chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dental work; appointment for a third dose; Knee surgery; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (Knee surgery), DENTAL DISCOMFORT (Dental work) and INTENTIONAL PRODUCT USE ISSUE (appointment for a third dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS on 02-Jun-2021 and Dental treatment NOS.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced JOINT INJURY (Knee surgery). On an unknown date, the patient experienced DENTAL DISCOMFORT (Dental work) and INTENTIONAL PRODUCT USE ISSUE (appointment for a third dose). At the time of the report, JOINT INJURY (Knee surgery), DENTAL DISCOMFORT (Dental work) and INTENTIONAL PRODUCT USE ISSUE (appointment for a third dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
52 y.o. female who presents with fever and chills. Started today, along with nausea, increasing pain in left inguinal area close to where she had a skin biopsy the day before. Skin biopsy shows calciphylaxis. Patient was also exposed to COVID 19 when her husband tested positive last Friday. She denies any respiratory symptoms. No chest pain, no shortness of breath, no diarrhea, no abdominal pain.
Arm swelling; lump/ lump still moving/ lump then moved up my neck/ the lump moved up into my head; lump hot to touch; Arm lots of pain/ painful on full right side of arm; Shoulders painful; Lump then moved up my neck  painful; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El2614) via an unspecified route of administration in the right arm on 06Apr2021 at 16:30(at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, or other products. The patient did not receive any medication within two weeks of vaccination. 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 vaccination. On 06Apr2021 at 17:30, the patient experienced arm swelling and could not lift arm, no range of motion and had lump which was hot to touch. The lump moved up her arm, caused lots of pain and could not use arm. The lump moved across the shoulders which was painful. She could not lie on the right side and the lump was moving and hot to  touch. The lump then moved up to neck, hot to touch, painful on full right side of arm shoulder and neck .The lump then moved up into her head. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 event arm swelling, lump, hot to touch, arm lots of pain, shoulders painful lump then moved up my neck hot to touch painful was recovered with sequalae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Arm  hurt and was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  hurt and was sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm  hurt and was sore). At the time of the report, PAIN IN EXTREMITY (Arm  hurt and was sore) had resolved. Not Provided          No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-372522 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow-up received and Reporter information updated.
She is currently 46 years old and states that she was advised to get GARDASIL 9; No additional information; This spontaneous report was received from a 46-year-old female patient, who was reporting on herself. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On an unknown date, after the patient's husband was diagnosed with head/neck cancer, she was advised to get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (it was not specified who advised it). Therefore, on unknown dates, the patient was vaccinated with the first and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route and anatomical location of administration, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). The patient reported that the first 2 doses of vaccine were covered by insurance but the third dose was not covered and the insurance company was requiring documentation supporting its necessity in this situation. No additional information was provided (no adverse event).
Extreme Positional Vertigo began in the middle of the night after my second covid vaccine on March 17, 2021, while I was in bed,  waking me when I turned in bed and accompanied by bilateral ringing in ears.  I had never before experienced positional vertigo nor ear ringing.  Vertigo continued limiting my ability to ambulate, look up/down/sideways and was accompanied by nausea.  I did  Brandt-Daroff exercises 2X/day for 2 weeks which decreased the nausea and vertigo while I was upright but still experienced vertigo during the night, with head movements,  when laying down, when sitting up after reclining .  I now have 75% improvement after one month of Cranio Sacral PT therapy in July.  I will be continuing Cranio Sacral therapy until the vertigo is hopefully resolved.  The bilateral  ear ringing remains and has increased slightly. Nausea resolved with improvements in positional vertigo.
Sharp pain upper (R) side of back pretty constant started 5-9-10 2 pm. Maybe fever pain not relieved with ASA.
