chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Inner restlessness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN8203; Expiration date was not reported) on the left arm on 10Mar2021 (11:00) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247; Expiration date was not reported) on 17Feb2021 (at the age of 58 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 10Mar2021 (15:15), the patient had fatigue and inner restlessness. The patient had not received treatment for the reported events. The outcome of the events was recovered on an unspecified date in 2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are needed. No further information is expected.
I had 1st dose Pfizer (EN5318) on 03/19, the 2nd dose (EN6207) on 04/09.  On 05/03, I started having headache on the right side of top scalp, like elctric shot every 1 to 2 minutes.  Never had this kind of headache before.  Tylenol didn't help.  On 05/07, went to emergency room, was given a steroid shot.  Still had headache but with less frequency.  On 05/13, had tearing of right eye, on 05/15, inable to blink, drooping and numbness on the right side of the face.  Was diagnosed Bell's Palsy by Dr. Conincidentally, My Sister-in-Law had two Pfizer doses on 04/06 (EN6207) and 04/28(EN8733).  on 05/29, she had all symptons that I had two weeks before and was dignosed Bell's Palsy.
pt recv vax;6 days post vax, red dots appeared on both thighs & pt exp low grade fever. pt was seen by MD on 25aug96 & was taken back to MD w/ legs covered w/rash. treated w/meds, condition worsened; sx lasted one month
Patient received Jynneos 0.5ml SQ on 6/13/23. The vaccine that was administered was 5 days beyond the best use by date indicated by pharmacy. Patient declined having any adverse events.
STARTED WITH FEVER (99.3), CHILLS, AND BODY ACHE, TOOK MOTRIN 400 MG AT 3PM; TYLENOL AT NIGHT. TEMP AT 1:00PM ON 10/19 WAS 102.5. TOOK TYLENOL ON 10/19/10 AT 1PM AND RECOVERED 2:00PM ON 10/19/2010. NO MORE SYMPTOMS AFTER THAT.
My left arm (where I got the injection) is swollen. Under my arm, on the upper left side of my chest is a decently large swollen lump that I believe to be my lymph node.  I just got this today, 2 days after my injection, and I haven't had it looked at yet.
Information has been received from a physician concerning a 75 year old patient with hypothyroidism, no known drug allergies and a history of depression and breast cancer who in August 2006, was vaccinated with the first dose of PNEUMOVAX (lot # not provided) 0.5 ml intramuscularly on the left deltoid. On October 2008 patient received a second dose of PNEUMOVAX (lot # not provided) 0.5 ml intramuscularly on the left deltoid. Concomitant therapy included CYMBALTA. On approximately 16-FEB-2009, "last week", the patient developed a pruritic, macular rash of the left deltoid area. The patient was examined in the office but no treatment was prescribed. No lab diagnostics studies performed. Patient is scheduled for an evaluation with an unspecified dermatologist. At the time of this report the patient had not yet recovered. Additional information has been requested.
Patient then missed subsequent doses in the HPV vaccine series.; Miscellaneous was chosen as the product type as it could not be determined if first dose in the vaccination series was GARDASIL quadrivalent or GARDASIL 9.; This spontaneous report was received from a pharmacist referring to a 16-year-old male patient. The patient's concurrent condition, medical history, drug allergies/ reaction and concomitant medications were not reported. On an unknown date in 2016 (reported as about three years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (strength, formulation, dose/frequency, route, lot# and expiry date were unknown) for prophylaxis (product origin unknown). On an unknown date, the patient missed subsequent doses in hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) vaccine series (product dose omission). The outcome of product dose omission and product origin unknown was unknown.
