chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First and Second dose: sore arm; She's not sleeping well at all; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 07:00 (Lot number: EL9269) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sleeping trouble" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "First and Second dose: sore arm"; INSOMNIA (non-serious), outcome "not recovered", described as "She's not sleeping well at all". The events "first and second dose: sore arm" and "she's not sleeping well at all" were evaluated at the physician office visit.  Additional information:  No other vaccines administered on same date with the Pfizer vaccine considered as suspect. No Emergency Room and Physician Office routine visit with HCP. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations with no Relevant Tests. Patient had to put ice on her arm to help as she had to work and she's sure working didn't help her arm. Patient thinks her arm was sore for about 3 days after both Covid 19 vaccines.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare professional refers to a 24 year old female patient. In 2012 the patient was vaccinated with the first dose of GARDASIL (Lot # not provided) (dose, route and frequency not reported). No other co suspects were reported. No concomitant therapy was reported. The reporter stated that the patient developed as "reaction" at the injection site (injection site unspecified). A skin biopsy was performed on 19-JUN-2013 and the result was a granulomatous reaction. The patient sought medical attention at the physician's office. Treatment was not given for the event. The outcome of granulomatous reaction was unknown. Additional information has been requested.
experienced full body inflammation:  - full body achy muscles tendons skin, including around entire skull and eye sockets;  - inflamed gut (unable to keep down anything, including water - vomited everything. also felt ulcer-like pain in upper & mid gut);  - difficulty moving because of muscle pain;  - persistent fever;  - persistent headache - nerve pain type timeline of symptoms:  - day of injection experienced body aches  -  day after injection - all symptoms and highest pain level. unable to hydrate because of vomiting.  - 2nd, 3rd, and 4th day after injection - mild fever, headache, and body aches. able to keep down water and soft foods.
Rash on left side of face, redness, mild edema-bendadryl 50mg given-resolved.
Nervous; Jittery; Nauseated; Arm really hurts; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervous), FEELING JITTERY (Jittery), PAIN IN EXTREMITY (Arm really hurts) and NAUSEA (Nauseated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for Blood pressure management, CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm really hurts). On 28-Jan-2021, the patient experienced NERVOUSNESS (Nervous), FEELING JITTERY (Jittery) and NAUSEA (Nauseated). On 28-Jan-2021, PAIN IN EXTREMITY (Arm really hurts) had resolved. At the time of the report, NERVOUSNESS (Nervous), FEELING JITTERY (Jittery) and NAUSEA (Nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 01-JUL-2015 the patient was vaccinated with an improperly stored GARDASIL dose, route, frequency, Lot number and anatomical location were unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. In August 2013 the patient was vaccinated with the first dose of GARDASIL (injection, route of administration, lot number and expiry date were not reported). In approximately in January 2015 the patient wanted to be vaccinated with the second dose of GARDASIL. No adverse symptom was reported. Additional information has been requested.
This report was received from a nurse. The nurse reported that three patients were administered expired ROTATEQ. This spontaneous report refers to first patient (out of three patients who were administered expired ROTATEQ) of unspecified demographics. Patients medical history unspecified. On 02-APR-2014, the patient received expired ROTATEQ, (dose unspecified) (lot number H016249, expiry date 27-MAR-2014). Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of received the expired ROTATEQ on 02-APR-2014 was unknown. No further information was provided. This case is linked with MARRS # 1405USA002806 and MARRS # 1405USA002805 as same reporter cases. Additional information has been requested.
Bivalent Moderna vaccine was ordered. A monovalent Moderna vaccine which expired 2/6/23 was given instead.
Experienced temporary short term memory loss after both the first and second doses of the Pfizer COVID-19 vaccine. Symptoms are worse in the days following the vaccine.
Injection was given up at the top of my left shoulder.  Felt pain and an unusual feeling in shoulder.  Next day pain and a band of heat around my bicep that lasted for a month and a half. Pain is constant, I have limited ROM. Tried NSAIDS, have had an MRI, 2 cotisone shots, PT, and now have been told I need a shoulder scope in order to fix my shoulder. I had no problems with this shoulder prior to the injection.
The patient presented to the ER with chest pain on April 11, approximately 13 days after receiving the second dose of COVID vaccine. She then developed dyspnea about a month later and was subsequently found to have a moderate sized bloody pericardial effusion and pericarditis on May 18th, for which no alternate cause has been found.
