chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I wasn't sure how to indicate which dose I'm reporting on.  It's my second dose of a vaccine but my first of Johnson & Johnson.  My first shot for Covid-19 was a Moderna shot, to which I had a bad reaction (immediate and prolonged lightheadedness reported already on this site).  My doctor advised me that my second dose should be a Johnson & Johnson vaccine, as per information he had received from the CDC.  So, 28 days after the first shot I had the Johnson & Johnson vaccine.  I experienced the expected side effects of body aches, chills, headache--no big deal on day 2, but on day 3, I started some lightheadedness, as did my daughter who had the shot the same day.  Her lightheaded subsided the next day, but mine continued into day 4 and got worse when it became accompanied by pressure in my head/ears, and it felt like I was talking in a tunnel with echoing.  I couldn't function the rest of the day.  Today, the head pressure is not there, but the lightheadedness and shakiness are still there.  I hope I fully recover from these shots, but I don't have a lot of hope.
hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 031L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Allergic to: Sulfa), Drug allergy (Codeine), Shellfish allergy, Lactose intolerant and Allergy to arthropod bite (sensitive to bug bite).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at a dose of a shot. At the time of the report, URTICARIA (hives) had resolved.            No concomitant medication was reported. After the 2nd shot, the patient had an allergic reaction. The patient had hives on pressure points, then it spread all over the body, and came together, it was itchy, raised and red. The patient took Benadryl but it did not work. The patient went to the emergency room and they gave a shot of prednisone and it went away. The patient took the first monovalent Booster, dose 3 on 01-Feb-2022 (Lot 037F21A & Exp. Date unknown), 2nd monovalent booster, dose 4 on 28-Apr-2022 (Lot 046L21A & Exp. Date: unknown). and bivalent Booster, dose 5 on Dec-2022.   Reporter did not allow further contact
Chronic hives and welts -urticaria accompanied with swollen upper lip, abdomen cramps, pain of dull and sharp pain with feeling like intestines are on fire, and vomiting. Symptoms continue to spread and worsen with treatment of Zyrtec and Pepcid. CT scan ordered along with multiple blood tests for possible allergies, urine tests and tests ran for Mast Cell Activation.
After vaccine administration, patient reported erythema and possibly mild blistering that occupied much of the upper arm where vaccine was given. Patient treated with acetaminophen and diphenhydramine and applied ice to area. Symptoms had improved after 3 days.
Information has been received from a certified medical assistant concerning a 20 year old female, who in May-2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient developed vaginal bleeding for about a month. On 23-JUL-2007 the patient was vaccinated intramuscularly with a 0.5mL second dose of Gardasil. Subsequently, the patient developed vaginal bleeding again. The patient was not due for menses. At the time of the report, the patient's outcome was unknown. The physician felt that the vaginal bleeding was unrelated. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a certified medical assistant concerning a 21 year old female, who on 16-MAY-2007 at 11:20 was vaccinated in the left deltoid with a first dose of GARDASIL (Lot# 657736/0389U). On 16-MAY-2007 at 11:20 the patient developed vaginal bleeding for about a month. On 23-JUL-2007 at 11:15 the patient was vaccinated intramuscularly in the left deltoid with a 0.5mL second dose of GARDASIL (Lot# 658222/0927U). On 23-JUL-2007 at 11:15 the patient developed some spotting for 1 week that was not related to her cycle (also reported as vaginal bleeding). The patient was not due for menses. The physician felt that the vaginal bleeding was unrelated. Additional information is not expected.
