chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning an 11 year old female with a history of Lyme disease, and ear infection, "reactive airways" and no known allergies or adverse drug reactions reported. On 01-Nov-2006, the patient was vaccinated  intramuscularly with 0.5 ml of Gardasil vaccine (yeast). Subsequently, the patient developed dizziness for about three weeks. It was reported that the patient "had some lab studies done and was referred to a neurologist (she had not seen him yet). The laboratory diagnostics included blood sugar, a urinalysis and vision screening (results not reported). The nurse practitioner reported that there were some family issues that were occurring also be a cause. The patient was referred to an eye physician because she failed her school eye exam. At the time of this report, the patient was recovering from the events. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Initial and follow-up information has been received from a nurse practitioner concerning an 11 year old female student with a history of lyme disease, and ear infection, "reactive airways" and no known allergies or adverse drug reactions reported.  On 01-NOV-2006, at approximately 16:30, the patient was vaccinated intramuscularly, into the right arm, with 0.5 mL first dose of GARDASIL (lot #653938/0954F) concomitantly with an intramuscular first dose of TRIPEDIA (lot #AC52B007AA) into the left arm and an intramuscular first dose of MENECTRA (lot # U2157BA) into the left arm.  On approximately 17-NOV-2006 the patient developed dizziness.  The patient was seen in the doctors office on 08-DEC-2006.  It was reported that the patient "had some lab studies done and was referred to a neurologist (she had not seen him yet)".  The laboratory diagnostics included blood sugar (105 on 08-DEC-2006), a urinalysis and vision screening.  The results of vision screening test not reported.  The nurse practitioner reported that there were some family issues that were occuring that could also be a cause.  The patient was referred to an eye physician because she failed her school eye exam.  At the time of this report, the patient was recovering from the events.  No further information is available.  This is in follow-up to report(s) previously submitted on 1/16/2007. Initial and follow up information has been received from a Nurse Practitioner concerning an 11 year old female student with no medical history who on 01-NOV-2006 at approximately 5:00 p.m. was vaccinated IM in right arm with her first dose of GARDASIL, lot  #653938/0954F. Subsequently, the patient experienced prolonged dizziness. The patient was seen in the office on 08-DEC-2006 complaining of dizziness, she was unsure of the onset date but it was after the injection. Her blood glucose (non-fasting) was 120 (see laboratory data section for abnormal urinalysis results). She was referred to a neurologist. Per follow up one week later, the patient was doing better. The Nurse Practitioner reported that she was unsure if the 2nd dose of GARDASIL should be administered. Additional information is not expected.
The patient is complaining of arm soreness since the Shingrix injection on 3/9/23. As of today (5/26/23), she is still experiencing some arm soreness. We recommended that she talks to her doctor.
Well I woke up the 8th of July with a sore throat and developed a pretty severe cough and then that Saturday, I think the 10th, I went to the on call. They did a Covid test and did a throat culture. Then they sent me home. Sunday night I developed a fever, the deepening cough, sore throat and runny nose. I called my PCD on Monday and they said well we do not want to see you but we can do a virtual chat. The DR prescribed a Z-Pack, my symptoms stayed and the cough got deeper as well, deeper in my chest. My fever was around 101. So I texted with my son, who is a pulmonologist and I messaged him for input. My son said I probably just had some sort of viral infection. I did my 5 day course of Z-Pack and I went back to the ER- on 7/18/2021 and said I needed a chest x-ray to make sure I did not have a pneumonia. So after I was clear they sent me home. At that point my son prescribed me Prednisone and Levothyroxine, and an Albuterol inhaler as well, which I started on the 19th of July. At that point I was worried, my symptoms were not subsiding, so I went to CVS to get another Covid test.
muscle pain and weakness mid April 104.1 fever May 31 hospitalized June 1 released June 9 facial parthesia -- hospitalized June 29 - July 1 EMG -- July 13 -- revealed Gullian - Barre Syndrome
100% deaf - left side facial palsy- scarring to skull bones- immune disease- temporary joint stiffness.
Started to feel "weird" right after shot given. Hyperventilated, very agitated for 90 minutes.
Herpes Zoster, L3 dermatome developed 14 days after first dose of vaccine
My husband is having brain fog after the 1st shot. He is having cognitive issues and can't remember some things. He can tell he is "off", This has never happened to him so it appears to be the shot.
