chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain ant + post ribs T4-T10; Nausea; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Pain ant + post ribs T4-T10), NAUSEA (Nausea) and VOMITING (Vomiting) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Sulpha).    On 26-Sep-2022 at 9:00 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Sep-2022, the patient experienced MUSCULOSKELETAL CHEST PAIN (Pain ant + post ribs T4-T10), NAUSEA (Nausea) and VOMITING (Vomiting). On 01-Oct-2022, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, MUSCULOSKELETAL CHEST PAIN (Pain ant + post ribs T4-T10) had not resolved.            No concomitant medication was provided by the reporter. Patient did not had any reaction with other 4 Moderna vaccinations. Patient had symptoms within 15 minutes of injection and still having pain ant + post ribs T4-T10.  Patient not had any rash.  No treatment medication was provided by the reporter.
Red and significantly swollen arm from shoulder to elbow with symptoms lasting 3-4 days.  Patient did not notify provider.  Symptoms resolved without treatment.
Baby had local reaction-site of injection, was red, puffy and hard to the touch. Site was left leg.
first dose on May 11th 2022 planning to receive second on Jun 29th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The pharmacist asked how to proceed if the patient was late for Engerix-B second dose. The first dose was on 11th May 2022 but due internal issues, they were planning to received Engerix-B second dose on 29th June 2022. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. This is one of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR093987:Same reporter US-GLAXOSMITHKLINE-US2022093620:Same reporter US-GLAXOSMITHKLINE-US2022AMR093989:Same reporter US-GLAXOSMITHKLINE-US2022AMR093990:Same reporter
pt to ED with c/o difficulty breathing and hypoxia; tested positive for COVID at an urgent care approximately 1 wk prior; O2 saturation 88% on 6L O2 via NC; diagnosed with COVID pneumonia; treated with Remdesivir, dexamethasone, Baricitinib, antibiotics, and bronchodilators; pt's condition deteriorated requiring intubation (FiO2 100%); ICU; DNR: family decided to take pt off of the ventilator and died in the hospital
patient rec'd vaccination and then c/o feeling hot, H2O provided. Pt then leaned forward and slumped in chair momentarily, eyes rolled back. Incident lasted just a few seconds.  Pt placed on floor and after a few minutes stated she was feeling better. Nurse support given,  water, juice crackers given, sitting in chair.  Vitals 5:45 BP 60/30, 5:58 BP 90/60, 6:03 88/60, 6:10 92/72.  Pt discharged home with mom feeling better.  Followed up with mom 10/21/20 and no further reactions occurred and no medical treatment needed.
I was at a public event three days later I woke with a scratchy throat and post nasal congestion and it became more noticeable throughout the day, a home COVID-19 test came up very mildly positive. A telehealth visit resulted in me taking PAXLOVID for a five day course. The outcome was by day five I was feeling better until on day seven had a negative COVID-19 test.
Localized rxn at site of injection no itching or soreness.  Size of Silver dollar approx.
7 days after shot - headache and arm became very sore with red rash and swelling and hardness.
I received and the next morning weak with no energy and very nauseous it lasted around three I rested and after the three days I was better.
achy, chills, fatigue, headache starting a few hours after vaccine.  Resolved with sleep, tea and over the counter Sudafed 4 hour night time with ibuprofen.
5/23 76y.o. female PMHx significant for CAD (s/p coronary stent, not currently on anticoagulation), HTN, multiple sclerosis, no prior abdominal surgery who presents with chief complaint of abdominal pain.
Nurse with Dr. office called the pharmacy on Thursday 3-14-2019 and asked what IMZ was the patient given. We faxed the Vaccine Administration Record and Informed Consent to them. Per Nurse, the patient was having a reaction and upon talking with the husband his wife's skin was red from the neck down and red all over. She was not in pain but knew she was having a reaction and she went to see the doctor for relief from the reaction.
