chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case initially received from other non-healthcare professional on 08-Nov-2018, concerns a 19-year-old, adult, female patient. The patient's vaccination history included unspecified flu vaccines without any adverse events. The patient had no relevant medical history and concomitant medications. On 05-Nov-2018, the patient was administered FLUCELVAX (QIVc) [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported] for protection against seasonal influenza. On 06-Nov-2018, the patient developed hives all over the body and swelling of the eyes, wrists, knees, and fingers. On an unspecified date in Nov-2018, the patient went to the emergency room (ER), where she was given Benadryl (diphenhydramine, paracetamol, phenylpropanolamine hydrochloride) and unspecified steroid shot and was sent to home. The reporter stated that the swelling and hives had not gone away. At the time of the report, the patient had not recovered from the events.  The reporter assessed the case as non-serious. This case was considered as lost to follow up, as the reporter had not given the consent to follow up. Follow-up received from the consumer on 15-Jan-2019: Med info number (SEQ19-00290) was added in additional information tab. This case was considered as lost to follow-up, since the consumer has not given consent to provide further information. It was confirmed that, the consumer couldn't provide the lot number. No new information was available. Hence, no changes were made in the narrative.; Reporter's Comments: A 19-year-old female patient experienced hives all over the body, swelling of eyes, wrist and knees, 1 day after receipt of FLUCELVAX QIVc vaccine. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed this case as serious (medically significant).
The pfizer adult vial was not mixed with 1.8ml of sterile diluent and patient was given 0.3ml. This was patient's first dose and we have been trying to get hold of patient but no answer. We will keep trying and inform patient of what happened and to not get the second dose. Also, we will tell patient about irritation and soreness at site of injection.
I do not have exact information on vaccine (either Moderna or Phizer).   He was vaccinated in February 2021 first dose, March 2, 2021 second dose by Health Services.   He had malaise, fatigue, weakness and slept for four days after first dose.  He had extreme malaise, fatigue, weakness and was unconscious for 4 days (3/2-3/5) until he passed away.
Information has been received from a registered nurse concerning a patient who was vaccinated with Rotateq. Subsequently, the patient experienced diarrhea and abdominal cramping. Subsequently, the patient recovered from diarrhea and abdominal cramping. The patient sought unspecified medical attention. Additional information has been requested.
It started twos after getting the vaccine. It started occasionally dizziness from April-December 2021. In December I started having Vertigo problems. An the balancing in January-March 2022. I had to go to the ER December 31, 2021 my blood pressure and balancing was off. I thought I was having a stroke. The ER doctor stated that I was having an anxiety attack. They prescribe me something for the Vertigo.
A rash dominant on both arms and other locations on body that makes skin feel like alligator skin having bumps and red spots.  Body aches that can inhibit activity. Periods of really bad body odor. Foods normally favorites that normally taste good, taste awful.  Treatment so far has been the application of Triamcinolone Acetonide Ointment 0.1% on rash areas twice a day.
This is a spontaneous report from a contactable medical assistant communicated to a Pfizer sales representative. This medical assistant reported similar events for 3 patients. This is the third of three reports. A 17-18 year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient experienced swelling and pain, malaise and possible fever in Aug2016 a couple of days after vaccination. The outcome of the events was unknown. Follow-up (07OCT2016): Follow-up attempts are completed. No further information is expected.
Pt brought this adverse reaction to this immunization to my attention, she states  that after receiving the immunization shot, there was not response until the  morning of 8/13 that her arm gradually swelled around the injection spot to a f" x  3" red oval raised hard and painful bump.  This bump and redness continued for 2  weeks.  Then the bump and redness gradually subsided. It was not until 9/9/20 36  days after the injection that the redness and bump became undetectable.
Received injections 07/28/2003; 07/29/2003 right arm tender and sore, 07/30/2003 upper arm reddened, warm and swollen around injection site to elbow.
evening of 2/25 started to have some chills but no chills when I woke up the next day.  on 2/26 in the evening there was an increase in joint pain.  I took 400mg ibuprofen at bed time.  During the night I woke up due to the pain and noticed that I had been sweating.   I took 400mg around 3am and went back to sleep.  Woke at 6AM on the2/27and still had joint pain but not as painful as the night before.  Couple hours later while taking a shower I noticed that my left arm at the site of the vaccine had a large red blotch.  It  did not itch or was painful but it was somewhat warm.  At that point I called my primary drs office and was advised to go to urgent care.  At Urgent care my arm was examined by a doctor and he ordered a Covid test and prescribed doxycycline as he felt I had cellulitis.
