chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AT APPROXIMATELY 5PM ON DAY OF VACCINATION, DEVELOPED SORENESS IN LEFT ARM. AROUND 10PM SHE EXPERIENCED EXTREME PAIN, COULDN'T LIFT HER ARM OR MOVE THE FINGERS ON THAT ARM. IT ADVANCED TO HER NECK AND BACK, SEVERE HEADACHE, STATING IT FELT LIKE SHE HAD BEEN HIT IN THE HEAD WITH A HAMMER. SHE ALSO FELT HEART POUNDING AND HAD CHEST PAIN. DESCRIBES ALL THE PAIN AS THROBBING. SHE RAN FEVERS (HIGHEST WAS 100.3) AND HAD CHILLS. DIDN'T GET OUT OF BED UNTIL 11:30 THE FOLLOWING MORNING.
Heavy vaginal bleeding noticed a few hours after injection. I have been spotting (1 pad daily) because of my birth control, but now I?m using 6-7 pads a day and soaking through them. I?m not sure if it?s related but I?m also extremely fatigued and having chills.  Should I ask for a blood test for my platelet count?  I?ve read it is a very rare reaction for some to have lower counts.
Patient presents to clinic 16 hrs after admin. Has red induration 10cm anterior upper arm at varicella injection site. Hot to touch/ complains of itchy. Instructed mom to physician for treatment. Took to ER - treatment Benadryl and steroid 12/29- mom says only small pink spot remains.
Flu like symptoms in beginning with upper chest and shoulder pain, fatigue, headache leading to shortness of breath, increased heart rate, blood pressure increased.   Had some tremors in hands and legs in the beginning.    Tests of heart are on going.   Left ventricle appears small.  Some changes in heart.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. No medical history, drug reactions or allergies were reported. On 24-OCT-2012, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX23 (lot # reported as H013847, expiry 15-MAR-2014). No concomitant medications were reported. On 26-OCT-2012, two days post vaccination the patient was seen in the practice and complained of redness, discomfort, less heat and swelling of arm. The patient sought medical attention (office visit). No treatment was reported. No laboratory diagnostic studies were performed. The outcome of redness, discomfort, less heat and swelling of arm was reported as recovering. This is one of several reports received from the same reporter regarding patient #3. Additional information has been requested.
Patient resident a Moderna booster dose of 0.5mL instead of 0.25mL. No adverse reaction reported after contacting Wellness Director.
Some of the vaccine leaked out and dripped on her arm; A spontaneous report was received from a 45-year-old, female patient who is an occupational therapist who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, incorrect dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number:B11J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, during the administration of the vaccine, the administrator used the pinch method and some of the vaccine leaked out and dripped on her arm. The reporter stated they are still determining if she received the full dose or less than the full dose. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, incorrect dose administered, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a 45-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot B11J20A), reporting Incorrect dose administered without any associated adverse events.
I could take ibuprofen to ease the pain; I could not move my arm or torso; Had a very swollen lymph node in my armpit / The swelling was very intense; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I could take ibuprofen to ease the pain), MOBILITY DECREASED (I could not move my arm or torso) and LYMPHADENOPATHY (Had a very swollen lymph node in my armpit / The swelling was very intense) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced PAIN (I could take ibuprofen to ease the pain), MOBILITY DECREASED (I could not move my arm or torso) and LYMPHADENOPATHY (Had a very swollen lymph node in my armpit / The swelling was very intense). In 2022, PAIN (I could take ibuprofen to ease the pain), MOBILITY DECREASED (I could not move my arm or torso) and LYMPHADENOPATHY (Had a very swollen lymph node in my armpit / The swelling was very intense) had resolved.            Patient received the booster at the on site clinic. Concomitant medication list was not provided. It was mentioned that the symptoms to occupational health and asked if patient could take ibuprofen for pain. The patient stated that it lasted for about 7 days. The swelling had gone down since and the patient was all better. Treatment information was not provided.
