chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On July 11, 2014 at 11:00am pt arrives at clinic with mother. C/O redness, swelling and warmth to touch on Rt. deltoid which started 10pm July 10th. Redness measured at 7cm x 12cm. Pt denies pain, nausea, vomiting, fever. Pt's mother instructed to go to the ER if sx worsen. Upon f/u call on July 14th at 9am, father of pt reported the swelling resolved with no further sx or concerns.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # L015460, expiration date 20-JUL-2017 and lot # M011116, expiration date 17-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Cold sore on my upper lip; Injection site soreness; Migraine; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 52-years-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:30 (at age of 52-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No medical history and concomitant medications were reported. Patient had not known allergies. Other medical history was no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Feb2021 21:30 the patient experienced injection site soreness, migraine and headache while patient experienced cold sore on my upper lip on 23Feb2021. Patient did not receive any treatment for AEs. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was recovering.  Information about lot batch requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Tingling in side of tongue at 10 minutes after vaccine/ tingling on right side of cheek at 45 minutes/ tingling on tongue & cheek; tingling on toes on right side of feet only/ tingling on foot; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female nurse (patient) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular route of administration on the left arm on 29Dec2020 10:00 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), vitamin B complex, zinc, and curcuma longa (TURMERIC), all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient experienced tingling in side of tongue at 10 minutes after vaccine, tingling on right side of cheek at 45 minutes & tingling on toes on right side of feet only on 29Dec2020 10:15. The tingling on tongue & cheek went away, but she was still getting tingling on foot at times. This never happened to her before the vaccine. No treatment was given and events were reported as non-serious. The outcome of the event tingling on tongue & cheek was recovered on an unspecified date and of tingling on foot was not recovered. The patient had not been tested for COVID-19 since the vaccination.
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 female patient received bnt162b2 (COMIRNATY), administration date 31Aug2021 (Lot number: FC3180) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Very dizzy". The event "very dizzy" was evaluated at the emergency room visit. Additional information: The patient reported that she had her first dose of the Pfizer-BioNTech Covid-19 vaccine a week ago today and she had been very dizzy ever since. She called her healthcare provider, her primary care, and they suggested she call Pfizer and they sent her to the Emergency Room just to make a precautionary type situation. She was on her way to the ER. She wanted to know if Pfizer had any information on dizziness after the vaccine. The report was not related to a study or programme. The reason for no lot number: of Covid-19 Vaccine was that the patient was unwilling to complete the report. The other products and investigation assessment was not provided. Consumer was unwilling to complete the report. Thus, further probing could not be done. Hence, limited information available. Follow-up attempts are completed. No further information is expected.
The vaccine was injected at noon. Exhaustion and tired feeling set in at 5:00 PM followed by a Raging headache. The patient awoke at 7:15 PM and took Advil for a severe headache. More Advil was taken at 2:00 AM the following morning. The headache went away, but came back again the following week.
