chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 57-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 57-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any accompanied AE.
Child was sitting on the exam table and was given the Tdap vaccine.  Immediately had a syncopal episode then presented with seizure -like activity for approximately 7 seconds. Hand/wrists contracted.  Child awoke - was oriented x3.  No loss of bladder function nor drooling from the mouth. Mom was instructed to take to the emergency room if any further activity noted and to make an appointment with his primary doctor. Mom verbalized understanding.
Administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Pharmacist reports that they administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home. Pharmacist stated that the beyond the use date was 09 Dec 2021 at 10:00 PM and they administered the vaccine from 10 Dec 2021 to 13 Dec 2021.
I had chills - cold, fever - 101.2, burning sensation on my feet and the palm of my hands and it was hurting. Joint  problems - after the vaccine- on my right hip. They told me to take Tylenol - every six hours - had a visit - NP at my doctor's office. The Tylenol helped. I was able to sleep - I just wanted to sleep. Those lasted 24-48 hours - except the joint pain on right hip didn't go away. After that I felt better - nothing else happened.  (I had had COVID December 14th of 2020.) When I had my regular doctor check-up about 2 -3 weeks ago. I had regular lab work done - and my ANA came back positive. My own immune system is fighting with my immune system. My doctor referred me to a rheumatologist - I went to see him and he ordered more lab work and all of those  tests came back negative. The joint pain on hip goes away and then it comes back - when I try to walk it comes back - I feel like my entire back is going to give out. I am still trying to walk.
Patient received Pfizer Covid Vaccine (lot #EW0187 exp. 8/31/21) first dose and while walking to the monitoring area he lost consciousness briefly and fell over chair that he was turning to sit in. After being laid flat, he immediately regained consciousness and was awake, alert, oriented x 3. VS BP 110/60, P-70 and pulse ox 100%, R-20. Color pale. He was moved to a geri-chair with his feet up. He refused to go to ER and stayed x 30 minutes to be monitored with no further incidents. VS at end of monitoring period 108/68, P-66, pulse ox 100%, R 20. Color became pinker, was able to tolerate drinking 240 oz. of water and eating a slice of cake. Offered to be transported to ED again but patient refused. Patient was instructed to follow up with ER or Primary Care Provider with any further  symptoms.
Rash around below inject site. Reaction occurred night after injection. Pt currently putting caladryl on it and going to take benadryl.
Patient returned to clinic 4 minutes after recieving flu vaccine reporting dizziness.  She started to collapse and was assisted to the floor.  She did not lose consciousness.  Denies shortness of breath, tachycardia.  911 called.  EpiPen Adult administered to right anterolateral thigh.  Patient reported extreme stress and emotional distress.  Patient transferred by ambulance to hospital for further evaluation.
pt recvd vax; T 105.7; to er; given ATB shot;
A patient received FLUZONE HD  instead of FLUZONE QUADRIVALENT no AE; A patient under 65 years old received FLUZONE HD no AE; A patient under 65 years old received before realized it was FLUZONE HD no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00850044) and transmitted to Sanofi on 09-Nov-2021.    This case is linked to cases 2021SA378207 and 2021SA376763 (same reporter).  This case involves a 15 month old patient (unknown gender) who was received before realized INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and accidental overdose) instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered).   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DIPHTHERIA TETANUS ACELLULAR PERTUSSIS) and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX) for prophylactic vaccination   On an unknown date, the patient received a 0.7 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number: UJ773AC and expiry not reported, form: solution) via intramuscular route in left thigh for prophylactic vaccination instead of FLUZONE QUADRIVALENT.  It was a case a case of actual medication error due to Wrong vaccine administered, Inappropriate age at vaccine administration and accidental overdose (latency same day).  It was reported "Physician called to report that she ordered FLUZONE QUADRIVALENT but was sent FLUZONE HD instead. The FLUZONE HD was administered to three patients under 65 years old before she realized it was FLUZONE HD. Adverse events (AEs) were reported for all three patients with as much information as the caller was able to provide. The caller was in a hurry to obtain/provide information and return back to her practice."  No other adverse event was reported.   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.
Patient had not previously had received a series of Covid vaccines.  Patient verbalized that he had, administrator did not have a resource to cross reference.  No adverse outcome
This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 36-year-old female subject who was vaccinated with Flu TIV .5 ml on an unknown date. The subject's estimated date of delivery was 1st November 2014. The subject received Flu TIV at week 35 of the pregnancy and during the third trimester of pregnancy. At the time of reporting, the pregnancy was ongoing.
2hrs after shot, cluster seizures for 20min. 2mg Methadone and 1mg Xanaflex, Diarrhea for 2 1/2 weeks
increased blood pressure.  had a systolic reading of 191 at home, came to pharmacy to check, had a systolic reading of 244
The pt experienced a strange rash all over her body with a high fever which began lasted for 10-14 days. The pt experienced a speech delay and began speech therapy at the age of 2 1/2 and has been a very frustrated child with sensory difficulties and communication deficits.
daughter who lives in another state had the same r/ (hive reaction with a rash); I still have the rash; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (daughter who lives in another state had the same r/ (hive reaction with a rash)) and RASH (I still have the rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (daughter who lives in another state had the same r/ (hive reaction with a rash)) and RASH (I still have the rash). At the time of the report, URTICARIA (daughter who lives in another state had the same r/ (hive reaction with a rash)) outcome was unknown and RASH (I still have the rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2022-437363 (Patient Link).
