chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has not been able to sleep; she had diarrhea / runny stool; headache; Consumer said she is afraid to receive the 2nd dose; This is a spontaneous report from a non-contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the consumer stated that since received the dose 1 on "Friday", she has not been able to sleep, she also said she had diarrhea, a runny stool, and headache. Consumer said she is afraid to receive the dose 2 and wants to know what will happen if she does not take it. This case assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information on lot/batch number cannot be obtained.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent condition and medical history of the patient were not reported. On 01-JUN-2016 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L039298, expiration date: 27-JUN-2017) (dose unspecified). (Incorrect storage of drug). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chills-Mild, Systemic: itching of neck-Mild, Systemic: Shakiness-Mild
She woke up the day after her second dose of the vaccine, and her sense of taste and smell were completely altered. It has been just under a month and her sense of taste and smell are still completely altered, Although this side effect may seem minor it has impacted her life in a big way. She says the food smells and tastes like "eggs" (sulphur) and either burnt or rancid. She is only able to eat a handful of foods because everything else she unable to get down because of the taste and smell.
I am the epidemiologist reporting on behalf of 70 year-old male patient.  Patient received two doses of the Moderna vaccine, according to immunization records. The first dose was on 4/23/21 and the second was on 5/26/2021.  The patient was found dead at home on 5/28/2021 (2 days post second dose). The death certificate lists ?cardiopulmonary arrest? as the immediate cause of death secondary to ?diabetes, hypertension, and heart disease? (many years). No additional information is available.
Severe headache, body aches, and fever within hours of the vaccine. By that evening I started having lower abdominal cramping. I take birth control without fail every morning to avoid having monthly menstrual cycles. When I have a cycle on a normal basis, no cramping and a max of 4 days that I may pass blood. I woke up on Saturday morning 08/28/2021 covered in blood from starting my menstrual cycle that should NOT have happened. This continued to carry on very heavy bleeding, then possible spotting for a day or two, then back to heavy bleeding. I bled for 16 days thereafter the vaccine. I also had heart palpitations after both the 1st and 2nd shot. Palpitations still come and go as well.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after use of product, the patient experienced swelling, pain, redness at the injection site. Outcome of the events was unknown.
Approximately 36 hrs after injection pt. took off bandaid and noted red, sore area at site of injection. Presented to our clinic where shot was given on day 2 - area appears red, rough 45 mm circular diameter. Spoke to pt by phone 2-25 - no change in red area or size, slight itching, slight headache. No treatment to area.
Teeth keep on bothering her; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "Knee replacement" (unspecified if ongoing), notes: Years ago. The patient's concomitant medications were not reported. The following information was reported: DENTAL DISCOMFORT (non-serious), outcome "unknown", described as "Teeth keep on bothering her".  Additional Information: The patient wants to set an appointment with her dentist because her teeth keep on bothering her. The patient was asking if this is possible. The patient had a knee replacement surgery years ago and will need to take antibiotics prior and after her dental appointment (dental appointment not yet filed, she is asking first if possible). The patient will also undergo another knee replacement on 25May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen, red, raised area right upper arm-much improved on 8/11/03. No fever.
Muscle in right arm extremely sore and noticed a big red swollen area about an inch lower than the point of injection.  I went to bed, woke up on 9/24/14 and thee's now 4 large thick swollen lines across my arm.
The patient came in for a second dose of Moderna one day early. The patient was registered in paper consent and sent to the Pfizer vaccine station. The RN vaccinated the client with Pfizer 0.3ml as his second dose. Rn stated, "patient was extremely anxious and the nurse was comforting him and did not focus on the first dose information. on card." RN did verbalize he is getting Pfizer for his second dose and the client acknowledged it.  The patient was monitored for 15minutes after being vaccinated and left the site in stable condition and did not report any discomfort.
Entire Lft Arm swelled. Fever, Aches. Vomiting.
