chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash all over body, face arm stomach, back, on set 3 days ago t100.1;
Right eyelid discomfort within an hour after receiving, swelling of right lid x 2 days
Red Dots all over the Body; Swell Up Red Dot area; Blisters on Foot, and Finger; Blisters on Gums; itching local; Redness local; Red/itchy eyes; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Dots all over the Body), SWELLING (Swell Up Red Dot area), RASH ERYTHEMATOUS (Redness local), EYE PRURITUS (Red/itchy eyes) and BLISTER (Blisters on Foot, and Finger) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement on 27-Mar-2020. Concomitant products included CLOPIDOGREL for Anticoagulant therapy, CARVEDILOL and OLMESARTAN for Blood pressure high, ATORVASTATIN for Cholesterol, PANTOPRAZOLE for Indigestion, LEVOTHYROXINE for Thyroid disorder NOS.   On 05-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Redness local), EYE PRURITUS (Red/itchy eyes) and PRURITUS (itching local). On 21-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red Dots all over the Body), SWELLING (Swell Up Red Dot area), BLISTER (Blisters on Foot, and Finger) and GINGIVAL BLISTER (Blisters on Gums). At the time of the report, RASH ERYTHEMATOUS (Red Dots all over the Body) had not resolved and SWELLING (Swell Up Red Dot area), RASH ERYTHEMATOUS (Redness local), EYE PRURITUS (Red/itchy eyes), BLISTER (Blisters on Foot, and Finger), GINGIVAL BLISTER (Blisters on Gums) and PRURITUS (itching local) outcome was unknown.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03-JUNE-2021 and does not contain any new information. On 09-Jun-2021: Follow up received on 09-JUNE-2021 and does not contain any new information. On 22-Jul-2021: Added patient demographics, concomitant medications and new events.
12/22 vaccination. Within a few minutes, after sitting down, I started to get really dizzy, lightheaded. Intermittent chills. Symptoms lasted 20 minutes. 12/23 24 hour post vaccine, symptoms returned. myalgia. Temp was higher then normal baseline; 99.4.  12/24 still had dizziness.  called employee health; mild / moderate reaction to vaccine. Tylenol.  Dizziness resolved.  12/25 symptoms resolved.  Following Monday, afternoon, felt extremely fatigued.  Touched base with COVID committee; UPMC/advised to get titers checked.
09:50 (L) deltoid with raised welts/extreme redness across top portion of shoulder and upper arm. Diphenhydramine elixir (12.5mg/5ml) 5.5ml administer P.O. 10:00 Childs lips, face and eyes began swelling. Epinephrine (1:1000 1 w/v ampule) 0.10ml given IM left anteriolateral thigh. Another staff member, RN, BSN phoned 911 for an ambulance to transport patient. EMS arrived 10:07 and child taken to ER by ambulance. ER doctor stated he felt it was a reaction to the DTAP given. Spoke with patients mother later on 06/22/2007.  She reports he is doing fine.  Reports he was given a steroid in the ER, however reports no further problems.
Diverticulitis; This is a solicited report facilitated collect based on the information received by Pfizer from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161; Expiration date was not reported), intramuscular on 28Apr2021 as dose 2, single for COVID-19 immunization; and adalimumab (HUMIRA), subcutaneous at 80 mg (with frequency and therapy dates unspecified), and then subcutaneous from 27Aug2020 and ongoing, at 40 mg (with frequency unspecified), for ulcerative colitis. Medical history included hypertension; cholesterol abnormal; non-tobacco user; abstained from alcohol; had COVID-19 from Jan2021 to an unspecified date, and was hospitalized for COVID-19 with gastrointestinal symptoms and a little respiratory on 15Jan2021. Concomitant medications included losartan for hypertension; pravastatin; balsalazide; omeprazole (PROTONIX); budesonide, formoterol fumarate (SYMBICORT); and nitrofurantoin. The patient previously took nitrofurantoin for anaphylactic reaction, and had drug allergy. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6204; Expiration date: Jun2021) , intramuscular (IM) on 31Mar2021 (at the age of 72 years old), and had epigastric pain and a little respiratory. In May2021, the patient had diverticulitis. The patient had tested positive for COVID-19 Test Nasal Swab on 15Jan2021, and then had tested negative on 12Mar2021. The patient had a blood work on 12Mar2021 (results were not provided). The action taken in response to the event for adalimumab was unknown. The outcome of the event was unknown. The reporter's causality for the event of DIVERTICULITIS was not provided. The manufacturer's assessment on the causal relationship between the suspect vaccine and the event was 'no reasonable possibility'. AbbVie's opinion was that there was no reasonable possibility that the event, diverticulitis, was related to HUMIRA 40MG/0.4ML(ADALIMUMAB).
