chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; worsened eye problem/lost vision; major eye problems that may lead to a possible cornea transplant because she was losing her vision; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient. Other Case identifier(s): 22K-163-4397226-00.  A 66-year-old female patient received BNT162b2 (BNT162B2), 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), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 2019 (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "eye surgery", start date: 1995 (unspecified if ongoing), notes: In 1995, the patient had Radial keratotomy vision surgery, since had vision issues relating to the surgery. The patient's concomitant medications were not reported. The following information was reported: BLINDNESS (medically significant) with onset Apr2022, outcome "not recovered", described as "major eye problems that may lead to a possible cornea transplant because she was losing her vision"; CONDITION AGGRAVATED (non-serious) with onset Apr2022, outcome "not recovered", described as "worsened eye problem/lost vision"; ILLNESS (non-serious), outcome "recovered", described as "sick". The action taken for adalimumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of blindness, condition aggravated.  The reporter considered "major eye problems that may lead to a possible cornea transplant because she was losing her vision", "sick" and "worsened eye problem/lost vision" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Post vaccination reports feeling dizzy w/no additional symptoms or complaints; medical monitoring w/ vital assessment: BP82/58 P 83 RR 19 O2 sat 98% RA; rest w/ po hydration and symptom resolve; BP 106/66 P 68. Released from facility w/ self.
This case was reported by a consumer via call center representative and described the occurrence of cold in a 60-year-old female patient who received Influenza vaccine. Concurrent medical conditions included systemic lupus erythematosus. Concomitant products included fish oil, PLAQUENIL, Vitamin B12 and Vitamin D. On 4th October 2015, the patient received Influenza vaccine. On 4th October 2015, less than a day after receiving Influenza vaccine, the patient experienced cold and flu symptoms. On 6th October 2015, the patient experienced nasal congestion and feelings of weakness. On an unknown date, the outcome of the cold, flu symptoms, nasal congestion and feelings of weakness were not recovered/not resolved. The reporter considered the cold, flu symptoms, nasal congestion and feelings of weakness to be possibly related to Influenza vaccine. Additional details provided were as follows: This case was not previously reported to anyone. This case was reported by the patient herself. The patient also concomitantly received living green multivitamin. The patient reported that, she received a flu vaccine, of an unknown manufacturer at a health fair this past on 4th October 2015. On that day she started felt like she had the flu or a cold. On 6th October 2015, 2 days after vaccination, the patient felt weak and had congestion in her nose. Till the time of reporting, she has not discussed with her physician, but she was encouraged to do so.
Swollen Lymph Nodes; Pain in Left Axilla/ Breast; Pain in Left Axilla/ Breast; mild muscle aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 11:30 (Lot number: FJ5682) at the age of 60 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Osteopenia" (unspecified if ongoing); "Elevated BP" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; LISINOPRIL; CALCIUM;VITAMIN D. Vaccination history included: Janssen covid 19 (Dose Number: 1, Batch/Lot No: 045A21A, Location of injection: Arm Left, administration date=17May2021), administration date: 17May2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "no adverse events". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Feb2022, outcome "recovering", described as "Swollen Lymph Nodes"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious) all with onset 01Feb2022, outcome "recovering" and all described as "Pain in Left Axilla/ Breast"; MYALGIA (non-serious) with onset 01Feb2022, outcome "recovering", described as "mild muscle aches"; FATIGUE (non-serious) with onset 01Feb2022, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain, breast pain, myalgia, fatigue.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
warmness at the injection site; bad headache; A spontaneous report was received from a consumer concerning a 63-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed head ache and injection site warmth..   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Fluticasone,Escitalopram, Atorvastatin  On 21 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient developed headache.  On 29 Jan 2021, the patient developed injection site warmth.  Treatment for the event included, Butalbital..   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, Headache, was considered recovered on 28 Jan 2021. The outcome of the event, injection site warmth , was considered as unknown.
