chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Not sure any liquid administered; A spontaneous report was received from a consumer regarding himself, a 75-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced possible vaccine underdose.  The patient's medical history was not provided. Products known to have been used by the patient were not included.  On 05 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 05 Feb 2021, as the patient received the vaccine, he noted that the nurse was fiddling with the vial for a long time. Patient stated that on the news it was said to go quicker, like 2 seconds and it took at least 10 seconds for this dose. Patient reported that the skin was punctured but is unsure if any liquid was administered. Patient reports always having a vaccine reaction and this time there was none. Due to the patient having zero side effects, they assume that they did not receive the vaccination.   Treatment information was not provided.   Action taken with mRNA-1273 was not provided.  The outcome of the events, vaccine underdose, was considered resolved.; Reporter's Comments: This report refers to a case of Vaccine underdose for mRNA-1273, lot 016M20A with no associated AEs.
Pain in the body after the first dose; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in the body after the first dose) and PYREXIA (Fever) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A1A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (Pain in the body after the first dose) and PYREXIA (Fever). At the time of the report, PAIN (Pain in the body after the first dose) and PYREXIA (Fever) had resolved.            Patient stated that he did not have any side effects after 2nd dose and feeling fine now.  Concomitant medications were not reported.  Treatment medications were not provided.
States, "I feel faint", immediately following injection. Head fell forward while sitting in chair. Skin pale, moist. Pt began to jerk in spasmodic motions. Face became red. Right arm rigidly extended above head. Episode lasted 20-30 seconds. After incident pt states, "what happened". No nausea/vomit.
A few weeks to a month later I developed a nagging cough that lasted for a few months before I developed GBS. I also had severe back issues that resulted in a disc issues
Body aches, slight fever, no appetite, very fatigued from 6 am to 8 pm , 16 hours after receiving my 2nd dose of the Pfizer vaccine.   Took Advil every 4 hours.  All symptoms gone next morning.
Diffuse rash spread across patients entire upper torso and along bilateral upper thighs. Pruritic rash. Occurred mildly after initial vaccine dose then worsened and spread the day after second dose. Non-blanchable annular lesions and in a pattern similar to pityriasis rosea
At about 9pm, patient reports fever 100.6, headache minor, nausea, sweating, and racing heart.  Symptoms lasted 3 hours and disappeared--went to back to normal.  Patient did not take any other medicine than usual. Patient has received Flu vaccines with no problems for years so can only relate symptoms to vaccine.
Red, itchy rash on left deltoid near injection site 9 days after shot. Slightly swollen & increasing in diameter a day later
pain in her right shoulder; blisters on the inside of her nose; Mucous stools; loose stool/Mucous diarrhoea mucous coming out; gas; stomach cramping; nausea; bad stomach problem; rash on the back of her right shoulder; headache; This case was reported by a consumer via call center representative and described the occurrence of gastric disorder in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced headache. On 20th January 2020, the patient experienced gastric disorder and itchy rash. On 21st January 2020, the patient experienced loose stools, gas, stomach cramps, nausea, blister and mucus stools. On 27th January 2020, the patient experienced shoulder pain. The patient was treated with loperamide hydrochloride (Imodium) and nutritional supplement (Probiotic). On an unknown date, the outcome of the gastric disorder, loose stools, gas, stomach cramps, nausea, shoulder pain, blister and mucus stools were unknown and the outcome of the headache and itchy rash were recovered/resolved.   It was unknown if the reporter considered the gastric disorder, headache, itchy rash, loose stools, gas, stomach cramps, nausea, shoulder pain, blister and mucus stools to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and caused a bad stomach problem. She reported that she had a headache with an itch and rash on the back of her right shoulder which has since resolved. The patient had loose stools, gas and stomach cramping with mucous coming out. She experienced little blisters on the inside of her nose. She had nausea with diarrhea and she tried the BRAT diet and a probiotic and nothing worked. She also experienced pain in her right shoulder. The reporter consented to follow up.
