chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad itching all over her body; Rash all over; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Mar2021 12:00 (Batch/Lot Number: EN6198) at the age of 68 years old as 2nd dose, single dose for COVID-19 immunisation. Medical history included allergy to codeine. Patient was not pregnant at the time of vaccination. Concomitant medications were not specified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took 1st dose of BNT162B2 administered in left arm on 13Feb2021 04:00 AM (also reported as PM) (Batch/Lot Number: Kn9808) for COVID-19 immunisation. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient took her second COVID-19 vaccine last 06Mar2021 (Saturday). A week later, on 13Mar2021, the patient experienced rash all over her body itching, this bad itching all over her body and it's really irritating. She has taken diphenhydramine (BENADRYL) thinking that would maybe help it and she was not getting any relief. She confirmed that diphenhydramine was taken as a treatment. The patient was wondering what else can she do and if had this reported from others. Outcome of events were not recovered.  No follow-up attempts are needed. No further information is expected.
Dizziness, Headache, NauseaVomiting, Fatigue Narrative:
onset of fever 8PM 20AUG96 w/ a 2-3inch knot in lt deltoid on visit of 3SEP96;knot still present but approx 1";
got second dose of COVID vaccine after getting monoclonal antibodies infusion/Fever/ had fevers of 101 degrees Fahrenheit; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient received the first dose on an unspecified date and came down with COVID in a week. The patient's medical history and concomitant medications were not reported. The reporter wanted to point out another thing at his urgent care, there were four other contemporaries of his, physicians his age who all got the first dose, and they all came down with COVID in a week. He said that one contemporary (patient) did already get the second dose after getting an infusion of the monoclonal antibodies, and after he got the second dose he had a fever for 4 days. He said that this patient already had all of his COVID symptoms go away prior to getting the second dose of the vaccine after getting the monoclonal antibodies infusion (also reported as "Eli Lilly monoclonal antibodies infusion therapy"). Physician said that patient did not postpone second injection for 90 days, even though prior to his second dose he got the infusion then got second dose, then had fevers of 101 degrees Fahrenheit. The event was assessed as not serious by the reporter. The physician does not think that getting the vaccine and having COVID is related, he thinks it was a coincidence. Patient got the vaccine through work. It was given through employee health department. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Location - Lt deltoid area large (circle) area, warm to touch, no complaint of itching. BENADRYL 25mg by mouth, and applied ice compress.
Severe left arm pain, not only at injection site but from left shoulder to left wrist. Other symptoms were joint pain (but only in knees), chills, low grade fever, headache. Began in the evening after I received vaccination (administered around 1000) and symptoms were gone by morning, other than mild injection site pain.
Myocarditis; This is a spontaneous report from a contactable consumer(patient). The 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 01Apr2021 12:45 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation.  Medical history included attention deficit hyperactivity disorder (ADD).There was no known allergies, no Covid prior vaccination. The patient's concomitant medications were not reported.  The patient experienced myocarditis on 18Apr2021 23:30 which led to emergency room with outcome of unknown. There was no treatment.   Information on the lot/batch number has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to 8 unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with VARIVAX (Merck) 0.5 ml, subcutaneous (lot # not reported). On an unknown dates the patients received doses of VARIVAX (Merck) which had undergone  supported temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
expired dose of the Engerix-B vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B adult) (batch number YL2L3, expiry date 14th October 2021) for prophylaxis.   On 12th November 2021, the patient received the 2nd dose of Engerix B adult. On 12th November 2021, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered an expired dose of the Engerix-B vaccine, which led to expired vaccine used. The reporter consented to follow up.
