chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blot clot in her head; This spontaneous case was reported by a non-health professional and describes the occurrence of THROMBOSIS (blot clot in her head) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blot clot in her head) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blot clot in her head) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713516 (E2B Linked Report).; Reporter's Comments: This is a regulatory case concerning an unknown years- old-female-patient with no medical history reported who experienced the seriousness criterion medically significant unexpected event of thrombosis (AESI) unknown days after a  dose of RNA- 1273 bivalent vaccine.  The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report.  Event´s seriousness assessed as reporting; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713516:Coworkers sisters case
Severe changes in menstrual cycle that have not gotten better since getting the vaccine. Off cycle, heavy, extremely painful, often more frequent. Spotting.   I have never had issues with my cycle like this. Majority of my female friends have been struggling with seminar issues for months now.
fatigue SOB on slight exertion light headed muscle pain feeling cold trouble concentrating rejected by Blood Bank X2 HGB too low  11+12
This case was reported by a nurse and described the occurrence of red rash on arm in a female subject aged between 30 and 39 years old who was vaccinated with hepatitis B vaccine recombinant for prophylaxis.  The nurse reported that the subject has no known allergies.  On 10/10/2005 the subject received 2nd dose of Engerix-B in her right arm.  On 10/18/20005, 8 days after vaccination with Engerix-B, the subject experienced a red rash around the injection site and on the other arm as well.  The subject was seen at a physician's office.  At the time of initial reporting, 10/19/2005, the events were ongoing.
The patient developed severe itching that began on the trunk and spread to entire body.  No obvious rash.  Treated with benadryl 50 mg IM.  Itching abated.
Breakthrough case of COVID, high temp 103, chills, headache, sore throat, sore joints, diarrhea, fatigue.
Fever 101.5, migraine, eyepain, severe arthralgias,  nausea and vomiting,  weakness,  inability tji think clearly.  Residual symptoms at the time of this report
As of 22Apr2021 patient was trying to get the second dose Pfizer Vaccine; patient was tested positive for the COVID Virus on 08Apr2021; patient was tested positive for the COVID Virus on 08Apr2021; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm on 10Mar2021 (Batch/Lot Number: EN6208) as single dose in arm/ shoulder at the age of 73-year-old for covid-19 immunisation, administered at home (someone came out and gave the patient the first dose).  Medical history included disabled, she could not read and write. There were no concomitant medications.  The patient was tested positive for the COVID Virus on 08Apr2021 (medically significant) and as of 22Apr2021 patient was trying to get the second dose Pfizer Vaccine.  The course of events was as follows: When the person who administered dose one Pfizer Vaccine came back the patient had the COVID Virus.  After the first dose of the Pfizer COVID Vaccine, patient thought she had the virus, but they did not test her. Caller was sent to get tested and tested positive for the COVID Virus after receiving the first dose Pfizer Vaccine. Patient quarantined after being diagnosed with COVID. On 20Apr2021 someone called and wanted the patient to come in and get the second dose of Pfizer Vaccine. The patient told this person she is disabled and cannot come. This person was supposed to call back on 21Apr2012 and let caller know and no one called back. Patient could not read and write and was unable to provide address, phone number or email. As of 22Apr2021 patient was trying to get the second dose Pfizer Vaccine. Patient did not mind answer questions, wants somebody to help get second dose Pfizer Vaccine. Caller asked if the questions from Agent will help caller get second dose Pfizer Vaccine. This report was not related to a study or program. She has not received second dose.  A Product Complaint was filed.
Headache, Fever, Rash, ErythemaMultiform, dizzy, arm soreness; 1/20-arm swelling, itching Narrative:  Evening of injection developed extreme arm soreness, dizziness, fever and headache; resolved in 3-4 days. 1/20/21- at injection site - swelling, rash, wheal; rash extending down arm, hot and itching. Recommended follow up with pcp. States icing seems to be helping.
This case was reported by a consumer via call center representative and described the occurrence of discomfort in a female patient who received SHINGRIX for prophylaxis. On 23rd July 2018, the patient received SHINGRIX. On 23rd July 2018, 16 hrs after receiving SHINGRIX, the patient experienced discomfort, fever and influenza-like symptoms. On an unknown date, the outcome of the discomfort, fever and influenza-like symptoms were unknown. It was unknown if the reporter considered the discomfort, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, 16 hours after she had the vaccine administered in her left arm she felt very uncomfortable and had a low grade fever. The patient stated she felt like she had the flu. The reporter did not give consent to follow up with a pharmacy.
