chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up with hives at night; Had a slight case of bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Had a slight case of bell's palsy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 076C2A, 011M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BELL'S PALSY (Had a slight case of bell's palsy) (seriousness criterion medically significant). On 08-Apr-2022, the patient experienced URTICARIA (Woke up with hives at night). At the time of the report, BELL'S PALSY (Had a slight case of bell's palsy) and URTICARIA (Woke up with hives at night) outcome was unknown.            No treatment information was provided.  On 27-Oct-2021, patient received first booster shot.  On 07-Apr-2022, next day of second booster shot, patient had a slight case of bell's palsy. Patient woke up with hives at night on 08-Apr-2022.  Company Comment: This spontaneous case concerns a 71 year old female patient, with no reported medical history, who experienced expected, serious (medically significant) AESI Bell's Palsy one day after receiving a fourth dose (second booster) of mRNA-1273.  She also had non-serious urticaria one day later.  Subsequent clinical course, labs and treatment details were not reported.  The outcome of the events is unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-538089 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 71 year old female patient, with no reported medical history, who experienced expected, serious (medically significant) AESI Bell's Palsy one day after receiving a fourth dose (second booster) of mRNA-1273.  She also had non-serious urticaria one day later.  Subsequent clinical course, labs and treatment details were not reported.  The outcome of the events is unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Relapsing Polychondritis" (unspecified if ongoing), notes: Relapsing Polychondritis; "known allergies: Avocado" (unspecified if ongoing), notes: known allergies: Avocado; "known allergies: latex" (unspecified if ongoing), notes: known allergies: latex; "known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Cecile; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, stop date: 14May2022; CRESTOR, stop date: 15May2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid started on 15May2022 and stopped on 13May2022. Clinical course was reported as, Rebound symptoms on 25May2022. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Woke up around midnight with chills and fever.  Took my temperature and it was 102.2.  My legs and arms were also tingling and my body was very achy.  I also felt weak and tired.  I took 2 500 MG Acetaminophen and went back to bed.  Woke up a few hours later and took my temperature and it was down to 100.  Woke up in the morning and took my temperature and it was back to normal.  I felt better and the reactions to the Zoster vaccine had subsided.
vax approx 130PM-6PM pt lying on sofa mom noted pt jerking, drooling & eyes focused immed took to ER states never stopped breathing just needed a little help; t102 R;
Back pain (mid-back, above belt line to right of spine) Stomach pain (mid-stomach, above belt line, below right rib cage) Nausea Treatment:  motrin, tylenol, heat and cold packs Symptoms began 02/27/21 and continue unchanged (12 days)
4 days /p DTP shot, infant had short episode about 5-10sec of stiffening of entire body, eyes closed, p/ which became limp & fell into deep sleep for about 5 min finally able to be aroused by father;
Injection site pain/ soreness Fever- 103.4 Headache- moderate to severe Chills
area of swelling rt arm from top of deltoid to beneath elbow (mid forearm) is 200cm x 200cm area of redness circumferentially @arm;pt to be seen 4JAN99;
I began having noticeable pain in the left side of my chest where my heart is located. Whenever I laugh, sneeze, or do any other type of activity that involves exertion, I feel a noticeable pain in my heart region. This pain began the morning after I received the first dose of the Pfizer vaccine.
pain in joints; Pain in joints and spine; This is a spontaneous report from a contactable consumer or other non hcp. A 80-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, lot number EN5318 and expiry date was not reported), via an unspecified route of administration, in Arm Right on 18Feb2021(at the age of 80-year-old), as Dose 2,Single for COVID-19 immunization at hospital. Historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, lot number EN5318 and expiry date was not reported), via an unspecified route of administration, in Arm Right on 28Jan2021 at 10:45 as Dose 1,Single for COVID-19 immunization. The patient medical history included hypersensitivity (allergies) since childhood and still ongoing, drug hypersensitivity (Allergy to IVP dye) from 1970 and ongoing since 1st administered, obesity from 1989 and ongoing, coronary artery disease from an unspecified date and still ongoing. Concomitant medications included valsartan from past 20 years and ongoing, atorvastatin from past 10 years and ongoing and metoprolol from past 20 years and ongoing, all taken for an unspecified indication. On an unspecified date, the patient experienced pain in joints and spine. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Child was given an undiluted dose of Pediatric Pfizer vaccine.  Discussed situation with medical director - determination was that no medical intervention was necessary.  PHN supervisor contact the parent via phone call (translation used), guardian advised of administration of undiluted Pfizer pediatric vaccine.  Guardian advised that no medical intervention was needed, reviewed when to contact emergency care if needed.  Guardian reported that child was experiencing no adverse events after vaccination.  Provided PHN's name and phone number if questions/concerns arose.
Inadvertently given Pfizer bivalent booster instead of monovalent booster for age range.  Vaccine education given.
