chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother reports several hours following his immunizations patient became very irritable and fussy and seemed to be very uncomfortable. Mom noted a rash on his right leg, abdomen, back and face. She described the rash as red, warm, raised, and hive-like. She reports patient seemed to be trying to scratch at the rash. He did not sleep well during the night. The rash seemed to resolve through the night and into the next day, with the exception of one area on his right thigh which remained red, raised, hive-like macluo-papular irregular shaped rash. No fever, no cough or congestion, no abdominal pain, eating well. no ear pulling.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient with none medical history. The patient was vaccinated with lot # (671416/1241AA, exp 12-MAR-2013) PNEUMOVAX 23 (no record of a previous PNEUMOVAX 23 vaccination) on 04-OCT-2012. The pharmacist reported that the patient developed an injection site reaction following vaccination. The injection site reaction was described as a swollen, red and warm to the touch area at the site of the PNEUMOVAX 23 vaccination, which developed the morning of 05-OCT-2012. The patient contacted the pharmacist for medical attention. The patient was given BENADRYL and ibuprofen for the adverse events treatment. The outcome of injection site swollen, injection site warm and injection site red were reported as not recovered/not resolved. Additional information has been requested.
One week after administration of Tdap, right arm became red, swollen, raised, warm and sore. Treatment was sought at a walk in clinic and KEFLEX was prescribed with a diagnosis of cellulitis.
Woke up with severe dizziness, nausea/vomiting and increased while at work(denies palpitations).  In ER 1/2/2021-CT of head(WNL), MRI (saw lesion and physician thought she had a stroke).  Neurologist consult on 1/3 and felt it was not a stroke and unsure the reason of dizziness..  1/3 no arm or leg weakness.  Order to see a cardiologist  d/t residual dizziness and advised against 2nd moderna covid 19 vaccine.
Information has been received from a 64 year old male consumer concerning himself who on 21-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 02-JUL-2007 the patient experienced broke out with chicken pox.  Unspecified medical attention was sought.  No product quality complaint.  Additional information has been requested.
Side effects/reactions similar to COVID symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms). At the time of the report, VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-406964 (Patient Link).
Appprox 20 hrs after vaccine I developed a rash; I developed a rash with a bit of swelling; heat/The same exact reaction occurred after my second dose in February; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 78 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CHOLESTYRAMINE. Vaccination history included: Bnt162b2 (1st dose, No events Reported), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Feb2021, outcome "unknown", described as "Appprox 20 hrs after vaccine I developed a rash"; SWELLING (non-serious) with onset Feb2021, outcome "unknown", described as "I developed a rash with a bit of swelling"; FEELING HOT (non-serious) with onset Feb2021, outcome "unknown", described as "heat/The same exact reaction occurred after my second dose in February".  Additional information:  No known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   Follow-up attempts completed. No further information is expected.
Diffuse urticaria 30 mins after vaccine injection. No dyspnea or cough.
Information has been received from a 63 year old male patient with headaches caused from some food products (unspecified) and no known drug allergy, who in approximately September 2008 was vaccinated with a dose of ZOSTAVAX 0.65ml. Concomitant therapy included PRILOSEC. The patient experienced headaches after receiving ZOSTAVAX, the patient reported "the intensity changed but they were pretty much there all the time". The patient's headache persisted. The patient sought unspecified medical attention. Additional information has been requested.
On 03/12/21, 39 yo M with No Known Allergies presented to Drive Up Covid Vaccine clinic. At 0922, pt was administered COVID-19 (Janssen) Vaccine 0.5 mL in left deltoid (Lot #1802070; NDC: 59676-580-15; Exp: 5/25/2021). 2 minutes after injection, pt became diaphoretic with tremors and loss of consciousness. Pt placed in reclined position, pulse present and became responsive and verbal within 30 seconds. Ice pack applied and EMS called. Pt was transported to a local hospital for follow up care. No additional information available.
Fever x 2 1/2 day rash appeared on 3rd day supportive care.
UrticariaPruritus Itching Narrative: employee c/o itching to scalp, leg, and face; 25mg diphenhydramine PO administered. employee reported symptoms have resolved.
