chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE INCREASE IN HEART RATE; CHILLS; NAUSEA; HEADACHE; MUSCLE SORENESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced severe increase in heart rate. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced muscle soreness. Laboratory data included: Heart rate (NR: not provided) 150 bpm.  Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 55 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe increase in heart rate, and the outcome of nausea, headache, chills and muscle soreness was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
MODERNA COVID-19 VACCINE EUA.  I AM HAVING A FAST HEARTBEAT.
Severe menstrual bleeding and cramps; Severe menstrual bleeding and cramps; Very significant change in mood; Depression; This Spontaneous report from a contactable consumer reported similar events for five patients. This is the second of five reports:  A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe menstrual bleeding and cramps, very significant change in mood and depression on an unspecified date. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101418500 same reporter/drug, different patients.
sharp pain in her right side; indigestion; burping; feeling like she has air inside like a rolling fart; fatigue; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer (patient) reported.  A 79-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 16Feb2021 (at the age of 79-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date (at the age of 79-year-old) as dose 1, single for COVID-19 immunization and patient experienced Fatigue. The patient medical history include Appendicitis from an unknown onset and unknown ongoing and concomitant medications were not reported. On an unspecified date, after the vaccination, she states she took a nap and upon awakening she developed a sharp pain in her right side which she feels like could be appendicitis and that gets worse when she walks around. She also reports indigestion, burping, feeling like she has air inside like a rolling fart.  She states after her first dose of the vaccine, she only felt fatigued for a couple of days. She wonders about appendicitis. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (01Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Initial report received 09 March 2009 from a health care professional which involved a cluster of two patients. Two patients, also reported as employees (ages and dates of birth not reported), had received FLUZONE during early September 2008 (one patient received FLUZONE lot number U2761AA, second patient lot number not reported), and on an unspecified date during March 2009, both patients were diagnosed with the "flu, strain B". One patient was confirmed as type B by the Tenzyme test. At the time of the report, it was unclear which patient received FLUZONE lot number U2761AA, and which patient tested positive for Influenza Type B. The patient's recovery status was not reported. No additional information was provided at the time of the report. The reporter for this case is the same as for case numbers 2008-02996, 2008-03923, 2008-03924, 2008-03925, 2008-03926 and 2008-03927. Documents held by sender: None.
On 8/22 I woke up with large red lesions all over my body. On 8/26 I was diagnosed with Granuloma Annulare by my primary care doctor. One week later I am still suffering from the lesions all over my body. I have missed one week of work so far due to this condition.
Varivax given on 7/11/19 @11:21am. Patient was monitored for 15 minutes after injection, and showed no signs of any adverse reactions. On 7/12/19 @ 11:00am she started feeling pain and itchy at injection site. She previously stated it looked and felt fire when she woke up on 7/12/19. As the day progressed, injection site was hot to touch with a knot.
Received email from client who received flu shot at school clinic. Later in the am she developed an "incredibly" fast heart rate, felt shaky and dizzy and said her lips turned numb. She left work and went home but eventually went to the ER and spent the night there. The doctor ran an EKG and did some blood work to confirm it wasn't something major. In the end he stated to her that "she was one of the unfortunate ones who got the reaction."  In addition he stated that her shot was done very high and might have hit a nerve or bone which also could have started the reaction.  I reviewed with the administering nurse her technique and she uses the same 3 finger, C technique on all clients.  This nurse has been excellent and has been observed twice by supervisory staff for technique and has never had any issues.
p/vax pt taking a biopsy of leg dx vasculitis;described rash a a dry rash;
Patient brought to emergency department at 2210 with concern for stroke d/t left sided weakness. Upon arrival patient appeared to have seizure like activity and was given 2mg of ativan and keppra 1000mg.  Patient remained able to converse with providers during episode.  Seizure activity/muscle twitching resolved after ativan/keppra administration.  At the time of filing this report the patient is being admitted to the hospital.
At first didn't feel anything, her arm was puffed up a little bit which did not bother her.  Then started to feel fatigued to the point of falling down.  Light headed, dizziness with vertigo which is not getting any better.  Has been taking Meclizine which did not help.  Still having the same symptoms, lethargic, cannot get any energy. Took some Tylenol and Ibuprofen about once a day but still having symptoms.