About 10 minutes after receiving vaccine, pt began throwing up clear liquid (his wife later told me he hadn't eaten anything today). He was sitting in a motorized shopping cart hunched over, but conscious. He was sweating, but could communicate and tell me he was breathing ok. Was conscious the entire time. We called 911 and the paramedics arrived within minutes and moved him to gurney to take vitals. Pt left to go to the ER due to abnormal vitals.
2nd dose of Pfizer COVID-19 vaccine given 1/20/2021.  On 2/17/2021 developed nasal congestion, fatigue, sore threat, fever, shortness of breath.  5 week pregnant at this time.
11/13/21, intense joint pain 9-10/10 on pain scale and 2 episodes of stress incontinence. Pain lasted 24 hours. 11/16/21, another episode of stress incontinence. Starting 11/17/21, mild persistent urinary irritation including tenderness to kidney percussion. By 11/21/21, slight persistent incontinence, not stress related but random drips, which has continued for the last month through the date of reporting with mild-moderate persistent bladder/urethral pain and persistent feeling of full bladder. Kegel exercises offer mild improvement for a short time, clitoral stimulation and orgasms dull these sensations. A previously damaged facial nerve has also flared up, causing the same tooth pain and paresthesia it caused when it was first damaged.
Vaccination has taken on April 1st at 11.45 am. After 2 hours severe pain started on injection arm. Swelling was present for few days. Today is 11th day and still have a pain in the shoulder and unable to lift left shoulder. Physician appointment has schedule for April 13th for treatment.
Initial report received from a healthcare professional (pharmacist) on 09 December 2013. This case is linked with cluster cases: 2013SA131929 and 2013SA131928 (Same vaccine, same reporter). A male patient, whose medical history and concomitant medications were not reported, had received a dose of Influenza QIV vaccine (manufacturer: not provided, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient developed Guillain Barre Syndrome and the patient was died. Laboratory investigations and corrective treatments were not reported. No autopsy details were reported. Documents held by sender: none.
Localized inflammation and redness L thigh size of quarter at first but doubled in size by next day, eventually whole lateral thigh red.
she was exhausted for 4 days and with the second shot, it was the same thing; a little confused and tired; a little confused and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "allergic to amoxicillin and penicillin" (unspecified if ongoing), notes: NDC, LOT, EXP: Unknown; "She broke out into hives all over her body" (unspecified if ongoing), notes: NDC, LOT, EXP: Unknown; "Pregnancy" (unspecified if ongoing), notes: Pregnancy 22 weeks, 5 months pregnant. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "allergic to amoxicillin", notes: NDC, LOT, EXP: Unknown. Vaccination history included: BNT162b2 (Dose: 1), administration date: 24Mar2021, when the patient was 33-year-old, for Covid-19 Immunization, reaction(s): "feeling dizzy", "extremely tired". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "she was exhausted for 4 days and with the second shot, it was the same thing"; CONFUSIONAL STATE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "a little confused and tired".  Additional information: The other products were not reported. The patient had not the booster shot, she stated that she was going to be getting the booster shot. There was no prior vaccinations (within 4 weeks).   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
approx 1 minute p/vax pt suddenly fell backwards bumping head against wall then slide to floor; never seem to lose complete consciousness but color became dusky & skin clammy; pt verbalized dizziness, BP 92/52, pulse thready;
11 year old was meant to get routine 11 yo MENACTRA but MA did not know that TRUMENBA was a different immunization (thought they were both the same meningitis vaccine) so gave TRUMENBA in error. We are newly carrying the TRUMENBA for 16 yo's if needed and she was unaware. The patient had no ill effects other than getting an incorrect injection and now needing to get the MENACTRA.