diagnosed with COVID; diagnosed with COVID; Nausea; large cold sore on lip and a canker sore on the roof of the mouth; large cold sore on lip and a canker sore on the roof of the mouth; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 16:30 (Batch/Lot Number: ER8731) at 47-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  Medical history included COVID-19 from an unknown date and unknown if ongoing (also reported as none and if COVID prior vaccination: No). The patient had no known allergies. There were no concomitant medications. On 13Apr2021 at 20:30, the patient experienced: large cold sore on lip and a canker sore on the roof of the mouth (non-serious). On 18Apr2021 at 09:00, the patient experienced: nausea (non-serious). On 05May2021, the patient was diagnosed with COVID (medically significant). The events, large cold sore on lip and a canker sore on the roof of the mouth and nausea, required a physician office visit; however, no therapeutic measures were received. The clinical course was reported as follows: Four hours after the injection, the patient developed a large cold sore on her lip and a canker sore on the roof of her mouth. On 18Apr2021 at 09:00 (also reported as five days later), the patient began experiencing nausea that she was still experiencing 18 days later. The patient was then diagnosed with COVID on 05May2021. The patient underwent lab tests and procedures which included Qualitative PCR (Nasal Swab): positive   on 05May2021. The clinical outcome of the events: large cold sore on lip and a canker sore on the roof of the mouth and nausea, was not recovered. The clinical outcome of the event, diagnosed with COVID, was unknown.
I am and was post menopausal and a few days after my vaccination I had a full period which lasted 5 days.  I have not had another period since.
Patient received monovalent Pfizer as a booster dose instead of bivalent Pfizer
Body aches , chills, headache and low grade fever started on Saturday 11/6. When temp goes up to 100.1, I would take take tylenol because I'm scared to get high fever because I'm pregnant. I am 27 weeks pregnant, EDD: 2/2/22. Currently still having the same symptoms as described above.
Sore arm, unable to lift arm above shoulder after 12 hours Body aches after 24 hours  Low grade fever after 36 hours
Neck has been hurting; My head hurts; Bad back pain down my spinal cord; some back pain in my body; This is a spontaneous report from a contactable male consumer reported for himself. A male patient of unspecified age received an unknown dose of bnt162b2 (Pfizer COVID-19 Vaccine, Solution for injection, Batch/lot number: EW0168, Expiration date: Unknown), via an unspecified route on an unknown date (Sunday), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient neck has been hurting, his head hurts and he got bad back pain down his spinal cord, some back pain in body too bad and he 'haven't been currently taken anything (voice feeble). The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient  developed sudden onset of myalgias, nausea, vomiting, abdominal pain, fever, RLQ pain and chills on afternoon of 2/23/05. Yellow fever vaccine was administered on 2/22/05. Patient hospitalized on 2/24/05 and an appendectomy was performed. Patient discharged next day without complications.
Developed a large red swollen area at the side of injections. Developed multiple large hives. Experienced a severe exacerbation of hip pain. Fatigue
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age and ethnicity received second dose of PREVNAR 13, via an unspecified route of administration on 30Apr2018 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) for immunisation on unspecified date. On an unspecified date, it was reported that the patient's arm was extremely sore and  developed soreness/body aches all over. The outcome of the event 'soreness/body aches all over' was recovering (reported feeling better at the time of this report) and not recovered for 'arm is extremely sore'. Information regarding batch number and expiry date has been requested.
minor rash on left ankle with minor swelling. Pt taking diphenhydramine and applying ice.
Pt. received Pneumovax 23 on 10/26/08.  Later that evening arm swelled on upper arm for approximate 2-3 inches around injection site.  Wife was concerned with swelling.  This was reported on 10/30/08 and swelling had subsided
Body aches, pain and soreness at injection site, headache, mild temperature. Symptoms lasted 24 hours
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium.
Developed SOB on 8/2/2021. COVID-19 testing negative. Was seen at urgent care on 8/4/21 for SOB and cough  given albuterol inhaler and steroid, Presented to ED on 8/6/2021. She had wheezing on physical exam and an elevated D-dimer. She was diagnosed with pneumonitis and discharge home
3 days after administration, patient experience numbness down Left arm, pain/soreness starts on area of vaccine, travels down outside of left arm to the wrist, no radiation upward.
Metallic taste then tongue tingle then skin turned red the throat tighten up and tongue felt enlarged.  Lasted 4 hours.
