chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 9 year old female with an unknown past medical history who was vaccination with a dose of varicella virus vaccine live. On 07/31/03 the pt developed 200 pox and fever of 103 degrees. No treatment was provided. It is unknown if the pt recovered. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Extreme/Unbearable Joint pain; Extreme/Unbearable Muscle pain; Extreme Fatigue; high fever; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 17May2021 at 10:00 AM (at the age of 31 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included arthritis, neuropathy peripheral, behcet's syndrome. The patient had known allergies to penicillin. Concomitant medications in two weeks included gabapentin; baclofen, ibuprofen; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 07Jun2021 patient experienced extreme/unbearable joint and muscle pain, extreme fatigue, high fever. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 12Jun2021 at 10:00 AM for covid-19 immunisation. The patient did not received treatment due to the events. The outcome of events was recovering.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
108 degree fever this AM, treated with ibuprofen and tylenol and ice, headache
This spontaneous report was received from a male patient of unknown age, reporting on himself. On an unkonwn date the patient was vaccinated with a dose of GARDASIL (dose, route and lot# not provided). The patient reported that he received the GARDASIL vaccine at age 34, which was other than indicated in the prescribing information (Inappropriate schedule of drug administration). No adverse effect was reported. Additional information is not expected as there is no contact details information.
Swollen painful lymph node in armpit and another between armpit and elbow; Swollen painful lymph node in armpit and another between armpit and elbow; Fever of 100 degrees; Deep muscle pain in small areas that lasted few seconds, moved from one part on body to another; Headaches; Congestion; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9269) via an unspecified route of administration on 05Feb2021 at 13:30 (at the age of 66-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism and pre-hypertensive. The patient had COVID-19 prior to the vaccine on an unknown date. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included HCTZ and levothyroxine sodium (LEVOTHYROXIN) from unknown dates for unspecified indications. The patient previously took penicillin from an unknown date for an unknown indication and experienced allergy. On 05Feb2021 at 14:30 the patient experienced swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcomes of swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
flu like sx, diarrhea every 3rd day, forgetful, h/a, ache joints, dizziness, SOB, shakes;
Body aches (across entire body); Chills; Sore arm where injected; Lethargy/ need to sleep; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) on 29Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. It is unknown, if the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown if the patient got tested for COVID-19.  On 30Mar2021 at 06:00, the patient experienced body aches (across entire body), chills, sore arm where injected and lethargy/ need to sleep. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of body aches, chills, sore arm and lethargy.  The clinical outcome of the events body aches, chills, sore arm where injected and lethargy was recovered on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/ batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: reporter reported for brother, patient name removed from reporter tab, and reporter address detail removed from patient tab.
On December 26, 2022, I had a runny nose and sore throat and tested positive for COVID-19.  I was able to pick up a prescription for Paxlovid.   I felt extremely fatigued and for a few days.  My respiratory symptoms continued.  As of today, I feel better but continue to have chest congestion.
Day after receiving my second vaccine, I had a high fever and chills.  On the second day the fever was lower, around 100 -101 F, but the fever persisted for 7-8 days at 99-100 F.  No other significant symptoms other than those associated with the fever, low energy, etc.  Other than reduced activity and acetaminophen, I rec'd no other treatment.
Patient was given expired vaccine. When informing the patient of error, patient did not report any adverse effects.  Will be coming in to be revaccinated.
Mother called after hours hotline number and complained of rash to child's back, "red dots like ink pen, ". Sent to ER, examined by ER doctor, who felt that it was possibly caused by immunizations, no other apparent cause found.
Patient stated his lips felt a bit "tingly" after injection. Had been for about 10 minutes but was getting better. Vital signs BP 138/80, SPO2 96% respirations 14, pulse 89bpm. No swelling of the lips or difficulty breathing noted. Pt denied any other symptoms.  Patient monitored for an additional 20 minutes. Stated that tingling had resolved. SPO2 at 98% and pulse at 86.
