chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Confirmed with customer that no other AE occurred; PROQUAD was administered after experiencing a temperature excursion; This spontaneous report was received from a nurse referring to a 4-year-old male. Information about patient's medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 07-MAY-2021, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rha) (PROQUAD), 1 dose, in the left upper arm (LUA), subcutaneously (SQ), Lot No. T005404 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rha) (PROQUAD), expiration date reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021(strength, dose detail and scheme of vaccination were not provided) for prophylaxis.   On an unknown date, before of the event the measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rha) (PROQUAD) vaccine was exposed to temperature excursion of 37.2 Fahrenheit degree (F), for a time frame of 3 hours, which was detected by the data logger. The reporter stated that the freezer door was inadvertently left open causing the temperature excursion and was noticed after the incident. No previous temperature excursion. No adverse events reported. Data logger was involved.
New large red swollen area at injection site, painful to the touch and itchy. New symptom appearing 8 days after injection. The same area had some slight swelling the day after the shot, but had improved,
pt reported feeling achy and tired for 2 days. then on the third day she said her fingers and face started to tingle. No trouble breathing just tingling. She said sometimes the tingling would be more on just one side of her face and lips.   Told the patient to seek medical attention right away or to contact her doctor to rule out any possible other causes to the tingling such as a stroke. Patient understood the importance and said she would seek help. I emphasized the importance of acting quick in the case that it may be a stroke.
After the vaccine I had extreme fatigue, nausea, vomiting. and headaches. The nausea was the worst. I had to get something to stop it and this lasted for five days.
Insomnia  Fever up to 101.5 Chills Cough Painful lungs  Tachycardia  Painful skin Achy weak muscles Stabbing headaches   Most symptoms are starting to decrease. I did not seek medical assistance
About an hour after receiving the vaccine, I broke out in a rash on my arms, chest and face. I went downstairs to the location they were giving the vaccines and the doctor on site gave me a Benadryl. The next two days, I felt feverish and sluggish. After that, I felt like I bounced back and the rash went away.
Pressure sensitivity in left underarm; pain in left underarm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Pressure sensitivity in left underarm) and AXILLARY PAIN (pain in left underarm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Pressure sensitivity in left underarm) and AXILLARY PAIN (pain in left underarm). At the time of the report, DISCOMFORT (Pressure sensitivity in left underarm) and AXILLARY PAIN (pain in left underarm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Reporter did not allow further contact
second dose of MENVEO administered; This case was reported by a nurse via other manufacturer and described the occurrence of extra dose administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received on last year.).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received second dose of Menveo vaccine, the patient received the first dose in last year. The reporter did not provide additional details because this was not a Merck product. No additional adverse events were reported. No product quality complaint was reported. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Menveo, which led to extra dose administrated.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. None of pertinent medical history was reported. None of drug reactions/allergies was reported. On 30-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX, dose/frequency:0.65ml/once, subcutaneous (dose number and lot# not reported). Secondary suspect therapies included PNEUMOVAX 23, which was vaccinated on 07-OCT-2014 (dosage, dose number, route, lot # not reported). Concomitant therapies included simvastatin (manufacturer unknown), tramadol hydrochloride, hydrochlorothiazide, DIOVAN HCT, atenolol and venlafaxine. On 01-OCT-2014, the patient experienced "blood shot eye". The patient also received PNEUMOVAX 23  on 07-OCT-2014 while she still had the "blood shot eye." She was not seeking medical attention from the pharmacist. She just happened to mention to the pharmacist that she had the "blood shot eye" when she came in to pick up a prescription. No treatment was given for "blood shot eye". The outcome of "blood shot eye" was reported as not recovered/not resolved. Additional information is not expected because the reporting pharmacist gave no consent to be contacted.
Two days after Vaccination a small rash appeared on right side of my face and under my chin.  After two winks it was spreading down my face and was bright red with no itching or pain. I say PCP on April 2nd who prescribed a five day course of Prednisone.  The rash faded a little but came back as soon as the Prednisone was out of my system.  The rash continued to spread across my face and under my chin.  I called PCP and was prescribed another five day course of Prednisone. On April 27th I saw Dr. (dermatologist) who did a biopsy and prescribed Triamcinoloone 0.1% (twice a day for 2 weeks).  It did nothing.  On May 11th I say Dr. again and he prescribed Clobetasol Propionate Cream, USP 0.05% (twice a day for 2 weeks and then 2 days each week). The rash faded but has never completely gone away.
