chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt passed out in chair (head down) shortly after shot. Didn't respond when mom & I asked if he was ok. Then regained consciousness, I called 911 - then he passed out & regained conscious again. Laid pt down on floor. Took BP. Paramedic arrived about 5-10 min monitored. Pt threw up. Pt was transported to hospital b/c pt said he felt it was going to happen again.
Large local reaction after 24 hours left arm. By 48 hours, a couple of urticarial type lesions and papular rash.
ended up having rebound headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (ended up having rebound headaches) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (ended up having rebound headaches). At the time of the report, HEADACHE (ended up having rebound headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
myocarditis; This is a literature report for the following literature source(s): "A report on short-term follow-up cardiac imaging and clinical outcomes of myocarditis after coronavirus disease 2019 vaccination". A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1 SINGLE,), for Covid-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: C-reactive protein: Elevated; Echocardiogram: LVEF 35%, moderate global hypokinesis of the left, notes: ventricle; NA, notes: Follow-up TTE, me- dian duration of fol- low-up 22 days (IQR, 18-38; Ejection fraction: 35 %, notes: In TTE On presentation; 45 %, notes: In CMR On presentation; 45 %, notes: In CMR  Follow-up; Electrocardiogram: Tall peaked symmetrical T waves, without QRS, notes: widening, P waves diminished; NA, notes: median duration of follow-up 159 days (IQR, 46-178); Electrocardiogram ambulatory: normal; Exercise test: normal; Magnetic resonance imaging heart: Global hypokinesis with LVEF 45%, edema, patchy, notes: subepicardial late gadolinium enhancement; Global hypokinesis with LVEF 45%, resolved edema,, notes: persistent slightly reduced late gadolinium enhancement. Follow-up CMR, median duration of follow up 117 days (IQR, 88-118; Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
on 2/1/2021 Resident Reported Back pain given Tylenol Medication orally For Relief. APPRoximately 30 Min Later. complaint of & Noted Diarrhea, Shivering, and vomiting SenT To ER 2/1 And Admitted Diagnosis: Sepsis
Pt recvd HIB/DTP/OPV on 10JUL91; on 19JUL mom reported pt not well; 20JUL pt hospitalized, had rectal temp 101; LP & blood cultures pos for H. Flu; Tx included Rocephin IV; Infant afebrile & remains hospitalized as of 22JUL;
The pt had come for a PPD skin test (for TB) on 10/25/2010. Instead of injecting 0.1ml of PPD, I injected 0.1ml of PPV 23 intradermally into her left forearm. On 10/26/10 pt developed small flat area (32mmx32mm) of erythema. Pt denied any pain or itching. On 10/27/10 the erythema was barely visible.
Sz like acitivty 1/2 to 1 hr post vax; adm to hosp to eval
Gut pain started 2 weeks after my shot on Friday 4/23.  I was admitted into the hospital for diverticulitis in which I have never had an episode prior.  After 2 scans I still have the infection and have been on antibiotics for 3 weeks now.  I also have significant joint pain on my right side which is the side the shot was administered on.  My right knee and ankle are inflamed and in severe pain.
Pt recvd 1st dose of Engerix-B 23APR91 & w/in 24 hrs exp both erythema & urticaria on upper body; vax discontinued; an ER visit was required & tx DPH;
After receiving the last vaccine which was the Typhoid patient stated that he was not feeling well. I lowered the head of the exam table, took his BP. I kept talking to him and called for help in the clinic room.
pt reported hives that started near the vaccine and then spread. The hives come and go. Pt also reported having a low grade fever of 100 degrees farenheit as well as intermittent vomiting.  Pt seen in clinic fo reaction.  tx-  - Continue observation of hives - If continue beyond another 1-2 days then could consider trial of daily antihistamine - Report to ED immediately if develops uncontrolled vomiting, respiratory distress, uncontrolled diarrhea, oral swelling, worsening of acute rash, or any other concerns
Tested positive for Covid on 12/31/2021; Tested positive for Covid on 12/31/2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Mar2021 (Lot number: EL3247) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATENOLOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: El3247, Location of injection: Arm Right), administration date: 08Feb2021, for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovered" and all described as "Tested positive for Covid on 12/31/2021". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No other vaccine taken in four weeks. No covid was detected prior to vaccination.  No follow-up attempts are possible. No further information is expected.
