chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in subjects of unspecified age and gender who were vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  The reporter noted that this event had occurred in "multiple" subjects, however the specific number was unknown.  Concurrent medical conditions included human immunodeficiency virus infection.  On unspecified dates the subjects received unspecified doses of Twinrix.  At an unspecified time after vaccination with Twinrix, the subjects experienced not responding to therapy and/or decreased therapeutic response (specifics of which were not described).  The reporter noted that this occurs when the subject has a high viral load (HIV) and/or low CD4 lymphocyte count.  The physician assesses titers at an unspecified time after vaccination with Twinrix; if the subject's titers show lack of response or incomplete response, further vaccination with Twinrix may be postponed until CD4 lymphocyte counts have increased.  The reporter noted that this depends on the individual subject and provider's judgment and that different providers manage this occurrence differently in the clinic.  At the time of reporting the outcome of the events was unspecified.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 67 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Low level Back surgery" (unspecified if ongoing), notes: other medical history: Low level Back surgery; "known allergies Sulfa" (unspecified if ongoing). The patient took concomitant medications for allergy relief from 05Aug2022, lot number: NOC 59726-801-12. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Sep2022) Positive, notes: I re tested positive a couple of days after finishing the antivirals. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient felt faint and dizzy, Her right hand started tightening up and she could not move it and it hurt.  EMS was called arrived within a few mins.  Her legs were becoming stiff.  She was immediately taken to the hospital by EMS for possible blood clot.
Patient had a rash resembling measles for two days. She also had a low grade fever with this rash and was feeling generally unwell. We did not seek treatment.
patient received on on 9/11 and the other on 11/11 shingles vaccine and a Fluzone HD, no AE; Initial information received on 06-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ292AB and expiry date:10-Jun-2020) via unknown route in the right arm, on 11-Nov-2019.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient received concomitant therapy with VARICELLA ZOSTER VACCINE (SHINGLES VACCINE) on 11-Sep-2019 and 11-Nov-2019.  It was also a case of actual medication error due to extra dose administered. It was reported that patient received two shots of Fluzone HD in two months. The patient received one shot on 11-Sep-2019 and the other on 11-Nov-2019.   At the time of reporting, 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 holders 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.
Information has been received from a nurse concerning a sixteen year old female patient with no medical history or drug allergies reported, who in November 2007, in France, was vaccinated subcutaneously in the abdomen with a first 0.5 mL dose of GARDASIL vaccine (yeast). There was no concomitant medication. Subsequently the patient complained of having pains in her stomach and nausea after the first dose that did resolve. On 04-DEC-2007 (reported as 12/04/2008), in Geneva, Switzerland, the second dose was given intramuscularly in the arm. No reports of adverse effects were indicated after the second dose. The patient sought unspecified medical attention in the office. No product quality complaint was involved. Additional information has been requested.
78 year old previously healthy female, active. Received Pfizer booster 5/31/22 and was admitted s/p fall and expressive aphasia June 15th. MRI and ct negative. Found to be thrombocytopenic. DDimer high. Platelets <150, PF4 came back negative. Initially thought of as vaccine related ITP. Started on steroids
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received 1st dose of the Moderna COVID-19 vaccine on Jan 28, 2022, after the manufacturer expiration of Jan 21, 2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 020F21A) for COVID-19  immunization. No medical history reported. On Jan 28, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 28, 2022, patient administered expired product (received 1st dose of the Moderna COVID-19 vaccine on Jan 28, 2022, after the manufacturer expiration of Jan 21, 2022). At the time of the report, administered expired product (received 1st dose of the Moderna COVID-19 vaccine on Jan 28, 2022, after the manufacturer expiration of Jan 21, 2022) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
pt recv vax 21JAN97 & 21JAN97 pt devel a red raised, painful inj site;
