chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Certified Medical Assistant concerning a 1 year old male baby who on 11-MAR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. Follow-up information indicated that the new person pulled out zoster vaccine live (Oka/Merck) by accident and the CMA did not check it close enough to see it was the wrong vaccine. No problems have been reported. This is in follow-up to report(s) previously submitted on 6/24/2006. Follow-up information was received which reported that the 12 month old male patient with no illnesses at time of vaccination who was vaccinated SC into right thigh with a first dose of ZOSTAVAX (Merck) (lot # 659325/1823U) on 11-MAR-2008. Concomitant vaccinations included a first dose of MMR II (lot # 657357/1670U) SC into left thigh on 11-MAR-2008 and a fourth dose of PREVNAR (lot# reported as C57539) IM into left thigh on 11-MAR-2008. On 20-MAR-2008 the patient experienced fever 100 C, fussiness and restless sleep. The patient was seen for appointment on 21-MAR-2008. TYLENOL and ADVIL were prescribed for treatment. It was reported that the patient was 16.93 lbs weight and 29 inches height, and has 3 siblings. Laboratory tests included varicella-zoster titer which indicated that the injection was immune. At the time of reporting, patient's outcome was unknown. Follow-up information was received which reported that on 19-MAR-2008 the patient developed a fever, 100 C that lasted for 2 days. On 21-MAR-2009 the patient was seen in office and was afebrile in office. On an unspecified date the patient recovered, it was reported that "no symptoms occurred". On 30-MAY-2008, the titer of varicella-zoster virus (VZV) IgG antibody was 1.61. No further information is available.
1 week from 2nd fax, itchy roof of mouth, sneezing and chilling. Came and went throughout the day for 2-3 days. I had been eating a lot of baked carrots, and wondered if I've developed an allergy to them, so stopped eating them. Hasn't recurred. Only because I today spoke with a friend whose arm at the injection site swelled and itched for several days one week from the injection, did it occur to me to report this as a possible reaction.
swelling & tenderness rt testicle 27APR97;rt testicle double in size;t101-102 ax w/APAP;warm baths 4-6x's/day-APAP;
1 week after injection, tinnitus began in my left ear (same side as injection) and has not stopped since.  No history of tinnitus.
Information has been received from a licensed practical nurse concerning approximately 75 female patients who were vaccinated IM with 0.5ml doses of Gardasil. Subsequently the patients experienced pain at the injection site. Unspecified medical attention was sought. Subsequently, the patients recovered. Attempts are being made to obtain additional identifying information regarding the patients mentioned in this report. Additional information will be provided when available.
Patient's husband reported she had swelling and redness from the injection site to the elbow after receiving vaccine
The next day, both arm muscles hurt then the legs and then cramp on my hamstrings 5-6 leg muscle aches, saw my doctor and he walked me through some exercises. I couldn't walk and after the 6 days I am back to normal.
Within half hour of injection the following symptoms began: Paresthesia on right side neck, face, right arm, right leg.  Symptoms in these locations included tingling, numb feeling, weakness.  These symptoms also spread to left side of face and left arm.  Half hour after injection nausea and spinning sensation.  Went back to clinic that administered the vaccine, we were in the same area of town, and the nurses on site took blood pressure which took them time to figure out how to use the arm cuff, and had me sit down.  they tried unsuccessfully to text message and get ahold of their advising nurse practitioner on the phone and were unable to get her to answer.  they said there was nothing they could do at that time.  I called a doctor for an on phone consult and was told to take Benadryl 50ML and ibuprophin.  The symptoms continued to be present.  The next morning when symptoms were still present at 9am i was treated in the emergency room.  24 hours after the injection still tingling and numbness in face, arm, leg,  as well as occasional sharp pains in neck.  Overall 6/10 pain at rest, 8/10 pain upon movement of right arm.  I feel as if dental Novocain was injected into my face and body.
Patient described a loss of hearing following vaccination and for the day afterwards.  The issue resolved on day 2 post vaccination.
Pt was seen in our clinic on 26AUG22 over concerns for an adverse event from the vaccine. PT has induration and erythema at the injection site starting 24-48hours after the vaccination, that has persisted now for 10 days.  PT advised the staff that he formed keloids and had eczema and was told he need the shot subcutaneously, but the patient reports that the technician gave the shot intradermally.   The condition is slowly improving, it is still to soon to say if the patient will scar (keloid) from the injection. which will require further treatment.
