chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood pressure high; This is a spontaneous report from a contactable consumer reported for herself.  A 85-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Apr2021 12:00, at the age of 85 years, (Batch/Lot Number: ER8737) as single dose for covid-19 immunisation. The patient had received the first dose of the vaccine on 18Mar2021 from lot EN6207, at the left shoulder. Medical history included hypertension from an unknown date and unknown if ongoing, diagnosed about 20 years ago. Concomitant medications included amlodipine besilate (NORVASC) taken for hypertension, start and stop date were not reported; hydrochlorothiazide, losartan potassium (HYZAAR) taken for hypertension, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported.  The patient experienced blood pressure high on 08Apr2021 with outcome of recovering. Prior to receiving the vaccine on 08Apr2021, the caller's blood pressure was slightly high when she went in that day because she was sent to a guy who was taking the blood pressure. The caller's blood pressure was 148 before receiving the vaccine. The caller was told to take her medication in the morning instead of the evening the day starting on 08Apr2021. At first the caller thought that her blood pressure was high the night of 08Apr2021 because she was told to change the timing of her blood pressure medication from the evening to the morning. The caller has had constant high blood pressure after the vaccine and she has never had it that high before. Monday morning, 12Apr2021, her blood pressure was in the 200s and was sent to urgent care, she was told to keep doing what she's doing. This morning the caller's blood pressure was 195.  The caller increased the dose of norvasc from one tablet to two tablets, on 12Apr2021 because her blood pressure was still high.  The patient underwent lab tests and procedures which included blood pressure measurement: slightly high   on 08Apr2021, prior to receiving the vaccine , blood pressure measurement: 148 on 08Apr2021 before receiving the vaccine, blood pressure measurement: 225 or 230-something on 08Apr2021 on the night, blood pressure measurement: 200 on 12Apr2021 her blood pressure was in the 200s and was sent to urgent care, blood pressure measurement: 195 on 12Apr2021, unspecified investigation: done before she had the first dose but she does not have it with her.  No follow-up attempts are needed. No further information is expected.
Cold sensation in her shoulder and left arm/she got a cold sensation throughout her body. Her right arm has a coldness, freezing cold, radiates and travels from arm to neck; feeling kind of anxious; Sharp pain on right arm towards chest.; shooting pain that goes into body on the side; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 08Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING COLD (non-serious) with onset 08Mar2021, outcome "unknown", described as "Cold sensation in her shoulder and left arm/she got a cold sensation throughout her body. Her right arm has a coldness, freezing cold, radiates and travels from arm to neck"; ANXIETY (non-serious) with onset 08Mar2021, outcome "recovered" (Mar2021), described as "feeling kind of anxious"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sharp pain on right arm towards chest."; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "shooting pain that goes into body on the side". Therapeutic measures were taken as a result of feeling cold.  Additional information: Today was 3 weeks ago that she had the vaccine. The date she took her vaccine until 4-5 hours later, she got a cold sensation in her shoulder and neck and left arm. She took a couple of Tylenols. She started feeling kind of anxious. That went away. About 5-6 days ago, she got sharp pains on right arm towards her chest. She did not think much of it and dismissed it. A few hours later, she got a cold sensation throughout her body. Her right arm has a coldness, freezing cold, radiates and travels from arm to neck. She had this episode 3 times. The shooting pains were there. It was like one shooting pain that goes into body on the side. It was not like she was screaming with pain. She was not looking for any kind of legal. She just wanted to know if these feelings would go away, the coldness or sensation. Her concern was she wanted to say if this was common or not. Her second dose was coming up next week, and she was reconsidering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided. Date of refrigeration: 06-DEC-2021.   This case was linked to MOD-2022-449524 (Patient Link).
second dose of Shingrix in November /  january 2021 patient presented shingles; shingles / shingles lesions in face; postherpetic neuralgia; pain in site of injection; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) (batch number 3GK5K ?, expiry date 17th September 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   In November 2020, the patient received the 2nd dose of Shingrix. On 17th September 2020, the patient received the 1st dose of Shingrix. In January 2021, between 1 and 3 months after receiving Shingrix and between 3 and 5 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and injection site pain. On an unknown date, the outcome of the vaccination failure, shingles, post herpetic neuralgia and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and injection site pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. After the administration of second dose, starting in january 2021 patient presented shingles (pain in site of injection, post herpetic neuralgia, shingles lesions in face). The reporter consented to follow up. The batch number of the suspect vaccine had multiple possibilities hence updated with 3GK5K ? as per sales data sheet.