Felt like throat swelling (R) arm sore up to shoulder + neck + head  Tx: Methylprednisolone 125 inj Benadryl 25 mg  Famotidine 20 mg  IV
3 episodes of seizure the day after - getting vaccines - went to ER - NL EEG, KEPPRA and VALIUM given in hospital. No seizures since.
approximately 12 hours after receiving the vaccine, patient awoke with angioedema with tongue swelling, but no airway compromise. He was given Benadryl, famotidine, and 100mg steroids.
pt recv vax & exp pain;pt concerned about arthritic type pain, started out in the sacroiliac area, that resolved w/tx;pt has it kind of between the shoulder blades & vertebrae;
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Admitted 10/28/2005 with GBS. In PICU for a few days. Now on rehab floor As of 11/03/2005.  10/23/06 Received medical records from hospital which reveal patient had admitting dx & d/c dx: Buillain Barre & Headache.  Admitted from 10/28/05-11/10/05 HPI: patient complained of midfrontal HA for 8 days prior to admit & also leg pain for unclear number of days prior to admit.  It was difficult for her to climb stairs for several days & to ambulate on the day of admission.  She had been extra fatigued & sleeping more than usual with decreased oral intake.  She was incontinent of urine on day of admission. Exam revealed marked weakness of the LEs. & DTRs in LEs were low.  Had difficulty with heel walking & rising from floor w/o using hands. Hospital Course: Neuro - MRI was WNL.  LP done & CSF studies showed elevated protein with normal glucose.  NCS consistent with demyelination on 10/29/05.  Received IVIG x 5 days.  Significant gains were made after IVIG. D/C to PCP, Neuro & REhab follow up as well as outpatient PT & mental health evaluation. 10/23/06 Received medical records from PCP which reveal patient seen 10/26/05 for HA & legs hurting, decreased appetite, not feeling well & shaky in AM.  Next visit on 12/1/05 s/p hospitalization.  Patient was approx 90% back to normal.  Strength was WNL in UE with good heel walking, poor toe walking & still unable to rise from sitting w/o using hands.  Last visit was on 2/14/06 when patient had fever, sore throat & stuffy nose.  Dx: pharyngitis & URI.
livedo reticularis, left ear neck fullness/heat, dry mouth Narrative: Started to feel left ear/neck fullness/heat and mild/faint livedo reticularis about 5 minutes to the employee by the end of a 30 minute observation period (although not yet totally resolved). Vitals were WNL and exam was benign (including observation of b/l ears, palpation of neck) other than light mottling over b/l arms. No s/sx of immediate allergic reaction or anaphylaxis. Only other associated complaint was dry mouth, which resolved with water intake (no difficulty observed while swallowing). No development of skin sx concerning for erythema multiforme. Precautions provided on contacting clinic she was evaluated in, employee health and emergency care.
pt recvd vax 1045AM presented back @ clinic 420PM w/blotchy red rash on face, couple red areas in back & chest called MD who gave Epi-diff breathing
Difficulty breathing -3/12-2:00 am - 9:00am Dizziness and weakness 3/12-6:30am - 8:00am muscle ache - 3/11 - 8:30pm - 3/13-1:00pm  chills- 3/11 -  9:30pm-1:00am headache
Severe muscle pain on left side.  Neck, shoulder, scapula, arm.  Seems to move - one day in one place and then another day at a different site.  All on the left side though which is the arm I had the shot in.
Patient has pain and soreness at site of injection since day of vaccination (44 days). She is going to get X-ray.
I woke up at like 3 am itchy everywhere I stayed up. I made an appointment with my allergist, and we went through all the stuff I ate and I hadn?t taken any medication that was different. The doctor said I had a delayed skin reaction. The doctor prescribed me Pepcid Zyrtec which helped but it didn?t stop all the reaction all together. I still have hives that pop up randomly. The doctor told me that sometimes it takes a few weeks to clear up completely. I still have some itchiness its just not as bad as it was before.
pt recv vax; erythema & induration 5x10cm at inject site; no tx;
10/18/19 1500 - TC from client's daughter, stating her father received flu and pneumonia vaccines at the Center flu clinic on 10/16/19. He complained immediately following injection of pain and burning at the site. These symptoms continued so client was seen by Dr. Client's daughter states Dr. concluded the injection sites were infected, and his pending surgery would need to be cancelled.  Client is diabetic and also has hx/o psoriasis.
5/14/06 malaise, arthralgia progressed to rash on chin, neck and thighs on 5/15/06 with rash worsening some with time.  Rash is raised, non-vesicular and quite itchy.  Swollen "puffy" left axillary lymph node with swollen painful lymph node under left collar bone - hard pea size., 5/16/06 headache, malaise, arthralgia and rash continue.  S/S improve with acetaminophen.