Diagnosis of Bell's palsy/ getting peripheral nerve palsy/Left side partial facial paralysis/droopy face; difficulty with blinking; This is a spontaneous report from a non-contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), via an unspecified route of administration on 09Jan2021 14:30 at left arm at single dose for covid-19 immunisation.  Medical history included type 2 diabetes, Hep B carrier. Concomitant medication included metformin, entecavir. On 17Jan2021 04:30 PM, the patient experienced left side partial facial paralysis, droopy face, difficulty with blinking...went to ER to rule out stroke, MRI and CAT scan normal. Diagnosis of Bell's palsy. First time getting peripheral nerve palsy. AE treatment: Prednisone, Valtrex, eye drops...IV steroids. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No known allergies.  The patient underwent lab tests and procedures which included computerised tomogram: normal, magnetic resonance imaging: normal.  The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
9/13/11 began with tenderness, slight swelling, pain to (R) upper arm, 9/15/11 red & warm to touch w/ numbness. 9/15/11 - a.m.: seen & treated by PCP - ice & MOTRIN.
GENERAL APPEARANCE WITH FEVER FOR 2 DAYS AFEBRILE TODAY. NAD, ALERT, ACTIVE. PATIENT PRESENT TO CLINIC WITH REDNESS @INJECTION SITE SKIN MOIST,WARM WITH ERYTHEMATOUS WARM MACULE ON LEFT UPPER ARM @VACCINE SITE. TX. START ACETAMINOPHEN AND COLD COMPRESS LOCALLY.
reported that her family all came down with COVID;  reported that her family all came down with COVID; This is a spontaneous report received from a contactable reporter (Physician/Pfizer Colleague).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, 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), COVID-19 (medically significant), outcome "unknown" and all described as reported that her family all came down with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Additional information: Vaccination status unknown as of 05Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a product varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
11/26/2018 @ about 2:30 began to feel exhausted and weak, then at about midnight that day, chills came over me and I began to uncontrollable shake and shiver, lasted about an hour, when I fell asleep, I woke up very disoriented, thought it was night but it was daytime. Rested for two days, on third day the symptoms subsided.
Fever, hives, no appetite, queasy stomach, tired, muscle aches, heart raced, hoarse throat. Went to work Tues, out on Wed and Thurs. Went to work on Friday still with the fever.  Fever broke 3:00 PM.
On 11/Oct/2006, a report was received, via a company representative concerning a 69-year-old female vaccinee. No details were provided regarding the vaccinee's medical history or concomitant medications. On 08/Oct/2006 the vaccinee received 0.5ml Fluvirin (batch number G9427), intramuscularly. On the same day, 08/Oct/2006, the vaccinee experienced a swollen arm, which was described as a cellulitis type swelling, from her shoulder to elbow. The vaccinee refused to take Benadryl. The symptoms continue. The vaccinee takes the flu shot every year and has not had this reaction before. Follow-up information will be sought. Follow up information was received on 21/May/2007 from a healthcare professional. No details were provided regarding the vaccinee's medical history or concomitant medications. The vaccinee received Fluvirin on 08/OCT/2006, one day later (09/Oct/2006) the vaccinee developed abnormal  swelling from the wrist to the shoulder. The event was treated with Benadryl and resolved in approximately 1 week. The reporter considered the event to be serious, medically significant as it caused pain and stiffness to the affected arm. No further information is expected.
Very red, warm, swollen left arm for three days. 11 hours after injection, I had fever, chills, headache, extreme fatigue and myalgia. I was in bed I on the couch with eyes closed for 28 hours. The next 12 hours I could only do half of my normal activity due to the fatigue and myalgia. The next 12 hours I was at about 80%. After that I was done except still had redness and swelling on left arm.
Heart problems; Palpitations / heart palpitations; Fever; Weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sleep apnea" (unspecified if ongoing), notes: Caller states she had sleep apnea, diabetes, and high blood pressure before her vaccines; "diabetes" (unspecified if ongoing), notes: Caller states she had sleep apnea, diabetes, and high blood pressure before her vaccines; "high blood pressure" (unspecified if ongoing), notes: Caller states she had sleep apnea, diabetes, and high blood pressure before her vaccines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 01Oct2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Heart problems"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "Palpitations / heart palpitations"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness".  Additional information: Agent states that the Caller reports having heart problems, fever, weakness and heart palpitations with the second dose. Agent states the Caller wants to know the correct timeframe to get her third dose, her third dose is scheduled on 15Nov2021. Caller states her doctor told her to wait 6 months after the second dose, to get her third dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician's assistant, via a company representative, concerning a 16 year old female patient, who on an unspecified date was vaccinated with a dose of Gardasil (lot # not specified), and fainted. No further information was available. This is one of two reports received from the same source (WAES#0710USA00631). Additional information has been requested.
