chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they are now testing positive for COVID 19; her daughter began to feel bad yesterday; This is a spontaneous report from a contactable consumer (patient's mother) for the patient (daughter).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 29Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter states that her daughter got her first dose of the vaccine on 29Aug2021. She states that they have not been exposed to anyone with COVID 19 and that they are now testing positive for COVID 19. She states that it has been 8-9 days and she tested positive on Saturday and her daughter tested positive today (06Sep2021). She would like to know if this is because of the vaccine and that they really don't have the virus? She makes an example of when people get the flu shot and then get sick with the flu. She states that it's the same because the vaccine is COVID that they put in their body. She states that her daughter began to feel bad yesterday (05Sep2021). The reporter would like to know if she can still get her second dose of the vaccine now since she has tested positive after the first dose. She also states that this vaccine is the virus so that is why she is testing positive right? She states that the vaccine puts the virus in your body. The patient underwent lab tests and procedures which included sars-cov-2 test: tested positive on 06Sep2021. The outcome of both the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
At approximately midnight (11 hours after receiving the vaccine), I woke up to use the bathroom. I started to feel really ill--sweating, nauseated, dizzy, faint. When I got up, I fainted and my head hit the bathtub. I also twisted/bumped my back. I was disoriented for several minutes. I went to the ER at Medical Center later that morning. I was found to be running a fever (I rarely get fevers, and my normal temperature is 97-98). I spent all day 5/28 in the Er.
Note: I'm not sure of the Lot number - it's definitely 088D_ _A.  The blanks could be a 2 or Z, and a 1 or an I.  So I received the booster shot at 11:30am on Friday and by 7am on Saturday I started feeling flu-like, with body aches and chills, and a fever of 99'.  Throughout the day, fever climbed to 104.  Arm (right) is sore with tight muscle, with increased redness and swelling below the injection site.  Fever, body aches and chills were gone as of Sunday.  Arm symptoms continue to remain and have slightly increased since day of injection.  Waiting a couple more days before I see a doctor to see if symptoms subside.  I did get a flu shot on 10/8/21 in the same arm, which could be cause of inflammation/reaction.
Migraine for five days (needed steroids to break) Nausea  Muscle aches Chills Sweating Stinging eyes Fatigue
Info regarding Prevnar vaccine was received from a healthcare professional regarding a 2 year old pt who experienced injection site reaction with swelling, induration, redness and pain. The child was also fussy. At 2 years of age, he received the 4th dose on 7/13/05. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 7/13/05. Dose regimen was 1 dose 1 time per day, IM. Concomitant therapy included Vaqta. No other medications were prescribed. EVENT DETAILS: The pt experienced an injection site reaction described as a 9-12cm area of swelling with hardness, redness and pain in the right thigh on 7/14/05. The day he was seen by the pediatrician. He was able to walk but was very fussy. He was treated with oral Benadryl and warm compresses. No additional info was available at the time of this report.
received an expired vaccine on 14Nov2019 Quadracel/no AE; 3 years 11 month received an expired on 14Nov2019 Quadracel/no AE; Initial information was received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years 11 month old male patient who received an expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] vaccine.  Medical history, medical treatment, vaccination and family history were not provided.   On 14-Nov-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used and Inappropriate age at vaccine administration.  It was unknown if any adverse event occurred or not.  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 Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim.
I had my vaccination on 10/18/2022. On 12/24/2022 I woke up at night and I had significant heart pounding. It was not racing but very hard beating. I did breathe exercises to calm down. This happened again on 01/11/2023 and I went to the emergency room. I was run through labs tests cardiac related and all were negative. I was prescribed medication for hypertension. I had a follow up on 01/18/2023. I do have upcoming medical appointments for EKG and a stress test. I will be seeing my doctor every 4 weeks to make sure there isn't anything significant going on to include ongoing stress tests.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the local dept. of health on a compliance improvement plan and has been reinstated vaccination privileges.
