chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose 1: 31Jan2021 and dose 2: 14Mar2021; dose 1: 31Jan2021 and dose 2: 14Mar2021; Headache; temperature; body aches; sore throat; exhaustion; nausea; difficulty breathing; congestion-sinus; This is a spontaneous report from a contactable consumer (patient) reported in response to non-health care professional letter sent. A 77-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6207, expiration date was not reported), via intramuscular, administered in upper left arm on 14Mar2021 (at the age of 77-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (lot number: EL9263, expiration date was not reported), via intramuscular, administered in upper left arm on 31Jan2021 (at the age of 77-years-old) as dose 1, single for covid-19 immunization. It was reported that on 02Apr2021 the patient experienced severe headache, temperature (101), body aches, bad sore throat, exhaustion, nausea, difficulty breathing, congestion sinus. Onset time: 4 days (as reported). Adverse events required to visit physician office. The patient underwent lab tests and procedures which included covid antibody blood test (sars-cov-2 antibody test): negative on 02Feb2021, Covid-19 (sars-cov-2 test): negative on 08Feb2021, Covid-19 (sars-cov-2 test): negative on 11Feb2021, temperature (Body temperature): 101 on 02Apr2021. No treatment was received for the adverse events. The reporter assessed the case as non-serious. The outcome of the events was recovered on an unspecified date of 2021.  No follow-up attempts are needed. No further information is expected.
Nov. 15, 08 developed left upper face and head tingling and tender to touch. Saw her doctor on Nov. 18, 08 and was put on VALTREX. On Nov.21, 08 developed more symptoms on left eye and was put on PREDNISONE for 7 days, also saw 2 opthamologist. As of Dec. 8, 2008 patient was much improved.
Was diagnosed with granuloma annulare from dermatologist. Had large ring like blisters all over my hands, elbows, thighs and feet. They started small a week after getting my moderna 2nd vaccine and then lasted for 14 days. Originally my primary care physician diagnosed me with hand foot and mouth. I didn?t treat the symptoms except for ibuprofen. Once the symptoms resolved after 14 days, I had one week of rash free hands and then the blisters returned. I still to this day have blisters appear daily and have to treat them with clobetasol ointment topically. Time of course: 5 months.
Onset of bilateral cold extemities, primarily hands, lasting > 1hour, and returning the next morning. On exam, hands cool to touch. No cyanosis, pt reports no loss of sensation or ROM. BP elevated, 160/80, P-64 regular. Pt reports usual BP 116/78. On 11/4/09 BP remains elevated-160/92, hands improved, still slightly cool. Advised to see PCP. Non-smoker.
10/18/13 Pt was given Flu vaccine. Child was not 6 mos of age yet.
Patient Fall as she was getting up from chair, states " I usually fall every time i received any shots", denies any pain or discomfort, BP 91/54 , P59, R22, BS120.
Care giver reports patient experienced hallucinations the night/the next morning of the COVID-19 vaccine. The care giver states the patient is seeing his deceased wife. At the time the second dose was due, the symptoms have not gone away per the caregiver.  The faculty contacted the doctor in regards to the reported side effect, however the doctor did not have a clear diagnoses or assessment regarding the patients condition. The Rph did not administer the second dose due the reported side effects. The daughter of the patient (who has power of attorney) was contacted by the faculty manager and she was okay with not giving the second dose.
Initial report received from a physician on 09 Dec 2009: This report is a medication error. The patient received H1N1 nasal spray on 09 Dec 2009 (MedImmune). A couple of hours later, 0.5 mL, intramuscular dose of FLUVIRIN was administered to the patient. No adverse effects were noted upon administration.
Crying x 6 hrs after appt, then very pale, tired, appearing for 6 hrs after, feeding poorly, slept at night and was improved the next day.