11PM on 21APR97 pt had fever of 102.5 episode of arms & legs stiffening, shaking, eyes rolled back, screaming, then staring;total episode <2min per childs mom;treated fever w/Ibuprofen effectively;
Minor pain/soreness in injection arm developed 7 days after first dose.  Rash developed 8 days after the first dose in injection arm and became swollen and warm to the touch. Swelling, rash, and soreness resolved on their own on the 9th day after the first dose.
Severe headache at 1 am, nausea at 6 am, vomiting started at 8 am with severe nausea and vomiting every hour until 5 pm.  Felt better next day in morning, but by 3 pm, headache and nausea returned.
pt recvd vax & devel paranoid delusions; pt has been given a dx of alzheimers; on f/u reporter attributes the pts react to alzheimers dissease & feels it is unrelated to flu vax;
the clinic he was going to get his vaccine at is closed due to a cyber attack so they are going to have reschedule his third dose; the clinic he was going to get his vaccine at is closed due to a cyber attack so they are going to have reschedule his third dose; no additional adverse event; This spontaneous report was received from a male patient of unknown age who was reported on himself. His pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 04-MAY-2021, the patient was scheduled for his third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The clinic he was going to get his vaccine at was closed due to a cyber attack so his third dose was going to be rescheduled. When the dose would be rescheduled was unknown at the time of this report. No additional adverse event reported.
Chills extreme sweating and intense body pain nausea and vomiting but no fever. Random sharp piercing pain all over body very restless sparactically
5:40pm Light itching (generalized). 5:50pm Water given per request.   Patient stated that she is feeling much better. 5:52pm Patient voiced that she is feeling much better.  Mom advised that if patient still feeling symptom to call 911 or urgent care.  Understanding verbalized.  BP 118/74, O2Sat 99%, HR 81.
One side effect I still have,  I now have very high blood pressure. I?ve been to my cardiologist,  wore a heart monitor for 5 days, follow up appointment in 2 weeks.  I?ve quadrupled my BP dosage, blood pressure is still high.
Patient fainted at check out desk. All necessary precautions were utilized. Patient walked to check out desk and started to fall forward. Desk staff and mom caught patient and lowered her to the floor. Patient became conscious and sent over to observation area and was monitored for 30 minutes. No injuries sustained during fall and was able to leave with mom.
Big red, warm spot below injection site that occurred starting 2 days post 2nd Pfizer vaccine. It began small and about an inch below the injection sight. It was warm to touch and painful, feeling much like a giant bruise. It grew on day 3 to about the size of a bagel (not sure what else to compare it to) on day 4. On day 5, the pain went away, but it itched like crazy. On day 6, it was still noticeable, but had faded and the pain/itchiness had gone away. By day 7, it was completely gone.
was vaccinated then her shingles was mild/ Suspected vaccination failure; shingles was mild; small rash of about 3 dots; This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash (The rash was so severe that it started on her stomach and wrapped around to her shoulder blade), walking difficulty and nerve pain. Previously administered products included Steroids and Gabapentin.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comments: The reporter stated that patient experienced shingles before she was eligible to receive Shingrix.  The patient had rash and was treated with steroids and gabapentin and had difficulty walking, rash for 3 weeks, and weeks of nerve pain and sensitivity. The patient received her first Shingrix injection on June 20 th on her birthday followed by a second dose 2-4 months later. Four months ago she noticed a small rash of about 3 dots so she contacted her HCP and was prescribed medication. The patient followed up with HCP 2 days later.  The patient shared that due to being vaccinated, the shingles was mild and only lasted a couple of days. The patient was thankful she had received the vaccine.  The HCP did not do a PCR test since she was already on treatment. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Blister - Information has been received from a physician concerning a 10 year old female patient who on 20 Sep 1996 was vaccinated sc in the left upper arm with varicella virus vaccine live.  Concositant therapy included brompheniramine malcate (+) phenylpropanolam (dimetapp) for allergic rhinitis and post nasal drainage at the time of vaccination.  On 23 apr 2000 the patient developed two small pin head size vesicles with a base of erythema over her abdomen on two separate locations.  there were a total of four vesicles which lasted for 2  weeks.  The patient is recovered.  No further information is avaiable.