Patient improperly given PREVNAR vaccination before age 65 with no immunocompromising conditions. Patient then given PNEUMOVAX vaccination 6 months later. PREVNAR was then most recently and incorrectly provided with a second PREVNAR dose after age 65. Age of patient at time of event: 65 years 20 days.
Prior to vaccination patient stated that she had no known allergies and she may or may not be pregnant. Couple minutes after administration pharmacy associate asked her how she was feeling, she said she was fine. At around 8 minutes after administration she started gasping for air and sweating profusely. She looked pale and nauseous. No swelling of the face or lips were seen. Patient was not speaking English, so her husband was translating for her.  I asked her if she had trouble breathing. She nodded yes. We called 911. He breathing was getting worse, so I administered Epipen.  Several minutes after administration she slowly started to feel better. Her breathing improved. By the time EMS arrived,  her condition improved significantly and she was reluctant to go with them but ended up going anyway.
Broke out in Shingles to th face, scalp and eye on right side.  I have NEVER had chicken pox or been exposed to my knowledge.  Emergency Room was baffled and yet had someone else in with similar case.  Blisters in eye and had to be dyed and checked for cornea damage.  Went to specialist 2 days later, cornea checked again.
Pt was feeling nauseated and dizzy several minutes after the shot. Pt laid down and was monitored by checking blood pressure.
pt recvd vax;exp d & T of 101;sx resolved w/out tx;
Pt. developed pain in the left deltoid area where vaccine was administered initially localized in the deltoid area, no rednes but with induration, pain progressed and radiated to the upper arm and eventually to the forearm. About 2 months later, developed weakness in the upper arm and could not raise arm above shoulder level. Pain 6 on a scale of 1 to 6, more when she uses  left arm. Has not seen a doctor yet had used Advil for severe pain which gives temporary relief.
COVID (+) WITH SYMPTOMS, NASAL CONGESTION LOSS OF TASTE AND SMELL Narrative:
Next day child c/o arm soreness; when mother looked at her arm it was red and swollen from shoulder to elbow and warm to the touch. Resolved in ~ four days with ice and Motrin.
Patient vomited about 5 minutes after receiving vaccine. She said she thought maybe her blood pressure had dropped because she felt very nervous about getting the vaccine.
Patient's husband said today that she began slurring her words and having muscle weakness around 12-25-16. She is still having difficulty walking, standing, and talking. Her doctor believes that her symptoms may be consistent with Guillain-Barre syndrome even though symptoms began approximately 3 months after vaccination.
Patient is a very pleasant 82yo M admitted for orthostatic syncope as well as brief acute respiratory failure with hypoxia in setting of COVID19.  He has a PMH of CKD G3a and HTN as well as likely vaso-vagal events.  Patient presented after having viral syndrome symptoms and poor PO intake for ~ 5 days with syncope after standing up to let dog out.  Patient did not have any alarm symptoms to suggest arrhythmia.  On arrival patient had fever but VS were largely normal at rest but he had marked drop in BP w/ standing.  Labs revealed an AKI on his known CKD.  COVID19 PCR was positive.  He was admitted for monitoring and briefly was hypoxic and required supplemental O2 so was started on steroids and remdesivir; he was given fluid for AKI.  Patient symptomatically improved rapidly and was able to tolerate much more PO intake than before, O2 was titrated off, and he was hopeful for DC, however he became febrile again, Cr increased, and repeat orthostatics remained positive.  Patient was given further fluids and monitored.  The following day patient felt significant further improvement and felt close to his baseline.  Orthostatics were minimally positive and patient had no symptoms with standing.  He was discharged off his BP meds and will f/u with PCP to evaluate their need for reinitiation.
Pt came into pharmacy on 10/3/14, she had swelling (blister like), shining, over entire outside of outer arm about the size of hand. She went to urgent care clinic and was given 2 antibiotics on 10/4/14.
HIVES, REDNESS OF SKIN, BURNING OF SKIN, HEART RACING, PEELING OF SKIN AT INJECTION SITE TREATING WITH BENADRYL, CLARITIN/ZYRTEC, HYDROCORTISONE CREAM
9 days after day of vaccination site around injection began to itch again with a red spot of approx. 1 inch. next morning red spot had increased to approx. 4 x 4 inches, still itching. Itch relief cream will relieve itch for 8 hours then returns.
