chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/4/21: 2nd dose of Pfizer Covid vaccine 12/23/21: FIrst symptom of LEFT sided ptosis (did not resolve) 1/13/22: Noticable worsening of LEFT ptosis 1/23/22: Limping began  1/24/22: Limping worsened with LEFT leg splinting (knee pointed inwards) 1/26/22: Presented to PCP; labs obtained:  WBC 9.4 (37N, 55L), H&H 14.2/41.9, Plts 274. ESR 2, CRP <1.0. Glu 84, cr 0.38, AST 33, ALT 17. Left lower extremity XR done and showed a "cortical irregularity of the left femoral head".  1/29/22: Presented to ED: Pelvis XR showing LEFT femoral head flattening and irregularity, possible AVN vs benign variant. Ortho consulted and felt consistent with LCP.  ***PLEASE SEE PAGE 2 FOR CONTINUED TIMELINE*** 2/3/22: Seen at clinic  was unable to bear weight, had a positive Gower's sign prompting non-con spine MRI which was normal.  2/4/22: Seen by Neuro for LEFT sided headache, LEFT eye ptosis and LEFT leg weakness; referred to ED and admitted.  2/4/22  2/11/22: Admitted for progressive LEFT sided weakness. Brain MRI showed diffuse cauda equine nerve root thickening and enhancement (greatest ventrally) and mild leptomeningeal enhancement circumscribing the conus; all suggestive of an acute inflammatory demyelinating polyradiculopathy (AIDP, GBS). Labs showed WBC 6.9, Hct 31.7, Plts 188; ANC 1173; ESR 19, CRP <0.8. Blood cultures from 2/7/22 were negative. LP done on 2/5/22 which showed CSF WBC 2, RBC 1, Prot 263, Glucose 50; Albumin 162.0, Synthesis Rate 32.43, IgG 17.4, IgG/Albumin Ratio 0.11, IgG Index 0.73. CSF Mycoplasma PCR neg. CSF cultures were negative. He received IVIG 2/5/22  2/7/22 which was subsequently complicated by symptoms of aseptic meningitis.  2/11/22  2/18/22:  Transferred to inpatient rehab, where he showed improvement by the time of discharge.  3/1/22  3/5/22 Admitted to hospital again due to gradual decline in LE strength to point of not being able to sit or walk independently. CIDP started to rise higher on the differential. Toto received another round of IVIG 2g/kg over 2 days  had again post-infusion reaction. Upon discharge had improvement in lower extremity muscle function.  4/4/22  4/7/22 Re-admitted to hospital due to worsening ascending weakness, and new progress nausea / headache in morning, worsening of his ptosis (which had never completely resolved since first appearing on 12/23/21) and blurry vision. He was found to have increased ICP and papilledema on brain MRI; notably, no evidence of demyelination of brain or brainstem. MRI head venogram was normal. Had an LP confirming increased ICP with opening pressure 26-42; WBC 26 (0% polys, 100% other cell types), RBC 2, Prot 150, Glucose 138.  CSF viral PCR panel negative (CMV, HSV, HHV6, ENV, Parecho, VZV PCRs). Culture negative. Elevated WBCs and Protein thought to be secondary to prior IVIG treatments and high protein supportive of CIDP diagnosis. Received IV Methylpred 30 mg/kg from 4/5-4/7. Started on Acetazolamide.   4/16/22 - Continues to follow with Neurology and Rehab / Therapy
pt recvd vax 1APR93 & mom states 2APR93 pt was fussy had t101; this cont on 5APR & 6APR; pt taken to MD & put on med; mom said pt not better-t101-104 giving APAP; pt has not eaten in 8 days-won't walk, lt leg hurts; no redness or swelling;
her husband and she had COVID in June; her husband and she had COVID in June; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "her husband and she had COVID in June". The reporter stated that she and her husband received the first 2 doses and 1 booster dose last February. She wanted to know if they should receive a fourth and fifth dose of this vaccine. The reporter mentioned that her husband and she had COVID in Jun2022. She declined to be transferred. They are 70 years old.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201324645 same reporter/product/AE, different patient;
Information has been received from a certified nurse midwife concerning a 25 year old female student with no known drugs allergies, who on 06-MAR-2009 was vaccinated with a second dose of GARDASIL (lot # 661531/1311X), intramuscularly into the left deltoid.  Three weeks post vaccination the patient developed severe hives and was hospitalized.  The patient recovered on an unspecified date.  Additional information has been requested.
Information has been received from a nurse on 15-Jul-2010.  A 4 month old male received the H1N1 injection on 14-May-2010.  The nurse questioned when the infant could receive the second dose.  Patient outcome is unknown.  No further information was provided.  The company considered the event as unassessable to the suspect drug, H1N1 injection.  Information derived from this AE report does not change the current safety profile of the product.
