chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Face, lips and tongue swelling after 2nd dose; Face, lips and tongue swelling after 2nd dose; Face, lips and tongue swelling after 2nd dose; facial pain is worse at the injection sites; red r ash; A spontaneous report was received from a healthcare professional concerning a 34-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events face, lips and tongue swelling after 2nd dose, a red rash,facial pain is worse at the injection sites/facial pain.  The patient's medical history was not provided.  concomitant product usage was not provided by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013l20a) via unknown route on left arm for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch013m20a) via unknown route on left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Face, lips and tongue swelling after 2nd dose, a red rash, facial pain is worse at the injection sites.She does receive Botox and said the facial pain is worse at the injection sites. She went to the doctor the following Monday. She was put on a topical and oral steroid, but told to wait on the oral steroid until 11 days after vaccine .  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information included was Botox injection, topical and oral steroid.   The outcome of event(s), face, lips and tongue swelling after 2nd dose, a red rash, facial pain is worse at the injection sites  was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  Rash and facial swelling is consistent with the known safety profile of mRNA-1273. Swelling of the face may occur in patients who have had facial cosmetic injections. Patient is known to have had Botox
Rash over face, nothing worked to treat. Progressed to arms, legs. Face became red at almost all times. Has never gone away.
Provider order "pneumo vaccine" Prevnar 13 was given. Client was supposed to receive Pneumo 23
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 11-MAR-2015 the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneously, lot # not reported) that underwent a supported temperature excursion. No adverse experience reported. Additional information has been requested.
Initial and follow up information has been received from the Merck Pregnancy Registry for GARDASIL and a nurse practitioner concerning an 18 year old female with a history of gonorrhoea and vaginitis who on 01-FEB-2008 was vaccinated with a first dose of GARDASIL (Lot number 658556/1060U). Concomitant therapy included LOESTRIN 24 FE and FLAGYL. On 28-APR-2008 the patient was vaccinated with a second dose of GARDASIL (Lot number 660387/1967U) and at same visit was found to be pregnant after a positive urine pregnancy test (LMP=02-Apr-2008). At the same visit the patient also had a regular pap test. It was reported that the patient was vaccinated in right leg. No problems reported. On 31-MAY-2008 the patient terminated the pregnancy. Upon internal review, terminated pregnancy was considered to be an other important medical event. Additional information has been requested.
This was my 2nd. COVID-19 vaccine. First one on Dec 31 caused a headache and itching at injection site. Today, 1/25, about 10 minutes after shot my eyes, face and neck began to itch. Developed small bumps. This continued to spread to armature torso and legs. Took Benadryl which seems to be helping. No difficulty breathing or swelling of any kind.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Jan2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Dec2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Deep vein thrombosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies:- Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shot late Tuesday, Chills Wednesday, and Thursday, 3:00 AM Fever of 102 with tylenol, Vomiting for 15 hours Symtoms resolved Saturday.
Not certain if this is an adverse event but ... since this is a new vaccine I thought I should report this  On 3/09/21,  I received my first Covid vaccine.  No abnormal reactions.  On 03/31/21  I started having pain on my  lower back with blisters appearing  04/03/21.  I went to the Urgent Care on  04/04/21 and was told it was shingles. I received a steroid shot and anti-viral medication. Told to take Advil & Tylenol for pain.    Second Covid vaccine was given 04/22/2021 without any other unexpected reactions or issues. I plan to get the booster sometime after Oct 22, 2021
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   Reporter stated that on 16-Oct- 2021, the vial was stored in the refrigerator. No temperature excursions were noted and no adverse events were noted in the patient.  No treatment medications were reported.
The patient began to experience severe hives all over his body starting 2 days after his vaccination.  He self-treated with hydroxyzine and prednisone.  When taking the prednisone, the hives go away but as soon as it wears off they come back.  The pharmacist advised the patient to contact his doctor to advise a course of action or if trouble breathing or other anaphylactic reaction occurs, go to the emergency room.
Received vaccine 1/24/21.  Lump started next day. Redness started a few days later.  No painful.
