; no problems w/prev shots of any type over many years. Causes me to question mrg's quality control, distributors disturb methods and in store controls.
10 of 42 pt were vaccinated w/pneumococcal vax & the pt devel swollen arms;
Pt reported a swollen, red arm around administration site of ZOSTAVAX. Instructed her to watch for worsening and see MD if it gets worse.
Fever of 99.6; Sore Arm like someone sucker punched her; Body Aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99.6), PAIN IN EXTREMITY (Sore Arm like someone sucker punched her), MYALGIA (Body Aches) and HEADACHE (Headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (Fever of 99.6), PAIN IN EXTREMITY (Sore Arm like someone sucker punched her), MYALGIA (Body Aches) and HEADACHE (Headaches). At the time of the report, PYREXIA (Fever of 99.6), PAIN IN EXTREMITY (Sore Arm like someone sucker punched her), MYALGIA (Body Aches) and HEADACHE (Headaches) outcome was unknown.      No relevant concomitant medications were reported.  No treatment information was provided.
While in the observation area the patient reported feeling  dizzy and might faint after 10 minutes from receiving the pfizer vaccine and the observer reported to the RN. I had the patient lay down in the observation area and took vital signs: 130/90, RR 17, 70 HR. Per protocol patient was given Zyrtec and further observed for 15 minutes. Patient stated no longer feeling dizzy advised patient if feelings return to report to urgent care or emergency room.
heart has been racing consitenty over 105bps (usually 60).; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were received as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient had the second vaccine for shingles and heart has been racing consistently over 105bps (usually 60).
"Pfizer-BioNTech COVID-19 Vaccine EUA"  second dose.   Other than sore arm, no noteworthy side effects for about 27 hours, then hands and forearms were possessed by wild tremors that made it impossible to hold them steady enough to read a paperback book.  Condition lasted about an hour, then ended as abruptly as it began.  Not painful but very spooky.
Information has been received from a RN concerning a 2 month old pt with no medical history or allergies who on 12Jul06 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Concomitant vaccinations administered on that same day included a dose of hep B vaccine recomb (Engerix B) and possibly other vaccines. The RN reported that on 13Jul06, the pt developed a fever of 101.1F. Unspecified medical attention was sought and no other lab/diagnostic tests were performed. On 14Jul06, 24 hrs after onset, the pt's fever resolved. Additional information has been requested.
9/1: Felt fine day of vaccine, went to sleep about 10pm. 9/2: Could not awaken at usual wake time of 5am, couldn't talk, profoundly weak, low grade fever ~100 degrees F, pt thought he was dying. Finally able to waken at about 5pm 9/2, still profoundly weak and muscle pain. Muslce pain lasted through 9/9 about 5am.
Patient was admitted on 1/27/2022  with complaints of fatigue, dizziness and 3 episodes of fall. In the ER EKG showed sinus tachycardia with PACs.  Workup showed unremarkable, screen for COVID-19 was positive, CTA chest, CT head, cervical spine and facial bones were unremarkable. Patient was started on oral antibiotics for possible UTI, IV fluids and was admitted to hospitalist service . Pt remained asymptomatic from COVID-19 infection.
Patient was given 0.5ml Adult Td IM in left upper arm for burn injury to groin area. Local reaction (redness & swelling) was noted at injection site 3 days later. Reaction was treated with Loratidine 10mg daily. The reaction subsided in about 5-6 days after the injection.
cellulitis; This is a spontaneous report from a contactable consumer (the patient)  A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27Aug2021 (Batch/Lot Number: FE3592) as single dose for covid-19 immunisation  .  Medical history included surgery.  There were no concomitant medications.  The patient experienced cellulitis (medically significant) on 2021 with outcome of unknown.    Only reason she waited to get the second dose was because she had a skin bacteria called cellulitis.  Follow up information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 31st May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were unknown. It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The reporter had entered medical information chat by mistake. The adverse event was collected in chat and transferred to the GSK Response Center.  The reporter was patient's husband and and reported that his wife received SHINGRIX and developed a slight fever and body ache. The reporter did not have vaccine information. The reporter refused to provide full address.
Irritable Bowl Syndrome-diarrhea; Gut ache; Loose stool; Stomach ache; Diarrhea; Hip Pain/Hips hurt; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea), GASTROINTESTINAL PAIN (Gut ache), DIARRHOEA (Diarrhea), DIARRHOEA (Loose stool) and ABDOMINAL PAIN UPPER (Stomach ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome (Patient had IBS-D with monthly occurrences ).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 25-Feb-2021, the patient experienced ARTHRALGIA (Hip Pain/Hips hurt) and AXILLARY PAIN (Sore arm).   On 26-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache).   On 02-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (Gut ache) and DIARRHOEA (Loose stool). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea).   On 26-Feb-2021, ARTHRALGIA (Hip Pain/Hips hurt) and AXILLARY PAIN (Sore arm) had resolved. On 27-Feb-2021, DIARRHOEA (Diarrhea) had resolved.   At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea), GASTROINTESTINAL PAIN (Gut ache), DIARRHOEA (Loose stool) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown.      This case was linked to MOD-2021-032382 (Patient Link).
