chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with doses of GARDASIL (route, lot number and expiration date were not provided). On unknown dates, there was an incorrect product storage as the multiple unspecified patients were administered improperly stored GARDASIL. No adverse events were reported. It was unknown if the patients sought medical attention. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
ROTATEQ #3 given on 5/19/08. On 6/10/08 pt diagnosed with intussusception. Treated at hospital. 7/23/08-records received for DOS 6/10/08-Presented with C/O irritability and intermittent crying since 3:00 am. Vomited. No bowel movement since 6/8/08. Subsequently had BM in hospital. PE: bowel sounds present. 7/23/08-DC records received for DOS 6/10-6/12/08-DC DX:Intussusception. Status post reduction of intussusception with air enema.
COVID POSITIVE BUT IT WAS NOT TOO BAD; 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, and batch number were not reported) 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 covid positive but it was not too bad. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid positive but it was not too bad was not reported. This report was non-serious.
Pt received injection from pharmacy on Wednesday evening - she developed rash around injection site - fever + chills. Today she came in and the redness and swelling was baseball size around injection site.
Started having itching all over and felt like throat was swelling shut beginning approximately 30 minutes after the vaccine was administered.
Child developed red swellings of both arms where she received vaccination 8/22/07. On exam, there were two 5 x 4 1/2 in red and slightly tender swelling on (Lt) arm and one 8x5mc on (Rt) arm.
Moderna COVID-19 Vaccine EUA. I received the 1st Moderna vaccine in my right arm Wednesday afternoon. Sunday morning I woke with a very tender, slightly swollen, lymph node in my right underarm. It was sore enough to prompt me to take Ibuprofen and nagged at me all day. I woke up with the same soreness Monday. Tuesday the lymph node was still a little swollen and tender to the touch but no longer sore to the point of requiring pain medication.
Patient just got the vaccine and was standing near pharmacy and fell to the ground.  On his way down he hit his head on the shelf and cut his head in 2 places.  When I got to him he was still out of it and within seconds he came to.  I had him stay laying down and he was very pale and sweaty.  We called 911 and they came within 5 minutes.  In that time frame I took his BP and pulse and it was low.  Ems took him to the hospital.
Fainted 10-15 minutes after receiving vaccines. Pt tried to get up and fainted again. After 30-45 minutes of observing pt, she was released. Pt's blood pressure, blood sugar and pulse all were normal.
Post vaccination reports tightness to throat, tingling in mouth w/ no respiratory symptoms or complaints reported / noted. Medical monitoring x 30 min w/vital assessment: BP 144/99 P85 RR 18 O2 sat 99%RA. Symptoms resolve post rest, monitoring, released from facility w/self.
I got hives sporadically on my body. My eyes got swollen and red and were itchy. My throat felt sore and scratchy, and then it felt as if there was a lump in my throat.  I felt heaviness in my chest, and I was wheezing.  I felt very tired and I was cold.  I didn't receive medical attention because in the morning the symptoms had alleviated.  I still had a little of heaviness on the chest, but it got better as the day progressed.
Mom reports on 8/30/14, child woke up with swollen bottom lip, hives and severe painful, erythematous, swollen knees. She was seen in ER, was given IV BENADRYL and steroids, and a breathing tx apophylactically. DC with MEDROL pack. All S & S resolved except knee swelling and pain after 3-4 hours.
Diagnosed with DITP (Drug Induced Thrombocytopenia) after urgent care visit & ER Visit.
Fever, chills, dizziness, muscle aches and pains, extreme fatigue. Treated with extra strength Acetaminophen. Symptom relief after 48 hours.
Angioedema, face swelling. Went to bed feeling fine and woke up with face swelling, mouth, throat and lips swelling. Delayed adverse reaction
Pt called 9/2 at 11:10 am notified me there is a blister about 3 inches from injection site. Pt came and recommended suggest comes to ER care for "redness about 2 inches and a blister. No trouble breathing going to follow up with urgent care.
