chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EYE SWELLING, FACE UNDER EYE WAS SWELLED DOWN; ITCHY ALL OVER, ON ARMS, BACK, LEGS, AND HEAD; MOUTH WAS GETTING BIG/SWELLING; COUGHING; UNCOMFORTABLE IN THROAT, LIKE ITCHING; LIPS SWELLING; HEADACHE; ALLERGIC REACTION; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received tylenol (coated tablet, oral, batch number was not reported) dose and frequency were not reported from 10-AUG-2021 for headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 09-AUG-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 10-AUG-2021, the patient experienced eye swelling, face under eye was swelled down. On 10-AUG-2021, the patient experienced itchy all over, on arms, back, legs, and head. On 10-AUG-2021, the patient experienced mouth was getting big/swelling. On 10-AUG-2021, the patient experienced coughing. On 10-AUG-2021, the patient experienced uncomfortable in throat, like itching. On 10-AUG-2021, the patient experienced lips swelling. On 10-AUG-2021, the patient experienced headache. On 10-AUG-2021, the patient experienced allergic reaction. Treatment medications included: cetirizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol was not reported. The patient was recovering from eye swelling, face under eye was swelled down, mouth was getting big/swelling, and lips swelling, and had not recovered from headache, itchy all over, on arms, back, legs, and head, allergic reaction, coughing, and uncomfortable in throat, like itching. This report was non-serious.
Shoulder sore starting morning after shot administered has continued since and pt. getting physical therapy for it.
This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of maternal exposure during pregnancy (pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 043L20A) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. The patient's last menstrual period was May 2020 and estimated date of delivery was Mar 14, 2021. On an unknown date, patient experienced maternal exposure during pregnancy (pregnant). The patient received mRNA-1273 (Moderna COVID-19 vaccine) during pregnancy. At the time of the report, maternal exposure during pregnancy (pregnant) resolved/not provided. No concomitant medications or treatment information reported. Most recent follow-up information incorporated above included: Feb 25, 2021: Additional information reported: address and contact details of the reporter, lot number, LMP, estimated due date and gestational stage.
Post vax, had red, warm, itching on entire upper and outer left arm; also swollen. Was instructed to put ice on for 15 minutes, 3 X today and start tomorrow with warm compresses. Take Tylenol and if PMD approves, take Benadryl. Call tomorrow PM and advise of status.
2:30pm vaccine administered. 6:00pm chest heavy, coughing, wheezing continued to get worse - very little air exchange. 6:30pm went to Urgent Care - sent to ER. 7:00pm seen in ER - treated and admitted overnight.
Smell of gasoline regularly; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Smell of gasoline regularly) and CHILLS (Chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Headache. Concomitant products included TOPIRAMATE (TOPAMAX) and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAROSMIA (Smell of gasoline regularly) and CHILLS (Chills). At the time of the report, PAROSMIA (Smell of gasoline regularly) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-027634 (Patient Link).
April 4, 2010, RN withdrew contents of ENGERIX-B made by GlaxoSmithKline. The dose is to be 10mcg/0.5ml but vial only contained 0.4 to 0.45mL. Both vials wasted and another vial obtained that contained the full dose. Lot #AHBVB817AA exp date 5/11/12. This same product problem was reported directly to GSK in February 2010 but not reported. Given this second occurrence, we felt we should report it.
She started having night sweats, chills, insomnia, and hot flashes.  Had completed menopause two years earlier.
Patient reported loss of bladder control, shaking, fever over 100 degrees. Pt did not report until the next day by which time the pt felt better. Dr. did tell her she could take BENADRYL.
Beginning 4pm 2/26- severe headache 10pm- 2/26- upper body aches began 1am- 2/27- violent chills, freezing cold to the touch 2am- fever began with 100.3 Fever continues all day, Tylenol and ibuprofen do not get it below 99.3. Felt dazed and lethargic. Fever continues until 7pm 2/27, highest of 102.3.  2/27- a pink rash begins on my left arm, painful to the touch and hot to the touch. Still have headaches, body aches and nausea.  2/28- still slight body aches, headache and nausea. The rash on my arm doubles in size and is now about 6x7 inches. Still very hot to the touch, still painful. Cold compress and Benadryl did not change the size or  sensitivity of the spot.  3/1- body aches and headache are slightly better, the red rash is slightly less red but the same size.
pt recv vax 28APR95 & 6MAY95 pt devel a fever of 101 & a mild rash & was fussy;tx w/APAP;
4-day history of fever, headache, congestion, cough productive of yellow sputum, weakness and body aches.  Symptoms started on Sunday and he reached a T-max of 103.  In the ED he tested positive for Covid PCR.  Covid pneumonia
Pain, redness, itching, and swelling in left arm.  Dizziness.
Got Covid; Got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Lot number: FH8028) at the age of 35 years as dose 3 (booster), single, administered in arm left, administration date 25Apr2021 (Lot number: ER8735) as dose 2 single and administration date 04Apr2021 (Lot number: ER8737) as dose 1 single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient did not received any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant) with onset 07Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 07Jan2022, outcome "recovering" and all described as "Got Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Device Date : 07Jan2022.  No follow-up attempts are possible. No further information is expected.