Within 2-3 minutes post vaccine, dizziness, felt like I was going to faint, weak, nauseated, loss feeling both hands, burning pain pressure back of nape of neck which spread to overall head.   Sat down right away,  pharmacist (? tech ; administered vaccine) were both very attentive. Stayed there 30 minutes.  My grandmother who is a nurse was right there with me.   I live with my grandmother; and she checked my BP at home: 120/86, Apical pulse 88 regular; rechecked today 7-20-21 and  it was 98/78, Apical pulse 72.  That night and next one to two days some dizziness and diff. sleeping due to pressure sides of head which is slowly improving and no more dizziness.
pt to ED after a fall at home; AMS with SOB; positive for COVID; Chest scans showed large right upper lobe lung mass; lymphadenopathy; presumably metastatic disease; multifocal pneumonia/pneumonitis; given steroids, ABX; family chose to have pt stay in SNF with hospice (Rehab) where she passed away
pt recvd vax 11AM & mom & child returned @ 1205 & eyes were swelling; lt worse than rt; lt 3/4 of way closed; no new rash; pt had genl fine body rash a/inject; ER report stated allergic react;
So far just arm soreness; This is a spontaneous report received from a non-contactable consumer (patient). This patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. Since an unspecified date in Jan2021 the patient experienced so far just arm soreness. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received a Pfizer bivalent booster for his second dose. Patient was monitored for 15 minutes and no adversed  reactions noted. Patient stated he was doing fine. Placed a call to the Director of Nursing and she was informed of what happened. Director of Nursing stated she will contact the family.
I started freezing and shaking uncontrollably; I started freezing and shaking uncontrollably; severe muscle aches and headache; severe muscle aches and headache; After two hours I was able to take my temperature, it was 102; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series of immunization completed, but manufacturer unknown., Dose: 1), for Covid-19 immunization; Covid-19 vaccine (Primary series of immunization completed, but manufacturer unknown., Dose: 2), for Covid-19 immunization; Covid-19 vaccine (First booster shot/ Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 11May2022, outcome "unknown", described as "After two hours I was able to take my temperature, it was 102"; FEELING COLD (non-serious), TREMOR (non-serious) all with onset 11May2022, outcome "unknown" and all described as "I started freezing and shaking uncontrollably"; MYALGIA (non-serious), HEADACHE (non-serious) all with onset 11May2022, outcome "unknown" and all described as "severe muscle aches and headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling cold, tremor, myalgia, headache, body temperature increased. Additional Information: After taking Tylenol finally went to sleep. The whole process lasted about 8 hours. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm swolen and bright red, approx. 10 inch circumference, extremely sore. One week later, half that size, dark purple, itchy. Upon rising on 9/11, entire body extremely achy, joints very stiff and painful.  Had to call for husband to help me walk and get seated. Could not even pour coffee. Could barely move. Took NSAID, which helped. Extreme fatigue for two days. Diarrhea followed two days later for two days. First shot only caused only a minor sore arm and minor fatique for one day.
Initial unsolicited report received from a consumer on 2 November 2015. This case involves a 64-Year-old female patient who was vaccinated with a dose of FLUZONE (route and site of administration, dose in series, batch number were not reported) on 29 October 2015. The patient had medical history of diabetes but declined to provide any further information and illness at the time of vaccination was not reported. The patient's concomitant medications were not reported. On 29 October 2015, immediately after vaccination, the patient's arm became red black and blue. Next day on 30 October 2015 the discolored area was larger. On 31 October 2015, the discolored area was extending towards elbow and the patient went to the clinic. The patient required ER/doctor visit. Other laboratory data was not reported. The patient's corrective treatment includes Keflex. The patient was not recovered from the event. List of documents held by sender: none.
Pt recvd. series of 3 shots exp pain @ time of first & second inject, edema, red hard & painful to touch & very hot, tender & red @ shot site; sore muscle; 3rd dose 26FEB91 exp painful inject in Feb91 had toxemia & C-sect delivery;
Day following vaccine became severely ill. Ran 102 + temp, severe neck pain, worst headache I have ever had, nausea.  This persisted for 4 days. On the fourth day I consulted the Infectious Disease provider at my location as I was scared I was going to have a stroke from the severe head and neck pain. They stated others had also been this sick from the Moderna vaccine and I should start feeling better, which I did the next day.
This spontaneous report as received from a medical assistant refers to a 9 years old Child, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Headache, 02/06/2022 I started having high blood pressure, as high as 201/97. Speech and coordination problems, balance problems, dizziness, nausea, vomiting.
Headache & Myalgia Narrative: Missed days 10/7-10/8/2021 Symptoms: Headache, chills, body ache and injection site pain
Five hours after vaccines high fever and convulsion about 5 minutes; lethargic. But not enough to be discharged from ER.