Information was received on 14-JUL-2017 from a physician assistant regarding an unspecified number of patients (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L023230, exp 28-JUL-2017; lot # L006428, exp date 30-JUL-2017; and lot # L037554, exp date 25-DEC-2017) (dose, route, and site of administration not reported). No adverse effects were reported. Temperature: 32 degrees Fahrenheit to 35 degrees Fahrenheit. Time Frame: 2 minutes. Previous temperature excursion? Yes 32 degrees Fahrenheit to 35 degrees Fahrenheit for 2 minutes. Total cumulative time: 4 minutes. Was call because of a data logger? Yes. No additional information was provided. Additional information has been requested.
Area on leg warm, red, no temperature.  Given Amox 250 mg/sec 1 tsp a day for 7 days.
several patients received vaccine from expired lot number with expiry of October 9 2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (several patients received vaccine from expired lot number with expiry of October 9 2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (several patients received vaccine from expired lot number with expiry of October 9 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (several patients received vaccine from expired lot number with expiry of October 9 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Dose administered after 30-day Use By Date or after manufacturer date of expiry.
it caused a severe flare up in my ulcerative colitis.  i have had no flare ups in over 2 years.  abdominal pain and cramping, , followed by diarrhea all day for 4 straight days.
pt recvd vax & was hospitalized & dx w/GBS; as of this date most of the sx have gone; pt had a sl bronchial or lung infection prior to Fluogen administration; No additional clinical details are available;
Felt sicker than hell; Back hurt like someone dropped a box on it; Shaking/Felt like he had a vibrator; Stayed in bed for day and half; Feels weak; Arm is still tender; Felt so cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sicker than hell), BACK PAIN (Back hurt like someone dropped a box on it), TREMOR (Shaking/Felt like he had a vibrator), BEDRIDDEN (Stayed in bed for day and half) and ASTHENIA (Feels weak) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack, COVID-19 on 26-Dec-2020 and Pacemaker complication. Concurrent medical conditions included Heart disorder.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced MALAISE (Felt sicker than hell), BACK PAIN (Back hurt like someone dropped a box on it), TREMOR (Shaking/Felt like he had a vibrator), BEDRIDDEN (Stayed in bed for day and half), ASTHENIA (Feels weak), TENDERNESS (Arm is still tender) and FEELING COLD (Felt so cold). At the time of the report, MALAISE (Felt sicker than hell) and BEDRIDDEN (Stayed in bed for day and half) had resolved and BACK PAIN (Back hurt like someone dropped a box on it), TREMOR (Shaking/Felt like he had a vibrator), ASTHENIA (Feels weak), TENDERNESS (Arm is still tender) and FEELING COLD (Felt so cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included heart pills.  Treatment information was not provided.
area across shoulders and down back hurts a lot, felt pressure in this area; area across shoulders and down back hurts a lot, felt pressure in this area; dry sore throat- feels like someone threw sand in her throat; Feeling achy, it was worse when she got up this morning; Feeling achy; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727) via an unspecified route of administration, administered in right arm on 22Mar2021 12:00 as dose 1, single for COVID-19 immunization (Clinic) (at the age of 29-year-old). Medical history included flu shot over six months ago from an unknown date. Family history of heart disease and dementia, Grandma and great grandma had dementia on father's side. Mother's side- grandma had heart disease. There were no concomitant medications. The patient experienced feeling achy on 22Mar2021 Around 3:00 PM or 4:00 PM (15:00 or 16:00), patient thought it was the weather, feeling achy about two or three hours after the shot, feeling achy, it was worse when she got up this morning on 23Mar2021 it was ten times worse- she had never felt like this before, area across shoulders and down back hurts a lot, felt pressure in this area, dry sore throat- felt like someone threw sand in throat both on 23Mar2021 07.30. Relevant tests were none. Patient wanted to lay down so didn't feel the pressure across shoulders and down her back. Patient scheduled to receive the second dose on 12Apr2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown ae and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose and route were not reported; lot # L004006 with expiry date 05-AUG-2016; lot # L009210 with expiry date 17-SEP-2016; lot # L030592 with expiry date 12-FEB-2017 and albumin status of recombinant human albumin (RHA); lot # reported as L0169304 (invalid lot number for PROQUAD (Merck) with expiry date 08-NOV-2016). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All                                                                                                       Subjective Patient is a 35 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience heart racing.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and skin changes.    Past Medical History: Diagnosis Date ? Salivary gland calculi   ? Tuberculosis 2002     ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, abdominal pain, muscle aches, dizziness and headaches       Previous Reactions: hx of having an allergic reaction to allergy injection.      Objective    Vitals Vitals:   03/12/21 1425 BP: 131/83 Pulse: 86 SpO2: 100%        Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is not diaphoretic.  HENT:     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Eyes:     Extraocular Movements: Extraocular movements intact.     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.     Gait: Gait normal.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)   Reassuring vitals and exam. Pt feels comfortable going home. Follow up with pcp as needed. Pt voiced appreciation of care today.    APRN Electronically Signed 3/12/2021 2:27 PM
headaches; tachycardia/fast heart beat; fever; body aches; joint pain/ joint ache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for work. The patient's medical history and concomitant medications were reported as none. The patient reported events of fever, headaches, body aches, joint pain, tachycardia, on 07Jan2021. Patient developed fever in the night, 100.5 at 1-3 am. Then, developed body ache and especially joint ache. She had a bad headache from 2-3 am. She also experienced a fast heart beat that started around 2-3 am. She received the vaccine at work. She started taking the paracetamol (TYLENOL) which did pushed down her fever. She thought it helped her headache as well and it helped her heart rate. Her headache was controlled with paracetamol. So she could not tell if it was improving, persisting, or worsening. Her heart rate at around 2-3 am was 115bpm, after paracetamol it got down to 105 bpm. Therapeutic measures were taken as result of the events included paracetamol (TYLENOL). The outcome of the events fever and tachycardia was recovering, outcome of event headaches was unknown, outcome of the other evets was not recovered. The report was reported as non-serious.
