chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Mom here with child today with reaction in left leg (DTAP), not right leg (HIB) as mom had previously reported. Child saw MD today and placed on Keflex. She has swollen "bullseye" like area with red perimeter with white mid center. Child walking on leg without crying.
PT SLUMPED OVER IN CHAIR UNCONCIOUS, PALE, DID NOT EAT PRIOR TO VACCINATION. PT WOKE UP, SX RESOLVED, DRINK AND SNACK PROVIDED. REFUSED TRANSPORT.
woke that night with shooting pain down left arm went on to develop paresthesias of feet and hand, overtime symptoms have lessened now occasional waking in night with one or both hands feeling sensation of being asleep have to move them for sensation to pass, only happening in feet now with pressure on them or crossing legs, now experiencing periods of tachycardia with light exertion - unclear if this is abnormal or not will discuss with MD at next visit
Large red swelling at injection site, 4" x 2 1/2", tender to the touch, hot to the touch, whole right shoulder, right trapezius, right pectoral and right side of neck painful, ichy at site of injection. Onset of symptomatic side effects - seven-plus days following injection.
Red/brown color rash developed approximately 32 hours after injection at the injection site, right posterior upper arm. A well-defined 3 cm area of erythema with several vesicles of clear fluid developed after about 48 hours. Assessed by MD in PCP's office, who advised keeping area wrapped. By 72 hours, vesicles drained, crusted over and erythema improved.
Vaccination Failure; Herpes zoster with vesicles and lesions which were painful and itchy; Lesions; Painful lesion; Itchy; Vesicles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, skin lesion, pain, pruritus and vesicles. The patient was treated with capsaicin (Capsaicin Cream). On an unknown date, the outcome of the vaccination failure, herpes zoster, skin lesion, pain, pruritus and vesicles were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster, skin lesion, pain, pruritus and vesicles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received the two doses of the Shingrix vaccine about two years ago and about two weeks ago, the patient developed herpes zoster with vesicles and lesions which were painful and itchy. The patient was not prescribed any antiviral therapy. The patient only applied topical Capsaicin Cream.
my whole body hurt for an entire day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (my whole body hurt for an entire day) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A, 7758 and 19337) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (my whole body hurt for an entire day). At the time of the report, MYALGIA (my whole body hurt for an entire day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow-up received and contains no new information.
This is a spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 36-year-old, adult female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse reactions after vaccination. The reporter assessed this case as non-serious. This case (201805338) was cross-linked to the original case 201805327 reported by the same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (36-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
weird rash on hand; 13 Days after 1st dose, redness appeared on left and right hand.; 24 hours after that, blisters and increased redness occurred in the area. Tested negative for COVID19.  Took a bacteria culture of the; This is a spontaneous report from a contactable consumer.   A 21-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 13Mar2021 at 13:30 (Batch/Lot Number: EN6204) at the age of 21 years-old,  as SINGLE DOSE for covid-19 immunisation  .  Medical history included   from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported.  On 28Mar2021,  at 0900, 13 Days after 1st dose, redness appeared on left and right hand. 24 hours after that, blisters and increased redness occurred in the area. Tested negative for COVID19 on 27Mar2021.  Took a bacteria culture of the area which grew NO bacteria. Taking antibiotics which have no observed effect.  The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Caller and her mom experienced that veins are popping up on their arms after taking the Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VASODILATATION (non-serious), outcome "unknown", described as "Caller and her mom experienced that veins are popping up on their arms after taking the Covid-19 vaccine". Therapeutic measures were not taken as a result of vasodilatation. Additional information: Reporter states patient experienced that veins are popping up on their arms after taking the Covid-19 vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administration Error: This was an 11yr old female who receive the 0.3ml of Pfizer COVID Vaccine on : 09/20/21 & 10/18/2021 - Adult series complete on a Pedi pt.  No complaints from pt. and no reactions voiced.  Parent notified
This spontaneous report as received from a nurse practitioner refers to a 16 year old female patient. On an unknown date the patient was vaccinated with her first dose of GARDASIL (dose, route and lot # not reported). The nurse practitioner reported that on approximately 11-FEB-2014 (about 6 weeks ago), the patient experienced muscle weakness after receiving her first dose of GARDASIL. The muscle weakness resolved without treatment on an unspecified date in 2014. The patient made phone call to office for medical attention. No lab diagnostics studies were performed. Additional information is not expected.
No adverse reaction observed or reported by parent. Pt was to receive Hep A vaccine but was vaccinated with an additional Hep B vaccine by inexperienced MA.
