chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of chills in a 18-year-old female patient who received BEXSERO (batch number 1684O1, expiry date unknown) for prophylaxis. On 7th September 2018 11:30, the patient received the 2nd dose of BEXSERO .5 ml. On 7th September 2018 14:30, 3 hrs after receiving BEXSERO, the patient experienced chills, nausea, injection site swelling, diaphoresis, low blood pressure, fever and leg cramps. The patient was treated with ADVIL. On 8th September 2018, the outcome of the chills, nausea, injection site swelling, diaphoresis, low blood pressure, fever and leg cramps were recovered/resolved. It was unknown if the reporter considered the chills, nausea, injection site swelling, diaphoresis, low blood pressure, fever and leg cramps to be related to BEXSERO. Additional details were received as follows: The patient's physician asked the patient in general to have breakfast before coming in to the office to get BEXSERO vaccination. In morning at 11:30 o'clock, the patient came to receive her shot of BEXSERO in left thigh. The patient sit for 20 minutes after vaccination with BEXSERO for observation. The patient went home after vaccination, had lunch and at about 2:30 pm came back to the office. The patient had shaking chills, a spike in temperature fever of 103 degree F and the patient was feeling nauseated. The patient also had cramping on the left leg where she received the vaccine, and was diaphoretic. The patient had a bit of a low blood pressure. The patient had some swelling at the injection site. However, the patient had no wheezing, no hives, no respiratory distress. The patient was given food and ADVIL. The patient was also kept in the office. The patient then went home. The patient had a low grade fever that night. The patient was given popsicles with sugar. She took ADVIL again at home. The day after vaccination, the patient was fine and had recovered from all the symptoms. This case was linked with case US2018165454, reported by the same reporter.
fever, chills, body aches, headache, fatigue,  extremely sore at injection site (swollen and bruised) -- worse than mederna shot.
Swollen tongue, fast heart beat, dizziness, headache, fever, cough, hoarseness.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified dates, the patients were vaccinated with an unspecified improperly stored doses of PEDVAXHIB, injection, lot # L002867 and expiration date 11-NOV-2017, (routes of administration and anatomical location were not provided). No adverse symptoms were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
A day after the injection experienced 6 episodes of dizziness/vertigo over a period of 8-9 hours. No more occurrences after that but felt shaky for the next 2-3 days. Had experienced incidents of this early in 2022 but only very short duration events and very sporadically over a 6-month period.  Had been diagnosed with benign positional vertigo and given exercises to prevent/treat this.  In the 5 months prior to vaccination had only 2 twenty second incidents. My previous Covid vaccinations were from Moderna.  The only reaction I had to those were a significant uncomfortable rash on my arm which lasted about 5 days.
Local reaction at vaccine site left thigh beginning one day after vaccines given. Induration, redness noted. 12cmx9cm area of induration/erythema on 9/27/02. No fever.
2/2/2021 vaccination  2/3/2021 24 hours later, I was getting really fatigue at work. Got to the point where hard time keeping eyes open, muscle stiffness, HA, chills, temp 100.5 was the highest. 3 days i felt run down, terrible body aches, HA.  *other symptoms have subsided EXCEPT the HA. I wake up daily with HA. I try to alternate between Excedrin, Tylenol and hot compress.  **1st vaccine; 'Covid arm'
The patient complained of headache, fatigue, fever and sore throat starting on September 24, 2021. Then on October 1, 2021, the patient saw large, slightly raised, scaly patch a few inches below the clavicle then the rash slowly spread from that area on her chest to her  back, chest, abdomen they were smaller scaly spots across her. Currently, the patient still has the rash but has now moved down to her legs.   The rash is  itchy and burns at times. The patient was diagnosed with Pityriasis Rosea which is caused by a virus and there no medication that can assist with the healing process as it is caused by a virus. This rash can take 10 weeks to leave the body and feel it was caused by the second dose of the Pfizer vaccination given on September 3, 2021.
Fever, chills, migraine, nausea, lack of energy, lack of appetite.
A day after the vaccine I noticed blisters along my gum line on my lower teeth. It?s similar to a canker sore, but two blisters on the gym and one on the inside of my cheek
pt recvd vax;severe febrile illness p/ vax;54 hrs later pt exhibited persistent inconsolable crying & fever of 103-106;tx w/ apap;seen in er on 13jan;still has t 100.6;rx w/ motrin;
Injection site reaction. Swelling, redness and rash spread around injection site about 2-3 inch x 1-2 in ribbon. Minor itching. MD treated with hydrocortisone 1% cream.
Soreness; Bruising @ site  quarter- size per caretaker (pt not seen).