Information has been received from a physician concerning his 79 yr old white wife with chronic obstructive pulmonary disease, asthma, osteoporosis and hypothyroidism who on 14Feb06 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, IM. Concomitant therapy included numerous medications. On 14Feb06 the pt experienced feeling of being cold and oral temp as low as 95.5F and local tenderness at injection site. The pt also experienced extreme fatigue which lasted about 2 weeks. The pt received a first dose of pneumococcal 23v polysaccharide vaccine 6 yrs ago. Unspecified medical attention was sought. Follow up reported that the pt experienced extreme fatigue for two weeks, then resolved (during Feb), asymptomatically. It was also reported that the pt experienced profound weakness, fatigue for 2 wks, resolved since. Additional information is not expected.
Had COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had COVID-19) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (Had COVID-19). At the time of the report, COVID-19 (Had COVID-19) outcome was unknown.            No concomitant medication were reported.              No treatment information was provided by the reporter.   This case was linked to MOD-2022-680224 (Patient Link).
Systemic: Abdominal Pain-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Severe, Additional Details: started vomiting and having non stop migraine when she woke up saturday after getting shot sunday, vomits any time she takes medicine, has had continuous headache, no relief with tylenol/ibuprofen/or sumatriptan
Within 24 hours of receiving the Tdap shot, I began having sensations of hot water being poured onto my feet. I had never had this sensation before in my life. It continued for the next week and from then on out, would come and go. In March of 2011 I experienced extreme symptoms of this and went to the doctor, where I was diagnosed with primary Reynaud's.  I continue to have daily symptoms and had never experienced any of this before receiving this immunization.  Please note that the approximate date was given for the immunization. Exact date and time would need to be requested from my physician. I do not know what brand the vaccine was, except that it was Tdap.  When I visited with my physician about my Reynauds I mentioned that the initial symptoms began within 24 hours of the shot.
pt recv vax 20JUL98 pt returned to office on 22JUL98 w/large red sl warm area around site of inj;pt was advised to  use DPH q 4hr & call if anymore problems;
Initial report was received from a health care professional on 12 January 2012. A female patient (age and date of birth not reported) had received an intramuscular injection in the left deltoid of FLUZONE, sanofi pasteur Inc., lot number UH460AB on 05 October 2011. A "couple of days after the vaccination" (date not reported), the patient developed a metallic taste in her mouth and had a raw tongue like "it was burnt from something hot". The patient stated the metallic taste was subsiding but she continued to have problems with her tongue. No illness at the time of vaccination was reported. The patient had no known allergies and a medical history of high blood pressure, elevated cholesterol and gastric reflux. The patient's concomitant medications included atenolol, ibuprofen, omeprazole, amlodipine, hydrochlorothiazide, XANAX, potassium chloride, multivitamin and fish oil. No other vaccinations within four weeks of FLUZONE were reported. It was unknown if the patient had received any previous doses of influenza vaccine. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Patient received Janssen COVID vaccine on 4/3/21. On 11/8/21, patient admitted to our facility with acute hypoxemic respiratory failure secondary to COVID-19 pneumonia (positive status on 11/5/21) and Bacillus bacteremia. As of 11/10/21 (today), patient is still admitted in our med/surg unit.
Approx 48 hours after injection, I noticed the injection site was swollen, bright red, and warm to the touch. I had a low grade fever of 100.6, and headache. I two, 200 mg ADVIL Liqui Gels, and returned to the clinic. The nurse (different from the injection day) said it was either an adverse reaction, or an infection. She gave me a script for: doxycycline 100 mg tabs (VIBRA-TABS, to start on 3/4/2019, if no improvement. Nothing improved, so i started taking the meds on 3/3/2019. For 10 days I am seeing some improvement, but not complete.
Initial misuse report received from a healthcare professional on 26 September 2013. A 4 year old patient had received FLUZONE 0.25 ml instead of 0.5 ml. it's an under dose. No adverse event was reported. List of documents held by sender: none
Information was received on 29-APR-2016 from a litigation consultant for a third party claims management service regarding a 72 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant therapies. The patient and her attorney are alleging that on 26-JAN-2016 (also reported 27-JAN-2016), the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L-22795, expiration date not reported) intramuscularly in the right upper arm and developed a blood clot. She is now unable to move her right arm. Upon internal review the events of blood clot and unable to move her arm were determined to be medically significant. Additional information has been requested.
This spontaneous report was received from a registered nurse, referring to unspecified patients. Patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23, lot # L017406 and expiry date 26-FEB-2017 also with lot # L019835 and expiry date 23-MAR-2017 (strength, dose, anatomical location and route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
4/7/99:Rt arm swollen from shoulder to forearm.Tx w/ antibiotics. Swelling has gone done now, but a rash on upper arm still remains.4/11 & 4/12-pt ran an elevated temp. & was fussy.
