chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Caposy Sarcoma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: new positive home test results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The treatment received for COVID-19 was with Paxlovid from 21Dec2022 to 27Dec2022.  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.
Mild soreness at vaccination site, mild body aches, low grade fever (99.1) lasted 1 1/2 days. Did not inform doctor.
10. Covid monitoring documentation. PT admitted 11/26/21 documented to have positive covid. PT received Pfizer 3/5/21 Lot EN6198 for dose 1. Dose 2 was Pfizer given on 3/26/21 Lot EP6955. PT expired on 12/12/21 due to COVID19 pneumonia.
Pt wife was in imz booth with pt - due to anxiety and prior incidences of feeling faint and dizzy post vaccine.   Less than 1 min after vaccine, pt was full body sweats, feeling lightheaded, disoriented and near fainting.  raised legs, applied cold compress x 2, bp stable gave cool water, advised to remain in booth - pt/spouse denied calls for emergency assistance due to anxiety - 10 mins feeling much better, slightly pale gave snack and powerade drink - bp stable. 30 mins came out of booth and stood for several minutes while I gathered more info and assessed ability to stand.  they left to go home.  follow up call 8 hours post reaction - patient rested, ate meal (had been fasting this a.m.) hydrated, feels fine
Patient received original series of COVID-19 vaccine with Materna 3/29/2021 and 4/26/2021.  He received his COVID-19 booster with Pfizer on 12/1/21. Patient presented to the hospital on 1/8/2022 due to symptoms of shortness of breath, mild chest discomfort and was found to have bilateral subacute nonocclusive segmental and subsegmental thromboemboli.  Patient was negative for COVID-19 and had no other risk factors for thromboembolic event.  No known family history.  Patient was treated with full anticoagulation.
Post vaccine patient collapsed out of chair. Disoriented, pale, "tingling sensation". Given 2 benadryl and water- ambulance arrived and took over patient care.
Triggered a migraine within a day. Within 3 days, muscle weakness and fatigue.  On day 11, muscles in jaw tight - unable to open or close my jaw. Difficult to eat.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received BOOXTRIX (batch number KG7E2, expiry date 29th MAY 2018). Concomitant products included irbesartan, Levothyroxine, omeprazole, Wellbutrin XL and Zoloft.  On 9th August 2016, the patient received the 1st dose of BOOSTRIX (intramuscular) .5ml. On 10th AUGUST 2016, 1 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be probably related to BOOSTRIX. Additional details were provided as follows: On 9th AUGUST 2016, at 09:21 AM, the patient received a dose of BOOSTRIX in left deltoid.
Red patch on arm at injection site, splotchy at first, solid red after a number of hours. Feels harder than the skin around it, slightly itchy. 2 inches by 3 inches.
Pt is 36 yo male, employee at this institution. He is s/p Moderna COVID-19 full vaccination: first dose on 1/2/2021, second dose on 2/9/2021. Underwent voluntary COVID-19 rapid testing on 7/8 after experiencing symptoms including headache, sore throat, and congestion/runny nose. Pt reported possible exposure to COVID-19. Rapid test resulted positive. Patient advised to self-isolate for 10 days after symptom onset and contacted by local health department.
I received the Johnson and Johnson vaccine on Saturday March 20, 2021. Later that evening, I started to experience diarrhea which followed by severe stomach pains. After that, a fever came then chills and body aches. My temperature was 100.08. The following day, I woke up and checked my temperature and it was 101.09. I went to the emergency room. They gave me fluids in an IV and something the pain as well as Tylenol. I was discharged and told to rest until Monday. I returned to on Tuesday.
