chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to an unspecified number of unspecified patients of unknown gender and age. On an unknown date, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB injection (lot#, dose, frequency and route not provided) that were exposed to temperatures that were outside of the recommended temperature range. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a nurse concerning an approximately 60 year old female who was vaccinated in the back of the arm with a dose of ZOSTAVAX. The patient had no initial reaction to the vaccine. Subsequently, 5 days later, the patient developed a 5 inch area at the injection site which was red, itchy, burning hot and hard. Medical attention was sought and the patient was given ice and BENADRYL and sent home. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Seizure like activity - full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or ~1.5-2oz).  Afterward, fell asleep for ~20 minutes.  Was his normal state of health upon waking up.   Brought in and had evaluation in the ER ~1 hour after event.  At that time had a normal physical exam.
Fever first night, chills and exhaustion headache for 3 days. On 3rd day I began bleeding (I had hysterectomy in ?96) I have high platelets due to cancer. I take oral chemo to try to keep platelets down. I have been having increased platelets. I went to PCP regarding bleeding asked for them to check platelets and platelets had dropped to 411!!!
6/16/2016 a client came to PHC on 5/9/16 to received vaccines which include MMR, Hep A, HPV9, MCV4 - Flu - Tdap, Hep B. She was screened as usual and denied being pregnant. Today she returned to the PHC to report to us that she is pregnant. Our plan would be to refer to her doctor and refer her to another office to assist.
Severe tinnitus, high pitched ringing in ears. Right > Left. Constant, sometimes very intense sometimes more quiet but never gone since 2nd vaccine.
Arm was stiff; Sharp pain in her left breast; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm was stiff) and BREAST PAIN (Sharp pain in her left breast) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm was stiff) and BREAST PAIN (Sharp pain in her left breast). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm was stiff) and BREAST PAIN (Sharp pain in her left breast) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was scheduled to receive the second shot but the clinic ran out of vaccine. Concomitant medications were not provided. Treatment information was not reported.
I believe I already submitted this statement at the time of the event, however I am being told to report it again due to new circumstances. The vaccine was administered in my left arm and within one minute I felt weak, hot, and very light headed. I was moved to a reclining chair with the assistance of two nurses. I lost consciousness and was told to stay lying down for half an hour. I became very hot on the left side of my body. This included my arm, leg, torso, and face. My husband was called to pick me up from work due to my reaction. I became lethargic about two hours post injection and developed itchy eyes and throat. My throat never became inflamed. My left arm became red and swollen and my torso began to turn red. This continued down to my left ankle. I was lethargic and painfully red and  swollen for two days and felt like i was sunburned on just the left half of my body. When I called the hospital to report the events, they stated they wanted me to continue to report on the application on my phone and to stay home. The symptoms subsided on day 5.
Chills, aches, moderately-severe headache. Treated with Tylenol; all symptoms went away after Tylenol kicked in. Symptoms started the evening I received the vaccine (~10:20 PM) and lasted 24 hours.
PATIENT REPORTS LARGE BLISTERS AT THE INJECTION SITE 1 DAY FOLLOWING VACCINE ADMINISTRATION. PATIENT TO URGENT CARE TO GET TREATMENT OPTIONS AND WAS PRESCRIBED A MEDICATION.
The night immediately following the vaccine I was woken up by rectal pain (similar to what I had had in previous Ulcerative Colitis flares, but not in at least 8-10 years) and for about a week after had blood in my stool. My colitis has rarely been well-controlled but these symptoms were unusual, and just as unusually they disappeared within a week. It might have just been a hemorrhoid (I've never had one as far as I know), but it seems like a small autoimmune / IBD flare.
4 days afterwards, I developed intense tinnitus in my right ear (the one affected by Meniere's) and fullness. The ringing, deafness & fullness continues until today. I have lost a lot of hearing acuity in both ears. I felt really ill (flu like) on 5/20/21. I had full body aches and severely sore throat. The PA prescribed Methylprednisolone 4 mg dosepak. I have been taking according to instructions. Today, I developed vertigo for the first time in 14 years.
Fever; swelling at the injection site; muscle fatigue; This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in 2019 at single dose for immunization. Medical history and concomitant medications were not reported. In fall of 2019, the patient experienced fever, swelling at the injection site and muscle fatigue, which all took place after use of vaccine. Clinical outcome of the events was unknown.
