chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; a patient received VAXELIS and VAXNEUVANCE by mouth on 6/15/2023; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions or concomitant drugs were not reported.   On 15-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (1 dose, lot#: w036242, expiration date: 01-OCT-2024; strength was not provided) orally for prophylaxis and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) injection (1 dose, lot#: u7536aa, expiration date: 30-SEP-2025; strength was not provided) orally for prophylaxis (incorrect route of product administration). On 15-JUN-2023, the patient was also vaccinated with rotavirus vaccine live oral 1V (ROTARIX) (formulation, strength, indication, route of administration, lot#, and expiration date were not reported). No additional adverse events (AE) were reported (no adverse event).
Patient only received one COVID monovalent vaccine.  They were due for their second monovalent vaccine, but were given the bi-valent vaccine instead.  We found out when the patient returned to the pharmacy on 11/25/2022.  Patient did not have any adverse effects to the vaccine.  We reached out to Pfizer for directions.  They stated that at the moment, the patient is no eligible for any other COVID vaccines.
SHORTNESS OF BREATHING; FUZZY VISION IN RIGHT EYE; SORE NECK FROM RIGHT EAR DOWN TO COLLAR BONE; SEVERE SORENESS AT THE INJECTION SITE IN RIGHT ARM/CAN NOT MOVE ARM; SORE TEMPLES ON BOTH SIDES OF HEAD; This spontaneous report received from a patient concerned a 61 year old of unspecified 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 was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the subject experienced shortness of breathing. On JUL-2021, the subject experienced fuzzy vision in right eye. On JUL-2021, the subject experienced sore neck from right ear down to collar bone. On JUL-2021, the subject experienced severe soreness at the injection site in right arm/can not move arm. On JUL-2021, the subject experienced sore temples on both sides of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breathing, severe soreness at the injection site in right arm/can not move arm, fuzzy vision in right eye, sore neck from right ear down to collar bone, and sore temples on both sides of head. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
All over body hives that cannot be contributed to anything else (no changes in diet, perfume, detergents, etc.). The hives come and go. Have been on a 12-day prednisone taper. Taking Allegra and Benadryl to deal with the itch. Maybe the 3rd morning in, I felt as though I was having trouble breathing, and I took a double dose of Benadryl.
Large swelling, itchy red patch. Very painful. Developed quickly after injection and lasted for over a week. Patient used ice for swelling and hydrocortisone cream for itching.
Higher than normal resting pulse rate : 90-105 the entire day. Fever: 100.9 from roughly 4pm until 8pm, when it dropped down to 99.7.  Back to normal the next morning.
My granddaughter who is 30 years old had a very bad side effects from it. She was very sick; This is a spontaneous report from a contactable consumer or other non hcp (patient's grandmother). A 30-years-old female patient received first dose of bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very bad side effects from it. she was very sick on an unspecified date. The Outcome of event was unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
(R) deltoid swelling, redness and pain -fever up to 103 degrees - muscle/joint pain - hives - swollen lip.
Diarrhea, blurred vision, headaches (migraine), dizzy feeling, ore throat, body aches. All have lasted for more than one week.
he has a sinus infection and took an antibiotic (Augmentin); tested positive; tested positive; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable other healthcare professional (patient).  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of COVID-19 vaccine last 09Jan2021 and was going to receive the second dose on 30Jan2021. He was being tested in their facility twice a week for COVID-19. He mentioned that for those two consecutive tests, he said he was positive last Tuesday and was negative on Thursday. However, this Friday 15Jan2021, the patient was tested positive and had no symptoms. He asked if he can have the second dose of the vaccine as a booster shot since he was tested positive. He mentioned that he also had a sinus infection and took an antibiotic (Augmentin). Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 09Jan2021, and COVID-19 test positive on 15Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  The reported a sinus infection was more likely an intercurrent disease, and less likely causally related to the first dose of BNT162B2. The case will be reassessed should additional information become available.  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.
