chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse was using the intradermal flu vaccine for the first time. The nurse experienced difficulty in dispersing the vaccine from the syringe. The patient was injected twice, but no actual fluid went into the patient. The patient was aware. The patient was called the next day and agreed to come in for a repeat injection as he did not recieve the vaccine the first two times.
Information has been received from a health professional concerning a female employee in her thirties, with no medical history, who on 2/22/05 was preparing a syringe with MMR and it splashed in her eyes. The patient's eyes were flushed with cool water and she was immediately seen by an eye doctor. It was reported that the patient's burning of the eyes persisted after 15 minutes of the incident. It was noted that there was no concomitant medication. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Patient felt dizzy, sweating, and rapid heart rate. We laid him on the floor picking up his feet which helped with his dizziness.  We had to call the ambulance because 30 minutes later he was still feeling this way.
Red rash like area where I received the injection. It's warm to the touch and itches a little. Still sore as well
Chills; Headache that felt like my head was going to explode.; Fever, temp of 101; severe joint and muscle pain; severe joint and muscle pain; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EN6202), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 16:00 (at the age of 80-year-old) as dose 2, single for COVID-19 immunization. Medical history included CAD (Coronary artery disease), GERD, inflammatory arthritis, allergies to penicillin and sulfa, and Covid-19. Concomitant medications included lisinopril (ZESTRIL); carvedilol; estradiol; pantoprazole. The patient previously received the first dose bnt162b2 administered in left arm on 04Feb2021 02:30 PM (Lot number: EL9264) as single dose for COVID-19 immunization. No other vaccine in four weeks. On 26Feb2021 at 05:00 AM, the patient experienced chills, fever, temp of 101, severe joint and muscle pain, headache that felt like my head was going to explode. The patient received no treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible.  No further information is expected.
Immunizations given and infant broke out with hives on chest, abdomen & legs as well as redness on right thigh injection site. No SOB noticed. Within 5 minutes redness & hives lightened HA. Infant sent to ER per recommendations of medical director.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 30-OCT-2015 the patient was vaccinated with the first dose of VAQTA (lot#/expiration date, dose and route were not reported). On 01-DEC-2015 the patient was vaccinated with the second dose of VAQTA (dose and route not reported, lot # reported as L009521 with expiration date 28-APR-2017), which was outside the recommendations per the prescribing information (inappropriate schedule of vaccine administration). No adverse effects were reported. Additional information has been requested.
Upon injection of the vaccine, safety mechanism for the syringe activated early expelling about 0.4 mL of the dose, approximately 0.1 mL was administered to the patient.
16 hrs p/inject pt had red, warm, swollen rt upper arm; tx discussed; 24 hrs p/inject t102 despite APAp therapy; mom had Pedi-Profen; pt vomited bld in emesis; seen by MD poss s.e. of pedi-profen
Dose discrepancy between the signed consent and the charting on patients Moderna booster. The signed paper work is noted that they received a booster shot which is a half dose, but the documentation in chart states they received a regular full dose. Can not guarantee or verify what dose was received but it is possible that instead of a half dose booster a full dose was received. No adverse effects or side effects noted.
Difficulty breathing, heart racing, legs and hands were shaking,  and he felt chills.
My heart was racing  I had shortness of breath  Chest felt heavy  I had body aches everywhere including my my private parts Cramps  Pain in my legs and inner thighs  I was shivering so bad  Difficulty walking  Very fatigue  I did manage to shower  Headache   Hard to sleep as I was then sweating through the night  All mentioned above happened within hours after getting vaccine. I am a single mom to two children so that itself was pretty frightening. I wish I would have known how bad it would affect me so I could have done laundry, dinner and all other chores before getting vaccine. I was blessed with family and my neighbor helping me feed my children and take them for a few hours. I honestly felt like I was going to die. 2 day was a bit better still felt very tired but managed to work ( I work from home). Third day still feeling bit shortness of breath and my energy only lasts for so long, definitely feel better than the first day but would have been helpful to know all above beforehand.