Within a few minutes after vaccination, patient let us know that she was having difficulty swallowing, and numbness in her right fingers. She thought it may be anxiety. We had her check her blood pressure, it was initially in the 140's/99, at 4:52 it was 142-119, at 4:57 128/99, at 5:09pm 133/102 at 5:11pm 153/101  at 5:22pm 134/98. After having the patient sit and have some water the blood pressure started lowering and all her other symptoms resolved. When she departed after 5:22pm she said she felt perfectly fine, advised that her blood pressure is a bit high, but she did not know her "normal" so advised her to keep an eye on that
little bit of soreness in her arm; Dose 1 on 02Mar2021 and Dose 2 on 20Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 2, single (Lot number: ER8732) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "for bone density" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: 1980; FOSAMAX taken for bone density abnormal; FISH OIL; VITAMIN D3; MULTIVITAMINS [VITAMINS NOS]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN6199), administration date: 02Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Mar2021, outcome "unknown", described as "Dose 1 on 02Mar2021 and Dose 2 on 20Mar2021"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little bit of soreness in her arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200974944 same reporter/patient/product, different dose/AE;US-PFIZER INC-202200975336 same reporter/patient/product, different dose/AE;
Hives, rash.  Started 12 hours after vaccination.  Has continued another 36 hours, so far (time we're completing this form).  Patient usually has delayed allergic reactions.  For instance, anaphalatic peanut reaction took 12 hours.
REAL COUGH; CONGESTION/NASAL CONGESTION; FEELING ACHY, BODY ACHES; COULD NOT THINK RIGHT NOW; FEELING ILL; NAUSEA; HEADACHE; FEVER; THREW UP; FEELING FOG,FEELING ALL CLOUDY; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (reporting on herself) concerned a 50 year old white female. The patient's weight was 200 pounds and height was 68 inches. The patient's concurrent conditions included: alcohol user (every once and a while) and non-smoker. The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient was not pregnant at time of reporting. The patient mentioned that she had no other known medical conditions. The patient also stated that she had covid twice once on Aug-2020 (pre-vaccination).The patient stated that she was told by her doctors that she had covid-19 on AUG-2020 but she had not tested positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported,1 total administered on 31-MAR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that on JUL-2021, the patient became symptomatic and tested positive for covid-19 and she experienced symptoms as nausea, body aches, headaches, congestion, nasal congestion but she did not had fever and real cough and stated that she threw up (coded as suspected covid-19 infection, suspected clinical vaccination failure).The patient also stated that the symptoms from her infection with covid-19 in JUL-2021 was resolved in early AUG-2021 and she was feeling ill again at the time reporting. On 21-SEP-2021, the patient experienced achy and suspected that she had covid-19 and was awaiting for the test results that she performed on 21-SEP-2021. Later patient experienced foggy feeling and mentioned that this 'COVID business' makes all cloudy. She also stated that she could not think at the time of reporting. The patient recovered from suspected covid-19 infection on AUG-2021, had not recovered from feeling fog,feeling all cloudy, nausea, feeling achy, body aches, headaches, congestion/nasal congestion, feeling ill, fever, real cough, threw up, and could not think right now, and the outcome of suspected clinical vaccination failure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition). This report was associated with product complaint (PQC): 90000194338.; Sender's Comments: V0: 20210944635-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. 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: SPECIAL SITUATIONS
Patient seen for annual wellness visit  We had documentation of Covid boosters given in April and May 2021 in our EHR, but no booster documented. Database was reviewed. Documentation of vaccine booster was not present.  He was offered, recommended, accepted, and recieved the booster dose.  Afterwards it was noted in database that he had received a booster on November 3, 2021 at an outside office there fore he received a 4th dose from our office on this day. Pt had no adverse reaction.
6 coworkers were very sick after the injections; This is spontaneous report from a non-contactable other HCP. This Other HCP reported similar events for 6 patients. This is 3rd of 6 reports. A patient of unspecified age and gender received the second dose of BNT162B2 via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter explained that 6 coworkers were very sick after the injections on Jan2021. The reporter did not share any symptoms. Rather, reporter noted that they were miserable the day after, and were all now back at work today. Event outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076551 Same drug and event, different patient
J&J COVID-19 Vaccine EUA.  I experienced severe heartburn for 12 days following the Janssen vaccination.  Heartburn was painful and continuous but exaggerated by certain foods.  Normally I never have heartburn.
pt recvd vax w/t102 2 days p/vax; pt listless, unaware of surroundings, eyes rolled back (all according to mom); pt seen @ clinic dx ear infect;
On 3/1/21 a used vial of  vaccine was reconstituted again with sodium chloride, they were reconstituted in error and patient received diluent only immunization. The immunization administered that day was not effective in providing protection against COVID.   Patient did not have any adverse reaction to the sodium chloride and returned on 3/8/21 to receive the correct dosage of  vaccine.