Woke up complaining of leg weakness, sore throat and a headache. Slept most of the day, around 6pm stated she could not breathe gave albuterol nebulizer.  During sleep around (10:15pm) heard chronic wheezing gave anyother albuterol treatment and 2 teaspoon of prednisone. Wheezing was still uncontrollable so I paged asthma clinic, the on call doctor called back and advice to give another albuterol and if systems continue to bring to ER.  Took daughter to ER at approximately 12am. She was admitted in PICU on continuous treatment and discharged on 10-29-09. On 11/05/09 took patient ER as her legs below knee to toes were freezing cold and she was screaming of intense pain.  She was admitted from 11/06/09-11/13/09. Since discharge patient continues to have intense pain and legs get cold.  I give her Motrin 2 teaspoon for the pain.  12/08/09 and 12/09/09 MR and DC summary for DOS 10/26/09-10/29/09 Final DX: reactive arthritis.   And Group A strep throat.  Pt c/o 1 day hx of cough, hoarseness, wheezing, sore throat, bilateral leg pain, stridor, positive substernal retractions, decreased breath sounds with poor air entry. Pt in stable condition, weakness in both legs, decreased ROM, diffuse tenderness from hips to toes. Tx: prednisone, Albuterol, Solumedrol, PCN for Grp A streptococcus infection.  12/08/09 and 12/09/09 Neurological consult for DOS 11/05/09. DX: Peripheral neuropathy following vaccination.   Pt c/o ankle, pain in legs, and weakness in legs for 10 days.  Pt had sore throat, dysesthesias, wheezing, SOB, and cough. Legs pain described more severe on R than L leg. Pain started on thigh and later on moved to ankle and joints. Tx: Gabapentin, ibuprofen.
Pt was given MMRV and nurse mistaken it as MMR and then child was given Varicella (Varivax) also. Child recieved 2 doses of Varicella today . Parents was notified to monitor child .
Dizziness, nausea, uncontrollable shaking lasting for 4 hours, chills, lethargy, barely able to walk, feeling of being on fire, feeling of being unable to catch a breath, dry eyes and mouth, severe sweating, not being able to control leg movements, unusual thoughts, confusion, stabbing pains in different parts of the body, all over aching in joints and muscles, rapid heartbeat.
Confusion, Headache, chills, body aches (unspecified) Narrative:
Immediately after received the vaccine, received experienced rapid heart rate, loss of conscious for 3 seconds, nausea, skin turned gray, confusion. The physician at side drove my car near to the ambulance. Physician, paramedics and medical staff assisted me inside ambulance. Electronic Blood pressure monitor in the ambulance marked BP 186/96 and HR 96. The paramedics performed several electrocardiograms. Paramedics inquired physician at site to complete an adverse event report. Physician states no report will be needed at this time.
Pain, redness at injection site that worsened 3 days post injection. Pt. also experienced tremors in hands. Surveillance, ice.
This spontaneous report as received from a licensed practical nurse refers to a 52 year old female patient with allergies to Codeine and Penicillin and no pertinent medical history. On an unknown date the patient was vaccinated with a does of ZOSTAVAX (dose, lot # and route were reported) on the triceps at a pharmacy. There was no concomitant therapy. The nurse reported "couple days after the vaccination", the patient developed redness, induration, and mild tenderness at the injection site. The patient sought medical attention by seeing a physician. No treatment was given. No lab diagnostics studies were performed. At the time of reporting, the patient's outcome was reported as recovering. This is one of several reports from the same reporter. Additional information has been requested.
Soreness in left arm, difficulty grasping objects, knot in muscle, difficulty in lifting arm above shoulder soreness began with immunization and has persisted.
Pt. received (L) deltoid IM vaccine (PPSV23) on 5/14/15. She called on 5/27 to report swelling and pain and limited ROM. She was advised heat / ice / NSAID's and had f/u appt. on 6/5/15. At appt. (L) arm symptoms completely resolved. She c/o new onset (R) arm symptoms. ((R) arm symptoms persist but ? related to vaccine).
Right arm became so swollen and hurt so bad, got red in color, and I had a fever of 103 degrees, couldn't move my right hand for two days. Still hurts today 1-20-16! Still can't taste food very well, and not hungry!
Muscle pain from shoulder to hand, also weakness in arm which has lasted from May up until present.
Patient hospitalized with apparent septic shock due to pneumonia on the evening of his vaccination. He died the following day 2/3
A report has been received from a Health Professional concerning a 48 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT 0.2 Millilitres. FLUMIST QUADRIVALENT started on 29-Jan-2016. HCP reported consumer received expired FLUMIST 0.2ml nasally 29-Jan-2016. FLUMIST QUADRIVALENT was continued. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious.