Pt had Rapid Afib (with h/o stable afib) events after each vaccination:  1-22-21/2-12-21/9-18-21----most significant after last vax (booster in Sept 2021)
Three days following first vaccine, in otherwise normal state of health, patient began experiencing right arm weakness and slurred speech lasting < 5 minutes. Occurred x2, fully remitting on each occasion.
Severe pain from shoulder to elbow at injection site; Sever pain from shoulder to elbow at injection site.; Sever pain from shoulder to elbow at injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 at 17:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 12May2021 at 20:00, the patient experienced severe pain from shoulder to elbow at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (ADVIL). The clinical outcome of the events severe pain from shoulder to elbow at injection site were not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
fatigue, stuffy nose, cough, fever, swollen lymph nodes in right armpit, swelling at injection site
Pain at injection site, numbness and tingling in fingers, edema at injection site with golf ball size knot, hive like rash appearing around area of injection site.  Symptoms not improved after ibuprofen and ice packs 72 hours later symptoms continue.
Immediate drowsiness and weakness.  Followed by nausea and hot sensations throughout body, which are ongoing. Weakness is prevalent. Nausea is number 8 on scale of 1-10. Injection site is a number 10 considering all other injections and vaccinations I?ve ever had.
Pt recvd vax & approx 1 wk following vax again devel abn liver function studies w/an inc in enzymes; was again hospitalized w/rt upper quad pain & tenderness; liver biopsy was nl; since that time had episode bouts of abdo pain w/vomiting;
1PM Phone call from patient states arm red, hot and swollen. 4PM Phone call from son states mom at doctor; arm is very swollen. Talked to patient at 4:30PM at home; got shot of Decadron and oral Benadryl. Talked with doctor 10/17/02 states severe local reaction.
Pt. noticed soreness to arm later that night and could not lay on that side when sleeping.  Swelling to arm and bruising at injection site and from posterior to anterior arm. Observed by nurse on 10/24/14, red raised area at injection site half-dollar sized.  Slight swelling extending to front of arm with bruising at front of arm at lower bicep area.
Left deltoid local reaction. Erythema, induration 8cmx6cm, edema, tenderness, warmth at site. Erythematous rash around site. No other urticaria, fever, or pruritus. No arthralgia.
had shots in AM-no problems that day;in PM on following day 22AUG95 began running a fever-temp 102-tx w/APAP had diarrhea & vomiting;seen in ER 26AUG95;seen ped clinic 28&29AUG was told probably virus or mild allergy;seen in ER again
Pt reported tongue numbness and mild swelling.  Observed mild tongue swelling.  BP noted to go high up to 186/90, and came back down to 145/92 over the course of about 30-40 minutes.  Otherwise vitals normal, tongue swelling improved, symptoms improved.  No meds given.  Pt remained calm and spoke with clear speech the entire time.
Information has been received from a licensed practical nurse and additional information was received from a registered nurse concerning a 38 month old female patient with no known allergies and no pertinent medical history who on 28-May-2002 was vaccinated with varicella virus vaccine live (Oka/Merck) at another medical facility. On 26-Jul-2004 the patient's mother called the physician's office and reported that the patient had rash on her chest and under her arms. It was noted that the patient started with viral symptoms one week prior (approximately 16-Aug-2004) to presentation in the physician office on 23-Aug-2004. Today, 23-Aug-2004, the patient presented to the physician office with a similar rash. There are 10-15 non-itchy lesions on the trunk of her body; fluid filled, ruptured, and scabbed. The patient will be sent to a dermatologist for follow-up. No other treatment was reported and it is unknown whether lab studies were preformed. In additional information, the registered nurse reported that the patient recovered on 01-Sep-2004. There was no product quality complaint reported.  Unspecified medical attention was sought.  No additional information is expected.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 30-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
severe case of cellulitis after 12 days of being vaccinated. administered a steroid shot with doxycycline antibiotic.