URTICARIA NOS; URTICARIA NOS; OEDEMA NOS; URTICARIA NOS. Information has been received from a registered nurse concerning a 42 year old white male with no past medical history and no known drug allergies who on 13JAN2003 in the PM was vaccinated IM in the left deltoid with the first dose of hepatitis B virus vaccine rHBsAg (Yeast)(lot # 644388/1038M). Ps: 11-FEB-2003 in the PM (lot #644388/1018M) given IM in the left deltoid; P3:09JUL2003 at 1:50PM (lot #643543/0233N) given in the left deltoid. There was no illness at the time of vaccination. After each vaccine in the series, the patient broke out in hives a few days after the vaccine. After the first and second doses of he vaccine, the reporter indicated that the doctor said the hives were "probably not" related to the vaccine. The hive resolved after a few days and the patient took fexofenadine hydrochloride (ALLEGRA) during the day and diphenhydramine hydrochloride (BENADRYL) at night. After the third dose on 09-JUL-2003, the hives came only 2 days after the vaccine on 11-JUL-2003. At the time of the report, on 14JUL2003, the patient had hives and was being treated with fexofenadine hydrochloride (ALLEGRA) and diphenhydramine hydrochloride (BENADRYL). No further details were given. The outcome was reported as not recovered. There was no product quality complaint No laboratory data or diagnostic tests were reported. Follow-up information indicated that the adverse experience onset was on 13JAN2003. Three days after vaccination, the patient returned to the office with a mild rash on the upper extremeties that changed locations from right to left during the day. This lasted approximately 3 days. After the second vaccination, the patient had a mild rash of the upper expremities with +1edema. He went to his personal doctor and was given an antihistamine. This lasted approximately 4 to 5 days. In both instances, the reaction to the vaccination was not suspected. After the third vaccination, a rash appeared on the upper extremeties and between his fingers and toes and at his armpits. The patient recovered  approximately 3-7 days after each vaccination.
Patient called stating that she was feeling like she had the flu--which is normal side effect but was also having some numbing / tingling on the right side of her face.  Pt is pregnant 13 weeks, child number 7, delivery date unknown
Patient stated that her arm swelled up from Shingrix shot, it appeared the size of a softball at first. Her arm was hot, big and had red circles. She had a fever + Headache. Her Neck was hot. Patient had full Range of motion with arm and neck though. Arm swollenness went Down. Her arm swelled w/1st shot but Not like this. As of 1/27 @ 1130 a, pt feels completely betteR.
Very aggressive and violent behavior including punching walls, breaking plates, hitting family members. Behavior has continued into the following day.
Almost fainting, dizziness, dilated pupils, black vision, could not speak, unable to move which occurred minutes after receiving the J&J vaccine. Side effects dissipated  within five minutes after onset. Normal BP recorded
Pt recvd measles vax on 30MAR91 & p/vax antibody titer was 0.8 (prior to vax antibody titer was 0.74); no further details were provided;
Two vaccines were given on 10/6/17 in the left arm. Patient felt pain immediately and he stated "something was not right."  Returned to office on 11/3/17 with Dr. who referred him to Orthopedics. Saw Orthopedics on 12/12/17 and also got an MRI. Patient did go to physical therapy for 4-5 visits with out help. Physical therapy sent him back to orthopedics. Was seen @ orthopedics on 5/2/18 and received another MRI on 5/5/18. Follow up appointment with orthopedics is on 5/9/18 to discuss further plans.