Pt returned to clinic to complain of sore, red left arm that started night of vaccination.  Today progressed to left bicep area although injection in deltoid.  Left inside of bicep area to antecubital area with diffuse redness and warmth noted.  No other break in skin noted.  Slight swelling noted to lower end of bicep area, but full range of motion of left arm noted.  No redness, ecchymosis, or swelling noted to Left deltoid.  Patient states pain in left arm is minimal but still concerned about reaction.  Encouraged to try moist heat to arm and follow-up with primary care or urgent care today or tomorrow if no improvement or increase in pain, redness, swelling or develops any fever.
DTap and IPV-given in left leg on 04/12/2002 left leg swollen from knee to thigh. Pt is limping and rates pain as "4" on the 0-5 pain scale.
Approximately 15 minutes after receiving the Covid 19 Janssen vaccine, while sitting in the observation area pt c/o of feeling SOB. Vital signs B/P 125/77, HR- 125, RR 30, O2 Sat 98% RA, No c/o pain. Pt consented to be moved to urgent care for further evaluation. Pt observed approximately 1 hour  in the Urgent care and seen by urgent care provider. Pt declined breathing treatment and signed out AMA d/t pt stating she felt better and tachycardia resolved. Last V/S documented at 11:39 am were  101/49, HR 114, RR 24O2 Sat 95% RA.
all the side effects I'm having from the shot; I have been sick over 30 days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (all the side effects I'm having from the shot) and ILLNESS (I have been sick over 30 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced ADVERSE DRUG REACTION (all the side effects I'm having from the shot) and ILLNESS (I have been sick over 30 days). At the time of the report, ADVERSE DRUG REACTION (all the side effects I'm having from the shot) and ILLNESS (I have been sick over 30 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
The shot was very painful and the pain got worse with every passing minute. Had many Dr. and PT apt and saw a surgeon. Am still in PT and still have pain.
Information has been received from a registered nurse concerning a 16 year old female who on 06-AUG-2007 was vaccinated IM with a first dose of Gardasil (lot # "0929U").  Immediately after the vaccination the patient fainted and "fell off the exam table and hit her head and in doing so bruised her knees."  The patient was "out" for a long time.  On 06-AUG-2007 the patient recovered.  Additional information has been requested.
Herpes zoster in C2 distribution on left. Prodrome for three days starting day after vaccination with lesions developing 4th day after vaccination.
Tongue, lips, face swollen Chest tightness, trouble breathing, neck tightness, heart rate
This spontaneous report was received from a nurse practitioner via company representative regarding a female patient of unknown age. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dosing details were not reported). The nurse practitioner stated that a medical assistant misunderstood some patient information and the second dose of GARDASIL 9 intramuscularly, was given 25 days after the first dose instead of required 2 months later. No adverse effect reported at this time. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX23 was unknown. The pharmacist was requesting a lot check for PNEUMOVAX23 lot H014653 (Expired date 19-APR-2014). This is one of several reports received from the same source. Additional information has been requested.
High blood pressure for first time in life, admitted to hospital to get it down, now on Lisinopril as a result. Also I went six months without a period. I was having period every two weeks for a couple years in pre menapause and after the booster I went 6 months  without one at all.
The night of the 13th, my better half noticed my arm getting a little red, just thought I laid on it wrong.  Next day, the 14th, it has become MUCH larger and started to itch Slightly.   Later that afternoon my arm started to ache.  By evening the aching pain has become pretty significant.   Can only describe is as extremely bad arthritis in my elbow and wrist joints.  It's the middle of the night now and since I can't sleep from the aching pain, decided to see if I can report this side effect and here we are!
Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient experienced numbness down her arm immediately after the injection.  It was reported that the numbness went away later that day.  Subsequently, the patient recovered from the numbness down her arm.  Additional information has been requested. This is in follow-up to report (s) previously received on 12/14/2007. Additional information was received from a nurese on 08-JAN-2008. The nurse stated that the doctor received VAERS form to complete, but he does not plan on completing the form. There is no specific patient that the nurse can identify who had numbness down her arrm, although the nurse states many patients complain of burning at the injectionsite.
