chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received COVID-19 Vaccine second dose with 25 gauge needles. Was advised by Pfizer the needle had to be 21 gauge or narrower; sore afterwards; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9267), via an unspecified route of administration on 18Feb2021 (at the age of 75-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure and high cholesterol increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient reported that she and her husband received the COVID-19 vaccine with the 25-gauge needle. Patient did not feel the COVID-19 vaccine when it was administered and was sore afterwards (Feb2021), it was advised by Pfizer the needle had to be 21 gauge or narrower and did not know if the second dose would be ok or not. The clinical outcome for the events was unknown.  No follow-up attempts are possible, No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021215248 same reporter, product, and event, different patient;US-PFIZER INC-2021215900 same reporter, product, and event, different patient
This spontaneous report (initial receipt 24-Oct-2014) concerns a 58-year-old female patient. On 12-Oct-2014, the patient received AFLURIA (batch number not reported) via intramuscular route in the left arm at 0.5 ml once for protection against seasonal influenza virus. On 12-Oct-2014, the patient experienced extreme pain at the injection site that expanded to the rest of her arm. She had difficulty moving her arm due to soreness. She reported that the injection was administered higher up on the arm with other injections. Outcome was reported as not yet recovered.
Severe body aches and muscle pain starting on the day after the 2nd shot.  On day 3 after the 2nd shot all upper body aches and pains were gone but lower back and severe left leg pain continued.  Left leg pain continued for several weeks at which time went to my doctor.  He concluded I was  having Acute Sciatica and ordered MRI.  I was sent to Dr for pain management on 03/19/2021.  I was given Steroid Injections in my back.  I did not have ANY back or leg pain until the day after my 2nd Covid-19 shot.
arm was sore for a few days at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore for a few days at the injection site) in a 69-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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore for a few days at the injection site). At the time of the report, VACCINATION SITE PAIN (arm was sore for a few days at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Patient endorsed to feeling fine
Dizziness, lightheaded. Vitals x 2,  Rest, Water.  Discharged by MD.
PATIENT WAS 11 YEARS AND 11 MONTHS AT THE TIME OF ADMINISTRATION. I ASKED THE PATIENT AGE AND WROTE DOWN ON FORM 12 YEARS OLD. I CONTACTED MOTHER OF PATIENT AFTER INCIDENT HAD BEEN DISCOVERED. SHE SAID HE IS FEELING OKAY WITH NO REACTION AT ALL.  SHE STATED, "MY SON IS A BIG BOY WEIGHING  140 POUNDS AND IS 6'0 TALL."
brief cyanotic (30sec) episode followed by lethargy & deep sleep;recovered by 30min;
Information has been received from a nurse concerning a 72 year old female patient, who on 05-APR-2011 was vaccinated with a dose of PNEUMOVAX 23, (lot#/667915/1111Z, expiration date: 02-MAR-2012), 0.5 ml, subcutaneously. On 06-APR-2011, the patient experienced injection site redness down her arm to the elbow, with pain and swelling. The patient sought unspecified medical attention. BENADRYL was given for the treatment of adverse event. At the time of the report, the patient was recovering. Follow-up information has been received from the nurse, concerning the 58 (previously reported as 72) year old, female patient, with allergy to sulfa, nabumetone and codeine, and who on 06-APR-2011 (previously reported as 05-APR-2011) at 15:15, was vaccinated in the left deltoid with the first dose of PNEUMOVAX 23, (lot#/667915/1111Z). Nurse reported that on 06-APR-2011, patient developed a knot on arm, pain, swelling and redness. Patient sought medical attention through emergency room/doctor visit. At the time of the report, the patient had recovered from knot on arm, pain, swelling and redness. No further information is available.
Moderna vaccine was administered outside of facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------- I21.4 ACUTE NON ST ELEVATION MI 2/10/2023 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 2/10/2023 PNEUMONIA
Patient stated she was afraid needles but has had  vaccines in the past. Questionnaire circled no however on past fainting with vaccines. Pharmacist had patient remain in chair and asked to sit before leaving for 15 minutes and when feeling ok. Patient became unconscious in booth  and hit booth made of thin plastic but remained up write and was in sitting position. Pharmacist immediately responded because heard noise, also just from intuition from patient nervousness. Patient was very warm to the touch, eventually awoke after pharmacist had technician call for EMS immediately, however was very disoriented, began to sweat profusely, not able to communicate (disturbances) and then proceeded to vomit. Pharmacist tried to get patient to lay on back patient was adamant on sitting forward near a trash can. Pharmacist applied cold compresses to neck for patient and forehead.  EMS arrived. Patient agreed to go to emergency room for further evaluation.