Narrative: Per PCP note. "He got Covid vax dose #1 Pfizer on 9/30/21, then got itching dorsum of left foot 10/2/21, no rash, but started having swelling on dorsum of foot and especially the 3 middle toes. This progressed to a couple of areas of serous drainage at the dorsum of foot and fifth toe. He was evaluated at ER 10/6/21 where he received prescription for clindamycin for "toe abscess"-- records of the evaluation are not available. Soon after the foot symptoms began, patient had pruritic skin lesions consistent with urticaria on his upper extremities and trunk. For this he was tx in ER w steroid, benadryl. All symptoms resolved by 10/7/21 and he has been doing fine since then. ALSO he had a genital herpes flare up on 10/4/2021, though symptoms have also resolved. Other than the Pfizer vaccination, he has not aware of any exposures to which he may have been allergic."
headaches; scratchy throat; dizziness; No energy; This is a spontaneous report from a contactable other hcp. A 56-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL3246) via an unspecified route of administration in Arm Left on 05Feb2021 16:00 (age at vaccination 56years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing, allergy to animal from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced that on 09Feb2021 04:00 she had headaches, scratchy throat, dizziness, no energy. Clinical course was reported as 4 days after vaccination, I had severe headaches, scratchy throat, and dizziness. I had no energy. This lasted for 2 days. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Headache, nausea, chills, muscle aches and tiredness. Treating it with naproxen, 22o mg tid
Havrix administered after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received HAV (Havrix 1440) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 10th June 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 10-JUN-2022 Reporter's Comment: The reporter stated that, Havrix was administered to a patient after the expiration date. The reporter consented to follow up via postal. Additional Supportive Information: Havrix was administered to a patient after the expiration date, which led to expired vaccine used.
Swollen glands in right side of neck, swollen left ear, pain and itching in left ear canal, swollen left jaw and pain in left jaw joint.
Pt had continuous vomiting and diarrhea with red tinge to vomiting.  She denied measurable fever, had chills and fatigue.
After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, slept all day, very weak, couldn?t remember what happen rest of day after booster (2-24)  or then next day  during sever reaction.(2-25) Day of shot arm hurt for several hours then went away. Day 3 still listless, tired, headache, foggy.
Pediatric dose given not adult dose on 5/11/16. No adverse rxn just not enough of dose.
pt recv vax 31AUG93 & devel fever 2SEp93 & was adm w/petechiae & fever on 4SEP93;WBC 24,000;cult negative (blood & Urine);
Large red welt started after vaccination and continued to get bigger. An outer raised ring formed and it became itchy. This lasted weeks. Additionally the glands under my left arm became  swollen and made my left arm hard to use. The redness in the location resolved with oral & topical benedryl and time but it left a depressed and bruised area in the tissue that is still there. I contacted my PCP on 2/4/21 and was seen by him virtually to ensure it was safe to get the second vaccine on 2/6/21.  He assured me it was  safe and  I received that  2nd dose on Saturday and have NOT yet experienced the large red welt/hive or symptoms yet that I did with the first dose.
No additional AE; PROQUAD was administered after TE. No additional AE.; This spontaneous report was received from a nurse and refers to an unknown age and gender patient, whose medical history, concurrent conditions, and previous adverse drug reaction/allergies were not provided.  On 29-JUN-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant human albumin, rHA)  (PROQUAD) subcutaneous injection, administered for prophylaxis (lot number: U026799, has been verified to be a valid lot number, and expiration date: 26-FEB-2023; strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not provided).  The suspect vaccine experienced a temperature excursion of -9.3 degrees Celsius (°C) for a time frame of 27 minutes. No previous temperature excursion occurred.  No additional adverse events were reported.
This spontaneous report has been received from a pharmacist (also reported as a nurse) referring to unspecified patients of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On 30-DEC-2016, the patients were vaccinated with an improperly stored ROTATEQ, with lot # M005732, expiration date 19-OCT-2017, lot # M031807 and expiration date 02-APR-2018 and with a lot number reported as # M011632, expiration date 25-JAN-2018, orally, (dose and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine was 1.4 Celsius (C) and the time frame was 46 minutes, also she stated that the previous temperature excursion was 9.4 Celsius (C) during 1 hour and 35 minutes, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007903: US-009507513-1701USA000848: US-009507513-1701USA007902.
high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the third of eight reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number can not be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter, drug, events, and different patients
Information has been received from a women in a physician's office concerning 6 pts who were vaccinated with Hep-A virus vaccine inactivated. In 1996, the pt's failed to seroconvert. Additionally it was noted that the pt's failed to seroconvert after therapy with Hep-B virus vaccine, recombinant (MSD) (WAES 00070242). Additional information has been requested.
Patient came in to the pharmacy to receive a MMR vaccine. Patient was given Menactra instead. Patient did not show any sign of reactions when she returned to the pharmacy 2-3 hours later. Wanted to report discrepancy.
