chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered too high, not in deltoid muscle, felt like at bone or AC joint. Very painful at administration, so much that I said, "ouch, oh my goodness that hurts" during the administration. Very painful when crossing arm in front of body.
adverse reaction; This case was reported by a consumer and described the occurrence of adverse reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient asked the information of the ingredients to review with physician before going to have the second injection. The patient experienced adverse reaction.
Pt received pfizer booster dose. during observation period 5 mins after vaccination, pt felt palpitations and dizziness. Pain 10/10 in upper/mid chest region, and in the back of her head. Pt's BP elevated 178/104 other vitals WDL. EMS called and pt was taken to ED for further evaluation.
PFIZER COVID-19 VACCINE EUA:  ADMINISTRATION ERROR- BOOSTER DOSE GIVEN TOO SOON.    RECEIVED 3 DOSES OF PFIZER COVID 19 VACCINE ON 06/15/21, 07/07/21, AND 12/10/21 RESPECTIVELY.  THERE WAS NOT 6 MONTHS BETWEEN 2ND AND BOOSTER (3RD DOSE).  THIS APPEARS TO BE AN ERROR THAT THE BOOSTER DOSE WAS GIVEN BEFORE 01/07/22.  NO ADVERSE EFFECTS REPORTED.
period has been varying; This is a spontaneous report from a contactable nurse (patient) via Pfizer via the Regulatory Authority Support. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 (Batch/Lot Number: ER2613) (at age 33-years-old) as dose 2, single for covid-19 immunisation. The first dose was received on 26Feb2021 (lot number: EN6201) on the right arm at age 33-years-old. Medical history included  immune system disorder from an unknown date and unknown if ongoing. Concomitant medication included unspecified immune disorder medication. Patient initially explained from Feb2021 to Mar2021 her period was late, it was about four or five days late. She later clarified start date as Mar2021. She explained she had gotten her period in Feb2021 right just before the vaccine or the day she got the vaccine, there or about. After she got the second vaccine was when she noticed it was delayed.  Throughout the rest of the months her period has been varying. She used to be able to tell time it down to the day when it would come on. Now she cannot. It was varying. It was 33 to 27 to 29 to 30 and now it has been 33 days and she still does not have it. She felt it was getting worse because it's longer in between.  She commented she has done fertility testing and her fertility is normal/good. She had this done Oct2020. It should not be dropping or changing like this. Outcome of the event was not recovered. Event did not led to emergency room visit nor physician office. The reporter considered the event medically significant.; Sender's Comments: Based on the reported information ,a causal relationship between the event and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; itching in tongue; back of throat; Itching in mouth, tongue, roof of mouth, back of throat; tightness in throat; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EW0162), via an unspecified route of administration on 17Apr2021 at the age of 53-year-old as single dose for covid-19 immunization. The patient medical history was reported as none. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication from 17Apr2021 to 17Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number:: EN6199; Expiry Date: Jun2021 ), dose 1 via an unspecified route of administration, administered on 12Mar2021 as single dose for covid-19 immunization. On 17Apr2021 the reporter reported that she has a mild allergic reaction she experienced Itching in mouth, tongue, roof of mouth, back of throat, Tightness in throat and her tongue swelling up "a little bit" after the second dose. Reporter also stated that her headache has ran from cheeks to the back of her neck, lasted for about 5-6 days. Was worst in the mornings as she took migraine medication. The reporter stated that she took Benadryl and a dose of her Inhaler before her second dose of the vaccine and she said she was still having to use her inhaler and take antihistamine daily. As her doctor had recommended that when she got the second vaccine to take the Benadryl beforehand and she could tell that the inhaler and Benadryl helped her after this dose of the vaccine. She was started to feel the symptoms but says she could tell that the medications were helped to fight them. The patient did not visit to Emergency Room or Physician Office. The outcome of events was recovering as reported by reporter.  Follow-up attempts are needed. Further information is expected.
Rash started on stomach, has spread to back and legs.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 15:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism and cinnamon allergy. The patient received medication (unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient experienced rash which started on stomach, had spread to back and legs. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event rash which started on stomach, had spread to back and legs was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt was to receive Moderna SARS-2-COVID 0.25ml booster dose instead, received 0.50ml dose Pt states that she had flu-like symptoms for a week after vaccine.