Within 3 minutes of receiving shot my heart started to race, I felt very warm, could not breathe and my body started to shake. I immediately called for help but was not heard. I removed my mask and sweater and just tried to slowly take deep breath until it stopped. It lasted about 5 minutes. Once I could breathe again I drank water, put my mask back on, and continued to slowly breathe for about 20 minutes.
This is a non-serious case from a medical assistant in the USA who reports a patient experienced cough after receiving FluMist. The reporter did not assess causality between events and FluMist vaccination. This case is being submitted according to the safety surveillance accelerated reporting agreement for FluMist. Within 24 hours of receiving FluMist on 11/5/04, a 44 year old male experienced cough, headache, runny nose, fatigue, fever, and chills. The patient was treated with OTC products and has recovered.
Pt with H/O  long-standing ITP, APLABs, VTEs, admitted with exacerbation of ITP and immune neutropenia after first dose of Pfizer COVID-19 vaccine.
Sharp pains down my spine and in my elbows and ankle joint. Neck sore, scratchy throat, headache
Right arm 2 inch circular area of erythema, swelling and pain on deltoid area. Plus fever of 101 degrees F, nausea, vomiting.
Mother states child developed low grade temperature on 10/12/01 and on 10/19/01 temperature was 105 degrees. Began developing rash on neck, chest, back, buttocks and arms on 10/22/01. Mother stated it looks like heat rash but I know its not.
Week prior to 12/29/2011, general weakness. 12/29 Abnormal gait, "rubbery" legs bilaterally. Within 30 minutes after onset, unable to walk. Unable to perform ADL. Hospitalized > 1 wk. High dose steroids. Dx of GBS after 4 wks with LP, tx of IVIG - 5 consecutive doses. Ongoing PT. Severe leg pain, limp.
Mother describes patient with lost voice and sensation of throat swelling. Does not endorse respiratory distress or angioedema. Declines coming in for evaluation since no respiratory distress.
Patient is experiencing redness, swelling and severe itching.  The itching started 3/24/21 and was mild, but patient stated it has progressively gotten worse.
Confirmed no other AE occurred.; product was administered to a patient on 9/14/2021 after a temperature excursion; This spontaneous report was received from a consumer, and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 14-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose for prophylaxis (lot number U008183 was verified to be valid, expiration date reported and established as 07-FEB-2023); (exact dose, route and site of administration were not provided).   The administered dose of vaccine experienced a temperature excursion of 12.9 Fahrenheit degrees (F) for 3 hours and 45 minutes; 11 F for 5 hours and 5 minutes; 13.2 F for 7 hours; and 14.9 F for 15 minutes. The administered dose of vaccine experienced also previous temperature excursion of 6 F to 14 F (7.5 F) for 1 hour and 10 minutes. The patient did not experience any additional adverse event.
Developed fever to 102.4 approximately 6 hours after vaccination. The next morning, was noted to be lethargic with seizure-like jerking of extremities. Admitted to our hospital, initial EEG was not consistent with seizures, but continued to have altered mental status. On 3/28/20, developed EEG-confirmed status epilepticus requiring intubation and 3 anti-epileptic medications to break seizures. Ultimately extubated on 3/30 and has continued to show steady improvement each day thereafter with no further seizures witnessed. Is now receiving inpatient rehabilitation.
Approximately 5 minutes after immunization was administered, pt. stated that he felt lightheaded, fell back against wall, and exhibited seizure-like activity.  Patient was staring, arms were posturing, lower extremeties began tightening and twisting. Activity lasted approximately 30-45 sceonds.  Patient was unresponsive during seizure activity but regained consciousness and was alert and oriented after activity.  EMS arrived shortley after.  Mother refused to let the patient ride in the ambulance but she did transoprt the patient to a local ER.
pt recv vax 21MAR97 & 31MAR97 body rash appeared;no fever on 2APR97 noted pt slacking w/body coordination which kept progressing pt was able to walk w/assist 12APR97;to ER
Changes in menstruation. Early period approx. 1.5 week after vaccine with repeat period and spotting 2 weeks after that.  No history of irregular periods.
pt recv vax & the next day pt was taken to ER for a rectal temp of 103;dx w/lt OM & possible febrile rxn to DTP;tx w/APAP & Ibuprofen & was recovered @ the date of this report;
All symptoms manifest together within 12 hours. Quarter-sized, hard, sore lump in arm at injection site, + redness and swelling- 10 days to subside. Flu-like symptoms: muscle/joint pain, neck and back pain/stiffness, mild nausea- 10 days to subside entirely.
