chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients complained of fever and severe chills, shivers so strong he put styro-foam between his teeth to protect them.  He spoke to his physician and determined that his cortisol was extremely (dangerously) low.  When questioned it was unclear if blood work was done to verify his cortisol level.  He also complained of body and joint aches , fatigue and general malaise. Patient has provided a detailed account of his reaction to the second vaccine.
Patient called 12/11/2013 to complain of redness, swelling, and heat at injection site; I advised to use Hydrocortisone and ice at injection site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 59 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EH3899), in left arm, on 12Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 301358BA), in left arm and on 01Jul2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Feb2023) Positive, notes: First tested positive on 01Feb2023 and started Paxlovid that evening; (09Feb2023) Negative, notes: I tested negative on 09Feb2023, day #8, after finishing Paxlovid on 02/06/23; (10Feb2023) Positive, notes: On Friday Feb 10th in the morning I woke up with nasal congestion and headache and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 01Feb2023 to 06Feb2023.  Additional information: I tested negative on 09Feb2023, day #8, after finishing Paxlovid on 06Feb2023. First tested positive on 01Feb2023 and started Paxlovid that evening. On Friday Feb 10th in the morning I woke up with nasal congestion and headache and tested positive again  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
Runny nose, coughing, then 5/12/2012 developed conjunctivitis and 5/14/2012 developed ear infection.
Information has been received from a public health nurse concerning a 37 yr old female who on 01Apr04 was vaccinated in the right arm with a second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 645907/0511N). Three weeks post vaccination, on approx 22Apr04, the pt developed pain and swelling in the right knee, left knee, ankles, wrists, hands, index and middle fingers. Unspecified medical attention was sought. The pt did not require treatment at the time of this report. The pt was to follow up with the physician on 29Apr04, at the time of this report, the pt's pain and swelling persisted. Additional information has been requested.
Several hours after receiving his Fluzone High Dose Quad vaccine, Client became immobile and had a very difficult time speaking. His wife gave him a dose of his Apokyn and he regained mobility, but it was still much more limited than his daily baseline. He took his regular nightly medications and slept from 10:30pm on 10/21 until 1:30pm on 10/22 when his wife called to report the reaction. His wife reported he also experienced a flare in his Parkinson's symptoms following both doses of his Covid vaccine, though neither instance was as severe as this response.
Was exposed to grandson on 07/11-11/11 and he was diagnosed with RSV. On 10/11 I became very hoarse, lost my voice, and horrible sore throat. I took cough meds and prednisone for my throat. After I completed the round of prednisone my sore throat returned and I developed congestion. At this time I took a COVID-19 test on 21/11 and tested positive. I called PCP and had telehealth visit and was prescribed PAXLOVID. Began taking PAXLOVID the evening of 11/21. Felt slightly better on the 11/22 and still feeling slightly better today.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-395985 (Patient Link).
A rash appeared on my arm around the injection site. It was very warm to the touch but did not hurt. It covered from my shoulder to my elbow. I used ice packs but did not require any other treatments. It lasted about 4 days before fading. I had no other symptoms so I monitored it on my own.
Extensive blistering on arm; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an female patient of unknown age who had extensive blistering on arm (blister), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious extensive blistering on arm (blister) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was reported as unknown.  There will be no information available on batch number for this case.
Pneumovax H012650 and influenza 1204301 given on 10/11/12; pt had fever 102.3 that evening. Fever came down to 101 with acetaminophen and got as high as 103.4. Patient admitted to hospital 10/13/2012 with evidence of pneumonia; WBC had significantly increased since clinic visit when vaccine was administered.
