chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 12-24 hrs. I was experiencing the RA flare up again. It was not as bad as the flare up after the 1st dose. I was on 20mg prednisone This lasted for about 3 days. I also had difficulty walking again. I also developed intermittent ringing in my ears which has continued and is still happening.
Dull aches which became worse from head to toe beginning about 7:00 PM; aches continued and worsened along with chills; went to bed at 11:00 PM; had to use 2 additional blankets, couldn't get warm for a few hours, finally fell asleep; awoke at 3:30 AM warm, had to throw off covers; went back to sleep, got up at 7:30 AM, very tired, aches had subsided but still sore; slept soundly for 2 hours on Sat afternoon; felt much better on Sunday. No other symptoms except for body aches/chills/exhaustion.
Pain starting close to top of shoulder radiating down my left arm.  2 whole days of being unable to lift my arm up in the air.  Shooting pain down my arm so bad that I am having a hard time sleeping at night as well.
Altered mental status 48 hours after vaccine. Couldn't remember how to turn on and off TV or lights, wandered at home confused, wet her bed. Arm where vaccine administered was immediately sore, swollen next day resolved 7 days later.
had the shingles vaccine and still got shingles/Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles vaccine and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
3/22/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  PATIENT FOUND TO BE PALE, CLAMMY, COOL TO TOUCH., SLOUCHING IN CHAIR WITH EYES CLOSED, SHE IS ALERT TO PERSON, PLACE AND TIME.   Assessment : Time of assessment  1855,  Alert and oriented FOUND TO BE PALE, CLAMMY AND COOL. .   Actions taken:  PLACED ON STRETCHER WITH FEET ELEVATED, WATER OFFERED AND DRINKING, vs AT 1855 bp 65/37, p 62. o2- 100%, hob ELEVATED CONTINUES TO DRINK WATER, NOW EATING CRACKERS, vs RECHECKED AT 1859, bp- 77/58, p- 98, O2 100%, VS AT 1900 VS- BP-105/75, P-97, O2 100%,        Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/22/2021  6:32 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc
Ever since I received the booster , I have had abnormal periods. My periods cause multiple sclerosis relapses. So my life has been hell. Please make people aware of this.
11NOV95 tingling in hands-sensitivity to hot/cold, dec strength in hands;16NO95 using cane leg weakness;seen by chiropractor x 2;17NOV95 seen by MD tested reflex:none, resp function 2-25 adm to hosp LP done GBS dx'd;
Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
experiencing late menstrual period and some heart palpitations at night while lying down since the second dose of vaccine.
Pt was experiencing itchiness in her left upper arm. Arm was slight;y red. No hives noted. Pt noticed a feeling of itchiness minutes after received the vaccine. No SOB or dizziness noted. No anaphylactic symptoms presented. Tx: Gave pt a dose of liquid BENADRYL & applied a thin layer of topical BENADRYL to pt's arm but avoided injection site. Had pt sit by pharmacy for 15 mins. Pt left in normal state. Followed up w/pt after leaving pharmacy and pt's arm & general state was fine. Pt did not think of this serious in any way.
Migraine started the same night about 07:30PM I checked my BP and it was 210/107. I also was lightheaded with off and  on nausea and low grade fever. I went to the ER and was monitored for about 3 hours. I was discharged once my BP went down to 157/77. Prescribed antibiotics and ZOFRAN.
He was throwing up and he was not eating; He was throwing up and he was not eating; Nauseous all day; Chills; Tiredness; Feeling sick; This is a spontaneous report from a contactable consumer (patient's father). A 14-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Jun2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.On 10Jun2021, the patient experienced feeling sick, he was throwing up and he was not eating, nauseous all day, chills and tiredness. The reporter wanted to know if those are normal adverse events with the Pfizer COVID-19 vaccine. Thee patient wanted to know if there was any recommendation for what he was feeling. The patient was referred to consult his doctor or health care provider for further guidance, as his doctor/healthcare provider was the most familiar with your medical condition.They wanted to know if those are normal adverse events with the vaccine.The case was assessed as non serious.The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fever, lethargy, lasted from about 3 pm on Friday August 17 until woke up ok on Sunday morning August 19. Fever went up to about 101. 2 on the afternoon of Saturday August 18.
Blister like sores on roof of mouth and gums; Blister like sores on gums; Blister like sores on roof of mouth; sores on gums; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 16:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received cefaclor (CECLOR) on an unknown date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 25Mar2021 at 09:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 08:00, the patient experienced blister like sores on roof of mouth and gums. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events blister like sores on roof of mouth and gums were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19, and sleeping all the time.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from suspected covid-19, and the outcome of sleeping all the time was not reported.This report was non-serious.This case, from the same reporter is linked to 20211152159.