This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 3rd booster of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, in left arm, on Oct 12, 2021, at 09:30, single dose, for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at the age of 65, on Mar 22, 2021, at 11:45; and the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at the age of 65, on Apr 12, 2021 11:30, both in the right arm, for COVID-19 immunization. Medical history included known allergies: sulfa drugs and sulfite. She was not pregnant at vaccination. She was not diagnosed with COVID-19 prior to vaccination. No concomitant medications. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications received within 2 weeks of vaccination. On Oct 12, 2021, 19:00, after receiving the booster at 9:30, she had a reaction: tongue and lips swelling. She is  allergic to sulfite preservative. She was wondering if it was in the booster. She took Benadryl and it subsided after about 10 min. Since the vaccination, she has not tested for COVID-19. The patient recovered from the event on Oct 12, 2021. Information about the lot number will be requested during follow-up.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Loss of mental clarity/fogginess) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Loss of mental clarity/fogginess). On 12-Mar-2021, FEELING ABNORMAL (Loss of mental clarity/fogginess) had resolved.        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.   Concomitant product use was not provided. Treatment information was not provided.
Systemic: Fainting / Unresponsive-Moderate, Additional Details: symptoms resolved within 10-15 min from onset. ? vasovagal response.
fever, body aches, chills for 48hrs,  a lot of pain at the injection site, painful to move arm
Redness and pain at the injection site for a day, which went away, and then a bruise appeared a day later and has remained for another 7 days
Tachycardia, hypertensive urgency, paresthesia of the lips about 3 hours following vaccination
ongoing headache everyday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 28May2021 as dose 1, single (Lot number: FC3182) at the age of 55 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "ongoing headache everyday". The event "ongoing headache everyday" required physician office visit. Therapeutic measures were taken as a result of headache. Additional information: Caller is calling about the Pfizer COVID-19 vaccine. Caller got both shots at (pharmacy name), confirmed 2 total doses of the Pfizer COVID-19 vaccine, and caller has been having an ongoing headache everyday, been to the neurologist and is still having headache. Calling to report headache. Start date of adverse event: Caller has his vaccine card. Caller is going to look on some medications that HCP prescribed for caller's headache to see a date. 03Sep2021 is when caller received the medication, Etodolac, for headache. Unknown exact date for when the headache started, but that is why caller got the medication, for headache. Vaccination Facility Type: Pharmacy/ Drug Store. Vaccine Administered at Facility: No. Got the flu shot the same day as the 2nd dose of the Pfizer COVID-19 vaccine. Vaccine Name: Unknown of the specific name of flu shot. AE Headache require a visit to Physician Office, no emergency room. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): No. Caller is just reporting headache today, not sure, has been to HCP about headache and HCP also prescribed Sumatriptan medication, 50mg, for caller's headache. Sumatriptan:NDC number: 65862, Lot number: SQ5021020-A, Expiration date: Apr2025, Formulation, dose: 50mg, tablets, count size 9 tablets. Indication: For headache, for migraine headaches. Is a sample of the product available to be returned, if requested (Y/N): Yes for both. Packaging sealed and intact? Yes for both.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200867377 same patient/reporter, different dose/vaccine licensing;
"SM received first dose of Pfizer vaccine lot EL1238.  Ambulated to seat independently post vaccination.  Approximately 3-5 minutes post vaccine SM began feeling dizzy and light headed with diaphoresis.  SM was moved to alcove and seated in a chair for monitoring.  SM stated no medical history but did feel dizzy with last flu vaccine.  As this writer was connecting monitoring patient lost consciousness, noted pupils largely dilated.  Lowered to floor by this writer and security office.  Legs were elevated with immediate return of consciousness. Rapid called for assistance. Orthostatic vital monitored.  When patient returned to floor began feelings that he was again losing consciousness.  Lowered back to floor without loss of consciousness.  Orthostatic vitals completed again. SM moved to cart.  Monitored for additional lying to siting to standing with complete resolution of symptoms.  SM left for home ambulatory and declined this writer to accompany to vehicle or call a family member.    VS Time     HR     B/P     SpO2 1357     74     125/72      100%  lying 1359     90     148/83     100%   laying 1401     85     151/85     100%   sitting on floor 1402     82     129/78     100%   chair 1404     71     132/70     100%   lowered back to floor blood sugar 111 @1407 1410     78     132/79     100%   moved to cart 1415     82     132/81     100%   laying 1420     74     135/83     99%     sitting 1426     83     132/89     100%   dangle 1430     86     129/76     99%   standing / marching in place
Small red bumps near the injection spot located in the upper forearm.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: BUD/ew0172) via an unspecified route of administration on 21Apr2021 at 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Apr2021, the patient experienced small red bumps near the injection spot located in the upper forearm. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event small red bumps near the injection spot located in the upper forearm was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Complaints of numbness and tingling in all four extremities, back pain, reduced range of motion of back. Referred to physical therapy. Currently seeing physical therapy weekly. Patient does not report improvements of symptoms.