I now have a lump (baseball sized) in my right arm pit. This is the same arm the the injection was given.
Severe local reaction. Received vaccine on 8/24/05, complained of severe swelling with warmth of entire upper left arm with itching and scratching.
This spontaneous report as received from a registered nurse refers to a 10 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number not provided)(route: unspecified injection). Approximately on 30-MAY-2013, "about one week ago" the patient experienced "a rash" after PNEUMOVAX 23 was administered. The outcome of rash was reported as recovered/resolved on an unspecified date. The patient had sought medical attention via office visit on an unspecified date. Additional information is not expected.
Reported fatigue, muscle aches, and chest pain.Followed up with her PCP  for the chest pain. EKG unremarkable. Cardiologist to follow up.
MY ARM AND SHOULDER BECAME INCREASINGLY PAINFUL TIL i COULD NOT LIFT M,Y ARM AND COULD NOT SLEEP. WENT T O DOCTOR SPECIALIZING IN ARM AND HE TOOK  XRAYS. i TOLD HIM i HAD HAD A BOOSTER SHOT FOR COVID AND HE SAID I HAD BURSITUS AND IT WAS A COMMON AILMENT RELATED TO THIS SHOT.  HE H AD PATIENT WITH SAME PROBLEM. HE GAVE ME A SHOT FOR THE PAIN AND HEALING. THERE IS NO INFO AT ALL  ABOUT THIS SIDE EFFECT...i AM NOT HAPPY ABOUT THIS AS THE PAIN IS VERY STRONG.
monday  oct 12 i noticed difficulty breathing .  i called clinic , made an appointment for tueday oct, 13 .
POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no illness at the time of vaccination and no history of allergy to vaccine, drug or food. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) .5 ml, administered on 03-MAY-2021 11:20 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021 11:20, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503927 and 20210504498.
21 year old dropping dead; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 21-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "21 year old dropping dead". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: It was reported that caller was asking on how Pfizer measures the success of the Pfizer covid 19 vaccine because the Pfizer vaccine killed less than the Moderna and the Johnson and Johnson. Caller also mentioned about the 21 year old dropping dead; that Pfizer was murdering people.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: 21 year old dropping dead
PATIENT RECIEVED MODERNA BOOSTER AT APPROXIMATLY 11:30 AM ON 12/17/21.  AT AROUND 6:30 PM, THE PATIENT REPORTS HAVING A MIGRAINE WITH SPOTS NOTICED IN FIELD OF VISION. PATIENT TOOK SOME ACETAMINOPHEN AT THIS TIME, WHICH DID NOT RELIEVE SYMPTOMS. WITHIN HOUR OF SYMPTOMS PATIENT WAS UNABLE TO SPEAK PROPERLY. PATIENT'S DAUGHTER TOOK THEM TO THE EMERGENCY ROOM AT LAKE CUMBERLAND REGIONAL HOSPITAL IN SOMERSET, KY FOR SUSPECTED STROKE. STROKE WAS RULED OUT AT THIS HOSPITAL. PATIENT WAS RELEASED SATURDAY (12/18/21) AROUND 3 PM. PATIENT'S SYMPTOMS RESOLVED SUNDAY MORNING. NO NOTICABLE SPEECH IMPAIRMENT NOTICED AT THE TIME OF THIS REPORT IN STORE.
DIZZY; FELT COLD; DRY HEAVES; COUGHING; SEVERE CHILLS; TIREDNESS; FEVER; HEADACHE; QUEASY/NAUSEA; FELT LIKE IN FOG; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included furosemide for blood pressure, spironolactone for blood pressure, and metoprolol for drug used for unknown indication.  On APR-2021, the subject experienced felt like in fog. On 07-APR-2021, the subject experienced dry heaves. On 07-APR-2021, the subject experienced coughing. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced queasy/nausea. Treatment medications included: ibuprofen. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced felt cold. On 08-APR-2021, the subject experienced headache. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, tiredness, and fever on 08-APR-2021, and headache on 11-APR-2021, had not recovered from severe chills, dizzy, queasy/nausea, and dry heaves, and the outcome of felt cold and felt like in fog was not reported. This report was non-serious.