I had the Pfizer vaccine and the only issues I had was major RA flair-ups.; This is a spontaneous report from a Contactable Consumer (patient). This 68-Year-Old male patient received 1st dose on 22Feb2021, 2nd dose of BNT162B2 on 15Mar2021, at single dose, at the age of 68 years old, location=Left arm for COVID-19 immunization. No Known allergies. Other medical history was liver disease, pre-diabetic, rheumatoid arthritis. No other vaccine in four weeks. Other medications in two weeks were abatacept (ORENCIA) infusion, celecoxib (CELEBREX), simvastatin (ZOCUR). I had the Pfizer vaccine and the only issues I had was major RA flair-ups. 16Feb2021, Orencia- no issues; 22Feb2021, vaccine 1st dose, around 1:30 am next day was awakened with joint pain that kept moving around to various joints thru the night and next two days. 15Mar2021, vaccine 2nd dose, more joint pain than usual until 25Mar2021. 25Mar2021, Orencia - next day instead of feeling better more joint pain. For example could only walk 2,000 steps instead of usual 6,000. 27Mar2021, started prednisone - felt a little better next day and day after that was back to my normal and for instance could walk 6,000 steps. 11Apr2021, stopped prednisone, still feel ok. 18Apr2021, flair up symptoms returned -started another 16 days of prednisone. Felt better after two days. 22Apr2021, Orencia infusion. 03May2021, finished Prednisone. No problems since. Outcome of the event was Recovered. AE Treatment was two courses of prednisone step down 20 mg to 5 mg. No covid prior vaccination. No covid tested post vaccination.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.
This spontaneous report as received from a healthcare provider refers to a patient of unknown age. ON an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J000445, expiration date 11-APR-2014, dose, route indication not reported) which was stored improperly. Additional information is not expected.
on day 4, patient thought she was having a stroke, had sob and heart palpitations, face had numbness, trouble thinking  and speaking, went to er, er was very busy, left and went to urgent care, had ekg and tested for clotting and thyroid, all tests came back clear. symptoms resolved on their own.  patient will be following up in the future with cardiologist
3-4 weeks after CABG went into DIC. 2 grafts completely occluded. Multisystem failure and death. Prior to CABG- Angina. started in April 2021
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax; frequent d, eyes swollen and puffy; fussiness and T of 104; took acetaminophen and tepid bath; to see MD;
Patient contracted COVID and was hospitalized. He later died- respiratory failure secondary to COVID-19 pneumonia.   This was not related to a vaccine adverse event, but reporting based on requirements.
Menectra was mixed with a MMR vaccine as a diluent inadvertently, no AE; Menectra was mixed with a MMR vaccine as a diluent inadvertently, no AE; Initial and live follow-up information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse and processed together.  This case involves a 18 years old male patient who received 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6565AA, expiry date: 28-Mar-2021) which was mixed with 0.5 ml MENINGOCOCCAL VACCINE [MMR] as a diluent inadvertently, via subcutaneous route in the right arm, on 03-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to product preparation error and labelled drug-drug interaction medication error.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reported sudden onset of feeling weak and dizzy. Paramedic on-duty observed patient to be pale and diaphoretic. Paramedic immediately brought equipment to patient and began care. Patient was noted to be hypotensive. Transport unit was called and arrived within minutes. Patient was assisted to EMS stretcher and transported by ambulance to healthcare facility for further treatment and evaluation.
Spots started - last evening 3/4/12. New spots every hour, vesicular rash, low grade fever, felt itchy 1-2 days before breaking out. 10-20 vesicular lesions - trunk, face, foot, legs, mild chicken pox. Calamine, BENADRYL. No school.
tiny red itchy spots on my abdomen; tiny red itchy spots on my abdomen; low grade fever; body aches; chills; fatigue; cause discomfort for 4 months all over my body.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [08Feb2022], this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 10:00 (Lot number: ER8727) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to nuts" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; TOPROL XL. Vaccination history included: Bnt162b2 (dose 1, single. Batch/Lot No: EN6203, Location of injection: Arm Right, Time (24 hrs): AM), administration date: 02Mar2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: RASH MACULAR (disability), PRURITUS (disability) all with onset 30Mar2021, outcome "recovered" (Jul2021) and all described as "tiny red itchy spots on my abdomen"; PYREXIA (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "low grade fever"; PAIN (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "body aches"; CHILLS (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "chills"; FATIGUE (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "fatigue"; DISCOMFORT (non-serious) with onset 30Mar2021, outcome "not recovered", described as "cause discomfort for 4 months all over my body.". The events "tiny red itchy spots on my abdomen", "tiny red itchy spots on my abdomen" and "cause discomfort for 4 months all over my body." were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash macular, pruritus, chills; patient was prescribed with steroid cream, Clobetasol cream. Clinical course: Initial experience after shot was low grade fever, chills, body aches along with fatigue which lasted 3 days.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse who is a 42 year old male patient. Information on patient's pertinent drug reactions or allergies. The patient's medical history included chickenpox (when he was child) and intrinsic tremors. On 01-AUG-2018, the patient was vaccinated with VARIVAX via subcutaneous route (dose, strength unknown), (lot # N031003, expiry date: 03-NOV-2019) for prophylaxis. On 09-SEP-2018, the patient had a car accident (road traffic accident) and paralyzed his arm (monoplegia). He had axillary nerve damage (axillary nerve injury), fractured C6 and C7 (cervical vertebral fracture) and had concussion. The patient forgot a complete week due to the concussion and was out of work for 8 months (disability). The patient was treated in an unspecified emergency department and wore a soft collar until February 2019. The outcome of road traffic accident, monoplegia, axillary nerve injury, cervical vertebral fracture and concussion was recovered. Causality assessment was not provided. There was no product quality complaint associated with this report. The event concussion was determined to be serious due to disabling.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Concomitant medications were not reported.  It was unknown if the patient received any other vaccines in the 4weeks prior to COVID-19 vaccine.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received. Updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master Case
Breakthru disease - Varicella severity I  - less than 50 spots counted in 30 seconds. Diagnosed at doctor's office.