Information has been received from a Certified Dental Technician (C.D.T) concerning a child patient with egg allergy who on an unspecified date was vaccinated with the first dose of ATTENUVAX. Secondary suspect therapy included the first dose of MUMPSVAX II. It was reported that when the patient was given the first dose of ATTENUVAX and MUMPSVAX II "his arm swelled up a little bit". The outcome of the patient was unknown. No further information is available.
Patient states she thinks the vaccine was administered too high in her arm. 24 days later, she is still experiencing difficulty moving the arm, intense pain and disruption of quality of life.
Pt recv vax on 10/16/97; 1 hr later pt exp dizziness, lightheadedness & nausea
There are big bumps.  They are swelling up; Itching; Looked as if she had shingles; Body is "not well"; Body began to ache/Felt like "when bees bite you, all over my body"; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (There are big bumps.  They are swelling up), PRURITUS (Itching), HERPES ZOSTER (Looked as if she had shingles), MALAISE (Body is "not well") and MYALGIA (Body began to ache/Felt like "when bees bite you, all over my body") in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced SWELLING (There are big bumps.  They are swelling up), PRURITUS (Itching), HERPES ZOSTER (Looked as if she had shingles), MALAISE (Body is "not well") and MYALGIA (Body began to ache/Felt like "when bees bite you, all over my body"). At the time of the report, SWELLING (There are big bumps.  They are swelling up), PRURITUS (Itching), HERPES ZOSTER (Looked as if she had shingles), MALAISE (Body is "not well") and MYALGIA (Body began to ache/Felt like "when bees bite you, all over my body") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
2 hours after the vaccine the patients arm started hurting really bad.  She felt dizzy and super chilled and cold.  Then she felt shaky with a bad headache.  She had a fever over 100 degrees.
Information was received from a pharmacist reporting on his father (age unknown) via another pharmaceutical company (manufacturer report #2014309969). The pharmacist reported that on an unknown date, his father was incorrectly "dispensed PNEUMVOAX23" rather than the PREVNAR 13 and the pharmacy did not know how to remedy the situation. Pharmacist believed there was a protocol that calls for dispensing PREVNAR 13 first. Additional information is not expected.
Intense heart racing in the middle of the night. Heart palpations throughout the next day. Sleepless nights.  Felt better after a couple of days.
UNKNOWN 6/29/09-autopsy report received-COD-Undetermined.
cold sweets; hives in both legs; stomachache; This is spontaneous report from Pfizer colleague. This Pfizer colleague reported in response to Non-HCP letter sent to consumer via telephonic follow-up activity. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, Single for COVID-19 immunization. The patient's medical history and patient's concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported)via an unspecified route of administration on an unspecified date as dose 1, Single for COVID-19 immunization and experienced tired, Weakness, Whole body aches. It was reported that the patient got her second shot recently and experienced cold sweets, hives in both legs and stomach ache on an unspecified date in 2021. Outcome of the events was reported as Unknown.   Information about lot/batch number has been requested.
Nausea starting evening of vaccination continuing 3 days.  Diarrhea evening of vaccination. Body aches day following vaccination continuing 3 days. Headache day following vaccination continuing 2 days.  Sore arm afternoon of vaccination continuing 4 days.  Swollen lymph nodes in armpits starting 2 days after vaccination continuing 2 days.
Moderna-Covid-19 Vaccine EUA I had no symptoms for the first 7 days. Not even soreness at the injection site. Then on day 7 the injection site became itchy under the skin, slight soreness. Day 8 more itchy under the skin, warm to touch, redness an soreness in the area not just at the injection site. Day 9 hive like rash, itchy under the skin, red  and soreness, warm to touch. I took a benadryl 25mg it took out the swelling in the hive like rash.  Thats my story. Now I'm very concern do I get my Second Vaccine on February 9,2021. Please advise me  on what I should do. I'm having a Tela-Med appointment with my primary on  Friday Jan.22
Only injection site pain for 1st injection lot EW0198 given 30JUN21. SEVERE, immediate reaction when 2nd injection given 21JUL21 - warm feeling radiated from injection site into chest, neck, head, all extremities with simultaneous extreme pins & needles throughout entire body & most intense in head (face, ears, tongue) along with extreme tightening of chest & hard to breathe (felt like chest was being crushed & gasping for air), nausea, tinnitus, dizziness, confusion, loss of balance (ready to pass out), body tremors/shaking all <1 hr, pins & needles >24 hrs, ear numbness >48 hrs; flu feelings 24-26JUL21; shortness of breath, tinnitus, brain fog & general unwellness all still persist to date- unsure if
Started with Stomach Ache, nausea and diarrhea, today about 5:00 AM she vomit (one time). I am a physician and her father, I gave her a metoclopramide 10 mg and right now she is feeling a little improvement.