Area became red, warm to touch, intermittently itchy. The redness began to grown along my arm down to the elbow. This got better with medication and time. Currently (2/28), there is some light pink/red color. I have noticed some of the same redness/warmth to touch on my knee and foot in the past 1-2 weeks on the same side of my body. Unsure if this is related to the vaccine.
In Oct90 10 out of 59 pts were found to have insuff or neg antibody levels during post serology testing for anti - HBs.  (see EBU910168 - EBU910174 - EBU910176 - EBU910177)
Dizziness, fatigue, muscle spasms, chills, chest pain, vomiting, insomnia
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number N4L77, expiry date 27th March 2016). Co-suspect products included HAVRIX (batch number K4H7M, expiry date 11th February 2016), HAVRIX (batch number 5324E, expiry date 30th October 2016), HAVRIX (batch number YZ27F, expiry date 18th March 2016), ENGERIX B (batch number AHBVC188BA, expiry date 18th January 2015) and ENGERIX B (batch number 772GY, expiry date 23rd November 2015). On an unknown date, the patient received BOOSTRIX, HAVRIX, HAVRIX, HAVRIX, ENGERIX B and ENGERIX B. On an unknown date, an unknown time after receiving BOOSTRIX, HAVRIX, HAVRIX, HAVRIX, ENGERIX B and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: HCP wants to know the stability of BOOSTRIX, HAVRIX and ENGERIX-B after being exposed to temps, out of the normal range at different times from January up until today. They recently had an inspection by the state and were made aware of the importance of maintaining the vaccine at the appropriate temp. All three vaccines were exposed to a low temp of 30F and only HAVRIX was exposed to a warm temp. of 48F. Multiple pts. have received doses of these vaccines after they were not stored properly. HCP hasn't gone through each pts. chart yet. She did not have pt. initials, DOB's, M/F data ready to provide, but said we can follow-up with her through mail/email. She did provide lot # and exp. date. For HAVRIX: lot# K4H7M Exp. 2/11/16, lot # YZ27F exp. 3/18/16 and lot # 5324E exp. 10/30/16. For ENGERIX-B: lot# AHBVC188BA exp. 1/18/15 and 772GY exp. 11/23/15. For BOOSTRIX: lot# N4L77 exp. 3/27/16.
Patient developed mouth tingling and facial rash within  15 minutes of receiving  vaccine. Po Zyrtec given to patient.
This case was reported by a healthcare professional and described the occurrence of unintentional overdose in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 October 2010 the subject received 1st dose of FLULAVAL (1 ml, unknown) and experienced unintentional overdose. The reporter stated six subjects, including the reporter, received 1 ml of FLULAVAL. At the time of the report no other information was provided. Follow-up information was received on 25 October 2010 from another healthcare professional. The subject was a 46-year-old female. On 12 October 2010, the same day after vaccination with 1ml of FLULAVAL, the subject experienced injection site lump, red hot to touch through 18 October 2010 and low grade fever for 2 days. The subject was treated with TYLENOL. The events resolved on 18 October 2010. The events were not considered serious. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Patient developed arthralgia, malaise 8 days after vaccination. Rash developed 10 days after vaccination. Rash description is consistent with a case of the measles. Max fever 102 on 7/29/04.
pt recvd vax 22JAN96 AM that afternoon rt thigh became red & swollen from site to groin & knee;pt was afeb & irritable;leg was sore & pt ran low grade fever throughout 1st night, but has been fine since
Rash appeared on neck and chest gradually spreading over entire body (scalp to bottoms of feet).  Severe itching cont. over 3 days and was treated with decreasing doses of prednisone.
Period of better breathing, that last a few hours in each occasion/a positive side effect; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Period of better breathing, that last a few hours in each occasion/a positive side effect) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a, 028a21a and 025a21a) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient is a cancer survivor.). Concurrent medical conditions included Asthma, Type 1 diabetes mellitus and Breathing difficult. Concomitant products included INSULIN (INSULIN, REGULAR) for Type 1 diabetes mellitus.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Period of better breathing, that last a few hours in each occasion/a positive side effect). On 20-Oct-2021, THERAPEUTIC RESPONSE UNEXPECTED (Period of better breathing, that last a few hours in each occasion/a positive side effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Blood glucose: high (High) High blood pressure after meals. On 19-Oct-2021, Blood glucose: high (High) High blood pressure after meals. On 20-Oct-2021, Blood glucose: high (High) High blood pressure after meals.         Concomitant medication include hormone replacement, thyroid medication and asthma medication.   This case was linked to MOD-2021-063657 (Patient Link).
This spontaneous report was received from a registered nurse and refers to a 17-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 22-JAN-2019, the patient was inadvertently vaccinated with PROQUAD lot# R021232, expiration date 21-JAN-2020 (exact dose, route and site of administration were not reported), instead of intended M-M-R II concomitantly with VARIVAX lot# R022117, expiration date 02-AUG-2020 (exact dose, route and site of administration were not reported). Concomitant therapy included sterile diluent. The nurse reported the provider who administered the doses confused PROQUAD with M-M-R II because the vials were the same color, so he thought they were the same vaccine. No adverse effect reported.