This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.   A 35-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El9267; Expiration Date: 31May2021) via an unspecified route of administration, administered in Arm Right on 13Feb2021, at 15:45 (at the age of 35 years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypoxia from an unknown date and unknown if ongoing. There were no concomitant medications reported. patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medication within 2 weeks. On 13Feb2021, 23:30 patient experienced symptoms of vertigo, blurry vision, tinnitus, anxiety. on 14Feb2021 patient experienced tired, dizzy, drowsy, he feels like if his brain is not 100% like a person who takes a lot of drugs. He would like to know how long it will take for his body to feel normal again, he feels like if his brain is not 100% like a person who takes a lot of drugs. He would like to know if he reschedules his second dose instead of 3 weeks after the first dose to 4 or 6 weeks will side effects be less severe once he takes the second dose. He would like to know if he decides not to receive the second dose of the vaccine if one dose will be enough for him to be protected against Covid-19, and if he takes both doses how long he will be protected (6 months, 1 year, 2 years). Patient did not received treatment for the events. The events vertigo, blurry vision, tinnitus, anxiety resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome for the events experiencing tired, dizzy and drowsy and he feels like if his brain is not 100% like a person who takes a lot of drugs was unknown. The outcome for events vertigo, blurry vision, tinnitus, anxiety was not recovered.   No follow up attempts are possible. No further information is expected.
I had ringing in my ears. I was very lethargic. I had chills and low grade fever. I have hearing lost in my right ear.
mom states had severe local rxn-gulf ball sized knot red & hot, unconsolable, constant crying over 4 hr same day, called MD;MD said allergic (did not see pt);pt recv DT/OPV/HB vax 10MAY96 w/no reported problems;
pain, swelling of arm shoulder &  elbow & inc temp; tenderness lt shoulder & elbow; fever of 102 on 25JAN95 & all day 26JAN95;
p/vax pt exp chickenpox;reporting hlth care professional noted child has 6 lesions;
01/16/2007 pt came to office stated went to ER c/o pain to left back of arm with swelling and redness told to have reaction to vaccine.
patient reported to the vaccination clinic to receive the 2nd dose of the Pfizer vaccine. after vaccination patient reported first symptom of having an upset stomach and began to lose vision while remaining conscious.  The patient was moved from the vaccination chair onto a patient bed with head elevated and given an ice pack. after   patient was placed on bed the patient still had loss of vision and the complained of itching on lower back area as well as difficulty breathing.  Patient was given 0.3mL Adrenalin brand  Epinephrine vial dose 1:1000 on L deltoid approximately 2 inches below vaccination site approximately 4 minutes after onset of symptoms. Vitals were monitored after Epinephrine administration and became stable. Emergency Department at the hospital was notified and reported to the room for transfer.
heart palpitations; he has an incomplete right bundle branch; This is a spontaneous report from a contactable consumer or other non hcp. A 21-year-old male patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on 16Mar2021 (at the age of 21-year-old) as DOSE 1, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. The patient received first dose of Pfizer vaccine on 16Mar2021 and within first 25 minutes developed heart palpitations. When he went home his heart rate was in the 110's. He went to the emergency room and had an EKG and his heart rate ranged from 88-110. The doctor said that he has an incomplete right bundle branch and he had to follow up with a cardiologist. The patient was asking whether this a dangerous side effect. Outcome of the events was unknown   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Narrative: COVID infection following COVID vaccine series 04/08 Janssen, dose #1 08/23 COVID swab, result: detected 08/23 pt cc:Loss of taste or smell exposure: unknown
pt experienced flu like symptoms beginning 6-7 hours after receiving the vaccine. She reported headache, body aches, chills, sore arm. Significant bruising the size of a tennis ball appeared 18 hours later around the area of injection and persisted for 10 days.
Massive PE, patient died. No history of DVT, we did a COVID test here and it was negative.  She had no PMH, we suspect the vaccine made her hypercoagulable. Had pleuritic CP, tachycardia, tachypnea.
Hours after shot I experienced muscle pain in lower back, arm , lower legs. Swollen glands, loss of smell and taste. Headache. Cough. Chills. Fever.
Pt exp facail puffiness & SOB; awoke w/coughing; also reports pruritis p/last inject; c/o achiness also feeling semi-disoriented;
swollen armpit; Pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer Support. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 27Aug2021 08:00 (Lot number was not reported) (at the age of 35-years-old) as dose 1, single for covid-19 immunisation. Medical history was none and there was no family medical history relevant to event. There were no concomitant medications. The patient did not receive any vaccination 4 weeks prior to COVID 19 Vaccine. In Aug2021, the patient experienced swollen armpit and had pain because of it. At the time of reporting, she was in an emergency room experiencing swollen armpit. The patient took the powdered Aspirin BC and Tylenol PM as treatment for the events. The patient's second dose was scheduled on 17Sep2021. The outcome of local swelling was not recovered, and outcome of pain was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Pt. began with (R) upper arm swelling/redness and pain within 24 hrs of receiving vaccine, slightly itchy. (R) arm abscess (13cm x 13cm induration). Started on KEFLEX 500mg 4x/dy x10 days, TYLENOL/antihistamines.