I have not had my period since receiving the first dose of the vaccine on 4/28/21. My cycle is usually extremely regular and it is unusual for me to have any variation.
Per report from patient's mother, the date after he received his vaccinations, he became severely depressed for 3 months.
I woke up with intense itching at n my head and stomach the morning after my injection and had intense itching the rest of the day and evening then I experienced a racing heart feeling that prompted me to take my blood pressure with my husband high blood pressure machine it said 104/69 with 88 for my heartbeat then the intense itching has continued til today April 9 although it?s not as bad as it was the first couple days and after contacting my drs office yesterday April 8, 2021 I was told by nurse to try Benadryl and it did seem to help a bit
Diarrhea; I had very dark black stool; Feeling of being unsafe like mentally mind just got blank and I became very emotional; I am still not right and tired; haven't got my previous stamina back yet; Injection site burning and my arm was burning; arm started to hurt; arm was burning; Dizziness; Weakness; Shortness of breath; Neck stiff; Headache; Chills; Joint pain; Fever; Stomach pain; Muscle pain in arm; arm started to hurt; Nauseous; Feeling of being unsafe like mentally mind just got blank and I became very emotional; Feeling of being unsafe like mentally mind just got blank and I became very emotional; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 61-years-old via an unspecified route of administration, administered in Arm Right on 25Jul2021 (Batch/Lot Number: FA7428) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included addison's disease from Dec1999. Concomitant medication included hydrocortisone (CORTEF) taken for addison's disease, start and stop date were not reported. The patient reported that on 25Jul2021, she was still not right, she was still tired. She had not gotten her previous stamina back yet. She experienced burning at the injection site and her arm was burning. She had dizziness, weakness and Shortness of breath. She had a very stiff neck, severe headache when she got home she was experiencing tiredness, chills, joint pain, Fever and Shortness of breath continued. She was getting stomach pain, stiff neck continued and then her arm started to hurt. She had muscle pain two days in the arm. She got nauseous then she got severe diarrhea for two days. When diarrhea stopped she had very dark black stool. She also have a feeling of being unsafe like mentally her mind just got blank and she became very emotional and she have been advised not to take the second vaccine. The events occurred on 25Jul2021. The patient underwent lab tests and procedures which included blood test: tested Covid negative before she got the vaccine but before she did the both she did the rapid. The other blood test that takes longer, she had done both test prior to the vaccine and sars-cov-2 test negative: negative on unspecified dates. The patient recovered from diarrhea on an unspecified date but did not recover from the other events.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a Pharmacist, via a company representative, referring to two patients of unknown ages and genders. Pertinent medical histories, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with ZOSTAVAX injection (dose, route, anatomical location and lot # were not reported). On an unknown date, "a month after vaccination", the patients had an outbreak of shingles. A product quality complaint was not involved. At the time of reporting the outcome of herpes zoster was unknown. The reporter did not provide the causality assessment between the outbreak of shingles and ZOSTAVAX. Additional information has been requested.
severe depression with crying flu symptoms: chills, fever, nausea, GI upset, full body aches, sensory impairment, fatigue
Swelling in armpit of the injection arm.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-health care professional).  A 49-years-old male patient received third dose of bnt162b2 (BNT162B2, Batch/Lot number: Unknown) intramuscular, administered in arm left, administration date 07Dec2021 09:30 (at the age of 49 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included Bnt162b2 (DOSE NUMBER: 2, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 08:45 AM, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 09:30, outcome unknown; INJECTION SITE SWELLING (non-serious) with onset 08Dec2021 12:00, outcome not recovered. Therapeutic measures were not taken as a result of injection site swelling.  The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications were received within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination was not tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from the physician and refers to an approximately 45 year old female subject enrolled in a study. The subject's concurrent conditions, medical history and concomitant therapies were not reported. On 23-JUN-2015 or about that date, the subject was vaccinated with PNEUMOVAX23 (dose, route of administration and anatomical location were not reported) lot # K018528, which was improperly stored. Action taken with study therapy was not reported. No adverse effects were reported. Additional information has been requested.
