chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wheezing; shortness of breath; flushing; sweating; nauseated; After 3rd infusion, (3rd loading dose) patient experienced shortness of breath, wheezing, flushing, sweating, nauseated; This is a spontaneous report from contactable nurse via Pfizer Sales Representative.   A male patient of age 44 received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 3, single for COVID-19 immunisation. Co-suspect medication included infliximab (INFLECTRA, Formulation: Powder for injection, Lot number: EJ1527), via an unspecified route of administration on an unspecified date as an unknown for an unspecified indication. The patient's medical history included Ankylosis Spond. Historical vaccine included BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in May2021 as a dose 2, single for COVID-19 immunisation, had received 2nd Covid Vaccination at least two weeks prior and the patient received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation, 1st shot of vaccine. The patient's concomitant medications were not reported. It was reported that, after 3rd infusion (3rd loading dose), on an unspecified date, the patient experienced shortness of breath, wheezing, flushing, sweating and nauseated. Used Humira prior switching to Inflectra. (Name) stated that, it was unknown whether it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Inflectra until Covid shot. The patient was not using Methotrexate. Being treated for Ankylosis Spond. No premeds were used prior to infusion. The reporter stated that, the events took place after use of product. The outcome of the events was unknown.
After getting vaccine, patient waited for any reactions. Patient started feeling dizziness, chest tightness, numbness and tingling around the mouth. Patient was taken back and took vitals. Healthcare provider examined patient.
November 21, 2022 Acute Bi-lateral Sub-massive Pulmonary Embolism
the vial was initially stored in the refrigerator on: 24-Oct-2022 and was administered by patient on 25-Nov-2022; No adverse event; Moderna Monovalent administered to patient 2 days after 30 Day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent administered to patient 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on: 24-Oct-2022 and was administered by patient on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent administered to patient 2 days after 30 Day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on: 24-Oct-2022 and was administered by patient on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent administered to patient 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on: 24-Oct-2022 and was administered by patient on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent administered to patient 2 days after 30 Day use by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on: 24-Oct-2022 and was administered by patient on 25-Nov-2022).    No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-679107, US-MODERNATX, INC.-MOD-2022-679108 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679107:same reporter (crosslink MOD22-029943) US-MODERNATX, INC.-MOD-2022-679108:same reporter (crosslink MOD22-029943)
Initial itchiness to injection site just after administration and then itchiness, mild redness and induration for 2 days, then resolution of all issues until 1/6/20 when site became mildly red, indurated and itchy again. This AM awoke with significant redness, induration, pain and itchiness that has increased in size over the past several hours go a softball size and now am also having chills, low grade temp, achiness and nausea
MILD PAIN IN THE AREA OF APPLICATION; This spontaneous report received from a patient concerned a 35 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced mild pain in the area of application. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild pain in the area of application was not reported. This report was non-serious.
Bulging red patch at injection; Incredibly tired; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site rash and fatigue.  The patient's medical history was not reported. Concomitant medication adverol was reported.  16-JAN-2021, prior to the onset of the events, the patient received the first dose of mRNA-1273 (lot/batch:039K20A) for prophylaxis of COVID-19 infection.  25-Jan-2021,when she was going into the shower saw a bulging red patch at injection 3 inches long and a couple inches wide and incredibly tired.  No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events vaccination site rash,fatigue is Unknown.
Half my upper arm has an inflammation, a rash, this afternoon the rash extended to other parts of my body up to my neck, my torso. Now is 4 hours later and after a shower it seems to have gotten better. The redness is getting paler but I still have a big circle surrounding the site of the injection. If I touch it, it seems like if I had water underneath.
Information has been received from a physician concerning a 7-month-old male who on 11-JUN-2007 was vaccinated with a third dose of Rotateq. Concomitant therapy included Prevnar, PedvaxHIB, IPOL and Daptacel. On 07-JUL-2007 the patient went to the emergency room in a hospital and had surgeries for intussusception and appendectomy (not further specified). It is unknown how long the patient was hospitalized. On an unspecified date, the patient recovered and was discharged. No product quality complaint was involved. The reporter considered intussusception to be an other important medical event and life threatening. Additional information has been requested. 9/20/07-records received with report-presented to ED 7/19/07 with 2 day C/O fever, vomiting, no stool.  Surgical repair of Intussusception.
Pt recvd MMR vax on 28NOV87 & 28FEB91 pt had t103-104, swollen glands & red throat; 4MAR91 rash appeared all over & @ time of dx measles was made;
This spontaneous report as received from an other refers to a patient of unknown age. On an unknown date, the patient was vaccinated (route not provided) with PROQUAD (lot number H021358, expiry date 23-NOV-2014). On an unknown date, an improperly stored vaccine used. The outcome of improperly stored vaccine used is unknown. Additional information has been requested.