This case was reported by a nurse and described the occurrence of extra dose administered in a patient who received HAVRIX. Previously admininstered products included HAVRIX (dose 1) and HAVRIX (dose 2). On 11th May 2014, the patient received the 3rd dose of HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: Nurse reported unspecified patient inadvertently received a 3rd dose of HAVRIX on 11 May 2014. No adverse event were reported. No further information was provided.
is 11/01/2023  Patient said that his arm still hurt and tender to the touch, but no redness or swelling at the injection site for the AREXVY vaccine that he got on 09/05/2023. He is not taking any medication for pain. I counseled and advised him to reach out to his PCP. 11/04/2023  Patient is feeling better and able to do yard works but still hurting. His PCP is not available until next week. 11/07/2023  Patient is feeling much better more than 50%. He did not see his PCP in person, only communicate through phone. He is using ice pack to help with the pain.
Birth weight 4111g at gestational age 40.1 weeks/Large for gestational age; Fetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 20-Jun-2019, concerning a female neonate patient.  The patient's mother was a 34-year-old adult female of height 66 inches and weight 140 pounds and body mass index (BMI) 22.6. The mother had 1 previous full term live birth and no birth defects were reported. The mother's family history neither had any major congenital malformations nor offspring with major congenital malformations. The concomitant medications included Prenatal Vitamins (minerals nos;vitamins nos). The last menstrual period (LMP) date of the patient's mother was 04-Aug-2018. The type of pregnancy was singleton. The patient's mother had not used tobacco, alcohol or illicit drugs during current pregnancy. On 19-Sep-2018 and 26-Sep-2019, the patient's mother underwent ultrasound scans and no major congenital malformation was identified.  On 10-Oct-2018, approximately at 9 weeks of gestation, the mother received Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: 252264, expiry date, dose, anatomical location and route of administration: not reported] for an unknown indication and the fetus was exposed to Flucelvax QIVc via transplacental route (explicitly coded as fetal exposure during pregnancy).  On the same day, the patient's mother underwent ultrasound scan and no major congenital malformation was identified. On 05-Feb-2019, the patient's mother was diagnosed with anemia and was treated with ferrous sulfate (dosing details: 1 tablet twice daily orally, from 05-Feb-2019 to 12-May-2019).   The mother's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD), both were reported as 11-May-2019.  The mother vaginally delivered a female baby at 40.1 weeks of gestation. The infant's characteristics included, weight 4111. grams (explicitly coded as large for gestational age), body length 54.6 cm and head circumference 33.7 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores at 1 minute was 8 and at 5 minutes was 8. There were no pregnancy complications noted. There was no major congenital malformation identified at birth.  This case is linked to 201904017 (the corresponding maternal pregnancy report).; Reporter's Comments: A female neonate was delivered with large for gestational age (weight) after receipt of Flucelvax QIVc at 9 weeks of gestation. The event can be explained by the pregnancy rather than suspect vaccine as there are no known biological mechanism to explain the event. Hence, the causality was assessed as not related to suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed this case as serious (medically significant).
One side of her face feels itchy and numb.  It started slightly the day after the shot but four days later she is still having symptoms.
Patient has been experiencing redness and swelling from the elbow up for almost 4 days. Patient is also stating they have pain in the left arm as well. Patient was concerned since it has been almost 4 days. Advised patient they may want to put some ice on their arm to decrease some of the swelling and that they may want to take some TYLENOL or ibuprofen to help with some pain relief. I also advised patient to contact doctor on Monday if it has not gotten better.
after getting vaccine, pt bacame diaphoretic with bp 79/47, no loc. pt brought to stretcher via wheelchair. water given and bp increased to 109/72 lying, 120/76 sitting and 119/76 stading. pt left with mother and sister
PAIN, REDNESS AND SORENESS THAT IS SPREADING AND GETTING WORSE. AREA IS RED AND SWOLLEN AND TENDER TO THE TOUCH AND WARM
tested positive for Covid-19; sore throat; runny nose; Incontinent of diarrhea stool; falling out of bed; Sore injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Heart disease, unspecified.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site). On 12-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) (seriousness criterion hospitalization), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), DIARRHOEA (Incontinent of diarrhea stool) and FALL (falling out of bed). The patient was hospitalized from 15-Apr-2021 to 19-Apr-2021 due to SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), DIARRHOEA (Incontinent of diarrhea stool), FALL (falling out of bed) and VACCINATION SITE PAIN (Sore injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment included convalescent plasma and Remdesivir. Action taken with mRNA-1273 in response to the event was not applicable.  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.   This case was linked to MOD-2021-082094 (Patient Link).; 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.
