chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vomiting; fatigue; muscle aches; chills; increased hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle aches), CHILLS (chills), HOT FLUSH (increased hot flashes) and VOMITING (vomiting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INFLIXIMAB (REMICADE), METHOTREXATE and TRAMADOL for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle aches), CHILLS (chills) and HOT FLUSH (increased hot flashes). On 01-Mar-2021, the patient experienced VOMITING (vomiting). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle aches), CHILLS (chills), HOT FLUSH (increased hot flashes) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pain, swelling, redness, bruising all over the left upper arm starting from the elbow
SWELLING, REDNESS AND ITCHINESS OF THE RIGHT ANTERIOR THIGH.
Fever; chills; headache; myalgia; fatigue; sore arm; This is a spontaneous report from a Non-contactable Consumer (Patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at Left arm on 17Jan2021 14:00 at single dose for covid-19 immunization. Patient was not pregnant. Medical history included COVID-19 prior vaccination. The COVID-19 vaccine was administered at Hospital. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's received the first dose of BNT162B2 on 26Dec2020 at left arm for covid-19 immunization. The patient experienced Fever, chills, headache, myalgia, fatigue, sore arm on 17Jan2021 23:00. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Jan2021. No treatment received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Vaccine expired past the 30-day recommendation. At this time there have been no symptoms of an adverse event.
Moderna COVID-19 Vaccine   Reactions to the Moderna vaccine included dizziness, weakness, body aches, fever (102*), fatigue and headache.
Patient lost vision in the left eye and was treated for optic neuritis. Patient still has vision loss in the left eye
This spontaneous report was received from a doctor of pharmacy refers to a 66 years old female patient who on 18-AUG-2012, was vaccinated with a dose of ZOSTAVAX (lot number 5663AE, Exp. Date: 21-MAR-2013) (dose and route not reported). No concomitant medications were reported. The pharmacist reported that on 18-AUG-2012, the patient developed red, swollen, raised and sore area at the injection site after receiving ZOSTAVAX. BENADRYL, TYLENOL and MOTRIN were given as a treatment for the experience. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The relatedness for red, sore, raised and swollen area at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Received 2 month series 7/19/99 6pm. Mother reports inconsolable crying 12:01 am to 4 am. Low grade temperature, 99.6. TYLENOL given - continues with fussiness today 7/21/99. Sleeping in time frame of 10-20 minutes since Monday 7/19. Loss of appetite.
Continual 103 degree fever, lethargic, low blood sugars, high white blood cell count with negative blood & stool samples. Vomitting, dry heaving, diarrhea (had to be prescribed zofran to keep anything in- stayed on zofran for 7 days). IV Fluids, IV Glucose- 3 ER VISITS, PALE SKIN, Rashes that would come and go. (Yesterday 8/31/22 - raised bumps on injection site).
She has uncontrollable blood pressure; Tachycardic; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INADEQUATELY CONTROLLED (She has uncontrollable blood pressure) and TACHYCARDIA (Tachycardic) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030421A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Diabetic and Hypertension. Concomitant products included INSULIN LISPRO (HUMALOG), INSULIN DEGLUDEC (TRESIBA), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), ATORVASTATIN, OMEPRAZOLE, BUPROPION, LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]) and VITAMINS NOS for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INADEQUATELY CONTROLLED (She has uncontrollable blood pressure) and TACHYCARDIA (Tachycardic). At the time of the report, BLOOD PRESSURE INADEQUATELY CONTROLLED (She has uncontrollable blood pressure) and TACHYCARDIA (Tachycardic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.         No treatment details were reported.  Other concomitant drugs include Fomasipian by mouth once daily, Vitamin DQ once a week 1.25mg capsule. Patient stated that when she lost weight her blood pressure got better.   Reporter did not allow further contact
had the vac & got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine and got shingles. The patient reported that it was mild one and thanked goodness and advised that one to still could get them. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Erythematous area approximately 6.5 cm X 5 cm indurated.  Slightly painful to touch, SI bruise.
I wake up almost every day now with tingling, numbness or pain in my hands. The right hand is worse than the left hand. Sometimes I am unable to open a basic water bottle as my grip strength is seriously compromised.  The evening of the vaccine I went to bed early as I was super tired. I woke up in the morning and felt flu-ish which I knew could be expected.  But my hands were cramped and it was hard to get them to open.  For two days I couldn't type or hold a fork--I had to manipulate my hands with something other than my hands to stretch them out and get them to open and to stop shaking.  It's been a bit over a month now and I'm still waking up with my hands sore, numb, asleep, cramped or a combination of all of these.  There has not been one day that I haven't woken up like that.  I have to type a lot for my work and it has compromised how much I can do at any one time.  My hands need a lot of breaks. I am an avid knitter but I haven't been able to do that at all since my second vaccine shot on May 10th and I struggle to do other things that require grip and dexterity as well - like carrying a bag or using a hammer.
Raised red area around injection site sore to the touch and itchy. Treatment - ice pack to area and Hydrocortisone cream.