Area where shot was given (sore). Very dizzy for 2.5 to 3 week (fainted 1st). Reported adverse symptoms to Employee Health in March 2007 when contacted to receive #3 Hep B injection.
Shingles developed, 1-2 days after the second dose; First dose 23Jan2021, second dose:06Feb2021; First dose 23Jan2021, second dose:06Feb2021; This is a spontaneous report from a contactable other healthcare professional.  A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 06Feb2021 13:00 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient has no known allergies, did not have covid prior to vaccination. There were no concomitant medications. The patient experienced shingles developed, 1-2 days after the second dose on 07Feb2021 17:00. Treatment for the event included pill medication and cream for rash. The outcome of the event shingles was recovering. The patient was not tested post vaccination.  Information on lot/batch has been requested.
Chicken pox on legs & arms. Welts & blisters. Headache <-- was verified by physician. On 9/21, pt reported pain & redness at injection site.
Blurred vision and headache on 8/11/21. Went to Hospital. CT Scan findings show Moderate to severe diffuse cerebellar volume loss.  Severe headache at home the night of 8/12/21 and ongoing as of today 8/13/21.
Patient had 4 day ED admission from 12/29 until 1/2. Sent by EMS on 1/4 worsening symptoms, weakness and SOB
NUMBNESS BOTTOM LEFT FOOT FROM KNEE TO FOOT. UNABLE KEEP OVERALL BODY BALANCE. CONSTIPATION. UNABLE CONTROL BLADDER.
Received a 5-11 yr old Pfizer bivalent for 5 thru 11  undiluted.....
Trachea blocked; could not breathe; current in arm that went down the arm and towards the chest; Dizziness; Cough; her arm hurts and her forearm hurts; This spontaneous case was reported by a consumer and describes the occurrence of TRACHEAL OBSTRUCTION (Trachea blocked) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced TRACHEAL OBSTRUCTION (Trachea blocked) (seriousness criterion medically significant), DYSPNOEA (could not breathe), LIMB DISCOMFORT (current in arm that went down the arm and towards the chest), DIZZINESS (Dizziness), COUGH (Cough) and MYALGIA (her arm hurts and her forearm hurts). At the time of the report, TRACHEAL OBSTRUCTION (Trachea blocked), DYSPNOEA (could not breathe), LIMB DISCOMFORT (current in arm that went down the arm and towards the chest), DIZZINESS (Dizziness), COUGH (Cough) and MYALGIA (her arm hurts and her forearm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Diphenhydramine. The patient was in ER (interpreted as Emergency Room) from 10.30 to 20.30 on 28-Apr-2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-101774 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-101774:
injection site itching; had 3x3 inch rash; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (had 3x3 inch rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itching) and VACCINATION SITE RASH (had 3x3 inch rash). At the time of the report, VACCINATION SITE PRURITUS (injection site itching) and VACCINATION SITE RASH (had 3x3 inch rash) had not resolved and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported. patient reported using diphenhydramine lotion to treat her symptoms
first dose was on July 2019 / never received Shingrix second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was a pharmacist Intern. The age at vaccination was not applicable for this report. The patient never received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was looking for guidance on a late Shingrix 2nd dose. The reporter consented to follow up by fax.
Early pregnancy loss at ~10 weeks since LMP, expectant management, treated with methylergonovine
35 y/o male smoker received PCV13 in error instead of PPV23.
Uncontrollable, full body shivering for three - four  hours. Fever of 101.4 for 24 hours.
10 days after receiving the Moderna booster, I started breaking out in hives. I've had them daily for nearly two weeks now. All over my upper body, anywhere I scratch or where rubbed against (by clothing, by hair, etc.), and also spontaneously breaking out in them. Red rashes and raised skin which itches horribly. I feel itchy most hours of day and night. I messaged my doctor, had a phone call with a nurse, and had a doctor's appointment the other day...no one had anything helpful or useful to say besides: wait it out. It wasn't until this morning, finding multiple online forums on hives showing up ~2 weeks after the Covid booster did I realize a correlation. It seems to be not an uncommon thing.