Patient awoke 1 week after vaccination and noted he was unable to hear on right side. Saw primary MD and ENT same day. ENT diagnosed "herpes" inside right ear - no external lesions or pain. Started Prednisone taper and Valtrex. After 1 week: still deaf on right. Now has vertigo, feels weak. 8/20/07-records received for DOS 6/13-6/22/07-DC DX: Dyslipidemia. Chronic Tinnitus. Presented with sudden onset of vertigo and right hearing loss about 1 week prior to admission. Long term history of bilateral decrease in hearing and also long history of chronic tinnitus. Vertigo worsened. Unable to stand or ambulate. PE: severe vertigo and inability to stand or ambulate. 1/11/2010 Still deaf in right ear; PO% hearing loss in left ear. Still suffer problems with balance, tinniture, headaches and vertigo.  Follow-up: Residual symptoms - My right ear is still totally deaf. My left ear remains significantly damaged and has recruitment; I still have significant problem in understanding the spoken word, whether by a person, on TV, radio, etc. I can no longer use the telephone as I can understand less than 25% of what's spoken, and sometimes none. My new hearing aid provides only minimal benefit and helps in only certain circumstance. I continue to be plagued with severe tinnitus and accompanying headaches. I still have a "balance" problem, and I've had some recurrence of vertigo. I feel all these problems are related to the ZOSTAVAX inoculation, as does my ENT. ZOSTAVAX contains a weakened strain of the Zoster virus which is knows to cause vision and hearing problems, even to the point of total loss of those senses. I'm totally convinced that my hearing loss is a direct result of the ZOSTAVAX inoculation. Additional comments - Recent Merck & Co. newspaper ads promoting ZOSTAVAX mislead the public when they fail to state the possible extremely serious side effect of loss of sight and/or hearing when getting the ZOSTAVAX inoculation. How can they get away with this? Other comments - My family doctor sends me to an ENT. The ENT says he can do nothing more for me and refers me back to my family doctor who also says there is nothing he can do for me, as he is not a specialist in ear problems. I call a vestibular neurologist whose technician administers some brutal tests. The doctor then sets up an appointment to see me, presumably to review the test results - on March 26, 2008. Such a time delay is criminal. I call my ENT's office for further guidance because I'm still suffering with significant problems. My ENT's PA says the results of the tests I just had are "normal"; yet I question why the specialist wants to see me in March. Now the PA wants me to get vestibular therapy, to see a neurologist for my headaches, and to see another audiologist for my tinnitus and recruitment. My family doctor can't help and my ENT and/or PA are just shunting me around from doctor to doctor. Meanwhile, I'm living in holy hell, the primary problem being the severe tinnitus in my right (deaf) ear. There appears to be no one doctor in charge of, or monitoring, my health. Unless you experience it yourself, you just can't imagine what I'm going through.
pt recv vax 19SEP90 & was unresponsive by mom p/having been put down for a morning nap p/feeding; resuscitative attempts were unsuccessful; COD attributed to SIDS; manner of death is natural
Four days after, I noticed a soft "lump" right axilla. Cancer Institute did an ultrasound.  "No enlarged lymph nodes." No sign of cancer The lump in my axilla got very large. "Not as big as a baseball but larger than a golf ball." I could wrap my fingers around it. Hard as a rock. Within a week my whole entire chest wall on the right (from side to sternum) was scarlet red. And I was getting another "lump" in the fold of tissue where my upper chest meets my upper arm.  I was put on Keflex 500 mg four times a day.   The redness in my chest wall subsided. Five days after being on Keflex, the lump on my chest was hard, red, very painful, "angry." Fevers, feeling "pretty sick." (Very uncharacteristic of me. I didn't miss a day of work through months of multiple rounds of chemo, 5 weeks of radiation.)   February 7 PCP requested I go the ER. Suspecting an abscess. They did an I&D. Expressed "lots of puss" and left a drain in. To be removed in 5 days. Placed on Bactrim twice a day for 5 days.