muscle pain; chills; nausea; tiredness; joint pain; almost completely immobile/she can hardly move/walks slow; loss of appetite; constipation; Feeling unwell; injection pain; This is a spontaneous report from a contactable consumer from medical information team. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: FM9309, expiration date was not reported) via an unspecified route of administration, administered in right arm, on 12Feb2021 12:30 (at the age of 83-years-old), at dose 2, single for covid-19 immunization. Medical history included spinal stenosis causing difficulty walking, arthritis, thyroid (as reported). Concomitant medication included ongoing levothyroxine sodium (SYNTHROID) taken as thyroid medication. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9263, expiration date was not reported) via an unspecified route of administration, administered in right arm, on 22Jan2021 (at the age of 83-years-old), at dose 1, single for covid-19 immunization and had a little sore arm and little woozy. The patient also had flu shot (INFLUENZA VACCINE), on an unspecified date in October (as reported) and experienced sore arm. On an unspecified date in 2021, the day after the vaccination, the patient was almost completely immobile; she can hardly move/walks slow and she experienced loss of appetite, constipation, feeling unwell and injection pain. The patient also experienced joint pain, chills, nausea, and tiredness on 13Feb2021 and muscle pain; started experiencing the muscle problem two days after the second dose on 14Feb2021. The patient had no investigation assessments reported. Therapeutic measures taken included Tylenol or Motrin for pain and Motrin for the other events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain/sore arm following each COVID vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Miscarriage, Tiredness, Tenderness, Medical marijuana therapy in 1994, Cyst removal (Ganglion cyst removal) in 2007, Cholecystectomy in 2017, Tubulization nerve repair in 2019 and Abortion. Concurrent medical conditions included Alcohol use (Eight glasses) since 1994, Tobacco user (Two packs of cigarettes per week) since 1994, Latex allergy (Allergy manifested by scratchy throat, swelling and hives.), Carpal tunnel syndrome since March 2008 and Crohn's disease. Concomitant products included MESALAZINE (APRISO) for Crohn's disease, INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/sore arm following each covid vaccine). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain/sore arm following each covid vaccine) outcome was unknown. Not provided.         It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided.   This case was linked to MOD-2022-589105, MOD-2022-589108 (Patient Link).   Reporter did not allow further contact
2 hrs p/vax mom reports hard crying x 3 hrs p/9SEP92 vax; t102 did not report non stop crying to MD; mom will speak to pvt MD about giving DT-DTP;
pt recv vax 2JAN97 & in JAN97 pt devel OM;tx w/Bactrim;25JAN97 pt devel a rash that was first noted on abd;pt devel two vesicles on back 7 scattered 1-3mm erythematous papules;also devel very fine erythematous pinpoint papules;
Tested NAAT positive for COVID 9/17/21 after being fully vaccinated.
Severe hypotension, bradycardia, chest pain, diaphoresis, shortness of air,. I awoke from sleeping because I could not breathe.  I am a RN and my husband is a nurse practitioner.  I was very symptomatic with chest pain, SOA, diaphoretic.  My husband could not feel a radial pulse but was able to auscultate my heart beat with a stethoscope.  My blood pressure was only reading 55/46 and my heart rate was 44.  I felt as if I was dying.  Over the next hour before calling an ambulance, my blood pressure began to come up.  The symptoms started to improve and dissipate so we did not call an ambulance but fear if I did not wake up I would have died due to the hypotension.    I?m assuming that this would be considered a syncopal episode.
5hr p/vax pt was being held by mom, went limp, crumpled to floor, when falling to floor, hit head then had 30second tonic sz;recovered conscious-was sleepy but had nl mental status;taken to MD for eval-nl exam;
diarrhea; Fever (100-101 C throughout the day; start approx. 9:00 am); Body ache; Nausea; Vomiting; dizziness; Migraine (pm); Head ache (am); Receiving the 3rd injection of Pfizer's COVID-19 vaccine (booster shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 13:10 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: MHx of Migraines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Time of Injection: 2:34 pm, Anatomical location: Left upper biceps, Lot number: ER8733), administration date: 31Mar2021, for COVID-19 immunization, reaction(s): "Chills", "Body ache", "Headache", "Low grade fever", "Severe lower back pain (hard to get up or sit)", "Severe wrist and thumb joint pain", "Tiredness", "Migraine"; Bnt162b2 (Dose 2, Time of Injection: 2:34 pm, Anatomical location: Left upper biceps, Lot number: ER8733), administration date: 31Mar2021, for COVID-19 Immunization, reaction(s): "Severe lower back pain (hard to get up or sit)"; Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 13:10, outcome "unknown", described as "Receiving the 3rd injection of Pfizer's COVID-19 vaccine (booster shot)"; MIGRAINE (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Migraine (pm)"; HEADACHE (non-serious) with onset 27Nov2021, outcome "recovered" (27Nov2021), described as "Head ache (am)"; PYREXIA (non-serious) with onset 27Nov2021 09:00, outcome "not recovered", described as "Fever (100-101 C throughout the day; start approx. 9:00 am)"; PAIN (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Body ache"; NAUSEA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Vomiting"; DIZZINESS (non-serious) with onset 27Nov2021, outcome "unknown", described as "dizziness"; DIARRHOEA (non-serious) with onset 28Nov2021, outcome "not recovered", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Lot # ??3527 (lot number letter not clear on vaccination card).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Extreme dizziness, nausea for several days, now it's intermittent.  Couldn't stand up without help for 5 days - spinning and dizzy.
I received the first injection on 1/4/2021 and had some normal soreness but, it was totally gone in 2 days. On the evening of day 7 (1/11/2021) I developed an red area at the injections site about 8inches by 4inches. The area is hot to the touch and a bit swollen.