Fever, chills and joint pain that lasted 2 days after the vaccine. Severe fatigue and shortness of breath that lasted 10 days after the vaccine.
ROUGHLY A MONTH AFTER VACCINE  HAD A SERIES OF SINUS INFECTIONS  AND STILL STRUGGLE WITH A TON OF SINUS PROBLEMS
Narrative:  Patient stated that he had chest pain after receiving 2nd dose of moderna vaccine. No lot or expiration information list in patients chart.
I had fairly severe flu like symptoms within 8 to 10 hours or so after the booster (3rd) shot of the same type (Pfizer) Covid vaccine. I had zero side effects from either of the first 2 shots in my series of 3. They have all been properly spaced apart, the first shot given 1/29/21 second 2/19/21 and the booster given 11/3/21. The reason for this report is that in addition to the flu like symptoms of fever, chills, headache and joint pains I also had and have muscle spasms, electric  pin needle like sensations, difficulty with balance, abnormal headache ((unlike any experienced before) facial twitches. I ha seen a dr and am going to be seeing a specialist.
I had a sore throat, runny nose, muscle aches, difficulty breathing and shortness of breath, and dizziness on 11/29/2022. I decided to take an at-home COVID-19 on 11/30/2022 which came back positive. So I went to my physician on the 1st who gave me another rapid antigen test and came back positive; my physician prescribed me PAXLOVID. My oxygen saturation level was in the mid-80s so my doctor mentioned if it dropped any lower, that I should go to the emergency room. After the course of the prescription, I caught rebound COVID-19 with worse symptoms including weakness/fatigue, fever, congestion and mucus/phlegm, headache, exhaustion, light sensitivity, and skin-touch sensitivity. I went back to the doctor again on 12/12/2022 where they tested to ensure I didn't also have pneumonia, RSV, and influenza; I was given steroids for 3 days for treatment, but it took about 5 days for full recovery.
Nausea, stomach cramps, full body aches, swollen red knot at injection site and extreme lower back pain that has gotten worse after 2nd vaccine shot
From telephone correspondence on 7/2/02 and additional faxed information received on 10/16/02, it was reported that a 37 year old adult female was vaccinated with TD ADS ADULT, lot # U0527AA, on 6/28/02. On 6/28/02 at 6:00 PM, she experienced tenderness and swelling, which lasted for three days. Patient was prescribed Motrin every 6 to 8 hours as needed, and she recovered.
A report has been received from a Health Professional concerning a 1 year 22 weeks 7 days old, Male patient, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 25-NOV-2015. Patient was administered FLUMIST yesterday. Patient does not have any known medical conditions and was currently not on any other medications. Parents of patient had not reported any symptoms post administration. FLUMIST (INTRANASAL) was discontinued on 25-Nov-2015. The outcome of the event of INADVERTENT ADMINISTRATION was unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between INADVERTENT ADMINISTRATION and FLUMIST.
Inflammation; Pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) and PAIN (Pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    Concomitant products included PREDNISONE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced INFLAMMATION (Inflammation) and PAIN (Pain). At the time of the report, INFLAMMATION (Inflammation) and PAIN (Pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown dates, the patient experienced inflammation and it was systemic so deals with it all in body, slept twenty hours because it was the only thing. Patient do to bear pain was dealing with and had all three covid vaccines still had no antibodies in system. Moderna vaccine was also considered suspect.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  On an unknown date, patient received covid-19 vaccine manufactured moderna.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
H1N1 injection administered on 10.23.09. Patient became ill 5 days later with pneumonia. History of pulmonary hypertension. PICU.
PATIENT BRIEFLY PASSED OUT AFTER RECEIVING VACCINES.  CAME TO WITHIN 30 SECONDS.  EMS WAS CALLED AND CAME AND CHECKED PATIENT AND OK HIM TO LEAVE.  NO MEDICATIONS OR ANYTHING WAS GIVEN.