Approximately 1 wk after 1st vacc shot patient experienced hives and intense itching beginning in neck region and ears, genital area.  Neck and torso followed.  Arms and legs followed, resolving slightly prior to second vacc shot.  After second COVID shot ~4 wks later (05/04/2021) symptoms worsened again within 24 hrs.  Hives and itching concentrated in neck area and ears; migrated to arms and legs.  No issues with breathing, no fever at any time.  Treated with Diphenhydramine with some relief, hydrocortizone cream topical also.
Initial and follow-up information has been received from a nurse practitioner concerning a 22 year old female with no drug allergies and no medical history, who on 28-AUG-2007 was vaccinated intramuscularly into the right deltoid with a 0.5mL first dose of Gardasil (Lot #0469U). There was no concomitant medication. There were no illnesses at the time of the vaccination. On 29-AUG-2007 the patient woke up in the morning and noticed, raised, red spots "all over body" (arms, legs, buttocks, stomach and back) (also reported as developed hives on her arms, legs, back and abdomen) totaling 10-12 lesions (also reported as hives), with severe itching, and no difficulty breathing. On 30-AUG-2007 she called the nurse practitioner and was treated with BENADRYL. The patient was advised to not receive any further doses of GARDASIL. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown (previously reported as the patient had not recovered). No product quality complaint was involved. Additional information has been requested. Additional information is not expected.
Information has been received from a physician assistant concerning his niece who was vaccinated with GARDASIL.  Subsequently the patient experienced depression.  It was unspecified if the patient sought medical attention.  Additional information has been requested.
Body rash affecting arms, thighs, chest and back. Rash started approximately at 11:30pm 2/7/2021 when in bed.  Strong itch woke me up.  Began taking Benadryl (Diphenhydramine HCI 25mg 1capsule at 2:30am 2/8/21 and continuing every 4-6hrs. Itchy feeling continues but is milder.  Rash is still evident.
temperature 99.7; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (temperature 99.7) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (temperature 99.7). At the time of the report, BODY TEMPERATURE INCREASED (temperature 99.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot #, expiry date, strength, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 34.5 degrees Fahrenheit for 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
July 1, 2022, I tested positive for COVID-19. I woke up with a real bad sore throat and it was so bad that I couldn't even drink water. I called my doctor on July 2, 2022, trying to get a prescription for PAXLOVID. The doctor told me I had to get a blood test first before they could prescribe me the PAXLOVID. The blood test came back normal and my doctor was able to prescribe me the PAXLOVID. I took the PAXLOVID for five days and tested positive for COVID-19 on July 12, 2022.
Was awakene by a sharp, shooting pain in my head. These shooting pains continued sporadically, but  did not stop throughout the next day. I did not time them but at least every five minutes they would come and jolt me.  About halfway thru the day 5/25/21, I took a 5. xanax and a tramadol and they subsided, however the sharp searing, shooting pains started up again in the later evening, probably when the meds wore off.  It is a sharp quick jolting pain almost electrical in the way they feel.  Also had brain fog and sporadic fever of 99.2 and sweating. I usually run around 97. something.  Today is Wednesday 5/26 and still have the sweating and slight brain fog and sporadic low grade fever that comes and goes. It is now 6:51 and the pains have seem to have subsided, thankfully.
I had Pfizer Booster shot; right underneath the shot, it's like a swollen area; it does hurts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (Solution for injection) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "I had Pfizer Booster shot"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "right underneath the shot, it's like a swollen area"; PAIN (non-serious), outcome "unknown", described as "it does hurts". Additional Information: When probed for consumer's name and Telephone#, consumer stated "I am calling because I had Pfizer Booster shot (unspecified shot) yesterday and I am having a side effect, it's little blue where the shot was given, so it feels like a mosquito bite and it's a little swollen (and it hurts)." Distortion on the line. Consumer stated, "My husband has the same thing (side effects) but he has right underneath the shot, it's like a swollen area and it looks like a big mosquito bite and if you touch it, it does hurts." Consumer was informed about the Role of Pfizer Drug Safety. When paraphrased the concern, consumer stated "Still have swelling."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very painful injection site, Malaise, joint and tendon pain all resolved within 5 days, except some lingering tendonitis