That evening a mild tremor began in my left calf. It progresses to my entire left leg, left hand. My left hand began to curl up, the tremor continued to increase. Although I have full ROM in the hands at rest the fingers are curled and my index finger points outward. The worsening occurred each day. I had electric type pain in the left foot. The previous double vision worsened in the left side. The symptoms then spread to the right side. My balance worsened.  I had an MRI of the brain and neck, contrast and non-contrast approximately a week after symptoms began. I went to the ER as the symptoms worsened. My left leg was dragging, I had trouble walking. IV toridol decreased symptoms. I was given Motrin at home with no result, then another anti-inflammatory, then a steroid, all with no results. I had several blood panels. After a month of symptoms we did another brain MRI and full spine MRI's all negative. We did extensive blood work for autoimmune, inflammatory and eight or so other items such as Lyme, Syphillis, arsenic and I'm not sure what else. The nuero exam showed normal reflexes and strength.  He did some nerve conduction tests. The right calf was normal. He couldn't assess the left because of the tremor. I feel my legs will 'give out' and feel weak when performing activities and was told it's from the tremor. I have cramps and spams in the left foot and lateral calf. My balance is much worse, I fell over today while walking. These are all symptoms that are similar to the brain tumor in that it mostly affected the left side, but they are much, much worse. The deficits I had from the tumor in 2008 have been completely stable. A year or so after the surgery stress could increase the double vision or balance but not since 2009.
Hypertension, shaking, high pulse, emesis, incontinence, low O2
BLOOD CLOT FROM GROIN AREA ALL THE WAY TO THE LEG; This spontaneous report received from a patient concerned a 63-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, osteoarthritis, bursitis, rheumatoid arthritis (RA), migraine headache, anxiety, and cholesterol, and other pre-existing medical conditions included patient had no history of blood clots and no prior heart conditions.  On 16-Mar-2021 around 09:00, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: Unknown) dose was not reported, frequency 1 total, administered on left arm for prophylactic vaccination. Concomitant medications included pantoprazole for acid reflux, citalopram for anxiety, simvastatin for cholesterol, and prn 1371 for migraine headache.  On an unspecified date in Feb-2021, the patient mentioned (heart doctor) had done some tests on veins making sure the patient's heart was open and does not have any blood clots. Laboratory data included: Diagnostic ultrasound (NR: not provided) Normal, and Doppler ultrasound (NR: not provided) No blood clots. 7 days later the patient was informed everything was fine and she got vaccinated on 16-Mar-2021. On 07-May-2021, the patient reported that her left leg started hurting. On 09-May-2021, the leg started swelling. On 11-May-2021, the patient was admitted to the hospital with a massive blood clot from groin area all the way to the leg. On 14-May-2021, she was discharged from hospital. The patient was hospitalized for 3 days. The patient stated her doctor will let her know if she can move around more next week, the patient is currently in lot of pain. Treatment medications (dates unspecified) included: apixaban, paracetamol, tramadol hydrochloride, gabapentin, and baclofen. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from blood clot from groin area all the way to the leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210500586-COVID-19 VACCINE AD26.COV2.S-This case concerns with 63 year old female  blood clot from groin area all the way to the leg -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Coded. Former 28 wk gest infant was on peds floor prior to discharge. He had been fed 45 min before event. Monitor alarm for bradycardia HR 78. RN responded, infant apneic, PPV initiated --> code after chest compressions, intubation, to NICU on ventilator. Extubated approx 48 hours; NPO while on vent. 10/22/2009 hospital records from 7/8-9/13/2009. Baby boy 28 wks per C-section , condition stable was out of NICU and preparing for discharge presented with sx of apnea, bradycardia, possible aspiration pneumonia post vaccinations 9/2009. TX: transferred back to NICU, vented and IV ABX. DC DX's: 28 wk premie, RDS, suspected aspiration pneumonia vs imunnization effect. ICD-9 codes: v30.01, 774.2, 775.4, 779.3, 765.14, 765.24, 770.89, 458.9, 770.81, 770.7, 773.2, 762.0, 362.22, v05.3, v06.3, 772.6, 761.7, 762.5, 348.0, 779.81
PT DX WITH SYNCOPE EPISODE AFTER PASSING OUT AT HOME AND BREAKING RIBS ON 12/14/2021
A series of bumps in various places over the body.  These increased in the worst places into a single red mass.  There were some blisters, though not many.  These itched.  Treated with cortisone cream for a day or two and eventually added over-the-counter Benadryl (by mouth) three to four times per day.  Six days after injection the itch began to be reduced and at the 10th day the rash is drying up.