ON jULY2ND-jULY 4TH FEVER, CHILLS, NAUSEA, VOMITING, BODY ACHES,. OVER THE NEXT FEW DAYS HE DEVELOPED CHEST PAIN, PALPITATIONS. CHEST PAIN WITH DEEP BREATH., LEFT HAND AND ARM WITH NUMBNESS, TINGLING
pruritus; rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (pruritus) and RASH (rash all over body) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Varicella (history of chicken pox), Shingles (Patient had shingles injection two years ago.) and Open heart surgery (Heart surgery in 2005) in 2005.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PRURITUS (pruritus) and RASH (rash all over body). At the time of the report, PRURITUS (pruritus) and RASH (rash all over body) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: No new information; Reporter's Comments: Crosslink: MOD21-050383 Patient calling back about paperwork he received in the mail from a prior adverse event he reported. Crosslinked case and updated contact information.
Pt complained of facial flushing and feeling warm all over. RN had pt seen by EMT on site. Pt is Pre-diabetic and on Metformin, FSBS-183. Pt stated that is very elevated for her. EMT gave pt information on how to aquire glucometer to do testing at home. Pt also stated she recently experienced a house fire and is under a lot of stress. EMT had pt stay for an extra 10 min and then relesed her to go home. - RN
1-1/2 hour after vaccine, severe onset dizziness, unwell feeling that lasted about an hour, then dizziness was off and on all day.   Heart rate 113, BP 140/90  (elevated for me).  That night developed chest pressure and palpitations with tachycardia in the 110s  that lasted all night until the next afternoon.  Questioned if it was side effect of vaccine.  Second Pfizer vaccine, lot FF2590, received 11/18/21 left arm IM had onset of sudden headache 1.5 hours after, relieved with ibuprofen.  Headache returned a few hours later with fatigue.  That evening, again developed tachycardia, heart racing/pounding that was constant all night, resolved by next morning.  Day 2 after vaccine had worst headache ever, dizzy, chills, nausea that was severe.  Day 3 after vaccine still with headache top and back of head, dizzy, chills, nausea as well as blurry vision.  Symptoms resolved gradually.  On 1/20/22, was diagnosed with Covid 19 (coworker diagnosed 1/7/22 - we are healthcare workers, masked, and both vaccinated), was very sick for about 10 days,  had telemed visit and treated symptomatically at home.   Have not had a booster yet due to concern about tachycardia that still continues as well as elevated blood pressure that continues (about 20 points higher than before I got the vaccines) and the fact I was sick with Covid after vaccination.  I was mandated to get these vaccines due to being a healthcare worker and have concerns about continued booster mandates given side effects I experienced and  getting Covid anyway.
mucus build-up; elevated glucose; fluctuated BP; Bad Headache; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (mucus build-up), BLOOD GLUCOSE INCREASED (elevated glucose), BLOOD PRESSURE FLUCTUATION (fluctuated BP) and HEADACHE (Bad Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (mucus build-up), BLOOD GLUCOSE INCREASED (elevated glucose), BLOOD PRESSURE FLUCTUATION (fluctuated BP) and HEADACHE (Bad Headache). At the time of the report, INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (mucus build-up), BLOOD GLUCOSE INCREASED (elevated glucose), BLOOD PRESSURE FLUCTUATION (fluctuated BP) and HEADACHE (Bad Headache) outcome was unknown.            No concomitant medications and treatment information were reported.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe
6/26 Covid Arm, Took Tylenol PM and rubbed Activz Silver Gel on.  7/10 Right Arm: Swollen Lymph Nodes and Knot in Center of armpit. Turmeric, Green Tea, Lymphatic Drainage Exercises. Tylenol  7/10 Right Arm: Skin Reaction (Delayed Medium Local Reaction) three about size of quarter. Uses same method above in 7/10 also applied Activz Silver Gel.   7/14 -Today  Finger, Neck, & back Stiffness; Difficulty Gripping. Seeing Chiropractor.
Patient reported today that the morning after the 2nd Shingrix dose she woke up with chills and malaise.  She states she is feeling better today.
