chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt has received second dose of the Moderna series. He had completed his fifteen  minutes of observation and after standing to leave, he collapsed onto the floor hitting his head at 1152. Myself,RN rushed over and began to evaluate condition.  Pt was oriented x4 and stated he had become light headed after standing. Stated that his head hurt from hitting it on the floor. Began monitoring vital signs. Initial VS showed BP of 138/82, Pulse of 83, and respirations at 14. Applied oxygen per nasal cannula until we could monitor oxygen level which was found to be 96%. After continuing to  talk with pt, he again passed out while still laying down. We were able to awaken him and he was still oriented x4. . Second VS  at 1159 showed BP of 130/82, P 82, and 02 of 96.  Pt reported his history of seizures. Continued to monitor. Third set of VS at 1204 were BP 124/78, P 78, R 12, 02 96. Police arrived at 1205 and ambulance arrived at 1209. Pt refused to be taken in  by ambulance and continued to converse. We sat pt up to sitting position. At 1207, BP was 124/80, P 79, and 02 96. He was then moved up to sit in chair but after sitting there at approximately 1215, pt again passed out but was supported by the EMT.  After regaining consciousness, he then agreed to be transported to hospital via ambulance.
Pt felt lightheaded once in parking lot after receiving vaccine around noon. Beeped horn at 12:10pm. Fainted and reports possible stiffening of limbs/seizure activity. Hx of fainting with needles. Pt was pale and lightheaded when nurse arrived to car at 12:11pm. 911 called immediately due to possible seizure. BP 90/50, unable to obtain pulse and O2 sats. Ambulance on scene at 12:17pm and patient transported to hospital via ambulance at 12:30pm. Pt was feeling better and responsive when he left scene.
Immediately after the shot, my arm was very sore. Since then, I have had pain when stretching my arm or lifting objects. I also cannot sleep on my left arm and I have very strong pain when taking my blood pressure in that arm.
A 19 y.o. male fainted about 15 seconds after being seated in the post IMZ waiting area. I had just walked away so didn't see it happen. I had him lie on the floor until he felt better. He was rubbing his head and thought he may have hit it on the floor. After 40 minutes he said that he felt ok and his head was not very sore. He declined to having us call for medical help.
body aching; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient complained of body aching after receiving Shingrix.  The aching lasted 24 to 48 hours. The reporter consent to follow up. This case has been linked with case US2020154014, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020154014:same reporter
Received the vaccine on 10/7 at 9 a.m. Felt fine and at approximately 7 p.m. same day started to feel muscle spasms in low back and legs and arm was sore. Sweats started to occur where I was soaked along with 102 temperature. Then I started to get the extreme chills. This lasted more than 24 hours and I had to call in sick to work on 10/8. Then on 10/9 in evening I had chest pains for 6 hours and on 10/14 started having abnormal menstrual spotting. This has occurred for several days and is out of the ordinary since I haven't had a period in 3 years.
Started feeling fatigued with low appetite same night (11/02/2021). Started vomiting overnight x 3-4 times and continued to be nauseous. Woke up next day (11/03/2021) at 9 am with disseminated hives throughout body. After getting up from the bed felt dizzy and fainted, loosing consciousness and falling to the floor (unwitnessed). Fainted 2 more times after getting up and had blurry vision prior and before syncopal episodes and coccygeal pain. Was taken to ER, received Benadryl (diphenhydramine) 50 mg/mL injection IV, 50 mg Solu-Medrol (methylprednisolone sod suc (pf)) injection 125 mg IV, sodium chloride IV bolus 0.9 % 1,000 mL. Discharged from ER with prescriptions for Medrol pak, Zofran prn and Benadryl prn. No more syncopal episodes have occurred. Continue to have itchy disseminated hives throughout body today (11/04/2021).