54yoM presented for a sudden-onset diaphoresis and loss of body strength. Pt had received COVID-19 vaccine this morning at the clinic and noted severe sweating all over the body while lying in bed @ approx 2030. Then pt described severe loss of body strength with dizziness as he was trying to sit up and get to his feet from the floor. Denied palpitation, chest pain, headache, N/V, LOC. His symptoms continued for 20mins until he drank a cup of water. At approx 2050, smoked E-cigarette and arrived at facility at 2100. On arrival, pt denied any symptoms, however, vitals indicated severe hypertension: BP 188/99, HR 56, T 97.6 F. Pt given 81mg ASA x2 and immediately transported to hospital.
BELL'S PALSY; OUTER EAR INFECTION/EAR ACHE, PAIN AND REDNESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 14-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient, experienced pain from 19-MAR-2021 to 21-MAR-2021. On 21-MAR-2021, the patient experienced outer ear infection. On the same day, she went to the Urgent Care and the physician gave her ear drops (unspecified) for outer ear infection which was used only for two times. According to her physician, her ear was a little red. She stated that as per her age and family history, she went to the emergency room on 22-March-2021 and found out that she had Bell's Palsy. She went to the ophthalmologist who gave Neo-Poly-Dex 0.1 percent (3.5 grams) ointment. Treatment medications included: dexamethasone/neomycin/polymyxin b.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bell's palsy, and the outcome of outer ear infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210407047-COVID-19 VACCINE AD26.COV2.S-bells's palsy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
10/11 patient got the imz, that weekend patients arm got sore and swollen. Patient went to the ER for this over the weekend. They stated it might be an allergy to the imz or a problem with the alcohol used to clean the area  He came back to the pharmacy to let us know on 10/15 about the adverse reaction.
fine macular rash over arm bilat-total length w/mild swelling, also over upper 1/2 trunk-inc on back;pt had flu sx approx 10 days earlier;
Patient reported stiff/sore arm 4 hours after given vaccination. It progressed with swelling and redness done to elbow. She went to an acute care center   where they gave her an rx for doxycycline. She tolerated doxycycline fine and now the swelling and redness is almost gone. Feels normal now.
Patient received the Pfizer COVID vaccine (lot EW0191) at approximately 1625 in the Collaboration Room, to provide more privacy at patient's request. Pharmacist vaccinated patient and remained with the patient for observation period. At 1630, the patient vomited and PHN approached to assess. Patient reported feeling hot and sweaty before vomiting, and relief after emesis. At 1632, vital signs: blood pressure 134/88, pulse 70, O2 97%, respirations 18. Patient reported having a similar reaction after receiving the 1st Pfizer dose and after the meningococcal vaccine. PHN noted no swelling or work of breathing. Patient reported a fear of needles. Patient did not follow up with his provider after the 1st dose of Pfizer COVID vaccine. Patient reported eating a full meal and drinking water throughout the day. PHN encouraged patient to follow up with provider and symptoms in which to call 911. Patient reported no allergies, medical conditions, nor medications. PHN offered patient Benadryl but patient declined. AT 1650, vital signs: blood pressure 122/80, O2 98%, pulse 80, respirations 16. Patient reported symptoms had resolved. Patient drank water offered by Pharmacist. Patient left walking with steady gait at 1703.
Patient received 3rd Dose of Pfizer Covid vaccine, Given on 1/6/21, 1/27/2 and 2/17/21
2:30p: I was called to assist pt as she was having a rxn to COVID vaccine. Had vaccine 10 minutes prior. Found pt pale, diaphoretic lips, cool and diaphoretic. Did not respond to name. Assisted pt to floor and elevated feet. Pt immediately opened eyes and was oriented x 3. BP 120/82. 2:35p: Pt awake, alert and oriented x 3. Color pinker and drier, cool compress to forehead. 2:37p: Pt remains asymptomatic, assisted pt to sitting position. 2:39p: Pt color pink, skin w/d. 0 c/o's. Assisted pt to wheelchair. Nurse from ER here and accompanied pt to ER.
Same day pt developed burning pain with urination and fever of 101F the same day.  Pt came to the hospital, was not determined to have a urinary tract infections. No fevers during time in the hospital.
pt recv vax; stated "blacked out" while driving car; denies episodes of dizziness, weakness or oth problems of possible immun side effects;
Swelling, large lump and pain at injection area. Shoulder pain and locking up in the joint during range of motion. Nerve pain almost as if shoulder is pinching a nerve. Still painful with lump at injection site on 4/20/2015.
Red and swollen injection site. Swollen lymph nodes, lasting 2 days. Fever and uncontrollable chills lasting 6 hours. Intense joint pain lasting 6 hours. Migraine is still ongoing 8 days later.