"Flu-like" symptoms at 24-48 hours. Upper left arm (deltoid) sore. Can barely lift arm. No swelling, redness, tingling or numbness. No fever, taking 2 (500 mg) acetaminophen 3 x day as needed. Applying heat. Husband doctor wrote for prednisone. Feeling better.
I received the vaccine on 11/30/2021. On Friday 12/17/2021 around 11:OOpm I have my heart beats per minute go from the mid-50's to above 100 while sitting in a chair watching TV. It caused shortness of breath, a bit of dizziness, slight headache and the feeling of nausea. All weekend my heart rate would drop to the low 80's and then back above 100. This lasted until sometime Sunday 12/19/2021 around 8:00pm. My heart rate dropped back to the mid 50's and I felt fine the next day. On 12/31/2021 around 11:30pm I was watching TV and my heart rate again rose from the mid 50's to over 100 while setting in a chair watching TV. Again I felt some shortness of breath, dizziness, slight headache and nausea. On 1/4/2022 I contacted my Urologist and asked him for a referral to a Cardiologist. On 1/26/2022 I saw the Cardiologist for some tests. He performed a blood pressure, heart rate and EKG. He diagnosed me with Atrial fibrillation (AFib). He put me on Amiodarone 200mg daily and Xarelto 20mg daily. I have been on the medication about for a month and I still have a high heart rate and some of the symptoms.
On Dec 27th 2021, I woke up severely sick. I had nasal pressure, chest congestion, and sore throat.  For 2 days, I had a bad headache. The respiratory issues bothered me the most. I took a COVID  test on Dec 29, 2021 and it was positive on Dec 31, 2021. I called my doctor and was prescribed  Medrol Dosepak for 6 days to help with chest discomfort and Albuterol inhaler and Budesonide nebulizer. I also took OTC Mucinex twice daily for 20 days.  I felt bad for 2 weeks.
double pneumonia; double pneumonia; This is a spontaneous report received from a non-contactable nurse via Medical information team. This nurse reported different events for 3 patients. This is first of three reports.   A 74-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunization. However, it was also reported that the patient received "PREVNAR 20" (pending query). The patient's medical history and concomitant medications were not reported. The patient died 3 years ago in 2018 because of double pneumonia in the hospital after getting a pneumococcal shot. The patient died in 2018. It was unknown if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.   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,Linked Report(s) : US-PFIZER INC-202101284946 same reporter/drug, different /AE/patient;US-PFIZER INC-202101284945 same reporter/drug, different /AE/patient; Reported Cause(s) of Death: double pneumonia; double pneumonia
Per mother, pt ate lunch, took longer afternoon nap, ate dinner. She had clinging. Temperature was 99F at 18:00. She fell asleep in mom's arms at 19:00. When she awoke at 19:45 she had a seizure X 30 seconds. Her eyes rolled back, turned white, foaming at the mouth, not breathing and had rhythmic shaking. Paramedics called and started IV. She was taken to ER and saw doctor and was told everything ok; no treatment. Seen by another doctor the next day and had an ear infection.
10/13/04: Red, hot and swollen area around site 1.5x2 inches. 10/14/04: redness has disappeared on arm now.
At 35 minutes, my lower face and tongue tingled and numbed lasting for approximately 15-20 minutes.
Systemic: patient complained of incresed heart rate of 75 at rest and 120 walking-Mild, Additional Details: patient called to complain of increase heart rate after taking shingrix, reported hr of 75 when still and 120 when exercise. pt was told this is within normal range but still insisted on reporting.
Migrane, vomiting, warmth at injection site, muscle of shoulder and neck on side of injection site was stiff and tight, fever of 102 F. Symptoms cleared by 6:00 am on 9/16/15.
they made a mistake of double dosing ipv to a patient, 1 dose from sanofi and 1 is from pediarix with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 years old male patient to whom administered by mistake of double dosing Ipv (Vero) [Ipol] to a patient, 1 dose from sanofi and 1 is Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix).  On 28-Sep-2023, the patient received a dose 2 at a dose of 0.5 ml of suspect IPV (VERO) suspension for injection (strength: unknown, expiry date: 10-Feb-2025 and lot W1A101M) via intramuscular route in the left thigh, also received Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix) (strength, expiry date, route, anatomical location and batch number: not reported) as immunization and they made a mistake of double dosing ipv to a patient, 1 dose from sanofi and 1 is from pediarix with no reported adverse event (extra dose administered) (same day latency)  Action taken: not applicable.  At time of reporting, the outcome was Unknown 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.
