chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHE RECEIVED THE FLU SHOT IN MID-OCTOBER AND DISPLAYED A FEVER DURING VETERAN'S DAY WEEKEND WITH NO OTHER SYMPTOMS.  SHE FELL OFF THE MONKEY BARS AT SCHOOL ON NOV 13 AND STARTED TO COMPLAIN OF TINGLING AND LOSS OF 'CONTROL' OF LIMBS ON RIGHT SIDE ON NOV 14.  SHE STARTED LOSING HER VOICE NOV 30.  SHE COMPLAINED OF HER HEAD TINGLING ON DEC 9 AND SUBSEQUENTLY WENT TO DOCTOR ON DEC 10 AND HAS HAD MRI'S, NERVE CONDUCTION TESTS, ETC AND WAS FINALLY DIAGNOSED WITH GBS ON/ABOUT DEC 12. 1/16/09-records received for DOS 12/10-12/13/08-DC DX: Guillain-Barre syndrome. Presented with C/O tingling all four extremities for about 4 weeks, back pain and leg pain. Day prior to hospitalization fell from monkey bar approximately 6 feet high. Subsequently C/O tingling in all 4 extremities. Seen by chiropractor. Few days later lost voice, whispery and hypophonic. DX: sciatica and recommended bedrest for 1 month. PE: reflexes absent ankle and knee jerk bilaerally. 12/29/08-follow-up visit with neurology, after 12/25/08 developed left facial palsy and at time of visit nearly resolved.  Voice remains with whisper and occasionally chokes on liquids. Jerky gait. Mild weaknesses throughout. 1/9/09-admitted with multiple cranial nerve palsy.  Began IVIG.  Discharged 1/13/09.  Follow-up 2/16/2010: Patient was down graded from GBS to CIDP and is getting monthly IVIG treatments.
About 8 hours after my vaccination I got a headache. 14 hours after my vaccination I  got a fever of 105.3
Pfizer vaccine was reconstituted with sterile water instead of normal saline and administered.   Patient is not reporting adverse effects at this time.
fever of 103/104; Oxigen level of 82 / 84; No antibodies against COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, in Jan2021, at single dose, for COVID-19 immunisation. Patient had no known allergies or other medical history. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included desvenlafaxine succinate (PRISTIQ), lamotrigine (LAMICTAL), simvastatin (unknown manufacturer). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on unknown date in right arm. The patient experienced fever of 103/104 (caused hospitalization, life threatening) on 02May2021 at 08:00 AM with outcome of unknown, oxygen level of 82 / 84 (caused hospitalization, life threatening) on 02May2021 at 08:00 AM with outcome of unknown, no antibodies against COVID-19 (life threatening) on 03May2021 with outcome of unknown. The events pyrexia and oxygen saturation decreased required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pyrexia and oxygen saturation decreased and included treatment with oxygen, antibiotics, fluids. After 8 hours the patient was sent to the ICU. The patient underwent lab tests and procedures which included body temperature: 103 on 02May2021, body temperature: 104 on 02May2021, oxygen saturation: 84 on 02May2021, oxygen saturation: 82 on 02May2021, COVID-19 antibody test: negative on 03May2021.  The information on the lot/batch number has been requested.
Localized 2-3 cm at injection site and 1-2 cm "welts" down arm and under arm. Instructed to take OTC antihistamine if needed and f/u with increased problems. Checked on pt and is improving.
Employee Presented to Employee Health Dept. with c/o of itchy, red area at post-vaccination site measuring 50x60 mm in greatest dimensions. The area is red and warm and appears to have been administered correctly in the subcutaneous tissue.
He had a very big red circle around the area of vaccination on the 3 times he got the dose of DTAP, and I noticed that he regressed after the last one on 12/5/12 and eventually was diagnose with Autism at age of 2, after going thru early steps at an earlier age.
Patient received 9th Anthrax immunization on 4/28/2007 and presented 4/30/07 with a swollen upper arm with redness, pain. Doctor prescribed Motrin and Benadryl, no more Anthrax vaccination.