9 month H/M. Received Flu shot on 12/2/10 in AM had fever 104.9 within 24 hours of vaccination; sleepy, moaning lasted 24-48 hrs - recovered.
5-10 minutes after shots-patient was feeling "something".  While at a store, parents noted patient's puffy eyes/face and spreading rash.  Urticaria.  Got per mouth Benadryl.  SQ Epi, monitored.  O2 home with per mouth Benadryl and Per mouth prednisone x1.
She received vaccine on 04/27/2023 and came back to the pharmacy on 05/02/2023 and said she had injection site reaction. She said her arm was red, warm to the touch and tender, sore and swollen.  I advised her to contact her physician.  The physician later ordered her an antibiotic in case it was a little cellulitis.
Body aches; Fever; Loss of appetite; Dizziness; Elevated liver function test; Anemia; This is a spontaneous report from a contactable consumer or other non hcp.   An 84-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6201), dose 2 intramuscularly, administered in Deltoid Left on 12Mar2021 as dose 2, single for covid-19 immunisation. Medical history included, hypertension, Blood pressure/Hypertension, gastroesophageal reflux disease, hyperlipidaemia, anaemia, anxiety. Concomitant medication(s) included sertraline (SERTRALINE); hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ); alprazolam (ALPRAZOLAM; melatonin (MELATONIN).Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Right deltoid on 10:00 as DOSE 1, lot number= EN6208 SINGLE for covid-19 immunisation   The patient was not pregnant at the time of vaccination. The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, after second dose, had body aches, fever, loss of appetite, dizziness that lasted for more than 2 weeks. Loss of appetite and dizziness continued, so saw my doctor and did blood work, which showed elevated liver function test and anaemia. Never had history of either problems before the vaccine. Repeated blood tests 1.5 months later and anaemia resolved, and liver function test is back to normal. On an unspecified date in 2021 with outcome of recovered. No treatment was received.The patient underwent lab tests and procedures which included blood test: anaemia on 2021, blood test: anaemia resolved on 2021,liver function test: elevated on 2021     Follow-up (13Jul2021): This is a follow-up spontaneous report received from a contactable physician. This physician reported in response to HCP letter sent for patient which included.  Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected
Patient noticed the injection site was red and hot the morning of 10/11/15 but no other symptoms reported. Advised patient to apply cold compress & take a dose of Benadryl. Patient returned to the pharmacy around 3 PM on 10/11/15 stating that she felt "clammy, tired, dizzy, & her ears stopped up." Reiterated the earlier instructions & advised her to lay down and rest (as she was at work) and to let use know of any further issues.
Patient was sitting  chair after receiving vaccine and begin to stiffen while falling to the left onto the floor.  Help was called and Patient's vitals were taken BP 120/70, P 88, Temp 97.2 Patient was given water to sip with a cold compress applied to the forehead and back of neck. Patient was more coherant at this time and stated that she believed that she fainted. Patient stated that she had not eaten since breakfast and was given a lollipop.  Mother verbalized that she understood the need to feed the child immediately and to watch for signs of lethargy, complaints of headache and abdominal pains and to go to the ER as soon as these are suspected.
Bell's Palsy.  Treated at emergency / urgent care.   symptoms may be subsiding now.
since he got the shot he does this thing with his throat; he has this thing that he swallows; tired; got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN), for Covid-19 Immunization. The following information was reported: OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "since he got the shot he does this thing with his throat"; DYSPHAGIA (non-serious), outcome "unknown", described as "he has this thing that he swallows"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ILLNESS (non-serious), outcome "unknown", described as "got sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter (patient's mother) noticed something since he had the shot, the 2 shots, and he had that thing that he swallows. She always saw him but he was never doing that until after the shot. She asked him to see the doctor as he had been doing that since the shot. He got the shot about maybe 4-6 months ago and ever since he got it, she had noticed that he was doing that. Stated it was hard to explain it. It was every few minutes that he was doing it. It aggravates her to see that. Reported that it was the same or getting worse but it's not getting better. He was about 6 foot tall. Reported that his symptoms started right after got the shot she thinks the 2nd dose (in upper arm), that if she had made a big deal after the 1st, he wouldn't have gotten the 2nd and he was not getting the 3rd dose. Also reported that he got Covid after he got the shots. He was diagnosed about 1 month ago, he and his girlfriend both live together and both got sick with it. He was improved but was tired a lot. The patient had no other conditions and did not receive any other products. The patient had no additional vaccines administered on same date of the Pfizer suspect. Prior Vaccinations (within 4 weeks) were none and no events following them. The patient had no medical history (including any illness at time of vaccination) and family medical history relevant to AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling of upper arm. From bottom of bicep up to shoulder. It is around the entire arm. Injection site lump/rash/swelling.
8 years old male patient was administrated with Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa (Infanrix) (batch number 8k443, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 4th May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 16-MAY-2022 Reporter's comment: Nurse reported that 8 years old male patient was administrated with Infanrix.  No adverse event was reported. The vaccine administration facility was the same as primary reporter. No expiration date provided Consented to follow up.  Additional Supportive Information: The 8-year-old patient received Infanrix, which led to inappropriate age at vaccine administration.