Itching on upper torso, arms and face and scalp noted 2-4 hr after receiving injection. Also had itching on arms- 2 days later
Approx 6PM unusually quiet, sleepy & difficult to awake, fever <102; Did not eat during this time - took only liquids;
Patient received  his second dose of Pfizer. I asked him to ask him to sit down for 15 minutes . He was okay and left and came back after about 30 minutes complaing  of dizziness and headache. I measured his BP it was 117/71 and pulse was 75. No breathing problems. I gave him gatorade to drink. After he drunk the gatorade  he felt better and left.
Pt c/o pain on left deltoid, pain and fever times 2 days. Pt was treated with Septra by mouth and dicloxacillin.
The day of the vaccine about 5 minutes after receiving it - increased fatigue. Next morning, increased headache 8 out of 10 for pain. It didn't dissipate - it was ongoing headache - Extra strength Tylenol; Excedrin; increase water intake and coffee...20th  went to Doctor - and I had headaches every since - Toradol - 2 mg injection; Furaset was ineffective; Sumatriptan was ineffective  fatigue has subsided but headaches are still there.
Intussusception 11/5/06 - 11/09/06 reduced with Ba enema.  12/8/06 Received medical records from hospital which reveal patient experienced a week of vomiting prior to admit.  No fever & no sick contacts.  Lethargic on admission 11/3/06 & anterior fontanelle was depressed & mucous membranes dry.  Abdomen was soft with no masses or distention.  Surgical consult done.  Air enema relieved the IS.  No further vomiting & patient d/c to home on 11/8/06.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 12-AUG-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Information has been received from a hospice nurse concerning a 16 years old female with unknown drug allergies and unknown medical history who was vaccinated with the first dose of GARDASIL. Subsequently the patient was diagnosed with Amyotrophic Lateral Sclerosis (ALS) shortly after receiving the first dose of GARDASIL. The nurse learned of the patient's experience when her family called seeking hospice care for her. The family did mention that the first dose of GARDASIL caused that to the patient. Unspecified medical attention was sought. It was unspecified if laboratory studies were performed. At the time of the report, the patient had not recovered. The Amyotrophic Lateral Sclerosis was considered to be disabling. In follow-up with the representative, it was learned that no contact information is available. No further information is available.
Large red raised areas on both checks; This is a spontaneous report from a contactable nurse (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: E51686), dose 2 via an unspecified route of administration, administered in right arm on 27Jan2021 09:00AM as single dose for covid-19 immunization at Nursing Home/Senior Living Facility. Historical vaccine included dose 1of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0140) via an unspecified route of administration, administered in Arm Left, on 06Jan2021 10:00AM. Medical history included anaemia, hypertriglyceridaemia and psoriasis. Patient had no known allergies. Concomitant medication's included piroxicam (PAXIL [PIROXICAM]), ferrous sulfate (IRON SULFATE), cyanocobalamin (B12 [CYANOCOBALAMIN]) and Multivitamin. Patient was tested with covid prior vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient has not been tested for covid, post vaccination. On 27Jan2021 09:00AM, the patient experienced large red raised areas on both checks. Patient did not receive treatment for the event. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
patient experienced bad flushing in her face; her arm was really sore for one day after the 2nd; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as second dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as 1st dose, single for COVID-19 immunization. The patient experienced bad flushing in her face which lasted for 30 minutes after the patient got the vaccine and her arm was really sore for one day after the 2nd dose on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Delivered baby on 5/11/09. Got MMR while still in hospital on 5/13/09. 2 hours later c/o numbness of tongue. Later c/o pain and tingling of l neck and back of head. the next morning c/o spasms/twitching of l eyebrow and below l eye & lip followed by numbness and paralysis l side of face and mouth. Now c/o twitching/spasms and weakness of l arm and leg. Going to see a Dr. today.
Dose 1: Thursday, January 8, 2021     Swollen throat lymph nodes/Sore arm   Dose 2: Friday, January 29, 2021    Day 1 - Sore arm     Sunday, Jan. 31 -          (NEW) Marble size lump on left clavicle           (Swollen, painful - Possible lymphadenopathy)    Tuesday, Feb. 2 -            (NEW) swollen/painful injection site on left arm           Continued marble size lump on left clavicle
On 11/3/2021, it was discovered the vaccine administered that day had been stored in the freezer longer than the recommended 14 days. Patient did not have an adverse event.