post nasal drip; Headache that comes and goes; 105 Fever; Has taste of pennies in his mouth; Lost sense of taste; Sinuses burned very badly all day like he had salt in his sinuses; Arm swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up), SINUSITIS (Sinuses burned very badly all day like he had salt in his sinuses), PYREXIA (105 Fever), HEADACHE (Headache that comes and goes) and DYSGEUSIA (Has taste of pennies in his mouth) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0388821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm swelled up). On 12-Apr-2021, the patient experienced SINUSITIS (Sinuses burned very badly all day like he had salt in his sinuses). On 19-Apr-2021, the patient experienced PYREXIA (105 Fever), HEADACHE (Headache that comes and goes), DYSGEUSIA (Has taste of pennies in his mouth) and AGEUSIA (Lost sense of taste). On an unknown date, the patient experienced UPPER-AIRWAY COUGH SYNDROME (post nasal drip). On 19-Apr-2021, PYREXIA (105 Fever) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm swelled up), HEADACHE (Headache that comes and goes), DYSGEUSIA (Has taste of pennies in his mouth), AGEUSIA (Lost sense of taste) and UPPER-AIRWAY COUGH SYNDROME (post nasal drip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt informed me that she usually passes out during shots.  I informed her to sit down and we will wait 10 minutes. i gave her shot she said she felt woozy but okay about 30 seconds later she passed out.  i was there to make sure she didnt fall out of her seat.  i gave her some water and kept her under supervision for about 10-15 minutes. patient left on her own accord
Fever to Tmax of 103, soft tissue swelling, erythema, and warmth of overlying skin at site of vaccine administration.  +Fatigue.
No Adverse event; 3 doses administered from vials that underwent a temperature excursion; 3 doses administered from vials that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 22-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Sep-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses administered from vials that underwent a temperature excursion). On 22-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses administered from vials that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion).    No concomitant medication information was provided.  No vaccines in this lot have been administered since the temperature excursion.  Date of excursion was 02-Sep-2022 and duration of the excursion was1 hour. There were no remaining doses. Storage condition at the time of the excursion was frozen storage. Individual vials or unbroken cartons was in the box. Vial size was 2.5 ml. Maximum or minimum temperatures reached was max minus 12.5°C. No date was provided for vials moved from freezer to refrigerator. Visual inspection showed no change in any vaccine state. Vial does not undergo any temperature excursions.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654338, US-MODERNATX, INC.-MOD-2022-654059, US-MODERNATX, INC.-MOD-2022-654306, US-MODERNATX, INC.-MOD-2022-654318, US-MODERNATX, INC.-MOD-2022-654323, US-MODERNATX, INC.-MOD-2022-654332 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter US-MODERNATX, INC.-MOD-2022-654059:same reporter US-MODERNATX, INC.-MOD-2022-654306:same reporter US-MODERNATX, INC.-MOD-2022-654318:same reporter US-MODERNATX, INC.-MOD-2022-654323:same reporter US-MODERNATX, INC.-MOD-2022-654332:same reporter
Ulcerative colitis flare up within 3 days of vaccine.  Had been in remission fornearly 2 years.  Got vaccine on 4/20/21, in hospital on 5/19/21.
Initial unsolicited report received from a non-healthcare professional (medical assistant) on 8 SEPTEMBER 2015. This case involves a 13 years old male patient who was vaccinated with a first dose of FLUZONE QIV (batch number UI431AB, expiry date: 30 JUNE 2016) in left deltoid on 1 SEPTEMBER 2015. Illness at time of vaccination, birth defects and medical conditions were reported as none. The patient was allergic to "peanuts tree nuts bananas", and history of egg allergy as an infant. Any other vaccinations within 4 weeks of vaccinations were reported as none. On 1 SEPTEMBER 2015, one hour following the vaccination, the patient began to feel ill and at 11 PM at same night the patient also had chills, body aches, scratchy throat, runny nose, and low grade fever up to 100.5 Fahrenheit. Laboratory investigations were reported as none. The physician advised to treat patient symptomatically with over the counter medications. On 3 SEPTEMBER 2015 AM, 3 days (reported as Symptoms lasted about 24 hours  after onset the patient was recovered from the events. It was reported that, the Allergist felt the illness was coincidental not allergy or vaccine related. List of documents  held by sender: none.
My girlfriend's husband lost hearing in one ear after he got the vaccine; This is a spontaneous report from a contactable consumer. This is 3rd case out of 3 cases. This consumer reported for a male patient (reporter's girlfriend's husband) that, A patient received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as a Dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter Stated, that the patient lost hearing in one ear after he got the vaccine so, on an unspecified date. Reporter seriousness for the event was Unspecified. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021694995 Same reporter, different drug/patient/ AE
Rash mild lower on SAT. Given Diphenhydramine 50 mg, Epinephrine 0.3cc.