I received the shot at 1030 in the morning.  Just after midnight of the next day, I woke up with a fever of 100.9, chills and body aches.  I did have some head congestion too.  It's now 1100am and I still have the same symptoms.  However the fever has dropped closer to 100.  I've been taking Tylenol to help with the aches and fever.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 27-JUN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Pt vaccinated with DTP/OPV experienced 2 hrs after immunization, pt. had 6 hrs of non-stop crying.
Pt C/O feeling dizzy,  light headed, and muscle pain in the neck. Tingling in the fingertips ( not new, this is ongoing). Pt placed in trendelenburg on stretcher. Vital signs x3., Pt also given juice and crackers. Pt stated didnt eat or drink in a few hours.  Dr.  spoke with pt's mother of symptoms and she was able to retrieve pt from site to home for pt's safety. Dr. informed pt to inform family dr. of incident and to schedule a follow up. Also informed pt if symptoms get worse to go to the nearest ER. VS: 1342 HR 78, Resp 20, BP 136/77, O2 sats 98%, / 1352 HR 79, Resp 20, BP 138/86 O2 sats 99%/ 1406 HR 75, Resp 20, BP 120/78, O2 sats 98%
PSORIATIC ARTHRITIS FLARE UP WITH PAIN; SMALL LUMP; ITCHY LUMP; RED LUMP; This spontaneous report received from a patient concerned a 53 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, administered 1 in total on 01-MAY-2022 for prophylactic vaccination. On Dec-2021, the patient was hospitalized for six days due to being sick with covid (covid-19 infection), oxygen saturation low, bilateral pneumonia, difficulty in walking and breathing and was prescribed steroids. On unknown dates, the patient experienced asthma, heart disorder and tachycardia and he also had occasional pain, muscle aches headaches and tiredness and was prescribed Amitriptyline when treated with covid-19 vaccine ad26.cov2.s (dose number in series was 1). On an unspecified date, patient was previously treated with additional dose of covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, administered 1 in total for prophylactic vaccination which is an off label use and inappropriate schedule of vaccine administered (dose number in series was 2). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 3) (suspension for injection, intramuscular, batch number and expiry: Unknown) dose was not reported, administered 1 in total on 22-JAN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. Concomitant medications included amitriptyline. In JAN-2022, the patient experienced psoriatic arthritis flare up with pain due to being off medication, small lump, itchy lump, and red lump (dose number in series was 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The patient recovered from small lump, itchy lump, and red lump, and had not recovered from psoriatic arthritis flare up with pain. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220222411. Sender's Comments: V0: 20220225398-covid-19 vaccine ad26. cov2.s-psoriatic arthritis flare up. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
This is a spontaneous report from a contactable physician reported through a Pfizer sales representative. A 20-years-old female patient received TRUMENBA (Lot number J28923, exp. date Jun2016, NDC number of TRUMENBA: 0005-0100-05), via an unspecified route of administration on 12Oct2015 at 0.5ml single dose. Medical history included asthma diagnosed when the patient was little. The patient's concomitant medications were not reported. On the same date the patient experienced rash near where injection site would have been. The patient was treated with BENADRYL. The outcome was unknown. Follow-up (09DEC2015): Follow-up attempts are completed. No further information is expected.
Low grade fever , body aches, fatigue for about 12-20 hrs.  Headaches day 3 after (Saturday)  Ibuprofen 7 hrs. after onset
Urgent Care visit 3/5: Pt reported itchy rash.  Pt given loratadine and triamcinolone ointment.  No further info available.
prescription was written for Shingrix for a 34 y/o immunocompetent patient with history of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 34-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment: The pharmacist reported that prescription was written for Shingrix of 34 year old patient who was immunocompetent. Shingrix had not been administered till the time of reporting. The reporter consented to follow up. Additional Supportive Information: The patient who was immunocompetent was prescribed with Shingrix, which led to off label use.