Flu swab tested positive for A strain; This is a spontaneous case, initially received from other health professional (nurse) via Company on 11-Feb-2020, concerning a 27-year old male patient.   The patient's current condition included asthma.   The patient's concomitant medications were not provided.   On 10-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0,5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261204 and expiration date: 26-Jun-2020] for influenza prophylaxis.    On 10-Feb-2020, the patient's flu swab was tested positive for A strain. The patient received Tamiflu (oseltamivir phosphate) as treatment medication.    At the time of this report, the outcome of the event was unknown.  The reporter did not provide causality assessment.  The event of flu' was assessed as serious due to criterion of medical significance, per company.  Company Comment: The event flu' was assessed as related to Flucelvax QIV.  Company comment: The patient developed Influenza after Flucelvax QIV was administered. Reportedly, four months after vaccination the patient's flu swab was tested positive for A strain. This is considered as lack of efficacy. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient developed Influenza after Flucelvax QIV was administered. Reportedly, four months after vaccination the patient's flu swab was tested positive for A strain. This is considered as lack of efficacy. Based on provided information, causal role of the suspect product is assessed as related.
Information has been received from a licensed practical nurse (L.P.N.) concerning a pediatric patient with no allergies, who on 29-MAY-2007 was vaccinated intramuscularly with a 0.5 milliliter dose of ProQuad (lot# 656312/0297U). Concomitant vaccinations included a dose of DTaP (unspecified) and a dose of poliovirus vaccine which were given in an alternate site. Subsequently, on an unspecified date following vaccination, the patient experienced nausea, fever and injection site swelling with redness and warmth, possibly cellulitis. Unspecified medical treatment was sought. It is reported that it is possible that the patient was treated with antibiotics. No laboratory or diagnostic tests were performed. The outcome is reported as recovering. No product quality complaint was involved. The reporter considered the patient's adverse experienced to be important medical events. Additional information has been requested.
On Saturday morning, I woke up with a red rash on the left side of my face. Throughout the day, the rash turned into itchy, blisters. I followed up with my primary care physician who diagnosed me with Shingles. Stating it could have been a correlation to the vaccine that compromised my immune system. I am on methyllpredinsone  and valacyclovir HCL.
Sore throat; This is a spontaneous report from a contactable Nurse (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 17Dec2020 06:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccines received in four weeks prior to Covid-19 vaccine. No Covid-19 prior vaccination. It was unknown if patient was tested for Covid-19 post vaccination. The patient was not pregnant at the time of vaccination. The patient experienced sore throat on 18Dec2020 05:00. No treatment was received for the adverse event. The event was non-serious. The outcome of the event was recovered on unspecified date in Dec2020.  Information on Lot/Batch number has been requested.
3x4 raised red hot oval shaped tender area at injection site; 3x4 raised red hot oval shaped tender area at injection site; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 07Apr2021 at 12:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included type 2 diabetes and high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and diltiazem (MANUFACTURER UNKNOWN); both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 17Mar2021 at 12:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. On 08Apr2021, the patient experienced "3x4" raised red hot oval shaped tender area at injection site which occurred on 1st day after 2nd vaccine. That was lasting and very slowly subsided over more than a week. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event "3x4" raised red hot oval shaped tender area at injection site was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Improperly stored temperature excursion; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 07-AUG-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot# S020160, expiration date 30-JUN-2021 ,for prophylaxis (strength, dose, route and frequency were not reported) and varicella virus vaccine live (Oka/Merck)(VARIVAX) lot# S038175, expiration date 26-NOV-2021, for prophylaxis (strength, dose, route and frequency were not reported).    The temperature excursion was of -50 Fahrenheit degrees (°F), time frame -6°F to 14 °F (10°F) for 1 hour and 15 minutes; 15°C to 46°F (44.8°F) for 1 hour and 30 minutes; 47°F to 77°F (50°F) for 2 hours and 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Cholestasis of pregnancy Diagnosed on 5/28/21.  Ursodiol  prescribed.  Induction scheduled for 6/4/21 (39 weeks 2 days).  Delivered baby girl at 39 wks 3 days via c-section.  She was 7lb 6oz at birth.
Knot - 1 inch on left leg. Rash started 5/6/00 on back-red. Rash started 5/10/00 on Abd. Knot is smaller.
Patient was in the 15 minute post-observation window and was scheduling his appt for second dose. Patient noted that he has a fear of needles and mentioned that he was feeling light-headed and experiencing tunnel vision..  He subsequently became diaphoretic and syncopal. He spontaneously recovered and was helped back into the chair. Did not fall to ground or hit his head. A SWAT was called. During SWAT evaluation, patient was given cool compress for neck and mentioned that this has happened before with injections. Subsequently had another syncopal episode and witnessed clonic seizure of roughly 25 seconds in duration. Patient again spontaneously recovered and was brought to the ED. the patient was unable to recall the events and has no history of seizure activity. Patient was given crackers and juice in ED and monitored for approximately 3 hours. Patient was discharged to home.