This spontaneous report as received from a nurse practitioner refers to a patient of currently 12 years old. The patient was vaccinated with, 0.5 ml SC (Merck) VARIVAX (Lot # 1770J) on 12-JUN-2000. The second dose of 0.5 ml SC (Merck) VARIVAX (Lot # 0012AA, in validation process) was taken on 28-JUN-2011. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced chicken pox. No treatment information was reported. The outcome of chicken pox was unknown. The relatedness for chicken pox was unknown for (Merck) VARIVAX. This is one of several reports from the same source. Additional information has been requested.
Vaginal bleeding in a menopausal woman with blood clots.; Vaginal bleeding in a menopausal woman with blood clots.; Also slept for 13 hours the day following the shot and had a continual headache with nausea; Also slept for 13 hours the day following the shot and had a continual headache with nausea; Also slept for 13 hours the day following the shot and had a continual headache with nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06May2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 56-year-old. Lot number EW0183. Medical history included menopausal woman. Concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at 10:30, Lot number EW0164, dose number: 1, in left arm. On 06May2021, the patient also slept for 13 hours the day following the shot and had a continual headache with nausea. On 10May2021, the patient experienced vaginal bleeding in a menopausal woman with blood clots. It was very concerning; the patient was going to Ob/Gyn soon. The patient underwent ultrasound and biopsy. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Follow up needed, further information has been requested
Narrative:  Patient came came in for an appointment to receive pfizer booster and flu vaccine today. Pfizer booster was administered to left deltoid and influenza was administered to right deltoid. During the 15 minute post vaccination monitoring, patient complained of feeling hot and itching to all over her body. V/S 168/98, 75,100%. Patient denies resp. distress. Resp. even and unlabored. Informed patient that she will be escorted to the ER for further evaluation, patient agreed. Offered to take patient via w/c she refused and requested she wanted to talk to the ER. Endorsed to the ER triage nurse to continue with patient care.
Patient called stating she was having blind spots in her vision that comes and goes. Also that her throat was becoming scratchy and felt like it could be swelling. Advised patient if throat was swelling she should seek immediate Emergency Care.
Developed hives on (R) arm, then developed hives on face. Given 25 mg of BENADRYL by school nurse. No improvement, EMS contacted. IV placed and given 40 mg IV SOLUMEDROL. Monitored in ER > 1 hr. DC'd on PO BENADRYL and prednisone. Referred to allergist.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of VARIVAX (lot # not reported) that were improperly stored on 04-SEP-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported and doses were administered to patients since 04-SEP-2012. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Narrative:  97yo male patient died on 10/5/2021. Patient lived in a private care home and had increasing edema without resolve with medications added and went to the hospital and the patient contained to decline and was sent home to be comfortable. Pt had received covid vaccines on 1/20/21 & 2/24/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Pt received DTap IM and IPV SQ on left deltoid. Area became erythematous and deltoid slightly firmer as compared to right deltoid.
doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:09 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 79.63 for dose administered on 31-Mar-2021 and 79.55 for dose administered on 2-Mar-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM. These vials were moved to fridge on 23-Mar-2021 and beyond use date for the vials was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021  Batch number 014M20A underwent temperature excursion on 2-Mar-2021 with temperature 27 to 29 degrees Fahrenheit from 09:00AM to 10:00 AM. These vials were moved to fridge on 24-Feb-2021 and beyond use date for the vials was reported as 26-Mar-2021. Product moved to clinic on 2-Mar-2021 Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported
Patient developed rash consistent with Erythema Multiforme. Pt given Atarax for pruritis and monitored.
Tingling at injection site and moving upwards approx 5-10 min post injection. No SOB or other symptoms at time. Itching and in throat and tongue approx 30min later.  Transport to hospital ED
seizures/They have worsened and have got more frequent; headaches; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent (mother).  A 32-year-old male patient received BNT162b2 on 09Dec2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "Atrial bigeminy" (unspecified if ongoing), notes: Atrial bigeminy diagnosed at three years old. Cardiologists and neurologist said his heart was fine and this was nothing contributing. He was always healthy when covid hit. Patient did not have family history relevant to adverse events. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EK9321 or EK4321, thinks it is EK9321 (populated lot number), Expiration: Apr 2021), administration date: 05Jan2021, when the patient was 31-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Lot: EJ1686, Expiration: Mar2021), administration date: 26Jan2021, when the patient was 31-year-old, for COVID-19 immunization, reaction(s): "seizures". Patient did not have prior vaccinations within 4 weeks aside from doses of COVID-19 vaccine.  The following information was reported: SEIZURE (medically significant), outcome "not recovered", described as "seizures/They have worsened and have got more frequent"; HEADACHE (non-serious), outcome "unknown", described as "headaches". Seizures was reported as worsened. He started having weekly seizures, lost his job and is unable to drive. The events "seizures/they have worsened and have got more frequent" and "headaches" required physician office visit and emergency room visit. Patient had numerous times to ER since having seizures at work and numerous times in ambulance. He was not admitted during these time. He went via ambulance when working. Confirms he was not admitted, he was released from ER and told to follow up with cardiologist and neurologist. He had been back and forth to neurologist. The patient underwent the following laboratory tests and procedures: Electrocardiogram: Fine; Magnetic resonance imaging: cannot find anything that would cause him to have weekly seizures. Therapeutic measures were taken as a result of seizure, headache. They put him on one medication for seizures called Lacosamide and then he was still having seizures so they added an additional medication, Lamotrigine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201291808 Same patient, similar event, different dose (dose 2);
Patient began with rash four to five days ago and continues to become more prominent and patient has all over entire body.
