chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated on 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005; Vaccinated on 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005; Vaccinated on 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005; This spontaneous report has been received from a lawyer and physician, via a fact sheet and an immunization record from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2303USA000650), concerning a 4-month-old female patient (pt). The pt's pertinent medical history or concurrent conditions were not reported.   On 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005, the pt was vaccinated with haemophilus b vaccine (manufacturer unknown) (exact dose, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis. These was considered to be following events: an inappropriate schedule of vaccine administered, inappropriate age at vaccine administration and an extra dose administered.   The pt's vaccines also included:hepatitis B vaccine (manufacturer unknown) (administered on: 21-SEP-2004, 29-NOV-2004, 21-JAN-2005 and 22-SEP-2010), unspecified diphtheria (+) tetanus (+) pertussis (DTaP) vaccine (administered on: 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005, 24-SEP-2009), unspecified inactivated Poliovirus vaccine (IPV) (administered on 29-NOV-2004, 21-JAN-2005, 27-DEC-2005, 24-SEP-2009), unspecified pneumococcal conjugate-7 vaccine (PCV7) (administered on: 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 22-SEP-2005), measles (+) mumps (+) rubella (MMR) vaccine (manufacturer unknown)(administered on: 22-SEP-2005, 24-SEP-2009), varicella vaccine (manufacturer unknown) (administered on: (22-SEP-2005, 24-SEP-2009), hepatitis A vaccine (manufacturer unknown) (administered on:22-MAR-2006, 26-SEP-2006), unspecified meningococcal conjugate vaccine (MCV4), unspecified influenza vaccine (administered on: 03-OCT-2012, 16-OCT-2013, 01-OCT-2014, 01-OCT-2015, 03-OCT-2016), unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid vaccine (TDAP) (administered on 01-OCT-2015), HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (administered on 03-OCT-2016), unspecified hpv vaccine (manufacturer unknown) (administered on 03-OCT-2017).   This is one of the three reports concerning the same patient.; Sender's Comments:  US-009507513-2309USA001193: US-009507513-2303USA000650:
headache    neckpain    rash on arm    eye pain    joint pain   brain fog
tingling in left arm and leg/tingling in right arm and leg; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; lot number: ER8730, Expiration date: Unknown), via an unspecified route of administration in the left arm, on 12May2021 18:45 as single dose for COVID-19 immunization. The patient's medical history was known allergies from sulfa. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included multivitamin, Vitamin D, Biotin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. It was reported that after administration, the patient experienced tingling in left arm and leg approx. 8 hours after shot, tingling in right arm and leg approx.36 hours after shot on 13May2021 03:00. No treatment was received for the adverse events. Patient reported no for seriousness criteria-Results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Several hours after injection developed bad headache. Had chills through the night and had flu-like symptoms including extra tiredness throughout the day. Headache continued into this morning ( 2 days after injection) Arm is much sorer than the first dose with rash extending down the arm about 6 inches past the injection site. Painful to touch the rash.
Patient experienced vertigo. She also experienced redness at the site of injection. She went to the ER, they determined she was developing cellulitis at the site of injection.
pain above injection site, mild below distal extremity. no swelling or discoloration. Pt. tensed up during the time of the vaccination. Ice pack applied
Early Morning dizziness, Room Spinning very fast, Nauseous. Could not stand without holding onto something.  Cleared up  except being dizzy. Evening 4:00 pm got very dizzy and a lot of vomiting and room would not stop spinning could not stand at all. Vomiting for at least 2 hours off and on.  DATE 04/11/2021  Date 04/12/2021   Dizzy spells throughout the day and fatigue.
Narrative:  Patient developed headache following Pfizer covid vaccine. Patient required no intervention and able to leave following normal monitoring period.
Got covid; Frontal sinus pressure; Eye Irritation; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Got covid), PARANASAL SINUS DISCOMFORT (Frontal sinus pressure) and EYE IRRITATION (Eye Irritation) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis. Concurrent medical conditions included Glaucoma and Diabetes.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PARANASAL SINUS DISCOMFORT (Frontal sinus pressure) and EYE IRRITATION (Eye Irritation). On 25-Jan-2021, the patient experienced COVID-19 (Got covid). At the time of the report, COVID-19 (Got covid) and PARANASAL SINUS DISCOMFORT (Frontal sinus pressure) outcome was unknown and EYE IRRITATION (Eye Irritation) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  Patient stated that he got prescribed an unspecified antibiotics and nasal spray on 15 Jan 2021.