This was the very first 2 year child this season I was going to vaccinate for Flu shot. The whole family of 4 came in for the vaccines. I knew the other 3 would have the same vaccine and were given the FLUARIX. The father got the shot first, then the little girl but she was very scared, screaming in the room. While approaching her with the shot, she waved her hand in front of the needle and got a scratch kind of injury. This distracted me. I meant to check the dose of the shot before I gave the younger child but by this time he was confused and getting scared. So the parents and I decided we would give the shot to him quickly and then proceed with the documentation to prevent further agitation. I reached for FLUVIRIN, checked the expiry date, but forgot to check the age range, and gave the child the vaccine. I did not realize my mistake until the next day when I usually go over my day and think of how I could improve myself. I called my manager and let her know and following her advice called the CDC first to know of what to do. I did not have access to the child's information until 3 days and my manager was aware of that. By the next day I received feedback from CDC that no exaggerated adverse events were anticipated and no further vaccination was recommended. The next day I informed the mother who was very upset and angry as to why she wasn't informed as soon as I came to know. I explained to her that it was because my manager told me that the policy was to first check with CDC what their advice was and inform VAERS which was also done by myself. I think this happened partly because the label only had the age information in small letter unlike FLUARIX which had that in big fonts to draw my attention to it. Also last year we did have FLUZONE MDV which looks like FLUVIRIN, so that was in my mind.
Right Arm and Shoulder Stiffened up while lap swimming at 07:00 am. Felt cold and felt pressure in my head. Came home and covered up as chills started. After 12 hours the fever gradually subsided as did the pain in my neck and shoulder. Was left with headache that remained overnight but the pressure was not like the day before. Saturday I was just tired, I think from the fever, but by the evening I was back to normal.
Noticed that my arm continued to hurt after initial pain had cleared. It is now Nov 18 and I still have pain in my arm which is more muscular, and occurs more if I use the arm which was not present prior to the flu injection.
One week to the day of receiving vaccine(1/13/21) I woke up with a large red hive-type spot near injection site.  The spot was hot to the touch and slightly swollen.  My arm ached and felt heavy.   The next day (1/14/21) the red hive-type spot had doubled in size.  The spot is still hot to the touch and my arm is still achy.  I spoke with a nurse at the health department and she recommended I report the symptoms here and follow up with my doctor.  I left a message for my doctor but have not heard back.  The day of my injection (1/6/21) the only side effect I had was a sore arm.  No other symptoms until 1/13/21.
Approx. 10-20 minutes after receiving MMR & varicella  vaccines pt started coughing. He was auscultated & found to be wheezing. Pulse ox 97% on room air. Cheeks were flushed, but no urticaria. Pt given albuterol neb x1 & oral diphenhydramine & had full resolution of wheezing & diminished facial flushing. Pulse ox after treatment 97% (about 30-40 mins. after vaccine).
A 52 yr old female experienced fever 3 hours and delirium 5 hours later after receiving a flu shot. The delirium episode lasted for 8 hours. Patient was incoherent and confused. She was rushed to the hospital where she was admitted for 3 days and stabilized. Battery of tests were ordered but patient is not sure of lab work ordered. Patient is currently doing fine.