Client spiked temp of 103 approximately 12 hours after getting immunizations, he was taken to local hospital and mom was told to treat the symptoms of the fever. At approximately 24 hours after immunizations, his temp spiked to 104.3. Parents took him to a different ER, they were told that it could be related to the vaccines. He had no other symptoms, no rash, nor were any of his siblings ill. Parents were told to avoid next booster of Dtap and next time get shots one at a time. At the 48 hour mark, he has temp of 100 and then was fine after that. No follow up with PCP.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. {Additional information has been requested. / Additional information is not expected.}
non-necrotizing (M-type) skin granuloma; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 17 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, the patient experienced non-necrotizing (M-type) skin granuloma. Three skin biopsies of right index finger were positive for iVDRV. The patient was treated with nitazoxanide, however it failed to clear RuV cutaneous infection.  The patient was also treated with TNF alpha antagonist (etanercept, adalimumab, infliximab) with no improvement. The patient underwent upper limb amputation. Rubella serology showed persistent RuV IgM antibody.At the time of the report, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (2202USA004885, 2202USA004886, 2202USA004887, 2202USA004888 and 2202USA004889).; Sender's Comments:  US-009507513-2202USA004885: US-009507513-2202USA004886: US-009507513-2202USA004887: US-009507513-2202USA004888: US-009507513-2202USA004889:
Vaccine injection site swollen raised approximately 1/2 inch and 4 inch diameter, warm, increasingly tight with abduction of left arm
Intermittent HA, SOB upon exertion, sent to ED, outcome unknown.
Chest, back tightness, chronic coughing going on two weeks, night chills, shortness of breath
This spontaneous report as received from a nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 18-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054:
Expired dose was administered/ It was the patient's third dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 2224M, expiry date 1st March 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th March 2022, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 18th March 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Medical assistant reported that, an expired dose of Engerix-B was administered by another staff member to the patient, which led to expired vaccine used. The reporter declined to provide additional information. The reporter did not consent to follow-up.
PATIENT RECEIVED 1ST COVID VACCINE WITH NO REACTION. PATIENT RECEIVED 2ND VACCINE ON 4/14/2021. ON 4/16/2021 PATIENT REPORTED HAVING A RASH ON HIS HANDS, CHEST, AND ARMS. HE SCHEDULED AN APPOINTMENT WITH HIS PRIMARY CARE PROVIDER ON 4/19/2021. PRESCRIBED PATIENT PREDNISONE TO TREAT RASH AND WANTED TO FOLLOW UP WITH PATIENT ON 5/3/2021. BETWEEN HIS 1ST APPOINTMENT AND HIS FOLLOW UP HE PRESENTED TO THE ER ON 4/29/2021 WITH INCREASED RASH, SWELLING OF ARMS, CHEST AND HANDS. ER DOCTOR PRESCRIBED PATIENT FUROSEMIDE AND BACTRIM. DURING FOLLOW UP APPOINTMENT ON 5/3 DAN WOLDT DISCONTINUED THE BACTRIM BUT ADVISED PATIENT TO CONTINUE ON THE FUROSEMIDE AND SCHEDULE AN APPOINTMENT WITH A DERMATOLOGIST. PATIENT HAD APPOINTMENT WITH DERMATOLOGIST 5/10/2021 AT 2:30 PM WHERE PRESCRIBER, MD PRESCRIBED PATIENT A TOPICAL TRIAMCINOLONE CREAM. HAD DIAGNOSED PATIENT WITH HAND AND FOOT SYNDROME AND WOULD BE CONTINUING TO MONITOR RASH. PATIENT HAS A FOLLOW UP APPOINTMENT WITH THE DERMATOLOGIST SCHEDULED FOR 5/25/2021 AND WAS ADVISED TO CONTACT DOCTOR IF ANY FURTHER RASHES COME UP DURING THAT TIME.
Child given PO vaccine IM.  No immediate reaction.  Attempted to follow up with family, but unable to contact family in the few days after incident.  Seen at four months by another provider - no physical abnormality noted in chart.
Chills Nausea Vomiting Excessive sleepiness High resting-state heartbeat High blood pressure  Severe allergy cough
patient left arm swollen, painful, a little red.  patient do not have shortness of breath or sickness.  rph gave patient a dose of tylenol 500mg and benadryl 25mg.  and consult the patient to repeat every 4to 6 hours as needed.  If symptoms getting worse then go to urgent care or er.
developed mild chickenpox 2/2007, rash began 2-3 wks after varicella case at school
Patient reported she had a Shingrix vaccine on 4/27/22 and that just a few days ago around May 30the she developed a blister on her jaw line. She stated she's had shingles in the past and that this was shingles.  She further stated this episode of shingles was due to her Shingrix vaccine from the end of April. Advised patient to see her doctor for follow-on treatment.