Starting on day 8, large golf ball size lymph node present under arm on in side of injection, (right).  Starting on Day 9, Rash and hotness around injection site.  Starting on Day 9, Small Rash on stomach
CHIEF COMPLAINT: Allergic reaction HISTORY OF PRESENT ILLNESS: Patient is a 43 year old female seen with complaints of the below issues. Patient received her employee influenza vaccination today and within 15 minutes, began to have severe itching of her face, sensation of facial swelling, itching of her upper body.  No history of allergic reaction to influenza vaccination.  Denies lip, tongue, or throat swelling.  No wheezing, nausea, vomiting, dizziness, or any other associated symptoms.  REVIEW OF SYSTEMS:  Has a history of asthma, but no fever or wheezing. ALLERGIES: Review of patient's allergies indicates no known allergies. PHYSICAL EXAM: BP 112/80 | Pulse 75 | Temp 97.8 °F (36.6 °C) | SpO2 99%   General:  No apparent distress and appears stated age.    Eyes:  The conjunctiva are non-injected with no lid edema.  Exam of the pupils are equally round and reactive to light.  The irides appear normal. Mouth & Throat:  Exam of the oropharynx reveals no erythema or exudates of the tongue, tonsils, and mucosa. Neck:  Symmetrical with no masses or thyromegaly.    Respiratory:  Assessment of respiratory effort reveals no use of accessory muscles.  Auscultation reveals no wheezing bilaterally. Cardiovascular:  Auscultation of the heart reveals a regular rate and rhythm with no audible murmurs.  Exam of the extremities reveals no edema. Lymphatic:  There is no lymphadenopathy of the head or cervical regions. Musculoskeletal:  The patient exhibits a normal gait and station with no clubbing or cyanosis of the digits. Psychiatric:  Normal mood and affect.  Answers questions appropriately.   Skin:  1 cm erythematous macular rash on left deltoid injection site where bandaid was placed, very faint erythematous rash on back of neck.   ASSESSMENT AND PLAN: Likely systemic reaction to influenza vaccination.  She was given Benadryl 25 mg and observed for one hour.  Only residual was slight chin itching.  Rash resolved.  Vitals stable.  Will have her off from work today.  Will likely need to skin test with influenza vaccination next year, and if negative, give in 2 doses, 10%, and if no reaction after 30 minutes, 90% of dose.  If any worsening, new, or concerning symptoms, seek medical help immediately.
As soon as I woke up, I read the Janssen pause news from my bed. I got up to go to the bathroom and upon finishing, I felt my heart rate skyrocket and felt faint. I immediately went back to the bed where I lost consciousness. My wife said my eyes were open and my body was rigid. I came too within a minute of that and was breathing heavy and sweating and very fatigued. My wife had called 911 as I was coming back to consciousness. The EMTs checked my vitals and all was normal. They asked if I wanted to go to the hospital, and I said no. My back was extremely sore all day, and I developed small red spots around my eyes. I went to my doctor later that day and told them about it. They took my blood for tests, which I have not heard back about, and they did not conclude anything, but did set me up with an appointment for an MRI of my head, given my past history.
Sore neck for 3 days now. Have tried getting ahold of somebody but am getting no responses to my calls. Have been getting text checks daily but still no call as requested.
Hives bp 112/74 pulse 82 o2 98% - cap benadryl 25mg given   patient recovered from symptoms after medicines . patient stated she had the same reaction from first dose.  -
Gave injection to patient sitting in chair at 11:07am.  Speaking to mother when 2-3 minutes later patient slumped over in chair headed towards wall and floor.  Ran over to her, picked her up with mother.  She was unconcious.  While carrying her to table she had a tonic clonic seizure with arched body for 3-4 seconds. Placed her on exam table on her left side. She regained conciousness almost as soon as we lay her down.  Appeared alert, asked what happened, said her arm really hurt.  Mother called 911 and resource officer notified.  Paramedics were parked outside and arrived within 2-3 minutes.  They did neuro exam.  Water and lollipop given to patient and she was able to leave clinic walking on her own after 10 minutes.  Father picked up mother and patient and they will take her to doctor office for f/u.  Store manager also aware.
Pain at Injection site; Slight headache; A sore injection arm that had inflamed to the size of a tennis ball.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (A sore injection arm that had inflamed to the size of a tennis ball.), VACCINATION SITE PAIN (Pain at Injection site) and HEADACHE (Slight headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced VACCINATION SITE INFLAMMATION (A sore injection arm that had inflamed to the size of a tennis ball.) and HEADACHE (Slight headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at Injection site). At the time of the report, VACCINATION SITE INFLAMMATION (A sore injection arm that had inflamed to the size of a tennis ball.), VACCINATION SITE PAIN (Pain at Injection site) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The patient was administered some expired FLUMIST QUADRIVALENT. Not reporting any symptoms. The patient experienced expired FLUMIST which started on 13-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Temp 100.7 oral, red raised lesions on abd, itching, vomiting. Tx sips of fluids. Tylenol PRN, to clinic if not resolved in 2-3 days
(L) arm started with swelling, quarter size hardness noted to (L) arm, swollen lymph node to (L) arm.
0.3 ML OF JNJ VACCINE ADMINISTERED AS BOOSTER OR THIRD DOSE AFTER TWO DOSES OF PFIZER VACCINE; OFF-LABEL USE; This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) .3 ml, start therapy date was not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced off-label use, and 0.3 ml of JNJ vaccine administered as booster or third dose after two doses of pfizer vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and 0.3 ml of JNJ vaccine administered as booster or third dose after two doses of pfizer vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211045143 and 20211045076.
Patient came down with cellulitis (Red, warm and swollen) on her Left Arm starting from the injection site but kept expanding until she went to urgent care clinic today.
LEFT RIB CAGE PAIN; MUSCLE TIGHTNESS; DIFFICULTY BREATHING; COUGH; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune hepatitis. The patient experienced drug allergy when treated with erythromycin, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:50 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced difficulty breathing. On 14-MAR-2021, the subject experienced left rib cage pain. On 14-MAR-2021, the subject experienced muscle tightness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left rib cage pain, and difficulty breathing, and the outcome of cough and muscle tightness was not reported. This report was non-serious.
