chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe dizziness; Moderate nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 11:15 (Lot number: EP6955) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC ALLERGY. The following information was reported: DIZZINESS (non-serious) with onset 22Mar2021 16:00, outcome "recovering", described as "Severe dizziness"; NAUSEA (non-serious) with onset 22Mar2021 16:00, outcome "recovering", described as "Moderate nausea". Therapeutic measures were not taken as a result of dizziness, nausea.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19. The patient has no known allergies to medications, food, or other products.   No follow-up attempts are possible. No further information is expected.
Pt stated that the immunization was injected directly into some scar tissue on her upper left arm and the following evening (Dec 21st) she experienced pain and swelling and the area was hot to the touch and she developed an abscess. Pt also stated that it got worse over the next several days until on Dec 26th she pressed on the abscess and a bunch of fluid shot out. She went to her doctor and had the wound cleaned and he advised her to come and see me.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions. No treatment information reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU received with non significant information
This spontaneous report has been received from a registered nurse concerning three unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was unknown. On unspecified dates, the patients received a dose of PNEUMOVAX 23 (lot # N010106, expiration date 15-NOV-2018; dose and route unknown) for prevention, respectively. On unknown dates, the patients experienced "severe pain at injection site, severe pain in the arm of administration and swelling within 24 hours of administration". The patients did not seek medical attention and no treatment was given for the events. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and  PNEUMOVAX 23 was not reported.
Patient states feeling dizziness the morning after receiving  vaccine. He was unsure if the vaccine was the cause because at the time the dizziness occurred he had just taken a 45 minute very hot shower (which is longer than he normally takes) and thinks may have dehydrated him. He states lost his balance after the shower as he was getting out of the shower.  Did not report any other episodes of the dizziness.
Pt received COVID Pfizer vaccine on 4/5/21. Pt became COVID positive on 4/17/21. Pt hospitalized for COVID on 4/21/21
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:12 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 03-Apr-2021, Excursion time was 9 AM, temp was 34 , total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were moved to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1 , on 27-Feb-2021, Excursion duration At 8AM: 38  9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM : 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5PM: 41  Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient received vaccines in the morning.  Child went to daycare for the afternoon.  When mother was undressing the child that evening noticed hive like welts on chest and arms.  Child came in for appointment on 7 December where mother stated that the child developed more this morning.
Patient received her Moderna Covid Vaccination at 09:55am in her left deltoid. At 10:07 am, Patient complained of itching at injection site. Approximately two minutes later, Patient complained of itching on right arm, neck and across back. Dr was consulted. Patient was given 25mg diphenhydramine at 10:23am. Patient was given a second diphenhydramine 25mg at 1030am. Patient was discharged 10:38 am. Patient's husband will drive home. At time of discharge, itching has decreased. No throat swelling or redness. No hives.  I have left a voicemail for patient at 2:12pm.At the time of this report, I have not heard back from patient.
Swelling and tenderness around the mouth where dermafill products were injected into.  Dermafill was performed approximately 4 1/2 months ago.  The swelling and tenderness lasted for three days.  No treatments were used and resolved completely.
tested positive on 14Jan2021; tested positive on 14Jan2021; This is a spontaneous report from a contactable nurse (Patient's wife). A male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 26Dec2020 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She states that her husband, who is also an RN, got first dose of the vaccine on 26Dec2020, was exposed to Covid on 09Jan2021, experienced symptoms on 12Jan2021, and tested positive on 14Jan2021. She wants to know if he can still get the 2nd dose which he was originally scheduled to receive on 16Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Within 5 min of receiving HPV #3 in a semi-lying down position she started having some tremors and passed out. B/P at that time was 102/59 with a pulse of 49. She was pale around lips. She was more woozy then passed out. She was placed in flat supine position and given juice & crullers. She stayed supine for another 30 min. When she started to get up she fainted at that time. At that time her BP was 94/58, P = 40. She was observed over the next 30-35 min and her BP increased to 107/64 with P = 40. Color much better. She was observed over the next hour and a half with BP & P observed every 15 min. She was observed for 2 hrs since coming in with BP 112/68.