02/18/23 presents to ED for "nausea, vomiting" "no significant past medical history"
pt  received on 9/30 and called pharmacy on 10/7 stating he was still having  pain from shoulder to elbow.
Feeling tachycardia daily since date of injection of COVID19 vaccine, sometimes more short of breath when going up stairs.
diarrhea (7+ loose stools each day starting on this day); headache; severe nausea; worsened muscle pain; new joint pain morning after (Included in aforementioned, but significant stiff neck.); new joint pain morning after (Included in aforementioned, but significant stiff neck.); fatigue/malaise; fatigue/malaise; This is a spontaneous report from a contactable other HCP report for self. This 30-year-old not pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) Intramuscular at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Asthma, anxiety, allergies to Acetaminophen (seizure like activity and fainting). No COVID prior vaccination. No other vaccine in four weeks. Other medications in two weeks includes fluoxetine, lorazepam, and Ibuprofen. Patient received first dose of bnt162b2 (lot number: EL0140) on 30Dec2020 and experienced injection sight tenderness, severe headache and fatigue. On 20Jan2021 5:00 PM after the second dose, patient experience headache, severe nausea, diarrhea (7+ loose stools each day starting on this day), worsened muscle pain several hours later, new joint pain morning after (Included in aforementioned, but significant stiff neck), fatigue/malaise. Patient received Ibuprofen and rest, supportive care due to events. The outcome of event was not recovered. Rapid Nasal Swab tested Negative on 21Jan2021.; Sender's Comments: The reported event diarrhea was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship, and considering no alternative cause reported currently.  The case will be reassessed should additional information become available.  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.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is all red) and VACCINATION SITE SWELLING (inflamed) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D30LZ0P) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN, ANASTROZOLE (ANASTRAZOLE DENK), TEMAZEPAM and GABAPENTIN. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is all red) and VACCINATION SITE SWELLING (inflamed). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (injection site is all red) and VACCINATION SITE SWELLING (inflamed) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Had vertigo for the first time in my life approximately 4 weeks after Johnson and Johnson vaccine.
Patient stated a few hours after injection a welt formed on her arm at site. It's warm to the touch and itching. Recommended topical Hydrocortisone and oral BENADRYL.
9/19 3:30pm Severe chills/shivering for 5 hours. Took 2 advil. Sleep 8:49 hrs.   9/20 4:30pm chills/shivering for 4 hrs. Covid antigen test at pharmacy, negative. 9/21 3:30am woke up nauseous but didn?t throw up. 4:30am shivering again. Took 2 ibuprofen. 5:25pm started shivering again not as bad.  9/22 6:30 feel I?ll, headache and body aches. Bed at 8pm feeling miserable. 9/23 1:30am diarrhea and nauseous but never threw up. Diarrhea 5 more times before doctor appt. Nurse took sub for Covid PCR and flu. Dr said he wouldn?t have tested if nurse hadn?t already swabbed.  He said it?s side effects from RSV vaccine. All swabs came back negative.  Extremely tired at 5pm and no energy. 9/24 felt ok most of day.about 5pm started to feel achy, no fever but not well and no energy.  9/25 Woke with another headache. Took 2 ibuprofen and went back to bed from 7:30-9am. From 5:30-6:55pm had chills and shivering as bad as first few days. Didn?t last as long because I took 2 ibuprofen and drank hot tea.  Report says I?m being timed out!
Redness, itching, rash and pain in area around the injection site. ie. COVID arm
sudden unilateral sensorineural hearing loss p/2 doses of hep B & 1 dose of hep A; Annual follow-up dated 09/27/00 provided no additional data.
continued sore area where shot was injected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 15Jan2021, for covid 19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "continued sore area where shot was injected". Therapeutic measures were not taken as a result of vaccination site pain.  Follow-up (21Oct2021): Follow-up attempts are completed. No further information is expected.
Redness reaction around injection site about 5 inches long and 2 inches wide, raised and warm skin going down towards elbow from upper deltoid. Pt noticed after 28 hrs after shower.
tuesday evening I felt a little dizzy  Wednesday morning I had an upset stomach and diarrhes. I still felt light headed.  stayed home and as the day progressed  things got better
pt recv vax 13NOV96 & 13NOV96 pt exp pain @ inj site;
Low grade fever (100.5 F) muscle pain, chills, headache, injection site pain. Medcation :Tylenol.  Symptoms went away after 10 hours.
