chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylaxis; she didn't feel well; she felt weak; felt like throat was closing; Her heartrate was 113; low grade headache; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was not sure if patient made her symptoms worse with her attitude, but in the first 5 minutes (27Jan2021), patient reported she didn't feel well, she felt weak, and felt like throat was closing. She was referred to the ED (emergency department) for anaphylaxis and given 1 dose of epinephrine. The ED said they do not know if it was an anaphylactic reaction.  Her heart rate was 113 (27Jan2021). After that, she rested for the rest of the day and now has a low grade headache and some of the typical side effects (unspecified). Reporter asked for the recommendation for the second dose. The events were not serious as per reporter. Therapeutic measures taken as a result of the event anaphylaxis. The outcome of the event anaphylaxis, didn't feel well, felt weak, felt like throat was closing, heart rate was 113, and low grade headache was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug.. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Had a fever of 103.5, disorientation, paleness, weakness, tachycardia of 120-130's, hoarseness and dizziness.
At her 04/01/2016 appointment, they sent us for blood work because patient didn't gain that much weight. We went on 04/22 and on 4/25 they called and asked me to come in because her sugar was high. (270). They checked at office and it was (174). I had to go to an endocrinologist the following day. After taking her A1C, which was 6.7, they admitted us to the Hospital to begin treatment for Type 1 Diabetes.
Pt received Tdap, Hep B and anthrax on 20Feb08 and found out that she is pregnant on 21 Feb08. Pt answered question on screening form regarding pregnancy as "no".
approx 10 hrs after receiving vaccinations pt broke out in a rash covering most of his body. The pt was very fussy, crying most of the day. The rash lasted approx 24 hrs.
pt admitted to hospital with increasing weakness, recurrent fall, increased confusion; fever, nausea, decrease in oral intake; found to be positive for COVID; UTI; treated with ABX; pt's condition worsened over the hosp stay; DNR and eventually made comfort care only; pt passed away in the hospital
immed feeling tingling & stinging sensation in lt arm, later inc itching of nose, back of neck, scalp; pain in lt cheek bone radiating to ear-abated on Sat; Friday PM inc sensitivity to noise & arms still red & warm @ inject site;
I had the following same reactions two months ago also with the 1st shot.  Both times it started 12 hours after the shot was given; fever, chills, severe headache, extreme soreness at shot area on arm, under arm and left side, nausea, palpitations, weakness.
2 DAYS AFTER THE VACCINE, PATIENT STARTED TO FEEL PAIN IN LEFT UNDER ARM. PAIN INCREASE AND NOTICE SWELLING ON THE SIDE ABOVE BREAST.  I COULD SEE AND FEEL THE INFLAMMATION.  THE PAIN INCREASE WITH TOUCH AND PRESSURE AND PAIN TRAVEL DOWN TO WRIST.  I WENT TO URGENT CARE THE NEXT DAY. I WAS PRESCRIBED  TRIAMCINOLONE CREAM  AND IBUPROFEN.
This spontaneous report was received from a physician via company representatives and from a support services director concerning a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 07-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 24 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 04-MAY-2015, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot#, expiry date, dosing details, anatomical location, were unknown) orally for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009095.
A few days post vax, the pt "felt like crap". This feeling resolved. On 3/20/00, following the third dose she began experiencing bilateral upper arm weakness, pain in back of knees with weakness, general weakness from knees to ankles with tender spots, constipation and diarrhea. As of 5/24/01, the outcome of the events was unresolved.