Chills, fever, fatigue, vertigo, watery eyes, soreness at injection site.  Vertigo and watery eyes continue after 6 days.
Arm soreness for 3days. Rash appeared around injection site about 5-6 days ago, not sure. Site is itchy
Frequent unifocal premature ventricular contractions; This is a spontaneous report from a contactable other healthcare professional. A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 21Dec2020 09:30 at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included fish oil (FISH OIL), zinc (ZINC). The patient previously took amoxicillin and experienced allergies. The patient experienced frequent unifocal premature ventricular contractions on 01Jan2021 12:00 AM. Patient reportedly lost his card. No treatment received for the adverse event. The outcome of the event was not recovered. The event was assessed as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with first dose of GARDASIL in August 2007 (reported as "five years ago"), and received second dose "today" (22-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. No known symptoms reported. The patient was not sure if she did received a dose of GARDASIL five years ago and was going to check with her other physician. It was unknown if the patient had sought medical attention. Additional information is not expected.
Last night, the injection site on her left arm became red, hard, warm, swollen, and itchy. She called this morning about 9:30 AM to report this to us.
Extreme soreness at injection site, very painful headache and pain in shoulder joint. Unable to lay on that side because of soreness, restless sleep because of discomfort. Soreness has spread around my arm and into my arm pit. Today is Saturday,January 14,2017 and the discomfort is still there. Would not want this injection again.
Awoke the next morning with SEVERE vertigo where I couldn't walk without having to hold onto the walls, had no balance and spinning severely just sitting in my chair.  Could not exercise, could not roll over in bed.  The spinning was like being on the tilt a whirl on warp speed.
This spontaneous report as received from a other health professional refers to a 17 year old patient. On 01-AUG-2017 the patient was vaccinated with PROQUAD for prophylaxis. Other suspect therapies included VARIVAX. On 01-AUG-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event. The outcome of wrong drug administered and no adverse event is unknown. The reporter considered wrong drug administered and no adverse event to be not related to PROQUAD and VARIVAX.
05/04/2021 4:30am - 05/05/2021 9:00 - aches, chills 05/04/2021 - 5/13/2021 - fatigue 05/04/2021 12:00pm - vomited  05/04/2021 7:00pm - fever 100.6°F - took fever reducer (ibuprofen) 05/05/2021 4:00am - 05/11/2021 9:00am - sore throat, coughing,  congestion, heavy breathing (hard to breathe)
*19:49 Vaccinator vaccinated minor client 19:50 Client losses consciousness falls forward to the floor Safety Officer called to assist  client regains consciousness  is A/Ox3 placed in wheelchair taken to Special Obs with mother and sister 19:51 Once in SO client looses consciousness again briefly EMS called by Site Director per Safety Officer request. Client able to get to cot vitals taken 19:53 BP 94/46 P 84 R 16  19:55 BP 98/62 P 74 R 18 19:59 EMS on site Orthostatic vitals taken were negative. EMS discussed transport of client with mother who refused transport documents signed indicating this with EMS client home ambulatory with family
blood sugar is higher; This is a spontaneous report from a contactable consumer (patient's wife). This 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration on 25Jan2021 (at the age of 76 years-old) for COVID-19 vaccination. There was no relevant medical history reported. Concomitant medications were not reported. On an unknown date, his blood sugar was higher. Sometimes he received testosterone injections and it stays high for a couple of days. The clinical outcome of blood sugar was higher was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
got sick with COVID 5 days later with mild symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 12Mar2021 (batch/lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked when was best time to get second dose of COVID-19 vaccine, after the patient got the first dose on 12Mar2021, then got sick with COVID 5 days later with mild symptoms on 17Mar2021. The outcome of the event was unknown.  Information on lot/batch number has been requested.
PATIENT CALLED 10/13/2021 STATING THAT HER ARM HAS BEEN HURTING SINCE VACCINE ADMINISTRATION AND THAT SHE HAS CONTACTED HER PROVIDER AND HAS AN APPOINTMENT FOR 10/14/2021.
