chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight inflammation where I had facial filler injections/inflammation in the same locations around my lips; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3246), via an unspecified route of administration in the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included low potassium but in general good health. The patient has no known allergies. Concomitant medications included metoprolol, progesterone, estradiol, and potassium chloride (K CHLOR). On 12Jan2021 06:00, the day after the shot, the patient noticed slight inflammation where she had facial filler injections. Eight days later she woke up with slightly more inflammation in the same locations around her lips. The patient was not sure if this was a side effect, but seems coincidental. No treatment was given for the event. The patient was not diagnosed with COVID-19 prior vaccination and has not been tested for COVID-19 post vaccination. The last outcome of the event was not recovered.
There actually were no adverse event or reactions.  I am filling out this form b/c I realized that this pt was under 50 years old and not immunocompromised.  The 2nd booster was given, but technically he didn't qualify to receive the 2nd booster.   I alerted his staff.  He is in a group home
This report describes the occurrence of bronchitis in a 50 year old female who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. This report was received from the subject and has been verified by a physician. The subject reported that she had no relevant medical history or allergies. However, she reported that concurrent medications included fluticasone proprionate+salmeterol xinafoate and triamcinolone acetonide nasal spray. Her physician reported that the concurrent medications were sertraline hydrochloride  and beclomethasone dipropionate nasal spray. The subject received her first injection of Twinrix on 9/17/02; no adverse experiences were reported following this injection. The subject received her second injection of Twinrix on 10/16/02. In November 2002, she developed a severe upper respiratory infection. She was seen by a physician, who made a diagnosis of bronchitis and prescribed two courses of amixicillin clavulanate. The bronchitis resolved. The subject received her third injection of Twinrix on 3/18/03. In April 2003, she again became very ill with bronchitis. As of 4/3/03, she was being treated with levofloxacin. The subject stated that she mentioned this respiratory infection as a possible reaction and he (her primary physician) said it was not likely the cause. I think it was since I reacted after two shots--same symptoms exactly ten days after each shot. The most recent information received was from the treating physician on 6/2/03. The bronchitis resolved. The reporting physician stated, Although I cannot exclude a cause-effect relationship, I am not suspicious of it. The reporting physician considered the two episodes of bronchitis to be serious because they required intervention (the administration of antibiotics) to prevent serious outcome. Therefore, this report has been reclassified as serious.
swollen; mild fever; she did not receive full dose because she felt leaking on her arm; she did not receive full dose because she felt leaking on her arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 08May2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162b2 on an unspecified date as a single dose for COVID-19 immunization without any issues. It was reported that after second dose administration on 08May2021, half of the dose possibly given according to patient she did not receive full dose because she felt leaking on her arm. The patient stated that she had swollen and mild fever after second dose. The Caller would like to know if they should do a tither test on patient to check for antibodies to vaccine and if the patient should be revaccinated. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
A lot of itching/ Itching at the injection site; Rash/ Rash on arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (A lot of itching/ Itching at the injection site) and RASH (Rash/ Rash on arm after first dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (A lot of itching/ Itching at the injection site) and RASH (Rash/ Rash on arm after first dose). The patient was treated with CORTISONE for Rash and Vaccination site pruritus, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (A lot of itching/ Itching at the injection site) and RASH (Rash/ Rash on arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.   This case was linked to US-MODERNATX, INC.- (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23-APR-2021 contains significant information. Vaccine dose number was updated. On 24-Jun-2021: Follow up received on 24-JUN-2021 contains no new information.; Sender's Comments:  US-MODERNATX, INC.-:crosslinked
There were NO adverse events. Pt has no signs and/or symptoms of distress. Reporting early administration based on age, considering that the child is not immunocompromised.
About the time of the first dose I began to experience tinnitus in my right ear. Later on, I also developed headache and itchy eyes when I experienced spikes in my tinnitus. One year and three months later, these symptoms persist, although my spikes are now down to (typically) twice a week and they appear to be less severe.  Subsequent dose and booster did not seem to affect for good or ill. I sought treatment from an ENT and pursued various treatments, none of which resolved the issue.
I felt like my arm was going to "fall off" and could not use it at all. However, it had been a long time since I had the TDAP and figured that it would work its way out. For several days, I felt like I had just been hit by a truck. Literally, I just laud in the bed. No fever or any of those symptoms. The main problem was that I could not move my arm without pain. Ithe has gotten a little better and I have tried to exercise it out to no avail. My range of motion is limited now and I have painted with certain movements and a lot of soreness. I've never had this happen with a vaccine before.
After vaccines baby was "zonked out all day," "barely ate", "difficult to arouse," "fine next day" per mom.