Fever of 101F; Chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101F), CHILLS (Chills) and FATIGUE (Tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and .048B21A.) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced PYREXIA (Fever of 101F), CHILLS (Chills) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 101F), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Body temperature: 101 f (High) 99 F.         Concomitant product use was unknown by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.
Day of injection: red spotting on palms. Gradually over the next 2 days, red spots spread up arms, first underneath anterior/medial parts of arms then to lateral and  dorsal parts of arms. Palms and tops of hands, forearms, upper arms, armpits, ribs, lateral abdomen down to waist line: covered in non-itchy red spots.  Spots spread  Day 2: itchy red spots on both ankles and Achilles? tendon areas, only itchy there. But redness spread up legs to middle of shins and around back on calves.  Very slight difficulty breathing, productive cough during early hours of being awake, went away and normal breathing as the day progressed.
Severe chills, and high fever at least over a 103.0, but I'm not sure how high it went because I was to sick to check. This was followed by intense muscle cramping in my chest due to the high fever.  I had migraines several times a week that have last lasted until the 2nd dose (today 5/10/2021).  Left arm also swelled to almost double the normal size for about 3 days.  Post shot fatigue lasted about a week.  I checked with an allergist and they said this was a strong immune response because I had had Covid previously, and not an allergic reaction. They also said that my second dose reaction should be less strong.
COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mitro valve prolapse" (unspecified if ongoing), notes: Mitro valve prolapse; "Super Ventricular tachycardia" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". 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 received Paxlovid (Lot: GD8744) from 12Aug2022 to 16Aug2022 for the treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
W/in 30min pt reported dizzy, itching all over & numb nose red & hot; W/in 45min pt stated throat closing off & tongue swelling. Med attention sought @ 45min-shot admin followed up by pills; 24 hrs later pt still feels yucky & weak;
Patient has prior allergies to other medications, never had to use epinephrine. Past allergies include: Percocet, tramadol, Toradol and latex tape. Patient stated she has some full budding numbing experience but no anaphylaxis. We gave her the J&J covid 19 vaccine and asked her to wait 30 minutes to be monitored due to her past allergies. Around 20 minutes patient let one of the pharmacist know she was feeling very flushed and dizzy. We brought her over to the side to be monitored more closely. We had patient elevate her feet to help with faint feeling and drink some water.  Within 5 to 10 minutes her symptoms  started worsening. Tingling sensation started going up her side of head and neck. It started moving to the front of her face. Once that happened I asked how her breathing was and she was starting to get short of breath. Soon after patients throat started to close. We administer 0.3 m of epinephrine and called 911. Pt was able to breathe a little better but within 5 minutes she was back to gasping for air, we administered another 0.3 mg of epinephrine and the paramedics arrived.
pt recv vax 10FEB98 & 11FEB98 exp flu-like sx including severe vomiting, nausea, fluid loss;pt hosp for a 4hr stay on 11FEB98 for fluid loss;pt hosp again from 14FEB98 to 15FEB98 for 24hr for fluid loss;
temperature of a 102 that got up too; he had very bad chills; aches in his chest and abdomen; aches in his chest and abdomen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 87-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2022 as dose number unknown (booster), single (Lot number: EL9267) at the age of 87 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DONEPEZIL; FAMOTIDINE; GABAPENTIN; ATORVASTATIN; HYDROCHLOROTHIAZIDE; TRAZODONE. Vaccination history included: Covid-19 vaccine (Primary immunization complete, Manufacturer unknown), for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious), ABDOMINAL PAIN (non-serious) all with onset 2022, outcome "recovered" and all described as "aches in his chest and abdomen"; CHILLS (non-serious) with onset 2022, outcome "recovered", described as "he had very bad chills"; PYREXIA (non-serious) with onset 2022, outcome "recovered", described as "temperature of a 102 that got up too". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, chest pain, abdominal pain.
I started getting symptoms of post nasal drip. The next day, I had chest congestion. I tested positive for COVID-19 with a home test. My symptoms progressed and my doctor called in a prescription for PAXLOVID. This helped with most symptoms and this is my 3rd day taking PAXLOVID.
After getting the vaccine I have been struggling with 1) extreme fatigue 2) ongoing leg aches/pain. I have seen the doctor about both issues, but was afraid to bring it up to my doctor as being related to the vaccine due to fear of "questioning the vax" and being labeled, judged, and/or treated differently or given different care.
Plugged ears, feels like she is in a tunnel.  No infection or impacted Ceram observed on assessment
Pt recv vax on 3/25/99; on 3/26/99 pt exp swollen/ red vax site, fever (102); dx=cellulitis; tx=Rocephin shot, Amoxil, Benadryl
Patient experienced CHF exacerbation.  He began with acute onset of chest pain and dyspnea.  Required extensive testing ( Echo, CT chest, cardiology eval ).  Patient presented to the ER twice with chest pain and difficulty breathing.