Only a few hours later, I had flu-like symptoms of total body aches, headache, lethargy and chills.  Injection site also was red and harder than normal.  Upper arm felt sore as well. The next morning the chills were gone but other symptoms persisted until bedtime that night.  The following morning I felt somewhat better and in 4 days I felt more like myself again.
Information has been received form a MA concerning a 13 month old female who on 05/07/03 was vaccinated with a dose of MMRII (Lot # 640790/1378L). Concomitant vaccination on 05/07/03 included a dose of varicella virus vaccine live. On 05/07/03, within minutes after vaccination, the pt developed a red area approximately 2 inches in diameter at injection site on the right thigh. Unspecified medical attention was sought. No treatment was required. Additional information has been requested.
ELECTRIC SHOCK TO THE BODY WHEN TRYING TO GO TO SLEEP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced electric shock to the body when trying to go to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of electric shock to the body when trying to go to sleep was not reported. This report was non-serious.
Localized redness and warmth adjacent to vaccine site. (vaccine given in L deltoid, reaction in L tricep)
Infant had approx 20 min episode of paleness, limpness and hand trembling that occurred around 9-10 hour after vaccine administration. That episode was preceded by 5-6 episodes of vomiting. Child was seen in ED and received through workup.
received the first dose of Shingrix two years ago / only received the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received 2 years prior to the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of report, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. No further information was reported.
Brain fog so severe that I cannot even drive my car.  My head is in an altered state, no clarity.  It feels like you are in a twilight or have had 4 drinks of alcohol.  Terrible feeling that does not pass.
This spontaneous report as received from 25 year old patient of unknown gender via facebook concerning herself/himself. On an unknown date the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacture unknown) (strength, dose and route unknown) for prophylaxis. The patient was waiting to be diagnosed with cervical cancer when the doctor found suspicious lesions on her/him. At the time of reporting, the outcome of adverse event was unknown. The causality was not provided. Upon internal review, cervical cancer was determined to be medically significant. Additional information has been requested.
Initial report received on 22 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 17-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3603AA received on 07 February 2011, lot number C3805AA received on 20 April 2011 and lot number not reported on 10 June 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 14 May 2012, approximately eleven months after the last dose. On 24 May 2012, the subject developed a paroxysmal cough without a whoop. On the same day, the patient received the fourth dose of PENTACEL (lot number, route and site not reported). The subject also experienced posttussive vomiting. Laboratory testing included positive PCR on 27 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Had numbness in my arm for around 6-7 weeks.  Had heart palpitations for 1-2 days after shot.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267208; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267228; 2019SA267230; 2019SA267231; 2019SA267232, 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  It was a case of actual medication error due to incorrect product storage.  At the time of report, 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 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.  Documents held by sender: none.
61-year-old gentleman with a history significant for HTN & HLD who presented with proximal bilateral lower extremity paresis of 1 day duration.  While he was still able to walk, he noted that his thighs felt weak and his knees kept buckling.  He has had multiple falls since the onset without serious injury.  His weakness had been worsening, prompting him to go to the ED for management.  He is noted tingling in the bilateral toes without sensory changes in the upper extremity.  MRI of thoracic and lumbar spine demonstrated enhancement of the cauda equina nerve roots.  Lumbar puncture demonstrated cytoalbuminologic dissociation.  He had received the influenza and shingles vaccine 10 days prior to onset of symptoms.  He was admitted to the General Neurology Service.
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-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) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
slight tightness in chest; This case was reported by a consumer via call center representative and described the occurrence of chest tightness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chest tightness. On an unknown date, the outcome of the chest tightness was unknown.   It was unknown if the reporter considered the chest tightness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and cause tightness in chest. Not severe but slight tightness.
Patient states hives in various places of her body. However, she reports zero issues at the actual injection site. I believe the reaction she is having is from something other than the vaccination, as she reports allergies to numerous things and carries an EpiPen everywhere she goes. That being said, I feel obligated to report this finding in case it has occurred in other patients as well, despite it being the allergy-sensitive version of the flu shot.
Patient was given a Pfizer vaccine that was outside temperature range.  Clinic Supervisor and Patient notified.  Supervisor called Pfizer company