The first dose caused a slight arthritis flare with the first shot; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199, Expiry date: Unknown), via an unspecified route of administration, administered in left arm (reported as left upper arm) on 06Mar2021 (reported as in the afternoon) (at the age of 46-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing crohn's disease (had this for pretty much her whole life) and ongoing arthritis inflammatory (reported as this is related to the Crohns disease). Patient was allergic to several antibiotics: Tetracycline, Penicillin, Cipro, and Bactrim (this was 20+ years ago). Concomitant medications were not reported. The patient previously received flu vaccine and experienced a sore arm, and she even had the pneumonia vaccine 5 years ago with no issues. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. It was reported that patient had blood work before the first dose and it was normal. Reported that the original lab works was done at the end of Feb2021. On an unspecified date in Mar2021, after first dose of vaccination, patient experienced slight arthritis flare. Reported that, It was expected and the doctor told her it would go away and it did. It lasted 48 hours, started a few days after the first dose. Adverse event required a visit to Physician Office. No relevant Family Medical History related to Adverse event. The patient underwent lab tests and procedures which included blood glucose resulted in 80's and thyroid function test resulted 2.0 on an unspecified date in Feb2021; blood glucose resulted 108 and thyroid function test resulted 6.2 on 10May2021. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Patient called to report "breaking out in chicken pox" on both arms after ZOSTAVAX - at least 40 spots on arms only.
1st dose -- sore arm 2nd dose -- developed a fever (100.2) with chills, lots of body aches, and skin sensitivity, especially on the trunk -- feels like a sunburn. No rash and fever responded to ibuprofen. Feel significant exhaustion today (day after) and skin sensitivity is less but still present. I had shingles prior to this (about 6 years ago) and had a deep tissue massage yesterday afternoon (I have them regularly).
Pt fainted 30 seconds after injection. Injection site was swollen + red after vaccination but looked normal 2-3 min later. Pt. Fell to floor + stayed their for 30 seconds. She regained consciousness after 10 seconds. EMS called. Vitals/EKG ok Felt nauseous for awhile afterwards
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Arm is still very sore; It is painful; Unable to reach above his head; I am losing range in it; I can''t reach certain ranges with it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is still very sore; It is painful"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "Unable to reach above his head; I am losing range in it; I can''t reach certain ranges with it".  Additional information: The patient had received his second dose of the Covid-19 Vaccine about five months ago and his arm was still very sore and he was unable to reach above his head. So, he wanted to know, how long was the sore arm come to normal and whether, he needed to be transferred to medical information as well. Consumer stated, his arm wa sore and he was losing range in it and it was painful and he could not reach certain ranges with it. Consumer stated, he did not have vaccination card with him to give the Lot number.   No follow-up attempts are possible. No further information is expected.
s/p vaccine 3 weeks Pt c/o headaches, nausea, vomiting, currently Pt continues to have headaches .
I think the nurse practitioner put the injection too high in my shoulder. Within a couple hours of getting the shot, my upper right arm began to hurt. As the day went on it got worse. By evening it was the worst arm pain I have ever felt in my arm. I could not lift my right arm at all. ( I could lift my hand by bending my elbow but could not use my deltoid muscle). I could not sleep that night due to the pain. I took Tylenol every 4 hours which only slightly helped.  The next day it hurt the same amount - very, very bad. Felt like a truck hit my arm. Had to have my husband help me put my shoes on. I could not drive.  That second night I took more medication. The third day the pain finally subsided for the most part. On day four I was all better.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 23-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of VAQTA which had the lot # N005274, expiration date 03-APR-2018, N008823, expiration date 26-MAY-2018 and N014945, expiration date 31-AUG-2018, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766.
Painful shot...daughter cried. Within a month she had an ultrasound and found mass on left arm where shot had been given. Going to Orthopedic surgeon next week. Unsure if connected however I believe it is.
