chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick after the 2nd dose; Have been fighting a fever after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after the 2nd dose) and PYREXIA (Have been fighting a fever after the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced PYREXIA (Have been fighting a fever after the 2nd dose). On an unknown date, the patient experienced ILLNESS (Sick after the 2nd dose). At the time of the report, ILLNESS (Sick after the 2nd dose) and PYREXIA (Have been fighting a fever after the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment products were not provided.
Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 66-year-old (non pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown,) via an unspecified route of administration on 16Feb2021 12:30 PM at single dose for COVID-19 immunisation. Patient did not take any other vaccine in four weeks. Patient's medical history included breast cancer and allergies to adhesive. The patient's concomitant medications were not reported. On 17Feb2021, the patient experienced headache, nausea. There was no covid prior vaccination and no covid tested post vaccination. Patient did not receive any treatment. The outcome of event was recovered on an unspecified date.
The patient was referred by her primary care provider's office to receive COVID-19 vaccination. She received her first dose of Pfizer-BioNTech COVID-19 vaccine at approximately 15:07 hrs. Due to her history of allergic reactions to multiple medications (including sulfa antibiotics and ceftriaxone), she was advised to extend her monitoring period to at least 30 minutes post-injection. At around 15:50 hrs I was notified that the patient was feeling a tingling sensation in her throat, itching, and a change in her voice. She was transferred to a stretcher for acute management of suspected anaphylaxis. Airway, breathing, circulation, and mentation were assessed immediately. EMS was called immediately via 911. Her vital signs were obtained, with a BP 168/90 mm/Hg, HR 105/min, RR 24/min. She reported shortness of breath at the time. There was no stridor or wheezing on exam. She appeared in mild respiratory distress. At 15:54 hrs she was given an intramuscular EpiPen injection (0.3 mg autoinjector) in her left thigh. At 15:58 she was given an intramuscular methylprednisolone injection (125 mg) in her right thigh. Immediately after that EMS team arrived and took over her care with plans to administer diphenhydramine intramuscularly, and will transfer to ED for further management. Throughout the event the patient remained awake, alert, and fully oriented.
Fever ranging 99F-102F; This spontaneous case was reported by a consumer and describes the occurrence of   in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient was a term infant who had had an uneventful delivery.  He did develop a fever in the first 24 hours of life, was treated with IV antibiotics but blood culture was negative so IV abx were stopped after 48 hours.  He was monitored for several days and did well.  He was scheduled for discharge and received HepB vaccine 24 hour prior to scheduled discharge.  12 hours after immunization, parents report his fevers returned and he developed a skin rash.  He also had difficulty breathing requiring supplemental oxygen by nasal cannula.  A few days later, he deteriorated dramatically, required endotracheal intubation and started having seizures.  He then became encephalopathic and had cardiopulmonary collapse as well as multi-system organ failure.  An EXTENSIVE work up was done.  No infectious, endocrinologic, hematologic or neurologic cause was found.  He developed massive ascites, hepatosplenomagaly and renal failure requiring peritoneal dialysis.  He had skin biopsies, liver biopsies, bone marrow biopsies in addition to an exhaustive amount of blood work for common and rare disorders-all were negative.  Patient eventually died at 6 weeks of age from Pseudomonal sepsis.  Lab studies showed on DOL #2 showed a normal CBC and differential.  <24 hours after the vaccine, showed severe thrombocytopenia which remained low throughout his hospital course despite twice daily platelet transfusions, etc.  4/11/2008 Autopsy report and Case Summary received for DOD 8/10/2007. Term infant developed fever (T=103'F), respiratory distress and irritability at 4 hrs of age.  Txd with Acyclovir for presumed viral infection, viral cultures (-).  Pt later developed macular rash which resolved. Pt developed fever and increasing respiratory distress ultimately requiring intubation on 7/8/07. Infant became edematous and developed thrombocytopenia and seizures. Transfered to higher level of care. Upon admission pt exibited temperature elevations, twitching, rash, throbocytopenia. Sepsis w/u (-). Pt dx: Bone marrow failure with gram-negative sepsis and renal failure. Deeply purpuric rash noted after admission.  6 wk hospital course was dominated by diffuse edema, respiratory distress, thrombocytopenia and renal failure.  ID consult suspect Neonatal Onset Multisystem Inflammatory Disease (NOMID).   Autopsy revealed anasarca, Pseudomonas pneumonia, multiple hemorrhagic infarcts of the spleen, hypoplastic bone marrow, cholestatic hepatopathy, and marked thymic involution.  Presumed COD:  Overwhemling sepsis.  Contributing COD: Pancytopenia.