Adverse event information provided in this submission, is per a report received by the Public Health Department from a submitting facility. Covid-19 vaccination information is from Immunization Registry.   Moderna 1/26/2021 Lot # 043L20A Moderna 2/22/2021 Lot # 011M20A  Moderna 12/15/2021 Lot # 045J21A  Moderna 6/14/2022 Lot # 059A22A  Patient presented to the Hospital 11/2/2022 accompanied by family. Patient is positive for COVID-19 and started on antivirals 11/1/2022. He presented to ER with altered mental status, generalized weakness and hypoxia. Symptoms and fever started 11/1/2022. Family stated patient was more confused.  He was seen in urgent care 11/1/2022. He was set up on home health monitoring. The home health care technician who came over to set up home health monitoring checked patient?s pulse ox and it was found to be in the 80s. The patient was directed to the ER for evaluation. Normal EKG. Elevated Troponin to 500. He became increasingly unwell in the past 24 to 48 hours with fever, increasing confusion, increasing weakness, nasal congestion, rhinorrhea. He was also said to be hallucinating. He tested positive for COVID-19 on 11/1/2022. He was taken to urgent care and was started on Paxlovid. He was brought to the ER  because of increasing weakness and hypoxia. In the ER, he was placed on oxygen. Routine labs showed hyponatremia and hypokalemia, he received a bolus of normal saline and potassium supplement. He was febrile with a temperature 102 °F. Chest x-ray was unremarkable. No leukocytosis, kidney and liver function unremarkable. Patient?s daughter was at bedside as patient is not a good historian. He denied headache, dizziness, chest pain, dyspnea, abdominal pain, nausea, vomiting, joint aches etc. Patient developed Acute hypoxic resp failure; found to be hypoxic 83% on 3L oxy mask overnight. Needed 1 5 L NRB mask to keep 02 sat > 90 %. It got worse in the and patient required up to 25 Liters. POA directed no further treatment. Given his advanced dementia and worsening resp failure from covid 19 pneumonia. Patient was placed on hospice care. Family agreed for that. ----- Patient expired 11/9/22 @ 2015
experiencing really bad muscle and joint aches/ore joint aches because it is in her elbows and underneath her armpits/her thighs hurt really bad; experiencing really bad muscle and joint aches/bad muscle aches all over her body; 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 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jul2021 (Lot number: FA7485) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Booster vaccine (eight weeks prior that is required every ten years, not sure of the product name), for immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 30Jul2021, outcome "not recovered", described as "experiencing really bad muscle and joint aches/ore joint aches because it is in her elbows and underneath her armpits/her thighs hurt really bad"; MYALGIA (non-serious) with onset 30Jul2021, outcome "not recovered", described as "experiencing really bad muscle and joint aches/bad muscle aches all over her body". Therapeutic measures were taken as a result of arthralgia, myalgia.  Additional information: The patient did not receive any vaccines within four week. The patient reported that she had it about almost a week tomorrow. Had like for the past 3-4 days really bad muscle aches all over her body. The patient stated it probably more joint aches because it was in her elbows and underneath her armpits and those kinds of places. Then stated her thighs hurt really bad. Finally clarified she was having really bad muscle and joint aches. Overall since Friday (30Jul2021), it had gotten worse. But the past two days it had been the same. The patient took one Tylenol pill and reported that it didn't do anything.  No follow-up attempts are possible. No further information is expected.
Burning in arms and hands, chronic severe systemic inflammation, and severe sciatica flare up. Neurological diagnosis of bi-lateral mild to moderate carpal tunnel syndrome with severe swelling from wrist downward to fingers, loss of strength in hands, loss of feeling in thumbs, middle and ring fingers.
Extreme muscle fatigue, weakness, diarrhea, headache, dizziness, excessive fatigue.
Fever /intense joint pain /chills /terrible headache Took ibuprofen 3 bad nights
taken to local E.R. after receiving HINI nasal mist.syncope episode @ home.discharged home the same day.clinical impression @ hospital panic attack,episode of dyspnea,syncope.
Several minute after injection 2 small hives appeared at site enlarging into a single large hive BENADRYL given po.
mom called 1207PM & stated that pt had been running a temp of 103.8 hx during the AM & not has started vomiting;stated that was given APAP q 4hr but temp was not coming down & all pt was doing was lying around;
Fever of 103.1, extreme body aches in muscle and bones ; and shooting pains, headache,  chills, nausea, entire evening 2/2/21going into.2/3/21. That day experienced pain could barely walk. Couldn?t raise my right arm.  Very tender to touch. Extremely tired , took Tylenol which reduced fever to 100.5.  Today 2/4/22 fever was 101.7. Now is normal temperature 99.0. Aches lessen and can move better. Still tired
Information has been received from a Registered Nurse concerning a female patient with allergy to penicillin and sulfa, who on 24-JAN-2011 was vaccinated subcutaneously with the first dose of PNEUMOVAX 23 (lot #665903/1427Y expiration date: 07-MAR-2012). Subsequently the patient experienced injection site reaction of pain, swelling and warmth. Patient was given antimicrobials (unspecified). At the time of the report patient had recovered. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Myalgia, Arthralgia, Fever, chills, injection site pain Narrative: Employee reported experienced fever (101 F), chills, body aches, joint aches, headaches, and injection site pain the evening after receiving the vaccine. Reports took ibuprofen and Tylenol (unknown dose/frequency). Reports felt better after taking Motrin (ibuprofen).