I experienced soreness all over my body, headaches, nausea, coughing, dry mouth, migraines, diarrhea, sharp stabbing pain in my left arm, back pain and I also passed out.
After I was administered the 2nd dose of the Pfizer vaccine at approximately 15 hours my right hand started to look red the next day the area was redder on the 3rd day I called my Dr. as the situation continued to get worse and I felt a lot burning sensation in my hand and I started to the right hand turning red. The Dr recommended take Benadryl for 3 days every 4 hours. On Friday I called my Dr as the symptoms continued to worsen and he told me to go to the emergency room. On June 19 I went to the emergency room and the Dr told me that he had never seen an allergic reaction like that he would be given an intramuscular medicine for inflammation called Decadron and he prescribed a cream for the area called Clotrimazole- Betamethasone Dipropionate 1% but the area continues with a lot of burning and it has spread to the area of the arms.
2pm Started breaking out in rash on face initially, then spreading to rest of body. No SOB. Taken to ER, Benadryl given. Initial and follow-up information has been received from a registered nurse concerning a 14 month old male with no known allergies and a history of imbilical hernia (also reported as no medical history) who on 21-May-2007 at 10:30 was vaccinated SC in the right lateral thigh with a 0.5 ml first dose of measles virus vaccine live. PROQUAD (Oak/Merck upgrade process) (lot # 655842/1330F). Additional suspect vaccination included a fourth dose of OMPC (MSD) (lot # 654904/0757F) given IM in the left anterior thigh. Concomitant vaccination included a fourth dose of PREVNAR (lot # BO8689C) given IM in the right anterior thigh and a fourth dose of IPOL (lot # 20527) given IM in the left lateral thigh. Additional concomitant therapy included POLY-VI-FLOR-DROPS. There was no illness at the time of vaccination. On 21-May-2007 at 14:00 the patient started breaking out in a rash on his face which spread to the rest of his body. There was no shortness of breath. The patient's parents took himto the ER and he was to follow up in the office on 22-May-2007. The patient was treated with BENADRYL. There were no labe tests performed. Subsequently the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Dizzy  I am not sure that I did not faint/ I laid down on the bathroom floor.
Received immunization on 6/24/15. Redness and hardness under bandaid. This happened that day & continued til he came into pharmacy Friday. Swelling down to elbow 2 days after vaccine received.
Myalgias for 17 hours on day of vaccination that completely resolved.  Myalgias and weakness started 4/15 and continued progressively for a week before presenting to the clinic.  Lab results showed rhabdomyolysis with CPK of 204,900 U/L and elevated transaminases (see levels below).  Referred to Emergency Department where she was admitted to the hospital for IV fluids.  Creatinine never increased and CPK/transaminases trended downward until release from hospital.   At clinic follow up visit on 5/6, patient reported resolution of pain and weakness although she doesn't quite feel 100%.
Red circular area approximately 3 to 4 inches below injection site is very sore, warm, and tender to the touch. Soreness and swelling in left brachium, left armpit, and left side of left breast; tender to touch. Slight burning/tingling from top of left shoulder to mid-brachium.
Headache, Arthralgia, Fever, injection site pain Narrative:  Employee reports injection site pain/discomfort, chills, fever, headaches, body aches. Reports taking Advil and Tylenol (unknown dose/frequency).
Pt recv vax on 6/13/97; on same day pt exp flashes of light in eye, headache & blurred vision
No adverse effect; The patient had her first dose of GARDASIL 9 on 10-JUL-2019 and is in the office on 13-AUG-2019 to get her second dose of GARDASIL 9; This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient had no concomitant therapies, pertinent medical history or drug reactions or allergies.  On 10-JUL-2019, the patient was vaccinated with her first dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date 18-AUG-2021, strength, dose and route were not reported) for prophylaxis. On 13-AUG-2019, she got her second dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, dose and route were not reported) (inappropriate schedule of vaccine administered). No adverse effects were reported.
Case number PHEH2014US024315, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 62-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 17 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Day of 2nd dose, patient reports a sore arm.  Day  following second dose, patient reports dizziness, malaise, nausea, vomiting, general weakness.  Reported to ED and was admitted to hospital for IV fluids to treat electrolyte imbalance secondary to vomiting.  Patient spent one overnight in hospital and was discharged without further complication.  Patient is now at home and called me to make the report.