Narrative:  COVID infection following COVID vaccine series 03/22, Pfizer, dose #1 04/12, Pfizer, dose #2 05/26 pt admit to ED cc:cough, chest congestion x 7 days dx: sinusitis/bronchitis LOS: 1 day 05/26 CXR impression: No acute abnormality. 08/20 pt cc: chills, cough, fatigue, loss of taste or smell, dyspnea, exposure: unknown 08/20 COVID swab, result: detected 08/20 SARS-COV-2 Variant Sequencing result: pending 08/28 COVID swab, result: not etected 08/30 CXR impression: Left pulmonary groundglass opacity in a COVID positive patient, most consistent with Covid pneumonia.
Tightness in throat & chest / head heaviness / lightheadedness immed. after Flu vaccine. Treated with Prednisone at Immed Care.
Tachycardia- I woke up at 4:00am  with my heart beating at 160 bpm. It was over 120 bpm for 4+ hours.  I felt short of breath and dizzy upon standing.
it was rpt fr HCP concerning pt who was vax 2jun1997 & in jan99 pt exp chickenpox
Received shot in right arm 11:55 am. 5 minutes later I felt a cold numbness in top back shoulder. Reported. Nurse said keep moving arm. 30 minutes later it began a needle feeling. 35-40 minutes visible swelling in neck above clavicle and right after lips tongue numb and tight chest and rapid heart. Ambulance came treated me with Benadryl 50 mg and SolMedrol enroute to local hospital. Bp approximately 223/100 and rapid pulse. ER did EEG, ct scan head, chest X-ray, blood tests. Continuing monitoring and low potassium (never low) so treated me with iv etc. still experiencing symptoms 6 days later. Primary dr prescribed prednisone 20 mg two daily and Benadryl when needed.
A physician reported that a 3 year old male received a single dose of Prevnar in February 2001. In February 2003, at 5 years of age, the child developed fever. The child's mother stated that her son's fever had persisted for seven days before he was seen in an emergency room on 2/23/03. A diagnosis of ear infection was made and he was treated with ear drops. On 2/24/03, according to the reporter, the mother indicated that her son developed vomiting. He had a decreased level of consciousness. A workup was performed which yielded the following abnormal electrolyte results: glucose 203; sodium 138; potassium 2.9; chloride 93; CO2 28. WBC ranged from 50,000 to 52,000; platelet count 667; haemoglobin 12. It was determined that he was septic and might be meningitic. He was treated with IV Rocephin. A lumbar puncture attempt was unsuccessful due to the child's state of agitiation. He was then transported to another medical facility. Physical examination revealed a temperature of 103.2 degrees F, pulse 108, respirations 13 and blood pressure was 124/88. O2 saturation was performed, the results were 92% on room air (borderline hypoxic); and 100% with blow-by oxygen. The examining physician indicated that the child appears to have a nonfocal neurologic examination; he is not talking and does not open his eyes. He appears to be in an altered level of consciousness. He expresses local pain and thrash around when being probed; moves all extremities. The child sits right up when bending his neck, thus, demonstrating a stiff neck. A DIC panel was ordered; the results were not yet available. A spinal tap was performed, 3cc of purulent cloudy fluid was obtained. The cerebrospinal fluid results were grossly abnormal. Laboratory tests were performed which yielded the following results: CSF white cell count 7880; neutrophils 98% with intracellular bacteria present; CSF glucose 0 and CSF protein, exceedingly elevated 476. The CSF gram stain showed gram-positive cocci in chains. His blood pressure remained stable about 104 to 107 over 60 to 80. Respirations were in the high 20s, low 30s. Pulse remained between ranges of up to 130, and saturations with the blow-by oxygen remained at 100%. The child was subsequently admitted to the pediatric ICU. An impression of bacterial meningitis was made given the gram stain, probably (group A) streptococcal pneumonia, possibly originating from the otitis media. He was treated with 500cc of intravenous normal saline, Rocephin. Vancomycin, Decadron and oxygen therapy. The reporter indicated that the boy was slowly improving.
Got shingles 4weeks after 2nd dose; This is a spontaneous report from a non-contactable consumer, the patient. A 52-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 on an unknown date as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient experienced shingles 4 weeks after the second dose. The patient underwent COVID-19 test (nasal swab test) on an unknown date and the result was negative. Therapeutic measures were taken as a result of shingles. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event shingles was recovering at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Diarrhea, loose stools a few times a day w/o bloody/melenic stools. Nausea w/o vomiting.  Urticarial rash.