18 year old presents w/ mother for ongoing rash  -Pt. received Moderna COVID booster on 12/18, mom believes rash is related to booster -Onset of rash began on the back of the scalp x10 days ago and moved to the back of the neck w/ itchy red bumps, sxs have since resolved, photos provided   -Rash is currently on posterior of lower Rt. arm and Rt. hand  -Pt. notes when applying pressure to an area it turns into a rash   -Reports hands and fingers have been swollen w/ increased redness and itchiness -C/O of wrist and ankle pain  - no joint swelling or pain  - abd pain  - no cough  - no resp symptoms -Currently using benadryl and zyrtec for treatment   -Denies any insect bites -Denies any other sxs - no new meds
Baseball-sized redness and swelling at injection site; pain and hot-to-touch. Later, itching.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 21-JUN-2016, the patient was vaccinated with an improperly stored PROQUAD injection (lot# M001152, expiry date 05-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
2 weeks (so far) of headaches, muscle soreness, what feels like low-grade fever.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: ENG203), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Benign Prostate Enlargement" (unspecified if ongoing). Concomitant medication(s) included: TADALAFIL, start date: Jul2021, stop date: 18May2022; TAMSULOSIN, start date: Jul2021; FINASTERIDE, start date: Jul2021; ATORVASTATIN, start date: Jan2019, stop date: 18May2022. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive; (24May2022) Negative; (28May2022) Negative; (29May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19 included with Paxlovid. The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6203 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations and an analysis of complaint history for the reported lot. and product type. The final scope included the reported finished goods lot EN6203, fill lot EN5336, and the formulated drug product lot EN5324. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Clinical course: Patient reported that he started Paxlovid the day he tested positive, 18May. he completed Paxlovid on 23May his symptoms were gone, and he tested negative on a home antigen test on 24May. His symptoms were mild during this initial bout with Covid, congestion, tiredness, and a low grade fever. On 28May, patient felt tired and a little congested but again tested negative. On 29May he tested positive. His symptoms have been mild on rebound, mostly congestion and some tiredness, no fever. No follow-up attempts are needed. No further information is expected.
Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC.   Treated with dexamethasone, remdesivir and empiric antibiotics.   Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29.   On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy.    On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29.
Pt presented with cellulitis to right upper arm, painful and warm to touch. Given Rocetin 1gm IM and a prescription for Augmentin 875 mg One tab twice a day for 10 days.
Patient received Covid vaccine in March (unknown date). He subsequently developed a burning chest pain and cough. Diagnosed with Covid May 20,2021.  Admitted to the hospital May 27th with new stroke symptoms and mycoarditis/NSTEMI
Allergic reaction type reaction. Heaviness in chest, Tingling in hands and feet, Light headed, Heart racing. Stayed 30 mins gave Benadryl 25mg X2 then patient decided to go to ER.
This spontaneous report as received from a physician refers to a currently 19 year old male patient. "15 years ago", in approximately May 1999 the patient was vaccinated with M-M-R II (strength, dose and lot# not reported) and VARIVAX (Merck) (strength, dose and lot# not reported). On an unknown date the patient's titers were low. The outcome of patient's titers were low was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Telephone call received at health department from RN at hospital on 04/06/2004 stating child brought to ER by mother as he had been sent home from school with rash.  ER physician made the diagnosis of measles.  Epidemiology nurse notified.  No treatment given.