Headache, Myalgia, Fever, DERMAL FILLER SWELLING. Narrative:
The pt was dx'd with chickenpox on 12/27/01. She received the Varivax vaccine on 7/10/96.
No additional AE or PQC reported at time of call; was inadvertently administered PROQUAD and MMRlI concomitantly; Information has been received from a physician referring to a 4-year-old patient of unknown gender. The patient's concomitant drug, pertinent medical history, drug reactions or allergies were not reported.  On 29-JUL-2021, the patient was inadvertently administered measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (0.5 ml, lot number: T030481, expiration date: 07-MAR-2022; strength and route were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5 ml, lot number: T006166, expiration date: 19-FEB-2022; strength and route were not provided) concomitantly for prophylaxis (Inappropriate schedule of vaccine administered). No additional adverse event was reported. The outcome of the event was not provided.
The pt experienced redness and blotchiness all over body. This began on the leg less than 24 hours post vax. In 24 hours the redness and blotchiness was all over the body. No local swelling, no fever and pt was not uncomfortable.
Booster shot given at 430pm.. woke up the next day feeling as if I had the flu. I had body aches, runny nose, headache, loss of appetite  and I was just so tired . I took DayQuil to get me through the work day but it was very challenging. I came home and slept until the next day and now I?m fine.
Broke out in Hives from head to toe, itching, took Benadryl: 50mg every 6 hours.  This provided some relief.
Information has been received from a 41 year old female registered nurse who on 9/5/06 was sprayed in the eyes with varicella zoster virus vaccine live (lot 0495F). She reported that the syringe and the needle separated after the Diluent had been added to the vaccine and the vaccine sprayed out the needle and got in her eyes. Her eyes were washed out. The nurse reported that her eyes were red and irritated and she had an appointment to see an ophthalmologist. No lab studies were performed. There was no product quality complaint involved.
Day 1 -2, arm of injection site very sore, subsided by day 4.   Day 6, arm of injection site had red rash.  Day 7-8, rash became itchy and hot.  Began taking Benadryl oral capsule. Day 8,  skin around red rash began peeling.  Began applying Benadryl gel at rash site. Will continue taking oral Benadryl capsule until rash subsides.
Pt recvd 1 dose of Engerix-B & w/in 1 wk of vax devel Gianotti-Crosti synd; seen by MD on 6JUL92; presented w/fever & fussiness; referred to a dermatologist who biopisied the rash; dx Gianotti-Crosti synd; papular acroderm;
Large localized swelling on bilateral thighs, L > R, with left side (site of Influenza and COVID vaccination) > 7inches x 6 inches of induration and erythema. R side (MMRV, DTaP/IPV) also red and swollen but 3in x 4in which within the realm of large reaction for DTaP dose 4 or 5
About 1 hour after vaccination, patient reported feeling numbness and tingling on the right side of face and hand. Numbness described as being similar to coming off of a local anesthetic from a dental procedure. The numbness and tingling started to subside about an hour after symptoms began.