The patient is a 36 yo male with a history of  migraines who presents for Virtual visit for evaluation and recommendations for AE after receipt of IIV (SEQ P100117090) 31 OCT  2019. He states about 12 hours after receipt he developed severe HA, facial drooping, hemiparesis. Does not recall which side. He was seen in ER but did not have confidence in the assessment.  He states symptoms resolved in a few hours. He has never had recurrence. He thought they said it may be allergy of some type and is very concerned he had a missed CVA.  He reports no immediate reaction such  as urticaria, pruritis, oral, face, throat, tongue swelling, CP, cough, wheezing, n/v/d. He has no history of adverse reaction to vaccines other than fever or typical malaise. He received both doses of COVID vaccine without AE.
Patient fainted in office hallway after receiving Gardasil #2 and Menactra. BP was taken - and was normal. Patient was observed by doctor 20 min after incident. was sent home when she was feeling well enough to leave.
Experiencing extreme itching all over body especially on back and chest.  Also pain in both knees and ankles.  Today, there is throbbing in my ankle bones and all my arthritic joints.  I have a history of eczema and skin problems since childhood, but these allergies are acting up to an extreme level now.
RASH, HIVE, BLISTERS ON SKIN; EDEMA OF LOWER EXTREMITIES . OCCURRING AFTER VACCINE AND STILL PRESENTLY EXPERIENCING
Woke up 12 hours after second shot at 3:30 in the morning. Was not able to sleep well for the next week. Had a prolonged headache. All of that eventually cleared but the lasting change is I now have tinnitus. It is constant and it does not go away.
Pt. rec'd dose of quadrivalent FLUMIST in office on 10/11/13. Dx: with pneumonia at O.V. on 10/21/13. Tx with: OMNICEF 250/5 / SIG: 10ml po every day x 10 days. TYLENOL and MOTRIN PRN fevers.
MILD COLD SYMPTOMS; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and no alcohol use, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug use and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: 23-AUG-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced mild cold symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild cold symptoms. This report was non-serious.
Lips started feeling really tight and itchy on the drive home from the vaccination site. When I looked in the mirror I had a really bad rash all over my face and my lips were swollen like I was stung by a bee. It was also burning, and it spread all over my torso, arms, back, and neck extremely quickly. I took three benadryl and it went away within two hours.
Hospitalized (11.26.21);  COVID-19 positive (11.25.21);  fully vaccinated  Admission Date: 11/26/2021 Discharge Date: 11/30/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus   HOSPITAL COURSE: Patient is a 48 y.o. male who presents to hospital with shortness of breath. Patient is fully vaccinated against COVID and began having symptoms approximately 1 week ago. Initial symptoms were fatigue generalized aches and fever. He subsequently developed a cough decreased appetite and worsening shortness of breath. He lost smell and taste, days ago.  Because of worsening shortness of breath he was seen in the emergency department yesterday. He was found to have a chest x-ray consistent with COVID pneumonia and positive COVID test. He was requiring 6 L of oxygen and admission was recommended but there were no available inpatient beds. The patient did not wish to board in the emergency department overnight and was discharged home on 6 L of oxygen. He did receive a dose of dexamethasone while in the emergency department yesterday. Overnight his shortness of breath worsened and he developed hypoxemia with oxygen saturations into the mid 80s. After several hours he eventually returned to the emergency department where CT scan showed diffuse bilateral ground-glass infiltrates but no PE.  Due to his worsening hypoxemia he was referred to the hospital for further evaluation care and transferred to bigger hospital for further inpatient care. 11.31.21:  Progress: improving Outcome Summary: Patient ready for discharge this afternoon. He has been able to maintain his oxygen sats above 90% on room air. Discharge instructions were provided and he will be leaving via private vehicle with family.  Pneumonia due to COVID-19 virus Assessment & Plan Patient with symptoms for approximately one week (11/19) Seen in ED 11/25 for diagnosis, found to by hypoxic Fully vaccinated Worsening hypoxia on admission, CT with diffuse infiltrates negative for PE Dexamethasone 4/10 Remdesivir 3/5 Vacillating between 5 and 6 L of supplemental oxygen.  He had some swelling and pain in the bilateral lower extremities.  I dosed with Lasix 40 mg once and got bilateral lower extremity Dopplers which were negative for DVT.