On 31Jan2022, she had fever and covid-19; On 31Jan2022, she had fever and covid-19; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2K-163-4265157-00.  A 19-year-old female patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 18 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Jan2022, outcome "recovering" and all described as "On 31Jan2022, she had fever and covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive, notes: On 31Jan2022, the patient experienced COVID-19. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "on 31jan2022, she had fever and covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The event indicating a lack of effect is assessed as related to the suspect drug bnt162b2 by the company, as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Dizziness, Headache, Bleeding, Myalgia, "lethargic"; "flush in face"; "difficulty sleepy"; "bloody nose"
right hand is swollen and is more painful. It radiates to her elbow; right hand is swollen and is more painful. It radiates to her elbow; right hand is swollen; was a little tired; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 17Feb2021 at 13:40 (Batch/Lot Number: EL9266) (at the age of 66-years-old) as dose 1, single for COVID-19 immunisation. Medical history included joint pain that started at the beginning of her thumbs and meets at the wrist (more in the right hand, has a little on the left); she had this issue before and it was probably arthritis; aching in her shoulder (she thought it might be from shoveling and she felt it before getting the vaccine); had half of her thyroid removed in Sep2014 or Oct 2014. Concomitant medications included levothyroxine sodium (SYNTHROID, 25 ug) taken for an unspecified indication from Sep2014 and ongoing. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient did not receive any additional vaccines on the same date of the vaccination. The patient experienced was a little tired 18Feb2021; right hand was swollen on 23Feb2021; right hand more painful, it radiates to her elbow on 25Feb2021. The adverse events did not require an emergency or physician visit. The outcome of event was a little tired was unknown; outcome of event right hand is swollen was recovering; and outcome of events right hand pain, it radiates to her elbow was not recovered.  No follow up attempts are needed; information on tot/batch cannot be requested. No further information is expected.
Dizziness, HYPOtension & Bradycardia Patient received the moderna vaccine at around 0750 on 1/5/2021. 0755 he reported feeling dizzy. Provider present, patient reclined. Pt PB approximately 70/35, bradycardic. 2L O2, Epi given. Brought to ER, BP increased to approximately 120/90 patient awake and talking.
COVID 19 Treatment; COVID 19 Treatment; 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 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "high BP" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID; METOPROLOL; ROSUVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Took covid test and positive results were immediate; (02Dec2022) positive, notes: Tested positive for covid on 02Dec2022; (12Dec2022) negative, notes: Tested neg for covid on 12Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: This is a notification generated from the system. As part of the simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in  Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 Adult 10 X 2.25 ml Multidose Bivalent Ba.1 Lot-# (CR): GJ5342 Conclusion of Previously Completed Investigation: The complaint for "Pfizer BioNTech Covid-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GJ5342. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. concluded that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. PR ID of Previously Completed Inv: 7704736.
Within 15 minutes of receiving the shot, I became extremely dizzy and lightheaded. I also had tingling and pain in the other arm from the wrist up to my neck. The medics took me into a room to lie down for 30 minutes and it seemed to pass. I have felt off and foggy for the past 3 weeks. And now for the past 3 days, I have been feeling the same feeling of lightheadedness and dizziness that I had after the shot throughout every day. I am sure this is related to the vaccine. I never had anything like this in my life. I did not take the second shot and still feel awful.  I have spoken to people who had the same immediate allergic reaction.
This spontaneous report was received from a pharmacist and refers to a 74-year-old female patient with an allergy to sulfa medications. No information regarding the patient's pertinent medical history or concomitant medications was provided. On 05-SEP-2017, the patient was intramuscularly vaccinated with one unspecified dose of PNEUMOVAX 23 injection (lot # N011305, expiration date: 20-JAN-2019) for the prevention of pneumonia. On an unknown date in September 2017 (reported as a few days later), the patient's arm was really inflamed and red. The patient sought medical attention and went to his doctor. There was an unspecified treatment given for the adverse events. The outcome of the events of "the patient's arm was really inflamed and red" was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. The reporter considered the events of "the patient's arm was really inflamed and red" to be life threatening. This is one of two report received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1709USA004758.