BECAME VERY ITCHY AND BY 1AM I WAS SCRATCHING SO HARD THAT I HAD MARKS ALL OVER ME AND COULDN'T SLEEP.  I TOOK A BATH IN AVEENO OATMEAL WALGREENS BRAND AND TOOK BENADRYL. I THEN SLATHERED LOTION ALL OVER MY SKIN WHICH HAD A RASH APPEARANCE.  PERHAPS HIVES I DO NOT KNOW SINCE I HAVE NEVER SEEN HIVES.
C/O dizziness, sweating, sensation of throat getting tight.  Called 911, brought to Medical Tent.  No obvious respiratory distress, V/S stable X 4 checks. No local injection site reaction, no hives/rash.   Was dizzy trying to sit up, tried X3 with paramedics present.  After 37 minutes able to sit up, taken to vehicle by W/C.  Refused to be transported to ER,  signed "Refusal of Medical Treatment Form.  Advised to F/U with primary care physician.
On 1/25/07 pt received #2 HepA-HepB vaccination in right arm after incident and wanted 15 min after injection at clinic.  On 2/8/07 pt reported that he had a high fever, sweats, chills and HA for 2 days following that vaccination, stayed in bed and recovered.  he did not report ADR prior to 2/9/07 because of language barrier.  Client did not seek medical attention for reaction and on mutual agreement-will not be administered th 3rf HepA-Hep series.
Chills, nausea, joint pain, headache, low blood pressure, dizziness, fainting, extreme fatigue. Worse overnight in the first 10 hours after administration, constant headache and body aches for the subsequent 10 hours. Experienced a single, short fainting event in the middle of the night when walking to get water.
HEADACHE, CHEST PAIN, THROAT PAIN (SWOLLEN NODES IN BACK OF THROAT)
Pt recvd booster dose of MMR vax on 27JUN91 & on 7JUL91 pt presented to ER c/o muscle spasms, neck pain, joint pain, t104.8 & sensitivity to light;
This spontaneous report as received from a physician's assistant refers to a 64 year old female patient with breast cancer, sulfa allergy-skin reaction and MSG allergy-does not tolerate foods with MSG. On approximately 09-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included ADVAIR, ZYRTEC, vitamin D (unspecified), CYMBALTA and ARIMIDEX. The physician's assistant reported that in approximately July 2013, the patient experienced a generalized rash, that began on legs and spread to include the face, trunk and arms, after she received ZOSTAVAX. The patient also experienced a fever, above 101 degrees, for first two weeks, and felt ill. The patient saw primary care physician one week later and was treated with acyclovir 800 mg TID and doxycycline. The patient was referred to physician assistant and was seen on 22-JUL-2013. The patient had lab studies: urinalysis was negative, complete blood count was negative, complete metabolic panel was negative, antinuclear antibody was negative, sedimentation rate was 55 and C-reactive protein was 4.21. Biopsy of skin was also performed. Biopsy results indicated a non specific granulomatous dermatitis. After biopsy results were obtained on 30-JUL-2013, "2 days ago", the patient was started on prednisone 40 mg to taper down to 5 mg, over the next 14 days. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
COVID vaccine breakthrough case. Pfizer 3/4/21 EN6202, 3/25/21 EN6207 and boosted 2/25/22 FK9729
Flu like symptoms, severe fatigue, aches and pains, chills, shaking within 24 hours - fatigue and weakness continued for 1 month... jaw pain and headaches began with 2 weeks and persisted for over 6 months. Fatigue and jaw pain intermittent past 6 months.
pt recv vax 22JUN95 & 21MAR96 pt exp full blown chickenpox w/greater than 50 lesions;
Knot and swelling at injection site. Approx. 2 months later, began to have aching in joints and severe exhaustion. Have/am still seeing 3 doctors and taking medications. Had 1st Anthrax 9/18/99 and 2nd Anthrax on 12/4/99.