This is a spontaneous report from a contactable pharmacist. A 71 year-old female patient of an unspecified race and ethnicity received PREVNAR 13, (NDC number: 0005197102, UPC number: 300051971022, lot N34936, expiry date Oct 2017) in the arm and FLUZONE QUADRIVALENT, (Sanofi Pasteur, lot UI684AD, expiry date 30Jun2017) in the opposite arm, both intramuscular on 20Oct2016 at 0.5 ml single for immunization.  The patient medical history and concomitant medications were not reported. On 20Oct2016 the patient started having pain in her arm and then the pain started in her body, muscles from her arm all the way up to her neck. She went to the emergency room where they discovered that there was an infection and they drained the infection. The patient was hospitalized due to the infection on 21Oct2016 and she was supposed to have surgery. Outcome was unknown. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events of pain in arm and muscle pain cannot be excluded based on the known adverse event profile and on the temporal relationship. Concerning the event infection, more information on the causative agent and clinical details is needed for a causality assessment. The Company moreover considers the administration of a concomitant vaccine an important confounder in the independent assessment of the causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient experiencing extreme pain that is radiating down the arm. Her pain was at an 11 last night (07/21/18). She had a hard time sleeping due to the pain and couldn't sleep on the side the injection was administered. Today her pain is at an 8. I told her to take TYLENOL and apply lidocaine to the arm to help manage the pain. I told her to follow up with her doctor in one weeks time if the pain doesn't subside.
Information has been received from a physician concerning a number of female patients who were vaccinated with a dose of GARDASIL vaccine and after that felt heat in their arms, at the injection site. The patients sought unspecified medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested
Legs paralyzed, BP 194/105. Hospitalized 12-16-10 -1-4-11. Rehabilitation center 1-4-11 - 1-15-11. Diagnosed Guillian-Barre syndrome.
Mild headache for two days   Today:  high pain in both elbows Delirium Exhaustion Dizziness Mumbling and garbled speech Uncoordinated movements
Chest pain, worse laying down, eased sitting up, difficult to take deep breath. Did not present to ER until 10/9/11.
expired acthib administered with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received via health professional and physician. GMI number: 01481511.  This case involves 16 months old male patient to whom expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to seven patient cases 2023SA046745, 2023SA045123, 2023SA045388, 2023SA046763, 2023SA046771 and 2023SA046834.  On 31-Jan-2023, the patient received expired fourth dose of suspect HIB (PRP/T) VACCINE at dose 0.5 ml once (lot: UJ594AAA, expiry date: 26-Oct-2022) via intramuscular route in the right deltoid for Immunization with no reported adverse event (expired product administered) at same day latency.  This situation is reported as a medication error due to seven patients being administered expired ACTHIB.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event expired product administered.    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 guidelines. 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.
no adverse event; Caller reported MMR II administered after temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-JUN-2022, the patient was vaccinated with an improper storage dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human Albumin (rHA) (M-M-R II) 0.5 milliliter, administered subcutaneously (SQ), lot # T033814, expiration date 05-OCT-2022, as prophylaxis (anatomical location was not provided) (Product storage error). Lot # T033814 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human Albumin (rHA) (M-M-R II), expiration date: 05-OCT-2022. No adverse events were reported.  The improper storage lot # underwent a temperature excursion of 46.5 degrees Fahrenheit (F) for about 24 hours and 38 minutes without previous excursions. No adverse events were reported.
An area 1-2 inches from the injection site that was sore and bruised; An area 1-2 inches from the injection site that was sore and bruised; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported same events for two patients. This is the second of two reports.  A patient of an unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced an area 1-2 inches from the injection site that was sore and bruised on an unspecified date. The events recovered on an unspecified date in 7-10 days.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019201602 same reporter/drug/event, different patients
Patients states that last night her arm was swollen, hard as a rock, and itchy, but t oday the swelling went down a bit and her arm is still itchy. She bought some loratidien and ibuprofen for the symptoms. She also applied ice.
Felt out of sorts when I went to bed...by Saturday morning had a fever of 102.2, headache, weakness, bodyaches, odd feeling in my lungs,  loss of appetite, and diarrhea....bedridden for 36 hours.  Also have very sore upper left arm. Sunday evening the fever was gone still very weak.  Monday I still have very tender, swollen, and red upper left arm and walking more than 20 feet I am short of breath (just like I had in February and March after having Covid.)