This spontaneous report as received from a nurse and healthcare worker concerning a patient of unknown age and gender. Information about patient's medical history was not reported. On 28-MAY-215, the patient was vaccinated with a dose of PROQUAD (Merck) (dose, frequency, route of administration and indication were not specified) (lot # was reported as K025761, expiration date: 18-JUN-2016) which was improperly stored. No adverse event was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Coronavirus infection; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS INFECTION (Coronavirus infection) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient experienced CORONAVIRUS INFECTION (Coronavirus infection). At the time of the report, CORONAVIRUS INFECTION (Coronavirus infection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns an adult male patient with use of Ibrutinib for an unknown indication,  who experienced the unexpected, non-serious  adverse event of special interest Coronavirus Infection on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and date of event onset were not provided. Coronavirus test and treatment were not reported. No information on any other doses of COVID-19 vaccination was provided. Ibrutinib is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to coronavirus infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with use of Ibrutinib for an unknown indication,  who experienced the unexpected, non-serious  adverse event of special interest Coronavirus Infection on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and date of event onset were not provided. Coronavirus test and treatment were not reported. No information on any other doses of COVID-19 vaccination was provided. Ibrutinib is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to coronavirus infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case was reported by a physician and described the occurrence of injection site cellulitis in a 17 month old male subject who was vaccinated with Infanrix for prophylaxis. On 2/27/06, the subject received 3rd dose of Infanrix in the left quadriceps muscle (lot AC14B021AA). On 2/27/06, the subject also received injections of ActHib (lot VE785AA), in the left thigh and MMRII (lot 0826R), in the left arm. On 2/28/06, 1 day after vaccination with Infanrix, the subject experienced injection site cellulitis, swelling injection site and injection site redness at the site of the Infanrix administration. The subject was seen at a physician's office. The reporter stated that the swelling and redness at the injection site "increased in size over the next 2 days". The events resolved on 3/8/06. The physician considered the events to be related to vaccination with Infanrix.
Rashes on arms/torso. Patient later went to the immunologist and was diagnosed with MCAS.  The immunologists said since it started a couple of days after the vaccine it may have been caused by it.
Patient received first dose of moderna on 4/20/21.  The vaccinating contractor that was used placed the wrong sticker on the card. The patient was unable to attend the 2nd dose clinic and received a Pfizer vaccine at a local CVS.  Therefore the error was mixed series
Initial report received on 15 December 2006 from a health care professional. A 64-year-old male patient, with a past medical history of hypertension, had received an injection of influenza vaccine, manufacturer unknown, lot number unknown, on 11 November 2006. Concomitant medications included Tarka, vitamins, and Lavitra as needed. There was no illness at the time of vaccination. A "few days" following vaccination, the patient became lethargic. He was subsequently admitted to the hospital on 25 November 2006 and diagnosed with renal failure, seizures, and hypercalcemia. All of the symptoms resolved by 29 November 2006 and, per the reporter, the patient recovered. It was "unknown why this occurred."
Client reported  dizziness and pressure in the center of her forehead one minute after vaccination.  Vital signs checked by onsite EMS;  BP 100/52, P 76, O2Sat 100%.  Monitored for 26 minutes.  Client stated, "I'm fine, can I go home now?"  Reported no more dizziness and decrease in forehead pressure.  EMS encouraged client to follow up with emergency services and PCP if needed.  Verbalized understanding.
Fussy, irritable, generalized tonic stiffness, vibratory shaking, gasping breathing patterns each episode lasting > 20 seconds.