After second dose caller had COVID; After second dose caller had COVID; This is a spontaneous report from a contactable consumer (patient himself) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in January2021 as dose 1, single; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in February 2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient after second dose the patient had covid. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unknown date in 2021.Patient treated with monoclonal antibodies. The reporter states that he really wants to know if the booster is going to be the same as the other two doses because he had no effects from them whatsoever. COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose is not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It is thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are doing studies to confirm this. We expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities like the FDA in the coming weeks. Note to frontline: This FAQ should only be used if an HCP or non-HCP specifically asks about the Pfizer statement on booster doses. For HCPs with general inquiries about booster doses, please refer to the SRD titled "Administration of More Than a 2-Dose Series (Booster Dose)". Non-HCPs should be referred to their HCP for further discussion. The outcome of the events was unknown. There was no product quality complaint (PQC) present.  The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100957896 Pfizer
This case was reported in a literature article and described the occurrence of uveitis in a 29-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine ;manufacturer unspecified given on an unspecified date. On an unspecified date the subject received 1st dose of Hepatitis B vaccine (unknown). One day after vaccination with Hepatitis B vaccine, the subject experienced uveitis, arthralgia, erythema nodosum and fever. This case was assessed as medically serious by GSK. Relevant test results included elevated sedimentation rate. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Information has been received from medical records concerning a female infant (full term normal baby girl weighing 7 pounds 8.4 ounces with a length of 19.9 inches, apgar 8/9) who on 17-SEP-2007 was vaccinated with RECOMBIVAX HB (manufacturer unknown). On 29-SEP-2007, the patient's baby was seen by a pediatrician due to constant crying. There was no fever and no cough, but some congestion. The baby was also spitting up 2-3 times per day after feeding about 20-30 minutes. On 28-SEP-2007 the baby had projectile vomiting but no diarrhea. There was no blood in emesis or stools. The patient was passing gas frequently. The physician assessed as questionable colic. On 16-OCT-2007 the baby was seen again for gas and having spit up. The physician recorded "maybe early VS or maybe normal bowel". On 11-DEC-2007 the baby was seen for a two week history of spitting up, being fussy, screaming before feeding and bed and with projectile vomiting times one in the am. There was no diarrhea, and stools were pasty-hard pebbles. The baby had a clear runny nose and congestion. The baby was assessed for GERD vs cow's milk/soy protein intolerance and constipation. On 21-DEC-2007, the baby had no vomiting on soy and no reflux was noted. 21-DEC-2007 the baby was vaccinated with ROTATEQ, DTAP (unspecified), POLIO (unspecified), HIB (unspecified carrier), PNEUMO (unspecified), RECOMBIVAX HB (manufacturer unknown). On 22-JAN-2008 the baby was seen by a pediatrician due to concerns from the mother of "raspy breathing/questionable wheeze" which started on 20-JAN-2008. Upon assessment, the baby's lungs were clear. On 22-JAN-2008 was vaccinated with ROTATEQ, DTAP (unspecified), POLIO (unspecified), HIB (unspecified carrier), PNEUMO (unspecified), RECOMBIVAX HB (manufacturer unknown). On 30-JAN-2008 the patient's baby was noted to have thrush on the lips and was treated with nystatin. On 28-FEB-2008 the baby was seen by a pediatrician for complaints of a questionable earache. The baby was noted to have an erythematous dry skin on both cheeks with a dry patch that had been enlarging and behind the left ear. Treatment with vaseline did not help. Dry skin was also noted on the trunk and extremities. The baby also had a cough and swelling in the left ear. The baby was diagnosed with a mild upper respiratory infection, eczema and dehydration and treated with nasal suctioning, TYLENOL, EUCERIN. At the time of this report, the outcome of the infant's events was unknown. No further information is available.
Information has been received from a registered nurse referring to a 13 years old male patient. On 24-JUL-2015 10:30 AM, the patient was vaccinated with GARDASIL 9 (first dose, lot # K026246, expiration 28-JAN-2017, dose unknown, intramuscular), which was exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because requested follow up information has already been received.