chrisvoncsefalvay/vaers-outcomes huggingface dataset:
During monitoring period post initial Pfizer COVID-19 vaccine, pt experienced lip swelling, "ball in throat," itching, lightheaded, sweaty, then chills, dizziness, fatigue, tachycardia, heaviness all over.  Medications Given: Epi-Pen injection 0.3ml SC in left thigh, Benadryl 25mg IM for itching given before and after Epi-Pen due to severe itching/rash. Patient  has had severe anaphylactic reactions to other vaccines previously that was not disclosed during intake. Patient remained in extended Observation for over 2 hours. VS: 140/82, P-79, Resp 17, O2 97% on RA. Refused to transfer to ER after observation. Later presented to ER with swollen eyes and SOB, rashes, sore throat and took fexofenadine at home.  Given additional diphenhydramine 25mg IV and methylprednisolone 125mg IV. Discharged from ED with medrol dosepak.
Engerix-B expired dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 26-year-old female patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20-DEC-2022) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B expired dose). The outcome of the expired vaccine used was 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: 13-MAR-2023 Sales representative received information from office manager that an expired dose of Engerix-B was administered to the patient. The reporter consented to followup via email. Vaccination date and patient initials were asked but declined. The patient received expired dose of engerix b which led to expired vaccine used.
Information has been received from a 42 year old female consumer, a "transplant candidate", who on 14-OCT-2009 was vaccinated with the third doe of PNEUMOVAX 23 (roue and lot # unknown). On 15-OCT-2009 the patient experienced painful arm and fever. The patient stated that she was a "High Risk" patient and she has been given PNEUMOVAX 23 (date, route and lot # unknown) twice before. The patient did not seek medical attention and at the time of this report the patient's outcome was not recovered. Additional information has been requested.
Friday 11/16/07 about 930AM received flu shot, felt tender that night, was like whelp hasn't gotten bigger. Allergy PCN; has gotten flu shot before; No other symptom. (3cm diameter); Patient also had sinus infection given CIPRO 500mg 1 tab po Bid #20
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Weakness-Mild, Additional Details: Patient presented to store 2 days post Shingrix vax, dose 2.  Stated she experience fever/chills/muscle weakness/flu-like symptoms 1 day after vaccine, took Tylenol and ibuprofen and felt better. Day 2 she noticed redness and swelling and hot to touch rash under the vaccination site. She called her primary care physician who told her to take 2 Benadryl tablets.  Pt requested we report her reaction.
Breakthrough case admission after 2 vaccines Pfizer 6/27/21 Lot# Ew0181;  Pfizer 7/19/21 Lot# Ew0181
vaccinated 7/7/2020. Other dose was administered 8/10/2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received  .   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 237ZH, expiry date 1st April 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On 10th August 2021, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 10th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient vaccinated  of with 1st dose of Boostrix on 7th July 2021.  Another dose was administered on 10th August 2021, which led to extra dose administered. The reporter consented to follow up.
I lost vision in my right eye for no reason, I went to the ER. They did a CAT scan ran blood test etc. searching for the reason i lost vision in my right eye.
I have had an excessive amount of skin issues since taking the vaccine. I bleed more easily now which I never did before and it takes considerably longer for it to heal. Also, I am noticing my skin quality has had major changes. I am starting to have acne in places all over my body that I have not had before or rarely had. Pustules on my arms, especially forearms, which is odd and has never happened before.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 20:00 as dose 1, single (Lot number: ER2613), in left arm, on 12Apr2021 at 01:00 as dose 2, single (Lot number: ER8729), in left arm and on 09Dec2021 at 19:00 as dose 3 (booster), single (Lot number: 33130BA) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "Known allergies: Mango" (unspecified if ongoing), notes: Known allergies: Mango. Concomitant medication(s) included: TYLENOL, start date: 10Jul2022, stop date: 12Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information:-Patient received paxlovid from 11jul2022 to 15jul2022 for COVID 19 treatment. Completed Paxlovid prescription as directed. No symptoms as of Saturday 16Jul2022. Started having symptoms again Tuesday 19Jul2022.