This case was reported by a physician via a sales representative and described the occurrence of limb swelling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date in May 2006, the subject received a dose of Infanrix (dose and lot number not specified). On an unspecified date in May 2006 before 30 May 2006, at an unspecified time after vaccination with Infanrix, the subject experienced swelling of limb. At the time of reporting, on the event was unresolved. Causality was unknown
PFIZER COVID VACCINE #3 GIVEN 12/22/2021, LOT #FL3198; family found pt unresponsive; EMS contacted; pt intubated and CPR started and continued en route; ROSC shortly before arrival; pt in shock with multiorgan failure; vasopressor support and mechanical ventilation; history of positive COVID test on 5/30/22 and was in quarantine in family member's home; positive COVID test 6/4/22 in hospital; pt status changed to DNR/active management; pt passed away in the hospital
Moderna Covid-19 Vaccine as dose1, dose2 and dose 3 of BNT16B2 vaccine; covid; high level of fatigue; Moderna Covid-19 Vaccine as dose1, dose2 and dose 3 of BNT16B2 vaccine; covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4256621-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jan2022 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Route of Administration: Intra Muscular, MANUFACTURER: MODERNA), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, Route of Administration: Intra Muscular, MANUFACTURER: MODERNA), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset Jan2022, outcome "unknown", INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Moderna Covid-19 Vaccine as dose1, dose2 and dose 3 of BNT16B2 vaccine"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "unknown" and all described as "covid"; FATIGUE (non-serious), outcome "unknown", described as "high level of fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, lack of efficacy, Fatigue , Off label use and interchange of vaccine products of the suspected vaccine BNT162B2 cannot be completely excluded.The case will be reevaluated should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
full blown generalized target; iris & deep-red multi-shaped lesions-trunk, face, neck & over large joints & feet; erythema multiforme;
Numbness and tingling in lips and tongue, no visible swelling, lasting for about two hours. After numbness and tingling had nearly subsided, I took two Benadryl tablets just in case and went to sleep.  Upon waking there was no more numbness or tingling.    9. Continued: multivitamin, vitamin D3, melatonin when needed for sleep, Tylenol, probiotics
This patient's arm became red, swollen, and itchy from the deltoid to the elbow.
Child's leg developed a walnut-sized hard lump around vaccine site. Over the following four days a red, slightly raised, itchy rash spread over the child's entire thigh, and began wrapping around the back. Nurse advice was contacted and Tylenol was prescribed. Rash continued to spread and the child was taken back into the pediatrician who prescribed antibiotics. Oral antibiotics, Sulfamethoxazole, were prescribed and may or may not have helped with the rash, which slowly began to recede. The lump remains and the pediatrician said that this is "normal" and can take months to resolve.
burning sensation all over inside the body; diaphoretic; This spontaneous case was reported by a nurse and describes the occurrence of BURNING SENSATION (burning sensation all over inside the body) and HYPERHIDROSIS (diaphoretic) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (Febreze.). No concomitant medication was reported  On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced BURNING SENSATION (burning sensation all over inside the body) and HYPERHIDROSIS (diaphoretic). At the time of the report, BURNING SENSATION (burning sensation all over inside the body) and HYPERHIDROSIS (diaphoretic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Feeling well when she got her flu shot. 24 hours later, had fever to 102, profound fatigue, non-productive cough. No myalgias, rhinorrhea, headache. ESR done 10/17/03 (18); repeat one week later (87). Considered to be reactivation of polymyalgia.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011867 with expiry date: 08-NOV-2018 (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 9C to 25C (9.9C) for a duration of 13 hours and 15 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 9C to 25C (11.5C) for 7 hours and 45 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009615:
Outbreak of the hives; Itchy; Rash lasted for over 3 months and started on the day of her first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Outbreak of the hives), PRURITUS (Itchy) and RASH (Rash lasted for over 3 months and started on the day of her first vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced URTICARIA (Outbreak of the hives), PRURITUS (Itchy) and RASH (Rash lasted for over 3 months and started on the day of her first vaccine). The patient was treated with PREDNISONE ongoing since an unknown date for Hives, at a dose of UNK dosage form and CORTISONE for Rash, at a dose of UNK dosage form. On 15-May-2021, PRURITUS (Itchy) and RASH (Rash lasted for over 3 months and started on the day of her first vaccine) had resolved. At the time of the report, URTICARIA (Outbreak of the hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-069975 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Added rash as an event, treatment drug and narrative were updated. Event outcome updated.; Sender's Comments:  MOD-2021-069975:Second dose
Information has been received from a physician concerning a 17 year old female who was vaccinated with the second dose of GARDASIL (Lot # not provided). After getting the second dose of GARDASIL the patient experienced fainting. Subsequently, the patient recovered from fainting on unspecified date. The reporter stated that the patient had no AE after first dose. It was reported that the patient sought unspecified medial attention. Additional information has been requested.