About 20 minutes after my shot I started experiencing a tiny bit of of tingling sensation at the corner of my left eye. It was cool and tingly. At first I just thought it was from my mask where the air was coming out. After several minutes I noticed it was extending down to my cheekbone. When it did that I noticed it wasn't from my mask and the air coming out of it. I told the nurse what I was experiencing. She asked me to remove my mask to look at my face and then she noticed a little bit of inflammation on the left side of my face. She decided to give me a Benadryl and wait another 30 minutes with her. While I was waiting for her to get the Benadryl I felt the tingling sensation going into my chest. Everything was specific to my left side. After 15-20 minutes of me taking the Benadryl the sensations started to subside. She then allowed me to go home after the 30 minute mark. When I got in the car I called the nurse of my pulmonologist to let them know what happened. They told me to come inside and they had me see the acute care clinic doctor. She ran an EKG and did some blood work I believe. But I can't remember. She basically said that it had nothing to do with the vaccine and wasn't aware of what it could be. She stated she never heard of anything like it before. November 21st we headed up to the mountains for vacation and when I reached about 8,000ft altitude I began experiencing nausea with light headedness. Which I have never experienced before because I've lived here my entire life. I had my husband pull over to see if I could acclimate to the altitude. We stayed there for 45 minutes and the symptoms were getting worse so we decided to descend altitude to 7,000ft and we stayed there for 45 minutes with no changes as well. My husband then brought me back and I felt better but still had the light headedness feeling and continued through until just this past 12/09/2021. Then my light headedness became worst to the point of where I felt like passing out. 12/09 and 12/10 I was going to acupuncture for the passed out feeling. The passed out feeling was resolved with both treatments. The next day 12/10 the same thing happened. My doctor ended up telling me they couldn't get me in. I went to an after hours clinic. They wanted to check my heart. My blood pressure had also increased during the week of 12/13 - 12/19. Since I had the second shot I've had more intense brain fog and more headaches. My headaches were lasting 2-4 days a time.
This spontaneous report was received from a 78 years old male patient reporting on himself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 27-NOV-2012. No other co-suspects were reported. No concomitant medications reported. It was reported that the day after the patient received the vaccine on 28-NOV-2012, his legs felt weak and was followed by vomiting. The patient also had nerve pain on his back "middle of the back". It was unknown if the patient sought medical attention. No treatment was given for the events and no lab diagnostic tests were performed. The outcome of legs felt weak, vomiting is unknown and nerve pain on his back. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information is not expected.
Rash at site of injection. Supportive care/wet compresses, tylenol prn for pain, benadryl q8 for 48 hrs, Cephalexin 250/5ml Oral suspension 3 ml po tid x 10days. Drew around margins of erythematous patch. Instructed dad to RTC in 24 hrs if redness/spreading worsens. Follow-up in 48 hours if rash persists or new fever/sx.
Pt reports random pain in muscle of arm and leg for 3 weeks (Note not site of vaccination).
Sudden tachycardia (108 ), blood pressure rise to 202/98, itchy  left arm at injection site
Individual had witnessed syncope. Temporary Loss of Consciousness Was sitting in observation area and dropped books and cell phone on floor Noted to be cold and diaphoretic  BP 102/64  Pulse 64/ min
On 10/30/2021, 36 hours post vaccine, it first started with some large hives on my throat. Then it grew to a large patch on my throat and upper chest, and they were really large, almond shape, they were large high up bumps, itching and burning, very red. It just started getting better about 2 days ago, 11/21/2021 when I got off the Zyrtec. Now I am left with what feels like a small patch of eczema or psoriasis, but no hives anymore. Right on my throat where I had the hives, it stretches and pulls on that dry patch, and I have been putting ointment like a Neosporin on it. I spoke to a doctor, and he suggested I take Zyrtec.
Pfizer-BioNTech COVID-19 Vaccine EUA About 5 minutes after receiving the vaccine my heart rate increased and sustained in the 140s-150s for about 10 minutes, it then subsided. My jaw and ears felt tight, then subsided. After about an hour, I felt normal.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L037561, expiration date: 29-SEP-2017 (dose and route of administration were not reported). No adverse effect was reported. Administered dose of vaccine experienced the temperature excursion of 6.1 degrees Fahrenheit 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Ten minutes after first vaccine dose, felt cross-eyed. AO x 4. BP 163/82 (pulse 76), O2 sat 100%.
