chrisvoncsefalvay/vaers-outcomes huggingface dataset:
18day p/vax pt exp multiple papules, 1-2 vesicles forming
Redness and swelling to site since receiving immunizations. Now includes right bicep warm to touch, pain when raising arm and pruritus.
Pt developed a gross generalized pruritic rash, myalgia, headaches, dizziness and fatigue. All symptoms improved with exception of the rash. Treatments: Symptomatic treatment with Benadryl, Tylenol, several types of ointments/creams, oral steroids and antihistamines.
Febrile seizure with temperature 102.5. Also acts very lethargic for the first 5 days after immunizations.
Patient fully vaccinated for COVID 19 and tested positive for COVID on 1/24/2022. Client was hospitalized and died on 1/30/2022, contributing COD was COVID-19
Pt developed left arm pain soon after receiving vaccine (11/10/21) and then woke the following morning (11/11/21) at 0400 with severe left-sided neck pain. Pt was inconsolable. Pain went away with time, heat and Advil.
Patient with vasovagal response after administration of vaccine. Appeared to be seizure-like in nature: limp and eyes rolled back. Head flopped back and he had significant twitching about 1 minute after vaccine administered. Out of it/motions lasted for about 30 seconds and then post-itical (lasted several hours). Patient felt this way until 11/29/20. As of 11/30/20, back to his normal self.
- Joint pain - headache -fatigue -nausea -vomiting -diarrhea -syncope -chills/shaking -sweating  -injection site soreness
Have used Pfizer (Comirnaty) and Moderna vaccines; Have used over-the-counter cold medicines ie Alka-Seltzer Power Max Gels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Have used Pfizer (Comirnaty) and Moderna vaccines"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Have used over-the-counter cold medicines ie Alka-Seltzer Power Max Gels". Therapeutic measures were taken as a result of nasopharyngitis.  Additional information: Have used Pfizer (Comirnaty) and Moderna vaccines. Have used over-the counter cold medicines i.e Alka-Seltzer Power Max Gels. The case was not severe and did not need a prescription. Age is 74.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient noticed itchiness and a rash that spread up his arm over his collar bone. He said that the area was very read and on about day 5 the area of the rash went numb.
about 10PM pt began vomiting, became limp & unresponsive; t102 ( 2 doses of APAP were given @ 430PM & 830PM); EMS was notified; transferred to hosp ER for eval
Feels like lt arm is asleep, mild tingling sensation at various locations on arm.Sensation happens at different times;she is able to move her arm.Hurt at site only during administration.
Patient called pharmacy and later came into pharmacy on 11/12/19 in to show/report arm is in pain 8 out of 10 to touch, swollen, and bright red.  yesterday on 11/11 the red and swollen area was a 1/2 of current size, after advsing twice over the phone and in person to seek medical attention, Patient wanted to wait one night, Patient bought tylenol and antihistimine.
Headache for 6 days now-varying from constant pain to sharp weakening pain. Chest Pain on right side to include pain all the way down to my lower back. Bodyaches. Swelling of glands in armpit area on Right Side.
Information has been received from a physician concerning a 64 year old female who, "two days ago" on 26-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (Lot 658602/1080U). The physician noted the patient was now presenting (date unspecified) with a unilateral rash under her neck that looked like shingles. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient was recovering. Additional information has been requested.
Left-sided facial swelling, eye swelling, neck swelling, itchy lips/throat, hives to left arm and swollen axillary lymph nodes. Prednisone 60mg (taper over 10 days), Benadryl, Zyrtec, Pepcid and Advil. Improvement after 4-5 days on medication. Complete resolution at day 10.
Sore arm and tired after injection. Woke up Feb. 20th at 3:00am with severe headache, face ache, pain in eye socket and teeth, neck ache, left shoulder ache, left arm ache
Nausea, migraine, very sore arm, unable to lift arm above shoulder height,  vertigo
Two hours following the vaccine I suddenly felt faint,dizzy and started sweating.  I almost fainted.  Following this I continued to feel much worse through the next few days.   With extreme body aches and pains.  Nausea was consistent for multiple days and was unable to eat and drink. Within a few days I was able to somewhat get my life back to normal yet I was unable to breath as well as before the vaccine.  It?s now august 10,2021 and I still get winded as it seems I cannot get it enough oxygen in my lungs.  I overall haven?t been well since June 05,2021 at 11:00 am just a few hours after the second vaccination.
