chrisvoncsefalvay/vaers-outcomes huggingface dataset:
29th Friday January 2021-Body aches, HA, aches-real bad in his bones, runny nose, muscle aches, congestion-no sleep Saturday 310th January-Lymph Noes-rt armpit-enlarged-rt neck nodes swollen also, he felt warm all over Sunday 31st January 2021-Very fatigued, BA, muscle cramps, a little congestion Today 1 February 2021-Body aches, taking motrin for his discomforts Reminded if his symptoms get worst-go to the ER, Go to his PCM also if he gets worse-talk to his supervisor if he needs to take off from work
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant drugs were not reported.  It was reported that there was a dark blue cap vial with a dose of 25 mcg for age group 6 months to 5 years instead patient was administered with 10 mcg dosage from the dark pink cap and a label with a yellow box.  Treatment medications were not provided.  This case was reported for patient 16 Out of 18(6 Patients-2nd dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Patient is 91y.o. male who presented to the hospital with chest and abdominal pain. Please note that patient was seen ibn ER the day before for a fall. Patient was diagnosed with COVID, was seen by ID and completed 3 days of Remdesivir. His breathing remained stable, did not require any O2. .  His troponin was elevated, peaked at 1.09, he was seen by Cardio and Eliquis was changed to IV heparin x 48 hrs. Echo did not show any WMA, EF 55%. He will continue with statin and Imdur. His chest pain resolved.His abdominal pain resolved while in the hospital, a CT a/p was done and was unremarkable.  Patient had a couple of BM that were reported as black by our staff, his Hg remained stable, FOB ordered but not done as did not have any other BMs. He was seen by Gi and recommended to continue Eliquis and PPI.  Patient is stable for DC with HC and 24/7 assistance.
COVID pneumonia; Will receive the second dose of the vaccine more than 36 days after the first one; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 PNEUMONIA (COVID pneumonia) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included ALBUTEROL [SALBUTAMOL], CITALOPRAM, DESVENLAFAXINE, FLUTICASONE, LORAZEPAM and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 PNEUMONIA (COVID pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will receive the second dose of the vaccine more than 36 days after the first one). The patient was hospitalized on 01-Apr-2021 due to COVID-19 PNEUMONIA. At the time of the report, COVID-19 PNEUMONIA (COVID pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will receive the second dose of the vaccine more than 36 days after the first one) outcome was unknown.        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.   Patient was not able to received the second dose due to hospitalization. No treatment information was provided.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up information will be processed at the same time as the initial report. Patient demographics were updated.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Pt recv vax on 9/2/98; on 9/5/98 pt exp huge red bump on arm, itching, w/ pain up and down arm for 3 dys.
temperature excursion; neck aches; Felt very very cold/ could not get warm for a couple hours; It was just a discomfort; shoulder aches; felt very chilled; body aches, had neck and should aches; This spontaneous case was reported by a consumer and describes the occurrence of MEDICATION ERROR (temperature excursion), NECK PAIN (neck aches), FEELING COLD (Felt very very cold/ could not get warm for a couple hours), DISCOMFORT (It was just a discomfort) and ARTHRALGIA (shoulder aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M2OA and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced NECK PAIN (neck aches), FEELING COLD (Felt very very cold/ could not get warm for a couple hours), DISCOMFORT (It was just a discomfort), ARTHRALGIA (shoulder aches), CHILLS (felt very chilled) and MYALGIA (body aches, had neck and should aches). On an unknown date, the patient experienced MEDICATION ERROR (temperature excursion). On 27-Feb-2021, NECK PAIN (neck aches), FEELING COLD (Felt very very cold/ could not get warm for a couple hours), DISCOMFORT (It was just a discomfort), ARTHRALGIA (shoulder aches), CHILLS (felt very chilled) and MYALGIA (body aches, had neck and should aches) had resolved. At the time of the report, MEDICATION ERROR (temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient drank fluids, juice and water to help with his symptoms. No further treatment was provided for the events.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: TCR form added.No new information
Client received Td injection at the ER for an injury at approx 1:00 p.m.  He left the ER and was admitted to Medical Center at approx 1:55 having difficulty in breathing and hoarseness.  3cc epi, 50 of Benadryl and 125 mg of Solumedrol administered and client recovered and was dismiss at approx 3:30 p.m.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Medium, Systemic: Unable to Sleep-Medium, Additional Details: pain in left arm, pt can not raise arm over head with out pain.
This case was reported by a physician and described the occurrence of an injection site reaction in a pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  On an unspecified date, the pt received the 5th dose of Infanrix. At an unknown time post immunization, the pt experienced an injection site reaction characterized by swelling, redness, and itching. A healthcare professional was consulted regarding the events. The events resolved after an unspecified period of time. Comment: The reporter indicated that three subjects experienced these events following receipt of Infanrix lot 594A2 for the fifth dose in the immunization series. However, the subjects are not presently identifiable.
Patient complain of redness and itching left upper arm, measuring 5-6 inches in length. No swelling, no deep pain as reported by patient 07/12/2006.