Left arm red and swollen 3" x 3", warm/ cold compresses and Tylenol for pain
fever shakes sore arm-RED area by injection site Resolved in about 7 days per client on 10/22/07
Patient received the COVID vaccine in the RA and immediately complained of the pain and stated she felt dizzy, faint, and lightheaded. She said she thought the needle was still in the arm until she felt the bandaid go on and realized it wasn't. She said she felt nauseous, and slouched down in her seat. I went to get a trash can just in case she got sick and she immediately got out of the chair and said she needed to lie down on the floor. We placed her on the pharmacy floor and she said she was having a hard time breathing and her head "felt funny and weird". I retrieved the EpiPen but she said she never had one and didn't want to get it yet. She was conscious the whole time and appeared to be hyperventilating so we never administered the Epipen. She said her fingers were tingly and requested we call the paramedics so we did. They arrived very timely and took over. They took her BP and it was fine. They asked if she wanted to go to the hospital and she said no. She stated she was starting to feel better, she could breath more easily. She  eventually was able to sit up and the paramedics got her to call her son to come pick her up and the paramedics walked her out of the store to meet him.
10 min after pt received immunizations the pt complained about hearing loss, blurry/loss of vision, headache, and nausea.
Feeling drained and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling drained and fatigued) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced FATIGUE (Feeling drained and fatigued). At the time of the report, FATIGUE (Feeling drained and fatigued) outcome was unknown.            No concomitant medications were taken by the patient.  No treatment medications were taken by the patient.  Patient reported that everything was fine on 14 Sep 2021.
To give context to the adverse event, in early November 2020 I was diagnosed with Bell's Palsy of unknown origin on the left side of my face. I was tested for COVID-19 and it came back negative. It resolved itself in about a month. About 8 hours after receiving the COVID-19 vaccine on 3/9/21 (about 6:30 p.m., I started to feel a slight headache. Because I had just had the vaccine, I was trying to avoid taking any pain medication, so I did not take anything for it. The headache got worse throughout the evening, and by 10 p.m. I would describe it as a moderate headache. It was primarily concentrated on the left side of my head towards the front, on my forehead and above the eyebrow. I went to bed without taking any pain medication. About 3 hours later, at about 1 p.m., I woke up, and the headache was much more intense. It felt like all the nerves around the left side of my face, including the nerve along my jaw line leading to the 7th cranial nerve that causes Bell's Palsy, were throbbing. I grew concerned about getting Bell's Palsy again, so at that time I took one ibuprofen Advil. After taking it, the headache subsided, although I continued to have a dull headache throughout the night and the next day.
Pt came in for varicella vaccine.  Was given ProQuad  by mistake.  System is not flagging it as an invalid dose.  Discussed with pt that she received ProQuad.
24-36 hours after injection - fatigue and slept for an extended time. Pain in arm of injection. 3 days after 2nd injection, hives on arms, legs, back, shoulders, tops of hands and feet.  Raised and looked like target hives.  Very itchy.
Extreme headache with severe aphasia, could not speak more than one word together.  Could not write more than one letter.  Rushed by ambulance to hospital to rule out stroke.  Admitted into hospital for 2 days for monitoring.  MRI, CT Scans taken, all normal.  EEG taken, focal slowing observed.  Follow up EEG 3 months later did not show focal slowing.  Epilepsy ruled out.
NEEDLE FELL OFF OF THE SYRINGE; AT GIVING VACCINE THE PATIENT GOT MOST OF IT; This spontaneous report received from a health care professional concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously vaccinated with covid-19 vaccine (unspecified manufacturer) (suspension for injection, route of admin and batch number not reported) dose was not reported for prophylactic vaccination (dose series 1). No adverse events associated with previous covid-19 vaccine (unspecified manufacturer) past vaccination were reported (dose series 1).  The patient received additional covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin and batch number not reported) dose was not reported, 1 total, administered on unspecified date (therapy start date and therapy end date were not provided). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced needle fell off of the syringe (drug delivery system malfunction) and at time of vaccine administration the patient got most of it (Inappropriate dose of vaccine administered). The patient reported while getting the Johnson and Johnson booster the needle fell off the syringe while being administered but she was told that she "got most of it" (dose series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the needle fell off of the syringe and at giving vaccine the patient got most of vaccine administered was not reported. This report was non-serious.
Pt has had a sore arm ever since the injection, it has now been over 2 months.  There is nothing visible on the skin; the pain is all on the interior/muscle.
