chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; Got the shot didn't help a thing; 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 provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient reported that, Shingles vaccine did not help a thing and got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
pt recv vax 18APR96 & pt devel a rash p/exposure to natural varicella;
FEVER; FEELING VERY SICK OVER THE NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. 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: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced feeling very sick over the night. On 10-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and feeling very sick over the night. This report was non-serious.
Mild erythematous patchy rash that persisted since first injection with some flare associated with second injection.  HA that began 5-7 days after first injection and flared again following second injection and persists until now.  Chest heaviness, unclear date of onset, overall waning.  Fatigue, achiness.  All unresolved - second injection was 4/1/21.
The first dose on day 8 gave me pain, discomfort and inflammation in the  neck on the left side. At the time of administering the second dose of COVID-19 from Pfizer immediately, I began to feel some hot flashes in my chest that ran from the left side of my arm to the other side of my chest, my heart suddenly accelerated over and over again they are at rest, a sensation in the chest that rose to my throat. These episodes continued to occur throughout the afternoon, preventing my heart rate from lowering and allowing me to fall asleep. Since that day, October 22, 2021, they continue to give me episodes of the sensation in my chest that rises to my throat and my heart jumps faster. This gives me total rest and about to sleep or doing any activity.
pain in the arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient (approximately 170 pounds, 5'11) received bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm on 28Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced pain in the arm where he received the injection. The outcome of event was unknown.  Information on lot/batch number has been requested.
Vomiting & diarrhea. The vomiting lasted for about 5 minutes & resulted in 5 or 6 purges. Diarrhea lasted on & off until 09/02/2016. The only treatment given was Pedialyte.
Left arm injection site extremely painful when moved or touched. Put arm in sling to prevent extreme pain.
2:10pm, after receiving the injection, patient felt dizzy upon standing.  Gave her a tangerine and water.   Sat down and felt hot, naseous, tightness inside body.  2:45 headache behind left eye and mouth tastes like medicine.    BP 150/80, O2 100%, HR64 RR28.  After an hour of resting, laying down, meditating, patient felt a little better, but still bad.  BP120/72, O2 100%, HR 88.  Patient left with a friend at 3:35.
Slight Headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Slight Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Slight Headache). At the time of the report, HEADACHE (Slight Headache) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment medication details were reported.   This case was linked to MOD-2021-407825, MOD-2021-407826 (Patient Link).
3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on chest, abdomen right trunk resolved within 6 hrs. 9:00 PM chills, body aches, nausea  resolved within 48 hrs 1:50 AM. Diarrhea resolved within 12 hours 2:00 AM. Vomiting multiple times resolved within 30 minutes
This case was reported by a healthcare professional and described the occurrence of wrong vaccine administered in multiple subjects of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline). On an unspecified date, multiple subjects received unspecified dose of KINRIX (.5 ml, unknown route and injection site; lot number not provided) DTaP/IPV or KINRIX were given for the fourth dose of DTaP. She thinks nurses need education and come from one job to another and don't keep trakc, so they just give 5 doses of DTaP and 5 doses of IPV or the primary series and KINRIX for the 4th and 5th doses. The subjects experienced wrong vaccine administered and inapprorpriate schedule of vaccine administered. This was 1 of the 3 cases receievd from the same reporter.
Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Severe, Additional Details: Post vaccine: 2 min after the vaccine pt reports that she is not feeling well. Pt transferred to the exam table safely. Pt lost consciousness, became apneic, and carotid pulse not palpable. Two chest compressions were given and pt gained her consciousness. 911 activated. Pt returned to normal state and denies any s/s. Pt reports that she was scared of the needle and that she had mild pain in her injection site and she panicked. She reports that she has had multiple similar events in the past.
LOOKING ROUGH; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnic origin.  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 (Janssen series 1) (suspension for injection, route of admin, batch number: unknown and expiry date: unknown) dose not reported,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was looking rough, and was hospitalized (date unspecified). Consumer reported that patient still in hospital, nine weeks, still looking rough. Number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from looking rough. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211230904-Covid-19 vaccine ad26.cov2.s  Looking rough. This event(s) is labeled per RSI and is therefore considered potentially related.
Within 10 seconds of getting the shot, my throat started burning badly. My body had a flushed feeling and my heart started racing. A time later, I started getting a bitter, metal taste in my mouth. It is nine days past my shot date. I still get a little burning or tingling in my tongue sporadically, along with the bitter, metal taste and extra salivation. Some days are worse than others. Today - day 9 - I tasted it all day.
Pt experienced shortness of breath, fatigue, nausea, tightness of chest and overall sick feeling for 1 week.