1-24-2021, 7:30 am. injection site swollen, red, hot to touch , and itching rash. Applied Cortisone cream, no results. 12:30 pm took two Benadryl, a little relief  9:45 pm took two Benadryl, better relief 1-25-2021, 1:45 am, took two Benadryl  7:30 am itching is better, took two Benadryl  12:30 pm reaction subsiding, still red, itching continuing to lessen
Diarrhea; Shortness of breath upon exertion; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and DYSPNOEA EXERTIONAL (Shortness of breath upon exertion) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL SODIUM gas for Secondary pulmonary arterial hypertension and TADALAFIL for an unknown indication.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 24-Nov-2020, the patient started TREPROSTINIL SODIUM (unknown route) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TADALAFIL (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and DYSPNOEA EXERTIONAL (Shortness of breath upon exertion). At the time of the report, DIARRHOEA (Diarrhea) and DYSPNOEA EXERTIONAL (Shortness of breath upon exertion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event ,was not provided.   Reporter did not allow further contact
SPANISH INTERPERETER USED:MOTHER STATES THAT ON THE DAY AFTER VACCINATION PATIENT DEVELOPED A RASH ON ABDOMIN AND UPPER LEGS. TEMP OF 100.3, LOSS OF APITITE, AND SORE THROAT.  SIMPTOMS RESOLVED EXCEPT FOR RASH.  MOTHER WAS ENCOURAGED TO TAKE CHILD TO A DOCTOR FOR FURTHER EVALUATION, AS ONE WEEK HAD PAST AND THE CHILD HAD NOT BEEN SEEN BY A DOCTOR.  MOTHER AGREED TO CALL A DOCTOR.
hyperpyrexia w/temp of 105.5 w/in 24hr has resolved w/APAP;
Got vaccine on 01/15/21 and on 01/16/21 around 11:30 pm I started having  rapid heart rate and shortness of breath. I also had a metal taste in my mouth. Before the rapid heart rate started, j bad chills, diarrhea and slight body aches. For about four to five hours my heart rate resting would be 60's and when a spell came on it would rise up to high 90's. It did this off and on every couple of minutes for about four to five hours. It was a very scary situation to be in: I can handle the chills, bod aches and diarrhea but when it comes to my heart rate bouncing around and taking my breath away, that was scary.
Pfizer-BioNTech COVID-19 vaccine- received a call from client at 1:45 PM, as she was calling to report something during the night she noticed that her lips had started to tingle. She does not report any other symptoms, but still feels a slight tingling sensation in her lips. 4/19/21 Called client states all symptoms resolved.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 1 day after receiving SHINGRIX, the patient experienced general body pain, stiff joint, mobility decreased, walking difficulty, exhaustion, chills, sweating, sleepiness and difficulty in standing. On an unknown date, the outcome of the general body pain, stiff joint, mobility decreased, walking difficulty, exhaustion, chills, sweating and sleepiness were recovered/resolved and the outcome of the difficulty in standing was recovering/resolving. It was unknown if the reporter considered the general body pain, stiff joint, mobility decreased, walking difficulty, exhaustion, chills, sweating, sleepiness and difficulty in standing to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX on the right arm. The next day after vaccination, the patient could hardly stand because the patient hurt from head to toe and all of her joints were stiff. The patient could not bend her toes and ankles and had trouble in walking. The patient was exhausted, slept almost all day for three days and had alternating chills and sweats. All the symptoms were lasted for three days. The patient stated that, each day the symptoms lessened in severity until they were all resolved within the three day time frame. The patient's physician told her not to receive the 2nd dose of the SHINGRIX. The reporter gave permission for her physician to be contacted. Unable to obtaine additional information. The reporter consented to follow up.