sore arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Feb2021 at 11:00 (Lot Number: EN6201, unknown expiration) as dose 2, single at the age of 75 years old (as reported) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9263) on 22Jan2021 at 14:30 in left arm at the age of 75 years old (as reported) for COVID-19 immunization. The patient called because he was concerned that his second COVID shot seemed extremely quick in a matter of few seconds. The patient wanted reassurance that the shot could be administered that fast. The patient experienced sore arm on unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible; information about batch number was already obtained.
One week after second vaccination, rash started on the inside of my right arm(injection arm) and then gradually spread to inside of left arm, i went to doctor 8 days later and she thought it could be from the cleaning they gave my arm for the colonoscopy I had the day the rash appeared. I was prescribed a steroid .I am now 13 days out from the second vaccination and still have the rash but it is no longer raised nor as red.
I almost died from a flu vaccine in 2007; This case was reported by a consumer and described the occurrence of near death experience in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Influenza vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient almost died from a flu vaccine in 2007. It was reported that the patient would never forget that.
pt exp burning sensation eyes;pt exp lower back pain;rt leg shaky & both legs hurting;took motrin;saw MD-poss pinched nerve;med given;could not stand or void;Dx transverse myelitis;disch w/cane & catheter;legs swollen; blood clot;Dx DVT
Pfizer vaccine given 5/20/2021   Per mom/ pt the shot was given at 11:02  around 11:07 he leaned forward and became unresponsive. He was slightly drooling from the mouth. Mom says that his body was tight and that he was shaking a little.  His eyes were closed and did not appear to be rolling back in his head.  This episode lasted for less than 1 minute.  He did not remember what happened and thought he wet himself after; which he did not.   About 1-2 min after that episode mom states that he appeared to " passed out" for less than a minute. The ambulance was called and he was taken to hospital.  He was evaluated and appeared well at that time. No fever.  EKG was done and per pt it was normal. No EEG was done.  He was discharged without admit That evening he has multiple episodes of vomiting > 10 times.  No diarrhea or fever. Seen today at  medical office for follow up. Vaccine not given at our clinic
Hurt my back/pain in his back; Lifted something that was too heavy and injured his back; Shivering; Fever; Injection site soreness; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Hurt my back/pain in his back), BACK INJURY (Lifted something that was too heavy and injured his back), VACCINATION SITE PAIN (Injection site soreness), CHILLS (Shivering) and PYREXIA (Fever) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 14-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced VACCINATION SITE PAIN (Injection site soreness). On 21-Sep-2022, the patient experienced BACK PAIN (Hurt my back/pain in his back), BACK INJURY (Lifted something that was too heavy and injured his back), CHILLS (Shivering) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Hurt my back/pain in his back), BACK INJURY (Lifted something that was too heavy and injured his back), VACCINATION SITE PAIN (Injection site soreness), CHILLS (Shivering) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Sep-2022, Body temperature: 100.6.         Patient had received 4 doses of the Moderna COVID-19 vaccine by intramuscular injection, 2 in Mar-2021, 1 in Aug-2021, and the most recent bivalent booster dose on 14-Sep-2022.   Patient took a CDC gummy in the morning after doing that napped that afternoon. Later, woke up from his nap and patient was shivering and had a fever of 100.6. He continued to had pain in his back and a fever. Patient was taking Tylenol for his symptoms. Patient spoke to his HCP who did not seem to have any notion about what caused his symptoms.
Patient hospitalized due to fevers, hypoxia to mid 70s, severe fatigue and lethargy which developed within hours of receiving vaccine.
