chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered on 12/21/2017, on 12/26/2017 patient presented with a fever up to 101 degrees F, symptomatically treated at home by mom and dad with otc antipyretics. On 12/28 patient presented to the office with a measles-like rash.
All over body rash, onset approximately 1.5 days after injection. Began on inside of left bicep in the early morning hours, but had spread to face, neck and upper torso by 10 am 2 days after injection. Went to see physician @ 3 pm same day. Blood pressure was the highest it has ever been: 192/86. Was given a steroid injection and prescribed Hydroxyzine and a steroid cream. Dr asked that I monitor BP and if it came down she would call in a prescription for prednisone.  BP did come down and began taking prednisone yesterday, 3/25/21. Rash has worsened so that the individual red spots have combined to almost completely cover my body in red. I have also experienced extreme fatigue and low grade fever, 99.5 degrees.
No adverse effect reported.; The patient was inadvertently administered a dose of ROTATEQ that had been improperly stored.; Information has been received from a certified medical assistant, concerning a 6 month-old patient of an unknown gender. The patient's pertinent medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported.  On 21-AUG-2019, the patient was vaccinated with one improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number S000961 with expiration date on 19-OCT-2020 and lot number R033255 with expiration date on 26-JUN-2020, administered orally (strength and dose number were not provided), for prophylaxis.  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at a temperature of 48.5 degrees Fahrenheit (°F) for a time frame of 15 minutes, there was a previous temperature excursion of 46.9 °F for a time frame of 5 minutes and the call was because of a data logger.   No adverse effects were reported.
inflammatory response on both cheeks; This spontaneous case was reported by a nurse and describes the occurrence of DERMATITIS (inflammatory response on both cheeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) injection for an unknown indication.  No Medical History information was reported.  In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient started HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) (unknown route) injected to the cheeks and chin area. On 02-Sep-2021, the patient experienced DERMATITIS (inflammatory response on both cheeks). At the time of the report, DERMATITIS (inflammatory response on both cheeks) had not resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.   The patient was injected with Restyane Defyne to the cheeks and chin area. The patient had inflammatory response on both cheeks and symptoms included cheeks would get red, hard and itchy and then resolved. Symptoms of the patient were recurring.   The patient did not receive any corrective treatment.
Pt with submental abscess unknown at time of vaccination presented on 17th with Dx I and d and W Ancef started. 10mn after 2nd dose Ancef developed diffuse pustular rash, and itching, VSS, rash, resolving starting the 19th.
Patient returned to the pharmacy the next day with redness, swelling and warmth at the injection site of her left deltoid muscle.
Strange vaginal discharge unlike any period or spotting. Dark in color and at mid cycle; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of an unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Sep2021 at 18:30 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in Sep2021, the patient experienced strange vaginal discharge unlike any period or spotting, dark in color and at mid cycle. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event strange vaginal discharge unlike any period or spotting, dark in color and at mid cycle was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse concerning a 53 year old female with HIV positive, and history of drug reaction/allergy to VIRAMUNE who on 12-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618F) 0.5 ml, IM into left deltoid at 0930 hours. Concomitant therapy included LUNESTA, CELEBREX, IMODIUM, NORVIR, LEXIVA. On 12-OCT-2006, at 1119 hours, the patient called the physicians office with a complaint of a site reaction stating that it was very painful. The patient reported she had no fever. The patient reported that it go better on 12-OCT-2006 in the evening after taking TYLENOL during the day. On 13-OCt-2006, the patient recovered. The nurse requested a lot check. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Extreme fatigue, nausea, strange headache,  miserable  (all for about 5 hours simultaneously)
pt to ED after being diagnosed positive for COVID; x 3 days worsening SOB, generalized weakness; PMH:  positive for sarcoidosis of lung and GERD; supplemental O2 given; hypoxemia worsened requiring BiPAP; transferred to ICU; intubated; tracheostomy later done but pt began to have fever and hypotension; tracheostomy leak suspected and tracheostomy was removed; reintubated; pt's condition continued to decline; worsening shock; experienced cardiac arrest and unable to be resuscitated; pt died in the hosp
pain on arms; pain on lower back; cannot sleep; joint pain/pain on knees/pain on both shoulders; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on arms), BACK PAIN (pain on lower back), INSOMNIA (cannot sleep) and ARTHRALGIA (joint pain/pain on knees/pain on both shoulders) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046Z1A and 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Surgery (she had knee surgery in March and took Diclofenac at that time) in March 2021. Concomitant products included ATORVASTATIN and CARVEDILOL for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PAIN IN EXTREMITY (pain on arms), BACK PAIN (pain on lower back), INSOMNIA (cannot sleep) and ARTHRALGIA (joint pain/pain on knees/pain on both shoulders). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and DICLOFENAC for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain on arms) and BACK PAIN (pain on lower back) was resolving, INSOMNIA (cannot sleep) outcome was unknown and ARTHRALGIA (joint pain/pain on knees/pain on both shoulders) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She stated she has been living with joint pain ever since second dose. She reports that she was otherwise healthy before the dose. She reports that the joint pain was not as severe and was 4-5 days a week in the beginning but is now all the time. She reported, I look like I'm 90 when I wake up in the morning instead of 64.' She mentioned she will not get the booster.   This case was linked to MOD-2021-406548 (Patient Link).