HEAVINESS ON THE CHEST; WHEEZING; SQUEEZE SOUND OUT AND COARSE VOICE; ARM HURT; ARM BRUISED; COULD NOT FOCUS; HEAD FELT LIKE A THOUSAND POUND  (BUT NOT A POUNDING HEADACHE); SWEATING AND DRENCHED; COULD NOT GET WARM; OOZY; TEETH CLENCHING; TINGLING PAIN; COULD NOT STAND UP (HUNCHED  OVER) FOR MOVING; HORRIFIC CHILLS; SHOOTING PAIN ON THE INJECTION  SIDE; FEVERISH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included severe asthmatic, hashimoto disease, polycystic ovaries, egg allergy, soy allergy, onion and garlic allergy, shellfish and molluscs allergy, tropical fish allergy, and sensitive to gluten. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced could not get warm. On 08-APR-2021, the subject experienced oozy. On 08-APR-2021, the subject experienced teeth clenching. On 08-APR-2021, the subject experienced tingling pain. On 08-APR-2021, the subject experienced could not stand up (hunched over) for moving. On 08-APR-2021, the subject experienced horrific chills. On 08-APR-2021, the subject experienced shooting pain on the injection side. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced could not focus. On 09-APR-2021, the subject experienced head felt like a thousand pound (but not a pounding headache). On 09-APR-2021, the subject experienced sweating and drenched. On 09-APR-2021, the subject experienced arm bruised. On 09-APR-2021, the subject experienced arm hurt. On 10-APR-2021, the subject experienced heaviness on the chest. On 10-APR-2021, the subject experienced wheezing. On 10-APR-2021, the subject experienced squeeze sound out and coarse voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oozy, horrific chills, and feverish on 10-APR-2021, and could not stand up (hunched over) for moving, and shooting pain on the injection side on 09-APR-2021, was recovering from could not get warm, head felt like a thousand pound (but not a pounding headache), sweating and drenched, and could not focus, had not recovered from wheezing, arm hurt, heaviness on the chest, and arm bruised, and the outcome of tingling pain, teeth clenching and squeeze sound out and coarse voice was not reported. This report was non-serious.
Quadracel was administered SQ instead of IM.; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old patient received a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot and expiry date was not reported) via subcutaneous route instead of intramuscular.  The patients past medical history, concomitant medication and family history were not provided.  It was an actual medication error due to inappropriate route of vaccination.  It was unknown whether the patient had any adverse event.  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.  Information on the batch number was requested.  List of documents held by sender: none.
I experienced a breakthrough case of COVID-19 with headache, stuffy nose, mild congestion and body aches.
Onset of right foot pain on 8/11/21,  Diagnosed with blood clot dorsum right foot.  "superficial" .  Has not started treatment at this time.  Meds awaiting at pharmacy
Client sitting in waiting area post vaccination. Ten minutes later mother noticed client became faint. Assisted to supine position by nurses. Noted rapid breathing, not labored, sobbing, legs/arms reported to be tingling. No rash, no edema. Vitals stable. Continued to sob and cry, trembling. Squad called. Client transferred to hospital at 10:05.
pt had severe redness, edema & local inflammation @ inject site; rapidly spread to involve the entire rt arm; minimal SOB;
Beginning approximately two months after my second dose, I began to experience shortness of breath. This remains an ongoing, periodic problem. Additionally, soon after the shortness of breath began, I also began to experience dizziness/head fullness that increases throughout the day. It makes it increasingly difficult for me to think, concentrate, focus. My head feels very heavy. I have never experienced anything like this before, and there were no other known changes. I've been to urgent care once, the doctor twice, and am now being referred to a specialist. My bloodwork is clean. There were no indicators on a neurological exam. The best way to describe this is that as the dizziness progresses, it's like my brain is being exposed to toxic gas and getting sick. A clinic assistant who herself began experiencing head and neck aches after the second dose described it as "bobble-head". I can relate to that too. It is seriously impacting my life, health, and ability to work. Since it began in August, it has persisted, occasionally worsening dramatically on certain days.
fatigue after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue after the first vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue after the first vaccine). At the time of the report, FATIGUE (fatigue after the first vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-373774, MOD-2021-373777 (Patient Link).