Day 14 and the patient hasn't gotten their second shot; Case reference number US-BN-2021-002039 is a spontaneous case report initially received on 28-Jun-2021 from pharmacist via regulatory authority (reference number: EUBAV21-0309) and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 14-Jun-2021, the patient was vaccinated with the first dose of RabAvert (Rabies Virus Inactivated, batch number: not provided) at dose reported as one vaccine, received intramuscularly and for pre-exposure.  On an unspecified date in 2021, through miscommunication, they were on day 14 and the patient had not received the second shot (explicitly coded as 'Inappropriate schedule of product administration').   At the time of initial reporting, it was unknown whether the patient experienced any adverse event.  The reporter assessed the case as non-serious and not related to the RabAvert.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration for RabAvert is listed by convention. Reportedly, the patient had not received the second shot on day 14 through miscommunication and that is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the suspect product but to a human action. The case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration for RabAvert is listed by convention. Reportedly, the patient had not received the second shot on day 14 through miscommunication and that is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the suspect product but to a human action. The case is considered as non-serious.
Patient presented to ED with small blood blisters to tongue, arms, and face; severe thrombocytopenia.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced accidental injected SQ. The patient received a dose on 15 Apr 2010. Relevant medical history was not provided. Indication for PREVNAR was not provided. Product was administered on 15 Apr 2010. Dose regimen was 1 dose 1 time per day (subcutaneous). Concomitant medications were not reported. The patient was accidentally injected SQ in 2010. No adverse events were reported. No additional information was available at the time of this report.
9-930 pt recvd vax & 1015-1030 food-egg mcmuffin; 1100 parent noted red around neck & face; 1230-1 parent noted hive-like eruptions face & neck lasting approx 10-20 mins then faded; 230-3 parent noted generalized redness, genital swelling;
One week after injection, left arm was covered in a red blotch big enough to cover about half of the arms diameter. No pain, arm felt itchy, no serious effects tied with it.
Developed Postural Orthostatic Tachycardia Syndrome (POTS) after receiving vaccine. Heart rate increases upon sitting up and standing by >40bpm, followed by light headedness, blackouts, fatigue, migraines, numbness in arms, and labored breathing. Bedridden for 2-3 days after each episode.
Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 16:45 (Lot number: EW0164) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Fatigue". The event "fatigue" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of fatigue.  Additional information: Medical history included many (unspecified). The patient received unspecified medication within two weeks of vaccination. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The event resulted in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
66 years old patient received MENACTRA vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Regulatory Authority (Reference number- 00644060) and transmitted to Sanofi on 16-Jun-2021.  This case involves a 66 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX); and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) for prophylactic vaccination.  On 14-Jun-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6878BA and expiry date:02-Mar-2022] via an intramuscular route at right deltoid prophylactic vaccination.  It was as of actual medication error due to product administered to patient of inappropriate age [Latency: on the same day].   It was reported that, medical Assistant (MA) asks for information regarding administration of MENACTRA to patients older than 55 years-old; what are the risks, any benefits that may exist, and whether there was a risk of interaction with concomitantly administered vaccines.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Some light fever and headache immediately after shot. 2 days later developed swelling of face, tongue, rash, hives and extream itching.  Continuing for up to 10 days post immunization and going.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 31-OCT-2012 13:14, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. I was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a male patient of unknown age refers to himself. Medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose number, frequency, route of administration, anatomical location, lot number was not reported). Concomitant medications were not reported. On an unknown date the patient developed an injection site rash after receiving ZOSTAVAX vaccine and by that time it was spreading down his arm. The outcome of events was not reported. The relatedness between events and ZOSTAVAX was not reported. Additional information is not expected.
From telephone contact with reporting physician it was stated that a patient (1 of 2) received a YF-Vax vaccination, lot # UA373AB (date not specified). Five days later the patient had a 5cmx4.5cm area of local redness at the injection site. Also see case U2001-00993, same reporter.
pt recvd vax & had severe headache on same eve x 4-5 days;