chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaginal itching; Appearance of vulvar ulcers; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 08:45 (Batch/Lot number: unknown) at the age of 20 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Genital ulcers" (unspecified if ongoing), notes: Epstein-Barr virus (EBV) resulting in genital ulcers at 9 years old; "COVID-19" (unspecified if ongoing); "Trimethoprim allergy" (unspecified if ongoing). Concomitant medication included: ZOLOFT. Vaccination history included: Bnt162b2 (Dose 1, single (Lot number: Not provided) in the left arm at 08:45 AM), administration date: 22Feb2021, for Covid-19 immunization. The following information was reported: VULVOVAGINAL PRURITUS (non-serious) with onset 17Mar2021 15:45, outcome "recovering", described as "Vaginal itching"; VULVAL ULCERATION (non-serious) with onset 17Mar2021 15:45, outcome "recovering", described as "Appearance of vulvar ulcers". The events "vaginal itching" and "appearance of vulvar ulcers" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vulvovaginal pruritus, vulval ulceration..  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received sertraline (ZOLOFT) within 2 weeks of vaccination. The patient received acyclovir as treatment for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and the result was pending.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
low grade fever; chills; diarrhea; This is a spontaneous report from a Pfizer. A contactable consumer (patient's wife) reported for a male patient (Reporter's husband)   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, 3 days after vaccination (JAN-2021) the patient experienced low grade fever (pyrexia), chills, diarrhea. The outcome for the events was unknown.   Follow-up attempts completed. No further information expected.
After 6 days (5-10-15) the shot area turned red, itchy and my arms, hands, feet, legs and face became red and developed red rash. Took antihistamine, next day rash disappeared and only red skin remained another day. Puncture site is still red and itchy.
I had chills. The next day, I felt like I had the flu. On day three, I developed an all body rash. I went to the doctor and they said to take Benadryl. It did not help. The rash went away after about five days.
Cellulitis of left upper arm. Rx given for KEFLEX and BENADRYL. No improvement after 28 hours with antibiotics per mother. Instructed parent to take child to ER.
This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. On 16-SEP-2013 the patient was vaccinated with ZOSTAVAX (route, dose, frequency, lot# and expiration date unspecified). On 16-SEP-2013, the patient was administered ZOSTAVAX that may have gone through an unsupported temperature excursion from 10-SEP-2013 to 16-SEP-2013. No adverse effects were reported. Additional information has been requested.
Information has been received from an office manager concerning an approximately 66 year old female with auto-immune system disorder who on 11-NOV-2010 was vaccinated with one injection of 0.5ml PNEUMOVAX 23. The patient experienced redness and a 'hot' sensation in the right arm at the injection site immediately after receiving the vaccination and both reactions were attended to by physician. At the time of report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
I95.9 HYPOTENSION 3/11/2023 SEVERE ALCOHOL USE DISORDER W ALCOHOL WITHDRAWAL, UNCOMPLICATED
Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot # M005972 with expiration date: 02-FEB-2018; lot # M043581 with expiration date: 28-SEP-2018 and lot# M047660 with expiration date: 02-DEC-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT), which were properly stored. The administered vaccines were improperly stored at temperature greater than -10°C but less than -14°F (-11.5°C) for 18 days with previous temperature excursion at temperature greater than -9°C but less than 8°C (-9°C) for 1 hour and 14 minutes; this information was registered in a digital data logger. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015810: US-009507513-1705USA015757:
The day after the vaccine I experienced extreme fatigue, Some nausea, slight headache and some flu-like muscle aches.   On day 13 I have a toothache that switches between my lower right jaw and my upper right jaw.  It comes and goes throughout the day and I have since experienced the same pain daily.  I have had no treatment for the pain.  I take Tylenol.
This spontaneous report was received from the patient's wife referring to a 79 year old male patient. The patient's medical history included unspecified allergies, prostate cancer 2 years ago and unspecified sinus disorder. The patient had no drug reactions or allergies. The patient was taking multiple unspecified medications. On 09-DEC-2015, the patient was vaccinated with first dose of PNEUMOVAX 23 (dosage information not provided). The reason for use was reported as "because of the patient's age and allergies". The patient's wife reported that the patient presented with unspecified weakness and dizziness on 12-DEC-2015, three days after receiving PNEUMOVAX 23 therapy. No medical attention was sought, no lab test was performed, and no treatment was given. As of the date of this report, he was still experiencing the adverse reactions. Additional information is not expected.
