chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe neck painSevere back pain; Severe back pain; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 16Feb2021 at 15:00 (Batch/Lot number was not reported) (at the age of 40-years-old) as dose 2, single for COVID-19 immunisation. Medical history included allergy to Sulfa. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. Concomitant medications included triamcinolone acetonide (NASACORT) taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient previously received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 26Jan2021 at 15:00 (Batch/Lot number was not reported) (at the age of 40-years-old) for COVID-19 immunisation. The patient experienced severe neck pain and severe back pain on 20Feb2021. The patient received no treatment for the events. The adverse events resulted to none. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient with severe swelling of injection area with erythema that was confluent and then development of extreme fatigue and muscle aches.
Early auto immune thyroid; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune thyroid disorder in a female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced autoimmune thyroid disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the autoimmune thyroid disorder was unknown.   It was unknown if the reporter considered the autoimmune thyroid disorder to be related to dTpa vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient trying to informed how the DTP vaccine injured every member of her family. The patient experienced early auto immune thyroid. The follow up was not required. This is 1 of the 4 linked cases reported by the same reporter.
Saturday evening, 8JUN96 started w/subjective fever, chills, body aches, muscle spasms of arm, chest, back, legs;redness & inc warmth @ inj site lt deltoid;
Patient reported the next day having purple bumpy rash on right leg below knee to ankle on calf and shin that was very itchy and felt like a sunburn pain. He went to doctor office and was diagnosed with shingles and treated with a steroid injection and given Valacyclovir 1 gram 1 tab twice a day for 7 days with subsequent resolution. He wants to know if this was indeed shingles rash or was this an adverse reaction to the vaccination? and should he get the second dose or not?
The following morning after receiving first vaccine began sudden onset high fever, severe shaking (could not hold a cup of coffee), chills (could not get warm), and sudden fatigue onset.  Slept for almost 36 hours with brief wakening and could not work and had no desire to eat.
Brain Fog and Fatigue still occurring to this date .  Hard to concentrate and my memory is spotty.
The patient received a third dose of HPV vaccine. The patient had initiated the series before age 15, which warranted 2 doses.   A letter was sent home to the patient along with consent form for the vaccines needed. The consent form had all 4 vaccines (Men B, Influenza, HPV, and Covid) highlighted as due. After administration, the mistake was caught that the patient did not need a 3rd dose of HPV due to age of series start. The clinical supervisor was notified and a meeting was held on 2/14/2022 to discuss actions to prevent this from happening again. The formed plan included printing off a list the day of the appointment for each patient in landscape form. Reviewing the database, administering vaccine, than writing on the database which vaccines were given and the list was sent home with the patient.
I WAS VERY COLD AND SHIVERING AROUND 10:00 PM , FEVER (101) AROUND 01:15 AM  TOOK TYLENOL AROUND 01:30AM
Parent declined HPV, but was administered by RN instead of requested Meningitis ACYW. No adverse events noted.
Breakthrough case admission after 3 vaccines Moderna 1/28/21 Lot# 007M20A;  Moderna 2/25/21 Lot# 031L20A;  Moderna 12/9/21 Lot# 005C21A
. This case meets criteria for vaccine breakthrough review. SxS started 11/17, tested positive 11/22 (unknown where).  Cough, SOB.
No adverse event; A patient was administered a Moderna bivalent booster dose on 24Feb2023, before she got the primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient was administered a Moderna bivalent booster dose on 24Feb2023, before she got the primary series) and NO ADVERSE EVENT (No adverse event) in a 14-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Feb-2023,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (A patient was administered a Moderna bivalent booster dose on 24Feb2023, before she got the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient was administered a Moderna bivalent booster dose on 24Feb2023, before she got the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A patient was administered a Moderna bivalent booster dose on 24Feb2023, before she got the primary series).    No concomitant medication was reported.    A patient was administered a Moderna bivalent booster dose on 24-Feb-2023, before she got the primary series. No treatment information was reported.
Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a, eight years old female patient who received a dose of QUADRACEL (batch number, expiry date, route and site of administration were not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that patient received a dose of QUADRACEL at 8 years old. It was accidentally administered by the physician. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Patient stated he was having swelling the night he received the injections on 9/7/18. He woke up with fever over 103 so he went to the ER. He received a shot of antibiotics and was discharged with BACTRIM for UTI and pain meds with stool softener. He did not pick up pain meds and stool softener. He will follow up with his PCP in a few days. I noticed swelling on the inner side of his right arm but not on the outside where he received the shot. Patient stated the swelling has gotten down and no longer has fever on 9/9/18.
1 day after-very itchy, swollen.  Progressed to a golf ball sized swelling at the inj. site surrounded by a softball sized swelling.  Bruising, tingling, tightness esp. around elbow area, low grade fevers on and off.Took Motrin and used benadryl cream then was started on Cephalexin & triamcinolone acetonide cream.  Applied reg. ice packs.  Today is day 12 after injection and still not better!