[Pfizer COVID Vaccine] treatment under Emergency Use Authorization(EUA): Pfizer Covid Vaccine- substantial lymphedema under armpit of injected arm. Dose of vaccine #2 on 1/12/2021. armpit sore to touch and patient experienced 6 lb weight gain from edema
Hives on lower back, sides of torso, under both arms pits/shoulders, inner thighs, and behind the knees. Itchy and becoming painful on third day of symptom.
there was an excrusion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant drugs were not reported.Treatment medications were not provided.Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021, reporter contact details updated.
suspected vaccination failure; had the worst case of 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year 6 months after receiving 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.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had this Shingles shot many years before the date of reporting when they first came out and one and a half years later the patient had the worst case of shingles that the patient has ever heard of. The patient stated forget the shot as far as he/she concerned. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown.
My husband developed cellulitis in arm, his arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (My husband developed cellulitis in arm, his arm is swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (My husband developed cellulitis in arm, his arm is swollen) (seriousness criterion medically significant). At the time of the report, CELLULITIS (My husband developed cellulitis in arm, his arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  Patient was diagnosed with cellulitis and right arm was swollen after receiving the Moderna COVID-19 vaccine. The reporter wanted to know if patient was able to get a booster dose of the Moderna COVID-19 vaccine. Company Comment  This case concerns a male patient of an unknown age with no reported medical history, who experienced the serious unexpected event of Cellulitis. The event occurred on an unspecified date after a dose of mRNA-1273 vaccine. ( Dose sequence not provided). The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of an unknown age with no reported medical history, who experienced the serious unexpected event of Cellulitis. The event occurred on an unspecified date after a dose of mRNA-1273 vaccine. ( Dose sequence not provided). The benefit-risk relationship of mRNA-1273 is not affected by this report.
28 yold male previously healthy who presented with recurrent loss of speech and motor function without loss of consciousness beginning 5/8/2021. Pt received his 2nd Pfizer COVID MRNA vaccination on 5/7/2021
Patient tested Positive for Covid 19 after getting full doses of the Moderna Covid19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested Positive for Covid 19 after getting full doses of the Moderna Covid19 Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested Positive for Covid 19 after getting full doses of the Moderna Covid19 Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested Positive for Covid 19 after getting full doses of the Moderna Covid19 Vaccine) outcome was unknown. Not Provided          No concomitant and treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021 and does not contain any new information
Fresh tenderness at the injection site two weeks after the shot. All of the initial injection swelling and redness went away after a few days but almost two weeks later the spot developed   a bruised and reddish appearance, and itching at the injection site.
Tinnitus; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  Additional Information: The patient had tinnitus and wanted to know if this was one of the side effects of COVID-19 shot. The patient was wondering if anyone reported any side effect with COVID-19 one shot, mainly tinnitus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician refers to an approximately 1 year old male patient. The patient pertinent medical history and drug allergies were none. Approximately on an unknown date in 2009 (reported as 6 years ago), the patient was vaccinated with VARIVAX (Merck) (dose, frequency, route and lot # were unspecified) and M-M-R II (dose, frequency, route and lot # were unspecified). Concomitant medications were unspecified. Approximately on an unknown date in 2009, within 10 minutes of vaccination, the patient developed swelling, stridor and diffused hives all over his body. The patient sought medical attention and the physician reported that the patient was administered an EPIPEN after the symptoms developed and was sent home. The outcome of patient developed swelling, stridor and diffused hives all over his body was unknown. The causality of swelling, stridor and diffused hives all over his body was unknown. No product quality complaint (PQC) was reported for VARIVAX (Merck) and M-M-R II. Additional information has been requested. This is a corrected report. Upon internal review, the events of swelling, stridor and diffused hives all over his body were considered to be medically significant as they were treated with EPIPEN and therefore the seriousness criteria for each one of these events was updated accordingly.
Patient received a COVID19 (Moderna) vaccine on 3/11/21 then received Pneumo Polysaccharide (Pneumovax 23) vaccine on 3/17/21 - there was not a 14  day minimal interval between vaccinations per CDC guidance
Muscle pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 28th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The pharmacist reported that the patient was continue to have muscle pain at the injection site of Shingrix vaccine.
I received an injection of PREVNAR 13 for immunization against pneumonia. I experienced chills, fever, headaches, nausea, vomiting and feeling sleepy.