1st Dose: Headaches, swollen lymph nodes  2nd Dose: Fatigue, body aches. Chest pains bad enough I went to the ER, 2 days later I went back to the ER because I my eye swelled shut, and my neck swelled up, and I had severe pain when I tried to swallow.
About 10minutes after vaccine patient felt light headed. Vital signs were within normal limits (BP: 130/60, Pulse: 80, Respirations: 12, Pulse ox: 96%), and patient started to feel better. Offered a snack but patient declined. Patient was reassessed after 10 minutes and patient was back to baseline and ready to go home.
Heart is beating pretty fast; It feels like her chest is like swollen like it is harder; Still feel like it's a lot of weight just being pushed on her chest; It feels like her chest is like swollen like it is harder; Still feel like it's a lot of weight just being pushed on her chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 at 11:00 as dose number unknown, single (Lot number: FM0173) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Jun2022, outcome "unknown", described as "Heart is beating pretty fast"; CHEST DISCOMFORT (non-serious), SWELLING (non-serious) all with onset Jun2022, outcome "unknown" and all described as "It feels like her chest is like swollen like it is harder; Still feel like it's a lot of weight just being pushed on her chest". The events "heart is beating pretty fast" and "it feels like her chest is like swollen like it is harder; still feel like it's a lot of weight just being pushed on her chest" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient called to Pfizer because she was having side effects from the shot (Pfizer COVID-19 vaccine). The patient just feel like her heart was beating pretty fast and it felt like her chest was like swollen like it was harder, felt like 'if she pressed it just feel push on the chest'. Yes so she went to the doctor yesterday (09Jun2022) and she got a EKG and everything and they said everything was fine but she still felt like it's a lot of weight just being pushed on her chest.
The pt developed temp of 100.2 deg. F., redness, soreness, swelling (approx. 20 cm in diameter) at injection site ten days post vaccination. On 04/29 hands, face, lips began swelling and the child received Benadryl in doctor's office.
About 5 minutes after the patient was vaccinated, he felt weak and faint.  His pupils dilated and he began to profusely sweat.  He then blacked out for about 15-20 seconds.  By the time EMS arrived within 10 minutes , he was coherent and felt fully recovered.
Received 4th rabies vaccine at facility above. Reported itchy pink rash/bumps over abdomen/trunk few hours after. No respiratory illness.
pt recvd flu vax & devel transverse myelitis coincident w/its administration; pt is an incomplete quadriplegic as a result of the transverse myelitis; Wyeth-Ayerst is awaiting further info;
felt very ill; sustained fever of 100.6-100.8; I am very weakened; exhausted; I have headaches; Muscle aches; Nasal congestion; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority. A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 12Jul2021 12:30 (Lot Number: EW0173) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Jul2021 18:45, approximately 4 -5 days after the first Covid vaccine, the patient felt very ill and had a sustained fever of 100.6-100.8 now for 6 full days that does not go away. Patient was very weakened and exhausted; also had headaches, muscle aches, and nasal congestion. The events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: 100.6-100.8 on 17Jul2021; Covid-19 test: inconclusive on 20Jul2021 and unknown results (pending)on 23Jul2021. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
About 12 hours after the vaccine, I developed a fever, chills and body aches which lasted about 36 hours, and they resolved on their own. I was really thirsty and for the 1st week after the vaccine my mind just felt mentally foggy.  A few months later on 10/19, I woke up with a sore throat with postnasal drip.  10/19, I had a COVID test performed which was negative, but the symptoms did not get better, and I developed a fever, chills, body aches, headache, sore throat and excessive fatigue so I got another COVID test done and on 10/22 I tested positive for COVID.  I still have a persistent cough, so I have an appointment with the Pulmonologist for further testing on Thursday 12/23.
Heart palpitations, profuse myalgia pain, chills, severe headache 1/24/22 myalgia pain in both arms.