Pt received the 1st COVID vaccine (Pfizer, Lot #: EW0179, and expiration date: 08/2021) at 11:02 AM. Patient flagged EMT  while sitting in the observation area. EMT  attended to patient who complained of "lightheadedness" and "shortness of breath." Patient was conscious, alert, and oriented to person, time, place, and situation (CAOx4). EMT explained to the patient that he wanted to have the patient move to the zero gravity chair, so vital signs and a full assessment could be done. Patient agreed and expressed that she felt steady enough to stand and walk on her own to the zero gravity chair. Patient then walked to the chair, while EMT  followed. At 11:27 AM, baseline vitals were taken, while patient was sitting: blood pressure: 118/88, heart rate: 72, respiratory rate: 12. Skin was warm, dry, and normal for ethnicity. Nurse then responded to EMT  with patient. Patient has a medial history of diabetes and is prescribed Metformin. Patient claimed she is allergic to Penicillin. Patient also explained to EMT that she was fasting so she had not had anything to eat or drink today. EMT offered the client a water, but she declined. EMT educated the client on the importance of eating and hydrating before a vaccine and recommended the patient do so before her next appointment. Patient continued to be conscious, alert, and oriented to person, time, place, and situation (CAOx4). A second set of vitals were taken at 11:33 AM, while patient was standing: blood pressure: 116/84, heart rate: 72, respiratory rate: 12. Skin was warm, dry, and normal for ethnicity. Patient tested negative for orthostatic pressures. EMT advised patient to stay an additional 30 minutes to continue to monitor for additional sign and symptoms, but patient refused. Patient then left the site with a steady gait, accompanied by her husband and daughter.
a painful lump on left pointer finger formed 4 days after vaccination & worsening 1 week later (solid bump with no pus); a painful lump on left pointer finger formed 4 days after vaccination & worsening 1 week later (solid bump with no pus); aggravated asthma (chest tightness); Body drug rash (swelling and pinkish skin color but no hives/welts); hands/fingers red; hands/fingers red hot/tingling/burning sensation; hands/fingers red hot/tingling/burning sensation; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm as a single dose on 10Mar2021 at 09:45 hours (at the age of 50 years), for COVID-19 immunisation. The medical history included breast cancer since 2008, hernia, asthma and migraines. The patient was allergic to PEG (polyethylene glycol). The concomitant medications included vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and DYMISTA. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 11Mar2021 at 09:00 hours, the patient experienced body drug rash (swelling and pinkish skin colour but no hives/welts); hands/fingers red hot/tingling/burning sensation and also aggravated asthma (chest tightness). On 15Mar2021, the patient experienced a painful lump on left pointer finger formed 4 days after vaccination and worsened 1 week later (solid bump with no pus). The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The patient received antihistamines (unspecified) and cortisone 2.5% inhaler as treatment for the adverse events. The clinical outcome of all the events body drug rash, hands/fingers red hot/tingling/burning sensation, aggravated asthma and painful lump on left pointer finger was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Elbow bursitis. So painful I drove myself to the hospital. Prednisone mostly cleared it up in a few days, but my elbow is still tender more than a month later. My activity and age do not make this a likely health issue for me.
This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old male patient received BNT162B2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 02Mar2021 as SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from 2020 to an unknown date had COVID-19 a year ago. His antibody went down. The patient's concomitant medications were not reported. On 03Mar2021, the patient experienced body aches, fatigue, high temperature, headache. The patient underwent lab tests and procedures which included body temperature: high on 03Mar2021 high. The action taken in response to the event for BNT162B2 was not applicable. The outcome of high temperature outcome was recovered and rest events outcome was unknown. Information on the lot/batch number has been requested.
MEWDS in my right eye; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 07May2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Long COVID" (unspecified if ongoing); "known allergies: Cruciferous Vegetables" (unspecified if ongoing); "covid prior to vaccination" (unspecified if ongoing). Concomitant medications included: BUDESONIDE; ALBUTEROL [SALBUTAMOL]. The patient did not receive any other vaccines with 4 weeks prior to the COVID vaccine. Vaccination history included: BNT162B2 (1st dose, Anatomical Location: Arm Right), for COVID-19 immunization. The following information was reported: RETINAL EXUDATES (medically significant) with onset 12Sep2021, outcome "not recovered", described as "MEWDS in my right eye". The event "mewds in my right eye" was evaluated at the physician office visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of retinal exudates. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the prolonged onset latency and the etiology of the condition, it appears unlikely that BNT162B2 contributed to the event MEWDS in the right eye. The event could've been caused by "long covid" prior to vaccination. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Upon receiving her first shot of Janssen COVID-19 vaccine on April 7, 2021 at a clinic, the patient experienced shortness of breath, body numbness and near syncope. The RN called 911 and patient was taken to the hospital ER. She was discharged after 3-4 hours, some shortness of breath persisted. On April 9, 2021 she experienced increase shortness of breath mid-day and went to the emergency room and was there for 6-7 hours and discharged without diagnosis. On April 13, 2021 in the evening, she had multiple symptoms including shortness of breath, headache, abdominal pain and leg pain. She was watching TV where there were talking about cerebral venous sinus thrombosis associated with the J&J vaccine and cautioned anyone with headache to see MD but she could not get an appointment at her regular clinic. Her husband then took her to the ER again and head CT was negative. She is still not feeling 100% with some shortness of breath on exertion.