Day after injection, tired, arm sore & redness, all went away. On Day 8 2"x2" raised red patch on skin, Day 14 patch is larger with welts and itches. No medicine taken or applied.
felt dizzy; VIRAL INFECTION FOLLOWING; This case was reported by a physician via sales rep and described the occurrence of dizziness in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and MENACTRA for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Influenza vaccine Quadrivalent unspecified season and MENACTRA. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Influenza vaccine Quadrivalent unspecified season, the patient experienced dizziness and viral infection. On an unknown date, the outcome of the dizziness and viral infection were unknown.   The reporter considered the dizziness and viral infection to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the dizziness and viral infection to be related to Influenza vaccine Quadrivalent unspecified season.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by the mother. The age at vaccination was not reported. The patient felt dizzy, followed by viral infection. The mother of the patient looked up Meningococcal B and was convinced that it was pulled up adverse reaction. She did not want to report it because it was 3 vaccines. It was unknown if the reporter considered the dizziness and viral infection to be related to Menectra. This case had been linked with US2020AMR261157 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR261157:Same reporter
foot numb from  shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (foot numb from  shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (foot numb from  shot). At the time of the report, HYPOAESTHESIA (foot numb from  shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided.
My right arm was sore for 3-4 days after the vaccination, but had stopped; then 7 days after vaccination, my right arm began to itch, and be sore again- and tricep area is swollen,  reddened, and warm.  I have felt general fatigue, but can not relate that to the vaccine, necessarily.
t104.7 or higher w/some irritability the noc p/vax given;
6 hrs p/vax eyes became irritated, red, swollen, shaking chills & fever 102+ lasted 4-6 hrs w/APAP 7 DPH;
At about 7 pm on day of shot, began to feel hot. Took temperature and found it in 99+ range.  Over next few days my fever ranged upwards of 102 degrees F.  It took about 3 days before temperature returned to normal.  Stayed in & out of bed for those days.
Information has been received from a mother concerning her daughter of unknown age. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with M-M-R II (strength, dose, frequency, route and lot# not provided). The reporter stated that after receiving M-M-R II the patient was diagnosed with a "serious issue" on unknown date. The outcome of "serious issue" was unknown. The causality was not reported. The reporter considered the serious issue was medical significant. Additional information is not expected as there is no contact information.
C/O shivers for 2 days after receiving vaccine on 9/1/19, noticed bumps on wrist of right arm. Bumps have continued to increase & are covering 3/4 of her arm. They itch & states had 10-12 bumps currently. Encouraged client to call her PCP to be seen. 9/9/19 Talk to client Left message to return call re condition of bumps on arm & if saw PCP. Client returned call & left message. States she seen her PCP on Friday 9/6/19 & is being treated for shingles. States is taken an antiviral medication & antibiotic medication.
Fever 104(began 1Aug90-2Aug90), screaming X 7 hrs, lifeless
1st dose /around Sept/Oct 2019 / 2nd dose in January 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on around September/October 2019).   In January 2021, the patient received the 2nd dose of Shingrix. In January 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccine schedule. The reporter mentioned that, patient received 1st dose around September/October in 2019. No symptoms reported. The health care practitioner did not have exact administration dates, lot, or expiration dates at the time of report. The reporter consent to follow up.
used sterile water to reconstitute the vaccine; used sterile water to reconstitute the vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 42CM4, expiry date 11th June 2023) for prophylaxis.   On 24th March 2022, the patient received the 2nd dose of Shingrix. On 24th March 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-March-2022 Additional Supportive Information: The certified medical assistant (CMA) stated that the patient came for the 2nd dose of Shingrix and the health care professional used sterile water to reconstitute the vaccine and the dose was administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further information reported. The reporter consented to follow-up via postal.
Prolonged ache in the deltoid that radiates down the arm to the elbow, that is not relieved w/ OTC MOTRIN.
- Rash generalized, worse on buttocks since Sunday, U shaped hive on (L) cheek. Fever 101 - 102 Thursday - Sat.
screaming 25 mins continuously 2-3 1/2 hrs post vax; rt leg swollen & red;
Began to feel fatigued around 4:00 pm, got severely cold at 6pm, teeth were chattering, temperature was 101°.  I fell asleep at about 8 pm because I was so fatigued I couldn?t keep my eyes open. Chills when I was trying to sleep. I was up a few times throughout the night sweating. The next morning I felt nauseous and had a bad headache and my body aches. I felt like this the whole next day and am still completely fatigued.
tried the new one and that one failed too / suspected vaccination failure; tried the new one and that one failed too; 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.   The patient's past medical history included shingles (had Shingles for nearly 3 years but it was getting better). Previously administered products included Shingles vaccine.   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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had Shingles for nearly 3 years but it was getting better. The old Shingles vaccine failed and then patient's doctor tried the new one and that one failed too. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.