This is a spontaneous report from a contactable consumer(patient). A 51-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 07Mar2021 12:00 (Batch/Lot number was not reported; Expiration Date: 30Jun2021) (at the age of 51-year-old) as Dose 1 0.3 ml single for COVID-19 immunization. The patient medical history included overactive bladder and the patient had a reaction from poison sumac and was given a cream or steroid. Concomitant medication taken for overactive bladder(Unspecified). No Family Medical History Relevant to AE, No Relevant Tests. Not visited Physician's office,Emergency room yet. It was reported that The caller started taking medicine for her over active bladder but she didn't have problems in the past when she took it so she doesn't believe it was what caused her rash. Also the day of the vaccine the caller took some Advil that evening for her headache and sore arm. The caller had a sore arm from a flu shot, unknown lot or expiration, received it in the beginning of flu season this year. The patient experienced rash, itchiness, redness on 16Mar2021 and headache on an unspecified date. The redness still red but not getting worse. The rash started in the morning of 16Mar2021 but it hasn't gotten worse. Treatment was taken for headache (Advil). The Outcome of the events rash, itchiness,redness was not recovered. Outcome of the event headache was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Blood pressure up and down; Vaccine was purple and not clear in vial; A spontaneous report, was received from a consumer (patient), a 70 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced blood pressure up and down (blood pressure fluctuation), and vaccine was purple and not clear in vial (product colour issue).    The patient's current conditions included allergy to dye and anaphylaxis. Concomitant medications were not reported.  On 24 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for the prophylaxis of COVID-19 infection.    On an unknown date in Feb 2021, after receiving the vaccine, the patient had her blood pressure up and down. The patient stated that the vaccine was purple and not clear in the vial on 24 Feb 2021, and still the pharmacist gave her.  The patient was hospitalized for her blood pressure fluctuations. Treatment information was not provided.    Action taken with second dose of mRNA-1273 in response to the events was not provided.  The outcome of the event, blood pressure up and down was not reported and that of event vaccine was purple and not clear in vial was recovered on 24 Feb 2021. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start  of the event, a causal relationship cannot be excluded. Further information has been requested.
patient had numbness to the touch at the injection site ,  the upper left chest area, and her upper back area behind left arm that is still occurring at this time 8/14/21
Raised, swollen, hard, bruised at injection site.  Treated with diphenhydramine 25mg and cold compress.  Patient remained at pharmacy for observation for 20 minutes.  No other reactions occured and patient felt fine and left pharmacy after 20 minutes
parents describe rt sided (arm) w/tremors, jerking movements spontaneously occuring primarily 1st 48 hrs p/vax; gradually resolving fussy & irritable throughout that period, no fever; plan: EEG, CBC, Mg, Ca, electrolytes, urine for amino;
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
Improperly stored vaccine was administered to a consumer; This spontaneous report has been received from a nurse concerning a 14-month-old patient of unknown gender and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 14-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (lot # S005249 with expiration date on 20-FEB-2020; dosage regimen and route of administration not reported) for prophylaxis; that had been exposed to a temperature excursion above 47 degree farenheit (F): 48.38F for 55 minutes and 54.32F for 7 hours and 14 minutes (no previous temperature excursions). Excursion was called by a digital data logger.
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Aprox. 2 min. after vaccine admin., pt. fainted and appeared to have a seizure.  Upon regaining consciousness, pt, began sweating and vomited. Pt was confused after the incident.  EMS was called and took over care. Pt was taken to local hospital.  Outcome of ER visit in not known.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE DVT OF RIGHT TIBIAL VEIN ACUTE DVT OF RIGHT CALF, UNSPECIFIED VEIN ACUTE DVT OF LEFT CALF, UNSPECIFIED VEIN ACUTE DVT OF BILAT CALVES, UNSPECIFIED VEINS ACUTE PULMONARY EMBOLISM 1/25/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
After first shot - got COVID on Dec. 31, 2020, was down till January 18, 2021 Second shot - headaches, body aches, for 2days.
FEVER; HEADACHE; MUSCLE ACHES; 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 patient experienced fever, headache, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and the outcome of fever and muscle aches was not reported. This report was non-serious.
I was 3 weeks pregnant when I received my first dose of Pfizer vaccine. At my first ultrasound they could not detect a heartbeat and I had a miscarriage. I had undergone alot of testing before I got pregnant and all my tests showed that I was perfectly healthy.
Ache bones, ache joint, ache joints and muscles, acid reflux, alopecia, amblyopia, amnesia, mood anxiety, heart arrhythmia, balance problems, concentration difficulty, loss of concentration, leg cramps, depression, energy loss, hair loss, heart palpitations, impotence, memory difficulty, memory failure, memory loss, memory bad, nervousness anxiety, pain back, pain knees and hips, pain lower back, pain joint and muscle pain and stiffness, pain bone and joint, pain muscle and joint, pain ear, pain back, sleep insomnia, sleep problems, sleep feel no refreshed upon waking up, tachycardia, weight gain,
Left Arm: Warm, tender, red, swollen, increased tenderness Plan: Ice to arm, ZYRTEC PO Q day, BENADRYL Q HS X 3 days, Clindamycin 250mg BID X 7days. Pt left clinic in stable condition
He reports he was seen in the ER on 20 January prior to onset of his symptoms for epigastric pain felt to be due to gastritis due to NSAID use; he was given acetaminophen, famotidine, and sucralfate which he has continued to use. Since 20 January, shortly after he left the ER he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affects his palms and soles, and resolve without post-inflammatory changes. Symptoms led him to present to the ER on 23 January where he was treated with oral antihistamine and corticosteroids with limited benefit. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 5 January, 15 days prior to onset of symptoms. He has used oral antihistamines with some benefit. He denies constitutional symptoms. score today is 4 (0, 0, 0, 0, 0, 0, 4, 0). No history of adverse reactions to prior vaccines.