Pt arrived to the hospital due to a fall at home. Was recently diagnosed with RSV. Pt denies cough, fever, nausea, or vomiting. Pt was positive for COVID-19 on admission.
nurse a administered MENQUADFI to a pt that was supposed to get Bexerio,with no reported adverse event; Initial information received on 27-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 19 years old male patient to whom nurse administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] who was supposed to get bexerio, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Feb-2023, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (Strength: standard) (lot: U7459AE; expiry date: 03-Nov-2024) via intramuscular route in the right deltoid for immunization who was supposed to get bexerio,with no reported adverse event (wrong product administered) (same day latency).  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event nurse a administered menquadfi to a pt that was supposed to get bexerio,with no reported 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 the guidelines. 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.
FUO + pancytopenia + acute encephalopathy   Workup revealing secondary HLH  Symptom onset with fatigue reported day after the COVID-19 vaccine dose
Myalgia Left hip pain, Abdominal pain LLQ, pain and weakness in left leg Narrative:  Took Tylenol on Dec 25 for pain. Jan 4 went to ER and was diagnosed with a DVT in left iliac vein. Will be on blood thinners for a year and will need to see an oncologist and a cardiologist.
FEELS LIKE A TOOTHACHE TIME 10X; LEFT LEG PAIN; LEFT LEG NUMBNESS; 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 (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 JUL-2021, the patient experienced feels like a toothache time 10x. On JUL-2021, the patient experienced left leg pain. On JUL-2021, the patient experienced left leg numbness. Laboratory data included: Pain scale (NR: not provided) 10 plus. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from left leg pain, and left leg numbness, and the outcome of feels like a toothache time 10x was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid test was negative; Positive, notes: Two days later, it was positive again. Therapeutic measures included Paxlovid from 04Aug2023 to 09Aug2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient vaccinated too early. Patient initially vaccinated on 4/16/21 at PHD. Today patient received second dose on day 8.
only the liquid component used; only the liquid component used; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA759A, expiry date 30th November 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comments: A health care professional reported that the patient might received a partial dose of Menveo with only the liquid component. The reporter consented to follow up. Additional Supportive Information: The patient received partial dose of Menveo with only liquid component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2022193714, reported by same reporter.; Sender's Comments:  US-GSK-US2022193714:same reporter US-GSK-US2022193714:same reporter
Patient reported difficulty swallowing and pain in jaw bone radiating to his ear (right side of face). Started feeling symptoms within 1 hour of injection. No trouble breathing or throat swelling reported.
After the vaccine I had a headache, chills, sleepiness, pressure at 180/150, tiredness, after a few days the symptoms were relieved but I still have the headache. I work in the hospital and they gave me medicine right there. In June 2022 I got COVID-19 and they gave me treatment, but I still have a headache and I had an MRI yesterday and I'm waiting for the results. I have problems with my left ear, I have like a ringing and I hear double, like an echo, this was after COVID-19.
Influenza 0.5ml was ordered and given to patient. She had a reaction maybe 10-15 minutes after vaccine was given.  It was described as; Urticaria.
fever 101.8, body aches , chills, back pain , cough, shortness of breath , loss of taste and smell, sore throat
tested positive with covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive with covid) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) 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 24-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive with covid). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive with covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.
My mother was found unconscious on the kitchen floor. She was taken to the hospital. She had different test including a Cardiac stress test and it was found to be okay. However, my mother developed a blood clot in her left leg. She still been under medical observation in the hospital.
Had arm soreness. I was tried as well. I had a bleed in my left eye on April 19th. I had a shot in my eye. Show that I had inflammation in my eye.
Severe pain in right top of arm to right hand & fingers. This has been a month of pain and not getting better.
Within minutes of having the GARDASIL vaccine her Throat got itchy and scratchy and her hearing got muffled for a few minutes. Dr.  checked oxygen levels and blood pressure both were fine.
Urinary tract infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 26-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 URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   Reported Treatment medication including antibiotics. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 26-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 URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   Reported Treatment medication including antibiotics.
Seriousness criteria: Other-Medically Significant Initial report received from another manufacturer on 14 November 2007 who received the report from a health care provider. An unidentified patient had fainted an unspecified amount of time after receiving vaccination with Menactra (lot number, route and site of administration not reported). Per the report provided by the other manufacturer, the "Physician does not want to be contacted." No further information was provided.
I was going by the excursion  expiration date  of  Pfizer of an expiration of 7 days thawed in the refrigerator. Walgreens policy of 5 days was past due. The vaccine was given 6 days thawed in the refrigerator.
Received MMR 2/20/08 developed rash, arthralgias, 2/28/08. Lab on 3/5/08 showed mildly low platelets.
C/O left upper arm pain #2 on pain scale at first, pain always there then worsen a month later with movement, unable to lift arm, pain #8 on pain scale. Has use TYLENOL and MOTRIN not effective. Seen by Dr. on 2/4/10, ordered x-rays to be done 2/6/10. Patient stated she received MMR in R arm and tetanus in L arm in 12/09 at Dr. office.