Neurology issues; Severely Altered Mental Status; booster; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received bnt162b2 (BNT162B2), dose 3 administered in Arm Left on 20Oct2021 16:30 (Batch/Lot number was not reported) at age of 50-year-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility. Medical history included Asthma, Congestive Heart Failure, Traumatic brain injury (TBI). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included influenza vaccine (FLU VACCINE VII) (lot number=308520) in arm on 05Oct2021 for immunisation; carvedilol; apixaban (ELIQUIS); famotidine; lactulose; montelukast; quetiapine; sertraline; simvastatin; tamsulosin; torsemide ; tramadol hydrochloride (TRAMADOC). The patient previously took first dose of bnt162b2 (Lot number: CEK 4176) in Left arm on 05Jan2021 at age of 50-year-old for covid-19 immunisation, second dose of bnt162b2 (Lot number:EN 5318) in Left arm on 05Feb202 at age of 50-year-old for covid-19 immunisation, morphine and experienced hypersensitivity. Evening of Booster, the patient experienced Severely Altered Mental Status and Neurology issues on 20Oct2021 11:00 PM. AE resulted in Emergency room/department or urgent care, Hospitalization for 7 days. AE treatment included 5 Psyche meds. The outcome was Not recovered. Covid test post vaccination Nasal Swab on 26Oct2021 with Negative result. Events were assessed serious as Medically Significant and hospitalization.  The events occurred in a location different from that of the reporter. This may be a duplicate report if another reporter from the location where the event occurred has submitted the same information to his/her local regulatory agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Other- Swelling of the tongue and throat. No issues breathing. Patient was given Benadryl and symptoms resolved in 10min. Patient was observed for 30min post reaction time.  Lasted 1 day
stored in the fridge for 40 days so 10 days over our recommended storage.; vaccine administered after beeing in the fridge for 40 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage.) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 004M20A and O29L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Shoulder pain since 15-Aug-2021, Hyperlipidemia, Peripheral neuropathy, CVA, Osteoporosis since May 2017 and Degenerative joint disease (Exacerbation of shoulder arthritis). Concomitant products included PREGABALIN (LYRICA), ROSUVASTATIN, ASA and PRAMIPEXOLE for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage.) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days). On 31-Aug-2021, PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage.) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 21 Jul 2021 vial was initially stored in the refrigerator. Total amount of time the vial was exposed to room temperature range noted that (8° to 25°C= 46° to 77° F): went over in a vaccine cooler, so the most would be 3 hours (start and end of the clinic).  No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   This case was linked to MOD-2021-304556 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Patient demographics, current conditions, concomitant medication, first and second dose information were added.
HEART IS RACING FAST; HARD TO BREATHE; HOT FLASHES; BODY ACHE; DIZZINES; WEAKNESS; SNEEZING; COLD CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 11:03 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101. On 08-MAR-2021 17:30, the subject experienced heart is racing fast. On 08-MAR-2021 17:30, the subject experienced hard to breathe. On 08-MAR-2021 17:30, the subject experienced hot flashes. On 08-MAR-2021 17:30, the subject experienced body ache. On 08-MAR-2021 17:30, the subject experienced dizzines. On 08-MAR-2021 17:30, the subject experienced weakness. On 08-MAR-2021 17:30, the subject experienced sneezing. On 08-MAR-2021 17:30, the subject experienced cold chills. On 08-MAR-2021 17:30, the subject experienced headache. On 08-MAR-2021 17:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills on 08-MAR-2021, and had not recovered from hot flashes, headache, body ache, dizzines, weakness, heart is racing fast, fever, hard to breathe, and sneezing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, felt very "clammy", and had general ague upon any type of exertion such as walking a very short distance using my rolling walker device.  This happened 3 times in approximately 2 hours on the day of vaccination.  The next day (03/05/21) my blood pressure and heart rate were very elevated (BP 174/111, Heart Rate 168); I went to the emergency room where they were unable to lower my heart rate but sent me home anyway.  03/7/21 I went to ER, where I was diagnosed with atrial flutter and admitted. The atrial flutter was corrected via cardioversion and I was released 3/9/21; I was prescribed Multaq 400mg, 2X/day and take it faithfully.
Administration error, the patient is 16 years old and Moderna is only indicated at this time for 18 years old and up. The patient experienced no ADRs
Pt stated that he was feeling lightheaded and dizzy while sitting in post-vac after receiving Pfizer (EW0196) vaccine.  Pt became pale and clammy to touch and sat down on floor.  Pt's mother stated "he gets like this when he gets shots." Pt denies any SOB, itching, pain, or other discomfort.  Pt has no orofacial swelling or visible hives/rash.  Pt was given juice to drink and stated that he felt better afterward.  Pt's skin returned to normal and he sat up in a chair.  Pt was released at 12:40 into care of mother.  Pt stated he was no long symptomatic and felt "back to normal."  Pt left clinic with mother, walking with steady gait, and in no apparent distress.
injection site started aching almost immediately but within 6-7 hours upper arm painful and hard, back of head so painful had to go to bed. Body became like a lead weight, couldn't raise my arms, couldn't turn over, couldn't reach my phone 8 inches away. Had shaking chills for 8-9 hours even though temp. was only 99.8. This was 10 times worse than when I had Covid. Thank goodness the severe reaction only lasted a day and a half then slowly got better over the next 2 days.Took week for arm tenderness to go away.