Both injections gave me high fever, cough, shortness of breath, high blood pressure and chest pain
Cerebellar encephalitis, cerebellar syndrome incoordination. Patient experienced 4/10 pain in the hands, arms, feet, back and hips. Patient also had an unsteady/disturbed gait and blurred vision/double vision-horizontal nystagmus; she also experienced dizziness, malaise, achiness, and a fever up to 100F. The patient also had episodes of incontinence. The discharge summary states encephalopathy and urinary tract infection
Immediately after receiving flu vaccine, Pt. c/o: Left arm being numb, tingling, and prickly. Later on right hand with same symptoms and neck pain.
PT WAS SCHEDULED AND RETURNED TO CLINIC ON DAY 22 AFTER INITIAL VACCINE. PT DID NOT HAVE VACCINE CARD UPON ARRIVAL TO CHECK THE DATE BEFOREHAND. SINCE PT WAS ON THE SCHEDULE TO RECEIVE 2ND DOSE OF MODERNA, IT WAS ADMINISTERED TO PATIENT EARLIER THAN THE 4 DAYS THAT ARE ALLOWED.  PATIENT WAS OBSERVED FOR 15 MINUTES WITHOUT REACTION. THE ERROR WAS EXPLAINED TO THE PATIENT AND ALL QUESTIONS WERE ANSWERED.
I received the shot on a Friday on my lunch hour and had arm pain for about an hour.  That night started developing some tiredness and body aches and a slight fever.  Saturday I could not get out of bed.  Chills, muscle aches and fever, ran a fever so high 104 plus I was delirious and could not get warm.  Sunday fever was down to 101.  Monday had a full blown head cold that lasted for 24 hrs.  About 2 weeks later I developed this right ear ringing.  It never stops and it is getting louder.  24 hours a day.
I had my first dose of the Pfizer vaccine at 10:30am on Sunday, March 21, 2021.  The next day I felt light headed and my stomach was queasy.  This continued all week with fatigue.  On Friday night, March 26, I  awoke during the night with discomfort in my lower left abdomen.  This quickly progressed to severe pain.  I could not find any position that would help the pain.  My whole abdomen felt awful.  I had to remove ny clothes so that nothing touched my abdomen.  My whole body broke into a sweat and I felt like I was going to pass out.  I am not sure of the timeline but after about 1 hour I had diarrhea which helped to relieve the abdominal pain.   I dosed for a time.  I developed rectal bleeding in the morning.  I went to the ER where an abdominal cat scan showed inflammation in the colon and blood work showed an elevated white blood cell count of 14.  I was sent home with antibiotics.  I continued with rectal bleeding for another day.  Subsequent blood work done 2 weeks after showed my white blood cell count was back to normal.  I am better but not 100%.  The doctor's feel I had intestinal ischemia or a bacterial intestinal  infection .
This patient was administered the Moderna COVID-19 Vaccine  Booster Dose 6-11 for his second dose in the primary series. Patient did not have any adverse reactions to this vaccine.
Fever, chills, nausea, body aches (I.e. muscle, joint pain) Tylenol  11/6 symptoms were the worse 11/7 symptoms improved still not ok 11/8 symptoms in morning - mild
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.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose 7 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Recently had a lumpectomy to remove breast cancer" (unspecified if ongoing); "Recently had a lumpectomy to remove breast cancer", start date: Apr2023, stop date: Apr2023; "Allergy to pine nuts" (unspecified if ongoing); "breast infection in mid May", start date: May2023 (unspecified if ongoing); "Allergy to morphine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 06Jun2023 to 11Jun2023. Clinical course included: She assumed she had a lower immune system right then due to her surgery.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229398 same patient, different drug, different event.;US-PFIZER INC-202300229412 Same patient and drug, different events;
Fatigue; Fever; Chills; Elevated heart rate; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 16:00, the patient experienced fatigue, fever, chills and elevated heart rate. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, fever, chills and elevated heart rate were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Rash on chest, upper abdomen, shoulder above injection site, swollen lymph nodes (R) armpit - achy since afternoon of Nov. 14th.