Rash on back that itches.   Hands are still Swollen from 1st shot.
leg swelling; patient could not walk; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA250699.  This case involves a 3 years old female patient who experienced leg swelling and could not walk after receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past vaccination(s) included Rotavirus vaccine and Pentacel for immunisation. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection via unknown route in unknown administration site for prophylactic vaccination (Immunisation) (strength, dose, batch number and expiry date: unknown).  Information on the batch number was requested.  Reportedly, rotavirus vaccine, PENTACEL, and possibly Prevnar-13 (the patient's mother knew she received 3 vaccines, but as unsure if Prevnar-13 was the name of the 3rd vaccine); after these shots, the patient developed seizures. When the patient developed seizures. at night the patient would arch her back, her eyes would open, and her body would lock up. The patient was hooked up to electrodes, and they confirmed that they saw seizure activity. The seizure activity was off and on, and at one point it occurred every day for a couple of months. The patient's mother reports that since these events occurred after the patient received PENTACEL. The patient's mother reported that even with the individual vaccines (DAPTACEL, ACT-HIB), the patient still had some reactions like leg swelling; states that the patient could not walk after one of her shots  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.
exhaustion with daily activity, sore muscles, headache, sleepy, felt feverish. I felt like I  had covid all over again. soreness in injection site
1st Moderna vaccine February 28, 2021; 2nd March 24, 2021. Frequent (but not debilitating)  imbalance/dizziness occurred after first shot and continued after second shot. After second shot, began feeling my heart beating even when at rest - not racing but I was very conscious of it beating. Began having internal vibrations in heart/chest area, but occasionally feel as if in arm/shoulder. Feeling is similar to having too much caffeine, being very nervous or like a purring cat. Vibrations more noticeable when I?m lying down/in bed at night. Discomfort (vibrations plus chest pressure) increases if on my side. Slight nausea. Dizziness continues. Vibrations more noticeable when I?m lying down/in bed at night. Discomfort (vibrations plus pressure) increases if on my side. Slight nausea. Symptoms also include slight, general dizziness (not like vertigo).
swelling ,hardness around the injection site, red hard rash down the same arms long the injection site on my back of my forearm.. looks like welts.  It is not itching
Narrative:  Covid+/pneumonia, mild SOB, poor oral intake, AKI, hx of liver/kidney transplant. Moderna 16/21 and 2/4/21. Hospital course: Patient is a 60 year old male with a PMHx simultaneous liver and kidney transplant on immunosuppressants, CKD, CAD, I-ITN, HLD, and GERD who was admitted to hospital on 11/1/2021 for acute kidney injury, Patient was also noted to be Covid positive, However, he was saturating well on room and stated that his symptoms had started 4 weeks prior, Patient reported receiving 2 doses of Moderna and was scheduled to receive his booster vaccine in the near future, In the ER, lab work revealed a BUN: 99.8, creatinine: 4.81 from a baseline ~2.5-3, K: 6.3. Patient was started on IV fluids, and nephrology was consulted. Creatinine improved with IV fluid administration, Nephrology suspected that AKI was secondary to volume depletion from poor oral intake with recent Covid infection, On day of discharge, patient's creatinine corrected to 3.41.
Patient developed feelings of throat closing up  and difficulty swallowing secretions shortly after receiving second dose of Pfizer vaccine on 19 May 2021. No rash, nausea/vomiting, dyspnea, or any other s/s noted, in no acute distress. Pt was administered Benadryl, Solu-Medrol and fluids. Symptoms resolved and patient was discharged with Benadryl and an EpiPen.
onset of gen urticaria 10 days p/vax;tx w/hydroxyzine & pred
pt recv vax 12MAR96 840AM & devel fever of 103 w/red rash around lt arm;mom gave APAP alternate w/advil;blood work done by MD;dx allerg to DTP
Sore arm; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, on 02Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Mar2021,  the patient experienced sore arm. The patient's weight was 130 on an unspecified date. The event took place after the use of the product. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Information has been received from a n office manager concerning a 48-year-old male, with no immunosuppression or cancer, who in January 2008 was vaccinated with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 31-MAR-2008, the patient had a negative mumps titer. A product quality complaint was not involved. Additional information has been requested.