Vaccination occurred just prior to 11:00 am, felt normal until shortly after arriving home at approximately 11:30. Dizziness, headache and fatigue have been experienced since, with occasional shortness of breath. Dizziness has at times been severe, as has headache. Fatigue has been severe throughout, with me sleeping much of an average day. I will be seeing my primary care physician Monday 4/5.
Mother reports that the pt was very upset, post vax. When he finally settled down and went to sleep, he had some myoclonic jerks. He also had a fever (not measured). Immunizations given on 8/20/01.
This lot of Pfizer was temporarily stored in the freezer and unthawed prior to administration.  Unknown whether the stability of vaccine was compromised.  Patient did not have any adverse reactions.  Offer to revaccinate per parents discretion.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 19-JUL-2010, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 6668512/0280Z with expiry date of 12-FEB-2012. No adverse effects were reported, The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
adverse event; Information has been received via pharmacy records, concerning a case in litigation and refers to currently 70-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 24-JUL-2013, the patient was dispensed with zoster vaccine live (ZOSTAVAX) 19400 UN solution, at the pharmacy (date of administration, dose, route of administration, lot # and expiry date were not specified). On an unknown date, the patient experienced an unspecified adverse event in association with zoster vaccine live (ZOSTAVAX). The outcome of the event was unknown. The causality was related.
12 hours after vaccine I got dizzy, extremely off-balance and needed help walking in my house.  I felt like I was being tossed about in a storm. When I  slept, I woke soking wet and believe I had a fever but didn't take temp.  It all lasted about 14 hours. A few hours after the 14, I felt completely normal.
Asthma attack while sleeping (wheezing, coughing).  Responded to Benadryl.  Have not had an asthma attack in over 20 years.  Still having some wheezing next day.  Called doctor for inhaler in case of emergency.
I woke up in the morning on 03-27-2021 and my whole face was swollen especially from my nose up. My eyes I could barely open and it looked like I just won a boxing championship since my eyes and around my eyes were extremely swollen.
Vaccine expired on 01-24-2022, spoke with mom on 02-01-2022 baby is doing great "not even fussy".  We decided to repeat dose at a later date.
Information has been received from an unspecified homeopathic professional via field representative referring to his/her niece, a female patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. In an unspecified time in 2017, the patient received a dose of GARDASIL 9 (strength, dose, frequency, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date in approximately 2017 (reported as 14 days post vaccination), the patient developed unspecified neurological symptoms, seizures, and she "has no vision." On an unknown date, patient had underlying bartonella infection "like cat scratch fever". At the time of reported, the patient was not doing much better. The causality assessment was not provided. Neurological symptoms, seizures, and has no vision were considered to be significant disability or incapacity by the homeopathic professional. Upon internal review, neurological symptoms, seizures, and has no vision were determined to be medically significant.
nerve numbness on left face, abdomen, lower leg and calf numbness; This is a spontaneous report from a contactable consumer or other non hcp. This report was received via a sales representative. A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed nerve numbness on left face, abdomen, lower leg and calf numbness in 3 hours of receiving the vaccine. He was afraid to receive the second dose due to the side effects. The reporter reported that regret involving case in this inquiry. Reporter felt like it may muddy the waters. So please de-emphasize reporter's personal involvement & perspective in this matter. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After receiving vaccine patient experienced a severe headache, insomnia and extreme fatigue that would not go away x 24 hours. H/A and fatigue continued x 1 week.