Within 7-8 hours arm pain and chill, body muscles and joint pains in feet and toes in the joints about 32 hrs. Back pains occurred on Sunday 11/14/2021 at 530PM I was bending over had nothing in my hand had a shooting pain in my lower back and can't sit up and took Advil and heating pad through Sunday-Monday till the 16 Nov at 4PM and and 17 Nov doctor responded and meds did not improve through 20Nov2021. 16-19 Nov did not go to work. Recovered now but still feel a little bit of pain.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in right arm from shoulder to finger
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 02-NOV-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No addittional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
kidneys and bladder overworking; kidneys and bladder overworking; yeast infection due to "kidneys and bladder overworking; This spontaneous case was reported by a consumer and describes the occurrence of RENAL IMPAIRMENT (kidneys and bladder overworking) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0171B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), EMPAGLIFLOZIN (JARDIANCE) and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, the patient experienced RENAL IMPAIRMENT (kidneys and bladder overworking) (seriousness criterion medically significant), HYPERTONIC BLADDER (kidneys and bladder overworking) and FUNGAL INFECTION (yeast infection due to "kidneys and bladder overworking). At the time of the report, RENAL IMPAIRMENT (kidneys and bladder overworking), HYPERTONIC BLADDER (kidneys and bladder overworking) and FUNGAL INFECTION (yeast infection due to "kidneys and bladder overworking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication includes unknown once weekly injection.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Diabetes could have played a causative factor on the event renal impairment; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Diabetes could have played a causative factor on the event renal impairment
Pt had brief tonic clonic seizure approximately 30 mins after vaccines and visit. Of note, child had first afebrile seizure 1 week prior on 2/9 and had already been set up for neurology FU.
Headache, Myalgia, Flu like symptoms, malaise, sore arm Narrative:
minor fever, body aches, chills, and swollen lymph nodes above collarbone on side of body where i received the vaccine.
The patient reports that she received the Janssen COVID-19 vaccine on 11-18-21.  She developed a migraine, stomach pain, diarrhea, and muscle pain.  She was seen in the ER  on 11-22-21 and was discharged on 11-23-21.  She had a note from provider excusing her from work on the 22nd and 23rd.  She continues to have pain and migraine.  She also has noticeable left sided facial droop.  She was off work because of her reaction from 11-19, 11-22, 11-23, 11-24, and 11-26.  She came to work on 11-24-21 and was trying to work but she is taking medication to treat her migraine, butal/acetamin/cf.  After talking to HR director and EH RN she was encouraged to go home and take the rest of the week off.
patient did not inform us he received the Pfizer vaccine on 4/02/21 and 4/28/21. no reaction noted. Patient marked to have never received the vaccine before.
MA accidentally injected a 15 month old patient, with only the Daptacel/Ipol portion of the Pentacel vaccine and the patient did not receive the ActHIB powdered portion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Regulatory authority (Reference number- 00642362) and transmitted to Sanofi on 15-Jun-2021.  This case involves a 15-month-old male patient who only received the Daptacel/Ipol portion and did not received the Act-HIB powdered portion, while patient was receiving a 0.5 mL fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [Diluent Vial: Lot number: U6986AA, expiry date: 22-Jul-2022, National Drug Code (NDC): 4928156005, Powder: Lot number: UJ529AA, expiry date: 22-Jul-2022, NDC: 4928154858, Box: Lot number: UJ529AAA, expiry date: 22-Jul-2022, NDC: 4928151005, Vaccine presentation: vial] on 15-Jun-2021 for prophylactic vaccination (product preparation issue).   Medical history, medical treatment, vaccination and family history were not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was a case of actual medication error due to inappropriate reconstitution technique. (Latency: same day)  It was reported that, the medical assistant (MA) accidentally injected the only the Daptacel/Ipol portion of the suspect and patient did not received the Act-HIB powder portion.   At the time of report, the MA wanted to know how she can give the ActHIB portion to patient and stated that, the error was occurred because she did not pay attention when she was getting the Pentacel out of the box and did not mix them together. The MA noticed the error after the patient was gone and when she was documenting.   At the time, it was reported that, the patient did not had any adverse event as result and discussed the way to give Act-HIB portion to patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd 3 doses of Hep B vax in FEB91, MAR91, & 23SEP91; on 25SEP91 devel severe pain in rt shoulder that radiated down arm w/numbness; pain in neck area of C4 & C5;
Patient states several hours after immunization, she began to experience chest tightness, throat swelling and difficulty breathing. Her family member took her to the local emergency department for treatment. I spoke to the patient the next day and there were no long term adverse effects at the time.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient said she had numbness on left side of her face 15 minutes after the shot and it went away after taking Tylenol. It happened again later that afternoon but went away after a few minutes. She told her doctor  about it right after it happened and right before the second shot. He told her both times this wasn't related to the vaccine and she can continue with the second dose. She also said she can't return to California without the second dose. Dr. advised to proceed