I am highly certain my immune system turned against me; shingles infection; a severe herpes simplex one outbreak in my throat; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: FC3182; Expiration date was not reported), via an unspecified route of administration in the left arm on 18Sep2021 08:00 AM (at the age of 37-years-old) as dose 2, single for COVID-19 immunization at an administration facility. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: FC3181; Expiration date was not reported), via an unspecified route of administration in the left arm on 28Aug2021 09:00 PM (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. No other vaccine was received by the patient in four weeks. The patient was not tested for COVID post vaccination. On 21Sep2021, the patient went to an urgent care facility unable to swallow with terrible ear and throat pain only to find out that she had a severe herpes simplex one outbreak in her throat. The patient was prescribed with 4x her normal dosage of valaciclovir hydrochloride (VALTREX). It was reported that normally the patient would never get an infection in her throat; never have before. A week later, starting on 28Sep2021, the patient broke out with severe blisters on her spine running up and down left side of her spine and have been told it was a shingles infection. It was reported that she was highly certain her immune system turned against her after the second shot and wanted to report these adverse infections because they have negatively affected her life. Treatment with VALTREX was taken for the events. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was not recovered.
This case was reported by a nurse via sales rep and described the occurrence of tingling in a adult female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown. It was unknown if the reporter considered the tingling to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. This case described the first nurse's adverse event. A reporter told that 1, 2 or as many as 3, was not even sure, nurses who had the FLULAVAL QUADRIVALENT vaccine experienced side effects outside of clinical trials. On 23rd January 2018, the reporter spoke with nurses at a clinic and the reporter reported some nurses experiencing possible adverse reactions with FLULAVAL. The patient experienced tingling on one side of her face. The unrelated questions from the physician were sent, but that these events had not yet been reported to safety. This was 1 of 3 case, reported by same reporter.
Vaccine date on lot expired. no adverse S&S. Vaccine to be repeated in one month.
Crawling skin and scalp; headache; fatigue; sore arm; general malaise; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Mar2021 09:45 (Lot number: EP7534) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing), notes: Chronic migraines; "post-herpetic neuralgia" (unspecified if ongoing), notes: post-herpetic neuralgia; "allergies" (unspecified if ongoing), notes: allergies; "iga deficiency" (unspecified if ongoing), notes: iga deficiency; "ADHD" (unspecified if ongoing), notes: ADHD; "food allergy" (unspecified if ongoing), notes: Pineapple. Concomitant medication(s) included: ALLEGRA 24 HOUR; FLONASE [MOMETASONE FUROATE]; ALBUTEROL [SALBUTAMOL]; CONCERTA. The following information was reported: FORMICATION (non-serious), outcome "unknown", described as "Crawling skin and scalp"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "general malaise". Therapeutic measures were not taken as a result of formication, headache, fatigue, pain in extremity, malaise. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID Vaccine. It is unknown if the patient has been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446526 same patient, different drug dose/event
Moderna Covid-19 Vaccine --Approximately 4 days after the second dose was administered on 3/1/21, I woke up with a totally weak left leg.  I would have fallen down getting out of bed except I usually first grab a cane because that is also the same leg that I had TKR in about 2 years prior.  I wonder of the vaccine somehow affected the artificial knee--but the whole leg was not able to bare my weight--as if the muscles and tendons were gone.  I used a walker to slowly bring back the leg support over about 5 hours.  I told my knee doctor about this on 3/9/21  and he said one other patient of his who also had TKR 2 years ago (same as mine) told him about the same thing happening to him.  Now I am having a "tight knee" in that same leg and am very worried.
low grade fever (99 F); nausea; headache; chills; This is a spontaneous report from a contactable consumer reported that a 86-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 86-year-old at the time of vaccination), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced low grade fever (99 f), nausea, headache, chills. The patient underwent lab tests and procedures which included fever resulted as 99 Fahrenheit. Reported that she mentioned she gave them Tylenol before the vaccination and read online that it was not allowed. The outcomes of events were unknown.  Information about Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
First day I was scared to go to sleep, I took Tylenol and Motrin off and on, because my first dose I didn't feel well. I fell asleep at 5 am, I was very weak, dizzy, fatigued and that last about 24 hours. My arm pain started radiating and moving towards my entire arm and into my left breast became swollen and my lymph nodes were swollen, then I started having severe diarrhea. Then my blood pressure 165/103 went up and had a horrible headache. I went to hospital afraid I was going to have another stroke. They did blood work and pushed fluids, waited for my BP to come down and discharged. I still feel very sluggish and I'm still get sharp cramping and I feel nauseated. I'm taking medication for GERD.
Redness, swelling, severe itching, pain, cellulitis. BENADRYL 50 mg Q 6hrs.
tingling; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tingling. The outcome of event was unknown.  Information about Lot/Batch is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167410 same reporter/drug/AE with different patient
I was woken up by an extreme headache, this was followed by chills, I could not get warm. After moving downstairs, then back up to get back in bed, I began sweating.  The series of effects lasted approximately  2 hours.
This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history was not reported. The patient received an improperly stored dose of VARIVAX (Merck) (route not reported, lot # L0030158 and Exp. date 11-AUG-2017) on 07-JAN-2016. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.