chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 11:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 11:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.78.  Concomitant products were not provided.  On 28 Apr 2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19 Apr 2021, vial was moved to clinic on 28 Apr 2021. 04 vials were sent to clinic. Vaccine BUD date was 19 May 2021.  On 28 Apr 2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41, 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
she had COVID-19; Tested positive COVID; Fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as SINGLE DOSE for covid-19 immunisation. Patient medical history was not reported. Concomitant medications included influenza vaccine (FLU). The patient experienced fever on 11Apr2021. Patient stated, she received the first dose of the vaccine on 03Apr2021 and on 09Apr2021 she was tested for COVID and on 11Apr2021 she got the results for being positive for COVID. The COVID 19 vaccine lot number is EW0150 and unknown expiry date and NDC number. Patient clarified that herself and family mem-bers tested positive for COVID 1 week after getting the first dose of the COVID 19 vaccine and then tested negative 2 weeks after that. Patient stated the appointments had to be rescheduled for the second dose of the vaccine. Patient asked what was the best time to get the second dose of the COVID 19 vaccine or does it matter. Patient stated people keep asking her why she was getting the second shot since she had the antibodies already that the second shot would be giving her. Patient asked should she try to get the second dose at all. Therapeutic measures were taken as a result of events. Patient stated she took Advil for fever and also got an albuterol inhaler. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Apr2021 positive. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
arm is bruised; arm swollen; neck pain; back pain; a little knot; shoulder pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 15-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (arm is bruised), PERIPHERAL SWELLING (arm swollen), NECK PAIN (neck pain), BACK PAIN (back pain) and NODULE (a little knot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), ATORVASTATIN for Cholesterol.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CONTUSION (arm is bruised), PERIPHERAL SWELLING (arm swollen), NECK PAIN (neck pain), BACK PAIN (back pain), NODULE (a little knot) and ARTHRALGIA (shoulder pain). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 14-Mar-2021, CONTUSION (arm is bruised), PERIPHERAL SWELLING (arm swollen), NECK PAIN (neck pain), BACK PAIN (back pain) and NODULE (a little knot) had resolved and ARTHRALGIA (shoulder pain) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the drug was not applicable.
I wasn't feeling well, I started having a really bad headache, fever, sore and achy like I had the flu. I started having problems heaviness and shortness of breath. I started getting a rash that turned into hives all over my entire body. I was having feelings of anxiety and overall not well. I'm still getting hives from it. The other clinic I saw was the clinic  5096342913. I still am using an inhaler from the shortness of breath.
About 8 days after vaccine, 02/02/2021, I noticed a 1-2 inch circular redness with light rash, and slight swelling with mild soreness. It is lighter red today, 02/05/2021, and has not increased in diameter.
Swelling, bruising, and soreness in left forearm and wrist progressively after injection, unclear if related to injection; seen by primary care provider the following day, followed up again 2 times the following week, referred to and seen by orthopedic hand specialist.
Vaccine was given in left arm 5 days ago. Left arm at injection site is red, swollen, sore, hot to touch, and itchy.  I have been taking Aleve once or twice a day for the pain. I just had a conference with a doctor  and he recommended I report this adverse reaction using this website. He categorized my symptoms as moderate because of the length of time of the reaction. He also recommended I put ice on it, rest it, and elevate it and continue taking Aleve as needed.
soreness at injection site; itchiness at site; red splotch surrounding injection site; fatigue; low-grade fever; This is a spontaneous report from a contactable consumer. A 66-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:00 (age at vaccination 66-years-old) as dose 2, single for covid-19 immunisation. Medical history includes Hypothyroidism, granulomatosis with polyangiitis (GPA) in remission and Known allergies possible penicillin from an unknown date and unknown if ongoing. Concomitant medication included azathioprine (AZATHIOPRINE), losartan (LOSARTAN), levothyroxine (LEVOTHYROXINE), pyridoxine hydrochloride (VIT B6), ergocalciferol (VIT D) was taken in two weeks. The historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EI9266) via an unspecified route of administration, administered in Arm Left on 15Feb2021 16:00 (age at vaccination 66-years-old) as dose 1, single for covid-19 immunisation. On 12Mar2021, patient experienced adverse events 4-5 days post-injection of 2nd dose, continuing soreness at injection site, itchiness at site, and on day 5 a red splotch surrounding injection site Within first 24 hours, fatigue and low-grade fever but resolved within 10 hours. No treatment was received for AE. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Outcome of the events fatigue and low-grade fever was resolved on unspecified date in Mar2021, and other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Severe pain starting in left hip then spreading to entire low back. Then entire body aches and heavy lasting through 2/14. On the morning of 2/15 pain was localized back in left hip and left thigh.
Ppatient had a red spot on the arm at the site of the injection, it was not raised or warm.
no additional AE information reported; a temperature excursion on ROT ATEQ and product administered; This spontaneous report was received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 07-JUN-2021, the patient was vaccinated with singe dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported, lot # T033812, expiration date 29-DEC-2021) orally for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 47 Fahrenheit (F) for a time frame of 1 hour.  No digital data logger was reported. There were no previous temperature excursions. No additional adverse event (AE) information was provided.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA003944: US-009507513-2106USA004087: US-009507513-2106USA004106: US-009507513-2106USA003971:
she got rashes all over her body; This is a spontaneous report from a contactable consumer (patient) received from Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Apr2021 as dose 2, single for Covid-19 immunisation. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single on 05Apr2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that after the second dose she got rashes all over her body on an unspecified date. The outcome of the event unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Anaphylactic shock, sudden onset of diffuse itchy rash, hives and dizziness, acute distress.   VS  BP 86/65 P 74 Resp 18 SpO2 100%  IV meds sodium chloride, Epinephrine, Pepcid, MethylPredniSolone sodium succinate
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months, in approximately 2018. The patient was 4 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1808USA010810; US-009507513-1809USA004055; US-009507513-1809USA004057; US-009507513-1809USA004058; US-009507513-1809USA004059; US-009507513-1809USA004060; US-009507513-1809USA004061.
Primary immunisation: Janssen covid-19 vaccine; Booster: Pfizer covid-19 vaccine; Primary immunisation: Janssen covid-19 vaccine; Booster: Pfizer covid-19 vaccine; Primary immunisation: Janssen covid-19 vaccine; Booster: Pfizer covid-19 vaccine; Fever; Nausea; This is a spontaneous report received from a non-contactable reporter (Other healthcare professional).   A 51-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 51 years as dose 2 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (johnson & johnson) (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 12Jan2022, outcome "unknown", and all described as "Primary immunisation: Janssen covid-19 vaccine; Booster: Pfizer covid-19 vaccine"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".   No follow-up attempts are possible. No further information is expected.
Patient was given wrong vaccine.  Her first vaccine was Pfizer and patient received Moderna as her second vaccine. Patient had no immediate adverse reactions with the moderna vaccine.
three menstrual periods/irregular bleeding after second dose. Bleeding started on June 26, again on July 4, and again on July 21. Fertility specialist diagnosed one possibly two ovarian cysts at 27mm and 33mm diameter via ultrasound. Treatment is watch and wait to see if they resolve naturally. My cycle was very regular prior to covid vaccine series.
Patient developed fever, seizure, Left arm weakness the following morning and was hospitalized. MRI showed Right Middle Cerebral artery infarct. Pt was treated with antiseizure medications, antibiotics, and Lovenox.  8/10/09 Hospital records received DOS 6/6/09 to 7/06/09. Assessment: Right middle cerebral artery infact with occlusion, seizure, Staphylococcus bacteremia/endocarditis. Mother noted child child was 'not acting right', had poor head and body control jerking movements in left upper extremity, and the head jerking towards the left side. Child was partially responsive and found to have a fever or 102F. The movements lated for 10 - 15 minutes, after that he was lethargic and sleepy. It was noted that he had decreased mobility of the left extremity. Transient tremor left lower extremity. Hyperpigmented marks and nevi left heel/ankle. Hyperpigmentation right forehead and right shoulder.
Enlarge lymph node, bilateral axillar and right groin. It was swollen and painful and turned black and blue. I started taking Motrin to help with the pain. A few weeks later I went to the doctor and had lab work drawn and my results were normal. It took four weeks to improve, the lymph nodes are still enlarged.
I woke up the dat after I received my covid vaccine, and my left wrist had some pretty significant pain. It wasn't swollen,  but I couldn't put any weight on it. I took some naproxen, put Voltaren gel on it, and took some turmeric hoping it would get better. It didn't. The next day, today, it is worse. I can't move it without it being very painful. I've been to the point of tears all day because of how bad it's hurting. I am contemplating going to an urgent care or ER.
Breakthrough covid case. Patient presented to the ED on 6/15/22 with c/o of congestion, cough, headache, fever. Exposed to a covid positive friend 2 weeks prior.  Fully vaccinated with Pfizer. Prescribed Paxlovid. DC home.