Fist injection on 3/29/21 Second injection on 4/19/21  Hospitalized on 6/29/21 with a PE (pulmonary embolism) in left lung.  Shortness of breath, chest pain, elevated heart rate  Still trying to determine the cause of the PE
A red circle about 2 inches around appeared on day 8, with slight itching, dryness, and tenderness. I had this after the vaccination as well; however, it faded. Not sure why it came back. I found some info about covid vaccine arm.  I still have this today and know there seems to be a ring around the edges (the ring is more red than the inside). This is  day 11 and I am concerned.
Increased lethargy on 1/14/21 at 9pm, Vital signs-106/66, Heart rate-112, temp 98.2; Sent to ER for eval admitted with fever.
This is a spontaneous report obtained from a contactable health care professional. A 18 year old female patient received, on 30Jul2016 at 13:15, meningococcal group b rlp2086 (Lot. M74091, Expiration date: Jun2017, NDC number: 0005-0100-01) intramuscular, in the right arm, at 0.5 ml, single dose. Relevant medical history was unknown. Concomitant medication included MENACTRA (Lot. U5410AA), received on 30Jul2016, intramuscular, in the left arm, at 1 DF, single dose. The vaccines was administered at the private doctor's office and was purchased with private funds. Illness at time of vaccination were none. On 30Jul2016, the patient passed out after receiving meningococcal group b rlp2086. The patient recovered on 30Jul2016, she was out for about a minute. The patient felt fine when she left the doctor's office.
hearing loss; Zostavax related injuries; 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 concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the prevention of shingles and/or zoster related conditions (dose, route, and lot # not provided). Subsequently to inoculation, the patient was treated for hearing loss and zoster vaccine live (ZOSTAVAX) related injuries (unspecified). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for this injuries. As a further proximate result, the patient has suffered ongoing significant medical and related expenses as a result of theses injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. As a further proximate result, the patient has suffered and will continue to suffer diminished capacity for the enjoyment of life, diminished quality of life, increased risk premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages. The outcome of the events was not recovered. Causality assessment between events and suspect therapy was considered as related.  Upon internal review, hearing loss was considered to be medically significant.
Approx. eight hours after administration, pt experienced intense fatigue and body aches, which worsened throughout the next eight hours.  Headache and loss of appetite were intermittent over the course of the next 24 hours.
Headache; Sore arm/ pain in the arm/I woke up in the middle of the night and I had pain in the arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 69-year-old male patient received second dose of BNT162B2 (Pfizer-BioNtech Covid-19 vaccine, Lot number: unknown, Expiration date: 31May2021), via an unspecified route on 03Feb2021 at 16:00 (at the age of 69-years) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient took first dose of BNT162B2 (Pfizer-BioNtech Covid-19 vaccine) on an unspecified date, as a single dose for COVID-19 immunization. On 04Feb2021 (one day after vaccination), patient woke up in the middle of the night and had pain in the arm and headache. Nurse and doctor told him that if he experienced any post-vaccination symptoms, he could take ibuprofen or Tylenol. Therapeutic measure taken as a result of events included Advil which he took on 04Feb2021 morning. Patient enquired if he could take ibuprofen or Tylenol or if this will affect the effectiveness of the vaccine. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
COVID-19 POSITIVE ON 4/9/2021 Narrative:  Other Relevant History:
About 5 min after vaccination (within the 15 min observation time), patient was pale, dizzy, feeling faint, sweating, and nauseous. She said  she was about to pass out. She was sitting on chair with head leaning back, and resting on the wall. I raised her legs, resting on another chair. About 2 min later, she vomited. About 1 min later, she started to feel better. She asked for water, and we gave her some lukewarm water. Her face started to come back to normal, and she started to feel better and better. She sat for another 20 - 30 min, she felt better and left the pharmacy.
I had 1 full-term natural birth pregnancy at 17 yrs. old on 3/6/1992.  My son was 51bs 4 oz.  After the vaccination, I experienced headaches, shortness of breath, and intermittent heart palpatations.  The heart palpitations were intense and frequent lasting over 24 hrs. I was directed by an on-call physician at Medical to go to the ER because heart palpitations is not one of the known side effects and it has not subsided.  I went to hospital ER unit where they did an EKG, Chest X-Ray, Rapid Covid Test, and drew blood.  Dr. stated I was experiencing a heightened reaction to the vaccine and should follow up with my cardiologist within 1 to 5 days.  I am currently schedulded to see my cardiologist at 4:30 pm today.  I experienced heart palpitations before when I received the initial dose but it only lasted for 3 hrs.