Flu shot 0.5cc given 10/19/2004. Pt noted mild redness, slight swelling , warm feeling around injection site by 10/21/2004.
Received HPV at 3:30PM. At 8:30 during volleyball fell on floor, fainted 3-5 Sec. sat up unable to talk, gasping for air for 3min.; improved and fine after5-6 minutes. Shaky was not seen or treated.
Dose #1: Just a sore arm   Dose #2: Within 24 hours my left ear hurt like I was getting an ear infection. I just assumed it was allergies. Within 48 hours my left eye began stinging and hurting, as well as continuation of a left  earache. Within 72 hours I noticed that me left eye blinking was delayed and not symmetrical with that of my right.  On May 1st I went to the ER and was diagnosed with Bell's Palsy. I had total loss of muscle/nerve control to the left side of my face. It affected my speech, ability to eat, and ability to drink.  I was scared that I was having a stroke and went to the ER.
Intermittent episodes of vertigo started about a week after the vaccine. Episodes occur with bending down, looking up, rolling over in bed etc. Feels like there is fluid in the left ear.
This patient was given Janssen Covid-19 vaccine, which is authorized for age 18+, and she is under age 18.
Significant musculoskeletal pain, most severe in the shoulders and neck (L>R) and severe headache that has improved but not totally gone away.  It has gotten to the point that I do not feel I need to see my doctor.  However I do feel it was severe enough that I should report it.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender who on 08-APR-2015 was vaccinated with an improperly stored dose of oral, ROTATEQ lot # K011663 (route was not provided). The excursion time for this lot was 36 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
7/22/20 6:30 - pain @ site; 9:30 Fever T- 98.9 -F. RESTLESS & SHIVERING IN BED ALL NIGHT. TOOK ACETAMINOPHEN, DIPHENHYDRAMINE 1x 7/23/20 8:30 AM T - 94.8 Felt better but more pain in R shoulder radiating down arm from injection site. 7/24/20 Felt better but pain persisted 4-6 days.
Received Pfizer vaccines on 3/25/21 and 4/15/21. Tested positive for COVID-19  by PCR from Bronchoalveolar lavage on 5/20/21. Had been previously positive for COVID-19 by PCR in November 2020. Patient has underlying follicular lymphoma. Admitted to hospital for IV Remdesivir and convalescent plasma on 5/22/21.  Had 3 month history of fever of unknown origin, persistent cough; hospital notes mention ground glass opacities on CT concerning for chronic COVID-19 pneumonia.
1st dose: headache (12-48 hours after injection), fatigue (12-48 hours after injection); arm soreness (for about 5 days after injection); swollen/sore lymph nodes in left arm  2nd dose: headache, low grade fever, fatigue, chills, muscle soreness(12-72 hours after injection); arm soreness (12-72+ hours after injection); swollen lymph nodes in left arm (12-72+ hours after injection)
Patient contacted Pharmacist (Administrating Person) of going to be night of injection with 102 deg F. fever, chills, and feeling of discomfort and aches in joints. Patient was asked to report any adverse symptoms, as she had experienced many of these same effects from the 1st administration.  Symptoms from 2nd dose were just or more severe than 1st dose, given 01/26/2019. Reason she reported now, was Pharmacist / Administrator of Injection had asked if she had felt any adverse effects from 1st dose. She had and would call back if these adverse affects were present this time. She called 3/28/19 in am to state what occurred and was on 2nd day after administration just now returning to "herself".
Major chills; Headache; Exhausted; Fever of 102; Diarrhea; Mild body aches; Sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not provided. The patient did not have any allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination.  On 02Apr2021 at 23:30, the patient experienced major chills, headache, exhausted, fever of 102, diarrhea, mild body aches and sore at injection site. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 02Apr2021 at 23:30, the patient underwent lab tests and procedures which included body temperature and the result was shown as 102. The clinical outcomes of the events major chills, headache, exhausted, fever of 102, diarrhea, mild body aches and sore at injection site were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
FEVER UP TO 104 DAY AFTER VACCINE.  ALSO HAD N/V AND DIARRHEA, HEADACHE AND BODY ACHES.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
Chills, fever, sweats, fatigue, exhaustion, while driving I feel asleep at a red light, confusion
Approximately 8 hours after pneumococcal vaccine administration, the patient experienced itching and a rash that started on his right arm, spread across chest wall, and reached his left shoulder.  A one-time dose of diphenhydramine 50mg IV was given, and the rash and itching subsided.
Fever ranging from 99.0 - 101.8. Severe aches in all joints, Extreme fatigue. Congested cough. Symptoms began on Saturday morning approximately 0200, continued through Monday 1530. Low grade fever on Monday. Took Tylenol and ibuprofen to reduce fever and pain.
Vomited x 2, 10 minutes after receiving vaccines.  30 minutes after receiving vaccines patient developed generalized pruritic rash with redness of extremities acrocyanosis.  Patient returned to clinic was given Diphanhydramine and Prednisolone and recovered within 30 minutes.