After my vaccination, on 9/30, I went traveling to visit my sister. I noticed my breathing was labored after taking a walk with her. My asthma was not backing up I did not need to use an inhaler. This continued while I was there. I came home and it still continued. I came home from a walk, and I really could not catch my breath and my smart watch indicated that I was in A-FIB on 10/26. I went to the ER and the Cardiologist thought it was just an Arrhythmia. They did not treat me for the shortness of breath and sent me home. One afternoon my breathing was so bad after a walk, so I contacted my PCP. I went in and she checked my lungs, and they were clear, but it felt like when I had Pneumonia. She said if it persisted to go back to the hospital. On the Tuesday before thanksgiving, 11/23, they had me in the ER and immediately admitted me to the hospital. During that time, they did every heart test imaginable. The doctor said during the stress test, my heart looked overall healthy but there was signs of A-FIB and Arrhythmia. They thought this started because of the shortness of breath and was pointing at pulmonary. They did all the tests at pulmonary and pointed their fingers at Cardiologists. They wanted to have a spirometry test done but I couldn't do that for a few more days. Cardiologist suggested to PCP that I should go to pulmonology doctor for second opinion. My lungs checked out totally clear at the hospital. That appointment is on January 5, 2022. I have noticed that my breathing has gotten better, it's not to the point where it was right before the vaccine, but it's better than what it was when I was in the hospital, and now I'm currently on two heart medications.
Pt vaccinated with DTP/OPV cried non stop for 1 1/2 hrs. Cry high pitched.
Approximately 1 hour after receiving H1N1 vaccine, her R hand felt very hot and tight but with no obvious tx measure change or swelling; this sensation progressed over the hours to her wrists, elbow and then had "electrical jolts" which made her arm twitch.
This case was reported by a physician to a sales representative and described the occurrence of fever in a 4 month old patient who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). On an unspecified date, the patient received a dose of Pediarix dose number not specified). At an unspecified time following the administration of Pediarix, on an unspecified date, the patient experienced "a fever greater than 103 degrees Fahrenheit." The patient was seen at a physician's office. The outcome of the event is unknown. The reporting physician considered the fever to probably be related to vaccination with Pediarix.
chills; Headache; body aches; This is a Spontaneous report from a contactable physician (patient) via a Pfizer Sponsored Program Corporate (Pfizer) Social Media Platforms. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported "Hang in there immune response kicked my butt at about 12 hr point (chills, headache, body aches)". The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient felt faint 10 min after receiving vaccination. She said she felt as though she had been hit by a truck and was very hot. She was sat down and feet propped up. Cold compress was placed on the back of her neck. She stated that she had not eaten anything today so we gave her something to drink in case her sugar was low. After a few minutes she stated her throat felt strange. I asked her if she felt like it was tightening  or lips or tongue swelling or issues with breathing. She stated she didn't know about the throat other than it felt strange. I gave her 25mg of Benadryl after getting permission from her just in case an allergic reaction was starting. She stated soon after that her throat was getting better. She sat for about 45 minutes in our immunization room until she felt better. She was no longer hot and feeling bad when leaving.
12/4   vaccine 12/5  woke up with fever 102.6.   Could only take small sips of water or tea.    Threw up what little food eaten.   Throughout the day tried:  3-5 blue berries(AM),   small flakes of Hawaiian roll (late afternoon),  small slice of banana (9pm).    Spent most of day in bed,  could barely watch TV for 30 minutes.    Sinus & ear pain all day.   12/6   woke up, temperature ~100.   Able to drink 2-3 ounces.   Appetite returning and able to take fluids normally.   Normal temperature by evening.   Sinus & ear normal. 12/7   no temperature.    Stay home from work to ensure better.   Light activity & normal appetite.    Very thirsty shortly before bed .   16-20 ounces of water and still thirsty, ~4 ounces OJ seemed to quench thirst. 12/8   no temperature.    Felt slightly off as got ready for work.   Left work after 3 hours at desk ? fatigued and poor concentration.     Felt tired remainder of the day.   12/9   no temperature  seem fine
April 1st am,very itchy and large red area near injection area,a little swollen,4/2 pm fever,4/3 am fever gone ,intense itch and red still the same