On 1/20 I began to experience sinus congestion and chest congestion which worsened over the next 2 days. I made and attended a telemedicine appointment on Friday, 1/22. Subsequently I was prescribed Mucinex 12 Hour, and Afrin No-Drip which eased the symptoms. I had a Covid test performed by the staff  which returned positive on Monday, 1,/25. After 1/30, my symptoms were improved enough that I was able to resume activity and after 10 days, was advised that I no longer needed to quarantine. I was administered my 2nd vaccination on February 10, 2021.
Received vaccine and then went home and took nap. When awoken from nap, he had grey streaking on his extremities following his veins.
It was discovered that the primary care office was keeping the vials of punctured vaccine past the recommended time as per the manufacturer (past 6 hours) Opened vials were stored for up to 28 days. Patient had no adverse effects
Mild Head & body aches starting one or two days later. None of the symptoms were strong enough to keep me from work or exercise.  Weds - Vaccine -- sore arm only / Thursday -- much more sore arm & possibly body/headache / Friday -- more significant, but still mild body & head aches / Saturday -- more significant, but still mild/moderate body & head aches.  The main thing that I want to report is that Saturday night (~75hrs after vaccine) -- my face became extremely hot, and it turned bright red as if I had a sunburn. I had no fever. This came on after exercise, dinner/wine, etc, so I don't know if it's related to the vaccine, but I have never had anything like that before, so I thought I should report it since this is a new vaccine. It remained red for a few hours and was red when I went to bed. When I woke in the morning, it was completely gone.
Rash on bilateral upper arms - 2-3mm pink papules (no pustules) - started 2 days after Tdap in 1 arm (left) and GARDASIL in the other (right). No other symptoms. No treatment.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Minor COPD" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, stop date: 20Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Immunity issues; Mouth (oral) sores; This is a spontaneous report from a contactable pharmacist.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, influenza vaccine and varicella zoster vaccine; all on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, 2 weeks after the vaccinations, the patient experienced immunity issues and mouth (oral) sores. Clinical outcome of the events was unknown at time of this report.   The information on the lot number has been requested.
At 3 months of age, constant ear infections, throwing up. (13) ear infections led to several hearing problem-tubes in ears, speech impediment. Now in special needs classes.
Immediately after vaccinations given patient began to feel dizzy and throat itchy and "like it was closing". Patient was given 25 mg BENADRYL - refused EMS - waited 20 mins and recovered.
A week after vaccination, I started having ringing in both of my ears. My ears were still ringing a week later so I saw my PCP who cleared wax from my ears and then referred me to an ENT specialist. I went to that appointment in June 2021. They ran a hearing test and it was fine. They are still ringing at this time. No better, no worse.
Ears became blocked about 15 minutes after the 2nd injection. Stayed blocked for approximately 24 hours.; now have an earache that will not subside; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the right arm on 31Mar2021 at 13:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6203) via an unspecified route of administration in the left arm on 09Mar2021 at 16:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, the patient ears became blocked about 15 minutes after the 2nd injection. Stayed blocked for approximately 24 hours and had an earache that did not subside. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events ears became blocked about 15 minutes after the 2nd injection. Stayed blocked for approximately 24 hours and had an earache that did not subside were not resolved at the time of the report.  No follow-up attempts are possible. No further information is expected.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 3:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 3:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   Expiration date was 12Jan2022. The patient was given dose from vial that were stored in an ultracold freezer which was colder than they should have been. The facility had a temperature excursion for the Moderna COVID-19 vaccine and the patient was administered the vaccine underwent temperature excursion.  The facility had a temperature excursion for the Moderna Covid-19 vaccine. Excursion duration was 1 month. On 19-Nov-2021, the vial moved from super cold freezer to the refrigerator, 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator, no vaccine state changes were noticed, none of the vials were punctured and no previous temperature excursions.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than the standard storage conditions.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Follow-up received contains no new information.
Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 14:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 12:00, the patient experienced headache and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache and chills were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
FELT WARM, SKIN FLUSHED, TINGLING IN EXTREMITIES. TOOK BENADRYL, HELPED SOME. SAW HER PCP AND HE PRESCRIBED ZANTAC ORALLY IN ADDITION TO BENADRYL.  BEGAN HAVING DIFFICULTY EATING.  SHE SAW DR. ON 11/13 AND RECEIVED A CORTISONE INJECTION.  THIS HELPED FOR ABOUT 24 HOURS, THEN SYMPTOMS CAME BACK. HAD LAB WORK FROM HER PCP AND RESULTS WERE NORMAL.