chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hypertensive crisis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004148.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: HYPERTENSIVE CRISIS (medically significant) with onset 2022, outcome "unknown". Therapeutic measures were taken as a result of hypertensive crisis.  Clinical course: On 07Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at 5 doses for COVID-19 immunisation. It was reported the patient experienced hypertensive crisis and now the patient was on four high-blood pressure pills. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
At 1034, vaccinator reported to learn nurse "I think the needle may be in the client because I cannot find it." At 1034,  co-lead nurse activated. Lead nurses assessed patient. Patient reported he felt 0/10 left arm pain and felt dizziness. Lead nurses examined syringe and confirmed that the needle was inside the syringe. Vaccinator confirmed that there was no spillage during administration of the vaccine and there was no vaccine left in the syringe. Patient reported no allergies, no medications, no medical conditions. At 1038, EMT assessed vitals: blood pressure 130/80 mmHg, pulse 85 beats/minute, and SpO2 99%. At 1046 paramedics arrived and assumed care. Paramedics confirmed there was no needle in patient's arm and patient refused to go to the hospital. Supervisor advised lead nurse to have patient wait in observation area for 30 minutes. Lead nurse was attending to  vaccinator who stated she felt "traumatized" and "overwhelmed". Co-lead and EMT attended to another patient reaction in observation area. At approximately 1058, lead nurses realized patient already left observation area. Syringe used was 1mL Vanish Point syringe 25G x 1".
? tiredness ? headache ? muscle pain ? chills ? injection site redness ? feeling unwell  above symptoms were disappeared at third day but still  lost sense of smell
Nose bleeds commenced daily in the mornings and evenings 2 days after. Headaches are frequent. Constant tiredness and fatigue.   Second shot if booked for April 20th - need to know if this will be safe  No temp, no fever, no loss of taste
About 3 hours after the shot: fast heart beat/thumping, weakness, shortness of breath. After talking with patient about 30 minutes later, patient stated he already started feeling better with no fast heart beat/thumping, or trouble breathing, but still felt weak.
high-frequency hearing loss; ringing in left ear; congestion in left ear; on and off pain in left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (high-frequency hearing loss) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (ringing in left ear), EAR CONGESTION (congestion in left ear) and EAR PAIN (on and off pain in left ear). On an unknown date, the patient experienced DEAFNESS (high-frequency hearing loss) (seriousness criterion medically significant). The patient was treated with VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at an unspecified dose and frequency; CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) ongoing since an unknown date at an unspecified dose and frequency; ALPHA LIPOIC ACID ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; AZELASTINE ongoing since an unknown date at an unspecified dose and frequency; FLUTICASONE ongoing since an unknown date at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. On 04-May-2021, EAR CONGESTION (congestion in left ear) had resolved. At the time of the report, DEAFNESS (high-frequency hearing loss) and TINNITUS (ringing in left ear) had not resolved and EAR PAIN (on and off pain in left ear) outcome was unknown.            The patient was taking no concomitant medications. Treatment included a two week trial for hearing aid that provided notch therapy for tinnitus but patient had not noticed any improvement in hearing or ringing. Completed the course of prednisone and antibiotic with no improvement.  Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Events added, case upgraded to serious and event details updated.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded
Patient received his first dose and fainted in the chair immediately after, when he saw a drop of blood trickle down his arm. Patient regained consciousness right after. Patient was monitored closely in observation and left the vaccination site in stable condition.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history or concurrent condition was not provided. On 16-JUN-2015, the patient received a dose of improperly stored M-M-R II 0.5 ml, (lot # J014876, expiration date 21-NOV-2015, therapy type rHA subcutaneously. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Tested positive for COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after first dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced COVID-19 (Tested positive for COVID after first dose). At the time of the report, COVID-19 (Tested positive for COVID after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment information was not  provided.  Patient reported that the patient and the patient's son received their first dose of the Moderna COVID-19 vaccine on 08-Aug-2021. The patient started to observe first symptoms on 16-Aug-2021, and started to feel fever on 17-Aug-2021.   This case was linked to MOD-2021-294007 (Parent-Child Link).   See case MOD-2021-294007 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Non significant follow-up appended.