Hr12 after injection headache started. Hr24- fever max 100.8, severe headache, chills, body ache. Hr 48 right eye pain started, headache in temple. Hr 60, full right eye red, extreme light sensitivity, pain. Hr 72- sought urgent medical care. Referred to ophthalmology . Diagnosis of episcleritis. Started on steroid eye drops.
I got vaccinated and was hospitalized for a serious breakout, suspected vaccination failure; serious breakout all over my back; Horrific pain; still suffer nerve pain; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization), pain and nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve pain to be related to Shingles vaccine.  Additional details were provided as follows:  The case was reported by the patient for himself/herself. The age at vaccination was not reported.  The patient got vaccinated with the Shingles vaccine and was hospitalized for a serious breakout all over the back and horrific pain. The breakout was healed but the nerve pain persisted at the time of reporting. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.
Case number PHEH2015US020168, is an initial spontaneous report received from a healthcare professional (medical assistant) on 07 Oct 2015. This report refers to a 66-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with expired FLUVIRIN (batch number: 1413901 and expiry date: not reported) at a dose of 0.5 ml intramuscularly on 06 Oct 2015. No adverse event was reported following this administration error.
FEVERS REQUIRING MOTRIN AND TYLENOL GIVEN ALTERNATING EVERY 4 HOURS.  THEN 05/30/2014 0900 THROAT SWELLING UNABLE TO SWALLOW WATER OR PILLS.  FEELING OF SWELLING OF THROAT AND TAKEN TO ER.  ANGIO EDEMA OF THROAT.
Moderna Dose 1 2/25/21 (023M20A) Moderna Dose 2 3/30/21 (003B21A) Moderna Dose 3 10/26/21 (939905) COVID Positive 1/17/22  1/17/22: This 80 yo F patient with a history of hypertension but no known heart disease had fallen yesterday, slipping on the ice.  She finally went to the emergency room today where they found left intertrochanteric fracture.  The patient did not pass out and did not obviously hit her head or sustain any neck or back injury.  She has not had any pulmonary symptoms, specifically no fever, chills, cough or shortness of breath.  The chest x-ray in the emergency room suggested a possible right upper lobe infiltrate.  She was given antibiotics but I am not convinced this is an infectious infiltrate, and I do not think it should postpone her surgery.  She has been active and is busy caring for her chronically ill husband, and has experienced no exertional chest pain, shortness breath, palpitation or syncope.  She does not have frequent falls.  She is not on any oral anticoagulants or blood thinners.  She has no history of blood clots, GI bleeding, seizures or other major medical problems.  1/19/22: The patient is a pleasant 80-year-old female with past  medical history of hypertension who presented to the emergency department 1/17 w/ chief complaint of left hip pain and fall.  Patient had slipped on the ice 2 days prior.  Patient was found to have a left intertrochanteric hip fracture. Patient was admitted and  underwent open reduction internal fixation intertrochanteric femur fracture with left hip intertrochanteric nailing 1/17. Patient was incidentally found to be COVID positive on admission. Patient was asymptomatic. Patient did well postoperatively working with PT/OT. Was cleared for discharge home by orthopedics. Will go home with home PT & OT, 21 days lovenox, PRN pain medication.
I had episode of vertigo once a month after the vaccine. Normally I don't get vertigo that often. I would get it like once a year prior to the vaccination, but never so were I had to go to bed. On 05/23/2021 , I woke up, around 5:00 AM  and the whole room was spinning. I told myself to go back to sleep maybe when  I woke up it would be gone, but it was more intense. I could not roll over without having severe reflex  vomiting's. I called the hospital and they told me if I couldn't get out of bed to call 911. My husband came in and said I was very green. I called 911.  The paramedics came in and I couldn't roll over without severe reflex vomiting if I tried to move.  I had to keep my eyes closed the whole time because I  couldn't look at anything  because it was continually spinning. The paramedics slid a carrier under my body , it folded up like a taco as they carried me out. They took me to the ER in the ambulance. In my house the paramedics gave me a fast acting anti nausea medication that dissolves on your tongue.  I was given meclizine, scopolamine patch, and something else but I don't remember when I got to the hospital. I was given an IV to keep me hydrated. I still continue to have vertigo at least once a month intermittently and transiently. Only once in late June it has gotten so bad were I had to bed and take Meclizine.