Vertigo that has not subsided for more than 1 week. Have never experienced it prior.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Cephalosporin and Penicillin. Concomitant medication(s) included: CITALOPRAM. Past drug history included: Cephalosporin, reaction(s): "Known allergies: Cephalosporin", notes: Known allergies: Cephalosporin and Penicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Warm bump at injection site; Red bump at injection site; Red bump at injection site; Prickly rash feeling on arm; Prickly rash feeling on arm; Bone pain; Achy feeling; Sore arm; Nerve pain; Not feeling great; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st November 2021, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site swelling, injection site erythema, tingling skin, prickly heat, bone pain, pain, pain in arm, nerve pain and feeling bad. On 4th November 2021, the outcome of the injection site warmth, injection site swelling, tingling skin, prickly heat and pain in arm were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the bone pain, pain, nerve pain and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site swelling, injection site erythema, tingling skin, prickly heat, bone pain, pain, pain in arm, nerve pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received the first dose of Shingrix vaccine and  within about 2 hours experienced warm red bump at injection site, prickly rash feeling on arm, bone pain, achy feeling, sore arm, nerve pain and just not felt great. The warm red bump, sore arm and prickly rash feeling had resolved on the day of reporting. The patient was still experiencing bone pain, achy feeling, nerve pain and not feeling great.   The patient asked if the second injection was required. The patient was referred to health care professional and advised Shingrix was a 2 dose vaccine.   No lot number or expiration date for vaccine was known. Patient declined to provide health care professional information. The reporter did not consent to follow-up.
About 3 minutes after vaccination, the patient started feeling very anxious and began rocking back and forth. She was also experiencing dizziness and blurry vision. She was lowered to the floor but wanted to remain in a sitting position. A couple minutes later she stated her fingers and arms up to her shoulders were numb/tingling. She was alert but was unsure if she was feeling the sensation in her throat as well. The pharmacist offered water to the patient and to call 911 as a precaution and both patient and boyfriend agreed. EMS arrived and assessed patient with vitals. All vitals were within normal limits. It was determined the patient was experiencing a panic attack and was instructed to continue to monitor for signs and symptoms and when to seek medical attention.
JNJ KNOCKED ME OUT FOR A WHOLE DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, 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 experienced JNJ knocked me out for a whole day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of JNJ knocked me out for a whole day was not reported. This report was non-serious. This case, involving the same patient is linked to 20211116367.
Recieved DtaP, Ipol, and MMR on 10/16/07.  On 10/17/07 developed redness, swelling, pain ,and itchiness.  Senn in our office on 10/18/07.  Diagnosised with L arm cellulitis secondary to immunization reaction.
Localized reaction from DTaP verses Hep B (same arm). Egg sized swelling with redness down to elbow-sleepy with 102 temp RT. Still has symptoms. late vaccine start, mom previously refused shots.
This spontaneous report as received from a Nurse refers to five patients of unknown age. On an unknown date the patients was vaccinated with ROTATEQ (lot# was not reported) which were improperly stored. No adverse events was reported. Additional information has been requested.
Left thigh swelling, redness; taken to emergency room 5-8-08. Told to use ice packs, Motrin.
I had giant sublingual glands; I noticed because one of my backteeth hurt and I looked in the mirror.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on an unknown date in Apr2021, (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient did not have allergies to medications, food, or other products. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On an unknown date in Apr2021 the patient experienced giant sublingual glands under the lower jaw of teeth and tongue and back teeth hurt (tooth ache). It was reported that within about 8 hours of getting the first dose the patient noticed about giant sublingual glands under his lower jaw teeth and tongue because one of his back teeth was hurt, when he looked in the mirror. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the events giant sublingual glands and toothache (back teeth hurt) were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
6/17/08 Pt c/o rash- Saturday 6/14/08 am. with itching to chest and over body for about 2 days "annoying" rash, then disappeared. Denies any shortness of breath, no fever or tongue swelling. Took a BENADRYL tablet x 1 dose and nothing else.
I got the single shot then I came down with the painful shingles/suspected vaccination failure; shingles; painful; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the 2 Shingles shots last year and then came down with the painful shingles, that lasted for several months. The patient did not wish it on anyone. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Intensely itchy hives and red skin.  Over the counter anti-histamines taken (loratadine, Benadryl)
Rash under injection site. Vomiting the evening of the injection. Abdominal pain so severe an ambulance was called and taken to the ER. Medication prescribed by ER doctor. Subsequent testing done 2 days later at urgent care for continued abdominal discomfort.
Nine days  after vaccine  ( today) arm began itching around injection site and when I felt it I found a hard knot about 1 1/2 around and  an itchy rash over about a 3 inch area around