Lt arm heavy, warm and sore. Alternate heat/ice, TYLENOL #3 for pain.
fatigue lasted for 2 weeks, vertigo, dizziness, cold sore,  fell oh 1/8/2022 and 1/15/22 fell at home
Ive been having severe headaches and sinus pressure since i took the second vaccine on 6/1. The headaches won?t go away and consistent every day
4/15 immediate post-injection reaction: "Patient evaluated for chest pain after vaccine. Patient with L sided chest pain and back pain immediately after vaccine. Patient had identical reaction after first dose. When patient was laid in bed and given oral hydration, pain resolved. Patient felt confident that this was anxiety as with his first vaccine. VS and exam WNL. 2 lead EKG showed NSR with no clear ST changes. Patient was returned home with wife as driver. " 4/16 reaction:  patient contacted PCP with complaints of "Nausea, stomach ache, headache, injection site discomfort, fatigue, some diarrhea."  Patient requested something for nausea.  Provider prescribed ondansetron.   4/22:  patient contacted PCP with complaints that since 2nd dose, he has felt "Fatigue and feet pain with swelling and intermittent numbness .  Also since then has not been able to control CBG, in AMs >200, using medications as prescribed." PCP monitoring; no medication treatments.
I felt fine until I went to bed. About 11:30PM I woke up very ill. I felt weak, shaky, terribly congested, my back was aching so badly I could barely walk. I had intense headache and nausea. My head was roaring. I had a 3 degree temperature. I was not having any asthma problems but I could barely hear my husband. I heard cracking sounds on my right ear and I could make out what he was saying if he spoke in my left ear. Today I still have unusual fatigue but the body aches and headaches have stopped. I was told that hearing loss can happen with the vaccine which I did not know at the time of taking it.
Grandmother had ped's md see child due to "blotches on arms, back of legs, and big red swollen (quarter size knot) area with blisters at injection site on right leg. Temp. was 99.5. Md said that it was a local reaction. Grandmother called to report the symptoms to Co. Health Dept., nurse advised to get a 2nd opinion with blotches on body and nurse could hear the child crying. GM said that the child seemed uncomfortable. Grandmother being a nurse at a hospital got a second opinion with the E.R. doctor that afternoon at Hospital. C. Reactive Protein and CBC was drawn and was WNL. Child was started on steroids. Grandmother said since starting steroids symptoms have almost went completely away and child is doing much better.
Fever of 103.1; Cold Chills; Body Ache; Pain At Injection Site; Very Tired, Extremely exhausted; Delusional off/On; Mild/Sever Diarrhea; Headache On/Off; Upset stomach; Loss of appetite; Lazy Feeling(Extremely exhausted); Left arm swelling arm & Injection Site; Left arm swelling arm & Injection Site; left arm pain, very red tender to touch; Very red tender to touch; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received bnt162b2 via an unspecified route of administration, administered in left arm on 10Jun2021 11:00 (Lot Number: Ew0180) as 2nd dose, single dose at the age of 27-year-old for covid-19 immunization. The patient was not pregnant. Historic vaccine was bnt162b2 via an unspecified route of administration, administered in left arm on 17May2021 13:45 (Lot Number: Ewv172) as 1st dose, single dose at the age of 27-year-old for covid-19 immunization. Medical history included Lung disease- Histoplasmosis, Stress Seurizes, chronic back pain, and Known allergies: Adhesive tape from an unknown date. Past drug event included ibuprofen and doxycycline and experienced allergies. Concomitant medication included cetirizine hydrochloride (CETIRIZINE HCL); oxycodone hydrochloride, paracetamol (PERCOCET, 5 mg); women vitamins (OLLY), all taken for an unspecified indication within 2 weeks of vaccination. The patient experienced left arm swelling arm & injection site, very red tender to touch/left arm pain, cold chills, body ache, pain at injection site, very tired, delusional off/on, mild/sever diarrhea, headache on/off, upset stomach, loss of appetite, lazy feeling (Extremely exhausted) on 10Jun2021. The patient also experienced fever of 103.1 on 10Jun2021 11:00 am. The patient underwent lab tests and procedures which included body temperature: 103.1 on 10Jun2021 11:00 am. Therapeutic measures were not taken as a result of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient had not been tested for COVID-19. The outcome of events was not recovered.