After vaccination, had whole body pain, and swelling at the injection site. It's getting better. However, after 2 weeks I had very bad itches and red dots at the injection area. It spreads to whole arm and last more than 2 weeks.  I take Allergra, prednisone and benadryl with Cortisome cream. It does not work.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Oct2021 (Batch/Lot number: unknown) (at the age of 46-years) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension. Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 07Apr2021, when the patient was 46 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2), administration date: 19Apr2021, when the patient was 46 years old, for COVID-19 immunization, reaction(s): "fatigue", "I felt symptoms of flu", "I was feeling too low and after that subsided", "Inappropriate schedule of vaccine administered". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Experiencing like serious chronic fatigue"; PAIN (non-serious), outcome "unknown", described as "pain"; SLUGGISHNESS (non-serious), outcome "unknown", described as "It was really hard just getting that on my work day feeling really sluggish and fatigued". Additional information: Patient stated, I had a questionnaire for feedback after I took both vaccinations and also the booster and I wanted to report the feeling of chronic fatigue after taking the second Pfizer vaccine and also currently, the booster which I took on 20Oct2021 and I have been experiencing like serious chronic fatigue. My energy came back early July and that was when I was approved to take the booster. So, I just recently on 20Oct2021, I took it and from that I had the same I felt symptoms of flu symptoms I was feeling too low and after that subsided like the second one, I took and then after it, this lingering effect from it and there was a little bit of pain before the fatigue. So, like it was really hard just getting that on my workday feeling really sluggish and fatigued. Patient also stated that, "I do not have, I just know that it was the Pfizer vaccine, but I do not have my vaccine card in front of me and also stated "So, the first time, the first, initial were both in my left arm and the last one I just had in my right arm." Treatment: Patient stated, "No, I did not take any treatment. I only take Vitamins, I take one a day Vitamins previously before vaccinations and still after, that is the part of my everyday regimen to take my one a day, vitamins." The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101721037 same patient and drug, different event separated in time.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: bp was 105/78 and hr was 85
2 days after vaccine, she fainted and later contacted her PCP. Patient may have been dehydrated with headaches after vaccine. Advised to seek medical assistnace for ongoing issues.
Employee fainted and was incoherent approx. one hour after flu shot injection was given. On 12/12/2001- ER visit and on 12/13/2001-follow up Dr. office visit
vaccine given outside of protocol. I mis-interpreted protocol and gave 4th dose outside of age range
The night of the injection she had vomiting, nausea, chills and fatigue. The next day she developed a rash across her back and she took benedryl, throughout the day the rash spread to her stomach and chest and she continued benedryl. The following day the rash spread to her neck and arms and she took more benedryl. She saw her PCP on Friday and they recommended Pepcid, Benedryl and Claritin. The itching has subsided somewhat.
Developed rash from the waist down about 12-16 hours after receiving FluMist.  Also developed swelling in the feet and ankles the following day.  Child was having pain.
Day after she felt fatigued, hot cold chills, unwell  Sxs then began on 11/23 as follows: swollen, red, painful L arm, tachycardia (HR 130)
Swelling near the right hand wrist. It is like a round bump; This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01U1) via an unspecified route of administration in the left arm on 15Apr2021 at 16:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood pressure high. It was not known if the patient had known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included thyroid (MANUFACTURER UNKNOWN), metoprolol succinate 50 (units unspecified) (METZOK) and cilnidipine (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in left arm on 25Mar2021 at 16:45 (at the age of 52-years old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced swelling near the right hand wrist. It was like a round bump. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event swelling near the right hand wrist; it was like a round bump was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, Fever, ACHES & PAINES, CHILLS Narrative:
Urticaria 5-10min p/vax & PPD; rash on face & lt forearm; chest clear on auscultation; given .15cc Epi SC; rx: DPH elixir 1tsp qid x 3days; 10OCT91 f/u PC rash gone w/in 24 hrs; no problems;
began complaining of a sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CHILDREN'S MULTIVITAMIN. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 10Nov2021 14:30, outcome "recovering", described as "began complaining of a sore throat". Therapeutic measures were not taken as a result of oropharyngeal pain.  Additional information: The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any treatment for the adverse events.  No follow-up attempts are possible. No further information is expected.
immediate metallic taste in back of mouth ( reminded her of iron supplements she takes).  The next day felt pressure in chest like indigestion, but she says that happens frequently.
The pt experienced erythema multiforme - minor which began 6 days post vax.
Call from client reporting that he received his first Flu shot this morning and now he is having body aches, chills, head congestion, heart rate up to 86 and having a sore throat.  He reported he has a heart condition and that his heart rate is 20 beats higher than it usually is.  He has and internal defibrillator and was first instructed to call cardiologist and during conversation he said he had trouble swallowing and he was instructed to go to ED.
Patient returned to pharmacy tonight after having received a flu and shingles vaccine this morning.  She complained that her arm was very sore and that she could not move it very well.  Upon examination, it did appear that the bandaids were a little highup on her arm closer to her shoulder.  I advised her to take Ibuprofen and benadryl to help with pain and sleep.  She had stated she had taken Aleve with no result and had been applying heat to the site.  I advised her to switch to ice instead of heat.  I told her she could go to the emergency room if she wanted too, but that it was common for pain to occur after immunization.  I advised that if she was still having pain after 1-2 days that she should contact us as well as her primary care doctor to be seen.
Pt recvd MMR vax on 4APR91 & exp sl fever; on 17APR91 tested pos for pregnancy; No further details were provided;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (Lot number: EW0191) as dose 3 (booster), single, administration date 06Mar2021 (Lot number: EN6198) as dose 2, single and administration date 13Feb2021 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: got Covid, will call the doctor after this phone call to ask if they should be retested. The patient and his wife got both Covid shots and their boosters and they both still got Covid, but only his wife has symptoms. Follow-up attempts are completed. No further information is expected.