Extreme increase in appetite; Extreme increase in appetite causing what seems like hypoglycemic episodes if hunger is not satisfied; 50-100% in food intake to satisfy hungrier throughout the day; Body shakes; Nausea; General unwell feeling will continue until a large meal is eaten; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 29-year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 21Dec2021 (Lot number: 3035BA) at the age of 29 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient did not receive any concomitant medications. The following information was reported: INCREASED APPETITE (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Extreme increase in appetite"; HYPOGLYCAEMIA (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Extreme increase in appetite causing what seems like hypoglycemic episodes if hunger is not satisfied"; HUNGER (non-serious) with onset 28Dec2021, outcome "not recovered", described as "50-100% in food intake to satisfy hungrier throughout the day"; TREMOR (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Body shakes"; NAUSEA (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 28Dec2021, outcome "not recovered", described as "General unwell feeling will continue until a large meal is eaten". The events "Extreme increase in appetite", "Extreme increase in appetite causing what seems like hypoglycemic episodes if hunger is not satisfied", "50-100% in food intake to satisfy hungrier throughout the day", "Body shakes", "Nausea" and "General unwell feeling will continue until a large meal is eaten" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of increased appetite, hypoglycaemia, hunger, tremor, nausea and malaise.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19.
MINIMAL TENDERNESS AT SITE AND YET NO WARMTH AND NOT INDURATED YET REDNESS ODDLY IS IMPRESSIVE --5 X 6 CM
Myalgias, Fever, Neck Pain Headache, Arthralgias, Chills, Diarrhea
Flu vaccine 9/30/20 On Oct, 16, 2020 developed fullness in ears & filling of fluid in Ears x 2 days (-) fever (-) pain, developed vertigo & dizziness Oct, 17, 2020 continued on Oct 18th with vomiting so went to ER. CT scan Negative given nausea meds meclizine, ondansetron & valium Symptoms subsided will follow up with her ENT
Rash all over body, fever, diarrhea, behavioral changes, 7 to 12 days after vaccines was given. Pt was given Benadryl and D/C all other meds.
Initial and follow-up information has been received from a physician concerning a 19 year old female with a penicillin allergy who on 12-SEP-2007 was vaccinated with GARDASIL.  On 08-OCT-2007 the patient was found to be pregnant.  The patient plans to terminate the pregnancy for non medical reasons.  The patient's outcome is unknown.  On 20-OCT-2007 the patient had an elective termination 8 7/8 weeks from her last menstrual period.  Upon internal review the elective termination was considered to be an other important medical event.  Additional information has been requested.
sudden onset of these:  Shortness of breath, fatigue, chest pressure,  chest pain, greatly reduced stamina
Chest Pain, Nausea, Fatigue, Dizziness,   Diagnosed with Pericarditis, Prolonged QT Interval, Microcytic anemia.  Visit to the cardiologist to occur for a follow up on 6/22/2021.  Reporting due to news reports about Pericarditis being linked to Pfizer vaccine.
DIAGNOSED WITH DIABETES WITH HBA1C OF 8.5 in August 2022.
Had Hep B / Tdap in (L) arm and Varicella and MCV (R) arm. (R) arm with sl. erythema afternoon of vaccines and left arm similar and since then worsened to swelling, pain and redness of (L) arm. No fever.
Nausea, foggy brain, all joints and muscles very sore.  Injection site very sore.
Fever to 102-103 X 24 hours, accompanied  by fussiness. A follow up report received 9/20/2002 adds: No site reaction documented. Tylenol used.
Pfizer-BioNTech COVID-19 Vaccine EUA. Rec'd Pfizer-BioNTech COVID-19 Vaccine on 1/22/2021 and 3/3/2021. Presented to ER on 7/15 w/low grade fever, chills, runny nose, sore throat, chest tightness, and SOB, Covid+. Admitted for Covid PNA. CXR w/Cardiomegaly and improving patchy bilateral pleural effusions. CT of the chest Volume overload. Transferred to ICU for worsening hypoxia. Continuous BiPAP support, but no improvement and remained hypoxemic and encephalopathic. Transitioned to DNR. Expired 8/4/2022. Pt received cefepime, vancomycin, metronidazole, dexamethasone.
Pt recvd 1st dose of vax 7AUG92 & several hrs following vax pt devel nausea, red itchy skin, hives, heaviness in chest, sl SOB; presented to MD office & treated w/DPH;