15 mins after vaccination she endorsed midline chest pain. She states that it felt like a pressure feeling. Over the subsequent mins this chest pain moved around to her left chest and to her right chest. No radiation into her arm. The pain did not worsen with ambulation. No palpitations. No SOB. No difficulty breathing. She denies itching of her throat. She denies any rashes nor pruritis.   She has had chest pain back in October. At that time she went to the ER and work-up was negative. She feels like this chest pain is secondary to her anxiety. She has never been formally diagnosed with anxiety. She is not on any medications for her anxiety.   She does not take any medications. She only takes a multivitamin daily. She endorses an allergy to tramadol. She denies any allergies to vaccines.  The patient was observed for 90 minutes after receiving vaccination. The reason for extended monitoring was secondary to her chest pain. During this observation period her chest pain did improve but did not go completely away. EKG was obtained without any signs of ischemia. As her chest pain was still present we did recommend that she be transferred to the ER. Despite extensive counseling regarding the fact that she could be having a myocardial infarction she declined transfer to the ER. The pt was extensively counseled on the importance that she present to the ER if her chest pain worsens or fails to go away. She was asked to schedule a follow-up with her primary care provider. This pt did leave against medical advise.
Patient given first dose of hepatitis B on 9/15/22, then administered a second dose on 9/21/22.
Whole body paresthesias, insomnia, nausea, vomiting, burning sensations in feet, "brain fog" AKA difficulty concentrating, fatigue, generalized weakness .  Symptoms have lasted a total of 2 months thus far but are slowly improving for all of the above. Most notable persistent symptom is burning paresthesias of the feet
Covid positive on 3/1/2022- given Sotrovimab 500 mg IV
Reaction; Bright red; Lot of heat; Very itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction), ERYTHEMA (Bright red), FEELING HOT (Lot of heat) and PRURITUS (Very itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION COMPLICATION (Reaction), ERYTHEMA (Bright red), FEELING HOT (Lot of heat) and PRURITUS (Very itchy). At the time of the report, VACCINATION COMPLICATION (Reaction), ERYTHEMA (Bright red), FEELING HOT (Lot of heat) and PRURITUS (Very itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Severe, scaby rash following nerve where shot administered. Lasted until current time despite treatment with antibiotics, cortisone etc. Currently in remission.
COVID-Arm received first dose 01/16/2021 in left arm 2nd dose 02/18/2021 right arm. After second shot felt arm pain in left arm original 1st shot site as well as right arm second shot  pain dissipated in about a week and now after almost two months after last shot having arm pain again in left arm only at injection site.  Thought this should be reported .
female died 3 days after receiving the first COVID vaccine shot of a massive stroke; This is a spontaneous report from two contactable consumers. A 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported the female died 3 days after receiving the first COVID vaccine shot of a massive stroke. Healthy patient. It was not reported if an autopsy was performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: female died 3 days after receiving the first COVID vaccine shot of a massive stroke.
The pt experienced an itchy red swollen arm at the site and most of upper arm following 1st, 2nd, and 3rd vax. After the 1st shote the pt experienced a migraine, the second shot the pt experienced and itchy rash on the inner arms and tops of feet, spots on inner thigh. The pt also experienced a rash cover the area between knees and feet.
Pt developed arm soreness 7/12 PM. On 7/13, nausea, mus aches and headache 10/10 which lasted 48 hrs, diarrhea, fever 7/13.
I got a floater in my eye-it was very scary, I was seeing spots that weren't there. The dr. said it was very big, it is a big viscerous floater and it is there for life