chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lymph node swollen; somewhat having trouble breathing; This is a spontaneous report from a contactable consumer (patient, self-reported). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3180 and expiry date was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date the patient's lymph node swollen and the patient somewhat having trouble breathing. The patient wanted to know what the patient was supposed to do. The patient did not receive any treatment for the event. Outcome of the events was unknown.  Consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call.
Patient experiencing throbbing shoulder arm pain.  Has little improvement with over the counter ibuprofen and ice.
Patient  under vaccinated with less than half Moderna Bivalent Booster; given 0.05ml. No adverse symptoms. CDC advised patient be revaccinated with full dose of vaccine.
I tested about 9:15 in the morning COVID-19 home test for work and I immediately left work, all I had was a sniffle and called the nurse at my university around 9:30 in the morning and we went over the COVID-19 recommendations and they advised me to go home and isolate which I did and on the 17th I saw a telehealth physician to go over symptoms and they prescribed me Paxlovid and a inhaler as needed and I am at home.
expired Pentacel by mistake; Initial information was received on 03-Feb-2021 regarding an unsolicited valid non-serious case from an other health professional (Agency Inquiry Number: 00459652).  It was reported that DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was expired and administered to a patient by mistake on an unknown date for prophylactic vaccination (Expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event 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 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.  There will be no information available on batch number for this case.
Started with itching eyes and then itching on the roof of the mouth followed by hives later in the day.  Took Benadryl 50 mg and symptoms did not worsen but did not totally go away.
08/12/2004 Began with swollen right cheek. 8/14/04 swelling larger and had pain down to chin-seen in office-treated with Augmentin.
sore arm for 1 day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm for 1 day) in a 49-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU Shot . Past adverse reactions to the above products included No adverse event with FLU Shot .    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for 1 day). At the time of the report, PAIN IN EXTREMITY (sore arm for 1 day) had resolved.            No concomitant medication was reported.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745549 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745549:
13AUG92 pt recvd 1st dose of vax & devel itching; 14AUG92 devel agitation, mood change, nervousness, could not work & irritability;
(*) Patient arm Red & Swollen and Fluid drainage. Went to Doctor and diagnosed as cellulitis at injection sit
no adverse event; improperly stored dose administered; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.  On 22-FEB-2021, the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, lot # T025367 with expiration date 18-NOV-2022, (route of administration and frequency were unknown) was administered to the patient (product storage error). The vaccine was stored at 47.6 degrees Fahrenheit for 24 hours. Digital data logger was not involved. It was unknown if there was a previous temperature excursion. No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T025367; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Acholic stool x 5 days starting 24hrs after vaccine. Dark urine, diarrhea with mucus. Temp to 103 x 1 day. Vomiting x 24hrs immediately within 24hrs of vaccine.
Progress Notes (Physician Assistant) ? ? Family Medicine Cosigned by: MD at 3/8/2021 10:37 AM Expand AllCollapse All     3/5/2021    Subjective Patient is a 36 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience chills and a "nasty taste" in her mouth. She described this to be a metallic taste later on and stated she could smell it as well which was making her nauseous. She also mentioned belching started after her vaccine. She denied difficulty breathing, difficulty swallowing, throat tightness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, skin changes, tongue swelling and vomiting.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of chills   Patient denies fever, facial swelling, chest tightness, shortness of breath, wheezing, dizziness and headaches    "Nasty" taste and smell. :     Previous Reactions: Denies    Objective    Vitals Vitals:   03/05/21 1124 03/05/21 1144 BP: (!) 145/61 126/55 Pulse: 93   SpO2: 100%          Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: water and Pepcid. Gave two lozenges to help with bad taste.  Follow up response to treatment: good. She had complete resolution of symptoms within a few minutes of taking the Pepcid 20mg solution. I continued to observe her for another 10 minutes and the taste did not return. Patient discharge: Stable to go home and follow up with PCP.
