chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves two adult patients (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number, expiry date was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was not reported whether the patient experienced any adverse events. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
felt dizzy; Vertigo; This is a spontaneous report received from a contactable consumer (patient) via Pfizer Sponsored Program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 28Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 07Feb2021 for COVID-19 immunization. On an unspecified date in 2021, patient experienced felt dizzy, vertigo. Therapeutic measures (aspirin, tylenol and pills) were taken as a result of felt dizzy, vertigo. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Unresponsive; A spontaneous report was received from Pfizer concerning a 50-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  intramuscular for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 31 Dec 2020. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: This case concerns a 51 year old, female patient, who experienced an unexpected event of Death, after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. There is no contact information and no further follow up information is expected.; Reported Cause(s) of Death: unknown cause of death
This spontaneous report as received from a pharmacist refers to a 62 years old female patient with morphine, codeine and PERCOCET allergy. The patient was vaccinated with ZOSTAVAX (lot #672676/0069AE, expire date 03-APR-2013) subcutaneous on 20-JUL-2012. There were no co-suspects or concomitant medications. On 20-JUL-2012, 45 minutes after the injection, the patient developed itch and swelling at the site of injection. No treatment was given. No Laboratory diagnostics studies performed. The outcome of itch and swelling at the site of injection was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
pt recv vax 17OCT95 & by 2PM arm was stiff & by 3PM it was too painful to work;tx w/APAP & moist heat;pain w/movement cont for about 1wk, & soreness cont for 3wk;
The individual test positive for Covid-19 today 01Nov2023; The individual test positive for Covid-19 today 01Nov2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, latency 20 days after the suspect product(s) administration, outcome "recovering" and all described as "The individual test positive for Covid-19 today 01Nov2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2023) Positive. Clinical course: It was unknown if patient received other Vaccine in Four weeks and other Medications in Two weeks. The Individual Test Positive for Covid-19 Today 01Nov2023 With Sinus Congestion, Sneezing, And Sore Throat. 20 Days After Vaccination. Patient did not have Covid Prior Vaccination and Covid Tested Post Vaccination. It was unknown if patient had any known Allergies and other Medical History.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353883 Same patient, different vaccine dose number, different AE;
Oral inflammation, burning, bumps on her tongue, canker soars. Still feels a little irritated but better. has taken benadryl and used ambesol and mouth wash.
Pt experienced cold sweats, tremors, confusion, tingling sensation, slurred speech, and LOC with post-episode exhaustion.  This episode occurred 12-24 hours after the first dose (4/19/21) and the second dose (5/10/21).
Parent reports vomiting starting evening of vaccine with rash and diarrhea 6/10/22. Vomiting and diarrhea resolved 6/11/22. Rash worse morning of 6/11/22, consistent with erythema multiforme. Parent adminsitered Benadryl without improvement.
no other symptoms or adverse effects; Caller is a nurse who reports GARDASIL 9 given today, but expired yesterday 04/03/2022. Vaccine had no temperature excursions. Potency was supported by Post-Expiry Memo. Caller reported patient had no other symptoms or adverse effects. No other infor; This spontaneous report was received from a registered nurse and refers to a patient of unspecified age and gender. Pertinent medical history, current conditions, concomitant medications, past rug reactions or allergies were not reported.  On 04-APR-2022 (also reported as "today"), the patient was vaccinated with an expire dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (ml) with a frequency reported as "today" (vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number S028738 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 03-APR-2022) as prophylaxis (expired product administered).  It was reported that the vaccine had no temperature excursions and that the potency was supported by Post-Expiry Memo.  No other symptoms or adverse effects (no adverse event) (also reported as "no other AE") were reported.
DEATH; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a company representative via Manufacturer on 16-JUL-2021 concerned multiple patients. Initial information was processed along with the additional information received on 21-JUL-2021. The patient's height, and weight were not reported.  Two patient's over 80 years old had underlying health issues, and pre-existing medical conditions of other 8 patient's were not reported.  The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 in total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, two patient's over 80 years old died from an unknown cause after being hospitalized, and eight patients also required hospitalization (hospitalization date unspecified). All patient's had contracted the virus more than two weeks after being fully vaccinated. The cases are confirmed with a positive test COVID-19 (coronavirus disease) (confirmatory test was not reported) (suspected covid 19 infection). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of suspected covid 19 infection was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint, 90000186727.; Sender's Comments: V0 20210741034-COVID-19 VACCINE AD26.COV2.S-Death  and suspected covid 19 infection. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
On 01/05/2021 patient noted itching at the injection site and a bumpy patch. Then on Wednesday morning she noted redness and a knot at the injection site. She has been taking ibuprofen to try to help symptoms. She did have discomfort at the site but can use her arm normally per her report.