Information has been received from a nurse concerning a 13 year old female with no medical history or known drug allergies who on 24-APR-2008 was vaccinated IM with a 0.5 mL first dose of GARDASIL (lot # 659653/1448U).  There was no concomitant medication.  On 24-APR-2008, 20 minutes after receiving the dose, the patient developed a red rash on her left face, chin, and neck.  The rash consisted of an area of redness, without lesions.  There was no itching or respiratory problems.  The nurse practitioner treated the patient with an unspecified steroid injection and prescribed a MEDROL dose pack.  The patient was seen in the office on 28-APR-2008, for an unrelated illness, and the rash had resolved.  No product quality complaint was involved.
started to feel dizzy after getting the first dose of the COVID-19 Vaccine today; just checked her blood sugar, and her blood sugar was high at 146.; This is a spontaneous report from a contactable consumer (patient's daughter).  A 60-years-old 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 right arm on  28Jan2021at  09:30 (at the age of 60-years-old) as a SINGLE DOSE for covid-19 immunisation .  Medical history included breast cancer female from 17Feb2019 (taking medicine for the breast cancer for 2 years), Cardiac disorder from an unknown date (problems with her heart about 2 weeks ago, and had to have her heart examined),  and Prediabetes  Concomitant medication(s) include takes medication for breast cancer and  prediabetes. No other vaccines were given within 4 weeks  No Additional Vaccines were administered on Same Date of the Pfizer Suspect. On 28Jan2021, The patient experienced  started to feel dizzy after getting the first dose of the COVID-19 Vaccine today and  just checked her blood sugar, and her blood sugar was high at 146. No Physician office visit and No Emergency room visit required due to the events. Reporter stated her mother is  feeling better now. Patient  checked her blood pressure and it was 127/72.  The patient underwent lab tests and procedures which included blood glucose: High 146  on 28Jan2021; blood pressure measurement: 127/72 on 28Jan2021,  cardiac stress test: unknown results on an unknown date, heart resistance test: unknown result on an unknown date. Caller asked what Pfizer recommends for the dizziness. The clinical outcome of the event dizzy was recovering which blood glucose high was unknown    Information on the lot number has been requested.
Sudden ringing in his right ear, numbness to the right of his face, arm and leg; This spontaneous report as received from a lawyer and refers to a patient of unknown age and gender concerning a case in litigation. The patient's medical history, concurrent conditions, historical drugs and concomitant therapies were not reported.  On 02-DEC-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for prevention of shingles (herpes zoster) (dose, route, lot number and expiration date were not reported).         On an unknown date, the patient sudden suffered ringing in his right ear, numbness to the right of his face, arm and leg. The patient was hospitalized and diagnosed with an acute ischaemic stroke. the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries.The patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The outcome of ischaemic stroke was reported as unknown. The reporter considered ischaemic stroke to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the event was considered medically significant.
I have had minor tinnitus over the past couple of years. Infrequent and rises and falls in volume (especially loud with migraines or stress). Heard as a high pitched ring in both ears, typically slightly louder in left. No perceived increase in volume after first shot (April 3, 2021). After my second shot (May 4, 2021) it has been extremely loud and constant for almost a week now. I have zero hearing loss (went to a ENT about two months ago and got tested) and am in overall good health.
Chills/heat flash 16+ hours after shot.; Chills/heat flash 16+ hours after shot.; Low grade fever, body/joint pains onset +12 hours after shot; Low grade fever, body/joint pains onset +12 hours after shot; Low grade fever, body/joint pains onset +12 hours after shot.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 08:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included inappropriate sinus tachycardia. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 20:15, the patient experienced low grade fever, body pains, joint pains with onset of plus 12 hours after shot. The patient also experienced chills, heat flash 16 plus hours after shot on 03Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, chills, heat flash was resolved on an unknown date in Apr2021 plus 24 hours after shot, while that of body pains, joint pains was resolved on an unknown date in Apr2021 plus 36 hours after shot. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 23Apr2021 at 08:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Feeling of a ?pill in the throat?. Metallic taste. Largening of the tongue. Maintained a patent airway with no breathing difficulties. Just feel very ?out of body?.
Pain in the left should join began within five minutes of injection, then traveled down to the elbow joint.  The left arm experienced a burning sensation off and on the rest of the day.  Within one hour, the pain had progressed to the neck .  Patient experienced eye and facial swelling, itchy throat and hot flashes within six hours of injection, Benadryl was given to alleviate symptoms.  Patient also experienced headaches.  Injection site and neck pain remained for more than 48 hours.
Pt started with a fever 09/05/08.  Pt has multiple blisters in trunk and a few on face and legs noted 09/07/08