No additional AE/PQC reported; Caller is HBP reporting an improperly stored, administered PNUEMOVAX 23 VIAL; This spontaneous report was received from a hospital-based physician (HBP) and refers to a 83-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.      On 05-JAN-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T021329, expiration date 03-OCT-2021, 0.5 milliliter for prophylaxis (anatomical location and route of administration were not reported).     Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 8.9 degrees of Celsius for 72 hours. There was no previous temperature excursion reported.  No additional adverse event or product quality complaint was reported
injection site soreness; This is a spontaneous report from a Pfizer-sponsored program. A contactable Female consumer reported for herself that:  A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced injection site soreness / fortunate enough to not get side effects aside from the injection site soreness on an unspecified date. Reporter stated that, she took pain medication before the first dose and she was asking if she could take another pain medication after the first dose that has nothing to do with the covid vaccine. Outcome of event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
1st dose of Engerix-B administered to the patient was a pediatric dose; 1st dose of Engerix-B administered to the patient was a pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 70-year-old female patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   On 12-JAN-2023, the patient received the 1st dose of Engerix B pediatric. On 12-JAN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 1st dose of Engerix-B administered to the patient was a pediatric dose) and adult use of a child product (Verbatim: 1st dose of Engerix-B administered to the patient was a pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUL-2023 The patient came and received her 3rd dose of Engerix-B and when he looked back at the records. The reporter consented to follow up via postal. The Vaccine Administration Facility was the same as Primary Reporter. The first dose of Engerix-B administered to the patient was a pediatric dose, which led to underdose and adult use of a child product.
Redness and tenderness on vaccine spot, reported by the patient five days after noticing, Has applied ice and hot creams, was advised to see a physician for possible skin infection.
This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (oral, batch number: UNKNOWN expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced sickness, and fatigue/tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient was recovering from fatigue/tired, and the outcome of sickness was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On 15-SEP-2015, 16-SEP-2015, 17-SEP-2015, 18-SEP-2015, 21-SEP-2015, 22-SEP-2015, 23-SEP-2015, 24-SEP-2015, 25-SEP-2015, 28-SEP-2015, 29-SEP-2015, 30-SEP-2015, 01-OCT-2015, 02-OCT-2015, 05-OCT-2015, 06-OCT-2015, 07-OCT-2015, 08-OCT-2015, 09-OCT-2015, 12-OCT-2015, 13-OCT-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L004014 exp. 04-MAR-2017 and lot # L016429 exp. 08-MAR-2018, (dose and route were not provided). The primary reporter could not confirm which vaccines were administered on which dates. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer, the patient. A 19-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Mar2021 at 11:30 (at the age of 19-years-old) as a single dose for COVID-19 immunization. Medical history included hormonal implant inserted in Feb2019 and birth control. The patient did not have any allergies to medications, food, or other products. Concomitant medications included etonogestrel (NEXPLANON) for birth control from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, within 12 hours of receiving the vaccine, the patient started to have period and it had not varied greatly in flow and cramps.  No therapeutic measures were taken as a result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events irregular periods and menstrual cramps was unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022).    Concomitant medication was not provided.    Treatment medication information was not provided by the reporter.
In the evening of 10/14/04 pt had swelling and erythema of rt arm from shoulder almost to elbow with presence of rash at outer margins. No changes in breathing were reported.
Left thigh abscess, red, hot non-painful around size of small apple (protudes out of contour of leg) Able to move left leg well. Began on  of vaccination 3/28/02 typically around site of DTaP vaccine. Treated with Keflex, previously witn Amoxil. follow-up with telephone call.
Incredible pain at the injection site that radiate down her arm, lasting through the night; Felt very fatigued after the vaccine; She didn't sleep well due to pain; This is a spontaneous report from a non-contactable consumer.   A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, on 18Dec2020 at first single dose on the arm for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient reported incredible pain at the injection site that radiate down her arm, lasting through the night. Also felt very fatigued after the vaccine. She didn't sleep well due to pain, fatigue may also be caused in part by this. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt received COVID vaccine (2nd dose) at 0857. Pt reported after twenty-five minutes that it was "difficult to take a deep breath". RN and EMT took VS. VSS. Clear lung sounds. RN told pt to remain for an additional 15 min of observation. Patient stable and able to leave on her own at the end of 15 min observation.
-red scaly rash on hand reported to doctor 10 March 2006. -soreness in arm, shoulder in hand still present to this day. -trouble lifting things and doing every day activities. - generalized arthropathy diagnosed by doctor
Circular rash on chest 3 areas. Appeared few days after vaccine.   Large circular rash on back of my left leg and another one on the back of my right. Both elbows with a small   All appeared around 9/3/21.
Entire body - joint/muscle pain/discomfort. Legs especially! Can not stand or walk for prolong time. It is now July and I thought this feeling would subside. Instead, the pain has increased in intensity. My doctor has prescribed gabapentin, but it doesn't seem to be working.
Heart palpitations and rapid heart rate average 110 bpm for about 14 hours .