Little bit of dizziness at first (about 30 min later). 48 hours later, difficulty swallowing. Called the doctor - they treated me for dysphasia - some time of allergic reaction. Prednisone and Benadryl were prescribed. It's still ongoing - I'm still being evaluated at this time. I am going to see an allergist. I am still having difficulty swallowing - on and off.  (Note: Flu - vaccine - in December 2, 2020 - guessing at which one.)
Severe itching and burning in the palms of my hands, and started on the soles of my feet. Also had typical  side effects: chills, aches, fever, headache, tired, muscle pain, that subsided within 48 hours. Was given a dose of a liquid steroid and prednisone for five days.
Redness, swelling and hardness at left injection site. Injections were given @ 10:35 am. Pt seen in the clinic again at 15:15 pm. Treatment: Band-aid removed and ice pack applied.
I had no side effects from the vaccine, but 2 days later  I started getting a severe pain in my right groin area  that spread to the left side also by the next day. The pain was severe and I wasn't able to walk for two days and even now, 9 days later, it still is giving me some pain. I don't remember hurting myself and I have no idea if the vaccine has anything to do with what happened, but I was told to report it . I called my healthcare provider and they told me to call the health dept and the health dept told me to go online and fill out this form.
PT DEVELOPED RASH AND FEVER ON 11/22/06, ALSO WITH PHARYNGITIS AT TIME OF VISIT.
Patient received VARIVAX 5/16/2011. Patient started with red spot around injection site 5/17/2011. Redness and rash spread down arm. Tender to touch. Pain with raising arm. Warm to touch. Yellow scab at injection site.
10/06/21 Received Pfizer booster injection in my left arm around 0715. Went to bed 1000 and was awaken with severe pain at 1300. The pain was severe for the first 5 days like the previous Pfizer injections.  No relief with Motrin or Excedrine.  At this time I still have pain and it never has gone away. It's like a tooth ache and is much worse with movement.  Around 10/13/21 I noticed loss of range of motion and strength. That also has gotten worse. Examples of pain on movement: pulling up a blanket, moving out to the side, laying on left side and reaching back. I can only move it back half-way ROM . Sleep about 2-3 hours at a time. If I roll on that side, I wake up. The pain is at the top of shoulder, outer left & right side, and between the shoulder and neck area.
Acute Transverse Myelitis with AIDP in the setting of recent Covid vaccinating and possible bacterial meningitis's.   Patient is in the hospital.
A report has been received from a Health Professional concerning a 10 month old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 04-Mar-2014. It was reported that they gave FLUMIST QUADRIVALENT to a 10 month old. FLUMIST QUADRIVALENT (Intranasal) was discontinued on 04-Mar-2014. The outcome of the event of gave FLUMIST QUADRIVALENT to a 10 month old is unknown. The report was considered to be non-serious.
Increased fussiness, unconsolable crying for 2 hrs, vomiting, increased sleepiness, attempt to give Tylenol (vomited).
1 wk p/finishing Vivotif had rash in arm, trunk, leg & face; has had it last 4 days, but it is getting better;
Ear pain , muffle . Weird  sound Everything smell like metal and taste like metal My sweat smell is stronger .
an expired PENTACEL was inadvertently administered to a patient with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid non-serious case received via consumer.  This case involves a 1-year-old male patient and an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was inadvertently administered to a patient 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 pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation.  On 18-Oct-2023, the patient received an 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ804AA, expiry date: 07-Oct-2023) via intramuscular route in left thigh for immunization and an expired pentacel was inadvertently administered to a patient with no reported adverse event (expired product administered) (latency: same day).  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.
Pt had J&J vaccine in 04/2021. Began to have severe headaches in 08/2021 and on 12/7/21 presented to hospital w/ a very severe headache. CTA showed a venous sinus thrombosis, confirmed on MRI. Pt was also on hormonal birth control but had no other known risk factors for a clot.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a infant male patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX. Additional details: No AE was reported.
Severe cellulitis left upper arm. Erythema, warmth, swelling. Methylprednisolone 125mg IM & prednisone PO.
I had a stroke two months after vaccine. My right arm lost feeling and I called 911. Had CT and MRI testing done. The CT showed that I'd had a stroke. I was hospitalized for 2 days. Was prescribed Amlodipine.  I started going to Occupational Therapy. Having another MRI done as a checkup in October 2022.
received expired vaccine of Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine of Moderna COVID-19) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine of Moderna COVID-19). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine of Moderna COVID-19) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment medications were reported No adverse event for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received and updated the I narrative supplement.
Irregular heart beat - like afib - skipping 1 or 2 beats several times a minute.  I noticed it the morning after the shot. It still continues but not as often Also extremely fatigued