Pt recv vax on 2/27/99; on 3/11/99 pt exp a rash w/ papular discrete lesions w/ white halo around them on abdomen, face & back, conjunctivitis, clear rhinorrhea
expired dose administered to a patient with no reported adverse event; Initial information received on 09-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of an unknown age and gender and reporter reported that expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received expired dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE suspension for injection (strength, expiry date and lot number: not reported) via unknown route in unknown administration site for immunization and (expired product administered) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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.
Diarrhea; Stomach hurting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL PAIN (Stomach hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN (Stomach hurting). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL PAIN (Stomach hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.
The night that patient received his first round of vaccinations he screamed for 4 hours straight- inconsolable.  I called the emergency room that evening and they told me that if he continued to cry for more than 4 hours to bring him in.  He stopped at 4 hours- exhausted.   During his next round of shots (4 months)his leg became so red and inflamed that we took him to the emergency room. We were told this was a site reaction. Patient is now 7 and is facing a myriad of challenges.  He developed language late and we sought speech therapy to bring that along.  His muscle tone and coordination are low.  He has been diagnosed with ADHD- Inattentive type, dysgraphia, dyslexia and PDD NOS (autistic spectrum).
Information has been received from a nurse practitioner for GARDASIL, Pregnancy Registry product, concerning a 22 year old female patient with no drug reactions or allergies and no pertinent medical history who on 10-OCT-2011, was intramuscularly vaccinated with a first, 0.5 mL dose of GARDASIL (lot # was not reported) in the left deltoid and on 15-DEC-2011, the patient was vaccinated with the second dose of GARDASIL lot# and dose were not reported), in the left deltoid. There was no concomitant medication. The nurse practitioner reported that the patient was vaccinated with 2 doses of GARDASIL and was pregnant (last menstrual period 27-NOV-2011, estimated delivery date: 02-SEP-2012, also reported as 09-SEP-2012). The patient was not experiencing any adverse effects or problems. Follow-up information has been received from a registered nurse. The nurse stated that the did not have any information regarding the patient. The patient transferred practices during her pregnancy and the physician's office did not administer GARDASIL vaccination. No forwarding physician information was available at this time. Additional information is not expected.
Toddler received a 2nd dose Pfizer when should have had 2nd dose Moderna
Patient experienced heart palpitations and irregular heartbeat while resting in chair watching TV.  Patient has no previous history of heart issues. Patient regularly tracks his heartbeat, typical at-rest heartbeat is approx 89 bpm. During event, at-rest heartbeat peaked to 120 bpm. Event lasted approximately 4 hours. Patient took several Tylenol which did help to calm down his heart.  Additional side-effects noticed during this time included pain over his entire body, as well as a numbness in his fingers.  Patient still experiencing mild pain across his entire body as of 8:00 AM on 8/26/2021.
I began having hives on my legs on August 17th, but I would only have one or two at  a time and I am allergic to tons of grasses and trees so I thought my dogs had probably rolled in something and then touched me. The hives continued through August on and off and then as we moved into September,  I was getting them more frequently. I would wake up with them in the morning put hydrocortisone cream on them and take my Claritin. Within an hour they would go away. Sometimes they would come back in the afternoon and evening, but mostly in the morning. I was trying to figure out if it was environment, but I was getting them in different locations (my house, my mom's house, my brother's house) so I started to think it might be something internal. Late September is when I started getting them on my trunk (mostly my ribcage and pelvic regions) and they were big welt like hives. This started happening every morning and it was a deep hard welt that was warm to the touch . Then in mid October, I started get them every day with more than just one or two and by the beginning of November I would wake up with them all over my trunk, back and legs. I received a shot of steriods to my butt and that helped to reduce them for about a week and then I had a repeat of hives all over at which point I took oral steroids and that seems to be working right now.
Patient presented to clinic O3/25/04 with complaint that at the site of an injection on anterior left thigh there was hardness, redness and warmth that began as a small area but had gotten bigger, more red and warmer.  It was causing pain and limiting his ability to ambulate.  He had no fever, his appetite and activity level were as usual, except that his play was limited by his pain and difficulty in ambulation. The area of redness and induration were outlined on his skin, and Mom was instructed to return within 24 hours if the area increased in size, or if it became soft, opened or he developed an elevated temperature.  She was instructed to use intermittent warm moist packs to the site for 15 minutes three to four times daily, and cephalexin p.o. for 10 days was prescribed.