Pt received vaccine on 6-6-19 and developed a reaction on 6-12-19 that caused pt to seek medical attention . Her arm was swollen at injection site with a large hematoma. She was instructed to ice it and take Tylenol. It did not resolve itself, so pt was seen on 6-14-19 at her primary care office, by the NP who thought it was an injury/hematoma, not a reaction to the vaccine . She was once again told to ice it and take Tylenol if needed. The patient then came to the Pharmacy on 6-17-19 to report the reaction. She then had bloodwork done on 6-18-19, which came back in normal range.Since that time, it was resolving itself( hematoma)slowly, but then had another flare up the evening of 6-24-19. The swelling increased and her arm became very painful, to the point where she was going to go to the ER. She iced it and it was relieved to some extent. She then saw her primary care physician on 6-25-19, where he stated she had an injury from the vaccination injection. At this point pt is not fully recovered still has limited range of motion, but states she is improving.
Patient fainted and lost consciousness. Fell off chair but didn't appear to hit head or any other bodily harm. He caught himself with his arm. Pharmacist came immediately to patient and had patient lie down and raise legs and patient began to feel better but still felt dizzy, lightheaded and sweaty. He stated that the room turned black and he felt very warm. EMS was called and upon arrival checked vitals and blood glucose was 84 at time of arrival. BP 153/106 and pulse 80 bpm. Over time patient was able to leave pharmacy and have family member pick him up. He did not take the ambulance and he felt better before leaving.
Case number PHEH2014US003847 is an initial spontaneous report received from a pharmacist on 21 Feb 2014 with a follow-up received on 21 Mar 2014: This report refers to a 16-year-old male patient. He was vaccinated with seasonal influenza vaccines (manufacturer and batch number: unknown) on undetermined dates in the past which were well tolerated. he was inadvertently vaccinated with FLUCELVAX (batch number: 004011A) intramuscular in to the left arm at a dose of 0.5 ml on 02 Jan 2014. This vaccination with FLUCELVAX was an initial application of the vaccine. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Follow-up information received from the pharmacist in 21 Mar 2014: Updated information about application, vaccination history and batch number and site of administration of FLUCELVAX.
constant crying for 5 hrs 15 minutes 2MAY93; seen in hosp ER treated for constipation; physical exam temp-nl;
hx of sz activity; MD ordered DTp stated that considers sz to be "static" condition; seizures x 2 in PM p/vax; t104.5 per mom;
No ADR timing ERROR, 2nd dose given 45 days after 1st Narrative: No ADR, timing ERROR, 2ND dose given 45 days after 1st dose.
I had been exposed to COVID-19 I started feeling feverish on the afternoon of June 14, 2002 came confirmed my fever took the home COVID-19 test. Once it came back positive called my doctor he called in Paxlovid that I started the evening. I slept almost the entire next day, I had fatigue and some coughing but I now feel better.
Parent states that patient had on left arm- swelling, red streaks, knot, fever up to 101 degree after varicella injection in left arm. Went to Dr. and was treated for reaction to varicella- titer drawn.
First started itching and the next day started hurting.  The arm began to swell slightly and by Friday (10/10) it was hot and had a ring around it.  It hurt to lift arm.
Injection site pain, with vaccine administration lasting 72 hours Redness at injection site, following injection until post-vaccine day 4  Dull headache, starting 80+ hours after vaccine administered Back pain, starting 48 hours later, still present post-vaccine day 4
About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal and upper arm.  Vital signs within normal limits.  Improved
1st shot only experienced an expected amount of soreness around the injection site. 2nd dose: experienced mild flu symptoms (body aches, fatigue, headache, lack of appetite) the day after the shot and the symptoms only lasted 24 hours with just some slight soreness leftover the next day. That same week on Friday I woke up with an intense migraine that came in and out even after taking Midol. This migraine started shooting pain from the top of my head, down through my neck, into my arms, and all the way down my back. These were sharp sudden pains that I would feel. I started to have muscle spasms in my face and felt a bit nauseous/didn?t have an appetite. I felt very foggy, like I was just floating around but also that my body weighed 1000lbs. I?ve been experiencing these symptoms for 4 days now. I?m mostly still struggling with headaches, some fatigue, and muscle aches. I?ll get these aches randomly throughout my body. Sometimes it feels a bit flu like, the same as it felt on the day after I had got my 2nd dose. I don?t know if these symptoms are related to the vaccine or not.
pt vax w/pneumococcal vax OCT89 & devel pneumococcal infection type III; 3 different blood cultures revealed a pneumococcal infection; pt hospitalized; it was also noted that pt had abscess of spleen or an infected splenic cyst;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: en6198), on 01Apr2021 as dose 2, single (Lot number: er8737), on 13Oct2021 as dose 3 (booster), single (Lot number: fh8020) and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "atrial fibrilation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive after having tested negative two days in a row; Positive, notes: Tested positive after having tested negative two days in a row; Negative, notes: Tested positive after having tested negative two days in a row; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had Paxlovid for COVID 19 Treatment from 31Aug2022 to 04Sep2022.