Excessive bleeding, tingling and soreness in arm, bruising still present after 9 days
Pt states he experienced major shaking/shivering or even trembling day after vaccine - he woke up from it, his wife had to sit on him to minimize shaking, lasted for about 30 minutes and was about to call 911 when it stopped. They thought he was having a seizure, but not sure and also reported this effect to his MD. The next day after church pt says he experience a lesser degree of shaking and maybe due to cold air outside, because when he reached hot car the shaking stopped. No injection site reaction reported. Patient is doing fine today 11/12/18.
cancer patient; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included neoplasm malignant from an unknown date. The Concomitant medication included osimertinib mesilate (TAGRISSO) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient had the vaccine with the cancer which was medically significant. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
1510 ? Received COVID vaccine. Asked to stay for 15 minutes of observation to end at 1535.  1520 ? Patient had a presumed vasovagal reaction with syncope and an unassisted fall to the floor with impact to back of head per the mother and sibling, who were the primary witnesses. Staff immediately responded for triage. Patient was already AOx4, but dazed. Placed on back, legs elevated onto chair. BP 117/65. HR 60s-90s. Patient reports being well hydrated and did eat lunch. No hx of vagovagal. Focused neurological assessment performed by on-site provider (PA) due to head injury, but stable with no overtly concerns for concussion. Recovering from vagovagal.  1525 ? Placed in reclining chair with ongoing monitoring and recovery time. Patient, mother, and sibling advised as to s/s of concussion for monitoring at home and when emergency medical assistance required by on-site provider. While gathering patient information for event reporting, also discovered that patient was given Moderna COVID vaccine, which he is not eligible for as a 15 yo. Patient and family notified of this error. Patient consented for his sister to be called at a future date to advise them of current guidelines on what to do for 2nd dose.   1540 ? Patient sat up in recliner for 3-5  minutes and provided orange juice. Stable. Asked to stand for 1 minute. Stable. Asked to step in place 10x. Stable. Ambulated around room with staff supervision. Stable. Neuro status also stable. Patient and family advised that he may leave and reminded of s/s to monitor for.
Hands swelling within 10 min. Elevated BP over 200. Hands flair up and go back down
blood sugars elevated; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH Covid 19 mRNA Vaccine, lot number: ER8732) via an unspecified route of administration in the right arm on 26Mar2021 at 0900 (at the age of 38-years-old) for COVID-19 immunisation. Medical history includes Type 1 diabetes. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 10:00 after getting the vaccine, the patient experienced blood sugars elevated for 2 days. The patient reported that he had noticed it at night when typically they are very stable. Further it was reported that they have since come down and are manageable again. The adverse event did not result in a visit to the doctors or other healthcare professional office/ clinic visit and emergency room/ department or urgent care. The patient did not receive any treatment for the event blood sugars elevated. The clinical outcome of the event blood sugars elevated was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a health professional concerning a 10 month old male who on 02May96 was vaccinated with a SC dose of varicella virus vaccine (lot616995/1499B). On 10Dec05 the pt developed less than 50 lesions and he had a fever. There was no other treatment other than diphenhydramine hydrochloride (Benadryl). It was reported that the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
freaking out/panicking; short of breath/can't get a full breath in; chest was hurting; Sore arm; stressed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 (Lot number: FC3181) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypotension/Low blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PANIC REACTION (non-serious) with onset 09Dec2021, outcome "unknown", described as "freaking out/panicking"; DYSPNOEA (non-serious) with onset 09Dec2021, outcome "unknown", described as "short of breath/can't get a full breath in"; CHEST PAIN (non-serious) with onset 09Dec2021, outcome "unknown", described as "chest was hurting "; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021, outcome "unknown", described as "Sore arm"; STRESS (non-serious) with onset 09Dec2021, outcome "unknown", described as "stressed ". Therapeutic measures were taken as a result of panic reaction, stress.  Additional information: Patient stated that she was okay and was probably just freaking out for nothing. She didn't know. Patient stated, "So, I am not sitting here freaking out every 5 seconds when I noticed something. I am just like short of breath, holding out there and it just kind feels like, I can't get a full breath in. I don't know, how to explain and my chest was hurting earlier. I am fine. " Stated, "I am one of those people that panic and I like, when I can't breath, I think I am going to die and like, I didn't want to get vaccinated." Treatment: patient stated she took a 0.25 Alprazolam pill to treat the panic that she was experiencing from it because panicking can make your breathing worse. So, she took one of those and she took an  gummy it's like some sort of natural herbs, that's good for stress relief. She took those today to try to keep her from panicking or freaking out of the anything and making her breathing any worse.  No follow-up attempts are possible. No further information is expected.
8 days after injection my arm at injection site turned red and swollen.  The affected area is about 5 inches wide and 4 inches long and quite sore.  I had only mild discomfort in arm the day after the vaccine and no swelling.  On the day of vaccination my face became very flushed but gradually receded and was normal by that afternoon,
Began with very tight sensation in jaw. Swelling of tongue and neck and decreased sensation in face followed, then soreness in lower back and kidneys. Breathing and swallowing became more difficult approximately one to one and 1/2 hours post injection. Lasted two days with antihistamines.