Father stated that child seemed "not himself". Child was not focusing on things and would not respond to his name for about one hour.
got both vaccine next year got shingles / Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included cancer and immunocompromised (patient's immune system was compromised).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got both vaccine next year got shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles).The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by a patient's wife via interactive digital media. The patient got both the shingles vaccine when it first was available and insurance did not cover it and the next year the patient contacted shingles and doctor told him it was because he had cancer and his immune system was compromised. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Pt stated she received a Tdap and then forgot and recieved a 2nd Tdap 06/15/2011 and developed fever of 103.5.  She went to the walk-in clinic and was treated with Z-pac because she had other signs of URI.  She also told me that she felt run down from previous bowel surgery.  Temp was 99.7 at clinic.
Blood glucose dropped to 46 within an hour of taking 10 units of Levemir. Shakiness, sweating.
Rash to injection site with warmth and swelling.  Bright Red, itchy.  No drainage.  Improving over time.
I received the vaccine on February 3, on February 4 at 0100 I woke up with chills. The rest of the day I would have chills and sweats. I was nauseous and threw up twice. I had a low grade fever of around 99 degrees but at one point it did go up to 101.3. My entire body hurt including my head and Tylenol and ibuprofen did not help. On February 5 I was feeling a little better, I still had body aches but could eat a little.   On February 6 at around 0500 I woke up with chest pain. I waited a little while to see if it would go away but it had gotten more intense. I am a cardiac ICU nurse so I knew what chest pain could mean. I got out of bed and at that time my chest pain was a 10/10 and I was having shortness of breath. I woke my fiancé up and told him I needed to go to the ER.  At the ER they ran test and admitted me to the hospital. They later diagnosed with myopericarditis with a small pericardial effusion.
Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 30155BA) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: on antihypertension meds (Atenolol, take 50 mg in the morning and 25 mg in the evening). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number: EK4176), for Covid-19 immunisation, reaction(s): "soreness in the arm"; Bnt162b2 (Dose 2, single, lot number: EL9261), for Covid-19 immunisation, reaction(s): "soreness in the arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in the arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367340 same patient, different vaccine dose number/different event;
Event occurred after 2nd dose. Patient was diagnosed with COVID Tylenol Discharged to Hospice
Mild abdominal cramping on day of and day after vaccine. On 12/6, I had abnormal and unexplained vaginal bleeding including some small clots. Lasted that night then ended.
Tingling in left arm, and into legs. Tingling has continued to this day since it began
Patient came to clinic requesting the booster vaccine. patient explained that he had received his 1st dose somewhere else, which he had no records of, on the day of the visit. He stated that he had received his 2nd dose somewhere else and provided a digital copy of the dose received with the provided lot# and date mentioned above. Patient explained that later on, if he locates his 1st dose information, he will e-mail it to us. Follwoing policy, patient is allowed to receive his vaccine based on verbal history that the patient provides on the day of visit. No requirements per policy to request proof of prior vaccination. On 11/30/21, patient received his booster dose per clinic's policy and left without any adverse effect after completion of 15 min monitoring. Patient e-mailed us on 12/1/21 and explained that he was wrong and he had never received a dose. However, he had tested postive for Antibodies and as per guidlines, he was told to only receive 1 dose, in order to complete the series.  This incident was reported. Per his request this was reported to Moderna, requesting further guidance. Received 2 different guidlines; either ask the patient to return and receive the full dose of 0.5 ml, or receive the remaining volume of the vaccine for 0.25 ml on the same incident date. Since neither instructions applied to patient anymore, as days had passed since the incident, Moderna suggested to contact CDC. After reporting to CDC, it was suggested to have the patient return and repeat the entire dose without minimum interval. They also suggested that 6 months later patient is eligible to receive his booster. On 12/08/21, patient returned and received 0.5 ml of Moderna, and was monitored for 15 minutes. Patient left the facility without experiencing any adverse effect. Patient was contacted on 12/10/21 to follow up. patient states he has not experienced any adverse effects. he also stated that on 12/9/21 he had slight temp elevation that has resolved.
PRODUCT GIVEN AFTER EIGHT TO NINE HOURS AFTER FIRST PUNCTURE; FLU LIKE SYMPTOMS; SORE ARM; This spontaneous report received from a pharmacist concerned a 41 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 08-MAY-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced product given after eight to nine hours after first puncture, flu like symptoms, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product given after eight to nine hours after first puncture, sore arm and flu like symptoms was not reported. This report was non-serious.
Narrative:  On July 29, 2022 an attending physician reported the patient had a  historical ADR of Moderna Covid - 19 vaccine induced Urticaria it was described  as "hives which occurred 3 days after the second dose of Moderna Covid- 19 vaccine and intermittent symptoms since"
Ct to receive PPD ID 0.1cc, instead received Adult Td 0.5 cc ID left forearm on 8/16/04. Mother of Ct. reports edema, redness and discomfort at site. Tx of cool compress, Benadryl/Tylenol for discomfort.