6 days later noticed a swollen lymph node just above the left collar bone area. top of left shoulder is now also lightly affected.
Severe vertigo,  nausea, migraine, cough, joint pain, fatigue, fever, then chills, [sore throat was mild].
She got her vaccine, she had a racing heart, sat in her car and decided to let it settle down as she was still at clinic and fell asleep.  She woke up and that had stopped.  She had racing heart issues in the past, but nothing recent kind of a panic attack.  This morning she was a little bit on the colder side, aches, malaise, tiredness and feeling like she was not thinking straight.  She does care for children in wheelchairs, and cannot get a grip on it and didn't feel well and not able to figure it out how to secure the child in it.  She had to have help with that and decided that she was not normal, something was affecting her.  She went to the nurse, her temp was over 100, and was a fever for her as she is normally at 97.8.  She took it again after she was ready to go, it was 102 degrees and was told to go home for a few days until she felt better.  She is stuffed up and having cold/flu symptoms, which is unusual for her.  On her way home she was falling asleep, but did make it home safely.   She is feeling better, not a pre-nausea state and has been able to hold down fruit and yogurt and is feeling hungry.  She does have a headache and feels she has some immunity.  She has been able to rest and feels that it should get better, and if things worsen she will call back.
I received the vaccine around 2:30/3 PM. The same night I began feeling as if my throat was itchy around 11 PM. I took a Zyrtec because I thought my friends dog was giving me a little allergies. 20 minutes later my throat itch got progressively worse to where I started to feel a little wheezy and harder to breathe. My arm where the vaccine was felt itchy. I had a rash all on my left arm and upper chest where I had received the vaccine. Immediately, I took a benadryl then went to sleep. Around 3 AM I woke up uncontrollably shivering. My fiance was able to get me a heater because I was so chilled with shivers but was sweating profusely. These shivers lasted about an hour to where I finally just went to sleep. I woke up around 7 AM with a pounding headache so I finally decided to take my temperature. It was 102 F. I ran a fever all day and brought it down to 100 with ibuprofen.  I ran a slight fever the next day as well with extreme fatigue.
Extremely sore arm about 4-5 hours after the shot. About a week later injection shot became very hard, red, warm to touch, burning and itching. Felt feverish the night before rash occurred. Subsided after 2 days then reoccured  then reoccured in the next 24 hours but not as bad.
High fever, lethargic, seemed to withdraw, within hours of vaccines, less vocal, still receiving therapy still in speech therapy. Numerous speech/hearing tests and autistic spectrum test. Diagnosed with speech delay and behavioral problems by PCP.
Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.; She is experiencing enough pain to give someone a Heart Attack/Chest congestion; Periodic neurologic pain; Totally out of it; Knees hurt; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Family history included Guillain-Barre syndrome.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.) (seriousness criterion medically significant), CHEST DISCOMFORT (She is experiencing enough pain to give someone a Heart Attack/Chest congestion), NEURALGIA (Periodic neurologic pain), SOMNOLENCE (Totally out of it), ARTHRALGIA (Knees hurt) and FATIGUE (Exhausted). At the time of the report, ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.), CHEST DISCOMFORT (She is experiencing enough pain to give someone a Heart Attack/Chest congestion), NEURALGIA (Periodic neurologic pain), SOMNOLENCE (Totally out of it), ARTHRALGIA (Knees hurt) and FATIGUE (Exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Patient was diagnosed with COVID back in JAN-2021.         The concomitant medication included was non specified blood pressure medication. No treatment information was provided by reporter.  Company comments:Very limited information regarding these events have been provided at this time. Further information has been requested.   This case was linked to MOD-2021-267517 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
Redness, swelling, itchiness, warm to touch at injection site. Slightly over 3 inches in diameter. Injection site is approx 6 finger lengths below acromium process. Neosporin and bandage along with ice applied. 400mg ibuprofen taken. Chills also experienced in evening when shot administered.