I felt pain in my left arm where the shot was given the next day along with feeling weak, achy, and very sluggish.  The following days all symptoms went away other than my arm.  The pain has moved down to the top bone area on my elbow and then the top and bottom of my arm.  I have lost full strength in my arm and sometimes it's somewhat painful and affects me all day long.  When I try to grab something with that arm, I feel pain especially in the lower arm.  Pain has not gone away, just gotten worse but steady now.  How long does the pain stay in my arm and when can I expect to get full strength back?  I mentioned this to the pharmacist when I got my 2nd dose and she told me to try Bio Freeze, which I tried but it does not help.
Pt stood up with the help of his cane after receiving his 2nd dose of moderna covid19. He started walking towards me as i held the door. He went stiff and started tipping over. I ran in and tried to keep him from falling. I guided him to the wall and down to the floor. His friend who also received the shot, came in to assist me since pt. is pretty big and was dead weight. His friend said this happens several times a day. We sat him up and waited. He then started having a seizure that lasted 3-5 seconds. Then he stated he was seeing black spots and felt weird. I called EMS and the police and EMT's took him out on a stretcher.
CVA with right hemiparesis. Medical Records received on 2/18/2005 states on PE, testing of 7th cranial nerve indicated right-sided facial weakness. Medical Receords received on 3/07/2005 states posturing. Per follow up report- stable at this time. Still has upper extremity hemiparesis.
i am having side effects of the vaccine; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced adverse drug reaction after vaccination. The patient asked if it is ok to be around infants and pregnant women after having the shingrix vaccine.
Hit me hard-I had severe pain all over-Headpain (bad) very stiff hard to get up-but I had to lay in tub of cold water for fever and pain. 102 degree temp also had nausea (stomach upset) loose stool for full day.
Bruising at site of injection; rash on arm and all over torso (arm, neck, trunk, back). Itchy rash and hives - took 1 week to disappear. Patient took BENADRYL for a week - until rash disappeared.
Eight days after injection, L arm became red, hot, and swollen.  I had a low grade temp.  Redness in L arm spread down upper arm measuring approximately 12x14 cm.  Stiff neck also.  Went to PCP and was told I had an allergic reaction and was told not to get the second dose.  I was told to take Benadryl and report my reaction.
after first dose:  painful lump in groin area on right side of body, which is the side of injection site.  lethargy and overwhelming fatigue lasting for roughly one week.
slight arm sorenessand a little bit more; This spontaneous case was reported by a consumer and describes the occurrence of   in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M201) for COVID-19 vaccination.     The patient's past medical history included Constipation, Thyroid activity decreased, Cholesterol, Anticoagulant therapy and Eye abnormality. Concomitant products included CLOPIDOGREL for Anticoagulant therapy, ROSUVASTATIN for Cholesterol, LUBIPROSTONE (AMITIZA) for Constipation, DIFLUPREDNATE (DUREZOL) and LOTEPREDNOL ETABONATE (LOTEMAX) for Eye abnormality, LEVOTHYROXINE for Thyroid activity decreased.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Pt vaccinated with DTP developed 3 x 4 swollen mass with overlying 1 1/2cm erythema.
pain in her arms, hands and legs; she had severe pain that radiated down the arm from the injection site; the patient experienced severe swelling the size of golf ball at the injection site; she had severe pain that radiated down the arm from the injection site; This spontaneous report was received from a registered nurse refers to a 39-year-old female patient. The patient's medical history included anxiety, depression and post bariatric surgery. The patient's current conditions included drug hypersensitivity, pancytopenia, pelvic pain, perineal pain, bilateral arthritis knee, osteoarthritis, pulmonary sarcoidosis, vertigo, vitamin d deficiency, sarcoidosis, thrombocytopenia, enlarged spleen, steroid inducted diabetes, arthritis, bradycardia, pacemaker, chronic fatigue syndrome, dizziness, dorsalgia, hypertension, folate deficiency, dyspepsia, hyper-somnolence, ovarian cyst, major depressive disorder, migraines, obesity and neuropathy. The patient is allergic to codeine, contrast dye, ZOFRAN, penicillin and sulfa drugs (unspecified). Concomitant therapies included prednisone(daily), sertraline hydrochloride (ZOLOFT), folic acid, cholecalciferol (Vitamin D3), metoprolol, methotrexate, cyanocobalamin (B12 injections), meclizine, sumatriptan (IMITREX) and alprazolam (XANAX).  On 29-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose and anatomical location were not reported) lot # S018405 with expiration date:23-MAR-2021, intramuscular for prophylaxis. On the same day, patient experienced severe swelling which is of the size of golf ball at the injection site (injection site swelling). It was also reported that the patient had severe pain that radiated down the arm from the injection site (pain, injection site pain) and soreness in her arms, hands and legs (pain in extremity). The patient sought medical attention and was treated with oral prednisone. No lab diagnostics/studies were performed. The outcome of pain in extremity, injection site pain, injection site swelling, and pain was reported as not recovered. The causality assessment was not provided. No product quality complaint was involved.   This is one of the two reports from the same reporter.