After the injection, she started experiencing headache and dizziness; After the injection, she started experiencing headache and dizziness; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Unknown) via an unspecified route of administration from 31Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that after the injection, she started experiencing headache and dizziness on an unspecified date in 2021. She reports the dizziness started 6 hours after the covid-19 vaccine injection and was really bad, like vertigo. She reports the dizziness is improving and not as bad today. She treated the headache with Tylenol. The outcome of the events dizziness was reported as recovering and headache was reported as unknown. The events were assessed non-serious.  Information on the Lot/Batch number has been requested.
This spontaneous report as received from a clinical medical assistant refers to a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On 30-SEP-2014, reported as "yesterday", the patient was vaccinated with ROTATEQ dose 2, 2 ml, oral (lot # was not reported). The medical assistant stated that the administered dose of ROTATEQ was improperly stored. No adverse effects reported. No treatment was given. This is one of two cases from the same reporter. Additional information is not expected.
Rash on left eyelid the evening after the vaccine - severe headache and congestion 3 days after vaccine
High fever of 104 rectal. Fussy, irritable, crying, sleeplessness. Rash all over legs, some on arms and feet and hands. Fever lasted for 2 days.
Vaccine administered that was 3 days past expiration for THAW time in the fridge. Thawed on 5/11/23, expired on 6/10/23. Vaccine administered on 6/13/23
Irregular menstral bleeding--Started bleeding on 6/6/2021, 12 days after my last period began on 5/26/2021. This "period" lasted 4 days. I then started irregular bleeding on 6/17/2021, 12 days after the other irregular cycle.. I am currently on my 7th day of this "period.," and bleeding got heavy on the 6th and 7th days ( I can't recall having a period that ever lasted more than 6 days).
plantar fasciitis in his right foot and ankle area; joint pain is very isolated to his right foot and ankle area; right foot and ankle are very tender; having to walk with a limp; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number EW0162) via an unspecified route of administration, administered in arm left on 13Apr2021 10:45 AM (age at the time of vaccination was 64 years) as dose 1, single for COVID-19 immunisation. The patients medical history included arthritis in all his joints. He received a flu vaccine in Sep2020 or Oct2020. He had a hernia surgery on 29Jan2021, and he was looking at his medical history and the doctor told him he was a healthy guy. He had a family history of cancer and heart disease. The patients concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) and Vitamin B12.The patient experienced no side effects for the first 24 hours. The patient reported about 30 hours afterwards maybe around 4:00-5:00PM the next day on 14Apr2021, tenderness in his right foot and ankle. He had been dealing with a case of plantar fasciitis in his right foot and ankle area that he thought he was over. He experienced the joint pain was very isolated to his right foot and ankle area. It was over a month ago that he had the plantar fasciitis. His doctor had prescribed an anti-inflammatory medicine and he had not been taking that medicine. He reported he and his wife were walking 4-5 miles a day and now he was back up to walking 1-3 miles a day. He was having to walk with a limp because it was so tender. There was none history of all previous immunization with the Pfizer vaccine considered as suspect and no additional administered vaccines, no any vaccine administered on same date with the pfizer vaccine considered as suspect. There was no any vaccine administered prior vaccinations (within 4 weeks) and no adverse event following prior vaccinations. There was no relevant test. The outcome of plantar fasciitis was unknown and other events was not recovered.  No follow-up attempts were needed, information about lot/batch number could not be obtained.
I began to experience fatigue around 1:00 pm  on 3/7/2021.  This was approximately 26.5 hours after receiving the vaccine.     I was also chilled with a slightly elevated  temperature  by 5:00 pm.     I felt fine by the morning of 3/8.
This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 year old male patient who was diagnosed as developmentally delayed. At 5 months of age, the patient received the third dose on July 24 2001. The patients concurrent illness includes bladder spasm with a past history of convulsion (at age of 1 EEG normal). Indication for Prevnar was immunization. Product was administered on Jul 24 2001. Dose regimen was 1 dose. Concomitant medication were not reported. It was reported that the patient was diagnosed as developmentally delayed on Aug 9 2004. His symptoms were described as did not know name, can't ride a bike, unable to balance on one foot, can't count three objects, and can't tie shoes. No additional information was available at the time of this report.