Shots given 02/01/2002. Started running fever 2/3/02 on and off to 2/6/02. On 2/6/02 at 19:00, temperature was 102.5. Tylenol given at 21:00; had full body seizure. Went to ER and was admitted. Did not inform anyone about receiving immunization.
Patient given first dose of COVID vaccine - Moderna. Shortly after, patient started experiencing itching and hives all over body as well as some nausea. Patient called EMS and was brought to ED
My daughter had symptoms of opsoclonus-myoclonus syndrome starting less than 24 hours after receiving Prevnar 2 and DTaP #4. She has been seen in the doctors office and receiving treatment since November 2001. Per annual report-She had opsoclonus-myoclonus syndrome after her shots.  She is still under medications and chemotherapy.
Patient had a syncopal episode approximately 10 minutes after three vaccines had been administered. HPV, meningococcal, tdap. No temp. 106/64 BP.
The evening following the vaccination I began to develop itchy red bumps on my legs and arms. Since then, they have become more irritating and have spread to include most of my upper legs, arms, and hands. I have also developed migraines and weakness.
his report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot  number FD0809. The local Public Health District, per guidance from the local Department of  Health (DH), Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the  dose of vaccine that you received is valid.
This case was reported by a nurse practitioner and described the occurrence of erythema in a 4 yr old male pt who received diphtheria adn tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The vaccine provider submitted this report directly. On an unspecified date, the pt received the fifth dose of Infanrix (lot 627A2). At an unspecified time following admin of Infanrix on 29Jan04, the pt experienced a severe injection site reaction characterized by redness and swelling. The pt was seen by the physician, who prescribed an unspecified antibiotic. The pt was seen by the physician. The event resolved six days later on 04Feb04. In the nurse practitioner's opinion, the events were possibly related to the use of Infanrix.
soreness at the injection site that permeated to his other arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at the injection site that permeated to his other arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd Engerix-B & 30 mins later was lightheaded;
strong pain in the left arm/pain on the pain scale was 8 or 9/ then on Sunday, it came down to 5 or 6; more fatigue the first 2 times; slight headache that lasted for 2 hours and was gone; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (strong pain in the left arm/pain on the pain scale was 8 or 9/ then on Sunday, it came down to 5 or 6), FATIGUE (more fatigue the first 2 times) and HEADACHE (slight headache that lasted for 2 hours and was gone) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 001A21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (strong pain in the left arm/pain on the pain scale was 8 or 9/ then on Sunday, it came down to 5 or 6), FATIGUE (more fatigue the first 2 times) and HEADACHE (slight headache that lasted for 2 hours and was gone). In November 2021, HEADACHE (slight headache that lasted for 2 hours and was gone) had resolved. On 29-Nov-2021, PAIN IN EXTREMITY (strong pain in the left arm/pain on the pain scale was 8 or 9/ then on Sunday, it came down to 5 or 6) had resolved. At the time of the report, FATIGUE (more fatigue the first 2 times) outcome was unknown. Not Provided          Patient takes some concomitant medications but did not mention names.  No treatment medications was reported.   This case was linked to MOD-2021-060967, MOD-2021-032180 (Patient Link).
Patient complained of SOB and dizziness. Patient was assessed by the Medical Assistant and Nurse Practioner. Patient was stable and provider instructed to notify PCP or seek ER help is systems persist or get worse.
after vax pt devel local react, numb lips, lightheadedness/returned at intervals approx. 8 hours apart x3 days. also exp pain, within 15 min.  above clavicles lasting 2 hours and would also return at intervals. inject site redness/itching/swelling would also come and go. Prior to the shot I ate eggs without allergy. In the past 3 wks I've had eggs 3 times and experienced nasal congestion, diarrhea, cramps and nausea. I respond to MSG and sulfates this way. 6/1/99 states was recently skin tested for allergy to eggs. Showed sensitivity, not true allergy. Follow up information received at Aventis Pasteur Inc on April 8, 2002 reported that the patient recovered from this experience. No further information is expected. This case is closed.
father states pt was crying all noc because leg hurt, would stand but not walk & would not eat; they were concerned because of high fever-t38C ;
screaming episodes, throw self on floor, stiffen entire body-unable to console or pick-up-banging head on floor, screaming, autism, loss of motor skills,catatonic;fever;dx lt ear infect
PATIENT REFERS THAT THE DAY AFTER VACCINATION SHE BEGAN EXPERIENCING PAIN IN THE RIGHT ARM (ARM VACCINATED) WHICH IS GETTING WORSE EVERY DAY.WILL BE GOING TO THE DOCTOR SOON.