sore arm; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "not recovered", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site soreness (mild); headache (severe); chills/shakes (moderate); chills/shakes (moderate); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:00 (Lot number: EL3247) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar II" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE. Vaccination history included: Bnt162b2 (lot number=EL3247,, lot unknown=False,, administration time=10:00 AM,, vaccine location=Left arm,, dose number=1), administration date: 03Mar2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021 18:00, outcome "recovering", described as "Injection site soreness (mild)"; HEADACHE (non-serious) with onset 25Mar2021 18:00, outcome "recovering", described as "headache (severe)"; CHILLS (non-serious), TREMOR (non-serious) all with onset 25Mar2021 18:00, outcome "recovering" and all described as "chills/shakes (moderate)". Therapeutic measures were not taken as a result of vaccination site pain, headache, chills, tremor.  Additional information: Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. Allergies to medications, food, or other products were none.  No follow-up attempts are possible. No further information is expected.
an 18-year-old patient last year who was fully vaccinated with MMRII who presented with a measles like rash post vaccination; This spontaneous report has been received from a nurse regarding to an 18-years-old patient of an unknown gender.   The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route of administration, indication, lot # and expiration date were not provided). Other suspect therapies included sterile diluent (STERILE DILUENT) (lot # and expiration date were not provided).  On an unknown date (also reported as last year), the patient was fully vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and on an unknown date, presented with a measles like rash post vaccination (rash morbilliform). The reporter stated that the Physician who cared for the patient did not believe it was measles nor was it related to the vaccine. It was unknown if the patient sought medical attention. At the time of this report, the outcome for the event was unknown.   The causal relationship between rash morbilliform and measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) was not provided.
Swelling, redness and itchiness of (L) upper arm from shoulder down to elbow. BENADRYL advised for itchiness.
Adacel was given at 17 yrs when was previously given at 11 yrs there was not enough time between doses.
next morning coughing , was admitted to hospital sept 6 with low oxygen levels, hard to breath, left hospital September 13th.
About   3 1/2  hours after my vaccine I began taking a walk with my husband ( no issues at all) when I very suddenly began dragging my feet , holding my right arm very stiffly, and showing significant signs of confusion.  He assisted me in getting back into our home, gave me baby aspirin, asked me questions as to his middle name, of which I  just starred back at him. I can remember him asking me questions, and  I was wondering why my brain was not responding.   My gait  had already returned to normal as I could take the steps into our home with no problem.  My brain fog lasted approx 30-35 minutes. He did bring me to our local ER , where tests were negative but I did stay overnight.
PATIENT REPORTED FEELING SWEATY, CALMMY, AND FELT LIKE HE WAS GOING TO PASS OUT. HE WAS LAID DOWN AND FEET ELEVATED. NO C/O PAIN OR DISCOMFORT. VITAL SIGNS AS FOLLOWS: 14:15 HR- 68 RESP 18 BP 138/85 O2 @ 96% RA 14:20 HR- 69 RESP 18 BP 138/82 O2 @ 97% RA 14:25 HR- 75 RESP- 18 BP- 132/82 O2 @ 98% RA. 14:30 HR- 71 RESP- 18 BP- 139/81 O2 @ 97% RA. PATIENT WITH NO C/O PAIN OR DISCOMFORT. RELEASED BYSELF TO HOME.
Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 10/Mar/2021) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Augmentin), Drug allergy (Neosporin) and Drug allergy (Codeine). Concomitant products included LEVOTHYROXINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (Chills). On 08-Apr-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Serology test: negative negative (Negative) negative.         No treatment medications provided by the reporter.
Redness, swelling, warmth, pain - started on 8/9 - was seen at walk in clinic & prescribed Cephalexin 500mg q8hours x 7 days
A patient was here around 8:15 to have his second dose of Moderna.  When I questioned him about the first dose, he reported having some reaction with the first one-two weeks after the first dose. When I ask what kind of reaction he stated that he was feeling anxiety. I waited 15 minutes after the vaccine and then left. Around an hour and 20 minutes later, he came back shaking. I ask the nurse to check his blood pressure and glucose levels because I don?t have a blood pressure cough or a glucometer. I asked if he had any other medical problem other than anxiety, and he said that he had not been to the doctor in a long time. The plant nurse checked his vital signs, and the BP, glucose, temperature, pulse, and oxygen were normal.   We both believe that he had a panic attack due to his anxiety history.  Around 10:10 am, the nurse called an ambulance. The patient continues saying that he feels bad.
This spontaneous report was received from a office administrator refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (manufacturer unknown) was properly stored and which was used for reconstitution of VARIVAX. On 23-APR-2018, the patient was vaccinated with improperly stored VARIVAX (0.5 ml, once) (lot# N027628 and expiration date: 04-OCT-2019) subcutaneously at a temperature from -9 degree Celsius (C) to 8 C (plus 0.3 C) for 1 hour 13 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. Lot number [N027628] has been verified to be a valid lot number for VARIVAX.
Second vaccine inadvertently administered too early.  Was given one week apart instead of 4 weeks, no adverse reactions noted.