Arm was sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history concomitant medications were not reported. On an unknown date, patient experienced arm was sore. The outcome of the event was unknown.   Follow-up attempts are completed. No further information was expected.
Left arm bigger than right arm. No redness but warm to touch. No fever 36.7 T. No pain. No complaint from pt.
was administered a dose of ACTHIB with an expired diluent with no reported adverse events; administered a dose of ACTHIB with an expired diluent with no reported adverse event; Initial information received on 21-Nov-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 1 years old male patient who was administered a dose of ACTHIB with an expired diluent with no reported adverse events after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE)and FLUORESCEIN SODIUM  for Prophylactic vaccination.  On 19-Nov-2022, the patient received a Series 4 of suspect HIB (PRP/T) VACCINE(Dose- 0.5 mL, Frequency-Total, Lot Number- UJ60RAAA (HIB), U7172AB (DILUENT) Route- intramuscular route in the left deltoid for Immunization, Expiry date-  23MAR2023 (HIB), 29OCT2022 (DILUENT)(strength-standard) (form : unknown).  On 19-Nov-2022 the patient developed a non-serious events was administered a dose of ACTHIB with an expired diluent with no reported adverse events (product preparation error),(expired product administered) following the administration of HIB (PRP/T) VACCINE.(latency-same day).  Action taken : Not applicable.  At time of reporting, the outcome was Unknown for all events .  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 the 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.
Swelling and redness of the arm within an hour after the vaccine. Tingling began in middle, ring, and pinky fingers within 20 minutes of injection. Numbness began within the first hour. Within two hours, I lost strength and 60% use of my left hand. The pinky and ring finger of my left hand have been either completely numb or tingling ever since my shot over one week ago.   I noticed mild numbness about 3-4 days after the first dose, but assumed I had just slept funny. When my arm became red and hand became tingly after my second dose, I realized this was an effect of the vaccine and not merely a pinched nerve in my sleep.
ascending paresthesia with RLE weakness and decreased tactile sensation; neuro evaluation pending Narrative:
No additional AE reported; Patient was administered a low MMRII Dose on 12/19/2022 due to Corresponding MMRII leaking outside of Corresponding Syringe Needle; Patient was administered a low MMRII Dose on 12/19/2022 due to Corresponding MMRII leaking outside of Corresponding Syringe Needle; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information of the patient's medical history, drug reactions/allergies, concomitant medication and concurrent condition was unknown.  On 19-DEC-2022, the patient was administrated with a low dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (therapy type: recombinant Human albumin (rHA), lot #U039549, expiration date: 14-DEC-2023, strength, anatomical location and route of administration were not reported) prophylaxis due to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) leaking outside of corresponding syringe needle (accidental underdose), (needle issue). Only the patient was exposed to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No additional adverse event (AE) reported (no adverse event).
I got sick from it; I had reactions (voice distorted); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "MS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 29Sep2021, outcome "unknown", described as "I got sick from it"; DYSPHONIA (non-serious) with onset 29Sep2021, outcome "unknown", described as "I had reactions (voice distorted)". Therapeutic measures were taken as a result of illness, dysphonia.  Additional information: Consumer stated, It says Pfizer 3013OHC. Its kind a hard to read if tell you the truth, may be its 301508 something. It's very hard to read.  Follow-up attempts completed. No further information is expected.The lot/batch number is not available despite the follow-up attempts made.
muscle pain and weakness starting 1 day after flu vaccine- Leg/Arms with development of reactive disorders. CK increased 30003, Dx Myositis 9/19/08 Reviewed hospital medical records of 9/9-9/11/2008. FINAL DX: Myositis Records reveal patient experienced progressively worsening muscle pain, weakness, throat soreness & arms tingling.  Tx w/IVF.  Improved & d/c to home.