Received 1st dose 4 years ago/did not receive a second dose until 16May2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 22M3K, expiry date 04-AUG-2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 4 years ago).   On 16-MAY-2023, the patient received the 2nd dose of Shingrix. On 16-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Received 1st dose 4 years ago/did not receive a second dose until 16May2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2023 The pharmacist reported that the patient received first dose of Shingrix about 4 years ago and did not receive a second dose until 16 May 2023. The reporter does not have the exact date or lot number information for the first dose. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Two days after the shot I started having blurred vision that kept getting worse, I was starting to have a hard time to see, especially at night driving. I went to the eye doctor that said I have fast growing cataracts, The doctor did say this is not an age related cataracts this is a fast growing cataracts.  I also hade muscle and body aches and headaches and fever, and I had horrible horrible fatigue to the point I had to take naps through out the day. I also had diarrhea for 3 days. And my arm where I got the shot was sore for almost 4 days.
eyeball filled with blood; Blotchy red skin felt like sunburn; burning skin; felt like she weighed a thousand pounds; sore all over,; This spontaneous case was reported by a non-health professional and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (eyeball filled with blood) in a 70-year-old female patient who received mRNA-1273  for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced CONJUNCTIVAL HAEMORRHAGE (eyeball filled with blood) (seriousness criteria medically significant), ERYTHEMA (Blotchy red skin felt like sunburn), SKIN BURNING SENSATION (burning skin), FEELING ABNORMAL (felt like she weighed a thousand pounds) and MYALGIA (sore all over,). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (eyeball filled with blood), ERYTHEMA (Blotchy red skin felt like sunburn), SKIN BURNING SENSATION (burning skin), FEELING ABNORMAL (felt like she weighed a thousand pounds) and MYALGIA (sore all over,) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever Chills, tingling left side of her face Narrative:  1/7 - felt like the watch on her wrist was heavy. Took tylenol and went home. At 1:00 onset of chills. At 9:00 pm onset of fever to 103. She also reports her face tingled like it did last time. The tingling is on the left side under her eye and above her lip. 1/8 her temperature is down to 100 degrees and the tingling is still present. 1/11 all symptoms resolved except minor tingling in her face. She is seeing her neurologist tomorrow for underlying neurological diagnosis and will let me know if the tingling doesn't resolve.
Started crying and cried from 2pm until 9 or 10. Wouldn't sleep for more than 40 minutes and would wake up and scream for hours. He quit smiling and babbling for almost 2 weeks. His reflux got much worse and he would throw up everytime I fed him for 3 days.
patient reported profuse sweating.  provided water and checked in on patient.  after 20 minutes sympotoms had resolved and patient was released
Seizure approximately 7:30AM the day after Tdap, approximately 17 hours later. Child has known seizure disorder and takes meds plus diastat PR at home. Recovered fully.
swollen lips; Hives broke on her arms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives broke on her arms) and LIP SWELLING (swollen lips) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced URTICARIA (Hives broke on her arms). On 28-Feb-2021, the patient experienced LIP SWELLING (swollen lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of UNK dosage form; PREDNISONE for Swollen lips, at a dose of UNK dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Swollen lips, at a dose of UNK dosage form. On 05-Mar-2021, URTICARIA (Hives broke on her arms) and LIP SWELLING (swollen lips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. On 27-Feb-2021, the patient was given steroids as a corrective treatment. All the episodes got worst at night. It all lasted for 7 days. I was thought that it's partly due to the vaccine because her doctor told her that other patients had it due to the vaccine. Benadrly used to help her a lot with allergies.
Lost my sense of smell and taste after about 3 hours.  Senses both returned about 36 hours after vaccination
Soreness in right chest and back shoulder blade; and limited movement of right arm making it difficult to lift heavy objects and difficulty tucking in shirt.
After beginning to not feel well--upset stomach, nauseous, lethargic , about 6 hours after shot, I had trouble sleeping and felt bad during the night. I woke up about 6am and when I was brushing my teeth I felt nauseous and very weak, and then I passed out. I hit floor hard and have a good size bump on the back of my head. For the rest of the morning ( day after my 1:30 second shot), I continued to feel weak and a little nauseous. I never had a fever. I'm sending this report the morning of the second day after my second dose, and I'm feeling much better--more energy and no nausea. ---But i was pretty sick annd passing out indicates a severe reaction. I'm small--only 4 ft 11 in and 95 pounds. For my retired friends and neighbors who have been vaccinated, the smaller ladies are having much worse side effects.
I have had joint pain since the day after my injection. My hips and knees and legs are aching so much that I need to take Tylenol 500mg twice a day. The muscles in my arms, buttocks, and legs also ache.