I received the 2nd Moderna Covid 19 Vaccine 2/5/21. That evening I experienced explosive diarrhea every 20- 30minutes from 11pm 2/5/21--7am 2/6/21 the next morning along with the regular aches and shivers expected. The diarrhea continued for 4 weeks when I sought help with a doctor 3/8/21. He prescribed Sulfasalazine to help the inflammation in my colon. I proceeded to get sicker on this med as I was allergic to it but was unaware of the allergy. I was finally sent to the Hospital where I was admitted on 3/17/21. I was immediately taken off the Sulfa Drug due to fever and bright red rash all over my body that just started 3/17/21. Colonoscopy performed 3/19/21 with biopsies taken. Results of the biopsies showed there was an event that caused a lack of circulation to my colon that started the diarrhea and colitis 2/5/21. I am now on decreasing dosage of Prednisone which is treating the inflammation. The Dr. who performed the colonoscopy and did the biopsies feels that this episode was somehow related the receiving the 2nd Moderna vaccine.
pt. received vaccine past the 12 hour expiration. No adverse event. MD contacted pt. pt. refuses revaccination.
No adverse effects; a patient was adminitered improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of an unknown gender. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies were not provided. The concomitant medications included sterile diluent.  On 04-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) for prophylaxis, lot number S009759 and expiration date 27-SEP-2020 (strength, route of administration and anatomical location were not provided) (product storage error).  The vaccine was exposed to a temperature excursion of 17.6-Farenheit degree (F) (range from 15º F to 46º F) for 56 hours and 40 minutes. There was a previous temperature excursion of 6.2º F (range from 6º F to 14º F) for 10 minutes. There was no digital data logger involved.  It was reported that the sterile diluent that was used to reconstitute the vaccine was properly stored.   There were no adverse effects reported.
Dizzy, throat felt like it was closing, could not swallow, heart was hard and fast. Sick to stomach nasal congestion,S.O.B.
Numbness and tingling in left hand and then 1 week later numbness and tingling, burning sensation in left arm, numbness and tingling in right foot, left foot. Symptoms getting worse.
4mo infant rec'd immun on 21MAR91; Hospitalized on 29MAR w/H. Influenzae Pneumonia & sepsis; At time of this report, still in Hosp & on oxygen;
Sept.23: Received vaccine. Sept.25: Headache, lethargy. Oct. 17: Had complete eye examination. Recommended seeing opthalmologist. Oct. 29: Woke to double vision. Nov. 3:  Acupuncture treatment for headache and impaired vision. Fever of 103 deg. by 6:00pm. Drank ginger ale to reduce fever. Headache gone 7:00pm fever broke. Nov. 5: Called primary care doctor, DO to report above. Spoke with Dr. Told to go to Emergency Room for an MRI. Followed inst. Had MRI at med. center, with report that their were no tumors or evidence of stroke. Followed up with appt. at primary care. Nov. 7: Talked with Dr. in his office. Told him I thought the double vision was an adverse reaction to a flu shot. (Non converm.) Nov.15: Appt.with Dr., Opthalmologist Spec. glacoma and cataracts. Diagnosis: Sixth nerve palsy. No evidence: glaucoma/cataracts. Follow-ups Dec. 7 & Feb.21, '06. Nov17: Follow-up treatment w/ acupuncturist. Nov18: Reading vision returning-Dbl/6' distance.
I had a small tickle and sore throat on September 3 and the person I got it from that happens to be a therapist called me on 09/04/2021 and she said she tested positive and I wasn't feeling good and it kept getting worse. After she called me, I figured that's why I was feeling sick so I went and got tested at a walk in clinic on 09/05/2021 and since it was a rapid test it told me in 15 minutes it was positive. Then I got really sick that night, so I went to the hospital on 09/06/2021 around 10:00 and I was sick but not horrible. They gave me viral pack of antibiotics and fluids and they gave me something for the pain. I was there for hours and they sent me home and told me to call my doctor. I had No taste, no smell, headaches, Pain, aches, low grade fever. I normally run 97 and one day I was 99, Fatigue was so bad, I had anemia before and that's bad and I couldn't walk past my yard, and this was worse. I also had Decreased breath sounds The next day, on 09/07/2021 I got some codeine cough medicine and I got bronchitis and Dr also gave me inhalers. It took the whole ten days. On 09/21/2021 I went to the pharmacy and do the nasal swab in the car and wait for the results, so I waited 5 days for that and it came back negative on 09/26/2021.The hospital didn't admit me because I wasn't in desperate need to be in hospital and my lungs were good. I am still having ongoing symptoms of fatigue which hasn't stopped at all, I run out of breath easily, COVID Brain (brain fog), Forgetting things, I know it?s age related but it's worse now. I do have my taste and smell  back, and not many aches and pains, no sore throat or headache. Just fatigue and brain.