Tired; had fever like 100, I checked around 11:30 I had 99/again in the afternoon I had 100 fever; Body and joints hurts; body ache; This is a spontaneous report from a contactable other HCP (Respiratory therapist, patient). This 50-year-old female patient received 2nd dose of BNT162B2 (COVID-19 Vaccine, Batch/lot number: EL0140) on 08Jan2021 at 9:30 in the morning on Upper Arm Deltoid for COVID-19 immunization. Medical history was Thyroid cancer. Concomitant drug was Levothyroxine for Thyroid cancer. Historical Vaccine was 1st dose of Covid-19 vaccine (Details: LOT#EK5723, Expiration date: Mar2021 (Pfizer). Patient experienced Tired; Body and joints hurts; Body ache, Had fever 100. Consumer stated, "Second one (vaccine) is the one which gave me reaction. (Pfizer)." Event details: I had Covid Vaccination, I did on Friday around 9:30 in the morning and I just want to report that I had a side effect yesterday like a Friday night itself I feel like little bit body ache and yesterday morning. I was so tired body hurts joints are hurting and by afternoon I had fever like 100, I checked around 11:30 I had 99, so I didn't want to take any medication. When I checked again in the afternoon I had 100 fever so I took some Motrin, I just want to report that. Outcome of the event tired was recovering, for other events was recovered.  Follow-up attempts are completed. No further information is expected.
"A nurse reported that a 7 year old male received Typhoid vaccine, USP, Heat Phanol Inactivated and Havrix vaccines. post-immunization, he developed increased bilirubin and scleral jaundice. CANCELLED: Follow-up information received from the vaccine provider on 08/21/00 indicated that the patient received typhim VI rather than Typhoid Vaccine USP, Heat Phanol Inactivated. From additional correspondence received on 03/16/01, it was reported "The child received typhim VI and Havrix , went overseasand became ill. Increased bile, nausea and vomit. Recovered and has moved to another part of the state. The file is closed.
Left thigh, 3 inch red, swollen, induration, warm to touch. Right thigh, 2-3 inch red, swollen induration, warm to touch.  No fever, no neurologic symptoms.
Did not get a second dose, but got a bivalent booster dose; Having breathing issues; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Jan2023 as dose 2, single (Lot number: GL0447) for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1), administration date: 18Mar2022, for COVID-19 Immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 31Jan2023, outcome "unknown", described as "Did not get a second dose, but got a bivalent booster dose"; RESPIRATORY DISORDER (non-serious) with onset 2023, outcome "unknown", described as "Having breathing issues". The event "having breathing issues" required physician office visit. Additional information: Caller was asking for guidance after an administration error. On 18Mar2022, a 61-year-old female patient got her first dose of the vaccine, and did not get a second dose, but got a bivalent booster dose on 31Jan2023. She has been having breathing issues and has had to see pulmonologist after that.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She got her vaccine, and seemed fine until June 8, 2022 when all of a sudden her mother heard a weird noise in her room, she went in and saw her gripping her chair with one hand, and her other hand in her hair (she has witnessed her aunt having seizures), and she knew to get her down on the bed.  She had incontinence, on her side and had to wait for the seizure to subside.  She then called EMS and had drooling and had to clean her up.  They took her to Hospital, Dr., who saw her and did MRI's, blood work, and other testing.  They never told them that she had anything on her head or anything.  Then she went to the pediatrician's office and they did an EEG as well.  They said that she had epilepsy which she had never had before.  Then in September of 2022 she had another seizure as she was not taking her medications that she was prescribed.  She fell at school and had a knot on her head.  She continues to take her medicine and has not had any more.  They redid her EEG in June of 2023 and it is clear.  She takes Keepra 500 mg twice a day.  If she has to take an attitude she has to take Vitamins and she has emergency medication which is a nasal spray for her epilepsy (Nayzilam).  They have changed schools, and is doing better now that she has.
My ankles, particularly the one where the calcaneous was shattered are swollen and painful and I?m walking with a limp.
severe pain and i couldn't lift my arm  for 3 days. My arm was like it was paralyzed
The patient developed Polymyalgia Rheumatica as diagnosed via severe proximal muscle pain/weakness  and elevated ESR/CRP that was very responsive to steroids.  symptoms recurred with steroid withdrawal and we have committed to long term slow steroid wean.  this occurred within 8 weeks of vaccination.  unclear if this was related to vaccine or not, but this is the 3rd case of PMR that I have seen in proximation to covid vaccine and will report the other 2 separately.