Paxlovid as Treatment of COVID-19; Paxlovid as Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 12:00 as dose 6 (booster), single (Lot number: GJ3275) at the age of 69 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 at 10:00 as dose 1, single (Lot number: EN6205), in left arm, on 26Mar2021 at 10:15 as dose 2, single (Lot number: ER8732), in left arm, on 18Aug2021 at 09:30 as dose 3 (booster), single (Lot number: FC3180), in left arm, on 24Jan2022 at 13:00 as dose 4 (booster), single (Lot number: 33025BD), in right arm and on 13Jun2022 at 10:00 as dose 5 (booster), single (Lot number: FN2908), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Diltiazem, reaction(s): "Known allergies: Diltiazem"; Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Paxlovid as Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 31Jan2023 to 05Feb2023.
Pt recvd vax & 3 days p/inject devel large, red, splotchy rash over entire body; rash subsided in 7-10 days;
This spontaneous report was received from a physician via a company representative concerning a 2 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of 2 milliliter (ml) of ROTATEQ (lot number and expiry date unspecified), orally as per the schedule. No concomitant medications were reported. On an unknown date, the patient was hospitalized for rotavirus. The patient sought medical attention. An unspecified treatment was provided. The outcome of the event was unknown. This is one of the two reports from the same source. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Engerix B for prophylaxis.  On an unspecified date the subject completed the Engerix B vaccine series.  It was reported that two pediatric Engerix B doses were given at each administration of the series so that the dose totaled 20 mcg/1 ml from two 10 mcg syringes (the adult Engerix B dose).  This was considered to be a medication error.  The subject was also tested and found to have not responded to therapy.  At the time of reporting the outcome of the events was unspecified.
I felt intense pain in my lower abdomen towards the right side; difficult to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: EW0158) at the age of 20 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "known allergies: Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts, pistachios, augmentin; "known allergies: pistachios" (unspecified if ongoing), notes: known allergies: Peanuts, pistachios, augmentin. The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "known allergies: augmentin", notes: known allergies: Peanuts, pistachios, augmentin. Vaccination history included: Bnt162b2 (lot number=EP6955, lot unknown=False, administration time=01:45 PM, vaccine location=Left arm, dose number=1), administration date: 20Mar2021, when the patient was 20 years old, for COVID-19 immunisation, reaction(s): "My period came a week earlier than it was supposed to". The following information was reported: ABDOMINAL PAIN LOWER (non-serious) with onset 12Apr2021, outcome "recovered" (13Apr2021), described as "I felt intense pain in my lower abdomen towards the right side"; INSOMNIA (non-serious) with onset 12Apr2021, outcome "recovered" (13Apr2021), described as "difficult to sleep". Therapeutic measures were taken as a result of abdominal pain lower, insomnia.  Additional information: Patient took ibuprofen and tylenol around the clock and she was not sure if reported events were connected to receiving the vaccine. Covid prior vaccination: No. Covid tested post vaccination: No. Other vaccine in four weeks: No.  No follow-up attempts are possible. No further information is expected.
I couldn't move for about 4 hours, I was slight paralyzed laying on the floor; IV (intravenous) by needle; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (BNT162B2), dose 2 intravenous (at the age of 78-years-old), administered in Deltoid Left (reported as left shoulder) on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 78-years-old), administered on 22Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient stated, "I received my second Pfizer shot (captured as Unspecified medication) on Monday (15Mar2021) and on Monday night (15Mar2021) I woke up on the floor and I couldn't move for about 4 hours, now finally got back into the bed by 5 o'clock in the morning and I was slight paralyzed laying on the floor and I felt it. You may did know about this because it is probably related to the vaccine. They have improved drastically (events), after yesterday I tried to get some sleep because I laid on the floor for 4 hours, but today I feel alright." The route of administration was "IV (intravenous) by needle." No treatment received for the events. The outcome of the events "I couldn't move for about 4 hours, I was slight paralyzed laying on the floor" was recovered on an unspecified date. The event Paralyzed was considered as serious (medically significant).  Information about Batch/Lot number has been requested.