Pt went to ED with complains of pruritus, erythema at injection site and shortness of breath after receiving her flu shot. She received diphenhydramine, ranitidine and methylprednisolone. She was discharged from the ED with one week of ranitidine and cetirizine.
Approx. 12:30 p.m. Inluenza injection given.  Approx. 3:30 p.m. client reports began feeling short of breath.  Approx. 4 p.m. client returned to our office.  Was SOB, face appeared slighly swollen, apprehensive, just not feeling well. No rash or redness noted anywhere on clients body or at injection site. Administered 25 mgs  2 capsules, po of Benadryl per standing order for reaction.  Client began vomiting and became clammy shortly after taking medication and vomited medication.  Continued to have c/o breathing problems.  BP 158/85, Pulse 71, Spo2 above 90%.  911 was called. 02 placed on client.  Client continued to be SOB, vomiting.  Client was transported to ER for further evaluation.   First influenza vaccine client had ever received.  Client has history of PAD. (Peripherial artery disease)
ESRD (end stage renal disease) on dialysis - Patient failed PD, had 1 CCPD on admission - Dialyzed through the HD tunneled catheter - MWF - Arrangement for Monday/Wednesday/Friday hemodialysis at DL.  - Has LUE fistula - not ready for use yet - Continue calcitriol and Renvela - Patient was also updated of dialysis after rehab; discharged from Health clinic to Skilled nursing facility.  ED visit and hospital admission within 6 weeks of receiving the COVID vaccine. Patient passed away on 3/16/2022
WE GAVE A SHOT TO A 16 YEAR OLD WHICH IS BELOW THE CDC GUIDLINES
skin lesion at the samllpox vaccination site scab seperation.  Patient had a robust take.  Initial scab separation @28 days, 1-2 wk scab separation the cycle started again with pustule, itching etc.  2nd scab separated  2 wks after pustule and on 6/18/03 pustule formed again this time no scab formation.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 14-SEP-1994 and 15-OCT-1998 the patient was vaccinated with M-M-R II, 0.5 ml, intramuscular. The patient had titers done for admission to a university and was found to be negative for measles titer. On an unknown date the patient experienced negative for measles titer. Patient did not seek medical attention. The outcome of negative for measles titer is unknown. Additional information has been requested.
Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 18-MAY-2007 was vaccinated (site and route not reported) with the 1st dose of Gardasil (lot# 656051/0244U).  On 17-Jul-2007, the patient was vaccinated (site and route not reported) with the 2nd dose of the Gardasil (lot#658100/0525U).  On 23-Nov-2007, the patient was vaccinated (site and route not reported) with the 3rd dose of the Gardasil (lot#658560/1062U).  On approximately 25-MAY-2007, 24-JUL-2007 and 30-NOV-2007, 7 days post vaccination, the patient developed a rash all over her body.  The physician stated that she was only aware of the rash after the 1st dose of the vaccine.  The patient was treated, the 1st time with a topical steroid.  No diagnostic laboratory tests were performed.  The patient recovered.  No other information available.  Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I experienced at 12am after my vaccine, got a spasms, took sublingual medication. Three days after I felt really tired and fatigued. On 04-08-2021, I started to have tachycardia and high blood pressure.  I went to the ER where they performed triponents, did a CT scan of my abdomen and a chest x-ray.    I still continue with tachycardia to this day.
I was exposed to COVID-19 on 05/05/2022 by someone visiting my office. The following Monday I started experiencing symptoms. I was feeling lightheaded and woozy and by midday I had a fever, so I took a home test. That test was positive. I saw my doctor the next day and started taking antivirals. By the next day I was feeling much better. Today, I am basically feeling fine except for some fatigue that could be allergies. I am doing my normal daily activities and going to work. However, I am continuing to test positive.
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR212309:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212282:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212283:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212310:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212311:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212284:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212285:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212312:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212313:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212286:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212314:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212315:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212287:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212288:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212316:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212289:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212290:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212317:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212318:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212291:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212292:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212319:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR201274:Same Reporter
Fatigue, aches, fever, chills, brain fog, euphoria. All of the symptoms have subsided. Now my body is having difficulty in regulating temperature.
headaches; floaters in her eyes; limp nodes swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; VITREOUS FLOATERS (non-serious), outcome "unknown", described as "floaters in her eyes"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "limp nodes swollen". The events "headaches", "floaters in her eyes" and "limp nodes swollen" were evaluated at the physician office visit.  Additional information: Reporter stated her daughter had both vaccines and was having terrible side effects. She was having headaches, floaters in her eyes, limp nodes swollen. She has been to an eye doctor and now is waiting to get a c-scan. The reporter said she will never get the vaccine because it was nothing but poison being put into human race. She wants to know if there is an antidote for all these side effects. Relayed number to PMI, read ISI transferred to PMI queue due to long hold time. Any medical questions addressed by this program forwarded/reffered to medical information reported as yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.