ED c/o allergic reaction the second Covid vaccine.  Patient states she received her second dose of Pfizer Covid vaccine this morning and about 5 minutes later began to feel shaky, then lightheaded and dizzy and felt like she was going to pass out.  She notified the nurse who felt the patient had some facial swelling and tightening of the throat and thus she was given an EpiPen.  EMS was called and the patient was transported to the emergency room and states she is feeling much better but is not at baseline.  Currently the patient denies headache, neck pain, sore throat, throat swelling, lip swelling, chest pain, fevers, chills, cough, shortness of breath, abdominal pain, vomiting, diarrhea, rash or focal neuro deficit
tested positive for Covid-19 after receiving both doses of Covid-19 vaccine; tested positive for Covid-19 after receiving both doses of Covid-19 vaccine; temperature; loss of sense of taste; Headache; This is a follow-up spontaneous report from program. A contactable consumer (patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on Mar2021 as a DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine include bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient tested positive for Covid-19 after receiving both doses of Covid-19 vaccine. Also had a temperature, loss of sense of taste and had a headache. Patient underwent laboratory test includes Covid-19 test resulted positive on 24Sep2021, she was sick for like 3 days then she felt better. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Developed jaw pain on left side, similar to TMJ only much worse than usual.  Sore gums on left lower jaw.  Pre-existing but aggravated after the shot.
Headache, low grade fever, sore throat, numbness in my left arm, tired, frailness
Cough, runny nose, ear ache, sore throat, shortness of breath  Hot tea - Echinacea Plus - "Traditional Medicines" tea - soothing
C/o left arm-seen by MD 1/15/10 12PM-?possible reaction to FluMist, GARDASIL or H1N1 rec'd. No additional doses at this time, no intervention necessary now.
Pulse 70, 02 94, temp 98.3 With in 6 hours back to normal Pules 58, O2 97 but temp was 98.9. by 12 hours normal but a sick feeling lasted about 2 more days. no red rash like shot one.
Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as when had first dose. 4:30 pm -acetaminophen 500mg  10:30pm severe right arm and shoulder pain 8/10. Nausea 11:30 acetaminophen 500 mg. Was trying to not take any medication for fear it would effect negatively the vaccine efficacy. continued nausea Did not sleep first night kept waking groaning in pain/R arm shoulder 5:00 am acetaminophen 500 mg body aches and continued severe arm pain. 10:40 am acetaminophen 500 mg  "                     and  "                    and nausea 11:30 am severe body aches, chills and fever 99*  with 500mg Acetaminophen. my Normal temp (96.8) 3:30 pm  "
Swelling of the lips with no other allergic reaction. Not sure if it developed after the first or second vaccine shot. Went to urgent care. Put on prednisone  steroid. Helped a tiny bit but still noctieable. Swelling came back after a few days of finishing the prednisone steroids. Went back to urgent care. Prescribed a topical dental paste for mouth. Hasn?t really helped.  It is still swollen after 6 weeks and ongoing
This case was reported by a physician via call center representative and described the occurrence of neuropathy peripheral in a male patient who received SHINGRIX (batch number 9NJ59, expiry date unknown) for prophylaxis. Concomitant products included SHINGRIX. On 19th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced neuropathy peripheral (serious criteria GSK medically significant), weakness of arms, injected limb mobility decreased and injection site inflammation. On an unknown date, the outcome of the neuropathy peripheral, weakness of arms, injected limb mobility decreased and injection site inflammation were not recovered/not resolved. It was unknown if the reporter considered the neuropathy peripheral, weakness of arms, injected limb mobility decreased and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: The reporting physician was the concerned patient. On 22nd August 2018, the patient received the 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX in the left deltoid. The patient provided lot number for each dose but did not have expiration dates to provide. The physician reported that the symptoms of weak arm came on gradually within a week or two where he had difficulty reaching up to a top shelf and then on 13th December 2018, he noted during a fitness class that he could not lift appropriate weight with his left arm. The patient reported that the neurologist had diagnosed him with axillary neuropathy secondary to inflammation from the injection site and that the issue had not resolved. The patient consented to follow up and requested any correspondence be directed to him since he was a physician.