Day of injection through Day 9 no reaction Day 10 post injection site red, warm to touch with mild erythema  Watch and see  I am a medical professional with an RN license
No additional AE/PQC; staff nurse administered a pediatric dose of RECOMBIVAX to an adult patient on 10-AUG-2020 and 12-AUG-2020; pediatric vaccine (0.5mL) 10-AUG-2020 and 12-AUG-2020; This spontaneous report has received from an office employee, referring to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 10-AUG-2020, the patient was vaccinated by a nurse, with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), at 0.5 milliliter (mL) (route of administration, scheme vaccine and anatomical location were not provided; lot number 9794C was an invalid lot number for hepatitis b vaccine (recombinant), expiration date was reported on 13-JUN-2020), as prophylaxis. On 12-AUG-2020, the patient received, by a nurse, another pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), at a dose of 0.5 mL (route of administration, scheme vaccine, anatomical location, lot number and expiration date were not reported), as prophylaxis.  The reporter stated that the nurse assumed that giving the additional dose of the pediatric vaccine (0.5mL) to the patient, to equal one adult dose (1.0 mL), would be sufficient (product administered to patient of inappropriate age and incorrect dose administered). No additional adverse event (AE) were reported.
Woke in night with left arm numbness two days after second vaccine.  Resolved spontaneously, but symptoms returned on 3/18 and progressed to numbness over left arm, leg, trunk and face.  Seen in ED and admitted for observation.  Negative CT head, CTA Head and Neck, MRI brain.  Started on Plavix, Atorvastatin and baby aspirin.  Linq device implanted.
Pt experienced a febrile seizure, fever of 102 on arrival to clinic. Seizure lasting approximately 30 seconds, pt was also lethargic, ibuprofen was given and there was no recurrence.
On May 16, 2021 I went to the ER with a rapid heart beat.  Went to follow up to the doctor. Wore a heart monitor and had another 3 minute event last week of June.  In Late July I had a stress echo that showed an AFIB response.  Had another brief  10 minute  episode  about a week later.   No further episodes until I had my booster  on 10/25/2021.  I had a 10 minute episode  on 11/10/2021.  I have had no episodes since.,
Pt c/o HPV burning, 5 min later c/o feeling light headed pt sat down and seized up, eyes rolled back in head x 45 sec. Pt then reported feeling tired/headache, but over all, pt had Tdap in the past no problem.
Loss appetite, abdominal pain, muscle aches, fatigue, anxiety, insomnia, depression.  DX abdominal ardour, reflux, gasses, dyspepsia. Hypertension, inguinal hernia.  1/20/2010 Extremities numbness.
The day after the vaccine I had autonomic dysfunction: Standing heart rate rising to 95-100 from a sitting value of 74. BP dropping from 138 systolic to 118 from sitting to standing. Never had these issues prior to the second vaccine
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about the concurrent condition, historical medication and concomitant medication. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB, lot # M014923/ expiration date- 17-FEB-2019, lot # M001814/expiration date- 15-OCT-2018, lot no. M027882/expiration date- 14-APR-2019. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day 1, 2, 3 - very painful arm with hardness at injection site and arm felt so heavy had difficulty lifting & using it Day 4, 5, 6 - each day arm feeling less painful Day 7 - hard hot bump at injection site, not aware of bump size, slightly itchy Day 8 - hard hot bump at injection site, now approx 3" in diameter, slightly itchy & painful
3 days after vaccination had acute onset of burning chest pain, worse with lying down and deep inspiration.  Initial EKG was normal but then developed ST changes.  Presented to ED where troponin was elevated to 6259, peaked at 7595.  MRI in hospital was consistent with myopericarditis.  Discharged 6/11/21 on cochicine.