9-10 days post vax the pt developed generalized chickenpox outbreak and fever. 5 days post onset the pts lesions dried up. His fever lasted 2 days. The pt sought unspecified medical attention. No further information is available.
Patient was contacted twice and  no reactions or complaints were voiced. Advised patient wait for second dose on or after 18th birthday.
Pt received the vaccine and had a breakout inside the mouth. 5-6 pronounced bumps that appeared on the same side as the injection and they lasted for a few hours and they just went away.
Muscle pain, stomach pain, nausea, high blood pressure -205/105, ringing in the ears, headaches, weak.
The patient did not develop any adverse reactions. It was error in administration by age. Only adverse reaction is marked, because it is a mandatory field.
Patient received two immunizations on 11/08/13. A Td in the left deltoid and adult Hep B  in the right deltoid. On the morning of 11/09/13, patient reports having joint pain, then swelling of her arm from elbow to shoulder with redness and warmth. Went to ER on 11/10/13. Diagnosed with cellulitis and given 2 antibiotics and Naproxen.
Right deltoid and large, red, raised, painful area on deltoid and fever. PREDNISONE 20 MG QWEEK, CETIRIZINE 10 MG QWEEK.
Injection was standard. Typical side effects occurred 12 hours after but nothing unusual. Heart symptoms a month or two after.
covid vaccine breakthrough case  dose 1 moderna 2/23/21  023M20A
21OCT98 took very hot shower today, @ the end of which felt lightheaded, dizzy & broke out in cold sweat;also noticed a hugh red spot on rt upper arm today;hard knot w/mild tenderness;
This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 15-SEP-2016, the patient was vaccinated with M-M-R II (lot number: M004305), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
Information has been received from a physician concerning 5 to 8 patients who in the past 6 to 12 moths were vaccinated with RECOMBIVAX HB three dose series but did not seroconvert. Their titers are negative. The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information has been requested.
Started feeling chest pain and heart rate elevated. Hard time sleeping, breathing a bit more labored. Went to the cardiologist yesterday and he said I have pericarditis.
Psychosis, short term memory loss, loss of appitite, fatigue Lasted 4 days ( until I got 1/2 my b1 infusion)
In 4 hrs - fever, aching. 12 hrs later - fever, arm swollen, upper joints ached, chills. 3 days later - fever, chills, fatigue, nauseous, both arms and elbows ache, dizzy. Starting to improve.
hives/hives were mostly concentrated on the arm where he got the shot; This is a spontaneous report from a contactable consumer(patient). A 52-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the right arm on 24Jun2021 (at the age of 52-years-old) at single dose for covid-19 immunization. The patient medical history included diabetes and schizophrenia. The patient's concomitant medications included metformin, glipizide, enapril maleate (ENALAPRIL), atorvastatin, risperidone. The patient previously received pneumonia and flu shot last month in May2021 (at the age of 52-years-old) for immunization. The patient wanted to know if hives were among the reported adverse events after getting the Pfizer BioNTech Covid-19 Vaccine. The patient started experiencing hives on 24Jun2021, the hives went away for a while but came back. He stated that the hives were mostly concentrated on the arm where he got the shot. The patient got the vaccine on 24Jun2021 and he broke out in hives. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Red swollen site 3 inches in diameter with a red ring around it and it itched.
I have got a prolonged shoulder pain and stiffness after the 2nd dose. It started in about one week and last until now or about 3 months. I cannot move my left arm and shoulder as wide as normal, otherwise it would cause a pain. It is slowly improving but not back to normal yet in over 3 months.
pt recv vax 3JUN97 & 16JUN97 pt devel several lesions on abd & a fever of 104;
starting February 5, I had mild swelling in the entire left leg treated with ice and anti-inflammatories. There was no redness, swelling, or pain at injection site. Symptoms seemed to be slowly subsiding. However, Thursday 2/11/21, I had a small patch of itchy, (but not painful) red rash on back of left thigh. By Thursday evening it had doubled in size. Friday am (2/12/21) it was a little bigger still. Then by Friday after work, my entire left leg was moderate to severely swollen and the rash covered a large part of the back of right thigh and was beginning to spread to the back of left calf.  Friday evening, I visited Urgent Care. The doctor there was concerned about a possible DVT and sent me to the ER. At ER, an ultrasound revealed no DVT. At no time did I have a fever. The ER doctor admitted me to the hospital where I remained until the afternoon of Monday, February 15. During hospital stay, I was treated with IV Vancomycin twice per day. That helped quite a bit to reduce rash and swelling but it remains at a mild level. I am currently Doxycycline Hyclate 100 mg every 12 hours for 7 days. I took the first dose of the oral med at the hospital on the day of discharge.