No additional AE/PQC reported.; VARlVAX and MMRII that has been administered since the excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   Since 22-OCT-2020, the patient was vaccinated but it was unknow which of the following vaccines were administered: varicella virus vaccine live (Oka/Merck)(VARIVAX) 0.5 ml (route and site of administration were not provided) with lot numbers: T000698 was confirmed to be valid, expiration date 07-JAN-2022, T015999 was confirmed to be valid, expiration date 08-MAY-2022, T017688 was confirmed to be valid, expiration 21-MAY-2022; Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (MMR II) 0.5 ml (route and site of administration were not provided) with lot number: T000890 was confirmed to be valid, expiration date 08-JAN-2022, S035354 was confirmed to be valid, expiration date 05-NOV-2021, S039312 was confirmed to be valid, expiration date reported as 24-DEC-2021 but upon internal validation was established as 04-DEC-2021.  The aforementioned doses of vaccines experienced the temperature excursion but exact temperature was unknown. The reporter stated that her "data logger" battery died and she had no temperature information for the freezer since 22-OCT-2020. No additional adverse event was reported.; Sender's Comments:  US-009507513-2012USA004559: US-009507513-2012USA004561: US-009507513-2012USA004562: US-009507513-2012USA004563: US-009507513-2012USA004565: US-009507513-2012USA004564:
Red area developed around injection site in the right arm several hours after receiving the PCV23 vaccine and became the size of a half dollar per patient's mother. Hives also developed in upper right arm after several hours and gradually spread to the lower arm. Right arm described as very sore. Patient denied fever, denied shortness of breath, and denied throat swelling/closing. The vaccines were given on 12/14/2018 and adverse reaction was reported to us by the patient's mother on 12/17/2018. Patient's PCP, NP was informed immediately. NP recommended cold compresses, ibuprofen as needed for discomfort, and to follow-up with an office visit if redness persists/worsens or if pt. develops a fever. Explained that the symptoms would improve slowly. NP also informed staff to do VAERS report.
Some arm pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some arm pain) and PYREXIA (Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Some arm pain) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Some arm pain) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-265941 (Patient Link).
Immediate rash after injection, severe chills, body aches,.  The reason for reporting adverse reaction is due to red blotches around the injection site.  Very red , swollen, and  hardness.
DIFFICULTY MOVING AND GETTING OUT OF CHAIRS; SLEEP DEPRIVATION; PHYSICAL DISCOMFORT; DIFFICULTY WALKING; STIFFNESS; JOINT ACHES; WEAKNESS; FATIGUE; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced difficulty moving and getting out of chairs. On 12-APR-2021, the subject experienced sleep deprivation. On 12-APR-2021, the subject experienced physical discomfort. On 12-APR-2021, the subject experienced difficulty walking. On 12-APR-2021, the subject experienced stiffness. On 12-APR-2021, the subject experienced joint aches. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from muscle aches, joint aches, fatigue, weakness, difficulty moving and getting out of chairs, sleep deprivation, physical discomfort, difficulty walking, and stiffness. This report was non-serious.
patient was not of age to receive the vaccine, patient was 4 and needed to be age 5  to receive vaccine
Guest received FLUMIST on Oct 1 2015 nad experience a slight cough and extreme lethargy.
edema, red and swollen showed Saturday and edema started Sunday. Very tired. Patient had the edema resolve before the appoint. MD thinks it was an immune reaction.
pt recv vax; devel T of 104 that lasted for 4-5 days;lab eval revealed blood tests nl;sx not related to vax;
Pt complained of feeling extremely hot, face turned red, had trouble breathing, felt dizzy. Had her sit down while we called 911. Took her blood pressure which was high 172/86. Took again 5 minutes later, it was 125/83. EMS arrived, checked her pulse, BP, and listened to her lungs. She declined to go to the ER.