fluttering of under heart on left side, extreme confusion, tiredness, aches and pains. freezing but heavy sweating. started the night <Monday night/Tuesday morning, of the dose given. feeling of tiredness and confusion still happening on 2/22/2022 but to a lesser degree. On Feb 17, 2022 went to emergency room where diagnosed with allergic reaction to vaccine.
pt recv vax 1030AM & pt woke up @ 2PM crying w/gen urticarial rash;brought to clinic 3PM evaluated & treated w/DPH;
vomitted several times during noc 24SEP; febrile w/in 1st 24 hrs of vax only; 0930 26SEP93 screamed, fell down w/grand mal sz 1 1/2 min; taken to ER:
Fever, then 1/19/21 at 10:00am metallic taste in mouth followed by severe fatigue and body aches and back spasms
After receiving his vaccine client complained of dizziness.  Vital signs obtained by EMS.  BP 207/99, HR 88, O2sat 98%.  Client advised to go to ER.  Client declined.  Client states he feels better.  Discharged home by EMS.
Headache and radiating neck pain for 1 day; Headache and radiating neck pain for 1 day; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced headache and radiating neck pain for 1 day. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to his/her 78 years old mother. The patient was vaccinated with 0.5 ml PNEUMOVAX 23 (lot number was not reported) by subcutaneous or intramuscular injection in her left arm on an unknown date in 2011. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in 2011 the patient experienced an injection site reaction. Her left arm swelled up with a huge red "knot." The patient was hospitalized, and had recovered on an unknown date. The patient had sought unspecified medical attention. Additional information is not expected.
No further information was provided.; temperature excursion that occurred on 10/11/2021 with PNEUMOVAX 23; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-OCT-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T039322, expiration date 09-SEP-2022 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered vaccine experienced temperature excursion of 23.9 degrees Celsius for 31 minutes on 11-OCT-2021. There were no previous excursions reported. No additional adverse event was reported.
Patient fainted (loss of consciousness) after the shot. Regained consciousness after administering  ammonia inhalant and complained of dizziness thereafter.
Severe vomiting- began 24 hours after receiving vaccine. Was unable to keep fluids down. Sought medical assistance to stop the vomiting.
Information has been received from a registered nurse concerning a 5 year old white male with reactive airways disease who on 05AUG1998 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine. There was no illness at the time of vaccination. It was reported that on 09JUN2003 the patient was exposed to shingles "2 weeks ago", broke out in a rash, came into the physician's office and was diagnosed with chickenpox. No diagnostics were performed. On 16JUN2003 the patient recovered. No further information is expected.
could not breath well in her cloth mask; throat hurt; fatigue for a few days; vaccination clinic accidentally gave her the Moderna vaccine and her daughter is 17 years old; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccination clinic accidentally gave her the Moderna vaccine and her daughter is 17 years old), PAIN IN EXTREMITY (arm hurt), DYSPNOEA (could not breath well in her cloth mask), OROPHARYNGEAL PAIN (throat hurt) and FATIGUE (fatigue for a few days) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013LVOA) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccination clinic accidentally gave her the Moderna vaccine and her daughter is 17 years old), PAIN IN EXTREMITY (arm hurt) and FATIGUE (fatigue for a few days). On 03-May-2021, the patient experienced DYSPNOEA (could not breath well in her cloth mask) and OROPHARYNGEAL PAIN (throat hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. In May 2021, FATIGUE (fatigue for a few days) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccination clinic accidentally gave her the Moderna vaccine and her daughter is 17 years old), PAIN IN EXTREMITY (arm hurt), DYSPNOEA (could not breath well in her cloth mask) and OROPHARYNGEAL PAIN (throat hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include chewable biotin vitamin.