patient received an expired dose of Quadracel vaccine which was expired 10 days ago/ NO AE; Initial information received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4-years-old male patient who received 0.5 mL once first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5500CA, expiry date: 16-Aug-2020, strength: standard, via an intramuscular route in the left leg) which was expired ten days ago (expired product used) on 26-Aug-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1/16 started with "not feeling right, felt off"  1/17  complained of nausea, no fever 1/18 lightheaded and nausea did not work. 1/19 continues with nausea, by mid-afternoon subsided, did work
I got hives around 30 minutes after vaccination all over my back. I also had very bad shooting pains that were bad enough to keep me up at night about a week after the injection in the spot that that I got the shot
Information has been received from a health professional concerning a 12 month old female, with no medical conditions or pre existing allergies, who on 30-APR-2007, at 14:30, was vaccinated subcutaneously into the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 656279/1503F). Concomitant therapy, that same day, included a first dose of Vaqta administered intramuscularly into the left thigh (Lot# 655320/1009F) and a first dose of M-M-R II administered subcutaneously into the right arm. There was no illness at the time of vaccination. On 01-MAY-2007, at 19:00, the patient developed a breakthrough of chickenpox, consisting of approximately 14-16 lesions, including one in the oral cavity. Unknown medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. At the time of reporting the patient's status was unknown. Additional information is not expected.
Left arm general soreness with gradual increase in swelling and redness. Unable to sleep on arm due to pain awakening me. The symptoms were worst between 03/07-03/09. It was very difficult to move my arm without pain. I am still experiencing this to a lesser extent. My arm is still swollen up about 1/2" to 1" in an area about 6"x 4" with a warm red area about 2"x4" at the lower end of the raised area. It is somewhat firm about 1&1/2" radius from the initial injection, which looks like a big mosquito bite or red zit. I also started experiencing a fever at around 2:00 pm on 03/07. This was the same day I started the live Typhoid series (as it is supposed to be taken on an empty stomach). This fever started low, and rose and fell between 100 and 101.7 on 03/08. I thought it was gone, but about 8 hours after my second oral dose of Typhoid, a low grade fever came back for the day on 03/09. That fever only lasted the one day, and never went over 100.5. I am now on my third live dose of Typhoid and am hoping for the best.
10-8 Patient called reporting hives, itching and swollen eyes Advised her to take Benadryl every 4-6 hrs and soak in oatmeal bath and report to MD. Called 10-9 and patient doing much better with mild itching remaining.
I have been a registered nurse for over 12 years. Recently, on Thursday February 18th, my PCR came back positive. Immediately after on February 19th, I went for another PCR and a RAPID, and BOTH were negative. I have been asymptomatic since the start of the pandemic and fully vaccinated since January 18th. When the contact tracers called me, they told me they do not take into account the fact that I am fully vaccinated and swabbed negative. In fact, none of this data is being collected. As a medical professional I think this information should be collected and is imperative information to collect to move forward from this pandemic. None of my contacts in my household or otherwise have gotten COVID since I tested positive.  I was told by the department of health I have to self-quarantine even though I am negative and fully vaccinated, and that they do not take into account my vaccination status or negative swab.  I contacted the cdc and the NYS DOH and political leaders. I heard back from the CDC saying they set guidelines. Clearly some states are not following them. I still get swabbed weekly although I am vaccinated.  Many of my fully vaccinated colleagues in the long term care facility have been in the exact same situation, being tested having a positive PCR then immediately negative. No one in their household or contacts tested positive either.
At day number 9, my  TWO arms got swollen , very red with hives. Disappeared the next day.
more than usual soreness in arm; diarrhea; felt like had a bad flu; more than usual heaviness in arm; primarily nausea; Chills; violently vomiting everywhere; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (more than usual soreness in arm), DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (felt like had a bad flu), LIMB DISCOMFORT (more than usual heaviness in arm) and NAUSEA (primarily nausea) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047AQ14) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (more than usual soreness in arm), DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (felt like had a bad flu), LIMB DISCOMFORT (more than usual heaviness in arm), NAUSEA (primarily nausea), CHILLS (Chills) and VOMITING (violently vomiting everywhere). At the time of the report, PAIN IN EXTREMITY (more than usual soreness in arm), DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (felt like had a bad flu), LIMB DISCOMFORT (more than usual heaviness in arm), NAUSEA (primarily nausea), CHILLS (Chills) and VOMITING (violently vomiting everywhere) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.