Patient broke out in red bumps that started out on her stomach then spread to other places.  On 01/28/11, I took patient to the doctor's office.  She was running a 101 degree temperature.  Doctor stated she had a mild case of chicken pox.  Patient's only exposure to chicken pox, that we know of, was from the vaccine.
got sick; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from the patient.  This case involves an unknown demographics patient who got sick (malaise), while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient got sick (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Seasonal allergy; Sinus congestion; Nausea; Headache; Chills; Fatigue; Vaccination site pain; Ache; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Seasonal allergy), SINUS CONGESTION (Sinus congestion), PAIN (Ache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Vaccination site pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF, Solution for injection in pre-filled pen. In 2021, the patient experienced PAIN (Ache), VACCINATION SITE PAIN (Vaccination site pain), CHILLS (Chills) and FATIGUE (Fatigue). On 16-Sep-2021, the patient experienced SEASONAL ALLERGY (Seasonal allergy), SINUS CONGESTION (Sinus congestion), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, SEASONAL ALLERGY (Seasonal allergy), SINUS CONGESTION (Sinus congestion), PAIN (Ache), NAUSEA (Nausea), VACCINATION SITE PAIN (Vaccination site pain), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            In 2021, the patient experienced arm pain after covid vaccine, achiness, chills and fatigue. On 16 Sep 2021, the patient experienced nausea, congestion and headache and seasonal allergies.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Headache, Myalgia, Fatigue, Injection site pain Narrative:   Other Relevant History:
Patient developed itching and hives hours after vaccination.  Patient states that after leaving the clinic she went to the beauty parlor and had her hair dyed.  Patient states she has had hives in the past and that she took Benadryl and felt better.
Flu like symptoms including; Fever; Aches; Chills; Congestion that lasted 1-2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EN5318) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing), notes: Verbatim: Anxiety. Concomitant medication(s) included: RISPERDAL taken for anxiety (ongoing). Vaccination history included: Bnt162b2 (1st dose , Lot: EN5318,, His first 2 doses were administered at the local hospital), administration date: 27Jan2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms including"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Aches"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; NASAL CONGESTION (non-serious) with onset 2021, outcome "recovered" (2021), described as "Congestion that lasted 1-2 days".  No follow-up attempts are possible. No further information is expected.
The vial for Pfizer 6 months- 4 years of age did not have enough diluent added to the vial- 0.22 mL was added to the vial instead of the correct 2.2 mL. Patient therefore got a higher dose of vaccine. Family was called multiple times to discuss vacine error, but no answer and no call back. No known adverse effects.
Pain at site of injection. Redness just below site of injection. Feeling achy all over.
On R arm: Hives, itching, tenderness and pain all the way to wrist Systemic: fatigue, low grade fever, soreness at injection site Ongoing
12/06/2021  COVID19 Booster Vaccination 12/08/2021  Intermittent Chest heaviness, L chest aching increased by leaning forward & palpitations limiting                                exercise. Intermittent nocturnal transient hand and foot paresthesia started.  12/15/2021  Routine negative covid 19 pcr 12/17/2021 Cardiology consultation for improving cardiac symptoms with ecg, hscrp, troponin & esr. 12/22/2021 16 days after the Covid 19 Booster Vaccination he awoke with prominent finger tremulousness that                              interfered with typing. The night before he had the onset of a Left Mid-Scapular Para-Spinal Ache and                              tingling.  01/23/2022   The finger tremulousness has persisted --  and in the previous week he noted the onset of a Vibratory Perception                               on the lower half of his face and on the back of his head and neck. He has also noted a daily spontaneous leg "kick"                              out.  01/27/2022  The intermittent vibration perception on the cheeks of his face and at the back of his head and neck has worsened                            and the finger tremulousness has persisted.