Diarrhea; Heart was beating fast; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: NEBIVOLOL HYDROCHLORIDE taken for hypertension; OLMESARTAN MEDOXOMIL taken for hypertension; AMLODIPINE BESYLATE taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension. The following information was reported: DIARRHOEA (non-serious) with onset 06Oct2023 at 04:00, outcome "unknown", described as "Diarrhea"; HEART RATE INCREASED (non-serious) with onset 06Oct2023 at 04:00, outcome "recovering", described as "Heart was beating fast". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, heart rate increased. Additional information: Patient took the new COVID-19 vaccination (Pfizer COVID-19 Vaccine) yesterday (05Oct2023) and at 4 o'clock this morning (06Oct2023), patient had a bad diarrhea and heart was beating fast but since then it has slow down.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
I drew up 6 vaccines for the same patient. I went to re confirm the two patient identifier and proceeded to administer the vaccines. I went back into my office to document the injections given, I came upon the MMRV vial and realized it was the combo and not the MMR itself. I then proceeded let my manager know as well as the provider and then spoke to the patient's parent and expressed my sincere apologies as to this incident. The mother was understanding and re assured the child would be ok but also highly advised for them to monitor the child for unusually high fever.
On 2/26/10 client noticed redness at site of injection. On 2/27/10 client noticed redness, swelling, warmth and pain at site, along with a lump the size of a 50 cent piece. Client advised to follow-up with PCP per RN.
No additional AE information provided; lhe patient was administered an improperly stored dose of ROTATEQ on 3/10/2020.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical condition, current condition and concomitant medication were not reported.  On 10-MAR-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (orally, lot#1660112 with expiration date: 18-OCT-2020; dose, strength and frequency were unknown) for prophylaxis. No additional adverse event (AE) information provided.  The vaccine was stored above 47 Fahrenheit (F) to 52.1F  for 15 minutes. The previous temperature excursion was above 47F to 55F for 21 minutes. The digital data logger was involved.
arm broke out/ flat rash; solid red rash; itchy rash; tingly rash; Fever; SC injection by her pharmacist, instead of an IM injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included covid-19.   On 27-AUG-2023, the patient received Arexvy (subcutaneous, right arm). On 27-AUG-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: SC injection by her pharmacist, instead of an IM injection). On 28-AUG-2023, the patient experienced fever (Verbatim: Fever). On 29-AUG-2023, the patient experienced rash (Verbatim: arm broke out/ flat rash), red rash (Verbatim: solid red rash), itchy rash (Verbatim: itchy rash) and prickly heat (Verbatim: tingly rash).  The patient was treated with hydrocortisone (Cortaid) and benadryl (nos) (Benadryl). The outcome of the fever was resolved and the outcome of the rash, red rash, itchy rash and prickly heat were not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the fever, rash, red rash, itchy rash and prickly heat to be related to Arexvy.     It was unknown if the company considered the fever, rash, red rash, itchy rash and prickly heat to be related to Arexvy.   Additional Information: GSK receipt date: 30 Aug 2023  The patient reported that she received the Arexvy vaccine 3pm and had some fever, up to 99.4, that lasted over the next few days (specific time range not provided). 2 days after the vaccination, the patient her arm broke out one day before the reporting day, in a solid red, flat, itchy, tingly rash, that is 3 inches wide and 8 inches long, on her right arm.  The patient was using topical Cortaid and Benadryl, both over the counter medications, to treat the rash, and has not seen her physician.  All the patient provided about these events were reported.  The patient reported that the pharmacist told her it was being administered as a subcutaneous injection.  The reporter consented to follow-up with health care professional. The reporter consented to follow-up. This is 1 of 2 linked reported, reported by same reporter. The patient received a dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route.
Patient reported on 02/11/2014 that immediately following vaccination she experienced pain in her left arm and neck and developed a headache. She stated these symptoms subsided after 24 hours. Reported still having soreness at the injection site. Denies any warmth, or redness. States not painful to touch. Feels as if muscle is "pulling" during certain activities. Reports difficulty sleeping due to discomfort. Interventions include Ibuprofen. Advised to report to PCP.
pt recvd vax;15-30 mins later,exp flu-like sxs & tingling in arm;4 hrs later low grade fever >100;sweating & clamminess,achy joints,nausea,& flushing on exertion;p/ 36 hrs,exp edema of face,particularly eyelids;
patient developed inflammation and redness above and below the right deltoid muscle where pneumovax 23 was injected. patient also had a lot of pain on the right deltoid. because the severity of the pain, patient had to go to ER.