Information has been received from a registered nurse concerning a 6 year old male child with no known allergies or past medical history who on 29-JUN-2001 was vaccinated SC with a first dose of Varivax (lot# 638652/0233L). Concomitant vaccination included a first dose of MMR (lot # 638702/0253L) given SC. On 08-AUG-2006 (also reported as 07-AUG-2006), the patient presented with 35-40 itchy, "insect bite like lesions" on his chest, back and legs. No other symptoms were noted. The patient was treated with BENADRYL. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
AFTER THE VACCINATION I HAD SORE ARM AND IT WAS SAME FOR ALL OF THEM. A MONTH LATER I GOT COVID.
Information has been received from a 57 year old female with a history of shingles and drug allergies to penicillin, erythromycin and "vycodine" who on 16-MAR-2009 (at around 3:30 pm) was vaccinated with a dose of ZOSTAVAX (Merck). There was no concomitant medication. After a few hours, she started experiencing headache and her heart started racing. Patient added that the next day, Tuesday, she developed an inflammation on the injection site that progressed to about 5 inches in circumference. Lot# was not available. The patient noted that she received ZOSTAVAX (Merck) because she previously had shingles and she got the vaccine because she didn't want to get shingles again. At the time of reporting (19-MAR-2009) the patient was not recovered. The patient sought medical attention by visiting the physician's office. No further information is available. Correspondence attempts were unsuccessful.
(Day 1 was day of vaccination). Sore arm started around the end of the day that was vaccinated. Sore arm got worse on day 2 and became extremely painful, especially if bumped. At 6pm on day 2 I started to feel ill and had aches and chills. I felt better the morning of day 3. Sore arm took a few days to get better.
Had trouble walking - seemed discoordinated would pull up and try to walk but would fall.  No fever, no irritability and shots were given in arm not leg.  Returned to normal next day.
Immediately after receiving vaccine, patient became flush, experienced throat tightness, SOB,  Epi 0.3 mg IM given. Patient transferred to ER.
severe pain at injection site as well as swelling  and severe pain in axillary lymph nodes of the left arm where the injection was received.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Patient did not report any medical history or condition.     On 30-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact
No additional AE; improperly stored vaccines administered; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.    Since 10-JAN-2022, the vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number u015476, expiration date 13-NOV-2022, had a temperature excursion and was administered on 22-MAR-2022 (dose and route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  No previous temperature excursions were detected.; Sender's Comments:  US-009507513-2205USA000524: US-009507513-2205USA000533: US-009507513-2205USA000544:
Rt thigh-> erythema( 6x3.5 cm, warmth, ttp at injection site->pt amble to ambulate and move limbs Lt thigh-> 2 small area about 5 cm of erythema at sites of injection This was noticed by parents on 4.25 but they did note after vaccination, pt was fussy and di not want her legs touch
Patient seen for concerns about redness and swelling of left leg, starting approximately 24 hours after administration of 18month vaccines.  Immunizations received 5 June and 24 hours after administration of vaccine, Patient developed swelling and redness around injection site that spread over entire leg on 6 June. 6/7, seems to be somewhat improved. Redness remains, but swelling mostly resolved. No fever, limping, increased irritability. No drainage from injection sites. No respiratory symptoms or change in mental status.
pt got vaccination approximately and 1:00 pm.  Pt. returned at 7:45 pm.  Pt is panicking, states that he feels his  hands are tingling and that he never felt this way before.  I asked if he ever had that tingling before and he said yes.   Pt. states that he has anxiety disorder.  pt does not have hives, sob, but does appear nervous.  Offered to call EMS in he felt that it was necessary, he stated "no," I'll just wait in my car.  I told pt he was welcomed to stay and sit in the building and we would call EMS if necessary but he repeated he would wait in his car.
Initial report received from a health care professional on 15 February 2011. A 43-year-old female patient received on 07 June 2010 a right deltoid injection (route unknown) of ADACEL, sanofi pasteur lot number unknown. The patient's medical history and concomitant medications were unknown. On 10 June 2010, three days after the vaccine, the patient had developed muscle aching in the right arm and soreness in the arms and legs. On 19 November 2010, the patient still had right upper arm soreness and was seen by an orthopedic surgeon who diagnosed her with adhesive capsulitis with acromid clavicular arthritis resulting from injection in the right deltoid. The outcome was reported as not recovered. Documents held by sender: None.
States "Received FLUVIRIN injection at 10:00 AM. At 1900 had itchy palms, tingling lips. Had swollen, red mouth, nose, lips, eyes, face. Developed rash on torso that became raised hives. Also had rash on side of legs. Had itchy head". States "airway felt like I swallowed a pill that got stuck in my throat. Took ALLEGRA D and started on MEDROL Pack at 1945 which she had gotten from her husband who was a Dr. Applied ice to rash. 2045 Itching stopped. In the am all symptoms were resolved.
No adverse event.  Pt received Afluria -Influenza vaccine- vaccine to be given to age 18 and above.  this individual is 15 yrs old