Pt. given IM injection in proper site. Site has become red, raised and puffy. Pt given diphenhydramine HS.
Vertigo, nauseous, sweaty Symptoms lasted 3 to 4 hours. Not like orthostatic hypotension when bp is low. Did not stop when sitting.   Did not vomit but felt very sick.   Hope it doesn't happen again.
This spontaneous report as received from a Licensed Practical Nurse refers to 4 year old female patient. There was no information about concurrent condition, concomitant medication and historical medication. On 01-AUG-2018, the patient was vaccinated with Oka-Merck PROQUAD lot # R002935 dose 1, subcutaneous in the left arm for prophylaxis. Other suspect therapies included KINRIX. Medication error occurred at the time of storage in clinical practice (Product storage error). Digital data logger was involved. This is one of several reports received from the same reporter.
Low grade temp, elevated heart rate 120-130, fatigue, heart rate 268 beats per min.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 23-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.
Onset of 102F fever the night of the injection with body aches and chills. for 36 hours. Also large rash/hives on stomach and left flank 48 hours after receiving the vaccination. Rash lasted 2 days.
Patient presented from home, she is mentally retarded.  She could not provide any history.  She is sitting in a motorized wheelchair.  She was seen here yesterday for respiratory distress, she was COVID-positive.  She was discharged with instructions to provide trach suctioning, oxygen and breathing treatment.  She returned this morning with respiratory distress, she was not given oxygen at the home.  The accompanying staff could not provide any meaningful history.  Patient O2 sat was about 76% on room air.  She was suctioned and supported.  As mentioned above patient cannot provide any history, she is nonverbal.  I reviewed her medical records.
This spontaneous report as received from a licensed practice nurse refers to a multiple unspecified patients of unknown age and gender. No information regarding concurrent condition and medical history was reported. On an unknown date, the multiple unspecified patients were vaccinated with GARDASIL injection (strength, dose, unit, lot number, expiry date and route were unknown) which was stored improperly. No concomitant therapy was reported. No adverse event was reported. The outcome of event was unknown. No further information was provided. This is one of several reports received from the same source. Additional information is not expected.
it almost feels like it restarted like a new cycle; Major cramping; painful cramping; Joint pain; last day every time but then it wouldnt stop and then once it is over 3rd night; This is a spontaneous report from a contactable consumer or other non hcp. A 46-year-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0183), via an unspecified route of administration, administered in Arm Right on 25May2021 as 2nd dose, single for covid-19 immunization Patient has already administered first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0171) via an unspecified route of administration, administered in Right arm as Ist dose, single for covid-19 Immunization. Patient's medical history included seasonal allergy, from an unknown date and unknown if ongoing. didn't have any other side effects for the second vaccine other than the place where she got her shot hurt a little bit for the first day and maybe like second day but the first shot, I did have like, I had my arm really hurt, like for like 4 days Id say and then I had like Joint Pain but I didn't get any kind of fluish symptoms or anything like that. But I did have like my hip and my knee hurt like I was like Oh my God am I getting old. So I guess that all that was. But I didn't get touchwood anything from the second vaccine other than what I am telling you. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for seasonal allergy, vitamins nos (MULTIVITAMINUM) taken for an unspecified indication, start and stop date were not reported. The patient experienced last day every time but then it wouldn't stop and then once it is over 3rd night on May2021, it almost feels like it restarted like a new cycle, major cramping, painful cramping, Dates for I feel like how much blood loss it is , Dates for My shot hurt a little bit for the first day and maybe like second day I had my arm really hurt on an unspecified date. Therapeutic measures were taken as a result of last day every time but then it wouldn't stop and then once it is over 3rd night, it almost feels like it restarted like a new cycle. Outcomes of the events were unknown.  Follow-up attempts are possible. further information is expected
Blurry Vision- warned of possible symptoms to seek emergency care (such as stroke symptoms) and if it does not improve by morning contact md.  Tiredness/Dizziness- informed this was a possible side effect to get rest and get up/move slowly, stay hydrated and symptoms should subside.