I had terrible red eyes and they watered bad. I was going on a trip and then mid-week I decided to go have them seen. I went to the ophthalmologist, and he determined that it was a allergy in my eye. He prescribed eye drops and it cleared up about 3 days of using the eye drops.
Pt experienced worsening of tinnitus after vaccination. Slowly improving now. Also experienced headaches after vaccination, also improving now.
She experienced ear sensitivity to high pitch noises; severe headache; not feeling well after that night; tightness around neck, chest, arm again; could not eat or drink water for 43 h; could not tolerate anything; could not eat or drink water for 43 h; felt week; felt extremely dizzy and nauseated; felt extremely dizzy and nauseated; auras; arm hurt a lot; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. Medical history included migraine neurologic condition not diagnosed yet, but she gets migraines often. The patient's concomitant medications were not reported. It was reported that She experienced ear sensitivity to high pitch noises. She felt ok during the first night, not feeling well after that night. She had on the second day after the second dose severe headache that she catalogued as extreme. She felt tightness around neck, chest, arm again, could not eat or drink water for 43 h, could not tolerate anything. On Saturday 54 h later from the vaccinate in bed for 24h straight, she felt week when she raised up and that afternoon, she got a lot of auras when she went to do the grocery and also felt extremely dizzy and nauseated. On Sunday Morning her body did not want to drink water and she did not eat until 3 pm; her arm hurt a lot and at 6 pm auras started again. She experienced for both doses water retention. She said that if she would know what the vaccine would do to her, she would have not been vaccinated with the Pfizer vaccine. She wanted to know how the vaccine works so to know if it overrides your system to product antibodies. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe bilateral headache and chills with nausea and unlike any headache I have ever had. Treaty with Goody headache powder, 2 vicodin and 16 hours of sleep. Outcome, it went away though I missed a day of work.
Eyes itch and swell by noon.  Vision problems, vomiting and diarrhea and cold sweats by 3:00 PM.  Disorientation, fast pulse and trouble breathing by 4:30 PM.  Called doctor told to go to ER, called ambulance right after that.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: Adverse event: Frequent sneezing, slight body ache start was 20May2022 and patient recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed severe rash (contact dermatitis) of 80% right upper extremity, left upper extremity, face and right thigh.
No problems until into the 2nd week. My shoulder and upper arm started feeling sore at first and then it started tingling , almost feeling like A mild Electric shock ,it continued from the time it started and has gotten progressively worse. It?s now giving me painful nerve tingling up and down the entire length of my left arm into my hand and the tips of my fingers. At times I lose the ?grip strength? in that hand and the ability to lift anything more then a pound or two with that arm. That lasts for anywhere from a few minutes to an hour or so. My P C doctor told me it was not related to my COVID shot. I told him I have never had this kind of feeling in my arm In my entire life
Respiratory infection; Foggy feeling in head; Productive cough; drainage; Generalized rash; This is a solicited report based on information received by Pfizer from a regulatory authority (Mfr. Control No.: 21K-163-4107716-00). A contactable consumer (patient) reported that a 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 18Sep2021 (vaccination age was 29 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) at Citrate free for moderate to severe chronic plaque psoriasis.  The patient's medical history and concomitant medications was not reported. In 2021, the patient experienced rash over entire body from vaccination. On 18Sep2021, the patient experienced brain fog felts like had since covid vaccination and sick with respiratory infection, coughing (Productive cough), drainage ongoing since vaccination. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The action taken in response to the event(s) for adalimumab was unknown. The outcome of generalized rash was recovering. The outcome of Productive cough, drainage and Respiratory infection was not recovered. The outcome of Foggy feeling in head was recovered with sequel in 2021  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: The event of Productive cough, drainage and Respiratory infection, Foggy feeling in head are assessed as possibly related to the suspect vaccine Comirnaty based on strong temporal association. As there is limited information in the case provided, the causal association between the event (generalised rash ) and the suspect drug cannot be excluded but consider also medical history of psoriasis.   "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."