21 week pregnancy, uncomplicated. Patient had COVID booster then developed urticarial rash 2 days later that did not respond to Benadryl or Zyrtec
This spontaneous report was received from a registered nurse referring to a patient of currently 13 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a medical assistant concerning a 22 year old female with no known medical history and no known allergies who was vaccinated with GARDASIL. Subsequently the patient experienced an unexplainable death.  The mother of the patient found her daughter unresponsive and dead in her bed.  It was noted that this death was reported to VAERS and the death was not caused by GARDASIL.  It is unknown if medical attention was sought.  The medical assistant considered the death to be disabling and life-threatening.  No further information is available.
Information has been received from a nurse practitioner concerning a pt who, "within the past week", on approximately 9OCT2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. "The following day", on approximately 10OCT2003 the pt experienced cellulitis at the injection site and a fever. No further information was available. Unspecified medical attention was sought. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and research and was released. This is one of 3 pts reported by the same reporter. The two other pts experienced injection site cellulitis after vaccination with the same lot. One of the three pts was treated with an unknown abx. Additional information has been requested.
5 minutes after injection started to feel dizzy. Not room spinning dizzy. More like a fogginess. Had a hard time comprehending. Trying to use my brain made the dizziness worse. Was unable to drive.  90 minutes after injection started feeling winded while laying down. Took 25mg of Benadryl at 2hr mark after injection.
Armpit of the arm that had the shot is swollen and hurts.; Armpit of the arm that had the shot is swollen and hurts.; This is a spontaneous report from a contactable consumer, the patient. A 21-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 in the left arm on 23Apr2021 at 10:15 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Concomitant medications were not reported. The patient previously received diphenhydramine hydrochloride (BENADRYL) and experienced drug allergy. On 24Apr2021, the patient's armpit of the arm that had the shot was swollen and caused hurt. It was reported that both swelling and pain were not that bad they were noticeable even when the arm was down and resting. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events armpit of the arm that had the shot swollen and hurts were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE; PEDVAX HIB was improperly stored and administered; This spontaneous report as received from a nurse, who refers to a patient of unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 29-JUL-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # S031500, expiration date 21-APR-2020, for prophylaxis (formulation, strength, dose number, dose, route of administration and frequency were not reported). Digital data logger was involved. The vaccines was stored at the temperature reported as 50 degrees of Fahrenheit (F) for1 hour and 46 minutes. There was no previous temperature excursion. No additional adverse event was reported. No product quality complaint (PQC) involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2008USA000307: US-009507513-2008USA000367:
pt exp swelling site of inject sore; doesn't want to move; had not given APAP p/shot; no fever; applied cold pack in office;
I received the vaccination on Tuesday and on Thursday morning. I started having this fluttering noise in my left ear. It lasts about a minute then stops then starts again.
presents to the ED with complaints of chest pain that started yesterday.  She states she got the first dose of the Covid vaccine in the morning.  Several hours later she started having generalized body aches, fever/chills, shortness of breath, nonproductive cough, and pain in her chest described as a pressure, worse with deep breath.  She states her symptoms have been persisting for about 24 hours, which concerned her so she presented today for evaluation.  She has not taken any OTC medications for her symptoms.  She is a smoker, but states she has not smoked since the onset of her symptoms.  She has a history of SVT that was treated with a cardiac ablation.  No known history of CAD.  No known family history of heart disease.  She did get a flu shot last fall.
tired; coughing; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced coughing two days prior to reporting (03Apr2021) and was very tired on an unspecified date. It was reported that patient did not have any fever and was taking Tylenol for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372956 Same reporter/drug, different patient/event.
Persistent diarrhea x 4-6 weeks. Elevated ALT, AST
This is an instance of breakthrough COVID-19 after which death occurred. The individual received the Moderna product on 02/06/2021, 03/26/2021, and 11/05/2021. They were admitted to hospital on 08/10/2022 for wound care for a non-healing decubitus ulcer. No respiratory symptoms were present but the individual tested positive upon admission to the hospital. Their condition continued to decline and they were discharged to home on 08/15/2022 to receive home hospice care. The individual died on 08/29/2022. It is likely this is an asymptomatic case that was detected incidentally. The individual did not develop any symptoms of COVID-19 at any time.
Lymph nodes swollen to the size of a tennis ball and this lasted for a week and I was prescribed medicine and the swelling went down. The swelling has gone down but not all the way.
Case number PHEH2014US025067, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 52 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 13 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
mom stated around 6PM pt became very lethargic w/a weird cry that last until approx 1030PM on 21AUG95; mom stated pt watched pt & did not take to MD; 25AUG95 930 mom called stated pt was fine & request DT next time d/t other child w/rxn DTP