pt recv vax 12NOV96 & was 1.5 wk pregnant;pt exp a spontaneous abortion;
allergic reaction; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; they started small and then grew up like a size of a golf ball, it's itchy and painful; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; red swollen and itchy like rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Oct2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included allergies. A couple of months ago she was rushed to the emergency room after eating pine nuts. They gave her some medicines and she had to stay there for couple of hours and then she went home. The patient's concomitant medications were not reported. The patient stated she took the Pfizer covid vaccine, and had an allergic reaction in Oct2021. She stated she had red and swollen, red swollen and itchy like rash like contact dermatitis, clarifying "It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis". She described it as putting your hands touching up plant and than they started small and then grew up like a size of a golf ball, it's itchy and painful, clarifying it just raised the swelling from the arm, 3 days later and was still itching. She stated that she took Benadryl last night (10Oct2021) but this morning (11Oct2021) three days later it was still itching. She also tried putting cold compressed arm. The patient stated she had an allergic reaction before and she stayed away from she was allergic to. She tried to stay away from things that aggravate her allergies.  The outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Suffered from weakness, fatigue, mild fever gradually getting worse leading to body aches, nausea and severe vomiting. Bedridden x 5 days, double vision and dizziness with left eye paralyzed. Hospitalized x 3 days, CT, MRI test were normal, ruled out stroke, labs drawn CBC, CMP, UA, Hemo A1C, results within normal limits, Vision consult and neuro eval, diagnosed with 3rd Ocular Nerve Palsy, Diabetes controlled. Presently recovering, continued double and blurred vision. Remain under Physician care.
Sent from clinic for L pneumothorax. Pt reports chest pain starting 14Feb2021, denies trauma.
Information has been received from a physician, referring to an adult patient of unknown age. Information of concurrent condition, medical history and concomitant therapy was not provided. On an unknown date, the patient was vaccinated with a 40mcg dose of RECOMBIVAX HB (strength, route, lot# and expiration date were unknown) for prophylaxis (incorrect dose administered). No adverse symptoms reported.
1. Cramping below waist all the way down. 2. Intense Arm pain, swelling (evening) 3. Whole body hurt. 4. Rash on arm. 5. Next 2 days extreme cold, body pain. Skin sensitive to touch felt like burning. 6. 1st & 2nd night very little sleep. 7. Evening different rash on both arms. Some itchiness. 8. 3rd day chest hurt like being beat up. Still dealing with symptoms.
Vaccinated with Pfizer for initial doses and boosted with Moderna on 12/19. On 12/21 I started experiencing unexplained spotting/breakthrough bleeding.  For reference, I have had a copper non horomonal  IUD since 2014 , regular 25 day cycle periods , no prior history of spotting and/or breakthrough bleeding, a normal pap as of  NOV 2021 , and a normal ultrasound as of OCT 2021. My last period ended on 12/17 and there is no chance of pregnancy as I have not been sexually active since 12/17.
Sore injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Right arm on 18Feb2021 16:30 at the age of 63-years-old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma and seasonal allergy from an unknown date. The patient had no known allergies. Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTIN) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEP [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported and unspecified seasonal allergy pill from an unspecified date received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has been tested for COVID-19 post vaccination. On 19Feb2021, the patient experienced sore injection site. No treatment was received for adverse event. The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): negative on 20Jan2021. Adverse event resulted in none of the above. The outcome of event was recovering.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that was improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Approximately 3 hours after vaccine given pt noticed a swollen lymph node in armpit of left arm. Took 2 OTC Zyrtec and went to bed. Next day left work early upon suggestion of school nurse, took 6 Advil upon suggestion of school nurse, applied warm soaks upon my suggestion to armpit. 2 days after, swelling in armpit is less and was able to attended a work seminar. Information was obtained from mother.
After 18 month DTPa, IPV, fever to 102 degrees and fussiness but decreased motion of arms and legs; resolving after 24 hours.
Burning pain and throbbing in legs. Low circulation in legs. Chest tightness. Rash across mid-section. Chest pain and rash improved after several days, pain and throbbing in legs persists after 7 days but starting to improve after running and walking daily.
Small red rash at injection site measuring 1.5 inch by 1 inch with red, warm, itchy skin about 180 degrees around arm from injection site. Arm was very warm to touch. Possible fever with mild headache.