3NOV98-4NOV98 chest pain-severe took to ER in PM;7NOV98 blurred vision-weakness;taken to ER;vision blurred again;MD did EKG & EEG all test nl;
AT TIME OF 2ND DOSE, PATIENT REPORTED EXPERIENCING TINNITUS THAT BEGAN AFTER DOSE 1. HE STATED IT IS LIKE A LOW HUMMING THAT HE NOTICES WHEN IN A QUIET ENVIRONMENT.
LOW GRADE FEVER; BODY ACHES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On 09-MAR-2021, the subject experienced low grade fever. On 09-MAR-2021, the subject experienced body aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and body aches on MAR-2021. This report was non-serious.
Headache, fever, chills, night sweats, body aches Narrative:  Side effects from day#2: soreness in arm headache fever (100.5F) body acghes chills night sweats all resolved by day#3
Pt. given HPV and TDAP. Approx 30 sec. later nurse called to exam room by pt's mother and saw seizure like reaction. Hands flexed and urinary incontinence. Present - non postictal. Referred to doctor - advised no further HPV vac.
5/2/21 BAD PAIN IN FACE, 5/4/21 WENT TO ER AND WAS DIAGNOSED WITH BELL'S PALSY
Information has been received from a registered nurse concerning less than 5 infants who were vaccainted with a first dose of Rotavirus vaccine. It was reported that the infants were vaccainted after the age of 12 weeks. medical attention was sought. There was no product quality complaint involved.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer / BioNTech, Vaccine, dose number=3, vaccine administration date=01Oct2021; vaccine brand other=Moderna, Vaccine dose number=4, vaccine administration date=28Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9261), on 18Feb2021 as dose 2, single (Lot number: EM9809) and on 01Oct2021 as dose 3 (booster), single (Lot number: 3D135BA) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jun2022 as dose 4 (booster), single (Lot number: 059A22A) and on 02Dec2022 as dose 5 (booster), single (Lot number: 043H22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "RLS/PLMD" (unspecified if ongoing); "RLS/PLMD" (unspecified if ongoing). Concomitant medication(s) included: FORTEO, start date: 24May2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Jun2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine, dose number=3, vaccine administration date=01Oct2021; vaccine brand other=Moderna, Vaccine dose number=4, vaccine administration date=28Jun2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medication in 2 weeks: Yes. Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=08Feb2023, treatment stop date=13Feb2023, lot number=unknown, indication=Treatment of COVID-19, Return of symptoms 2 days after taking Paxlovid. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Made me shiver; Was in the bed; It made me tired; Not hungry; Thirsty; Just very cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shivers in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shivers (Verbatim: Made me shiver), bedridden (Verbatim: Was in the bed), tiredness (Verbatim: It made me tired), appetite absent (Verbatim: Not hungry), thirst decreased (Verbatim: Thirsty) and cold (Verbatim: Just very cold). The outcome of the shivers, bedridden, tiredness, appetite absent, thirst decreased and cold were not reported.   It was unknown if the reporter considered the shivers, bedridden, tiredness, appetite absent, thirst decreased and cold to be related to Shingles vaccine.     It was unknown if the company considered the shivers, bedridden, tiredness, appetite absent, thirst decreased and cold to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingle shot it was two shots and he/she glad got it the shot made her/his shiver, was in the bed and it made her/him tired not hungry or thirsty just very cold. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
07/04/2020 @ 0900.  Awoke to left upper arm itching with swelling (at injection site), redness, and warmth. Every morning thereafter symptoms increased in severity. On 07/06 awoke with new symptoms including  a headache, low grade temperature, and nasal congestion. 07/07 - all symptoms got worse. Took a hot shower and took Tylenol. Awoke 07/08 and symptoms had improved. Symptoms today include - resolving nasal congestion, left upper arm with swelling, redness, and warmth.  No longer has a headache, fever, or itchiness.  Has not had any previous reactions to vaccinations. Stated her mother had a seizure within 5 minutes after Tdap vaccination and needed medication for her reaction. Patient denies and difficulty breathing, shortness of breath, or throat swelling. Reported today is the first day she is starting to feel better.