Weakness, presyncope starting 12 hours after injections given, persisted into next day.
Sore arm, body aches, feeling hot and cold and nausea. Took ibuprofen.
Rash 2 wks, oral steroids, oint (Rx), BENADRYL.
This initial spontaneous case, received on 02-Nov-2017, was reported by other health professional and concerns a 10-year-old male patient. The patient was allergic to cashews, peanuts and pistachios. The concomitant medications were not reported. On 02-Nov-2017, the patient received FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195240A, expiry date: Jun-2018). It was reported by the nurse that, they started using new thermometers from the previous day (when the nurse left it was in range and when she got there in the morning, heard the alarm sound). The minimum temperature was 34.3 and the high temperature was 37.9, it was below 36 for 11 hours 24 minutes (explicitly coded as incorrect product storage). On 02-Nov-2017, the patient received FLUCELVAX QIV after temperature excursion (explicitly coded as drug administration error). The nurse was not aware of the adverse events developed after vaccination; however reported as no adverse event and the patient was fine. The reporter assessed the case non-serious.
pt recvd vax; devel inject site rxn which included localized pain, redness & tenderness but w/out fever;atb were given;
HR increased from 60?s to 120?s and stayed there for 24 hours. Blood Pressure went form 120/70 to 220/130.  and similarly stayed for 24 hours since episode I have had extreme muscle weakness  since.
1638: Presented with dizziness, lightheaded, feeling flush, feels impending sense of doom, BP 138/82 (high for patient), Heart rate 75, Patient alert and oriented X3, Respiration easy and unlabored, Denies shortness of breath 1645: BP: 138/82 HR 82 99% Biox 1647: Went to get husband in the parking lot 1648: EMS called 1650: Husband with patient, patient still nausea  1653: Petechial rash observed to upper chest 1654: resting in supine position in recliner 1655: 118/70, HR 99, 99% Biox, 20 respiration 1700: EMS here  1703: no flu shot this year 1706: Left with EMS ?   Patient reques
getting sick; get discomfort; Soreness wrapped around under my armpit, right arm, chest area, not debilitating/Pain traveled under armpit and around the right side of the chest/Sore back and armpit; Soreness wrapped around under my armpit, right arm, chest area, not debilitating/Pain traveled under armpit and around the right side of the chest; Soreness wrapped around under my armpit, right arm, chest area, not debilitating; sore ribs; light headed; soreness in my scalp/when I touch my head, it just feels sore; sniffles; soreness in my back below my shoulder blade/back pain below right shoulder blade towards the mid-back; soreness in my back below my shoulder blade; pain; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), via an unspecified route of administration on 21Mar2021 (at the age of 66-year-old) as dose 2, single for COVID-19 immunisation. Medical history included retreatment of root canal from an unknown date performed a couple of days before first dose of Pfizer COVID-19 Vaccine administered. He did not take any pain killers prior to the first dose of Pfizer COVID-19 Vaccine, and did not take any antibiotics prior to that first dose of Pfizer COVID-19 Vaccine, sharp pain in the back, which was isolated pain from an unknown date and due to that the patient wasn't able to sleep. Concomitant medication included amoxicillin taken for oral infection due to root canal 28Feb2021 to 07Mar2021. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6203; Expiration Date: not reported), via an unspecified route of administration on 28Feb2021 (at the age of 66-year-old) as dose 1, single for COVID-19 immunisation and had lightheaded, slight headache and also received Shingles vaccine, 2 doses, which were maybe 1 year ago or so, before the pandemic, he felt pretty crummy for 3-4 days and he was unable to provide lot number, or expiration date. The patient experienced light headed on 21Mar2021, sniffles on 21Mar2021, soreness in scalp/when touched head, it just felt sore on 21Mar2021, soreness in back below his shoulder blade/back pain below right shoulder blade towards the mid-back on 21Mar2021 soreness wrapped around under his armpit, right arm, chest area, not debilitating; pain traveled under armpit and around the right side of the chest; sore back and armpit on 22Mar2021, sore ribs on 22Mar2021, got discomfort on 24Mar2021, pain in Mar2021,  , getting sick on an unspecified date. The outcome was recovered for dizziness and sniffles on 22Mar2021, not recovered for discomfort, soreness in my back below my shoulder blade, and soreness in my back below my shoulder blade/back pain below right shoulder blade towards the mid-back, soreness in my scalp/when I touch my head, it just feels sore and the outcome was unknown for rest of the events.  No follow-up attempts are possible. No further information is expected.
Mother of patient stated an area of redness, about 3 inches in diameter, appeared on the right deltoid area. pt stated to his mother that the area was itchy. No other symptoms reported.