Information has been received from a physician concerning a 43 year old male smoker who in June 2007, was vaccinated with a first dose of VATQA (lot # 657842/0494U), and a second dose VAQTA (lot # 657842/0494U) in July 2007. Concomitant therapy included hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown), and PRILOSEC. On an unknown date the patient has experienced fatigue, which was noted to have been "discovered in office chart review". At the time of reporting the patients status was unknown. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
About 5-10 minutes after shot, patient came back and said she felt dizzy. I had the patient sit down and she then said she had severe dizziness and almost passed out in a store the previous week. She thought she felt better today, so she marked our questionnaire as not feeling ill. When I checked back w/ her after 10-15 minutes, she said she felt worse and is nauseated. I offered to call ambulance but she refused and said she wanted to wait a little longer w/ her daughter. When I went back into the pharmacy she and her daughter left.
Vaccine administered 10/15/2012.  The vaccine was Hepatitis B the first of the series.  Patient noticed the next morning that she had hives that started on her back.  Over the course of the next week and 1/2 the hives broke out on both legs, both underarms and some on the abdomen.  The patient states she has not had fever. She also reports no hives or redness or pain at the injection site.  The patient describes the hives as red bumps that are itchy and painful.  The patient has not taken any medications for the hives nor has she changed anything in her routine that could have caused them.  I suggested that the patient try Benadryl or a topical cortisone ointment if she had used either of these before with no adverse reactions.  I also suggested that if the hives continued or worsened that she seek medical attention.  The patient stated that she had used Benadryl in the past with no ill side effects other than a tired feeling. I suggested trying a 1/2 dose to see if that helped relieve the itching.
SWELLING IN THE LEFT FOREARM, SWELLING ON HEAD AND PIGMENTATION ON PATIENTS RIGHT SOLE.
Muscle was tender so site was massaged day one. Site became swollen to golf ball size day two, with redness, and more tenderness; massage continued. Site continued to be swollen though area increased from approx. 1" to 3" and became more red and more tender with itch on day three. Day 4 swelling has decreased along with tenderness and itch. Site still somewhat red.
Immediately after the injection at 4pm my arm became sore and immobile.   That same evening I woke up at 2am and was freezing cold.  I crawled to my closet to get my warmest sweater and put it on.  I was not able to walk.  I crawled back to my bed.  Several minutes later I began shaking uncontrollably.   I was unable to control the shaking for over 15 minutes.  I knew at the time I was experiencing a seizure but could do nothing to control it.   The violent shaking finally stopped.  I looked at the clock and it was 2:20am.   The following morning I was not able to get out of bed until 9am.    For over a week I could barely walk and was not able to work.
Headache, Myalgia, Arm redness, fatigue, chills Narrative:
death J18.9 - Pneumonia N17.9 - Acute renal injury
C/O Left leg numbness.  Pt has family with her.  Refuses transfer, patient able to bear weight.    1007 am BP - 120/90, Pulse 85 (RA), 02 -98%  1009 am BP 192/92 LA
I got flu shot on 10/5/2020. I woke up on 10/7/2020 with my feet feeling like pins and needles. The feeling progressed to my hands. My hands and feet felt burning/tingling/numbness and still do. On 10/12/2020, I had an appointment with my PCP who told me to immediately go to a neurologist. On 10/13/2020, I went to neurologist and got numerous tests done and was told I have Guillain-Barré syndrome. I have neuropathy in my hands and feet and still feel the burning/tingling/numbness sensation. I was prescribed gabapentin for nerve pain. On 10/14/2020, I got brain MRI. On 10/15/2020, I began my 3 day EEG study which I completed on 10/18/2020. I am waiting for insurance to approve the IVIG treatment.
Three after receiving the second vaccine you developed a knot on my arm like the vaccine did not go anywhere. I called to the doctor to find out what I needed to do or if I should come in. I was advised to put a warm compress on my arm, use Epsom salt, massage my arm to help get the vaccine to disperse throughout my system. Subsequently every dose of the COVID-19 vaccine after the second dose has made the area get bigger, my arm is even more painful. I made an appointment to see my doctor, I cannot lift my arm, if I touch the mass accidentally the pain is horrible. I will be going in for an ultrasound to find out if they can see what is going on in the mass.