Little weak; Feels likes he has cold; This is a spontaneous report from a Pfizer-sponsored program  received from a contactable consumer (patient). A 84-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Feb2021 23:30 at single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first single dose of bnt162b2 via unknown route of administration on an unknown date at unknown dose, single for covid-19 immunization. In Feb2021, patient stated he feels likes he has cold, a little weak. The patient not received treatment for the events. The events were as considered as non-serious. The outcome of the events unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a medical assistant referring to a 5 year old male patient. Concurrent conditions and medical history of the patient were not reported. On 14-SEP-2015, the patient was vaccinated in left thigh with dose of improperly stored (Merck) VARIVAX (dose and route were unspecified) lot # L018001, expiration date: 19-MAY-2017. Concomitant therapies included MMR II vaccinated in right thigh and PEDIARIX vaccinated in right thigh. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
The patient's husband presented to the pharmacy with a prescription for Clindamycin. The patient's husband stated at the counsel window that the antibiotic was prescribed by the patient's doctor to treat a swollen arm due to the shingrix vaccine the patient received 6 days ago.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 29Jan2021 as dose 2, single (Lot number: EL9263), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Mellitus Type II" (unspecified if ongoing); "Migraines" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: METFORMIN, start date: Mar2021, stop date: 28Jun2022; TOPIRAMATE, start date: Sep2021; ESCITALOPRAM, start date: Mar2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 29Jun2022 to 03Jul2022.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug Ineffective and COVID 19  and the suspect drug BNT162b2.   The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt developed headache and fever 102F, redness and pain at the site of injection. The headache and fever continued, headache worsened into neck stiffness and pain, and upper extremity joint pain. Pt sought care from emergency room. LP, CXR and blood work negative. Treated with pain medication, ibuprofen and Tylenol. Fever and Headache continued x 8 days total.
This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose of VARIVAX (merck) (lot# unspecified) in her right forearm "under the skin" on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient had received M-M-R at some time in the past. This is one of the two reports regarding the same patient. The other report is 1301SUSA000105. Additional information has been requested.
11:30am-Pt was given Tdap, HPV, & Meningococcal Vaccine while sitting on exam table. Pt stated she felt "lightheaded" following injections and was instructed to lie down, but pt declined. Very shortly after the pt received immunizations, she fainted. As she was moving from sitting to lying down, she actually slumped forward. The drawer holding some books on the exam table was open. She apparently landed onto the drawer first and then rolled off the drawer landing on the floor. The pt awakened immediately upon becoming supine, as Dr. rushed into exam room upon hearing the loud noise. Initially pt denied discomfort but then did discover that she had some discomfort on the dorsal aspect of her R wrist. The pt was observed closely for quite some time and then allowed to sit up. Even when standing after 15-20 min., she was a little lightheaded. Further questioning revealed pt had no PO intake for the entire day. She was given a couple of glass of apple juice and was brought to parent vehicle via wheelchair. Pt mother was instructed to push fluids for remainder of the day and continue to monitor.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 62-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 62, on Mar 14, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), for COVID-19 immunisation. The patient had dizziness, onset Mar 16, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
High Fever (103.4/taken underarm), Behavior/lethargic, Vomiting, Headache.
Shortness of breath, High fever, rash, swelling and pain on arm. Heavy chest pain, headache, tiredness
Pt parent reported that pt was having a difficult time breathing/wheezing. Triage nurse scheduled f/u appt for 11/10 (9:15am) as no immediate need/stress. MD administered albuterol (0.083%)
VAGINAL BLISTERS; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. 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, and batch number were not reported) dose was not reported, administered 1 in total, therapy start date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaginal blisters, and was hospitalized (dates and duration unspecified). The patient symptoms went away after treatment with (dates unspecified) valaciclovir hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaginal blisters. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220141559.; Sender's Comments: V0:20220141775-covid-19 vaccine ad26.cov2.s - vaginal blisters . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recvd vax & 3 days post vax pt exp coughing & loose congestion;addl voice comes & goes;sxs persist
Patient returned call to clinic after leaving. Stated her face was red, she felt like her skin was slightly sunburned and she had a metallic taste in her mouth.  Patient's current location was one block from the clinic and the patient was advised to return immediately unless symptoms were severe. If severe, patient was told to call 911. Patient returned with stable vital signs, a flat circular rash to back and abdomen, and erythematous skin to face.  Patient was treated with 2 injections of 50 mg Benadryl 10 minutes apart.  After approximately 50 minutes of observation, patients skin color returned to normal. Rash was visible but diminished. Patient denied respiratory complaints and remained alert and oriented X3 throughout. Patient was discharged home. Patient later reported no further problems upon return home.
Headache; Fever of 102F; Chills; Fatigue; Nausea; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever of 102F), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever of 102F), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and ARTHRALGIA (Joint pain). At the time of the report, HEADACHE (Headache), PYREXIA (Fever of 102F), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102f 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included None.    Reporter did not allow further contact