We offered employees free flu vaccine.  Patient recd the flu vaccine 12/12/03. Rt arm, IM. She had received HBV left arm 12/11/03 by another employer. (Do not know HBV manufacturer name.) Patient advised me today (12/15/03) that Friday evening and Saturday her arm became swollen and sore.  By Sat. the left side of her right breast also became very tender and swollen. Very tender this a.m. when I checked her. I sent her to a clinic this a.m. 12/15/03 where she was seen by a CRNP who referred her to ER for IV therapy.  Patient has no primary care provider. Dx: Rt arm cellulitis; severe breast &arm/shoulder involvement & pain; axillary lymph node enlarged. She recd a HBV injection 12/11/03 in left arm as documented below. Done by another employer so I don't have knowledge of manufacturer etc. Signed consent form w/no contraindications.  Was 1st time she ever recd vaccine.
Bulls eye size rash extended down near elbow; Bullseyes size rash extended down near elbow; Swelling; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (Bulls eye size rash extended down near elbow), ERYTHEMA MIGRANS (Bullseyes size rash extended down near elbow), SWELLING (Swelling) and DISCOMFORT (Discomfort) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028120A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced SWELLING (Swelling) and DISCOMFORT (Discomfort). On 30-Jan-2021, the patient experienced ERYTHEMA MIGRANS (Bullseyes size rash extended down near elbow). On 31-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Bulls eye size rash extended down near elbow). On 20-Jan-2021, SWELLING (Swelling) and DISCOMFORT (Discomfort) had resolved. At the time of the report, VACCINATION SITE CELLULITIS (Bulls eye size rash extended down near elbow) and ERYTHEMA MIGRANS (Bullseyes size rash extended down near elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Minor flu symptoms the day after the second shot.  Chills, aches, low energy.
Gave vaccine to patient with incomplete vaccine consent form--asked the patient questions about allergies and reactions but did not document them on the form before giving the vaccine.
Complaint of itching sensation on either extremity one week after vaccine.  Scratched areas and developed hives.  Saw doctor on 12/06/2005 and 01/17/2005 for persistent pruritus, generalized.  Treated with Hydroxyzine.
felt sick; LEFT KNEE SORENESS; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick) and ARTHRALGIA (LEFT KNEE SORENESS) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   In January 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In February 2021, the patient experienced MALAISE (felt sick). In 2021, the patient experienced ARTHRALGIA (LEFT KNEE SORENESS). At the time of the report, MALAISE (felt sick) outcome was unknown and ARTHRALGIA (LEFT KNEE SORENESS) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: Lost Over 100 pounds.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.   On 01 Feb 2021, the patient received 1st dose covid 19 vaccine manufactured by Moderna and She felt sick after getting first covid vaccine. On 26 Feb 2021, she had a break of 20 days of Humira due to bariatric surgery on 01 Mar 2021 and discharged from hospital on 03 Mar 2021 and she lost over 100 pounds weight. It was unknown if she was enrolled in a covid 19 vaccine trial.   No treatment information was provided.  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.   This case was linked to MOD-2021-621013 (Patient Link).
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. Patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients received doses of improperly stored VAQTA (lot# K012457, expiration date: 04-JUN-2017 or lot# L004742, expiration date: 18-AUG-2016), dose and route were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Fever starting Saturday (10/17/15) to Sunday. Pt had febrile seizure 10/18/15 at 1630pm. Dx: pharyngitis at ED. Tmax 104.0. Given ROCEPHIN, MOTRIN, and ZITHROMAX.
Pt started experiencing pain at the injection site. A consistent light pick rash started developing around her arm following the injection and still has not gone away at day 5 after the dose. She experienced fatigue and not feeling well after the shot too. She said the rash is itchy and there is a hot burning sensation. Pt was advised to get hydrocortisone cream to rub on area and continue taking Benadryl for the itching until she sees the md on 4-19-19.