Onset of chronic Sinus Rhythm with Supraventricular Ectopy with chest tightness and respiratory difficulty immediatey 5 minutes after the first Covid vaccine dose; Onset of chronic Sinus Rhythm with Supraventricular Ectopy with chest tightness and respiratory difficulty immediatey 5 minutes after the first Covid vaccine dose; Onset of chronic Sinus Rhythm with Supraventricular Ectopy with chest tightness and respiratory difficulty immediatey 5 minutes after the first Covid vaccine dose; This is a spontaneous report from a contactable other healthcare professional. A 52-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 12Mar2021 13:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included neuropathy peripheral from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, DCIS stage 0 (breast cancer) from an unknown date and unknown if ongoing. Concomitant medications included (TETANUS DIPTHERIA) taken for an unspecified indication from 20Mar2021 to 20Mar2021; duloxetine hydrochloride (CYMBALTA) and baclofen (BACLOFEN) taken for an unspecified indication, start and stop date were not reported. Patient received any other vaccinations prior to vaccination within 4 weeks. Patient received Cymbalta and Baclofen with in 2weeks prior to vaccination. Patient had no allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. On 12Mar2021 13:15 the patient experienced onset of chronic sinus rhythm with supraventricular ectopy with chest tightness and respiratory difficulty immediately 5 minutes after the first covid vaccine dose. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included heart monitor and diagnosis and DBT treatment. Respiratory difficulty and chest tightness persisted for two weeks. Chronic Sinus Rhythm with Supraventricular Ectopy continues to persist to date. The outcome of the events Supraventricular extra systoles, Chest discomfort, Dyspnoea was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Pain, Redness and swelling left upper, lateral and anterior arm beginning evening of administration. The area involved is where Tdap administered. MMR given posterior left posterior upper arm, without symptoms. Pain and swelling worsened over course of week. Neck stiffness, mild, beginning 4/4/18. No difficulty swallowing or breathing.
fatigue/felt very tired; muscle weakness/legs were weak; This is a spontaneous report from a contactable consumer or other non hcp. An elderly female patient received BNT162B2((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on unspecified site at 11:00 on 04Feb2021 as single dose for COVID-19 immunization. Medical history included hyperthyroidism and hypertension. Concomitant medications included lisinopril, levothyroxine sodium, trazodone. On 04Feb2021, the patient experienced fatigue and muscle weakness. The outcome of event was recovered on unspecified date on 2021.  Follow-up (10Feb2021): New information included that the patient received the Pfizer vaccine approximately 11 am on 04Feb and later in the day (approximately 6 pm)  and she felt very tired and her legs were weak.  Follow-up attempts are completed. No further information is expected.
7 days after the vaccine the site became itchy and a welt about 3 inches in diameter an medium pink in color appear at the injection site. . I have a photo of this  on her arm.
Vaccination during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3005243) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) had resolved. Not Provided          Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter. grav in hebd 12+0   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2022: Translation received on 11-Jan-2022, Contains no new information.
no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 31-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Approx 4-5 hours post injection to (R) deltoid developed pain which increased to the point where limited range of motion increased with severe pain.
Patient reported red, uncomfortable, slightly swollen left arm to myself Mon, Dec 12TH.  Discomfort was relieved with cold packs and rest.
1 day p/vax pt devel inj site rxn of cellulitis. This is 1 of 5 pt to exp rxn w/lot #449578
Swollen, redness, hot to the touch at injection site. Headache, runny and stuffy nose, pressure in head mainly around eyes and forehead.
IPOL vaccine was given 2 days after being drawn into a syringe and stored in appropriate temperature with no reported adverse event; Initial information received on 30-Aug-2023 regarding an unsolicited valid non-serious case received via physician.  This case involves a 20 (age units not specified)and unknown gender patient, IPV (VERO) [Ipol] vaccine was given 2 days after being drawn into a syringe and stored in appropriate temperature with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 30-Aug-2023, the patient received a 0.5 ml dose of suspect IPV (VERO) suspension for injection (strength, expiry date: unknown) (lot: V1B891M) via intramuscular route in unknown administration site for immunization and ipol vaccine was given 2 days after being drawn into a syringe and stored in appropriate temperature with no reported adverse event (poor quality product administered) (latency: same day).  Action taken with poliomyelitis vaccine (Inactivated) (Ipol) was not applicable.  Outcome: unknown   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.
Body Ache and fatigue began the afternoon of 12/26. Body ache intensity increased on 12/27. Loss of sense of smell became apparent on the afternoon of 12/27.