I had nausea and bed reddin for a month and treated with ginger.  I haven't taken any medications for it. This has been going on for 16 months. This is been going on since Oct 2021. I am on a restricted diet to control the nausea. I get dizzy and vertigo. I don't know if it is related.
RASH ON BOTH ARMS AT INJECTION SITE SPREAD TO NECK AND BACK STARTING THE EVENING AFTER GETTING IMMUNIZATIONS. COMPLAINED OF IT BEING VERY ITCHY. ITCHY THROAT AND SLIGHT TROUBLE BREATHING. MOM GAVE HIM BENADRYL EVERY 4 TO 6 HOURS THROUGH THE WEEKEND AND ALBUTEROL BREATHING TREATMENTS AND CALLED OUR OFFICE REPORTING SYMPTOMS ALREADY IMPROVING. INSTRUCTED MOM TO CONTINUE BENADRYL AND ALBUTEROL AND F/U IF NOT IMPROVING OR SYMPTOMS WORSENING.
Chills, aches, fatigue. Approximately 24 hours after second dose injection.
fatigue; Nausea; body aches.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), NAUSEA (Nausea) and MYALGIA (body aches.) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (fatigue), NAUSEA (Nausea) and MYALGIA (body aches.). On 31-Mar-2021, FATIGUE (fatigue), NAUSEA (Nausea) and MYALGIA (body aches.) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090372, MOD-2021-090372 (Patient Link).   Reporter did not allow further contact
After receiving Gardasil #2, Hep A #1 vaccines, pt was placed supine (b/c hx of feeling dizzy after 1st Gardasil). Approx 1 min. after vaccines, pt had 3 second tonic clonic activity of arms and legs with flexion of neck twice. No incontinence. Pt was lucid, AA and ) immediately post-event. Pt felt lightheaded for 30-40 mins. She slowly transitioned from supine to sitting to ambulatory. Exam was non-focal and VS normal. Dx: syncope with seizure.
This spontaneous report refers to a 53 year old male patient reporting on himself. The patient's medical history included two prior cases of hives in 1995 (date unspecified) and June of 2005, and in both cases the hives went away after about 3 weeks following treatment with unspecified steroids (approximately in 1995 and in July 2005 respectively). None drug allergies were reported. In October 2012, the patient was vaccinated with ZOSTAVAX (concentration, dose, lot number and expiration date were not reported). Concomitant therapies included lisinopril(manufacturer unspecified). In December 2012, the patient developed hives after vaccination with ZOSTAVAX. Patient sought medical attention, he contacted his physician. There were performed unspecified allergy tests but results were not reported. Patient received treatment with oral steroids (manufacturer unspecified). The hives have not resolved despite repeated courses of steroids (manufacturer unspecified). Additional information has been requested.
Severe muscle pain in left arm from shoulder to elbow. Could not move left arm without lifting it with right hand because of pain. Severe pain for 4 days. Could not drive because of pain. Began to use  left arm on 5th day. Took Naproxen Sodium 220mg for pain but only eased the pain slightly. Two months later I still have muscle pain and take Naproxen Sodium 220 mg so I can sleep at night.
Information has been received from a company representative concerning her 59 years old mother (a registered nurse) who on 17-JUL-2012 was vaccinated with 0.65 ml dose of ZOSTAVAX (lot # not reported). No other co-suspects were reported. No concomitant medications were reported. In July, the patient had a rash on her arm above where the shot was given. No lab diagnostics studies were performed. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
COVID vaccine breakthrough case. Moderna 2/3/21 029L20A, 3/3/21 023M20A and boosted 10/20/21 036C21A
I noticed severe lymphadenopathy right neck, scapular region and back ,as well as erythema, rash and swelling at site that is still present today 1/21/2021. Pain is severe taking Tylenol
This is continuation of worsening symptoms since last report  started around 8/1/2021. I had additional symptoms that could be related.When I do a workout using 40 pounds of weights now I have different responses to my daily activities. The same daily activities seem to provoke a severe level of pain to my cervical area. On 8/27/2021 had a steroid injection in my neck area to calm it down.I had a MRI on 9/22/2021 on my lower L5,S1 Lumbar as a result of increased symptoms.
Woke up with small blister like rash under both arms, between elbow and wrist, back, abdominal area, front left leg and buttocks area.  No itching.  Complained of some bruising at injection site. Called to report his symptoms on Monday, October 12th.  Stated he was noting some improvement in symptoms. Medical Director made aware of event.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-JAN-2013 the patient was vaccinated with GARDASIL dose 1 (dose and route were not reported). On 17-JAN-2014, the patient was vaccinated with GARDASIL dose 2 (dose and route were not reported) and on 22-APR-2014 the patient was vaccinated with GARDASIL dose 3 (dose and route were not reported). The patient experienced inappropriate administration schedule and no adverse symptoms reported. Additional information has been requested.