FATIGUE, BODY ACHE, FEVER RESOLVED 2/2/2021 Narrative:
Patient was already current on her Hep A vaccines.  In error, patient was given Havrix (Hep A) vaccine, instead of the Kinrix (DTaP) vaccine.
Period was due April 1st but it was 11 days late. (Period usually comes every 30 days give or take a day).
Pain in side (rear cheek), pain side of left leg, unable to stand for more than 30 seconds without discomfort, unable to walk and climb stairs without pain.
Since having the vaccine, I have been experiencing very irregular menstruations. I have never in my life experienced this, I was always pretty regular. I went to my OB DR to run test to be sure I am not peri menopausal. Test were negative. She also did an internal sonogram to check for anything and that was negative. After, I  read an agency report that there are other women experiencing the same issue after the vaccine, so I thought to report it. Also not sure if its related, but having major mood swings. Which I never had prior.
pt recv vax 19JUN97 & 8JUL97 pt devel a rash that was initially thought to be insect bites;pt presented to MD 11JUL97 w/mult lesions that were red;some lesions were crusted;pt alert & active;
first dose 2020, not received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March or April 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
much worse tinnitus and hearing loss; much worse tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "hearing aids", start date: Oct2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Time: 10:00 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8729), administration date: 14Apr2020, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "COVID test result Positive", "after covid in Dec2022"; BNT162b2 (Dose: 2, Time: 10:00 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EW0182), administration date: 19May2020, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "Have lost half of my hearing ability", "Noticed ringing in my ears", "headache". The following information was reported: TINNITUS (disability) with onset Dec2022, outcome "not recovered", described as "much worse tinnitus"; DEAFNESS (disability, medically significant) with onset Dec2022, outcome "not recovered", described as "much worse tinnitus and hearing loss". The events "much worse tinnitus and hearing loss" and "much worse tinnitus" required physician office visit. Therapeutic measures were taken as a result of deafness, tinnitus. Clinical course: Aug2020: Tinnitus, gradual and continued hearing loss. Got hearing aids Oct2022. After COVID in Dec2022- much worse tinnitus and hearing loss under ENT Care- steroids, meds. Seriousness criteria was reported as being persistent/significant disability/incapacity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201390482 same patient, different vaccine dose/event;US-PFIZER INC-202201390515 same patient, different vaccine dose/event;
severe pain in left arm at injection sight.  pain quite severe for 2 weeks and gradually became less as days passed.  today 1/8/2020, there ix still minor pain but almost gone.  I did not report this to the doctor.........i have had flu shots for the past 8 or 9 years.  this is the first adverse reaction.  i just assumed the person that gave me the injection hit a bone or something.
7:00 pm: Sneezing, blowing nose frequently, cold and sweaty at the same time overnight, slight headache in morning, By 7:00 am, symptoms receded to nothing except loss of appetite.
After receiving the new 2023 pneumococcal vaccine on 2/13/23 I did not have any noticeable side effects. However, about 8 days later, my arm began swelling at the injection site and was very sore and painful. The swollen area grew in diameter by over an inch for 3-4 days. I experienced severe headaches, joint and body aches, and chills.
Patient presented on 07/15/2021 with a four day history of feeling cold all the time. Also has a cough, fatigue, mild sore throat, and nasal congestion.
Had seizure in car when leaving the facility, about 1/2 hour after the vaccination.
Joint and muscle pain that is worse than I think is typical. Joint pain was somewhat similar to that caused by ciprofloxacin, in my knees. Muscle pain was intense enough that it caused mobility problems that lasted a few days after the side-effects themselves disappeared. Basically, the side-effects seemed to trigger an Ehlers-Danlos flareup that lasted several days where I was barely mobile. I've since recovered and feel normal again.
First 24 hours, slight headache.  2nd 24 hours, body aches, slight fever, and slight headache.  2nd 24 hours for a few hours during nighttime sleep, felt like fever spiked (probably 101 or higher, didn't take it), increased body aches, and a little more intense headache.  36 hours later woke up with a slight headache and slight body aches.
Pain at injection site lasting 3+ days; redness starting day 2 lasting 3+ days; lethargy, headache, general malaise day 2 only.