1. Viral laryngitis  2. Viral pharyngitis  3. Cough  4. Sore throat
Numbness in left arm and leg increasing over several hours  Additional medications not fitting in #9:  Crestor, famotidine latanaprost eye drops, dorzolamide HCl/timolol maleate eye drops
Heart palpitations especially bad the first evening, then very slight over the next 5 days. At this time, no further symptoms.
Swollen gland under my arm  that received the shot; Achy; Tired; Slight headache; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Shingrix. On 8th September 2021, 1 days after receiving Shingrix, the patient experienced pain, tiredness and headache. On 9th September 2021, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the pain, tiredness and headache were recovering/resolving and the outcome of the axillary lymph nodes enlarged was not recovered/not resolved.   It was unknown if the reporter considered the pain, tiredness, headache and axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received vaccine two days before the reporting date and felt achy, tired and had a slight headache one day after vaccination. On the morning of the reporting date, the patient woke up feeling better but had a swollen gland under their arm that received the shot.  The patient was asking if this was a normal reaction.
Excess energy immediately following the vaccine;  diarrhea starting about 16 hours after the vaccine; general metal fogginess (as expected).  But NOTHING SERIOUS.
This spontaneous report as received from a pharmacist refers to a over 60 years old female patient. On 13-DEC-2013 (reported as 3 days ago) the patient was vaccinated with a standard dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot number and site of administration were not reported). On 16-DEC-2013, the patient came back to the pharmacy and presented with egg shaped lump at the injection site. There was no treatment given for the adverse event. The patient sought medical attention via coming back to the pharmacy. The outcome of egg shaped lump at the injection site was reported as not recovered. The relatedness between vaccination with ZOSTAVAX and egg shaped lump at the injection site was not reported. Additional information has been requested.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 78 years old male patient who had a fluzone high-dose injection to a patient that has an egg allergy, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history included egg allergy. On an unknown date, the patient received a  0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ023AA, expiry date- 25-Apr-2019. It was a case of contraindication to vaccination. (Other relevant tests included No lab test.) Final diagnosis was gave a fluzone high-dose injection to a patient that has an egg allergy. Patient had experienced no side effects at this time.
Five minutes after receiving injectable H1N1 vaccine, developed dry cough & generalized itching.
Information has been received from a "healthcare worker" concerning a female (patient 2 of 4), either 14 years or 17 years old, who was vaccinated with the first dose of Gardasil (yeast) 0.5 ml IM in the gluteal region. The patient experienced "knots in her neck and ill feeling" one to two weeks after receiving the vaccination. The healthcare worker noted that the patient was being treated for "something else that had absolutely nothing to do with the vaccination". This patient "had no problems". Additional information has been requested.
Heart palpitations; Pressure in chest when exercising; Pain in chest when exercising; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration  in the left arm on 18Jun2021 at 09:00(at the age of 26-years-old) as a single dose for COVID-19 immunisation. No medical history or known allergies reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication of the patient included finasteride (MANUFACTURER UNKNOWN); on an unknown date, for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jul2021, at 10:00, the patient experienced heart palpitations, pressure and pain in chest when exercising.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events heart palpitations, pressure in chest when exercising and pain in chest when exercising was not resolved at the time of this report.
A few days after I recieved first Vaccine I was shopping, and could barely push the cart half way through my shopping, I was exhausted by the time I made it home, and  went straight to bed, leaving my groceries on the floor until I could get energy to put them away. I am constantly tired, and doing the smallest activity exerts so much energy. I was finally able to get in for a physical, and the blood test results which showed I am low on Iron. I have not been low on iron since I went through the change of life, over 10 yrs ago. I have been giving blood on occasion, and my iron has been fine up until recently. I will start taking iron as soon as it arrives. I have been trting to eat more iron fortified foods.
Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient who received ADACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The last menstrual period and estimated date of delivery was not reported. At the time of vaccination the patient was pregnant. Lab data not reported. It was unknown if any adverse event occurred. Documents held by sender: none.
Patient received Pfizer Bivalent booster on 1/6/23, which was unnecessary due to having received the Moderna Bivalent booster on 9/18/22.  Patient does not have additional risk factors that would warrant the additional bivalent booster at this time.
Had 105 fever & vomiting 1 time during the night; Father had given APAP for fever; Felt vomiting was fr ice cream had a/going to bed; OK by next morning;
Our clinical team was at a company's health fair giving COVID-19 vaccinations. The patient stated she had received her primary series, but had not received her first booster vaccination. The card presented did not have a booster vaccination listed, only her primary series.  After the clinic, our billing department discovered the patient had received her first booster already and did not disclose that information. She is only 31 and is not immunocompromised, therefore she was not eligible to receive another dose.