Patient complained of feeling dizzy, no shortness of breath or no chest pain were noted. After enhanced observation dizziness resolved and she was discharged
Initial Report Received: 26-Dec-2018 A physician reported that patient CU, a 52-year-old female patient (race not provided) was administered with HEPLISAV-B which was stored improperly for approximately 5 days. Relevant medical history was not provided.  The patient had no known allergies. Concomitant medications were not provided. On 26-Dec-2018, the patient received a dose of HEPLISAV-B (lot # 1036463, expiration date 28-Jul-2019) in the left deltoid, which was stored improperly. It was stored out of temperature range for greater than 8 hours, for approximately 5 days. The patient reported no adverse reactions. No further information was provided. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of improper storage of product in use as non-serious. The event of improper storage of product in use is unlisted per HEPLISAV-B; Sender's Comments: The company assessed the event of improper storage of product in use as non-serious. The event of improper storage of product in use is unlisted per HEPLISAV-B.
The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 01Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable medical assistant via Pfizer Sales Representative and from a contactable nurse. This medical assistant reported similar events on five patients. This is the second of five reports. A 81 year-old female patient of unspecified ethnicity received PREVNAR 13 (lot number M06898, NDC number: 0005-1971-02) on 28Oct2015, at 0.5 ml single, in deltoid. Relevant medical history and concomitant medications were not reported. The patient experienced cellulitis on 28Oct2015. No admission to hospital was involved. She received KEFLEX to treat the event and she recovered on an unknown date.
Patient states she was fully vaccinated with Moderna COVID vaccine, completed second shot in March.  We do not have a copy of her COVID vaccination card or know her lot numbers, she was advised to e-mail this information to her primary care provider's office.  Her symptoms of fatigue, fevers, body ache, headache, and nasal congestion started on 7/30/2021.  She tested positive for COVID on 7/31/2021.
Mild urticaria about 20 mins after immunizations 4-5 lesions on back, left arms with some mild edema of lower lip. Before patient left the clinic lesions on back disappeared and lip swelling was reduced. Benadryl 50 mg IM right deltoid , lot #019223
Information has been received from a physician concerning a 19 year old female with a penicillin allergy and no other pertinent medical history reported. On 22-DEC-2006, the patient was vaccinated intramuscularly with one dose of Gardasil (Lot #654885/1424F). Concomitant therapy included Ortho Tri Cyclen. On 22-DEC-2006, the patient felt nauseous shortly after administration. The patient then fainted for approximately 10 seconds while she was at the office. The patient remained in the office until she felt "normal" again. The patient then went home where later she felt sick again. The patient went to the emergency room and was then released. It was reported that there were no laboratory diagnostics performed at the physician's office and it was unknown it any were performed in the emergency room. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.
Onset of needle type pain in muscles, pain in left arm, shoulder, and back with severe twitching in shoulder, legs, arms and hands.  generalized weakness especially when raising arms. Started approximately 2 weeks after flu and tetanus vaccines which were administered on 11/24/2003.  Has received flu and tetanus vaccinations in the past without incident.  Patient is currently followed by 3 PMDs and a neurologist. *Denies history of GBS.  *Patient refused to sign consent for health department to obtain records from PMDs or neurologist.