Information has been received from a nurse practitioner concerning an 80 year old female with hypertension and arthritis and a history of herpes zoster who on 28-AUG-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck) in her left arm.  Concomitant therapy included MOBIC.  On 28-AUG-2008 the patient was splashed on the left arm with ZOSTAVAX due to technical problems with the syringe and needle (the needle separated from the syringe as the practitioner was attempting to administer the vaccine).  The area of the left upper arm was washed thoroughly at the time and the patient was then administered a complete dose of ZOSTAVAX (Oka/Merck).  On 29-AUG-2008 the patient developed a rash on her right buttock.  On 01-SEP-2008 the patient went to the office and was examined by the nurse practitioner.  The exam revealed that "sparse lesions that were healing and crusted".  No laboratory or diagnostics tests were performed.  The patient was prescribed acyclovir.  At the time of this report, the patient was recovering.  Additional information has been requested.
pos for Hep C virus p/vax; 14DEC91 pt donated blood to red cross 29OCT90, 1MAR91, 21MAY91, 7AUG91, w/o post result; pt notified false pos test result;
Patient reported that she had the vaccine on Friday 01/11/19 at 2pm and on Saturday morning at 2am developed arm pain, fever, chills, nausea, vomiting and fatigue. The symptoms continued and she felt better on Sunday 01/13 and reported the side effects to us on Monday 01/14/19 when she reported that she was feeling much better.
The following information was obtained from the above-referenced literature article received on 14 August 2008.  The author wrote: "A 20-year-old man developed acute disseminated encephalomyelitis after receiving smallpox vaccine and typhoid vaccine (dosages not stated).  He was successfully treated with immune globulin (IVIG).  The man received smallpox vaccine, and 2 days later, received typhoid vaccine.  Twelve days after receiving smallpox vaccine, he developed an ascending , circumferential numbness in his lower extremities that progressed to profound muscle weakness over 24 hours.  He had decreased sensation up to his nipple line, symmetric hyperreflexia with 3-4 beat clonus, and significant lower extremity weakness.  Catheterisation produced 900mL of urine.  Within hours of presentation, he required intubation and, 48 hours after presentation, an MRI revealed multifocal diffuse T2 hyperintensity throughout his brain and spinal cord.  CSF examination revealed 27 leucocytes, 40 erythrocytes, glucose of 80 and protein of 113.  He had an elevated myelin basic protein level (6.0).  Oligoclonal bands were absent.  The man started receiving high-dose methylprednisolone sodium succinate, but remained obtunded and quadriplegic with hyperreflexia.  On day 7 of symptoms, he received a 5% IVIG 2 g/kg infusion over 8 hours followed by steroid taper.  Within 12 hours, he was able to raise his arm and, within 48 hours, he regained spontaneous eye opening.  He was extubated and, 19 days after IVIG therapy, fine motor control had returned to his upper extremities.  However, his recovery plateaued after 2 weeks.  He then received IVIG 150g boluses at weeks 3 and 4, but showed minimal improvement.  By the 4th week, sensory deficits had recovered down to his umbilicus.  He was subsequently transferred to another facility and, at that time, he had good strength and fine motor control of his upper extremities.  He also could move his right lower extremity with gravity, but his left lower extremity remained significantly impaired.  Over the next year, he showed improvement following physical and occupational therapy.  He continued to have detrusor sphincter dyssynergia and required cholinergic receptor antagonists and daily catheterisation."
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: EMTs called and transported to hospital, patient conscious and answering all questions
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a mother regarding her 2 month old son who developed a mild fever 101 degrees Fahrenheit and swelling at the injection site,  the size of a quarter. The pt received his first dose on 08/11/03. Event Details:  Post immunization the pt developed a mild fever 101 degrees Fahrenheit, and swelling at the injection site the size of a quarter. . RElated Cases: See related cases : HQWYE173023DEC04, HQWYE279929DEC04, AND HQWYE280029DEC04. No additional information was available at the time of this report.