About 20-28 minutes after the injection, I was driving, I felt a little light headed, but didn't think much about it.  I was waiting behind another car for light to turn green to turn left and the next thing I knew I was in the middle of the intersection and cars were honking at me.  I was able to complete my turn.  I must have blacked out.
Approx 6 hours post vaccine, started with loss of appetite and nausea.  Then chills, and severe full-body aches (severe enough to cause crying).  Weakness and exhaustion; slept 20 of last 24 hours.
therapy non responder; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 62-year-old female patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Havrix.  Additional details were provided as folows: The patient received the 1st dose of Havrix and her physician told her she had no immunity, thus leading to patient to be therapy non-responder. The patient had not received the booster dose and had no time to get it because she has to travel. The reporter did not consent to follow-up.
The patient got the Moderna vaccine on 9/11/2021. She got J&J vaccine today from our office. She did not report she got the Moderna before got the J&J. We found it from system. Per the patient, she had adverse reactions from the Moderna and she did not want to get the Moderna 2nd dose. However, her workplace required COVID 19 vaccine. That's why she got J&J today per patient.
I started having super bad cramps. They felt like period cramps, but they were way worse. I couldn't get out of bed. I also had body aches as well. I didn't feel good. I took ibuprofen 600mg, but that didn't do anything. I ate and wasn't pregnant at the time. I went to urgent care. They did blood and urine tests, but they didn't find anything. It's still occurring. I take ibuprofen. They are messing around with my birth control, but I do not have a diagnosis yet.
Following her covid vaccine patient presented to the observation area where she reported a headache.  Within minutes she was in and out of consciousness with seizure like activity.  Vital signs were stable, however her O2 sat was at 86%. Patient was transferred to the ED & admitted to the hospital. Admitted to the hospital. Patient with history of migraines and seizures. Evaluated inpatient for possible vaccine reaction vs. seizure vs. psychogenic seizures vs. AMS related to metabolic encephalopathy vs. B1 deficiency.
Chills starting date of vaccine administration.  Fever (100.2) for 24 hours.  Red, swollen, itchy arm at injection site for 5 days.  Body aches for 72 hours.  Headache for 36 hours.
Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine administration
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Dec2020 at 12:00 as dose 1, single (Lot number: EK5739), in left arm, on 07Jan2021 at 12:00 as dose 2, single (Lot number: EL3249), in left arm, on 05Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 29Apr2022 at 00:45 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication included: LISINOPRIL. Past drug history included: Dilantin, reaction: "known allergies Dilantin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (07Feb2023) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 02Feb2023 to 03Feb2023.
full body cramping; numbness in limbs; extreme weakness; This spontaneous report as received from a registered nurse refers to a 14-year-old female patient. The patient's concomitant vaccine included unspecified Covid vaccine. There was no information about the patient's concurrent conditions or medical history provided.  On 10-JUN-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mg, intramuscularly, lot # T008151, expiration date: 21-JUN-2022 (anatomical location was not reported) for prophylaxis.   On the same day, reported as 3 minutes after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient had full body cramping, extreme weakness and numbness in limbs. The patient sought medical attention and was transported to hospital via ambulance as a treatment.  The outcome of the events was unknown. The causality assessment was not provided. 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 Sharp & Dohme Corp.; devicelotnumber: T008151; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
fever of 103 p/4hr p/shots;cranky, fever for about 3 days;ongoing fever on & off w/2 febrile sz to date hosp 3x for fever & observations extremely fatigued, fever, no appetite ongoing now;
Approximately 3 days after receiving the 2nd dose of the Moderna COVID-19 vaccine, this patient developed chest pain. He presented to the hospital where subsequent testing revealed pericarditis and myocarditis. Workup included EKG, labs, CTA of coronaries. His symptoms improved by time of discharge. He followed up as an outpatient and underwent cardiac MRI which confirmed diagnosis of myocarditis.
hives all over the body; went to ER; was seen in office & given Epi & a prescription for Atarax; received 1st dose in October w/o problem;
Ear itching, red around injection site, not warm or swollen. Told pt to take BENADRYL and contact MD. Also it could be side effect.
Syncope/ incontinence of urine/ possible seizure (unwitnessed by medical staff) within 15 minutes of administration.
Patient developed a rash all over her stomach approximately 24 hours after the injection. She also developed a rash and redness at injection site which was expected. For her rash on her stomach, she took a Benadryl for 2 days and the rash subsided after about 3 days. Patient has experienced this kind of allergic reaction from other medications.