Physician reports a 43 year old women received injection of Tetanus Toxoid Adsorbed, Purogenated on march 14, 2000. Physician reports pt developed pain at the injection site. The patient did not require medical treatment. The pt's last dose of tetanus toxoid was administered in 1990. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Tetanus Toxoid Adsorbed, Purogenated lot 462-809.
Pfizer-BioNTech COVID-19 Vaccine EUA.  Symptoms:  joint aches, fever, chills at night, dull headache, fatigue, general malaise (?fogginess?), diminished appetite, slight nausea.  Joint aches, dull headache and fatigue started about 11 hours after the vaccine was administered around 8:15 a.m. on Monday, 4/5/2021.  Fever and light chills set in overnight, interrupting sleep.  Fever of about 100.9  on Tuesday morning. Took 1 dose of ibuprofen in the morning and 1 dose of acetaminophen in the afternoon. Fatigue, joint aches, light headache, diminished appetite and malaise throughout Tuesday.  Fever and a few chills overnight. Fever of 101 degrees Wednesday morning, with diminished appetite and slight nausea, along with general malaise and aches and fatigue. Took 1 dose of ibuprofen mid-morning. Symptoms improved throughout Wednesday, so that by about 7 pm, they seemed mostly resolved.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history or concomitant medications. On or about 26-FEB-2009, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (dose, route, and lot # not provided). The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 31-MAY-2013, the patient was treated by a her healthcare providers at a medical office for shingles. She was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
A nurse reported that an 11 year old male patient received a dose of Flumist nasal solution on 12/11/2003. The patient has no significant medical history. Indication for Flumist was immunization. Product was administered on 12/11/03. Dose regimen was 1 dose 1 time per day. There were no concomitant vaccines or medications. On 12/12/03, one day post immunization, the patient developed fever to 102.3 degrees F, nasal congestion and cough. At the date this event was reported, the cough and nasal congestion persisted and the patient's fever was recorded at 98.5 degrees F. Treatment information was not provided. No additional information was available at the time of this report.
about a week after i had, and continue to have numbness, pain, pins and needles in my fingers and hand (on the side that i received the shot. These occur in the night hours and based on recent adverse vaccine reporting are in line with symptoms of guillain-barré syndrome, which has been reported to be one rare neurological side effect of this specific vaccine
PCR tested positive; PCR tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "recovered" (15Jan2022) and all described as "PCR tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: I developed symptoms and PCR tested positive. Clinical course: It was reported that, patient was an academic faculty member in a college of medicine. During the pandemic, patient worked in clinic providing patient care 4 days/week without fail. It was stated that, fortunately, patient vaxed in Dec2020, Jan2021, and boosted in Sep2021. On 10Jan2022, had developed symptoms and PCR tested positive. By 15Jan2022, patient's all C19 symptoms had resolved.  The lot number for bnt162b2 was not provided and will be requested during follow up.
1015 syncopal episode BP 126/78 P 56 SpO2 99% 2lpm NC, loss of bladder, sternum rub done 1020 nausea, moved to recliner 1024 dizzy, BP 116/73 P73 SpO2 99% 3lmp NC 1025 accu-check 87 1029 vomiting 1031 BP122/78 P 78 SpO2 3lpm NC 97% 1033 BP 105/69 1035 to  Urgent Care with staff   * husband reports similar episodes with different medications*
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4990), in left arm for covid-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 04Jun2022 at 01:00, outcome "recovering"; PAIN (non-serious) with onset 04Jun2022 at 01:00, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 04Jun2022 at 01:00, outcome "recovering"; RASH (non-serious) with onset 04Jun2022 at 01:00, outcome "recovering", described as "rash on upper body and arms". Therapeutic measures were not taken as a result of chills, headache, pain, rash. Addition information: Other vaccine in four weeks was none. Covid prior vaccination was none. Covid tested post vaccination was none. Known allergies was none. Other medications in two weeks included: blood pressure, cholesterol and thyroid. No follow-up attempts are possible. No further information is expected.
Information has been received from a licensed practical nurse referring to a 4 year old male patient. On 13-APR-2015 the patient was vaccinated with a dose of PROQUAD (lot # K022444, expiration date 13-MAY-2016, strength, dose and route were unknown) which was improperly stored. No adverse effects were reported. Additional information has been requested.