Very sick from first shot; Very bad mark in upper arm where shot was given; When I touch my arm at injection site it is very very hot; Swelling on same arm; insomnia (wakes up every 30 minutes); diarrhea; stomach pain; extreme nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick from first shot), VACCINATION SITE BRUISING (Very bad mark in upper arm where shot was given), VACCINATION SITE WARMTH (When I touch my arm at injection site it is very very hot), PERIPHERAL SWELLING (Swelling on same arm) and INSOMNIA (insomnia (wakes up every 30 minutes)) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced INSOMNIA (insomnia (wakes up every 30 minutes)), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (extreme nausea). On 09-May-2021, the patient experienced ILLNESS (Very sick from first shot). 09-May-2021, the patient experienced VACCINATION SITE BRUISING (Very bad mark in upper arm where shot was given), VACCINATION SITE WARMTH (When I touch my arm at injection site it is very very hot) and PERIPHERAL SWELLING (Swelling on same arm). At the time of the report, ILLNESS (Very sick from first shot), VACCINATION SITE BRUISING (Very bad mark in upper arm where shot was given), VACCINATION SITE WARMTH (When I touch my arm at injection site it is very very hot), PERIPHERAL SWELLING (Swelling on same arm), INSOMNIA (insomnia (wakes up every 30 minutes)), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (extreme nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication included Over the counter medications  Treatment medication included Zyrtec, Tylenol, TUMS, Equate Sleep Aid, nausea medication.  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-074039 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 : second dose Lot number  was updated On 11-May-2021: Follow up received on 11-MAY-2021: second dose Anatomical location, treatment, new events were updated
Day 1, more arm soreness than 1st shot.  Day 2, couldn't raise arm above shoulder, Fatigued, fever 102+, achy.  I was instructed to take Tylenol as soon as fever, etc., kicked in since I had a reaction to the 1st shot.  Which I did.  Consequently I did not feel nearly as bad with fatigue and achiness as with the first shot even though the fever was still erratic.  Day 3, I developed a huge red mark on my left arm beginning at the injection site and wrapping down my arm in snake fashion about 5" long (would have been more if straightened out instead of snaking down).  That redness stayed about 3 days and continued to be sore and hot to the touch.
The patient broke out in hives about 8 days afterher second vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies (unknown), hypothyroidism and allergies to penicillin. The patient had received an unspecified concomitant medication. The patient had not received any other vaccine within four weeks prior to the COVID vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6207) via an unspecified route of administration in the right arm on an unknown date in Mar2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021 at 21:00, the patient broke out in hives about 8 days after her second vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event hives which included treatment with cortisone shot and prescriptions. The clinical outcome of the event hives was recovering at the time if this report.   No follow-up attempts are possible. No further information is expected.
hives; fatigue; itching arm; face itching; nausea; stomach cramps; arm hurts near injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach discomfort, at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Painful gas from 4pm to 7am, refusing to nurse.  Periodic painful gas for 36 hours following Small red bumps on arms,  legs, back and stomach appeared 48 hours after.
BODY ACHES; SORE ARM AT INJECTION SITE; This spontaneous report received from a parent concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced sore arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm at injection site, and body aches. This report was non-serious.
Patient states irritation started at 22:00 November 12, 2002. Patient went to bed and was awaken by itching sensation at 2:30, November 13, 200. Unable to get back to a sound sleep. Rash noted at 2:30. Patient reported to clinic at 8:00 November 13, 2002. Benadryl 50mg q 6 hours, 60mg once a day x 5 days. RTC November 14, 2002 for FU.
After 48 hours employee had redness, hardness, itchiness, large bump for 3 days.
got the shots but I also took the singles to/ Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got the shots and also took the shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Left deltoid swelling, redness, warmth and pain. Temp last evening (Sun) 7-14 of 100 orally. Lower back achiness as well as systemic myalgia, afebrile today Monday 7-15-13 given script for KEFLEX 500 mg  TID for 7 days (daily if needed) oral temp spikes again.
p/1st vax @ clinic 21APR98 mom describes the following event;pt awoke several times the noc of receiving vax & was shaking violently;paternal grandma questioned sz activity;no fever noted;
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient reported vomiting, nausea, and dizziness soon after vaccination. The following day patient developed rash across chest and torso, "slight" itching, fever, and headache and took diphenhydramine. Two days after vaccination patient woke up with swollen armpits bilaterally. Non-steroidal anti-inflammatory drugs improved armpit symptoms.  Patient had telehealth visit for symptoms and prescribed Epi-Pen to use when needed.
Only the diluent was given with the injection not the actual vaccine. Age of patient at time of event: 4 months.
at 3pm -initially -Sore at sight, muscle sore, not moving arm by 6pm- swelling at vaccination site, pain in arm, redness, slight swelling 8:30 AM (10/31) large hard bump at vacination site, soreness, redness