Caretaker states pain, erythema, and tenderness developed at sites of vaccines given 3 days prior to ER admission at hospital. Erythema & warmth surrounding injection site on (R) thigh, and both arms. Fever for one night, Temp of 103.3 degrees F. Vaccines given 3/25. Seen by PMD and started on KEFLEX & BENADRYL on 3/27 erythema worsened since 3/27, especially on (R) thigh.  5/8/09 MR received for DOS 3/29-30/2009 with D/C DX:  Allergic Reaction to vaccine.  Cellulitis.  Obesity.  Asthma. Pt presented with redness and swelling at injection sites on the bilateral arms and R thigh with fever. Initially prescribed abx and benadryl by PCP but continued to worsen.  PE (+) for above with tenderness and warmth as well. Admitted for IV abx. D/C improved next day on oral abx.
Mild erythematous rash to face and R arms/itching. Tx: Benadryl/Tylenol/Motrin prn.
Headache, severe congestion, sore throat, body aches, fatigue, joint aches.
Headache, light bruising, fever, stiff neck, redness and hard know appeared post 24 hours.
Patient reported swollen, red, itchy arm, but stated it was "getting" better on day of report.
Patient stated left eye completely closed, eyes drooping, , burning eyes, foggy vision. Hearing affected. Swelling in throat and tongue
PFIZER VACCINE WAS PLACED IN FREEZER 05062021 AND DUE TO BE MOVED TO REFRIGERATOR 05192021.  VACCINE WAS LEFT IN FREEZER UNTIL 05212021 THEN MOVED TO REFRIGERATOR.  THE IMMUNIZATION PROGRAM WAS NOTIFIED OF ISSUE ON 05252021 AND SENT EMAIL STATING  VACCINE AS SAFE TO USE .   05272021 IP EMAILED  VACCINE WAS NOT SAFE TO USE AND TO DESTROY THE VACCINE.  THEN IP EMAILED 05282021 THAT PFIZER PHARMACIST HAD DEEMED VACCINE STABLE AND IT WAS SAFE TO USE SO DOSES GIVEN 05252021 WERE GOOD.
encephalopathy: seizures, 5-6 episodes during 1st 24 hrs
Had an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003379. A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "Had an allergic reaction". Additional information: Adverse event information: On 05Sep2022, it was reported that a patient started treatment on an unspecified date in 2021 with Pfizer BioNTech COVID-19 vaccine at unspecified dose for an unspecified indication. It was reported the patient had an allergic reaction to Pfizer over a year ago. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My Dad started experiencing symptoms of CJD Creutfeldt Jakob Disease within months of the 2nd vaccine dose. He  was unable to sleep, he also had coordination issues and double vision. After receiving his booster on 12/16/21, he went drastically downhill within one week, He became unable to walk unassisted, had memory and cognitive issues, had trouble feeding and caring for himself, He could no longer drive. or be left alone for long periods of time. After seeing multiple specialists through January 2022, he was hospitalized and a Lumbar punch was performed.  Three weeks later on Feb 28th, 2022 his test results returned positive for CJD. My Dad came home from the hospital on hospice and passed on 4/21/2022.
Extreme dizziness, lightheadedness, lack of concentration, muscle aches/ spasms. Muscle aches /spasms lasted for 6 days.
Having cramps in legs, thigh and calf; This is a spontaneous report from a contactable consumer (parent). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date in May2021 as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced having cramps in legs, thigh, and calf. The reporter just wanted to see if it was just normal or something they should be concerned about. The outcome of the event was unknown.                    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dtap was given to a 11 month 7 day old when due at 15 months. Was due for Polio at the time, so combo was given in error
Flublok Quadrivalent was administered to 5-year-old patient with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a health professional via agency (reference number: 00318069) and transmitted to Sanofi on 15-Oct-2020.   This case involved a 5-year-old female received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Unknown batch number and expiration date) via unknown route in unknown administration site (Product administered to patient of inappropriate age) for prophylactic vaccination on 11-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. No other concomitant vaccine was administered.  It was a case of actual medication error due to Inappropriate age at vaccine administration (Latency: Same day).  At the time of reporting no adverse event was reported.  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.
some minor soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Mar2021 (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: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "some minor soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At approximately 7pm, patient felt light headed and fainted and hit his head. He ended up in the hospital where they took blood and did a CAT scan. He had very low blood sugar and low blood pressure. Everything else was normal.