On 02/08/2023 I was coughing and ran a fever. I tested positive for COVID-19 on same day. Also, same day I had a telehealth visit with provider and provider prescribed Paxlovid. I then had more coughing, fever and fatigue.  On 02/15/2023 I tested negative for COVID-19 but still running fever for 2 more days. I am still experiencing fatigue.  I also have severe allergies and vision loss. I have made follow up appointments with doctors for treatment. I also have gained weight due to being tired and not being as active as before.
CHILLS; HEADACHE; SEVERE NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced severe nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe nausea, and the outcome of chills and headache was not reported. This report was non-serious.
The patient was inadvertently administered 0.25 ml of Moderna instead of 0.5 ml Moderna second dose in primary series. Patient were monitored 15 minutes without issue and left clinic. Error noticed during data entry into Roster.  Medical provider notified and recommended the following. CDC recommendations of another 0.25 ml injection be given on the same day for optimal benefits. If patient refuses to come back for this dose, CDC will recognize 0.25 ml as an adequate second dose in the primary series. Therefore, in 6 months patients will be eligible for booster dose of 0.25 ml in 6 months.  Patient notified and returned the same day. An additional 0.25 ml dose of Moderna was administered to the patient. Patient was monitored 15 minutes without issues.
This spontaneous report was received from a registered nurse via a company representative concerning an approximately 30 year old (reported as in their 30s) patient. On 14-DEC-2012, the patient was incorrectly vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route unspecified). No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
Mar. 24, 2022 @ 1542 pt. reported that she is experiencing a rash on her face and neck with no other symptoms.  She had received her 3rd and final dose of Hepatitis B vaccine on Mar. 22, 2022.  Upon follow-up at 1749, she stated she was home, her symptoms have remained the same and she had just take over-the-counter Benadryl.  Mar. 25, 2022 @ 0736 upon follow-up, pt. stated she had taken a total of 2 Benadryl and the rash has gone away.
Both times I got vaccinated I had/had horrible diarrhea my skin burns and my eyes hurt
Mild Swelling of right arm; Mild Chills; Pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in right arm), VACCINATION SITE SWELLING (Mild Swelling of right arm) and CHILLS (Mild Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Pollen allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for COPD.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in right arm), VACCINATION SITE SWELLING (Mild Swelling of right arm) and CHILLS (Mild Chills). At the time of the report, VACCINATION SITE PAIN (Pain in right arm), VACCINATION SITE SWELLING (Mild Swelling of right arm) and CHILLS (Mild Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included nasal spray with antihistaminic for pollen allergy No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
Hives; His body was red; Allergic reaction to Covid vaccine ingredient; This is a spontaneous report from a contactable consumer(patient's mother). A 23-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 28Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunization. The patient's medical history and concomitant medications reported as none. On 29Mar2021, the patient had an allergic reaction to the first vaccination of the Covid vaccine Pfizer (Couple of hours after), he broke out with hives, his body was red, so he went to an allergist, they did confirm that he was allergic to one of those ingredient (Covid vaccine) and allergist said he should not get his second vaccine, so he was not able to do that (second vaccine). No doctor prescribed the vaccine, he just found it online. Events lasted 2-4 days. He was recovered at the time of the report but he was scheduled to get his second shot this but the allergist told him, he should not get the second shot. The patient did an allergy test determined to see he was allergic to ingredient of Pfizer vaccine, just one test two days before. The patient had not taken any treatment for the allergy (event). The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
On the day after I got my fourth dose, I experienced an elevation of heartrate and blood pressure. On 11/9/2022, I took my BP in the morning, and it was 152/71; my BP was in the 120s-135 range prior to the fourth dose. My heartrate was 86 that day; my heartrate is normally in the 60s-70s. I also had extreme fatigue and stayed in bed all day. On 11/10/2022, I took my BP at 7:28AM; my BP dropped to 128/74, and my heartrate had dropped to 79. I stayed in bed for most of that day, because I still felt wiped out. I then got up and had a light meal. On 11/11/2022, I went to bed at 6:30PM.  On that day, my BP was 129/71 with a heartrate of 73. On 11/12/2022, my BP was 124/71 with a heartrate of 72. On 11/13/2022, my BP was 143/84 with a heartrate of 75. On 11/14/2022, my BP was 149/82 with a heartrate of 67. On 11/15/2022, my BP was 145/77 with a heartrate of 65. On 11/16/2022, my BP was 150/80 with a heartrate of 65. On 11/17/2022, my BP was 149/81 with a heartrate of 61.