Patient complaining of right shoulder pain x3 months that started after she received the COVID-19 booster on 12/20/22. The patient reports that she has had limited mobility of right shoulder due to the pain experienced with movement. The patient endorses pain with external shoulder rotation, horizontal adduction, and shoulder extension to the back. Pain is relieved by heat but is really affecting her ADLs.  Patient also reports intermittent jerking of her arm when using her right arm doing detail work at the  nail salon.
Patient has received High-Dose Influenza vaccine for several years without problems.  Patient states this shot was given in the middle of her right upper arm.  2 hours after vaccination, she developed severe right arm pain and 30 minutes later, her arm was weak and she had trouble lifting her arm.  She has been seen by her PCP and Orthopedics, placed on Gabapentin and Prednisone with no consistent improvement.  Right shoulder s-ray, cervical spine x-ray and EMG all negative.  She continues to have intermittent pain to her right upper arm with difficulty lifting her arm and weakness.
My shingles in my right eyed flared up and caused throbbing and discharge in my eye. I was told to increase the dosage of my medicine to twice a day.
Information has been received from a physician who heard from another physician concerning a female (from a gymnastics class) who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced tingling in her extremities. The outcome of the patient was not reported. This is one of the several reports from the same source. Additional information has been requested.
pt recvd vax; fever, HA, n, chills on 1feb96;
Information has been received from a registered nurse concerning a female in approximately her mid 40's with no allergy to yeast (any other allergies unknown) who on 06-FEB-2008 was vaccinated IM with her third 1.0 ml dose of RECOMBIVAX HB (lot # 656876/0874U) in the left deltoid. On 07-FEB-2008 the patient developed severe cellulitis of the left arm from the injection site down to the end. The left arm was hot to touch, swollen and painful. The patient sought unspecified medical attention. The patient was treated with KEFLEX 500mg times a day and possibly BENADRYL. The redness had resolved and swelling decreased since starting on treatment. The patient continued to have left axillary lymph node pain that "felt tight but better." It was also noted that the patient failed to seroconvert after the past first and second completed series of RECOMBIVAX HB. The nurse mentioned that the patient was not currently taking any type of immunocompromising agents. There was no product quality complaint. In follow up information from the doctor's office it was reported that no further changes noted. Issue resolved. Additional information is not expected.
The annual Influenza shot caused me severe pain in my right arm - from the base of my skull to the index finger on my right side (side of injection) Last year 2006 I had a reaction from the base of my skull.
Patient falsified name upon presenting to the clinic and received 0.5ml dose of Covid-19 Moderna vaccine as a 2nd dose instead of a 0.25ml Moderna (booster), as clinic staff learned that patient previously received the full dose Janssen Covid-19 vaccine on 3/25/2021.
When I had my first inj. 3 days later I developed a significant rash. Now it appears to have returned on my left arm but significantly smaller
FLUBLOK being administered to pediatric patients; 12 years with reported no adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases CLUSTER: 2022SA402396, 2022SA402704, 2022SA402436, 2022SA402443, 2022SA402500, 2022SA402505, 2022SA402514, 2022SA402525, 2022SA402530, 2022SA402619, 2022SA402662, 2022SA402707, 2022SA402718 and 2022SA402964.  This case involves a 12 years old female patient who was reported with flublok being administered to pediatric patients; 12 years with reported no adverse event while receiving vaccine influenza quadrivalent recombinant vaccine[Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP RL1 9V (yeast) (Gardasil 9) for Immunisation.  On 16-Sep-2022, the patient received a 1 dose of suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 ml once with standard strength (lot UJ887AA, expiry date- 09-Jun-2023) (with unknown formulation) via intramuscular route in the left deltoid for Immunisation.  On 16-Sep-2022 the flublok being administered to pediatric patients; 12 years with reported no adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
she is nursing mother; She is been very lethargic since then and very tired; She is been very lethargic since then and very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number, unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "she is nursing mother"; LETHARGY (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "She is been very lethargic since then and very tired".  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021290930 same drug, different patient/event
Reported soreness at injection site for a continued long period of time with body aches and unusually tiredness which has lasted for weeks.