About 5 hours or so after the injection I began to feel a stiffness and soreness on my left forearm and left shoulder. The soreness in the forearm persisted for about a few hours and the pain was negligible unless I applied a slight squeeze to my forearm, which caused significantly more pain. At that strength I would normally not feel any pain at all, but it was strong enough to cause me to almost instantly release my grasp. The pain in the shoulder was also negligible but caused far less pain when pressed compared to my forearm. My shoulder symptoms lasted until I woke up the next morning.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EK5730), in right arm, on 12Jan2021 at 16:45 as dose 2, single (Lot number: EL1283), in right arm, on 07Sep2021 at 10:30 as dose 3 (booster), single (Lot number: FC3181), in right leg and on 19Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 64 years, in right arm for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no relevant medical history. Other medical history was reported as none and patient had no known allergies. The patient did previously receive a COVID-19 vaccine. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. This report was about COVID-19 treatment. Patient received the vaccine. Patient did not take any medications within 2 weeks. Patient received anti-viral Paxlovid treatment from 26Jul2022 to 30Jul2022 for treatment of COVID-19. The reported seriousness of the events was non-serious.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 06Aug2022.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
My finger tips under my nails turned blue on my left hand (same side as my injection).; Nausea; Headache; My arm is sore; Fatigue; This is a spontaneous report from a contactable consumer reported for herself A 27-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:30 (Batch/Lot number was not reported) at the age of 27 years as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); collagen (COLLAGEN); lepidium meyenii root (MACA ROOT). The patient reported that "my finger tips under my nails turned blue on my left hand on 12Mar2021 17:00 with outcome of not recovered, nausea on 12Mar2021 17:00 with outcome of recovered, headache on 12Mar2021 17:00 with outcome of recovered, " my arm is sore" on 12Mar2021 17:00 with outcome of not recovered and fatigue on 12Mar2021 17:00 with outcome of recovered.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
My arm has not stopped twitching since I have received the vaccine 2.5 hours ago. I can still use it. It is a localized twitch on the back side of my arm an inch above my left elbow (same side as injection).
Rash located only on his chest and shoulders, not itchy, but about 30 spots of pink light-colored dots; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration on 26Jan2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, the patient had a rash. It was located only on his chest and shoulders, was not itchy, but was about 30 spots of pink light-colored dots. It was dots, a quarter inch to the size of a quarter that do not itch. They are not all round, they can be oblong, they are a lighter pink. The patient said that since they were where his suspenders go that the skin might just be getting irritated. The patient tried Neosporin which was not helpful, and Mellaluca oil which made it darker red. The patient reported that he called local clinic to schedule an appointment and they asked him to talk to Pfizer first to see what their recommendations were. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Pfizer COVID19 vaccine and went to the observation area.  Others in the observation area noted that she had a red rash on her chest.  Patient noted that she felt warmth in area but no itching.  She denied chest pain, shortness of breath, itching, oral mucosal swelling. She was given diphenhydramine 50m g by mouth one time. She was observed for 40 minutes in treatment area with improvement of redness and rash. Patient was stable when left the treatment area. She was instructed to go to ED if rash worsened or if she developed oral mucosal swelling, difficulty breathing/SOB. Recommended that patient consult her primary care physician and see an allergy specialist before getting her second dose.
He completed Pfizer COVID vaccines on 1/20/21. He lives in the local nursing home, and he was tested COVID positive on 6/7/21. He became hypoxic and was admitted at Hospital on 9/9/21. His symptoms are confused, drowsy, fever 102.6. He is in stable condition on 2L oxygen on hospital day 6.
1/30/09 - seen in office with redness, swelling 8 x 10cm with soreness to injection site.  2 x 2 cm ecchymotic right arm about inj. site.  Encouraged rest and ice.
This nurse consulted with overseeing MD at MC. Dr. said it is okay to still give the vaccine and patient advised to keep rash covered if it develops and to report any reaction. Symptoms noted by patient were redness, raised area at vaccine admin site and slight itching (less than previous vaccine reaction.) Symptoms lasted approx. 1 week.
Pain on the face; Side rash upper face area; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Pain on the face) and RASH (Side rash upper face area) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergy to Sulphur). Concomitant products included CLOPIDOGREL, FAMOTIDINE, CARVEDILOL, LAMOTRIGINE, TOPIRAMATE, ROSUVASTATIN and FELODIPINE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FACIAL PAIN (Pain on the face) and RASH (Side rash upper face area). At the time of the report, FACIAL PAIN (Pain on the face) and RASH (Side rash upper face area) outcome was unknown.            Treatment information was not provided.
Information has been received from a physician concerning an approximately 11 year old male who on 04-NOV-1999 was vaccinated with a dose of VARIVAX (Merck).  The patient developed rashes recently and came to the clinic on 06-MAY-2009, the rashes were confirmed as chickenpox.  Additional information has been requested.
Acute renal failure with acute cortical necrosis, ultimately requiring hemodialysis for ESRD and was additionally diagnosed with idiopathic generalized epilepsy and placed on Keppra after presenting with sore throat.  Treated with 3 days Ceftriaxone for E. Coli UTI on UCx. Discharged from Medical Center to Home/self-care. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.