patient received only the solution portion of the Pentacel/no AE; Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case received from an other health professional via the Medical Information under reference number - 00708879.   This case involves a 3 month-old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], but only with solution portion (Act-HIB) (Product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  On 22-Jul-2021, the patient received first dose 0.5 mL (standard; total) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ458ABA and expiry date 21-May-2022) via an intramuscular route at the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency was on same day).   It was reported that "HCP (Healthcare Professional) stated PENTACEL come with two components and she didn't combine both. HCP stated she gave the solution, Act-HIB and wanted to know how she can fix the error. HCP wanted to know if she can reconstitute the powder with saline and give that or redo the PENTACEL shot. Caller states that she administered a Pentacel and she may have be rushed or was distracted but she only gave the solution portion of the vaccine".  At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Headache; chills; joint pain in legs; muscle aches in thighs; blood pressure 160/140; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021 and was forwarded to Moderna on 13-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure 160/140), HEADACHE (Headache), CHILLS (chills), ARTHRALGIA (joint pain in legs) and MYALGIA (muscle aches in thighs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy ((some) Penicillin, sulfa, beta blockers, Angiotensin receptor blockers), Congestive heart failure (Congestive heart failure-left ventricle), Blood pressure high, Diabetes, Hyperlipidemia and Acute otitis media with effusion. Concomitant products included CANDESARTAN, CARVEDILOL, LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN, PANTOPRAZOLE, FOLIC ACID, EZETIMIBE (EZETIM), POTASSIUM CHLORIDE (KLOR-CON M20), CYANOCOBALAMIN (NASCOBAL), FLUTICASONE PROPIONATE (FLUTICASONE PROPRIONATE) and COLECALCIFEROL (D-3) for an unknown indication.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure 160/140). On an unknown date, the patient experienced HEADACHE (Headache), CHILLS (chills), ARTHRALGIA (joint pain in legs) and MYALGIA (muscle aches in thighs). In April 2021, BLOOD PRESSURE INCREASED (blood pressure 160/140) had resolved. At the time of the report, HEADACHE (Headache), CHILLS (chills), ARTHRALGIA (joint pain in legs) and MYALGIA (muscle aches in thighs) had resolved.            Treatment was not provided   This case was linked to MODERNATX, INC.-MOD-2021-051847 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-051847:First dose
Fussiness / irritability; This case was reported by a physician via sales rep and described the occurrence of irritability in an unspecified number of infant patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.  On an unknown date, the patient received Pediarix at an unknown dose. On an unknown date, unknown after receiving Pediarix, the patient experienced irritability. On an unknown date, the outcome of the irritability was unknown.   It was unknown if the reporter considered the irritability to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not applicable. The physician stated that when he first used Pediarix, infants experienced fussiness and irritability so he got tired for the calls so they switched to Pentacel and he has not seen this. The reporter did not agree to follow up.
4/22 2am (day prior to 2nd Pfizer dose) broke out in rash/hives on both arms (armpits to wrists) and both legs (thighs to knees).  Have had recurring rash/hives almost daily since then.  It wasn't until the morning of 8/10 that rash/hives spread to entire body fully arms, legs, torso, back.
Information has been received from a registered nurse concerning a  24 month old male patient with no pertinent medical history or drug allergy who on 12-SEP-2009 in the morning was vaccinated with a dose of PNEUMOVAX 23 (Lot # 662667/1435X), SC in left thigh. On 12-SEP-2009 afternoon after receiving the vaccine, the patient developed local reaction of redness, swelling, and tender to the touch. The area was raised and the patient could not walk on his leg. He had a temperature of 101.4 degrees. The patient's mother was instructed to give him MOTRIN and apply cold compresses tothe area. The patient's mother has sought medical attention through a call. At the time of this report, the patient had not recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 662667/1435X were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the physician concerning this patient. The physician reported that the patient on 12-SEP-2009 received a dose of PNEUMOVAX 23 (Lot # 662667/1435X), SC in left thigh. The same day, patient experienced fever of 101.4 degrees after 3-4 hours of vaccination. The patient was to bear weight on leg, seemed to be in severe pain, tender to touch. The patient has sought medical attention. At the time of this report, the patient recovered from the events. Additional information has been requested.
1126 states felt funny VS 86/63 HR 79 100 RA taken to cot to monitor/evaluate denies any pain or discomfort only just weak and funny, requested drink of water and leaned back on bed 90 degree angle noticed she was not focusing 1130 VS 78/45 58 100 RA taken to ER via WC due to Hypotension.  1830 LM for her to call me on her cell for follow up
very sore; Initial information received on 23-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.   This case involves female patient who experienced event very sore (pain) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any, concomitant disease or risk factor.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE).  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event very sore (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "what a beautiful woman, wish I knew her- got moderna booster and high dose flu shot yesterday and very sore".  It was unknown if there were laboratory data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
had COVID last year after she had the first vaccine for COVID and prior to the timeframe where she could get the second dose of the vaccine. Both times she's had COVID; had COVID last year after she had the first vaccine for COVID and prior to the timeframe where she could get the second dose of the vaccine. Both times she's had COVID; could not wake up for the first 1-2 days; Doesn't eat or drink; bedridden for a while; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2021US222266_OS.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EATING DISORDER (non-serious) with onset 2022, outcome "recovering", described as "Doesn't eat or drink"; BEDRIDDEN (non-serious) with onset 2022, outcome "unknown", described as "bedridden for a while"; SOMNOLENCE (non-serious) with onset 2022, outcome "recovering", described as "could not wake up for the first 1-2 days"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "had COVID last year after she had the first vaccine for COVID and prior to the timeframe where she could get the second dose of the vaccine. Both times she's had COVID". Clinical course: The patient reported she had COVID last year after she had the first vaccine for COVID and prior to the timeframe where she could get the second dose of the vaccine. Both times she's had COVID, she reported that she could not wake up for the first 1-2 days and doesn't eat or drink as a result. She was improving, but states she was bedridden for a while.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a certified medical assistant (C.M.A.) concerning a 59 year old female with a history of pneumonia and no history of drug reactions/allergies who on 02-OCT-2006 was vaccinated with Pneumovax 23 (lot # 650457/0937P) 0.5 ml IM in left deltoid. Concomitant therapy included Atenolol and DIOVAN. On 02-OCT-2006, a couple of hours after the vaccination, the patient developed pain, redness, and swelling around the injection site. The swelling and pain spread to underneath her underarm and over the patient's breast. Also, the patient fever up to 101-102 degrees Fahrenheit. Medical attention was sought. No lab diagnostic studies were performed. The patient was treated with TYLENOL. The symptom improved on therapy. On 07-OCT-2006, the patient recovered. Additional information has been requested.