Point of injection continues having a hot tingling feeling and penis now has bumps that have not gone away after using several OTC like jock itch, and abreva.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with and improperly stored dose of ZOSTAVAX (strength, dose and route of administration were not provided) (lot # L027321 expiration date 21-OCT-2016). The registered nurse stated that ZOSTAVAX was exposed to the following temperature conditions: 7 F degrees during defrosting cycling. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
for 18 y.o. woman who experienced a 10-15 second seizure in observation area. No trauma. Found to have low CBG, history of anemia. No seizure disorder. Alert and talking while waiting for transport.
Severe pain on shot site (left arm) to elbow.  Pain is described as severe charley horse that one would get in legs.  The spasms are constant.  I am now very weak to grasp with left hand.  I am taking Advil and Aleve to help minimize the pain but that is hardly working.  I am using heat/ice, the ice only seems to aggravate.
Patient received the H1N1 vaccine on 10/21. (Vaccine was not given within this facility) On 10/22 he did not feel right and by Friday was having significant tremors and difficulty speaking. He does not remember this, but family member described as "thrashing his arms." He was seen here in the ER the eve of 10/22, was admitted and evaluated by Neurology then discharged around 6 pm 10/24. He was brought back to ED a couple of hours after discharge because he had further problem speaking and the shakes. He has no prior history of seizures, but does have some underlying tremors in his fingers chronically. Possible reaction to the H1N1 vaccine. 11/24/2009 MR and DC summary for 10/23-24/2009, patient with  LOC, difficulty walking and with speech, tonic-clonic movements. Neiro consult, started on Topamax 12/16/2009 OP Neurology MD visit for 11/19/2009 revealed that patient had been taking high doses of Ultram and neurologist felt the generalized seizure activity could be related, patient did have another seizure episode early November 2009, repat EEG and MRI Brain were wnl, will be seeing a Psychiatrist for his increased anxiety which was the reason for taking the Ultram, told not to drive for 3 months and will RTC 3/201012/31/2009 DC summary and consult records for 10/24-10/26/2009, patient returned to ER on 10/24/2009 with c/o's altered mental status, expressive aphasia, rt sided tremors.  01/07/10 PCP medical records received. Service dates 10/07/09 Post hospitalization - fine tremor. Cold feet, mild Raynaud's.
APN states that pt fainted as soon as vaccine was administered. Pt states she had not eaten all day and denied ever fainting with shots or vaccines and for any other reason. Pale, clammy skin- nausea vomiting.
Hospitalized for covid; symptoms include subjective fever, cough, nausea/vomiting, fatigue, and myalgia
Elevated temp up to 104 AX (48 - 60 hrs); Non-responsive to anti-Pyretic;
Experience growing fatigue over course of oral vaccines (8/16,18,20,22). Started experiencing severe nausea and headache on 8/21. Spiked a fever - temperature unknown - but experienced delirious state. Also experience muscle aches, severe cramps and diarrhea. By Friday (8/25) had developed a mild rash, and also had heartburn and numbness in the face. Went to see my physician on Friday. Unable to sleep much during this period of time. Monday (8/28) doctor prescribed anti-nausea and diarrhea medication. Symptoms seem to be subsiding at this point in time (8/30).
pt recv vax 20JUL95 & 7AUG95 pt exp sz;pt completely gray, was swallowing tongue, eyes were rolled back in head, saliva was coming from mouth;dx epilepsy;
Information has been received from a medical assistant referring to a 5 year old male patient. Information about concurrent condition, concomitant therapies, drug reactions/allergies and medical history was not provided. On 29-NOV-2014, the patient was administered his first dose of VAQTA (1 dose, lot # and route unknown) for prophylaxis. On 19-NOV-2015, the patient was administered his second dose of hepatitis a vaccine, inactivated (VAQTA) (lot # unknown). On 17-NOV-2017, the patient was inadvertently vaccinated with his third dose of VAQTA (25/0.5 ml, 1 dose, lot # unknown) (extra dose administered). No adverse effect reported.
Patient experienced a 45 minute episode of kaleidoscope vision  starting small and growing to 50% of vision before fading away.
I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 10/2/2022 HTN (HYPERTENSION)
At 1108 on 02/23/2023 patient was administered 0.25 mL of Moderna 6m - 5yr Bivalent booster. Patient tolerated injection well during the 15 minute observation period. Parents notified. Confirmed with Pediatrician that no harm will come to the patient.
Patient reported lightheadedness and feeling shaky a few minutes after receiving Pfizer injection. An ice pack was applied to the back of his neck and he was given water and graham crackers. Vitals taken at 6:25 pm shortly after symptom onset: BP 140/90, HR 86, RR 12. He was observed until 6:45pm at which time he stated that he was feeling much better. Repeat vitals done at 6:45pm: BP 117/78, HR 86, RR 12. Patient left in good condition.
Red, swollen at injection site size of golf ball, hot to touch, itching - treated with Benadryl and cool compress.
Initial report received from a patient on 08 August 2007. A 53 year old, female patient (with no known allergies) developed chills, achiness and had difficulty sleeping. 7 hours after she received Adacel (lot number unknown) intramuscularly in the left deltoid on 07 August 2007. She also stated her "heart was beating fast" and her "breathing rate had increased." She denied having any illness at the time of the vaccination. At the time of the report, she was feeling better, but had not completely resolved.
Information has been received from a lawyer regarding a case in litigation, which was reported in a published article, title as stated above, concerning a female who alleged that after receiving two RECOMBIVAX HB (manufacturer unknown), the first on 07-NOV-1996 and the second on 11-DEC-1996, suffered an encephalopathy, Reye's syndrome and mental and physical deficits as a result of the encephalopathy. It was reported that "this was a 10 year old claim that the RECOMBIVAX HB vaccination brought on the Reye's syndrome". The court found that "there was nothing improper in the decision to refer to damages for pain and suffering". Upon internal review, encephalopathy was determined to be other important medical event (OME). No further information is available.
Appetite lost; Had a fever running for a little while; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite lost) and PYREXIA (Had a fever running for a little while) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced DECREASED APPETITE (Appetite lost) and PYREXIA (Had a fever running for a little while). At the time of the report, DECREASED APPETITE (Appetite lost) and PYREXIA (Had a fever running for a little while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
the patient received M-M-R II intramuscularly.; No adverse symptoms reported.; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On an unspecified date, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, lot number and expiration date not provided) intramuscularly for prophylaxis. No adverse symptoms were reported.
After the 2nd vaccine I developed headaches, after 2 weeks of being  fully vaccinated, I had such severe head pain, I went to the ER, I had had a stroke, was sent home and a week later, 4 more strokes occured.
Child received 2nd dose on 5/11/10. Child was admitted to hospital for intussusception on 6/15/10 which required surgery correction.
An hour after vaccine was received I started to experience a pain on the left side of my neck like a strained muscle, it has been 2 weeks now and I am still experiencing this pain in my neck.
Patient vaccinated 8/24/21, 3/19/21, 2/26/21. History of lung transplant. Initially positive for COVID 6/21/22. Admitted 7/15/22 with COVID symptoms and positive PCR.
Servere diarrhea, servere dizziness, weak, pain in my tummy,
I had a welt the size of a quarter at the injection site. This was red, raised about 1/4" and lasted for 10 days post vaccine.  There was mild pain (not painful, but more annoying, although slightly painful to the touch).
did hard physical labor yesterday;arm sore & swollen (fifty cents size) in lt deltoid;
Fever of 101.8 started at 4pm the day after the vaccine, followed by sever body aches, fatigue. Tylenol and fluids taken. 11/13/21- fever, body aches, fatigue, lack of appetite continued. Headache with blurred vision started at approximately 5pm.
Pfizer-BioNTech COVID- 19 Vaccine  Vaccine recipient was 15 years old at the time of administration of vaccine.