About 1 hr after injection, she experienced pain in the total upper portion of Right arm, redness, swelling & hot to the touch.  Felt tired, and sleepy for 2 days along with arm pain, etc. This reaction appeared as a tall red band starting about 4 inches above the elbow and continued to about 1 inch below the elbow.
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Jan-2012. The patient received expired product on either 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Increased number of apneic and bradycardic events requiring intervention (stimulation for same PPV x 2), increased work of breathing and baseline O2 support on 2L nc high flow. (anemia stable, caffeine level same as without AS/BS, I:T.27, CRP mildly elevated). Vanco and Cefepime started and baby changed to nasal IMV. Antibx stopped after 3 days. Back to 2L after 4 days. 11/27/2009 notes from NICU dated 8/13-8/14/2009, premie baby with increased apneic, bradycardic events, increased work with breathing, retractions, nasal flaring, tx: supplemental O2
-nausea -dizziness -feeling off balance -floating feeling when I go for walks -black out when I sit up too quickly -heart palpitations at night -eyesight is odd and I feel as if I'm cross-eyed at times -ears are extra sensitive to loud noises -fatigue -overall quality of life has been severely affected  All of these symptoms were constant for the first 6 weeks after receiving the third shot. They are not as bad now, but they still come and go. I have not had any treatment. Also, if I attempt to drink alcohol it tends to worsen my symptoms.
Fever above 102, vomiting, jaw/neck pain, light sensitivity, 4 episodes of staring.
Right after the vaccine I had slight pain in the injection site, Joint pain in my knees and muscle pain in the side of my thighs, it has affected my mobility. It's hard to go up steps, sitting  and standing has become difficult. I was referred to physical therapy which helped me for a while but the pain has returned.
burning at injection site/pain at injection site; achiness; weakness; headache; difficulty sleeping; nausea; heart pounding; chills; tired; cold feeling; This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th May 2019, less than a day after receiving Shingrix, the patient experienced injection site burning, pain, weakness, headache, difficulty sleeping, nausea, heart pounding, chills, tiredness and feeling cold. On an unknown date, the outcome of the injection site burning, pain, weakness, headache, difficulty sleeping, nausea, heart pounding, chills, tiredness and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site burning, pain, weakness, headache, difficulty sleeping, nausea, heart pounding, chills, tiredness and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow up with her pharmacy or physician on an unknown date. The reporter consented to follow up. Event tab and Analysis tab: the outcome reported for all AES in the structured field is "recovering" instead of "not resolved" (outcome uploaded).
Received ZOSTAVAX on 7/14/11, 48 hours later noted extreme fatigue & (L) retinal hemorrhage with protracted recovery & laser surgery, foll week.
Patient reported swelling of half of lateral upper arm and itching of skin which occurred the day after receiving the vaccine. Swelling and itching resolved over the next 4 days.
Client reported being anxious prior to vaccination, but did some deep breathing which she felt helped calm her down.  After the injection, she felt dizzy, "the room was spinning" and she was not able to focus on what the vaccinator was saying.  She reported feeling dizzy to the vaccinator who kept her seated and provided bottled water.  Clinic Manager and Vaccine Group Supervisor took initial vital signs.  Client also appeared to be shaking.  10:20am: BP: 130/96, HR: 90.  At about 10:25am, client reported feeling better.  VGS moved client to a seat near the clinic staff area to complete her 30 minute waiting period.  VGS took vital signs.  10:30am: BP: 120/90, HR: 88.  Client was no longer visibly shaking.  She reported that her husband was waiting in the car to take her home.  Client's condition improved and was released from the clinic to return to her home.  Client was escorted to her car by the Deputy Safety Officer.
Moderna COVID-19 vaccine EUA Lip swelling in the area of dermal fillers