Difficulty breathing; Cold; Headache; Chills; Extra dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Difficulty breathing), NASOPHARYNGITIS (Cold), HEADACHE (Headache), CHILLS (Chills) and EXTRA DOSE ADMINISTERED (Extra dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung cancer and Vocal cord disorder NOS in 2013. Concurrent medical conditions included Arthritis since 2013, Allergy, Nausea and COPD. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for COPD, PREDNISONE for Dyspnea, ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, OXYGEN, GUAIFENESIN (MUCINEX), MONTELUKAST SODIUM (SINGULAIR), APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BAYER ASPIRIN), PARACETAMOL (TYLENOL ARTHRITIS), ERGOCALCIFEROL (VITAMIN D2), OXYCODONE and ALPRAZOLAM (XANAX) for an unknown indication.    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced DYSPNEA (Difficulty breathing), NASOPHARYNGITIS (Cold) and CHILLS (Chills). 18-Aug-2021, the patient experienced HEADACHE (Headache) and EXTRA DOSE ADMINISTERED (Extra dose). On 18-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose) had resolved. At the time of the report, DYSPNEA (Difficulty breathing), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. Patient took the Fentanyl with saline and Advair 500/50 for COPD. Antibiotics once daily to help clear the lungs and prevent from pneumonia   This case was linked to MOD-2021-294195 (Patient Link).
pt recv vax 12SEP98 & 14SEP98 pt exp a rash w/pruritus;the reporter felt that the pt exp were not r/t vax;pt sought unspecified med attention;
arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis", start date: 2009 (unspecified if ongoing), notes: Pulmonary Langerhans autoimmune of her lungs. States this is why she is high risk. Concomitant medication(s) included: B12 [CYANOCOBALAMIN]; LISINOPRIL taken for blood pressure measurement; OMEPRAZOLE taken for gastrooesophageal reflux disease; PEPCID AC taken for gastrooesophageal reflux disease; SIMVASTATIN taken for blood cholesterol; TRAZODONE taken for sleep disorder. Vaccination history included: BNT162b2 (Dose 1), administration date: 30Jan2021, for COVID-19 immunization, reaction(s): "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised", "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised", "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised", "arm soreness"; BNT162b2 (Dose 2), administration date: 20Feb2021, for COVID-19 immunization, reaction(s): "she got a hive on her face in a different spot on the same side of her face", "arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 19 year old female who was vaccinated with the first dose of the Gardasil. Subsequently, the patient developed malaise all over the body, which lasted for about a month. Unspecified medical attention was sought. Subsequently, the patient recovered from malaise all over the body. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a physician concerning a 19 year old female who on 25-MAY-2007 was vaccinated with the first dose of the GARDASIL. On approximately 25-JUN-2007, the patient developed myalgia, flu-like symptoms, and redness and swelling at the injection site. It was reported that the patient did not alert office to her symptoms until she returned for the second dose of the vaccine. The physician discussed the patient's symptoms with her and decided not to administer the second dose. The patient's symptoms resolved one month after the initial dose of vaccine was administered, on approximately 25-JUN-2007. Additional information is not expected.
This case was reported by a nurse via sales rep and described the occurrence of joint pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced joint pain and fever. On an unknown date, the outcome of the joint pain and fever were unknown. It was unknown if the reporter considered the joint pain and fever to be related to SHINGRIX. Additional details were reported as follows: The field reporter contacted GlaxoSmithKline adverse event line. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient experienced joint soreness and fever for 2 days. The reporter did not provide any additional information as this report was already submitted the occurrences directly. The reporter did not agree to follow up to GSK. This was one of four cases reported by the same reporter.
Muscle weakness within 2 weeks of receiving Covid-19 vaccine. Progressively worse until diagnosis of Dermatomyositis in September. Treatment is prednisone, methotrexate, IvIg infusion.
I tested positive for Covid-19 on April 16, 2023 I experienced sore throat; congestion; headache; exhausted; I was prescribed Paxlovid for my symptoms.
AFTER ADMINISTERING VACCINE, PT START EXPERIENCING NAUSEA, DIZZINESS, VERTIGO AND NUMBNESS. PT WAS CONTINUOSLY MONITORED BY PHARMACIST UNTIL EMT ARRIVED. BY THE TIME EMT ARRIVED, OR VITALS WERE NORMAL, SO PT REFUSED TO GO TO THE HOSPITAL.
