chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
Expiration date for vaccine lot 3 had been extended and vaccine remained frozen until date of administration.  Vaccine was given 2 days past expiration date.  Moderna consulted and deemed the vaccine viable so revaccination was not necessary.  No adverse effects were reported by patient.
Patient was given Moderna vaccine, but was found that  she was only 17 during billing process.
backache (no fever and no other symptoms); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 10:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 31Mar2021, for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious) with onset 22Apr2021, outcome "unknown", described as "backache (no fever and no other symptoms)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Unconsolable crying for 3 hrs-high pitched, fever 101, local redness-no seizure or staring spells; DT given when pt seen in peds clinic;
received vaccine that was had taken too long in shipping; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 75 years old male patient who was vaccinated with a 0.5 ml dose of vaccine IPV (VERO) IPV (VERO) lot PIA124 (Expiry date 26-Apr-2020) via unknown route in the right thigh.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  It is an actual medication error due to incorrect product storage. It was reported that vaccine that was not valid, it had taken too long in shipping.  It was not reported that if any adverse reaction was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Very significant muscle pain in upper arm.  6-7 on the 1-10 pain scale.  No redness or swelling in the skin.
the vial was initially stored in the refrigerator on 21NOV2022, expiration date of 25NOV2022 and administered on 28NOV2022; No Adverse event; Expired Moderna dose administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna dose administered to patients), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 21NOV2022, expiration date of 25NOV2022 and administered on 28NOV2022) and NO ADVERSE EVENT (No Adverse event) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna dose administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 21NOV2022, expiration date of 25NOV2022 and administered on 28NOV2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna dose administered to patients), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 21NOV2022, expiration date of 25NOV2022 and administered on 28NOV2022) 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 (Expired Moderna dose administered to patients) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 21NOV2022, expiration date of 25NOV2022 and administered on 28NOV2022).    No concomitant medication were reported.  HCP stated that 2 patients were administered a dose of the Moderna COVID-19 after the expiration date of 25-NOV-2022. Monovalent vaccine of Individual vial with Unknown vial size  The vial was initially stored in the refrigerator on 21-NOV-2022. The vial did not undergo any temperature excursions. Patients have not reported any adverse reactions to the dose at the time. No treatment information was provided by the reporter.
Fever; Bone aches; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Batch/Lot number: EW0175) at the age of 34 years as dose 2, 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. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/lot number: Er8732, Anatomical Location: Arm Left), administration date: 02Apr2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s): "Severe headache", "fatigue", "Loss of appetite", "Body ache".  The following information was reported: PYREXIA (non-serious) with onset 23Apr2021, outcome "recovering", described as "Fever"; BONE PAIN (non-serious) with onset 23Apr2021, outcome "recovering", described as "Bone aches"; HEADACHE (non-serious) with onset 23Apr2021, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of pyrexia, bone pain, headache.  No follow-up attempts are possible. No further information is expected.
3/25/2021 THURS 5:30pm  Dizzy, achy, tired. runny nose, congestion, cough. restless night hard to sleep with coughing                                                hard to breathe 3/26/2021    called off work. could not function. same as above... general malaise . by far worst day! weight on chest just want to sleep 3/27/2021    general malaise eased up. less tired...BUT late in day low grade fever and chills. super tired want to sleep 3/28/2021    general malaise lifts a bit. The fever and chills are gone. still stuffed up coughing/hacking up. productive cough with                                 mucus/sputum . 3/29.2021   MONDAY  back to work. still feel "not right"  congestin and coughing BUT feel better energy wise.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided), 0.5 mL, IM.  The physician reported that the patient had deep whelps down her arm as a result of PNEUMOVAX 23 vaccine.  At the time of this report, the patient's outcome was unknown.  It was unknown if the patient sought medical attention.  No laboratory tests were performed.  Additional information has been requested.
I noticed hair loss that was gradual. It is noticeable now. I went to my dermatologist and suggested a medication. I also talked to my PCP about that. I have not been on the medication long enough to notice. I also have a swollen lymph node which is on both sides. This lasted for 6 weeks. I had a mammogram which did not indicate anything. I have also had blood work to check my hormone levels which was normal.
Chills, headache, body aches, fever, nausea, diarrhea, vomiting
Patient was given the 12+ purple top Pfizer vaccine instead of the 5-11 y orange top Pfizer dose.  Patient waited 30 minutes post vaccination in clinic. No reactions or symptoms during this time.
Approximately 1 week after receiving vaccine patient  noticed a itchy/sore rash across back of neck. He assumed it was from poison ivy or brown tail moth so had been treating otc. He went to doctor this week (about 3 weeks after rash originally began) and doctor diagnosed as shingle rash.
Patient scheduled an appointment on 09/12/2019 to report " a knot in his muscle". His mother states it formed shortly after receiving the HPV vaccine the previous month during his annual physical exam. Patient developed a 1.5in x1.5 in mass centrally located in his right deltoid. When pressed it causes him pain.
+ SARS Covid 8/11/2022 (Hospitalization). Dizziness, nausea, vomiting, and mild productive cough.
Within 15 minutes, I began feeling numbness and swelling up the left side of my neck and face (through the jaw and cheek). After this lasted about five more minutes, my heart began to race very rapidly and my body began to shake. I felt dizzy and lightheaded. The numbness lasted for about 4 hours. My heart continued to race on and off for about 3 hours.
11 year old patient was given expired product with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from other helath care professional on behalf of a consumer via Medical Information (Reference number- 00342166) and transmitted to Sanofi 02-Nov-2020.  This case involved a 11 years old patient of unknown demographics who received a suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported, expiry date: 23-Oct-2020) via unknown route in unknown administration site for prophylactic vaccination, on 26-Oct-2020 (Expired product administered).  Relevant medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was a case of an actual medication error due to expired product administered (latency: same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
headache, congestion, loss of taste, loss of smell, sore throat, body aches. starting 12/8/21
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Lot number: ER8735), in left arm and on 11May2021 as dose 2, single (Lot number: EW0173) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Nov2021 as dose 3 (booster), single (Lot number: CILFZIA), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 27Sep2021. The patient was 8 weeks pregnant at the time of exposure to coviD-19 vaccine mrna (mrna 1273). The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 04Jul2022. Concomitant medication(s) included: CALCIUM, start date: 01Sep2021; IRON, start date: 01Mar2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: 16May2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (23May2022) Negative, notes: Had previously tested negative on a home antigen test. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: Symptoms returned (congestion, body aches) today, then tested positive on a home antigen test. Had previously tested negative on a home antigen test on 23May2022. No known allergies.  No follow-up attempts are possible. No further information is expected.
tested positive for COVID-19; Caller would like to can her son still have no smell before receiving the second dose; This is a spontaneous report received from contactable consumer (patient's mother) via a Pfizer-sponsored program . A 18-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Mar2021 (at the age of 18-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that the patient tested positive for COVID-19 after going to college on 04Sep2020 and the patient tested negative for antibodies on 12Nov2020. After receiving first dose, patient tested positive for COVID-19 on 25Mar2021, and patient still have no smell before receiving the second dose. Reporter stated that she would like to know if the patient should stick to the 3-weeks schedule, second dose was scheduled on 07Apr2021. Reporter wanted to know that if the vaccine will give with COVID-19. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Developed a dry constant cough about 12 hours after the vaccine that is getting worse four days later; Constant flashed between freezing cold and boiling hot; Constant flashed between freezing cold and boiling hot; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170) via an unspecified route of administration in the arm left on 07May2021 at 16:30 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The medical history included trigger finger, asthma, allergy to pollen and mushrooms. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included fluticasone propionate (FLONASE), levocetirizine dihydrochloride (XYZAL), amoxicillin (MANUFACTURER UNKNOWN) and ephedrine hydrochloride,  guaifenesin (PRIMATENE), all from unknown dates and for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 15:30 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. On 08May2021 at 05:00, about 12 hours after the vaccination, the patient experienced a dry constant cough, which was getting worse four days later and also had constant flashed between freezing cold and boiling hot. The adverse events resulted in emergency room/department or urgent care. It was unknown whether the patient received any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dry constant cough, constant flashed between freezing cold and boiling hot was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Abrupt onset of excruciating pain in right shoulder and upper arm  followed by  progressive weakness of muscles in the right upper arm and shoulder loss of sensation &  numbness, a sensation of tickling, prickling, or burning on the skin of the right hand #1 and #2 digits and an abnormally unpleasant or painful sensation to a light touch.