FELT DIZZY AND FAINTED. CALLED 911. WAS ABLE TO RECOVER BEFORE 911 ARRIVED
Broke out in a rash that looked like some shingle sores and some chicken pox. Lasted about a month but still have some sore occurring now. Levocetirizine & Triamcinolone. Lesions in mouth that Dr thought was cancer but removed and was not cancer. Nerve pain in legs and arms.
This spontaneous report as received from a nurse practitioner refers to a 62 year old male patient. On 14-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000447, expire date 11-APR-2014), 0.65 ml injection. Concomitant therapies included T-DAP (unspecified), which was given on 14-MAY-2013. The patient experienced injection site redness (but no rash) after receiving ZOSTAVAX. The patient did not seek medical attention. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
3/23 Same evening,  non itchy rash on left forearm,  gone by 3/24 morning. 3/29 woke up with left armpit pain, no lump, but swollen and painful
THERE WAS IMMEDIATE SWELLING FOLLOWING THE INJECTION AND A LITTLE BLEEDING.  WELT WAS ABOUT 1.5 INCHES IN DIAMETER AND COLD COMPRESS WAS APPLIED AND A DIPHENHYDRAMINE 25MG TABLET WAS TAKEN ORALLY.  OBSERVATION WAS CHANGED TO 30 MIN AND CLIENT WAS ASKED TO REPORT ANY ITCHING OR FURTHER SWELLING.   AT 3:50, STILL SWOLLEN AND DIAMETER WAS ABOUT 2 INCHES IN DIAMETER.  AT 4:05, SWELLING DIMINISHED SLIGHTLY. AT 4:12, SWELLING CONTINED TO DIMINISH AND CLIENT DID NOT WANT TO CALL A DRIVER AND WAS RELEASED TO DRIVE HOME.
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot #: M027884 with expiration date: 19-APR-2019) (dose, strength, frequency and anatomical location were not reported), intramuscularly, for prophylaxis. The administered vaccine was improperly stored at temperature 29 °F for 2 hours and 40 minutes without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. Additional information has been requested.
Night one- mild headache. Next morning- uncontrollable dreams which resulted in waking with hallucinations, amnesia, and mild dissociation.  Sweaty, fever, jaw locking.
Information has been received concerning a pt who was vaccinated June 2000 with the first dose of varicella vaccine. On 06/27/00 the pt developed swollen glands under her left ear. The pt did not seek medical attention.
Developed symptoms of Appendicitis in the evening of 6/15/21 and had an emergency Appendectomy on 6/16/21.  Presently experiencing surgical incision infection and recovering from the emergency appendectomy  Started oral antibiotic on 6/19/21  Post-op follow up appt scheduled for 6/29/21
Fever and Rash. She was treated with IVIG on 5/13 for concerns for systemic inflammation and symptoms of Kawasaki disease.
Patient states that day after vaccine he experienced dizziness, nausea, and headache lasting several days. Patient called pharmacy on day 6 post-vaccine and said dizzines has not yet subsided but other symptoms have.
Pt recvd 1st dose of Hep B vax 11MAR91 & on 14MAR91 devel generalized rash that started on arm; 2 days later devel lesions on mucous membranes; dx pityriasis rosea & tx meds; pt recovered fr exp & recvd 2nd dose of vax;
Redness, itching, slight swelling and tenderness to upper right arm where Hepatitis A (HAVRIX) injection had been administered.
I'm having an issue with my right shoulder after my first vaccine all the way down to hand. I can't hold my arm a certain way because if I do it hurts really bad.
pt recvd vax 18AUG92 & on the following day pt reported loss of taste & smell to MD; to date, has not regained ability to taste & smell;
12 year old given 10mcg Pfizer dose (5-11 y/o formulation) as 2nd dose in series. 1st does given was 30mcg Pfizer dose (12 and up formulation) on 11/12/21