Hives onset on 4/30 all over (scalp to upper legs).   Outbreak of hives has continued since then, sometimes painful with bruising.   Had one course of steroids and taking daily antihistamine.
pt recv vax & a titer drawn during college (nursing school) was negative;pt recv an additional dose;a titer was drawn prior to employment in a hosp & titer was again negative;
Patient said she had blurry vision, hand tremors and chills lasting approximately 3 hours. No treatment was necessary but the patient stated had they been much worse or lasted much longer she would have seeked treatment.
Cough, sore throat, arm pain at injection site, heat coming from injection site, low grade fever (99,6), congestion, headache
Headache, Myalgia, Palpitations, States palpitations were self-limited Narrative:
Almost immediate change in  menstrual cycle within 2 days of receiving the 2nd dose of Moderna. Cycle went from being completely regular and consistent for 30 years to  sporadic, change in intensity and duration, with no predictable pattern.
Patient received 1st dose of HPV. That night developed hives all over body - itchy & uncomfortable. BENADRYL given with some relief. After 2 weeks pt still has off & on splotchy skin - hive like reaction. Seems to flare up with exercise or in eve.
Felt like I was going to pass out. Tingling and numbness around my tongue, and traveling up my neck to me head and sinuses.
We discovered 3 vials of diluent were missing from the Shingrix box of the lot number entered. We are trying to determine if diluent alone was given in 3 instances to the 9 patients that received vaccination from this lot. The patient information entered was for only 1 of  the nine. Please let me know if information is needed on all patients. Investigation ongoing and communication plan to follow.
Red round skin around injection that grew from quarter size to large over several inches long and wide. Seems to be no other adverse reactions.
No adverse effects were reported; patients were administered one dose each of improperly stored Rotateq; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 20-MAR-2019, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ)orally, lot # R016790, expiration date: 20-APR-2020 (also reported as 04-APR-2020, but upon internal validation established as 20-APR-2020). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 9 degrees Celsius (8.5 degrees Celsius) for 7 hours 1 minute. Previous excursion was reported as above 9 degrees Celsius (9.6 degrees Celsius) for 33 minutes. Digital data logger was involved.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA008780:
pt recv vax 9JUL96 & mom called facility 15JUL96 stating pt has been crying & has had a fever ever since vax;mom states that she doesn't have correct thermometer but pt feels warm;recommend mom take pt to MD;mom took pt to MD no tx given;
Woke up with dry cough.  Developed into runny nose, flushed feeling and slight fever.  After 4 days had COVID test done.  Test came back positive.  Lost sense of taste and smell after 5 days.   Same symptoms for about 10 days.  Gradually got better.  Had televisit with doctor.  Mild symptoms so no treatment necessary.   Taste and smell returning though still not completely.
On 04/27-cold symptoms-cogesting, runny nose, fussy, etc. On 04/28 the symptoms got gradually worse. On 04/30, extremely fussy when eating (very little). On 05/01, in the early morning, the pt started high pitched screams and fever. COD as per autopsy report: Global hypoxic-ischemic brain injury, remote; RSV. Per F/U 5/13/02, At 8:00 AM on 2/27/02, she was found unresponsive. EMS arrived and she was asystolic and unresponsive to resuscitation. She was pronounced dead in the ER. Final DX: Global hypoxic-ischemic brain injury, remote; static encephalopathy due to remote meningoencephalitis (clinically); severe bilater cortical laminar necrosis; bilateral atrophy of cerebral hemispheres with subdural membrane formation; neuronal loss and gliosis of thalamus and basal ganglia; centrolobular cerebellar sclerosis; respiratory syncytial virus (RSV) bronchitis/bronchiolitis.
On 1/17/2021 @ approximately 1130, I ran upstairs and began experiencing extreme shortness of breath, dizziness and increased heart rate with what felt like palpitations, as well as a massive headache. The symptoms resolved subsided after 10 minutes, but returned again shortly afterwards. After taking some Advil 200mg x 1, my symptoms improved but I still remained fatigued and had difficulty breathing at 100% the rest of the day. After the 2nd episode 911 was contacted and FD arrived at my home. All vital signs, pulse & O2 were WNL, except BP @ 153/99. I've had one previous experience with this and it was while taking Izoniazid as a TB prophylactic after a 6 month treatment. As of today, my symptoms have resolved and am back to  my usual state.