body is inflammed; body is completely red; Inflammation in ears and tongue; red line in her front; Chest pain; body is all disfigured; Headache; Hands were swollen; back of my was inflammed; balls at back of my head, red and hot areas; red and hot areas that itched; Inflammation of eyes; Chest pain; a little feverish; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (red line in her front) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfa allergy). Concomitant products included SERTRALINE, BUPROPION, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ZOLPIDEM for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PYREXIA (a little feverish). On 26-May-2021, the patient experienced the first episode of CHEST PAIN (Chest pain), INFLAMMATION (Inflammation of eyes) and ITCHING SCAR (red and hot areas that itched). On 28-May-2021, the patient experienced SWOLLEN JOINT COUNT (Hands were swollen), INFLAMMATION (back of my was inflammed) and INFECTION (balls at back of my head, red and hot areas). On 30-May-2021, the patient experienced SEPSIS (red line in her front) (seriousness criterion medically significant), INFECTION (body is inflammed), INFECTION (body is completely red), INFLAMMATION (Inflammation in ears and tongue), the second episode of CHEST PAIN (Chest pain), WOUND (body is all disfigured) and HEADACHE (Headache). On 20-Apr-2021, PYREXIA (a little feverish) outcome was unknown. At the time of the report, SEPSIS (red line in her front), INFECTION (body is inflammed), INFECTION (body is completely red), INFLAMMATION (Inflammation in ears and tongue), INFLAMMATION (Inflammation of eyes), SWOLLEN JOINT COUNT (Hands were swollen), INFLAMMATION (back of my was inflammed), INFECTION (balls at back of my head, red and hot areas), ITCHING SCAR (red and hot areas that itched), the last episode of CHEST PAIN (Chest pain), WOUND (body is all disfigured) and HEADACHE (Headache) outcome was unknown.            Treatment medications included Injectable steroids, epinephrine, Benadryl and prednisone 20 mg.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Updated medication list and allergies.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Mother called today. States son received FluMist 5 days ago, he has rash noted this am.  Rash is from head to toe, red dots, stomach most noted to be blotchy.  States no fever.
my thyroid TSH level was way out of normal range (32.19ulU/ml). I was exhausted for months after the vaccine and finally got it check in July, when the TSH level was discovered. The only change in my life was the administration of the vaccine.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 24-JUL-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Received the RSV shot as a stand-alone injection. Since the vaccination, the area around the injection site has been red, slightly swollen and itchy, and extremely tender.  This is the 4th day, and the reaction persists. This is a far more pronounced reaction than I've had to any previous injection, including all five of my Covid vaccinations, flu shots, Shingles shot, allergy shots, etc.  Other side-effects - headache, unusual fatigue - cleared after two days (but were still unusual for me, since most vaccinations are non-events that don't have persistent side-effects.
Two days after vaccination patient developed new onset itchy, raised rash over the left arm, chest, face and neck. Clinical signs consistent with eczema/contact dermatitis/atopic dermatitis, but patient does not have a history of these disorders. No shortness of breath, diarrhea, fever, vomiting or other signs of anaphylaxis.
Had an allergic reaction to the Covid shot within seven days after receiving the shot. Fever, huge burns with the breakouts, over half of the body. Inside of the mouth and down throat and lungs affected right now.  Still in progress
Fever of 102, 3 hrs after Pediarix mother took child to hospital where pt was treated for c/o sepsis in a 2 month old.
Pt presented with painful vaginal ulcers bilaterally.   HSV 1 and 2 swab was negative as was a bacterial culture. Ulcer consistent with Lipschutz Ulcer.  Pt also had low grade fever and malaise.  All symptoms started within 24 hours of second dose of the vaccine.
She states after 24hr she had fatigue and a headache and possibly low grade fever then, next day she had fever of 102.5 and 3rd day all was fine.
Shortly after receiving Pfizer Covid vaccine, complaints of lip tingling. Visible swelling of lips. EpiPen IM administered x1. 911 called.  EMS transported to hospital.