Left shoulder pain with shooting pain down left arm developed after injection within 24 hrs. No improvement over last 2 months. weakness and hard to lift
Wednesday, September 11, 2013 - I took ibuprofen immediately after injections (Influenza and Pneumococcal Polysaccharide). I received both injections in the upper part of the right arm. Soreness in upper right arm at injection site was present within 1 hour of injection time. During the evening, I developed chills, body aches, extreme tiredness, and a general "bad" feeling. These symptoms grew stronger throughout the night. The pain around the injection site intensified and the area of soreness grew across the outer part of my arm. I took TYLENOL and ibuprofen alternately every 6-8 hours throughout the night. Thursday, September 12, 2013 - I woke at the usual time and was feeling worse (the chills, body aches, extreme tiredness, and a general "bad" feeling, and extreme soreness in my upper right arm continued and I also developed a headache). I went to work hoping that the symptoms would subside. Instead of subsiding I was feeling worse within the first hour of the school day so I requested a substitute and took the remainder of the day off. Back at home I went to sleep immediately. Around midday I became very nauseated but did not vomit. I ran a fever throughout the day that ranged from 99.8 to 101.6. I woke up around 4:00 pm and the nausea had subsided but the other symptoms continued. Near 8:45 pm I noticed a and a red "blotch" approximately 2 inches in diameter was present at the injection sites and a red band had spread across my outer arm toward the front of my body. The red area was hot to touch and swollen. Even though my arm was extremely sore and sensitive to touch and movement I continued to move it to try to "work out" the soreness. I continued to take TYLENOL and ibuprofen alternately every 6-8 hours Thursday day and night. Friday, September 13, 2013 - I woke at the usual time symptoms had lessened except for the arm soreness to I went to work. The 1 inch band grew to approximately 3 1/2 to 4 inches wide and extended around my upper arm. It was swollen, hot to touch, extremely sore, and very red. Several people at different times described the redness as looking like a bad sunburn. My arm felt like it had a tight band around it. Throughout the day the other symptoms continued to subside. I continued to take TYLENOL and ibuprofen alternately every 6-8 hours Friday day and night. Friday night I took CLARITIN. Saturday, September 14, 2013 - Red band around my arm began to fade but the swelling, tightness and soreness remained. I continued to take CLARITIN. Sunday, September 15, 2013 - Red band around my arm continued to fade and the swelling, tightness and soreness began to subside, I continued to take CLARITIN. Monday, September 16, 2013 - Red band around my arm fading and the swelling, tightness and soreness continued to subside. I continued to take CLARITIN. Tuesday, September 17, 2013 - Symptoms no longer present. I continued to take CLARITIN.
Medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, in early May, 2001, the pt received his 3rd injection of Havrix and his 1st dose of Hep-B (Engerix-B, see report 20010157291). Three weeks later, he experienced unspecified neurological symptoms and subnormal temperatures. The vaccinee was seen by a physician, who suggested that the pt might be experiencing Guillain-Barre syndrome. The pt felt that his symptoms were possibly related to an unspecified sexually transmitted disease. This report is considered to be "Medically Serious". As of 6/27/01, the outcome of the event was unknown. F/U states the pt was seen by a neurologist. Nerve conduction studies were performed, which led to a dx of brachial plexitis. The pt stated that "other factors were involved" in the development of this event and that his symptoms were possibly related to an unspecified sexually transmitted disease or unspecified virus. The pt stated that his neurologist does not consider the brachial neuritis to be related to IZ. However, as a precaustion, the pt has elected to discontinue the Engerix-B IZ series. The most recent information received on 7/13/01, indicated that the brachial plexitis and subnormal temperatures were ongoing. Brachial plexitis is considered "Medically Serious".