ON 5/14/2018, MONDAY, PATIENT RECEIVED AT PREVNAR 13 INOCULATION FROM PHARMACIST IN THE UPPER LEFT ARM IM.  PATIENT EXPRESS SOME "TINGLING" DOWN THAT ARM AS SHOT WAS BEING GIVEN. PHARMACIST WITHDREW THE NEEDLE AND GAVE REMAINDER OF THE VACCINE IN A DIFFERENT SITE ON THE SAME ARM.  PATIENT HAD NO ACKNOWLEDGED DISCOMFORT AT THAT SITE, BUT DID EXPRESS SORENESS AT THE FIRST SITE. PHARMACIST SAW NO INJURY, HAD PATIENT ROTATE ARM, AND ASK THAT SHE REMAIN AT THE STORE, SEATED, FOR A FEW MINUTES TO BE SURE THERE WERE TO FURTHER DEVELOPMENTS. PATIENT DID SIT DOWN, BUT LEFT BEFORE THE PHARMACIST COULD CHECK HER ARM AGAIN, ABOUT 5 MINUTES. PATIENT CAME INTO DRUG STORE AGAIN ON 5/23/2018 COMPLAINING OF DISCOMFORT, SORENESS, AND SOME PAIN IN THE SHOULDER WHERE THE SHOT WAS GIVEN.  NO LESIONS, SWELLING, OR BUMPS WERE PRESENT UNPON PHARMACIST VIEWING. PHARMACIST SENT HER TO HER FAMILY PROACTIVE PROVIDER AT ONCE.
At end of workday, pt felt cold. He went home - got colder. By 745 PM, he was very chilled. He took his BP - 190/100 and decided to go to ER. At ER, temp was 101 w/ BP elevated. Was given TYLENOL. Lab work/chest x-ray done. BP came down as did temp. Discharged from ER.
She felt like if she was going to faint; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 19May2021 as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient received the first dose of the Pfizer BioNtech Covid-19 vaccine on19MAY2021. A little bit ago, today she felt like if she was going to faint, she would like to know if this could be a side-effect from the vaccine.the outcome of the event was unknown.   Information on the lot/ batch number has been requested. Additional information has been requested.
No reported adverse events or side effects; Expired vaccine used; This spontaneous report was received from a nurse concerning a 23 months old patient. No concurrent condition, medical history or concomitant therapy was reported.   On 29-JUN-2021, the nurse accidently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T008698, expiration date 04-JUN-2021; at the dose of 0.5 milliliter, intramuscular) to patient for prophylaxis (expired product administered). The patient had had no reported adverse events or side effects. The nurse confirmed that administered vaccine had no previous temperature excursions.
Woke up shaking, heart pounding.  Had red rash on arm.   Got in to see Dr the next day, ecg results warranted an echocardiogram.  Results came back with a ruptured cord to a mitral valve leaflet.  Have had minimally invasive mitral valve repair surgery on 4/15/2021.
This initial spontaneous case, was received on 13-Oct-2017, by a pharmacist, concerning a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. It was reported that, on an unspecified date, one of the resident was given last year's AFLURIA (TIV) (explicitly coded as expired vaccine used) (dose, route of administration, anatomical location, batch number, expiry date was not reported). The outcome of the event was not reported. The reporter considered this case as non-serious.
Haematemesis; vomiting; This is a spontaneous report based on the information received by Pfizer from MSD (Manufacturer Control No: MCM-002637). A contactable other HCP reported for a 2-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date as single dose for prophylaxis; diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), route of administration, start and stop date, batch/lot number and dose were not reported for prophylaxis; rotavirus vaccine live reassort oral 5v (ROTATEQ), route of administration, start and stop date, batch/lot number and dose were not reported for prophylaxis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced haematemesis on 17Aug2021, vomiting on 17Aug2021. On 17Aug2021, the patient experienced vomiting, and the vomit had visible blood clots (Hematemesis). The patient was admitted to the hospital and was hospitalized for one day on an unknown date. The outcome of the events was recovered on an unspecified date. The reporter assessed the causal relationship between Vaxelis and the reported event of vomit had visible blood clots as not related.  MSD Company comment: Hematemesis was assessed as serious (hospitalization). Considering the current knowledge of the vaccine and the existence of alternative explanations (co-suspect vaccinations administered the same day), the causal relationship between Vaxelis and Haematemesis is assessed as not related.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Haematemesis and vomiting are considered as unrelated to Prevenar 13;  a possibly contributory role of oral rotavirus vaccine live in triggering gastrointestinal reactions might not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate