chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a Medical Assistant concerning a 17 year old female patient who on 15-MAR-2007 was vaccinated IM with her first dose of Gardasil, lot #654702/0011U. The reporter reported soon after the injection "her arm hurt really bad" and was stiff. On 16-MAR-2007 the patient developed sporadic twitching of her whole body. The reporter stated that the patient "looked as if she had Tourette syndrome. " On 17-MAR-2007 the patient was examined in the emergency room and was released a few hours later. She was examined by her primary physician and gynecologist. She had an appointment with a neurologist. She has not had any improvement in her symptoms of sporadic twitching, however arm pain and stiffness were subsiding. The reporter considered the events to be disabling because the patient was unable to perform her activities of daily living for a week. Additional information has been requested.  7/7/2009 Neuro consult received for 3/20/07-4/13/07 with DX: Intermittent myoclonus. Pt presented for consult after developing twitching in the L leg and shoulder which developed on 3/16/07, one day after receiving HPV vax in R deltoid. Pt also c/o shoulder pain and RUE pain making it difficult to use the R arm. Pt c/o increasing frontal H/A since that time as well. Plantar responses were flexor on the right and extensor on the left. Intermittent jerky movement mostly upper part of body toward left shoulder and rarely in the legs.  F/U 3/30/07 with continued H/A and blurred vision but improvement in twitching. RUE pain improved, but now sharp pain in top of neck. Tx with Naproxen which was later d/c due to epigastric pain. Topamax started.  7/14/09 PCP records recd. Seen 3/19/07 for dx: motor twitching. See neuro records.  7/17/09 ER records received DOS 3/17/07 to 3/18/07. Assessment: Shoulder Twitching. Patient presented with sudden onset left shoulder twitching (intermittent). Left shoulder muscle pain. Ativan prescribed, symptom improved, and patient discharged.
A few days later, I started having light headiness and dizziness.  I checked my sugar level and it was low.  I start having blowing and SOB. I had weight gain.  I contacted the doctor, he gave me water pills.  I then got really dizziness and passed out.  Then he took me off the blood pressure medicine and put me on blood thinner medicine.  Then on April  29th, I went to the hospital and they determine that I was dehydrative.  I am fatigue as well.
4 days of slowly progressive, but still mild classic pleomorphic rash-in form of papular, vesicle & 1-2 crusted;rash distribution not typical of chickenpox only 5-7 on head & face, 8-10 in diaper area & rest scattered over rest of body;
Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the morning of 1/14/21.  Pain got steadily worse to the point of full body myalgias, severe fatigue/weakness and severe nausea.  Almost passed out at work and ended up being bedridden for the rest of the day on 1/14 and all day 1/15 and 1/16.  Also had hematuria that developed on 1/15.  Went to urgent care clinic on 1/16 and received one bag of IV fluids and zofran for the nausea.  CBC, CK, CMP all normal but 1+ hematuria on U/A.  Symptoms finally improved on 1/17
In August of 2022 I went to the doctor for check-up.  I had a low-red blood cell count and that I had anemia.  I had been feeling tired for some time.  I am active but my energy level is lower than usual.  I was sent to an oncologist because it was non-iron related anemia.  The oncologist recommended folic acid, but this did not help with my blood count.  I have another appointment with the oncologist at the end of the month.  My symptoms are low energy, gout and dizziness.
itchiness; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itchiness after use of product. Patient's hands, feet and low back were itchy on and off for the first two days. Reporter was a little concerned, stating "I always associate itchiness with allergy and God forbid, anaphylaxis, but it seemed to all go well." The outcome of event was unknown. Reporter wanted to know if patient should be put on an antihistamine before getting her second vaccine in two weeks.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Per pt received vaccination on 12/19/02. About 2 hours after immunization given at site of injection arm hot and red, weakness in arm the next day, developed stiff neck pain and stiffness in joints, headache to 2-3 days and numbness in arm. Called her physician on 12/21/02.
Patient received vaccine after not reporting any allergies or concerns. Patient went to sit in waiting area for 15 minutes. About 10 minutes after his vaccination, patient fell off his chair to the ground and had a syncopal event. He appeared to lose consciousness for a few seconds and then became alert. He had a slightly bloody nose, which we cleaned up. We laid him down on the floor and monitored his blood pressure while applying a cool compress to his forehead and neck.  He was doing fine, so we continued to monitor him for another hour. He mentioned he had not eaten since the night before at 5pm. We gave him a protein bar and some juice and water( after about 1/2 hour) and he felt much better.   We advised him to contact his doctor if he did not feel better later today. Patient received a ride home.
pt recvd vax & devel t101, h/a, confusion, unable to concentrate, neck ached, eyes sensitive to light, rt arm hurt, nausea w/no emesis, body felt achy, especially upper torso, congestion & runny nose & infected eyes;
She got her vaccine, was fine.  When she woke up on Saturday she woke up wtih the worst Migraine in her life.  She took a a Neurtek which did not help.  She then had really bad chills, then she got really bad body aches where everything hurt including her feet, joints and muscles.  She felt it was a reaction.  Later in the afternoon she had shortness of breath, and she had a little chest pain.  She started itching all over, and itching got worse.  Her lips started to tingle and her face got a little swollen.  After her lips started to tingle she went to the ER.  She went to Health Care.  In the ER they gave her 25 mg of Benadryl and Pepcid IV, and then they also gave her Solumedrol 125 mg IV, and and a breathing treatment.  She also got really dizzy with the vaccine and very light headed.  The combination of the medicine given to her in the ER worked and they sent her home on Prednisone for 3 days.  She is feeling much better now, and still has some occasional itching.  She does have a call in to her doctor and has to FU in 3 days after her ER visit.
Right thigh swollen, hard, and red site 2 in by 1 in. Patient placed on antibiotics. AUGMENTIN 600mg Bid x 10 days.
Parent presented on 8/23/2021 and requested Pfizer covid 19 vaccine for patient and gave an incorrect DOB (the same day).  We had no prior fills for the patient, and his profile was created that day.  With the understanding that the patient had just turned 12, we administered a 1st dose of the adult Pfizer vaccine (For age 12 & up, 0.3mL IM).  In early January 2022 a report alerted us that he may have been under age 12, and gave incorrect DOB. Review of database showed all the patient's childhood IMZ under a different DOB, and the patient's PCP confirmed patient's DOB. Database showed the patient received a 2nd dose of adult Pfizer on 09/13/2021 and staff at that pharmacy informed us that they also had been given the DOB, and that this immunization was also the only service they had provided for the patient.  We left several messages with the patient's contact number, and on 01/14/2022 the patient's mother returned our call.  When asked about the conflicting DOB, she said she "didn't know how to answer that".  When informed that her son may have received the Pfizer vaccine a few months before he turned 12, the minimum age under the EUA , she only stated that she was "happy with the service that you (the pharmacy) provided", thanked us (the pharmacy) for doing "important work", and did not provide any further information or concerns.
Information has been received from a physician concerning an approximately 3-year-old female who in approximately August 2004, at one year of age, was vaccinated with the first dose of Varivax. The physician reported that in approximately 2006, the patient developed chickenpox characterized by 50 lesions. The physician noted that three lesions were on the patient's chest, some were on her legs and some were on other parts of her body. Unspecified medical attention was sought. Subsequently, the patient recovered from the chickenpox. Additional information has been requested.
Absence of menstrual period. I have always been on a regular cycle.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 15:45 (Lot number: 301308A) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: AMENORRHOEA (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Absence of menstrual period. I have always been on a regular cycle.". Therapeutic measures were not taken as a result of amenorrhoea.  Additional information: Dose received: 2, product: COVID 19, brand: Pfizer, brand unknown: False, lot number: 301388A, lot unknown: False, administration date: 05Oct2021, administration time: 16:45 PM, dose number: 2, vaccine location: Left arm.  No follow-up attempts are possible. No further information is expected.
Patient is experiencing pain and soreness in the left arm. She is unable to lift or move her left arm without soreness. Patient is also experiencing a popping feeling in the arm.  Patient has taken Ibuprofen but has not gotten relief.
Fever tMax 103.9, myalgias, golf ball-sized axillary lymph node, migraine, nausea, shortness of breath.
Vaccine given at 11 AM 8/27/07. At about 1130 pm he awoke shaking/shivering, fever 100.8, muscle aches, vomiting. Went to ER at 12 midnight. Given Solumedrol, Toradol, Ativan, Benadryl, Pepcid. Given Prednisone to take x 2 days. Feeling better today. Left ER at 3 AM.
Patient complained of getting hot. While sitting in the chair, he fell to ground, hitting head on the back of the chair. This patient was evaluated by EMT and Nurse. Patient denies double or blurred vision, nor nausea or vomiting, nor headache, nor dizziness, but some soreness at back of head. No noted swelling at this site.  At  3:44 pm, vitals were: O2 sat 97%, B/P 110/60, HR 86, R 20. Offered water and tolerated well. Patient's family accompanied him to this event. At 4:07pm, vitals , O2 sat 99%, B/P 112/68, HR 86, R 20.   At 4:26 pm, paramedics were called, and arrived, and evaluated patient.  Vitals now, O2 sat 100%, B/P 125/73, HR 76, R 20. Paramedics deemed patient stable to go home. At 4:35 pm, patient released to go home with family.
Patient reported muscle aches, chills, fatigue, malaise for 2 days after vaccine
Tested positive for covid no 12/31/22, the symptoms I had were fe ver/ chills, body aches, headache, cough, sneezing, fatigue
approx 24 hrs. after vax pt exp batching erythema, rt arm, requested m.d. visit
I tested positive for COVID-19 on 12/10/22. I had a sore throat, body aches, fever of 103, and congestion. The fever lasted for a couple days. The congestion lasted a little longer. I still have some fatigue. I contacted the doctor and was prescribed albuterol. I also took guaifenesin and dextromethorphan. I am feeling better, but still have fatigue and shortness of breath.
Pt recv vax on 11/17/98; on same day pt exp burning/ red vax site-LA
Headache, Myalgia,  Chills, fatigue, pain at injection site Narrative:
5-16-06 evening developed fever of 104, orally.  Describes it as a "damp fever", very sweaty, pale, body aches.  Did not sleep well for 2 nights, so sweaty she had to lay a towel on the bed.  Uncomfortable.  Better by 5-18-06 in the afternoon.
first dose July 2019/ second dose 18-OCT-2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019).   On 18th October 2021, the patient received the 2nd dose of Shingrix. On 18th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was recovered/resolved.  Additional details were provided as follows: The patient self reported the case. The patient was out of the country and did not receive his second Shingrix dose until 18th October 2021, which led to lengthening of vaccination schedule. He had nothing else to report. The patient did not consent to follow-up.
Information has been received from a nurse practitioner and a female consumer with drug hypersensitivity (No otherwise specified) who on unspecified date in 2008 was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient developed an extreme case of shingles and pain. The patient had an allergic reaction to the medication she was given for the pain and spent most of her time in bed. The patient noted that instead of preventing, the vaccine gave her shingles. As of 18-NOV-2008, the adverse events persisted. The reporter felt that extreme case of shingles and pain were related to therapy with ZOSTAVAX (Merck). Follow up information received from the nurse practitioner reported that a 68 years old female patient (weight 136 pounds, height 66 inches) with hypertension, osteopenia, allergic rhinitis, asthma and chronic low back pain, who on 23-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 659409/0409X) subcutaneously. The patient called the clinic due to painful rash on the right T 10-11 on 30-JUN-2008. The patient was seen on the clinic on 02-JUL-2008, a visual exam was performed, the patient was diagnosed with extensive herpes zoster on the right T 10-11, and this was the first of many visits for extensive herpes zoster on the right T 10-11 distribution. The patient was placed on LYRICA 75 mg twice a day. The herpetic neuralgia persists. It was reported that the patient had a history of chickenpox during childhood. The patient extensive herpes zoster and herpetic neuralgia was considered to be disabling by the nurse practitioner. Additional information is not expected.
Left Jaw pain at temporomandibular joint, (Trigeminal neuralgia?).   No numbness or paralysis.  Jaw aches.  Best description is after the anesthetic from dental work wears off and jaw aches from injections and dental procedure.   Injection given at 1pm left arm.   Painless injection.  Injection site pain increased to moderate throughout day.    Jaw pain began at 10:45pm.    Next morning jaw pain still present.  Took two naproxen 200mg tablets at 05:30 am.
Starting at 0100 on 03/11/2021. Awoke with symptoms of fever with  chills, headache, neck and back pain (moderate to severe), pain in what seemed the bones of the skull and mandible (moderate to severe), nausea and vomiting, unable to take fluids, unable to sleep besides 60 mins. 24 hrs post vaccine.   Vomiting lasting 12 hours and nausea continued without ability to take fluids. Dr. prescribed Zolfan and after the first dosage, fluids were tolerated.  Fever lasting less than 48 hours, muscle soreness was mild by 48 hrs and continues as mild at this point, 78 hrs hrs post vaccine.
Patient requested Pfizer Bivalent 12+; Moderna Bivalent 12+ was administered.  No symptoms or signs that were outside of normal for this patient were observed.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On or about 04-SEP-2012, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to Plaintiff's zoster vaccine live (ZOSTAVAX) inoculation, Plaintiff was treated by a physician for shingles. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The outcome of the event was unknown.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  .
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2021 as dose 2, single (Lot number: EW0172) at the age of 52 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: (well managed with medication); "obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE, start date: 01Aug1991; BUSPIRONE, start date: 29Sep2021; LOSARTAN, start date: 15Jun2015; HYDROCHLOROTHIAZIDE, start date: 15Jun2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Positive, notes: positive Covid test AM; (21Apr2022) Negative, notes: Day -1 negative Covid test AM; (26Apr2022) Negative, notes: Day 6 (26Apr) negative Covid test in evening (01May2022) Positive, notes: Day 11 (01May) tested positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19.
12/24/2021- I was sitting at the table have Christmas dinner, I moved my foot, I notice my left foot had gone to sleep. I tried to shake it to wake it up, but it stayed asleep. The next morning the whole left leg was also asleep. It is not numb, It is usable, it is just  asleep. And it stayed asleep since 12/24/2021, the whole left leg, all the way up to the waist. We are thinking it is a pinched nerve. I have an appointment with the specialist at a Spine doctor next week. To let them figure it out. I called my doctor through email and she referred me to a Spine doctor. Note: I did have a colonoscopy on 11/01/2021.
Felt a little woozy and light-headed. Vitals wnl. Stabilized.
Mouth is 100% numb; Random ulcer.; Mouth is 100% numb and swollen inside; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 12:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included unspecified birth control medication (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. On 17Apr2021 at 16:30, the patient experienced mouth is 100% numb and swollen inside and randomly got a random ulcer. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mouth is 100% numb and swollen inside and random ulcer were unknown at the time of reporting.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
during our covid site visit from on 12.15.22. it was discovered that we had a pfizer batch in the frig that was past BUD date. during the investigation they went back through all the covid injections that were given and saw this patients lot number was given past the BUD date. patient has been contacted and revaccination was offered . manufacture was notified and reports were filed pending outcome.
Shot was administered in my left rotator cuff.  Immediate pain, followed by SIX MONTHS of pain, inability to use arm, and physical therapy.  One year later, rotator cuff and arm are still painful.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 20-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
severe thrombocytopenia lowest platelet count 25,000;duration 2mo no ICH or other critical bleeds;
My 15 year old daughter received two doses of GARDASIL. Within 2 months she went from being an athletic to being too sick to function on a daily basis. She has been diagnosed with Hashimoto's thyroiditis and POTS. Prior to receiving the 2nd vaccine, she was on the high school volleyball team. She is now under the care of a cardiologist and an endocrinologist. I am pro-vaccine but I am very afraid that the GARDASIL initiated an immune response to her system that caused the Hashimoto's and the POTS.
pt recvd MMR vax & approx 3APR91 devel a rash; no further details were provided;
Itchy rash on chest and arms, muscle and joint pains and swelling. Also swollen hands and fingers.