pt developed immediate (within minutes) redness of face; redness extended to arm and to neck, back of neck and now is concentrated on front of neck with an area of dry skin on temple; the areas affected burned for several hours;
Exposure to COVID-19 (via daughter); cough; Body temperature abnormal; This is a spontaneous report from a contactable consumer (patient's wife). A 64-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Apr2021 (Lot Number: EW0162), as single dose, for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing blood cholesterol increased, ongoing diabetes mellitus. Concomitant medication included losartan (unknown manufacturer) for hypertension. The patient experienced exposure to COVID-19 (via daughter) (non-serious) on an unspecified date with outcome of unknown, body temperature abnormal (non-serious) on 21Apr2021 with outcome of unknown, cough (non-serious) on an unspecified date with outcome of unknown.  No follow-up attempts are needed. No further information is expected.
Headache for 3 days - not attributable to other cause, don't usually get headaches. Treated with tylenol, rest and hydration. Had to take the day off related to headache on day 3, then improved.
Two week after the shot, I came down with a case of Shingles  ( I received both doses of the Shingles Vaccine) last dose  towards the end ofJuly My glands under  my are at the injection site saw swelling and 2inch area around the site swelled up
I received the first dose of the Moderna COVID vaccine on 1/4/21. On 1/12/21 I developed blurred vision in my right eye that is still present. The vision is in my periphery, lower right quadrant. It comes and goes but is mostly present throughout the day.
Fatigue, muscle aches, chills, diarrhea, redness/swelling/bruising at injection site.
This case was considered medically important for the events of possible behavior disorder and head banging. Information regarding Prevenar was received from a healthcare professional regarding a 5-year-old male patient who presented with a history of intentionally hitting his head against walls and other objects, possible behavior disorder and experienced neck pain and headaches. The patient received the third dose on 24-Jun-2003. Relevant medical history was not provided. Concomitant medications were not reported. The reporter noted the patient is currently being assessed (but has not been diagnosed) for a possible behavior disorder with a history of intentionally hitting his head against walls and other objects. Additionally the patient has experienced neck pain and headaches. No treatment was reported. The patient's outcome is unknown. No additional information was available at the time of this report.
Upper arm swelling and erythema. Rx: cool compress, Benadryl if needed, Tylenol as needed.
On 13 JUL 2007 we received from the regulatory agency the following information: A 32-year-old female patient was vaccinated with RABVERT (manufacturer and date of vaccination unknown). Further suspect vaccinations (same day?) Included ENGERIX B vaccine, REVAXIS and Typhoid. Patient was likely to be conceiving just at the time of the second dose of vaccines. The fetus has Down's syndrome and a cardiac abnormality. Patient has had a termination of pregnancy. After internal discussion on 24 JUL 2007 we decided to create an additional case for the fetus. (see case MA2007-0753). We received a follow-up information from the regulatory agency on 06 AUG 2007 without new information. (#GB-MHRA-ADR-20139770 and MHRA no. ADR2019770-001). This case was previously recorded as MA2007-0753. Follow up health authority report received on 09 Dec 2009: The mother (see case PHHY2007GB01352) was likely to be conceiving, just at the time of the second dose of the vaccine. The Foetus had Down's Syndrome and cardiac abnormality. No other information was provided.
Within hours of receiving the Covid-19 Moderna vaccine I experienced  diarhea, three seperate times. The next morning I experienced severe lower back pain 10 out of 10, I suffer from chronic back pain, it generally doesnt go above 7 out of 10 on the pain scale.  on my left side, the same side as the injection in my arm. Two days later my lower back pain is less intense 8-9 out of 10.
5 days after my first dose I started experiencing lightheadedness and extreme tight pressure and chest discomfort, that was ongoing but told it was probably not related to the vaccine however after second dose Lot number ER8732 received 3/24/21 mental fog that was not that prior to the vaccine has persisted and has yet to  go away, numbness that comes and goes and a heavy feeling/ dizzy feeling comes and goes.
Sore arm and mild chills beginning around 7:00pm. Chills increased in severity throughout the night. Did not experience fever, only chills. Nausea began at night around 11:00pm and vomiting at least three times during the night up until after 4:30am. Nausea continues mildly into morning,, 12/28/2021. Able to eat dry toast to stave off nausea and vomiting.