At 7 days post-Moderna booster vaccine (following two initial Covid 19-Biontech/Pfizer innoculations 6 months prior) I noticed a tender enlarged tonsillar lymphnode under the left ear/jaw line. 12 hours later the mandibular LN on the left was also enlarged. 24 hours later the left axillary LNN were also enlarged and tender. 72 hours later the lymphadenopathy and pain had spontaneously resolved
Left arm - noted severe pain, redness, warm to touch, feverish, weak and fatique - s/s presented - pt admitted to intensive care on 1-6-12.  Pt remained in hosp until 1-18-12. Dx - Serum Sickness, renal failure, lethargy, hypotension, increase liver and ammonia level secondary to Zoster vaccine. Pt continues to present with redness at site and weakness.
VERY DEBILITATING; HEADACHE; DIZZY; SORE ARM; This spontaneous report received from a patient concerned a 50 year old female. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced sore arm. On 20-APR-2021, the subject experienced very debilitating. On 20-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, and sore arm on 09-APR-2021, and had not recovered from headache, and very debilitating. This report was non-serious.
Debilitating, severe neck and shoulder pain the next day that continued for a week Stiff neck, spread to back pain Unable to work/left work early Still have stiff neck and feel strain doing my normal day-to-day tasks
Foggy Head about 30 minutes post vaccine. Very dizzy and off center that night and the entire next day - about 24 hours.  Was walking sideways at times Happening on and off since
Headache, intracranial pressure, nausea, joint pain, tingling in (arms, hand, legs), heavy arms, vertigo, light-headed.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm has been with excruciating pain ever since shot/ pain inside the arm/ it aches inside), PAIN (all the arm aching, and it got worse), INFLAMMATION (maybe there is inflammation inside?), INSOMNIA (waking up at night because of the pain/last night 4am she woke up and had to put ice) and NERVE INJURY (feels like nerve damage) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 039B21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in March 2021. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced PAIN (all the arm aching, and it got worse). On 15-Dec-2021, the patient experienced INSOMNIA (waking up at night because of the pain/last night 4am she woke up and had to put ice). In December 2021, the patient experienced PAIN IN EXTREMITY (left arm has been with excruciating pain ever since shot/ pain inside the arm/ it aches inside), INFLAMMATION (maybe there is inflammation inside?), NERVE INJURY (feels like nerve damage), MUSCLE TWITCHING (little twitches inside the arm from shoulder to elbow), PAIN (really painful), TENDERNESS (it was tender at first, but not now), FEELING ABNORMAL (felt tired and a little crappy for a day) and FATIGUE (felt tired). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. In December 2021, FEELING ABNORMAL (felt tired and a little crappy for a day) and FATIGUE (felt tired) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm has been with excruciating pain ever since shot/ pain inside the arm/ it aches inside), PAIN (all the arm aching, and it got worse), INFLAMMATION (maybe there is inflammation inside?), INSOMNIA (waking up at night because of the pain/last night 4am she woke up and had to put ice), NERVE INJURY (feels like nerve damage), MUSCLE TWITCHING (little twitches inside the arm from shoulder to elbow), PAIN (really painful) and TENDERNESS (it was tender at first, but not now) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication taken were birth control. For treatment patient used ice. Patient also reported that hot shower made it worse. Patient did not have headache. This case was linked to MOD-2021-426881, MOD-2021-426691, MOD-2021-426905 (Patient Link).
This case was reported by a pharmacist and described the occurrence of severe abdominal pain in a more than 65-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline) and an unspecified Influenza vaccine. Concurrent medical conditions included high blood pressure treated with unspecified blood pressure medication. Concurrent medications also included LASIX and RESTORIL. The reporter administered the 1st and 2nd doses of ENGERIX B adult to the subject in the past and no adverse event occurred. Historical vaccination included FLUARIX or FLULAVAL vaccinations (unspecified) and the subject did not experience any adverse event. On 17 September 2014, the subject received 3rd dose of ENGERIX B adult (unknown route and injection site, batch number not provided) and an unspecified dose of Influenza vaccine (unknown route and injection site). On 19 September 2014, 2 days after vaccination with ENGERIX B adult and Influenza vaccine, the subject experienced severe abdominal pain. On 20 September 2014, the subject was hospitalised. The hospital suspected that her liver enzymes would be high, but the results had not come back yet when the reporter spoke with the subject. At the time of reporting, the outcome of the event was unspecified.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75 years old female patient who received vaccine FLUZONE HIGH DOSE lot UJ030AB, expiry date:05-05-2019 via unknown route in the left deltoid on 03-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Vaccine underdose. It was reported that when removed the bandage it was saturated with liquid and not blood. She was concerned she didn't get the full vaccine dose. 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 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. Documents held by sender: none.