Initial report was received 27 August 2008 from a physician. A seven-month-old female patient with a medical history of mild eczema, experienced a seizure on the same day she had received a third dose intramuscular right thigh injection of DAPTACEL, lot number C2957AA. The patient had received a third dose intramuscular right outer thigh injection of PCV-7, lot number C96205B (manufactured by Wyeth) and a third dose (oral) of "ROTO", lot number 0406X (manufactured by Merck) concomitantly with DAPTACEL. The patient had not been ill and had not been taking any concomitant medications at the time of vaccination. On 27 August 2008 (also reported as 26 August 2008), the patient had been seen by their physician for their routine six month well child check up with no problems noted. The patient was immunized with DAPTACEL, PCV-7 and "ROTO". The patient's father administered TYLENOL drops post injection and dropped the patient off at day care. The mother picked up the patient at 16:00 from day care and the patient was "OK". At 18:00, the mother noted an increased temperature and started to administer TYLENOL when the patient experienced a seizure. The patient was taken to the emergency room and was reported to be on a ventilator. At the time of the report, the patient's recovery status was not reported.
This case was reported by a consumer and described the occurrence of right knee pain in a 70-year-old male subject who was vaccinated with LYMERIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  The subject's medical history included thyroidectomy.  Concurrent medications included Thyroxine sodium (Synthroid).  On 12 April 2001, 1 May 2000 and 29 March 2000 the subject received 3rd dose, 2nd dose and 1st dose of LYMERIX (all injections in the right arm).  In November 2007, a little over 6 years after the 3rd vaccination with LYMERIX, the subject experienced right knee pain with fluid on the right knee.  This was considered to be a systemic reaction.  The events were considered to be disabling.  At the time of reporting, the subject was being tested for Lyme disease.  Developing Lyme disease following vaccination series with LYMERIX is considered to be a vaccination failure.  At the time of reporting, the knee pain was unresolved.  The outcome of the other events was not known.
Patient presented to the ED on 2/21/2021  and was subsequently hospitalized for atypical chest pain and shortness of breath. Patient presented to the ED on 04/12/2021 with Hypotension due to hypovolemia and was subsequently hospitalized. Both visits are within 6 weeks of receiving COVID vaccination.
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 08-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
I boosted with Moderna in Oct 2021 and very loud tinnitus began the following week; I had the J&J in March 2020. The tinnitus remains after all these months so I'm interested in knowing my options for further boosters as I can't contribute to this tinnitus any more with another mRNA booster.
(R) subcutaneous upper arm with 3.5 x 4 cm raised erythm warm tender patch treatment plan ice motrin prn
12/29/21  presenting today for Headache (1 day) and Cough (1 day) Physical Exam    Constitutional:      General: She is not in acute distress.    Appearance: She is well-developed.  HENT:     Head: Normocephalic and atraumatic.     Right Ear: External ear normal.     Left Ear: External ear normal.     Nose: Mucosal edema, congestion and rhinorrhea present.  Neck:     Trachea: No tracheal deviation.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds. No murmur heard. Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Musculoskeletal:     Cervical back: Normal 12/29/21  Lymphadenopathy:     Cervical: No cervical adenopathy.  Skin:    General: Skin is warm and dry.     Findings: No rash.  Neurological:     Mental Status: She is alert and oriented to person, place, and time.
A pharmacist reported that a 45 year old female, post vax in 1968, developed a "severe" anaphylactic reaction described as "generalized pain all over, couldn't move, couldn't eat and feeling of doom". She was seen in an emergency room.   Follow-up dated 6/22/00 from a dermatologist at a life care facility indicated that the pt was seen on 3/28/00 where a laceration was sustained on 3/19/00, on her left knee was noted. There the pt informed the reporter that she experienced joint stiffness following receipt of a booster in 1960. The pt was sent to a local ER for evaluation and tetanus IZ.
Still tired; Slurring his words; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 08:30 (Batch/Lot number: unknown) at the age of 68 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 17Mar2021, outcome "unknown", described as "Still tired"; DYSARTHRIA (non-serious) with onset 17Mar2021, outcome "unknown", described as "Slurring his words".  Additional Information: The patient mentioned that he did not see slurring of words in reported side effects, that's the reason he called, to ask about if event was relative to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.