Significant "Covid Arm" after booster shot. A red, swollen area on my left arm between shoulder and elbow, radiating from the injection site started to appear around 24 hours after the vaccination. The area was hot to the touch and painful with minor itching. This area continued to expand over the 72 hours following the vaccination reaching a max diameter of approximately 6.5".  I received the vaccination on Friday 11/26/2021 and monitored over the weekend while taking ibuprofen and antihistamines. Since there was no improvement and the area continued to expand I contacted my primary care physician and she was able to see me at 12:30pm on 11/29/2021. She gave me a prescription for a 5 day oral steroid which I began taking at around 1:30pm on 11/29/2021. I continued to see the area expand throughout the remainder of the day.  At bedtime on 11/29/2021 I took another dose of antihistamines.  When I woke up on 11/30/2021 the area was the same size as the previous evening but the redness and swelling appear to be less severe.  I took the second dose of oral steroids around 9am on 11/30/2021. At the time that I am completing this information (11/30/2021 11:00am) my arm definitely shows improvement. Also of note, I was given a flu shot at the same time, in the right arm. The injection area of the flu shot also appeared red and swollen but only an area of ~ 2" in diameter. This is the first time I have had a reaction from a flu vaccine despite getting one each year.  This was very mild and started to  resolve before I started the oral steroids.   Additionally, I should note that I had a much milder form of Covid Arm after the 2nd shot. This appeared around 3 days after my second vaccination but mainly consisted of red discoloration and minor swelling. This lasted for a couple of days and went away without any treatment. I have received a total of 3 covid vaccination shots and all were in my left arm.  I also have pictures of both reactions if needed.
Sudden, high level adrenaline response with nightly nocturnal panic attacks and tremors. Began immediately after dose 2 and stopped suddenly exactly 3 months later.  Muscle twitching, fatigue, and soreness. Internal vibrations and tremors. Began on 5/1/21. I have twitched, jerked, and spasmed every day since. Symptoms began alleviating approximately 3 months later but still persist.  Severe lower back pain - Began 5/2021. Mostly resolved by late August 2021.  Joint pain and cracking - Began 5/2021. Mostly resolved.   Enlarged lymph nodes - detected via mammogram and follow-up ultrasound 5 months after second dose. Radiologist believes I am experiencing an long-term protracted immune response to the vaccine.
redness and swelling at shot site with-in five min. of shots  gave benadryl no other treatment needed
Nausea x 24 hours, ongoing severe R frontal headache, L upper arm (injection site) was red, raised, with severe itching.  Headache persisted for almost a month.
I had fever, chills, and malaise the next day. I also developed itching and redness on both palms and soles. Symptoms resolved over 24 hours.
Some mild chest pain; I felt a little fatigue; Fever; I could not sleep; Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (I could not sleep), DECREASED APPETITE (Loss of appetite), CHEST PAIN (Some mild chest pain), FATIGUE (I felt a little fatigue) and PYREXIA (Fever) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 027A21A and 044B21A) for COVID-19 vaccination.     The patient's past medical history included Suspected COVID-19 (Maybe (several tests yielded negative results)).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced INSOMNIA (I could not sleep), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever). 22-Oct-2021, the patient experienced FATIGUE (I felt a little fatigue). On 23-Oct-2021, the patient experienced CHEST PAIN (Some mild chest pain). At the time of the report, INSOMNIA (I could not sleep), DECREASED APPETITE (Loss of appetite), CHEST PAIN (Some mild chest pain), FATIGUE (I felt a little fatigue) and PYREXIA (Fever) had resolved.            Treatment medication was not provided. Concomitant medication was not provided.  On 23-Oct-2021, the patient started having some mild chest pain, but did not saw the physician, or anything like that.  On 25-Oct-2021, the patient still had the chest pain, but was much better now. And all the other side effects were a lot better. Whenever the patient get a viral infection, the patient did not felt like eating at all.   This case was linked to MOD-2021-363021, MOD-2021-363022 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received contains no significant information. On 27-Oct-2021: upon follow up receipt: Event outcome was updated(recovering-recovered) and narrative was generated accordingly.