Pt received TD & PNEUMOVAX on 11-9-10. She returned to clinic on 11-10-10 with redness and edema to right upper arm. Treatment of ice & BENADRYL until symptoms resolve.
CLOGGED EARS; SORE EVERYWHERE; HEADACHE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no history of drug abuse or illicit drug use. The patient was healthy and does not take any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-SEP-2021, the patient experienced clogged ears. On 01-SEP-2021, the patient experienced sore everywhere. On 01-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, clogged ears and sore everywhere was not reported. This report was non-serious.
After six days still in the afternoons and evening are feeling very fatigued/low energy with a slight headache.    It was purported to only cause 1-2 days of side effects; however, now almost a week after, still feeling them.   STRONGLY SUGGEST THE INFORMATION ON THIS VACCINE BE MODIFIED TO INCLUDE THAT SIDE EFFECTS MAY LAST A WEEK OR LONGER.    I keep up to date on all vaccines and NEVER have I had a reaction like this, somewhat blindsided by the experience, thus my first "adverse event" report filing.
Client left the clinic after receiving immunization.  Reports that after approximately 30-45 minutes her throat felt swollen and sore and her skin was flushing.  Patient was transported by ambulance to local hospital where she was treated for anaphylaxis per the patient.
Had some light headaches/ Headache; Herat was racing/ Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Herat was racing/ Heart racing) and HEADACHE (Had some light headaches/ Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2022, the patient started UPADACITINIB (RINVOQ) (Oral) 15 Tablet (15 Tablet, 1 in 1 D). In May 2022, the patient experienced PALPITATIONS (Herat was racing/ Heart racing). On an unknown date, the patient experienced HEADACHE (Had some light headaches/ Headache). At the time of the report, PALPITATIONS (Herat was racing/ Heart racing) had not resolved and HEADACHE (Had some light headaches/ Headache) outcome was unknown.            Relevant concomitant medications were not reported.  The patient reported that her heart was racing, like when drink too much caffeine. She took at 11 am and the racing did not stop until 3 pm. She had some light headaches.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality for the event of heart was racing and headaches with RINVOQ was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Approximately 10 minutes after receiving injection, patient reports feeling tightness in her throat. Benadryl 25mg po given & taken to ED via WC.
small patch in eye,diagnosed with Shingles; rash in forehead, scalp and back of the head; pain in scalp; pain in back of head, left forehead; This serious case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 06-MAR-2023, 3 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: small patch in eye,diagnosed with Shingles) (serious criteria GSK medically significant), rash (Verbatim: rash in forehead, scalp and back of the head), scalp pain (Verbatim: pain in scalp) and headache (Verbatim: pain in back of head, left forehead).  The outcome of the ophthalmic herpes zoster, rash, scalp pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, rash, scalp pain and headache to be related to Shingrix.     It was unknown if the company considered the ophthalmic herpes zoster, rash, scalp pain and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAR-2023 The case was self reported by the patient. The patient received first dose of Shingrix vaccine then on Monday she started with pain and rash in left side of forehead, scalp and back of the head. The patient reported that she was having a small patch in her left eye too and was diagnosed with shingles.  The reporter consented to follow up.
Pt said, "I have some stiffness/pain radiating up arm and across back of neck to left shoulder. I don't know if it is arthritis or shot".
Report 2001003631-1 describes pain in a female vaccinee of unspecified age who received LYMERIX. The information in this report is received via a journal article and has not been verified by a physician or other health care professional. In may 1999, the vaccinee received her second dose of LYMERIX. "Shortly after vaccination", the vaccinee began experiencing burning pain in her back, numbness in her arms, and aches and swelling in an ankle. "Just the thought of walking across the yard hurt me", said the vaccinee. By December, 1999, the pain was so intense, the vaccinee was considering reconstructive surgery for her ankle. As of 02/01/01, the outcome of the events in unknown. The adverse events of "numbness", "ankle pain", and "ankle swelling" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Pain from mid clavical to upper arm and warmth in Deltoid began 24 hours after injection, with crescendo for 24 hrs, then gradually decreased pain.  Decreased range of motion for 3 days due to pain, even passive movement was not tolerable on Day 1 of the reaction.  Temp 99.4 (oral).  Took 800 mg Ibuprofen twice daily for two days, applied ice.
Pt received both Pfizer COVID-19 vaccines on 1/27/2021 and 2/17/2021.  Pt reported a cough on 3/8/2021, around the same time her daughter was admitted inpatient for COVID-19 (had not received vaccine yet).  PCP tested her for COVID-19 via SARS-CoV-2 PCR on 3/8/2021 and it was positive.   Pt has only had mild symptoms thus far.
Pt recv vax on 10/15/98; on 10/16/98 pt exp swelling, erythema & tenderness at vax site; tx=Keflex; dx=cellulitis
EXTREME MUSCLE AND JOINT PAIN THROUGHOUT MY BODY DURING THE NIGHT AND INTO THE MORNING.