High Fever; body aches; muscle pain; headache; tired; This is a spontaneous report from a non-contactable consumer (Patient). A 23-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 at 11:00(at the age of 23-years-old) administered in Arm Left as a single dose for COVID-19 immunisation. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 18Feb2021 at 12:00 PM administered in Arm Left as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10Mar2021 at 21:00 PM, the patient experienced High Fever, body aches, muscle pain, headache, tired. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Itching (not at injection site) on eye, forehead, and scalp.  Mild on day of shot, but worse the following 2 days.    The only thing I am allergic to is Neosporin, so I don't know if any of those ingredients are in the Pfizer vaccine.
Pt. self identified as immunosuppressed prior to injection, on 30 min monitor until 1604.  At call time, pt c/o mild lightheaded that started 10 min ago approx.  VS 128/64, HR 86, OxSat 98%.  Pt sipping juice, alert and oriented.  reports no lunch prior to coming.  Pt sitting in chair during extended monitoring.  Boy friend with pt.  Pt assessed by medic with RN. Declines food.  Pt instructed to bring lunch prior to next injection, bring snack and identify at registration as both inmunosupressed and reactive on first injection.  Pt to be cotted on injection #2.  Supervisor is aware.  Pt stable @ 1620 BP 112/68, RR 18, HR 84, OxSat 98%.  Pt discharged with boyfriend who will escorted drive patient home.  Pt asymptomatic at discharge.
Onset redness, swelling and pain in left arm 8 days after injection.  Progressive worsening over next 24 hours.
STARTING 24-36 HOURS AFTER VACCINE ADMINISTRATION PT BEGAN WITH 102 FEVERS, LIMITED ROM IN SHOULDER R/T PAIN AND SEVERE TENDERNESS TO PALPATION. AREA ALSO RED AND WARM TO TOUCH
This spontaneous report was received from a Licensed Practical Nurse refers to an unspecified number of age and gender patients. The nurse reported that improperly stored PEDVAXHIB (lot# unspecified) (dose, route and location unspecified) might have been administered (exact dates of administration unspecified, the PEDVAXHIB was improperly stored in June of 2013, exact date of improper storage was unspecified). No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Arm reddened, hot to touch same day of injection; increased temperature of 102.6 degrees F; asking and N/V same day after shot. 12/05/01 arm continuing to hurt like swollen muscle and pain shooting to elbow when using or lifting objects.
rash with little stripes on his lower left leg calf; His fever was >97.1 this morning; Husband started feeling tired on same day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash with little stripes on his lower left leg calf), FATIGUE (Husband started feeling tired on same day after receiving 1st dose) and PYREXIA (His fever was >97.1 this morning) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical History was provided by the reporter.  Concomitant products included QUETIAPINE, PRAVASTATIN, ATENOLOL, MEMANTINE HYDROCHLORIDE (NAMENDA), NORTRIPTYLINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), PARACETAMOL (TYLENOL EXTRA STRENGTH), VITAMINS NOS, MAGNESIUM and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Mar-2021, the patient experienced FATIGUE (Husband started feeling tired on same day after receiving 1st dose). On 12-Mar-2021, the patient experienced RASH (rash with little stripes on his lower left leg calf) and PYREXIA (His fever was >97.1 this morning). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (rash with little stripes on his lower left leg calf), FATIGUE (Husband started feeling tired on same day after receiving 1st dose) and PYREXIA (His fever was >97.1 this morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: >97.1 (Inconclusive) fever was >97.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Varicella Blisters occurred starting on day 15, low grade fever and headaches starting on day 13
BlurredVision, Headache, Arthralgia, Angioedema, Tachypnea, HYPERtension, Tachycardia, Lymphadenopathy, fatigue, fever Narrative:  Fever for 5 days after first dose, unwell fatigue and tired, node swelling after each dose, these persists. Night sweats, axillary nodes, edema persist. Self-treating with NSAIDS. No pre-dose medication.  Other Relevant History:
REDNESS/CELLUTIS/ DURATION 20-24 MM/ WAD GIVEN  MONITOR/ TAKE MORTRIN/ BY NURSE
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection.  She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness.  Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious.  Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious.  Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness.  Patient had tachycardia and self-reported palpitations.  Received IV fluids and observation on telemetry with no rhythm disturbance.  Patient discharged 1428 on 12/24.  On 12/29, patient returned to ED at 0326  for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation.  Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619
Metallic taste on tongue resolved in about 4 hours since injection Hand of injection arm (left) of thumb area was sore and hurtful like a strained muscle. Swelling of the thumb/hand/wrist area. Pain subsided approximately 5 hours after injection. Swelling of hand/thumb subsided about 7 hours. Wrist is still slightly swollen and has been for about 32 hours at this reporting. Fatigue and lethargy onset about 12 hours since injection and lasting for the next 14 hours at time of onset. Chills onset 12 hours since injection and lasting for about 3 hours since onset.